Session 3: Requirements for Registration and Licensing of Premises for Pharmacy Business

Total Session Time: 120 minutes

Prerequisites

· Session 1

Learning Tasks

By the end of this session students are expected to be able to:

· Define important terms

· Identify sections in the Acts relating to registration and licensing of premises for Pharmacy business

· Explain sections in the Acts relating to registration and licensing of premises for Pharmacy business

· Explain requirements for registration of premises for pharmacy business.

· Explain requirements for licensing of premises for pharmacy business

· Describe procedures for application for approval of location, registration of premises and permits prior to operate the business of pharmacy.

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Handout 3.1 – 3.6 Application forms and Inspections checklists

· The Pharmacy Act, 2011 and The Pharmacy Regulations, 2012

· Computer

· LCD Projector

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Presentation of Session Title and Learning tasks
2	10 minutes	Presentation Buzzing	Identification of Sections in the Acts relating to Registration and Licensing of Premises for Pharmacy Business
3	15 minutes	Presentation	Explanation of Sections in the Acts relating to Registration and Licensing of Premises for Pharmacy Business
4	30 minutes	Presentation	Requirements for Registration of Premises for Pharmacy Business
5	10 minutes	Presentation	Requirements for Licensing of Premises for Pharmacy Business
6	20 minutes	Presentation	Procedures for Application for Approval of Location, Registration of Premises and Permits prior to operate the Business of Pharmacy
7	10 minutes	Presentation	Application forms and Inspection Check Lists
8	10 minutes	Presentation	Key Points
9	10 minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Important Terms (10 minutes)

Activity: Brainstorming (5 minutes)

ASK students to brainstorm on the following question:

o What is the meaning of each of the following terms: business of a pharmacy, pharmacy, pharmacy practice, premises, retail pharmacy business, superintendent, wholesale pharmacy, and wholesaler?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMERIZE by using the content bellow

· Definitions:

o Business of a pharmacy: includes professional pharmacy practice and any activity carried on by a person in relation to medicines, medical device or herbal medicines.

o BRELA: Business Registrations and Licensing Agency mandated to register companies, business names and intellectual property rights such as patents of inventions, industrial designs, trade and service marks and issue industrial licenses.

o Council: means the Council established under section 3 of the Pharmacy Act 2011

o Dispense: means supply of medicines or medicinal products in accordance with a prescription lawfully given by a medical practitioners

o Inspector: means an Inspector appointed, authorized or recognized as such under the Act

o Pharmacy: means any approved premises wherein or from which any service pertaining to practice of a pharmacist is provided, and shall include a community pharmacy, consultant pharmacy, institutional pharmacy, or wholesale pharmacy.

o Pharmacy practice: means any acts pertaining to the scope of practice of a pharmacist, pharmaceutical technician or pharmaceutical assistant as approved by the Council.

o Premises: includes a land, building, structure, basements and a vessel and in relation to any building includes a part of a building any cartilage, forecourt or yard, and in relation to a vessel includes a ship, boat, air craft, and a carriage or receptacle of any kind, whether open or closed or place of storage used in connection with any service pertaining to practice of a pharmacist.

o Registrar: means the Registrar of the Council appointed under section 12 of the Act.

o Retail pharmacy business: includes the retail sale of medicines products but does not include a professional practice carried by a medical practitioner or veterinarian.

o Sell: means sell by wholesale or retail and include import, offer, advertise, keep, expose display, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale or prepare or posses for the purpose of sale and barter or exchange supply or dispose of to any person whether for a consideration or otherwise.

o Superintendent: means a Pharmacist In-Charge who supervises a pharmacy and is registered as such by the Council under this Act(Pharmacy Act,2011);

o Wholesale Pharmacy: means a pharmacy that buys medicines, medical devices or cosmetics from importers and sell in bulk to retail pharmacy;

o Warehouse/ godown- a building for storage of pharmaceutical products;

o Wholesaler: means a person who buys medicine, medical devices or cosmetics from importers or local manufacturers and sells in bulk to the retailer

STEP 3: Identification of Sections in the Acts relating to Registration and Licensing of Premises for Pharmacy Business (10 minutes)

Activity: Buzzing (5 minutes)

PROVIDE students with the Pharmacy Act 2011 and Pharmacy Practice Regulations 2012

ASK students to pair up and buzz on the following question for 5 minutes

o What sections relate to registration and licensing of premises for pharmacy business?

ALLOW few pairs to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMERIZE by using the content bellow

The following are sections that relate to registration of premises for pharmacy business:

· Section 34, Pharmacy Act, 2011; states the registration of premises

· Section 36 of the pharmacy act 2011 states the application of permits

· Section 18, Pharmacy Practice Regulations 2012, states conditions for establishment and operation of a pharmacy

· Section 20, Pharmacy Practice Regulations 2012, states application for pharmacy registration

· Section 21, Pharmacy Practice Regulations 2012, states registration of a pharmacy

· Section 27, Pharmacy Practice Regulations 2012, states categories of registers.

STEP 4: Explanation of Sections in the Acts relating to Registration and Licensing of Premises for Pharmacy Business (15 minutes)

Explanation of sections:

· Section 34 of the Pharmacy Act 2011stipulates requirements for Registration of premises dealing in pharmaceutical businesses as prerequisite. The legislation prohibits the use of any premises for dispense, sale, sell, supply or storage of pharmaceuticals unless the premises has been registered by the Pharmacy Council for that purpose. This section states the following:

o A person shall not sell, dispense or supply medicinal products except in premises registered under this Act.

o An application for registration or renewal of registration of premises shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Council may prescribe.

o The Registrar or any person in his behalf shall-

§ keep a register of all premises registered under this section;

§ register premises if he is satisfied that the requirements to be complied with by the applicant as prescribed by the Council from time to time have been complied with; or

§ have powers to approve the location and name of the proposed premises.

o The Council may, for good cause, refuse to register or cause to be removed from the register, any premises which is or has become unsuitable for purposes for which they were registered.

o A person who contravenes the provisions of subsection (1) commits an offence and upon conviction shall be liable to a fine not exceeding ten million shillings or imprisonment for a term not exceeding two years or to both.

· Section 36 of the Pharmacy Act 2011 requires all dealers in such business to apply to the Council for permits and obtain such permits before starting operation. It also prescribes terms and conditions that must be adhered during the application for the registration and permits. This section states:

o A person shall not sell, dispense or supply medicinal products unless he has obtained a permit issued under this Act.

o An application for a permit shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Minister may prescribe.

o The Council shall not issue a permit to sell medicines and related medical supplies under this section unless the Council is satisfied

§ that the premises in respect of which the application relates shall be stored, meets the prescribed standards;

§ that the equipment are available for storing the medicines and related medical supplies;

§ with the suitability of the equipment and facilities which are used for distributing the medicines and related medical supplies; and

§ with the arrangements made or to be made for securing the safe keeping, and the maintenance of adequate records in respect of medicines and related medical supplies stored in or distributed from those premises.

o A separate permit under this section shall be required in respect of each set of premises in which the business is carried on

· Section 37, sub section 1 of the pharmacy act states types of permits

o The Registrar shall, subject to sub section (2) and upon an application made to, and on approval by the Council, issue the following pharmacy permits for-

§ retail;

§ distribution;

§ institutional; or

§ any other business as the Council may deem fit for the purpose of this Act.

o Where the Council is satisfied that the applicant is a fit and proper person to carryon type of business set out in subsection (1) and the premises in which the business is to be conducted meets the prescribed standards, it shall, issue a permit appropriate to such business subject to such general or special conditions as the Council may consider to be appropriate to impose.

o A permit issued under subsection (1) shall be in the form and manner as set out in the regulations made under this Act.

o Where the Council considers that the applicant is not fit and proper person to be issued with a permit to carry on any business specified under this section it shall refuse to issue the permit, as the case maybe.

· Section 18 of the pharmacy practice regulations 2012 states the conditions for establishment and operation of a pharmacy:

o A person shall not establish and operate a business of a pharmacist unless the premise is registered in accordance with the Act.

o A premise registered under these regulations shall be required to comply with the good pharmacy practice and registration guidelines of a business of a pharmacist

o There shall be a separate application and registration of each premises intended for use as pharmacy as shall be prescribed by the council in the registration guidelines.

o Each registered premises for establishment of a pharmacy shall be issued with a registration certificate which is non transferable.

· Section 20 of the Pharmacy (Pharmacy Practice) regulations, 2012 prescribes terms and conditions that must be adhered during the application for the registration and permits.

o Any person requiring to operate a business of a pharmacist under these regulations shall be required to submit a duly completed application form to the Registrar accompanied:

§ A copy of any lease agreement, sub-lease agreement or other agreement in terms of which the applicant has the right to occupy the proposed pharmacy premises;

§ If the owner of the premises, submit a certified copy of the title deed or similar document evidencing his right to ownership of such premises;

§ A copy of site plan of the roof and floor plan of the building, if applicable, indicating the location of the pharmacy premises in relation to adjoining or surrounding businesses and access to and from such premises a copy of the plan layout of the actual pharmacy premises;

§ In case the applicant is a partnership, a copy of the partnership agreement, stating the name of the pharmacist designated to accept responsibility for the duties as superintendent as prescribed under these Regulations;

§ An application fee prescribed by the Council; and

§ Any other information as may be requested by the Council.

o The notwithstanding the provisions of these Regulations, every application made under these regulations shall be required to comply with all the requirements prescribed by the Council in the registration guidelines and good pharmacy practice of a business of a pharmacist.

o The Council shall inspect or cause an inspection of the proposed pharmacy premises, if found to satisfy with the requirements, the application shall be accepted, if found unsuitable, the application shall be deferred or rejected with reasons in writing.

· Section 21 of the pharmacy practice regulations 2012 states registration of a pharmacy

o The Registrar shall:

§ If satisfied that the application complies with the requirement for registration as prescribed by the Council of register such pharmacy or;

§ If not satisfied that the application with the requirement of these Regulations or the Act submits the application to the Council for consideration. The council may:

(i) refuse to register the pharmacy in the manner prescribed under the Act;

(ii) Register the pharmacy subject to such conditions as it may deem fit; or

(iii) Register such pharmacy

· Section 27 of the pharmacy practice regulations 2012 states the categories of registers:

o For purposes of registration of pharmacies in terms of these regulations, there shall be the following categories of pharmacies:-

§ Community pharmacy;

§ Wholesale pharmacy;

§ Institutional pharmacy;

§ Consultant pharmacy;

§ Manufacturing pharmacy; and

§ Any other premises registered under the Act

STEP 5: Requirements for Registration of Premises for Pharmacy Business (30 minutes)

· Types of premises/pharmacies: premises registered under section 34 of the Pharmacy Act and 27 of the pharmacy practice regulations:

o Retail pharmacy

o Wholesale (distribution) pharmacy

o Institutional pharmacy

o Medical devices shops

o Vessel/ motor vehicles carrying medicines

o Consultant pharmacy

· Location:

o Registration of premises for retail pharmacy shall be given if it is at least 300 meters away from the existing retail pharmacy to encourage fair distribution of services closer to the community. However, the Council shall have power to review this requirement from time to time basing on the service need by the community and population increase especially in cities and municipal centres.

o For wholesale business distance between existing wholesale and retail pharmacies is not considered.

o The premises shall be located away from sites or activities that emit obnoxious materials like fuel fumes/fumes and contaminants, open sewerage, or any other place as the Council may deem unfit for the business to be carried out.

o Premises located within shopping centers such as malls, supermarkets shall be confined and restricted from other activities conducted therein.

o The premises shall be designed such that, it shall have no direct link to building with bar, garage, restaurant, medical laboratories, dispensary, clinics or in direct link to residential houses where the business is housed.

o The premises should have a postal address and physical address of the premises to include plot and house number, street/hamlet, district and region where the business is to be carried out, clearly indicated in the application form for easy communication and reach during supervision and inspection.

o The premises should have a signboard conspicuously displayed and the pharmacy identification logo displayed at the main entrance.

· Premise design:

o The premises shall be durable, safe and made of permanent building materials so as to protect pharmaceuticals from potential harmful influences.

o The premises shall be roofed with corrugated iron sheets, concrete slabs or tiles and shall have the floor minimally made up of terrazzo, tiles or any other hard washable surfaces.

o The premises shall be designed and equipped so as to provide protection against rodents, birds, vermin or any destructives insects or animals.

o The rooms shall be painted with white/creamy washable paint with smooth washable finishing.

o The surrounding should be maintained so as to minimise dust, soil and other contamination to enter the building.

o Sufficient lighting and ventilation shall be provided to enable all operation to be carried out.

o Premises should be sufficiently secured to prevent theft and unauthorised entry and a “NO SMOKING” sign should be conspicuously displayed at the entrance.

o The premises shall be provided with suitable equipment and facilities for proper storage, safety keeping and handling of pharmaceuticals.

o In retail outlets where compounding of extemporaneous preparations is taking place there shall be availability of simple dispensing equipment like balances, mortar and pestle, measuring cylinder and a sink in the dispensing area.

o In Premises providing human and veterinary Medicines, separate displaying shelves and storage cabinets shall be provided for each category.

o Premises dealing with pharmaceutical products shall not stock in the same registered premises chemicals or pesticides used exclusively for plant protections.

o Premises shall have separate secured cabinets with lock and key for keeping controlled Medicines (Schedule I medicines).

o Approval of storeroom located within the pharmacy or warehouse at mezzanine or underground shall be subject to adherence to other premises requirements including provision of sufficient light, air conditioning facilities

· Premises layout:

o Retail premises

§ Retail Pharmacy must have a minimum of three rooms with clear demarcation and linked to each other for displaying, dispensing and storerooms. The premises must have one main secured entrance and where applicable an emergency rear door.

§ The minimum total size/ area of the premises shall at least measure 25 m². The rooms should have not less than 2.5m internal heights.

§ The rooms should be equipped as indicated in the inspection checklist with adequate shelves or pallets as the case may be for proper display and storage of medicines respectively.

§ For the retail pharmacies that plan to offer other services approved by the Council, shall get approval from Council, must have extra separate rooms and must comply with standards stipulated for the provision of such services.

o Distribution (Wholesale) Premises

§ Wholesale pharmacy shall have not less than three rooms with clear demarcation and linked to each other for display, receiving and dispatch, record keeping and storage. The premises must have one main secured entrance.

§ The premises shall have a minimum total size/ area of at least 40m^2. The rooms should have not less than 2.5m internal heights.

§ The rooms should be equipped with adequate shelves and pallets for proper display and storage of medicines as indicated in the inspection checklist.

o Retail and Distribution (Wholesale) Premises

§ Premises for both retail and wholesale business are professionally not encouraged. These premises shall be given permit depending on circumstances

§ Premises for both retail and wholesale business shall have at least three rooms namely; display, receiving and dispatch room; sales, record keeping and dispensing room; and the storage room.

§ The minimum total size/ area of the premises shall at least measure 60m2. The rooms should have not less than 2.5 m internal height with clear demarcation/partition for retail and wholesale business.

§ The rooms should be equipped as indicated in the inspection checklist with adequate shelves and pallets for proper display and storage of medicines respectively.

§ A clear demarcation of wholesale receiving/dispatch area from the retail part shall be provided to allow orderly receipt/dispatch of pharmaceuticals in bulk.

§ There should be a separate entrance doors for retail and wholesale business.

o Warehouse Premises

§ Warehouses shall be designed and constructed to ensure good storage conditions, sufficient lighting and ventilation.

§ Warehouses shall have sufficient capacity to allow storage of various categories of pharmaceutical products.

§ The floor shall be durable to withstand heavy traffic and loads, easy to clean; the premises shall be provided with well-fitted shelves or pallets.

§ The premises shall be equipped with temperature and humidity control facilities/monitors and fire extinguishers. The required temperature storage condition shall be below 25 centigrade and daily records should be kept within the warehouse. In case different temperature and humidity conditions are used, these need to be justified.

§ A wall thermometer should be available

§ A residential home shall not be used as a warehouse.

§ Warehouse shall only be used for storage purposes and no sells shall be allowed

o vehicle for carriage or transportation of pharmaceuticals

§ All vehicles for carriage or transportation of Pharmaceuticals shall be approved by the Council

§ Application for permit shall be made in prescribed forms (annex?)

§ Vehicles for carriage or transportation of pharmaceuticals shall be of light colour and easily cleaned. It shall be dust proof, ventilated, water tight, covered to prevent direct sunlight and provided with special facilities to maintain cold chain (in a case of cold chain products)

o storage facilities

§ Storage facilities shall protect products from deterioration or infestation by vermin and pests. Specified storage conditions shall be monitored and maintained accordingly.

§ Controlled storage environment e.g. air conditioning, refrigeration for cold chain products shall be monitored using suitable temperature recording devices and records reviewed and filed.

§ There should be provision for lockable shelves for keeping schedule IA medicines and substances.

§ A confined adequate space shall be provided within the premises for storage of returned, recalled, expired, quarantined and substandard or counterfeit pharmaceuticals.

§ All pharmaceuticals shall be stored off the floor in well – fitted shelves or pallets.

STEP 6: Requirements for Licensing of Premises for Pharmacy Business (10 minutes)

· Every premise registration certificate shall expire on the 30^th June after every three year from the date of registration. Therefore all dealers of pharmaceutical business shall be required to fill and furnish to the Registrar their applications for registration of premise and business permits three (3) months before 30^th June after elapsing of such period. Submitted with other documents stipulated in.....must be original copy of the registration certificate of the premise and business permit. Premises registration certificate shall remain valid provided that the following conditions are met;-

o Premises start to operate within six (6) months following the approval or registration

o Three (3) years from date of issuing have not elapsed

o Business permit is renewed yearly.

o The premises have been maintained and remained in conditions which led to its initial registration

o There is no change of business name, ownership or location.

· The permit must be annually renewed unless suspended, cancelled or revoked by the Council.

· Every permit issued by the Council shall expire on the 30^th Day of June every year. Therefore all dealers of pharmaceutical business shall be required to fill and furnish to the Registrar their applications for renewal of permits three (3) months before 30^th June.

· The renewal shall be done by filling application form for permit form completely and accurately with all the required information fiby;only filling in the application form for permit and pay the respective annual permit fee prescribed under Pharmacy Fees and Charges Regulations, 2012.

· On submission the forms must be accompanied

o With a payment receipt of fees as prescribed under The Pharmacy (Fees and Charges) Regulations, 2012.

o Original copy of the expired business permit

o A copy of premise registration certificate

o A certified copy of the contract agreement between two parties (Proprietor and Superintendent)

o A copy of registration certificate of the superintendent issued by Council

o A letter of commitment from the superintendent to supervise the said pharmacy

o Copies of certificate of other pharmaceutical personnel working in the pharmacy and their certified contract agreements.

· Dealers who shall delay to renew their permits beyond 31^stJulyof the following financial year shall be required to pay to the Council the prescribed annual permit fee together with 25% penalty as stipulated in regulations 38 (1-5) The Pharmacy (Pharmacy Practice) regulations,2012.

STEP 7: Procedures for Application for Approval of Location, Registration of Premises and Permits prior to operate the Business of Pharmacy (20 minutes)

· Approval of location (Section 34 (c) of the Pharmacy Act). The following procedures shall be adhered by applicants;-

o Shall apply for the approval of location to the Registrar, through zonal coordinators, respective Regional Pharmacist (RP) and District Pharmacist (DP).

o Application for the approval of location of the premises shall be made in a prescribed approval of location form.

o The Application form shall be obtained from Pharmacy Council office, zonal coordinators or through RP and DP offices of the respective Regions and Districts or through the Pharmacy Council Website www.pctz.or.tz

o Applicant shall be required to fill in completely and accurately all the required information in the approval of location form.

o On submission the form must be accompanied

§ With a payment receipt of fees as prescribed under The Pharmacy (Fees and Charges) Regulations, 2012.

§ Copy of the site plan of the building indicating the location of the pharmacy premises in relation to adjoining or surrounding businesses and access to and from the premises’

§ Copy of the professionally drawn floor plan indicating the actual layout of the pharmacy premises drawn to scale with exact measurements.

· Application for the registration of the premise and business permits (Sections 36 of the Pharmacy Act and 19 and 20 of the Pharmacy (Pharmacy Practice) regulations, 2012). Upon successful final inspection and inspectors approve the premise that is suitable to provide pharmaceutical services, applicant shall

o Apply for the registration of premise and permits to the Registrar, through zonal coordinators, respective Regional Pharmacist (RP) and District Pharmacist (DP).

o Forms must be filled in completely and accurately with all the required information

§ Application form for Registration of Premises

§ Application form for Permit to operate business of a pharmacist

o On submission the forms must be accompanied

§ With a payment receipt of fees as prescribed under The Pharmacy (Fees and Charges) Regulations, 2012.

§ A certified copy of the contract agreement between two parties (Proprietor and Superintendent)

§ A copy of registration certificate of the superintendent issued by Council

§ A letter of commitment from the superintendent to supervise the said premise

§ Copies of certificate of other pharmaceutical personnel planned to work in the pharmacy and their certified contract agreements.

§ A copy of registration certificate of names/business/ corporate from relevant authorities (BRELA).

§ A copy of lease or sub-lease agreement or any document evidencing his right to ownership of the premise.

§ Final approved plan of the layout of the pharmacy premise (roof and floor plan if necessary).

o If the applicant is a pharmacist and is the owner he is not obliged to 29 (ii)

· Inspection of new premise

o Upon receipt of the duly filled approval of location form, inspectors will visit the said area/premise for first inspection

o The inspector or any other public officer authorized by the Council shall make sure that the premises applied for registration is inspected to verify if all the requirements have been met

o The inspectors shall use the inspection checklist when conducting the inspection of new pharmacy premises and give their observations and recommendation on the suitability of the premises.

o If the premise/area failed to comply with the required standards, applicant will be informed immediately during inspection in writings, either to address short falls or to look for another location/premise.

o The applicant after first inspection report, if allowed may continue with process of construction/renovation of the premises. Shall do so in six (6) months and upon completion shall inform the registrar/regional/district pharmacist for final inspection within prescribed.

o In case an applicant fails to inform the Council within 6 months for final inspection, the Council will cancel/refute the report and declares for any interested person(s) to use the said area for the same business

o The applicant after a successful final inspection report shall apply for registration of premise and for the permit to operate business of a pharmacist.

· Registration:

o Upon receipt of duly filled of all forms necessary for application, premises inspection report and all other necessary documents from the inspectors, the officer authorized by the Registrar shall scrutinise all the documents and if satisfied that all the requirements have been met, shall compile and give its recommendations to the Committee responsible for registration of premises for consideration.

o If the premises registration or licensing requirements have not been met, the applicant will be informed accordingly to address the shortfalls before reconsideration.

o The Council may register, withhold, reject or register with conditions any application by providing reason(s) for his/her decisions.

o All applicants, whose applications have been approved, approved with condition, withhold or rejected as the case may be, shall be informed in writing’s on the status of their application.

o Before starting the business, approved applicants will be required to purchase all necessary material necessary for the operation of the pharmacy i.e. Logo, reference materials, dispensing coats etc.

o The Registrar shall then issue the Premises Registration Certificate and the respective permits, which allow the applicant to start carrying out the business of a pharmacy.

STEP 8: Application forms and Inspection Chexk Lists (10 minutes)

· The annexes include

o Application form for approval of location of premises

o Application for registration of premises

o Application for permit

o Inspection check list for new pharmaceutical premises

o Inspection form for new pharmaceutical premises

STEP 9: Key Points (10 minutes)

· Sections in the Acts relating to registration and licensing of premises for Pharmacy business include section 34, 36 and 37, also sections 18, 19, 20 and 27 of Pharmacy (Pharmacy Practice) regulations, 2012.

· Requirements for registration of premises for pharmacy business: Registration of premises for dealing in pharmaceutical businesses is a prerequisite requirement which ensures quality pharmacy practice prior to commencing of such businesses.

· This requirement is stipulated under section 34 of the Pharmacy Act, 2011. The legislation prohibits the use of any premises for dispense, sale, sell, supply or storage of pharmaceuticals unless the premises has been registered by the Pharmacy Council for that purpose.

· Furthermore to this, section 36 of the same Act requires all dealers in such business to apply to the Council for permits and obtain such permits before starting operation.

STEP 10: Evaluation (10 minutes)

· What sections in the Act relate to registration and licensing of premises for Pharmacy business?

· What does section34 in the Act state relating to registration and licensing of premises for Pharmacy business?

· What are the requirements for registration of premises for pharmacy business?

· What are the procedures for application for approval of location, registration of premises and permits prior to operate the business of pharmacy?

References

MoHSW (2011), the Pharmacy Act 2011. Dar-es-Salaam: Government Printer

Pharmacy Council of Tanzania (), guidelines for registration of premises and licensing of

pharmaceutical business

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act, Government Printer, Dar es salaam Tanzania

Handout 3.1: Application Form for Approval of Location of Premises.

(Made under section 34(3) (C) of the Pharmacy Act, 201)1

Registrar,

Pharmacy Council,

P. O. Box 31818,

Dar es Salaam.

SECTION A: APPLICANT INFORMATION

1. Name of Applicant__________________________________________________

2. Physical Address of the Applicant______________________________________

3. Contacts (cell phone)_______________________________________________

SECTION B: INFORMATION OF THE PROPOSED AREA (ALL GAPS MUST BE FILLED CORRECTLY)

4. Physical address of the proposed area.

Street_______________Ward________District______Region __________

Plot No.__________

5. Name and distance from the nearby outlet ( Pharmacy, DLDM) in Metres __________________________________________________________________

6. Name and distance from the unsuitable area (Petrol station, Bar, open garage etc) in Metres ________________________________________________

7. Proposed Business name (BRELA Certificates if any)________________________

8. Type of Business :- ( A).Retail, (B).Wholesale, (C).Wholesale & Retail, (D).Warehouse (E).Institutional Pharmacy

SECTION C: DECLARATION

I/We declare those, the information given above are true and correct, knowing that it is an offence to produce documents/tender false information to public office.

_____________________ __________________

Name and Signature of the Applicant Date of application

SECTION D: FOR OFFICIAL USE ONLY.

Accounts Department

Total fee paid _____________________________ Received date ______________

Pay slip/Receipt No.______________________ Signature_____________

Inspection Department.

I/We inspected the area/building of the proposed premises on (date) ________________ and I/We have found that the said premise location does not/does meet the required standards.

Reasons for rejection____________________________________________________

Name, Signature of Inspector 1______ Name, Signature of Inspector 2________

Handout 3.2: Application for Registration of Premises

Section 37 of the Pharmacy Act, 2011

Registrar,

Pharmacy Council,

P. O. Box 31818,

Dar es Salaam.

SECTION A: APPLICANT INFORMATION

I / We hereby apply for registration of my/our existing/ new premises in accordance with the Pharmacy Act, 2011

1. Name of applicant...................................................................................................

2. Postal address .................................................. Address....................... Tel No.................... Fax.............................. Email............................................................

3. Full name(s) of Partner(s) and Directors(s)……………………......................…………

4. Situated at/lying between Plot /Vessel/ Truck No ……………………………………… Street/Village/Ward…………………………District/Municipality/City……………….

5. Premises to be registered for the business of ……………………………………………

6. The business will be under the supervision of a registered superintendent Mr /Ms /Mrs. /Dr. /Prof (Full name)………… whose qualification is………… and his/her registration number is ……...... of …......… (Year). (Please attach a copy of registration certificate and acceptance/commitment letter from the proposed superintendent)

7. The proposed name of the premises is ……………………………………………………

8. If my/our premises is registered and licensed I/We shall keep it in hygienic condition and good state of repair as required under the above mentioned Act and Regulations made there under.

9. I/we have not been convicted at any offence relating to any provision of the Pharmacy Act, 2011 and Regulations made there under or any other written law related to the business being applied for within 12 months immediately preceding this application and have not been disqualified from holding a license/certificate and my license is/is not suspended.

N.B. False declaration constitutes an offence.

Date………………………… Signed……………………

Applicant

SECTION B: DISTRICT/MUNICIPAL/REGIONAL/PHARMACY COUNCIL INSPECTOR’s REMARKS

(Delete which inapplicable) (In case there is no District Inspector this part should be filled by Regional Inspector)

I (Name) Mr. /Mrs./Ms./Dr./Prof………........................................……………………………. District/Municipal/Regional/PC Inspector of Postal address……………………………… Hereby certify that, I have inspected the above mentioned premises in Section A as per attached inspection checklist and found that it complies/does not comply with standards prescribed for registration of premises.

Please give reason(s) if it does not comply ………………………………………………….........……………….……………………..………………………………………………………………………………............

Name of Inspectors(s) Signatures & stamp Date

1. ………………………………… ……………………………

2.…………………………………. ……………………………

FOR OFFICIAL USE ONLY

Fees Tshs………………………………………Receipt No…………….of……………………

Registration granted/not granted because………………………..........................................

Registration No……... Approved by Management meeting No………......Of........………

........................................................ ..........................................................................

Date Signature of Registrar and stamp

(To include bank details of the Pharmacy Council) and reference regulation 48 (2)

Handout 3.3: Application For Permit

(Section 37 of the Pharmacy Act, 2011)

Registrar,

Pharmacy Council,

P. O. Box 31818,

DAR ES SALAAM.

PART I: APPLICANT INFORMATION

1. Name of Applicant..................................................................

2. Postal Address of the Applicant.............................Tel./Mobile............................................

3. Full name(s) of Partner(s) and Director(s) ..........................................................................

I/We hereby apply for renewal/a new permit of selling the following:

.......................................................................................................................................

PART II: PREMISES INFORMATION

1. Name of the premise..................................................................................................

2. Pre Premises situated at/lying between Plot/Vessel/Truck No............

3. Street/Village/Ward........................ District/Municipality/City..................................................................................

4. Premises category: retail pharmacy/wholesale pharmacy /retail and wholesale pharmacy/Godown

5. Facility Identification Number (FIN). ............................... of (year)....................................

6. Existing Permit No................................ Dated............................. Expiring on ...................

PART III: SUPERINTENDANT INFORMATION

1. Full Name........................................ Person Identification Number (PIN) .........................

2. Residential Address: ............................................................................................................

Telephone/Mobile No......................................... E-mail address: ..................................

3. Employment status: Employed/Self-employed

4. Designation & Address of present working place.................................................................

5. Date of last renewal of Pharmacist registration for the year..... ....and receipt No........

6. Signature of Superintendant Pharmacist.................................Date.......................................

PART IV: APPLICANT DECLARATIONS

1. If my/our premises is registered and licensed I/we shall keep it in hygienic condition and good state of repair as required under the above mentioned Act and Regulations made there under.

2. I/we have not been convicted of any offence relating to any provision of the Pharmacy Act, 2011 and Regulations made there under or any other written law related to the business being applied for within 12 months immediately preceding this application and have disqualified from holding a license/certificate and my/our license is/ is not suspended

N.B. False declaration constitutes an offence

.......................................................... ...............................................

SIGNATURE OF APPLICANT DATE

Handout 3.4: Inspection CheckList for New Pharmaceutical Premises

(For Retail, Wholesale, Warehouse or Both Retail and Wholesale)

(Made Under Section 37 of the Pharmacy Act, 2011)

This form must be correctly filled in capital letters and sent to the Registrar, Pharmacy Council together with application form for consideration on registration of a new premises

Any false information entered in here by inspector(s) may lead the Registrar, Pharmacy Council to take disciplinary action against the Inspector. Only Inspectors as recognized by the Pharmacy Act, 2011 shall fill in this form.

PRESCRIBED REQUIREMENTS:-

i. Name, Physical address and Location of the New Premise:

________________________________________________________________________

Location (Plot No, House No, Street/ Hamlet, Ward, District and Region) ________________________________________________________________________________________________________________________________________________

Name and distance from nearby Retail Pharmacy (in meters) ___________________

Distance from petrol station/bar/garage (In meters) ____________________________

ii. Full name of proprietor:

Individual_____________________________________________________________

Company_____________________________________________________________

Please, attach copy of certificate of company registration (name)/ Memorandum and Articles of Association (Yes/No)

iii. Name of registered superintendent:

Pharmacist____________________ PIN ________________year of Reg________

Name and address of previous pharmacy which he/she were supervising____________

1. Size of building and number of rooms/compartments and their sizes:

Retail pharmacy/Medical Devices

Size of the Building in Square meters (M²) __________________________________

Presence of:-

At least three (3) rooms (i.e. Display room, dispensing room & Store room) _YES/NO

i).Display room_________________________________________________YES/NO

Smooth Shelves with sliding glasses_________________________________YES/ NO Fan___________________________________________________________YES/NO

AC____________________________________________________________YES/NO

Waiting chair(s) for customers______________________________________YES/NO

Any other (mention) __________________________________________________________________________________________________________________________________________

ii).Dispensing & Store room__________________________________________________________YES /NO

Air Condition________________________________________________YES/NO

Fan_________________________________________________________YES/ NO

Lockable shelves for Prescription drugs and controlled substances_________________________________ YES/NO

Presence of source of water and a hand washing basin/sink________________ YES/NO

Provision for sitting desk for superintendent_____________________________YES/NO

Dispensing window with sliding glasses_______________________________ _YES/NO

Open shelves/pallets________________________________________________YES/NO

Strong and secured windows_________________________________________YES/NO

Refrigerator_______________________________________________________YES/NO

Any Other (mention) ______________________________________________________

Wholesale Pharmacy/Warehouse/Medical Devices

At least three rooms (i.e. Display/Dispatch room, Sales/Record keeping room and Store room)

(i) Display/Dispatch room___________________________________________YES/NO

Presence of source of water and a hand- washing basin/sink_________________YES/NO

Ceiling Fan_______________________________________________________YES/NO

AC______________________________________________________________YES/NO

Waiting chair(s) for customers________________________________________YES/NO

Reception Desk____________________________________________________YES/NO

Display cabinet with glasses__________________________________________YES/NO

Any other (present facility (mention)________________________________________________________________________________________________________________________________________

(ii) Sales/Record keeping room_____________________________________ YES/NO

Ceiling fan_____________________________________________________ YES/NO

AC____________________________________________________________ YES/NO

Provision for sitting desk for superintendent__________________________ YES/NO

Lockable shelves for keeping document__________________________________ YES/NO Any Other (mention) _____________________________________________

(iii) Storage room_________________________________________ _______ YES/NO

Air Condition______________________________________________ _____ YES/NO

Strong door toward store room_____________________________________ YES/NO

Strong grilled window________________________________ ____________ YES/NO

Open shelves/pallets______________________________________________ YES/NO

Confined area for recalled and expired drugs___________________________ YES/NO

Any other facility (mention) ___________________________________________

2. Security of the Premises.

i. External.

Provision of adequate barrier__________________________________ _____ Yes/No

Presence of strong grilled windows__________________________________ Yes/No

Provision of main entrance double doors; Grilled door outside and glass door inside____________________ _____________________________________ Yes/No

Presence of only one main entrance door______________________________ Yes/No

Any other present barrier to prevent unauthorized access (mention) ______________

ii. Internal.

Provision of suitable lockable storage poisons________________________ Yes/No

Provision for a special cupboard for storage of controlled drugs__________ Yes/No

3. Equipments.

Presence of water supply and hand wash basin/ Sink in dispensing room__Yes/No

Presence of Dispensing measure (beakers, measuring cylinders etc) ____ Yes/No

Presence of weigh balance and weights____________________________ Yes/No

Presence of mortar and pestle, spatula and dispensing tray_____________ Yes/No

Presence of Hot Plate or any other source of heat___________________ Yes/No

Source of clean and safe water___________________________________ Yes/No

Any other (mention) ____________________________________________

4. Record Books (To be provided during operation).

Ledger book or an appropriate inventory control system________________Yes/No

Prescription only Medicines Book (Dispensing Book) ________________ _Yes/No

Controlled drugs Book_________________________________________ _Yes/No

General sales drugs Book (Both) __________________________________Yes/No

Expired drugs Book____________________________________________ Yes/No

Complaints Handling Book__________________________________ ____ Yes/No Visitors Book_________________________________________________ Yes/No

Inspection Reports Register_____________________________________ Yes/No

Written procedures for maintenance of cold chain products_____________ Yes/No

Intern and field work register book_______________________________________

5. If the Proprietor is not a pharmacist, is there any commitment letter or contract agreement___________________________________________________ Yes/No

(Contract agreement is mandatory before the permit is issued; only contract formatted by the Council is accepted)

7. For both retail & wholesale pharmacy entrance for retail clients should be separated from entrance of wholesale clients (Clients should use a separate entrance)

Handout 3.5: Inspection Check List for New Pharmaceutical Premises

(For Retail, Wholesale or Both Retail and Wholesale)

(Made Under Section 37 of the Pharmacy Act, 2011)

General observations

i. ______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

ii. ______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

iii. _______________________________________________________________________________________________________________________________________________________________________________________________________________

(NB: Size of the building should not be less than 25m² for retail business and not less than 40m² for whole sale, whole sale & retail businesses should be not less than 60m², distance should not be less than 300m for retailers from each other)

Recommendations

iii. __________________________________________________________________________________________________________________________________________

Inspector’s declaration

We (names) (Signatures) (Date)

(i) _____________________________________________ __________________

(ii) ____________________________________________ __________________

Have inspected the above mentioned proposed site/premises/plan and to the best of our knowledge, we hereby admit that the information we have given is true and correct. We understand that any given false information may lead the Registrar, Pharmacy Council to take disciplinary action against us.

Owners /Incharge Certification

I (Full Name of Owner) _____________________________________________________________________

Certify that my proposed site/premises/plan has been pre-inspected by above named inspectors and I agree with the information provided.

................................................... .......................................

Signature of Owner/Incharge Date

Handout 3.6: Inspection Form for new Pharmaceutical Premises

(For Retail, Wholesale Or Both Retail and Wholesale)

(Made Under Section 37 of the Pharmacy Act, 2011)

General observations

ii. _____________________________________________________

iv. ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

(NB: Size of the building should not be less than 25m² for retail business and not less than 60m² for whole sale, whole sale & retail businesses, distance should not be less than 300m for retailers from each other)

Recommendations

iii. ____________________________________________________________________________________________________________________________________________________________________________________

Inspector’s declaration

We (names) (Signatures) (Date)

(i) _____________________________________ __________________

(ii) ____________________________________ __________________

Owners /Incharge Certification

I (Full Name of Owner) _____________________________________________________________________

Certify that my proposed site/premises/plan has been pre-inspected by above named inspectors and I agree with the information provided.

Signature of Owner/Incharge

Session 4: Historical Background of Pharmacy Practice

Total Session Time: 60 minutes

Prerequisites

· Session 1

Students Learning Tasks

By the end of this session students are expected to be able to:

· Define Pharmacy Practice

· Explain Historical Background of Pharmacy Practice

· Explain Importance of Pharmacy Practice

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Computer and LCD projector

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Presentation of Session Title and Related Tasks
2	15 minutes	Presentation Brainstorming	Definition of pharmacy practice
3	10 minutes	Presentation	Background of pharmacy practice
4	20 minutes	Presentation Buzzing	Importance of pharmacy practice
5	05 minutes	Presentation	Key Points
6	05 minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Definition of Pharmacy Practice (15 minutes)

Activity: Brainstorming (5 minutes)

ASK students to brainstorm on the following question

o What is pharmacy practice?

ALLOW few students to respond

WRITE their responses on flip chart/ board

CLARIFY and SUMMERIZE by using the content bellow

· The “ Pharmacy Practice” means the interpretation, evaluation, and implementation of Medical Orders; the Dispensing of Prescription Drug Orders; participation in Drug and Device selection; Drug Administration; Drug Regimen Review; the Practice of Telepharmacy within and across state lines; Drug or Drug-related research; the provision of Patient Counseling; the provision of those acts or services necessary to provide Pharmacist Care in all areas of patient care, including Primary Care and Collaborative Pharmacy Practice; and the responsibility for Compounding and Labeling of Drugs and Devices (except Labeling by a Manufacturer, Repackager, or Distributor of Non-Prescription Drugs and commercially packaged Legend Drugs and Devices), proper and safe storage of Drugs and Devices, And maintenance Of required records.

· The practice of pharmacy also includes continually optimizing patient safety and quality of services through effective use of emerging technologies and competency-based training.

STEP 3: Historical Background of Pharmacy Practice (10 minutes):

· The history of pharmacy as an independent science is relatively young.

· Until the birth of pharmacy as an independent science, there is a historical evolution from antiquity to the present day that marks the course of this science, always connected to the medicine.

· Although people have been using medicinal substances to treat themselves for as far back as there have been people, the pharmacy profession has more recent origins. Nevertheless, its roots can be found over 4000 years ago.

· Pharmacy’s roots

o The pharmacy profession can be traced back at least as far as the Sumerian population, living in modern day Iraq. From around 4000 BC, they used medicinal plants such as liquorice, mustard, myrrh, and opium

o The Ancient Egyptians had specific preparers of medicine, known as Pastophor.

· The future of pharmacy

o In the coming decades, pharmacists are expected to become more integral within the health care system. Rather than simply dispensing medication, pharmacists are increasingly expected to be compensated for their patient care skills.

o In particular, Medication Therapy Management (MTM) includes the clinical services that pharmacists can provide for their patients. Such services include the thorough analysis of all medication (prescription, non-prescription, and herbals) currently being taken by an individual.

o The result is a reconciliation of medication and patient education resulting in increased patient health outcomes and decreased costs to the health care system

o Below are some pharmacy symbols used in different areas of pharmacy business

STEP 4: Importance of Pharmacy Practice (20 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair and buzz on the following question

· What is the importance of pharmacy practice?

ALLOW few pairs to respond and others to add points not mentioned

WRITE their responses on flip chart/ board

CLARIFY and SUMMERIZE by using the content bellow

· Having seen the background, definition and highlights of pharmacy practice, let’s now look unto the importance of pharmacy practice

· In geriatric pharmacy practice:

pharmacy practice is important because, Elderly patients are unique in that they possess an altered metabolic capacity for medications due to, for example, increased body fat and water, decreased muscle mass, decreased cardiac output and perfusion, decreased protein binding, reduced liver function, and reduced physiologic reserve—all of which lead to unique medication selection and dosing requirements compared to younger adults. As a result of concomitant disease states, multiple medications are often prescribed for elderly patients by a variety of providers. They also often require additional assistance to understand how to take their medications to avoid possible adverse drug effects.

§ Lack of mobility, vision/hearing difficulties, and possible altered mental status may further hamper proper use of medications by the elderly.

§ There is a shortage of healthcare professionals trained in geriatric pharmacotherapy and seniors older than 75 years of age are under-represented in clinical trials, resulting in a poor evidence base on which to make individualized therapeutic decisions.

As the number of elderly patients continues to increase, the contribution of the pharmacist to quality, long-term medication management will require dramatic expansion.

· Pediatric pharmacy practice:

The pediatric patient population spans the years from birth through adolescence, presenting a unique challenge with regard to drug therapy administration and monitoring. Unlike adults, dosing is most commonly based on body weight, and pharmacokinetic variables are standardized relative to weight and/or body surface area. Since physical growth and organ system maturation are dynamic processes throughout the aging continuum, frequent individual dosing calculations and adjustments are necessary, particularly in infants.
Pediatric disease states, such as cystic fibrosis can further impact pharmacotherapy due to differences in pharmacokinetics seen in this particular subset of patients. Pediatric patients are under-represented in clinical trials, resulting in an inadequate evidence base on which to make individualized therapeutic decisions. Most commercially available drugs are not formulated for use in infants and children.
In addition, the pediatric patient population poses a higher risk for medication errors. Pediatric patients are three times more likely to suffer from a medication error; and a relatively small magnitude of error, as compared to adults, may result in more serious consequences, especially in the youngest, most vulnerable patients.
Pediatric patients frequently experience adverse drug reactions similar to adults, but adverse reactions in the pediatric population may be harder to recognize or be of greater or lesser intensity.

· The practice of pharmacy may include but is not limited to:

The custody, preparation and dispensing of medicines and pharmaceutical products;
The selection and provision of non-prescription medicine therapies and therapeutic aids;

Health promotion, including health screening;
Administration of medicines, including injectable medicines;
Researching and evaluating information and providing evidence-based advice and recommendations on medicines and medicine-related health issues;
Teaching and advising;
Policy development;
Management;
Manufacturing; and
Auditing

STEP 6: Key Points (5 minutes)

· Pharmacy practice means the interpretation, evaluation, and implementation of medical orders.

· The pharmacy profession can be traced back at least as far as the Sumerian population, living in modern day Iraq. From around 4000 BC, they used medicinal plants such as liquorice, mustard, myrrh, and opium

· The practice of pharmacy aimed at providing and promoting the best use of drugs and other health care services and products, by patients and members of the public.

STEP 7: Evaluation (5 minutes)

· What is pharmacy practice?

· What is the historical background of pharmacy practice?

· How is pharmacy practice important to the community?

References:

World Health Organization (2001), WHO policy perspectives on medicines. Globalization,

trips and access to pharmaceuticals Geneva: Retrieved from:

http://www.who.int/medicines

The Council on Credentialing in Pharmacy (February 2009), scope of contemporary

pharmacy practice, Washington, DC,

International Pharmaceutical Federation (2000), journal statement of policy on good

pharmacy education practice The Hague, The Netherlands

Tietze K. (1997), Clinical skills for pharmacists: A patient-focused approach Mosby Inc.

USA

Epstein RM, Hundert EM. (2002), JAMA: Defining and assessing professional competence.

287(2), 226-235.

Session 5: Standards of Pharmacy Practice

Total Session Time: 120 minutes

Prerequisites

· None

Students Learning Tasks

By the end of this session students are expected to be able to:

· Define Profession

· Describe the Standards of Pharmacy Practice

· Explain the Acts Pertaining Profession of Pharmacy

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Computer and LCD projector

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Presentation of Session Title and Related Tasks
2	20 minutes	Presentation Brainstorming	Definition of Profession
3	30 minutes	Presentation	Standards of Pharmacy Practice
4	50 minutes	Presentation Small group discussion	Acts Pertaining Profession of Pharmacy
5	10 minutes	Presentation	Key Points
6	05 minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Definition of Profession (20 minutes)

Activity: Brainstorming (5 minutes)

ASK students to brainstorm on the following question

· What is the meaning of the term profession?

ALLOW few students to respond

· WRITE their responses on flip chart/ board

· CLARIFY and SUMMERIZE using the content bellow

· A frequently used definition of (the medical) ‘profession’ is that of Cruess and Cruess (2004):

Profession: an occupation whose core element is work based upon the mastery of a complex body of knowledge and skills. It is a vocation in which knowledge of some department of Science or learning or the practice of an art founded upon it is used in the service of others. Its members are governed by codes of ethics and profess a commitment to competence, Integrity and morality, altruism, and the promotion of the public good within their domain. These commitments form the basis of a social contract between a profession and society, which in return grants the profession a monopoly over the use of its knowledge base, the right to considerable autonomy in practice and the privilege of self-regulation. Professions and their members are accountable to those served and to society

· The above definition emphasizes autonomy in practice. The practice of every profession and therefore also that of the pharmacist, comprises four components:

Meet a social need or necessity within the practice;
A clear stance regarding the responsibility of the individual professional for meeting the social needs
The expectation to work in the patient’s interest
A requirement to work within the healthcare paradigm

STEP 3: Standards of Pharmacy Practice (30 minutes)

Pharmacy Practice as per The Pharmacy Act, 2011 Section 38:

· The Council shall, for the purposes of pharmacy practice, prescribe

the scope of practice of persons registered, enrolled or enlisted under this Act or the services or acts which shall, for purposes of this Act, be deemed to be services or acts pertaining to the pharmacy profession and the conditions under which the services may be provided;

o the services to be provided in the various categories of pharmacies, and the conditions under which the services shall be provided;

o Rules relating to-

§ Code of Conduct for Pharmacists, Pharmaceutical Technicians and Pharmaceutical Assistants registered, enrolled or enlisted under this Act;

§ Good Pharmacy Practice

§ The services for which a Pharmacist may levy fees and guidelines for levying such fees;

o The titles or trading names under which a pharmacy may be conducted; and

o Matters relating to investigation and inspection of the pharmacy practice and the conduct of the business of a pharmacist.

Pharmacy Practice as per The Pharmacy Regulations, 2012, Part II

Scope of practice

· A Pharmaceutical personnel who holds a valid licence shall only assume those duties and responsibilities within his scope of practice and which he has acquired and maintained necessary knowledge, skills and abilities

· A person registered in accordance with the Act shall not, whether directly or through same other person, receive any payment or reward from any other person for the purpose of issuing a prescription.

Condition under which services or acts must be provided or performed

· the services or acts pertaining to the scope of practice of pharmaceutical personnel registered under the Act shall be provided in accordance with the Act, Good Pharmacy Practice and Code of Ethics and Professional Conduct as published by the Council

STEP 4: Acts Pertaining Profession of Pharmacy (50 minutes)

Activity: Small group discussion (25minutes)

DEVIDE student in small manageable groups

ASK students to discuss on the following question

· What are the acts pertaining profession of pharmacy

ALLOW students to discuss for 10 minutes

ALLOW few groups to present and the rest to add points not mentioned

WRITE their responses on flip chart/ board

CLARIFY and SUMMERIZE using the content bellow

In accordance to The Pharmacy Regulations, 2012, Part II, Section 5

· A registered person shall have regards to the following pertaining to the profession of pharmacy;-

o The provision of pharmaceutical care, by taking responsibility for the client’s medicine related needs and being accountable for his needs, which shall include but:

§ Evaluation of a client’s medicine related needs by determining the indication, safety and effectiveness of the therapy;

§ Dispensing of any medicine or scheduled substance on the prescription from an authorized practitioner;

§ Furnishing of information and advice to any person or public with regard to the use of medicine;

§ Determining client compliance with the therapy and follow up to ensure that the client’s medicine related needs are being met and

§ The provision of pharmacist initiated therapy

o The compounding, manipulation, preparation or packing of any medicine or scheduled substance or supervision thereof;

o The manufacturing of any medicine or scheduled substance or the supervision thereof;

o The purchasing, acquiring, importing, keeping, processing, using, releasing, storage, packaging, repackaging, supplying or selling of any medicine or scheduled substance or supervision thereof;

o The promotion of medicines or medical products asper the provision of the Act or any other written law;

o Promotion of public health;

o Provision of Consultancy services and

o Any other act as may be prescribed by the Council

STEP 6: Key Points (10 minutes)

· Profession is an occupation whose core element is work based upon the mastery of a complex body of knowledge and skills.

· The standards of Pharmacy Practice is described in The Pharmacy Act, 2011 under section 38 and The Pharmacy Regulations, 2012 under Part II, section 3and 4

· The section 5 of The Pharmacy Regulations, 2012 describes the acts pertaining profession of pharmacy.

STEP 7: Evaluation (5 minutes)

· What is profession?

· What are the standards of pharmacy practice?

· What are the acts pertaining profession of pharmacy?

References:

Appelbe and Wingfield (2001): Pharmacy Law and Ethics, 7th Edition. Pharmaceutical Press, London

MoHSW (2012), The Pharmacy (Registration Foreign Pharmacist Amendment) Regulations; Government Printer, Dar es salaam Tanzania

MoHSW (2011), The Pharmacy Act, 2011; Government Printer, Dar essalaam Tanzania

Wingfield, Badcott. (2007), pharmacy ethics and decision making, (p. 25), London. Chicago: Pharmaceutical Press.

Session 6: Code of Ethics and Professional Conduct for Pharmaceutical Practitioners

Total Session Time: 120 minutes

Prerequisites

· None

Students Learning Tasks

By the end of this session students are expected to be able to:

· Define important terms used in Code of Ethics

· Explain the Background of codes of ethics

· Explain codes of ethics

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Computer

· LCD project

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Presentation of Session Title and Related Tasks
2	20 minutes	Presentation Brainstorming	Definition of important Terms used in Codes of Ethics
3	20 minutes	Presentation	Background of Codes of Ethics
4	60 minutes	Presentation Small group discussion	Explanation of code of ethics
5	10 minutes	Presentation	Key Points
6	05 minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Definition of important Terms used in Code of Ethics (20 minutes)

Activity: Brainstorming (10 minutes)

ASK students to brainstorm on the following question according to their understanding

· Define the following terms?

o Pharmaceutical personnel

o pharmacist

o pharmaceutical technician

o pharmaceutical assistant

o intern pharmacist

o professional misconduct

o pharmacy practice

o professionalism

o pharmacy council

o breaches

ALLOW few students to respond

WRITE their responses on flip chart/ board

CLARIFY and SUMMERIZE using the content bellow

Definition of Terms:

· Pharmaceutical personnel: As per this code of ethics and professional conduct means registered pharmacist, enrolled pharmaceutical technician, enlisted pharmaceutical assistant and intern pharmacist.

· Pharmacist: Means a person registered under section 16 as per Pharmacy Act 2011, Cap 311

· Pharmaceutical technician: Means a person enrolled under section 24 as per Pharmacy Act 2011, Cap 311

· Pharmaceutical assistant: : Means a person enlisted under section 28 of Pharmacy Council Act 2011, Cap 311

· Intern Pharmacist: Means any person registered as such under section 17 of Pharmacy Council Act 2011, Cap 311

· Professional misconduct: Means any conduct which is in breach of the code of conduct, prescribed under the Pharmacy Council Act 2011, Cap 311

· Pharmacy Practice: Means any act pertaining to the scope of practice of a Pharmacist, Pharmaceutical Technician and Pharmaceutical Assistant as approved by the council

· Professionalism: Means active demonstration of the following traits: Knowledge and skills of a profession, Commitment to self-improvement of skills and knowledge Service orientation, Pride in the profession, Collaborative relationship with the patient Creativity and innovation, Conscience and trustworthiness, Accountability for his/her work, Ethically sound decision making, and Leadership.

· Pharmacy Council: Means a council established under Section 3 of Pharmacy Council Act 2011, Cap 311.

· Breaches: Means an act of breaking, violating or disregarding any obligation of code of ethics and professional conduct.

STEP 3: Background of Codes of Ethics (20 minutes)

· A profession is distinguished by the willingness of individual practitioners to comply with ethical and professional standards, which exceed minimum legal requirements. The role of pharmaceutical personnel is developing and recognized as the expert on medicines within the overall health system, to ensure people maintain good health, through responsible use of medicines.

· To practice as pharmaceutical personnel means undertaking any role, whether remunerated or not, in which an individual uses his professional skills and knowledge. Pharmaceutical practices are not restricted to the provision of direct clinical care, but also include working in a non-clinical relationship with consumers, patients or care takers, in the discovery, development, and manufacture of medicines, in maintaining the supply chain or in procurement. Besides this, pharmaceutical management or administrations, in education, research, advisory, regulatory, or policy development roles are considered to be important role to this cadre.

· The code of ethics will therefore apply to pharmaceutical personnel in all pharmacy practice settings. At all times, Codes should strive to provide the best possible care for consumers, patients and care takers, with due regard for the limitations of available resources and the principles of equity and justice.

· These codes of ethics and Professional Conduct for pharmaceutical personnel therefore intend to reaffirm and state publicly the obligations that form the basis of the roles and responsibilities of pharmaceutical personnel. These obligations, based on established ethical principles, are provided to enable and guide pharmaceutical personnel in their daily practice of the profession.

STEP 4: Explanation of Codes of Ethics (60 Minutes)

Activity: Small group discussion (30 minutes)

DEVIDE students into small manageable groups

ASK students to discuss on the following question

What are the explanations for the above codes of ethics?

ALLOW students to discuss for 20 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMERIZE using the content bellow

CODES

The principles or Code and their supporting explanations and obligations form the basis for the provision of a consistent high quality professional service which safeguards and promotes the well-being of the community and maintains public confidence in the profession. The principles are equally important and are listed in no particular order.

As pharmaceutical personnel:

1. Must have regard for human life

2. Must honor and dignify the profession

3. Should ensure availability of safe, efficacious and quality medicines.

4. Should ensure access to essential medicines

5. Should promote and ensure rational use of medicines

6. Should have good pharmaceutical personnel – patient/clients relationship

7. Must ensure privacy and confidentiality

8. Should be competent and have a lifelong learning

9. Should have good pharmaceutical personnel-other health care providers relationship

10. Must ensure well-being of the community

GENERAL OBLIGATION

In the areas of practice pharmaceutical personnel must promote, develop, implement and maintain policies, laws, regulations and standard guidelines that are designed to ensure provision of quality pharmaceutical care services.

CODE ONE: REGARD FOR HUMAN LIFE

Pharmacy profession aspires to improve the quality of human life through the provision of medicines and related services. Therefore, pharmaceutical personnel have the highest regard for human life and are dedicated to increasing opportunities for individuals to enjoy the full benefits of healthy lives within the limits of their natural endowments.

Obligations:

(i) Induction or inhibition of gestation:

Pharmaceutical personnel must not:

a. Provide contraceptives to under-aged persons, or any other persons legally incapable of making independent decisions, without involving medical practitioner, their parents or legal guardians in the decision making process.

b. Provide medicines for the purposes of inducing illegal abortion.

(ii) Growth, development and performance enhancer:

A pharmaceutical personnel must:

a. Disregard the use of performance enhancing, growth and sexual stimulants drugs without medical supervision.

b. Disregard the use of medicines that are intended to modify the physical, mental or psychological personality of a person.

(iii) Termination of life:

Pharmaceutical personnel must not:

a. Supply medicines for any criminal termination of human life and should take reasonable precaution against those who intend to procure medicines for such purpose.

b. Support the use of medicines in any act of voluntary euthanasia.

c. Participate in any act or scheme designed to cause mass annihilation or suffering of other human beings.

CODE TWO: HONOR AND DIGNITY OF PROFESSION

Pharmaceutical personnel by virtue of their mission are health care providers and therefore derive much respect from the community. They are also respected by other health care workers as experts on medicines and as a reputable source of information. Therefore, pharmaceutical personnel rightfully regard and should portray themselves as responsible persons specialized on medicine activity, use and custodians. They uphold the honor and dignity of the profession and do not engage in any activity that may bring their profession into disrepute.

Obligations:

(i) Adherence to the law:

Pharmaceutical personnel must:

a. Observe the provision of the Pharmacy Act, Cap 311 and Tanzania Food, Drugs and Cosmetics Act, 2003 and other related laws.

b. Ensure the observance of all legal and professional requirements in relation to pharmaceutical aspect of the business.

c. Ensure there is no any breach of the law, whether or not directly related to pharmacy professional practice, which may bring the profession into disrepute, if happens it may be considered to be misconduct.

(ii) Allegiance to the profession:

Pharmaceutical personnel should:

a. Play his part in providing the best services and should avoid any act or omission that could prejudice the public or impair confidence in the pharmaceutical profession as a whole.

b. Have due regard for the reasonably accepted standards of behaviour both within and outside his professional practice.

c. Not use or permit the use of his qualifications or position to mislead or defraud.

d. Not agree to practice under terms or conditions that interfere with or impair the proper exercise of professional judgment and skill that cause deterioration of the quality of professional services, or require consent of unethical conduct.

(iii) Relation with other pharmaceutical personnel:

Pharmaceutical personnel:

a. When appropriate demonstrates willingness at all times to provide advice and support to colleagues.

b. Should actively be involved with his professional organization in the provision of training, coaching and mentoring.

c. Should refrain from publicly criticizing colleagues or their actions, exercising discretion in relation to all professional matters.

CODE THREE: AVAILABILITY OF SAFE, EFFICACIOUS AND QUALITY MEDICINES

Pharmaceutical personnel are involved in all activities that lead to the availability of medicines to patients: These activities include research, training, manufacture, supply chain, regulatory, advisory, policy development, prescribing and dispensing. Pharmaceutical personnel must ensure that the medicines are safe, efficacious and of good quality and his professional services is available all the time.

Obligations:

Pharmaceutical personnel:

a. While assuring the safety, efficacy and quality of medicines under his charge, must acts with all honesty, integrity and concern for the patient.

b. In any practice must ensure compliance, with all professional and ethical requirements for conducting his professional roles in the respective Authorities.

c. Should not collude with any person to perform acts specifically pertaining to the profession of pharmacy, which have negative implications to the professional, patients and public in general.

d. Must not withhold any information relating to the efficacy, safety or quality of any medicine or method of practice whenever required to do so by a Governing Authority.

e. Must condone any act by a fellow pharmaceutical personnel, another healthcare professional or any other person that withholds information on safety, efficacy or quality of any medicine or method of practice.

f. Must not make false or unjustified claims as to the efficacy, safety or quality of any medicine.

g. Should not enter into any agreement with a medical practitioner, other healthcare worker or any other person that put in danger the right of the patient to the most appropriate medicines.

h. Should only offer advice on homoepathic or herbal medicines or other complementary therapies or medicines if he has undertaken suitable training or have specialized knowledge.

CODE FOUR: ACCESS TO ESSENTIAL MEDICINES

Equitable access to essential medicines is a major concern to pharmaceutical personnel. There are patients who cannot afford medicines they need, therefore a pharmaceutical personnel should promote the use of cost effective therapies and discourage the purchase or use of non-essential products.

Obligations:

Pharmaceutical personnel:

a. Should not participate in any scheme designed to profit him or his partner(s)/employer by sacrificing the quality of medicines or the well-being of the patient.

b. Should assist patients to make choices about their own best interests.

c. Has a professional obligation in ensuring that the patient is provided with the right, cost effective and safe therapies.

d. Should facilitate access of medicines to the patients without showing personal interest.

e. Beyond any reasonable doubt and for the interest of the well-being of the patient may establish repeat medical services, however must guard against any possible misuse of such services.

CODE FIVE: PROMOTE RATIONAL USE OF MEDICINES

Technical, legal, social-cultural restrictions and lack of awareness prevent many clients to access medicines they need and therefore are major concern of pharmaceutical personnel. However, pharmaceutical personnel should only participate in promoting methods and campaigns that encourage rational use of medicines so as to prevent unnecessary effects that may occur on use of medicines.

Obligations:

Pharmaceutical personnel:

a. Must ensure all information and publicity for medicines and services are legal, decent and truthful; Be presented and distributed in a manner so as not to bring the profession into disrepute; and not to abuse the trust or exploit the lack of knowledge of the public.

b. Must guarantee that information and promotional material relating to professional services comply with the role of pharmaceutical personnel as skilled and informed advisers about medicines, common ailments general healthcare and well-being.

c. During promotion must present so as to allow the client to decide independently whether or not to use a service and should not disparage the professional services of other pharmacies or pharmaceutical personnel.

d. Must not make any solicited approach, for promotion of medicines to a member of the public by any means of communication.

e. May display the prices at which they sell medicines.

f. Shall not deviate from the prescriber’s instructions when dispensing, except when necessary to protect the patient.

CODE SIX: PHARMACEUTICAL PERSONNEL – PATIENT RELATIONSHIP

· Pharmaceutical personnel’s establish and maintain a unique relationship with each patient that is based on an ethical covenant. The word “covenant” means that Pharmaceutical personnel have moral obligations in return for the trust given to them by society. Pharmaceutical personnel’s encourage shared responsibility for adherence to medication regimens and achieving desired drug therapy outcomes.

· This principle implies that the best pharmaceutical service, no matter how provided it occurs where the opportunity exists for direct contact between patient and pharmaceutical personnel.

Obligations:

Pharmaceutical personnel:

a. Has a duty to tell the truth, to act with conviction of conscience, and to avoid discriminatory practices and behavior.

b. Should try to have a direct contact and communication with patient as a person in the process of providing pharmaceutical care services.

c. Must be aware that individual patients have a right, under data protection legislation, to access his records.

d. Must assist patients in their expression of needs and values, and should recognize their rights, but not prejudiced by, factors such as patient’s race, ethnic origin, culture, belief, social and marital status, gender, sexual orientation, age, or health status.

CODE SEVEN: PRIVACY AND CONFIDENTIALITY

The pharmaceutical personnel preserves the confidentiality of information about individual patients acquired in the course of his professional practice and does not divulge this information except where authorized by the patient or required by law. Pharmaceutical personnel protect their patients by serving them in a private and confidential manner. Pharmaceutical personnel should not divulge information that identifies the patients; except in instances where there is a compelling need as for professional judgment grounds, to share information in order to protect the patient from harm, or where authorized by the patient or required by law.

Obligations:

A pharmaceutical personnel:

a. Must provide pharmaceutical care services with consideration for the personal privacy of patients.

b. Must ensure affirmative duties exist to institute and maintain practice that protects patient confidentiality.

c. Should make sure where appropriate, reveals to the patient the boundaries of professional confidentiality. Pharmacy care may require that other health care personnel have access to or be provided with relevant information.

Whenever possible, the patient should be informed, and generally, it is up to the patient to determine who should be informed and what personal information should be released.

d. When is confronted with the necessity to disclose, confidentiality should be preserved as much as possible. Both the amount of information disclosed and those to whom the disclosure is made should be restricted only to that information which is necessary.

e. Must ensure that electronic and manual systems, which include patient specific information, incorporate access control systems to minimize the risk of unauthorized access to the data.

f. May recognize the patient’s family member of choice, and with patient’s consents attempts to facilitate, where appropriate the participation of others should be allowed in the care of the patient.

CODE EIGHT: COMPETENCE AND LIFE LONG LEARNING

Pharmaceutical personnel’s should take responsibility to maintain their own competence and strive always to perfect and enhance their professional knowledge.

Obligations:

A pharmaceutical personnel:

a. Must commit himself to lifelong learning designed to maintain relevant knowledge, skills and attitude in order to execute its duties, development or improvement and audits their performance as part of the review.

b. Should be professionally competent and abreast of the latest developments in the area which associated with his functions and scope of practice.

c. Must undertake a minimum of hours continuing education structured to meet their personal needs, and be able to provide evidence when required.

CODE NINE: PHARMACEUTICAL PRACTITIONER-OTHER HEALTH CARE

PROVIDERS RELATIONSHIP

· Close professional cooperation between pharmaceutical personnel and other health care providers is encouraged to achieve the best possible outcomes for the patient.

· Therefore, Pharmaceutical personnel’s should maintain an effective professional relationship with other health care providers and respect their abilities, opinions and achievements.

Obligations:

A pharmaceutical personnel:

a. Should refrain from publicly criticizing other health professionals or their actions, exercising discretion in relation to all health matters.

b. Should as much as possible maintain an effective communication with other health professionals

c. Must share information relating to the efficacy, safety or quality of any medicine or method of practice with other health care professionals.

d. Must corporate with other health professionals in matters relating to health care.

CODE TEN: WELL-BEING OF THE COMMUNITY

Pharmaceutical personnel understand that the well-being of the community rests on the good health of individuals that make it. He should promote healthy lifestyles, hygiene and provide health care services that promote individual’s health. Also they should lead lives that are exemplary to the rest of the community.

Obligations:

A pharmaceutical personnel:

a. Must promote, develop, implement and maintain policies which are designed to prevent ill health and to promote healthy lifestyle of the community.

b. Has a professional obligation to exercise control over all medicinal and related products that are manufactured, purchased or supplied so that they are safe, efficacious and of good quality.

c. Must not condone the use and abuse of drugs or any other substance that can induce changes in the personality of a person.

d. Shall not sell in pharmacy products such as tobacco, liquor and related products except when meant for medicinal purposes.

e. Must take sufficiently reasonable steps to ensure that working conditions are so arranged so as to protect the safety of the public and people working in the premises.

f. Must ensure that the external and internal appearance of community pharmacy and hospital pharmacy are dignified, reflects the professional

nature of pharmacy and inspires confidence in the nature of healthcare it provides as stipulated under the Pharmacy Act, Cap 311 and its regulations.

g. Should ensure that before providing diagnostic testing and health screening services they must comply with standards and all other concerned strive.

h. Should have completed the training required to ensure competency with the diagnostic services, equipments and procedures to be used in the interpretation of results and must be aware of limits of the test provided.

i. Engages in dialogue with patients, provides public education to community groups and seeks opportunities to advocate for health promotion to benefit society as a whole.

STEP 5: Key Points (10 minutes):

· As per this code of ethics and professional conduct;

Pharmaceutical personnel mean registered pharmacist, enrolled pharmaceutical technician, enlisted pharmaceutical assistant and intern pharmacist.
Professional misconduct means any conduct which is in breach of the code of conduct, prescribed under the Pharmacy Council Act 2011, Cap 311
Pharmacy Practice means any act pertaining to the scope of practice of a Pharmacist, Pharmaceutical Technician and Pharmaceutical Assistant as approved by the council

o A breach means an act of breaking, violating or disregarding any obligation of code of ethics and professional conduct.

· As pharmaceutical personnel:

Must have regard for human life
Must honor and dignify the profession
Should ensure availability of safe, efficacious and quality medicines.
Should ensure access to essential medicines
Should promote and ensure rational use of medicines
Should have good pharmaceutical personnel – patient/clients relationship
Must ensure privacy and confidentiality
Should be competent and have a lifelong learning
Should have good pharmaceutical personnel-other health care providers relationship
Must ensure well-being of the community

STEP 6: Evaluation (5 minutes):

· What is

o Pharmaceutical personnel?

o Pharmacist?

o Pharmaceutical technician?

o Pharmaceutical assistant?

o Intern pharmacist?

o Professional misconduct?

o Pharmacy practice?

o Professionalism?

o Pharmacy council?

o Breaches?

· What are the codes/ principles of ethics?

References:

Appelbe and Wingfield (2001): Pharmacy Law and Ethics, 7th Edition. Pharmaceutical Press, London

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act, Government Printer, Dar essalaam Tanzania

MoHSW (2005), The Pharmacy (Education and Training) Regulations; Government Printer, Dar essalaam Tanzania

MoHSW (2011), The Pharmacy Act, 2011; Government Printer, Dar essalaam Tanzania

Pharmacy Council. (2015), Code of ethics and professional conduct for

pharmaceutical personnel, Dar-es-Salaam: Government printer

Royal Pharmaceutical Society of Great Britain. (2007), Code of ethics for pharmacists and pharmacy technicians. London, UK: 1 Lambeth High Street

Session 7: Health Care Delivery and Referral System in Tanzania

Total Session Time: 120 minutes

Prerequisites

· None

Students Learning Tasks

By the end of this session students are expected to be able to:

· Define health care system

· Mention goals of health care system

· Mention levels of health care delivery system in Tanzania

· Describe the referral system in health care delivery

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Computer

· LCD projector

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	05 minutes	Presentation	Definition of Health Care System
3	15 minutes	Presentation Brain storming	Goals of Health Care system
4	15 minutes	Presentation Brainstorming	Levels of Health Care Delivery System in Tanzania
5	60 minutes	Presentation Group Discussion	Referral System in the Health Care Delivery
6	05 minutes	Presentation	Key Points
7	05 minutes	Presentation	Evaluation
8	10 minutes	Presentation	Assignment

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Health Care System (5 minutes)

· Health care system is a system which consists of all organizations, people and actions whose primary intent is to promote, restore or maintain health

· Source WHO 2005

STEP 3: Goals of Health Care System (15 minutes)

Activity: Brainstorming (10 minutes)

Ask students to brainstorm on the following question:

· What are the goals of health care system?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

The goals of health care system are;

· To promote universal health care

· To ensure that all people obtain the health services they need without suffering financial hardship when paying for them.

· To ensure good health for the citizens,

STEP 4: Levels of Health Care Delivery System (15 minutes)

Activity: Brainstorming (10 minutes)

Ask students to brainstorm on the following question:

· What are the levels of health care delivery system in Tanzania?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

· The organization structure includes five levels as follows:

National Level

§ The central level, is the Ministry of Health and social Welfare

Regional Level

§ This level sometimes referred to as an extension of the MOH. It has the regional secretariat and one hospital in the region.

District hospital level

§ The district is the focal point for the implementation of the national health policy managed by the local authorities.

Divisional Level

§ This consist of a health centre which provides both curative and preventive

Ward Level

§ This is the lowest level (dispensary) of the formal health care delivery system.

STEP 5: Referral System in Health Care Delivery (60 minutes)

Activity: Small Group Discussion ( 50 minutes)

DIVIDE students into manageable groups

ASK students to discuss in groups on the following questions

· Describe the referral system in health care delivery

ALLOW students to discuss for 20 minutes

ALLOW each groups to present for 5 minutes

CLARIFY and SUMMARIZE by using the contents below

· Referral System is an organizational structure for coordinating, linking, & transferring responsibility of care.

· May be done by:

o a generalist to a specialist

o a specialist to a specialist

o one hospital to another

· Government’s referral system assumes a pyramidal pattern of a referral system recommended by health planners that is from dispensary to Consultant Hospital (Better Health In Africa, 1993).

· The following are health facilities from low level to the highest level through which a referral system go through;

o Dispensary Services

The dispensary caters for 6,000 to 10,000 people and supervises all the village health posts in its ward. This is the first level where patients are attended to. If the patient cannot be attended to at this level because of the complexity of the condition is then referred to the next level which is a health centre

o Health Centre Services

A health Centre is expected to cater for 50,000 people which is approximately the population of one administrative division. This is the second level where patients are attended to. If the patient cannot be attended to at this level because of the complexity of the condition is then referred to the next level which is a health centre

o District Hospitals

The district is a very important level in the provision of health services in the country each district is supposed to have a district hospital. For those districts which donate have Government normally negotiates with religious organizations to designate voluntary hospitals get subventions from the Government to contract terms. Patients are referred to here from Health centres and dispensaries present within the District

o Regional Hospitals

Every region is supposed to have a hospital. Regional Hospital offer similar services like those agreed at district level, however regional hospitals have specialists in various fields and offer additional services which are not provided at district hospitals. Patients from districts are referred to these hospitals for further management

o Referral/Consultant Hospitals

This is the highest level of hospital services in the country presently there are four referral hospitals namely, the Muhimbili National Hospital which cater the eastern zone; Kilimanjaro Christian Medical Centre (KCMC) which cater for the northern zone, Bugando Hospital which cater for the western zone; and Mbeya Hospital which serves the southern Highlands.

STEP 6: Key Points (5 minutes)

· Health care system is a system which consists of all organizations, people and actions whose primary intent is to promote, restore or maintain health

· Goals of health care system include the promoting of universal health care and to ensure good health for all citizens

· Referral system in health care delivery operates through ;Dispensary Services Health Centre Services, District Hospitals Regional Hospitals, Referral/Consultant Hospitals

STEP 7: Evaluation (10 minutes)

ASK questions based on the learning tasks

· What is health care delivery system?

· What are the goals of health care system?

· How many level s of health delivery system that respond to health needs?

· What are the health facilities that are involved in referral system?

ASK participants if they have any comments or need clarification on any points.

STEP 8: Assignment (10 minutes)

Activity: Take home Assignment (10 minutes)

DIVIDE students in groups or individual.

ASK the students to work on the following assignment

· Describe public-Private Partnership (PPP)

ALLOCATE time for students to do the assignment and submit

REFER students to recommended references

References

Tanzania MoHSW, (May, 2007) Primary health services development program

(phsdp) 2007 – 2017.

MoHSW (2011), The Pharmacy Act, 2011; Government Printer, Dar essalaam Tanzania

MoHSW (2005), The Pharmacy (Education and Training) Regulations; Government Printer, Dar essalaam Tanzania

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act, Government Printer, Dar essalaam Tanzania

Appelbe and Wingfield (2001): Pharmacy Law and Ethics, 7th Edition. Pharmaceutical Press, London

Session 8: Medicines and Medical Supplies Provided at Different Levels of Health Care Delivery System

Total Session Time: 120 minutes

Prerequisites

· Session 7

Students Learning Tasks

By the end of this session students are expected to be able to:

· Identify medicines and medical supplies provided at dispensaries level

· Identify medicines and medical supplies provided at health centres level

· Identify medicines and medical supplies provided at council hospital level

· Identify medicines and medical supplies provided at referral hospital at regional levels

· Identify medicines and medical supplies provided at zonal referral, national and special hospitals

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Standard Treatment Guidelines and National Medicines List

· Computer

· LCD projector

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Objectives
2	20 minutes	Presentation Buzzing	Medicines and Medical Supplies Provided at Dispensaries level
3	20minutes	Presentation Buzzing	Medicines and Medical Supplies Provided at Health Centres Level
4	20minutes	Presentation Group Discussion	Medicines and Medical Supplies Provided at Council Hospital Level
5	20 minutes	Presentation Group Discussion	Medicines and Medical Supplies Provided at Referral Hospital at Regional Levels
6	20minutes	Presentation Group Discussion	Medicines and Medical Supplies Provided at Zonal Referral, National and Special Hospitals
7	10 minutes	Presentation	Key Points
8	05y minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Objectives (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Medicines and Medical Supplies provided at Dispensaries Level (20 minutes)

Activity: Buzzing (10 minutes)

ASK students to pair up and buzz on the following question for 3 minutes

What are the medicines and medical supplies provided at a dispensary level

Refer students to handout 8.1: The National Essential Medicines List (NEMLIT)

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using National Medicines List

STEP 3: Medicines and Medical Supplies Provided at Health Centres Level

(15minutes)

Activity: Buzzing (10 minutes)

ASK students to pair up and buzz on the following question for 3 minutes

What are the medicines and medical supplies provided at health centre level

Refer students to handout 8.1: The National Essential Medicines List (NEMLIT)

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using National Medicines List

STEP 4: Medicines and Medical Supplies Provided at Council Hospital Level (20 minutes)

Activity: Small Group Discussion ( 10 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

What are the medicines and medical supplies provided at council hospital level

Refer students to handout 8.1: The National Essential Medicines List (NEMLIT)

ALLOW students to discuss for 10 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using National Medicines List

STEP 5: Medicines and Medical Supplies Provided at Referral Hospital at Regional Levels (20 minutes)

Activity: Small Group Discussion ( 10 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

What are the medicines and medical supplies provided at referral hospital at regional level

Refer students to handout 8.1: The National Essential Medicines List (NEMLIT)

ALLOW students to discuss for 5 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using National Medicines List

STEP 6: Medicines and Medical Supplies Provided at Zonal Referral, National and Special Hospitals (20 minutes)

Activity: Small Group Discussion ( 10 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

What are the medicines and medical supplies provided at referral hospital at regional level

Refer students to handout 8.1: The National Essential Medicines List (NEMLIT)

ALLOW students to discuss for 5 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using National Medicines List

STEP 6: Key Points (10 minutes)

· Different levels of health care delivery system may have different medicines depending on the capacity of a health facility.

· Review a list of medicines for Dispensaries

· Review a list of medicines for Health Centre

STEP 7: Evaluation (5 minutes)

· What medicines and medical supplies are provided at dispensaries level?

· What medicines and medical supplies are provided at health centres level?

· What medicines and medical supplies are provided at council hospital level?

· What medicines and medical supplies are provided at referral hospital at regional levels?

· What medicines and medical supplies are provided at zonal referral, national and special? hospitals

References

Appelbe and Wingfield (2001): Pharmacy Law and Ethics, 7th Edition. Pharmaceutical Press, London

MoHSW. (2013). Standard treatment guidelines & National essential medicines list. Dar-Es-Salaam, Tanzania: URT.

MoHSW (2011), The Pharmacy Act, 2011. Dar es salaam, Tanzania: Government Printer.

MoHSW (2005), The Pharmacy (Education and Training) Regulations. Dar es salaam, Tanzania Government Printer.

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act. Dar es salaam ,Tanzania Government Printer.

UNHCR (2011) UNHCR's Essential Medicines and Medical Supplies Policy and Guidance 2011.Geneva, Switzerland

Handout 8.1: The National Essential Medicines List (NEMLIT)

Levels of Medicines Use

A Medicines used at Dispensaries level

B Medicines used at Health Centres level

C Medicines used at Council Hospital level

D Medicines used at Regional Referral Hospitals &Referral Hospital, at Regional Levels

S Medicines used at Zonal Referral, National and Special Hospitals


Name of drug	Route of administration dosage forms and strengths		Level of use
1.0 ANASTHETICS AGENTS
1.1 General Anaesthesia
Ether anaesthetic	Liquid for inhalation, bottle 500ml		C
Halothane	Liquid for inhalation, bottle 250ml		C
Ketamine	Injection (hydrochloride), 10mg/ml in 20ml		C
Isoflurane		Liquid for inhalation, 250ML
Thiopental	Powder for injection (sodium salt), 0.5g, in 20ml		C
Oxygen	Cylinder (medical gas) for inhalation		C
1.2 Anaesthetics, Local
Bupivacaine	Injection 0.5% (hydrochloride) in 7.5% dextrose heavy spinal		C
Lignocaine	Injection (hydrochloride), 1% in 10ml vial		A
Lignocaine	Injection (hydrochloride), 2% in 2ml vial		B
Lignocaine in Dextrose	Injection (hydrochloride), 5% and 7.5% dextrose, in 2ml ampoules for spinal anaesthesia		C
Lignocaine	Injection (hydrochloride) 2% with adrenaline 1:100,000 in 2ml ampoule for dental use		B
Lignocaine Spray		C
Lignocaine	Jelly (hydrochloride) 2%, 5% in 30g tube		B
2.0 MUSCLE RELAXANTS, CHOLINESTERASE INHIBITORS AND ANTICHOLINERGIC
Gallamine	Injection (triethiidide) 40mg/ml in 2ml ampoule		C
Neostigmine	Injection (hydrochloride or hydrogen tartarate), 1mg/ml in 1ml ampoule, Injection (hydrochloride or hydrogen tartarate), 2.5mg/ml in 1ml ampoule		C
Pancuronium	Injection (bromide) 4mg/ml in 2ml ampoule		C
Suxamethonium	Powder for injection (bromide or chloride) 50mg/ml in 2ml vial		C

Obidoxime

Inj 250mg/mL

Pralidoxime

Powder for reconstitution 1g/vial

3.0 ANLGESICS, ANTIPYRETIC, NON-STEROIDAL ANTI-INFLAMATORY MEDICINES AND MEDICINE USED TO TREAT GOUT

Acetylsalicylic acid

Tablets 300mg

Allopurinol

Tablets 100mg

Diclofenac

Tablets (sodium/potassium salt) 25mg, 50mg

Diclofenac

Injection (sodium salt), 75mg/ml in 3ml ampoule

Diclofenac

Gel

Diclofenac

Tablets 100mg (Slow release)

Diclofenac

Rectocaps 100mg

Colchicine

Tablets 0.5 mg

Ibuprofen

Tablets 200mg

Indomethacin

Capsules 25mg

Piroxicam

Capsules 10mg

Mefenamic acid

Tablets/Capsules 500mg

Paracetamol

Tablets 500mg

Paracetamol

Syrup 125mg/5ml

Naproxen

Tablets 250mg

Tramadol

Tablets 50mg, 100mg

Tramadol

Injection 50mg/ml in 2ml

4.0 ANTI-MIGRAINE MEDICINES please work on it the drug of choice in migraine condition

Acetylsalicylic acid

Tablets 300mg

Paracetamol

Tablets 500mg

Ergotamine Tartrate

Tablets 2mg

5.0 ANALGESICS NARCOTIS AND ANTAGONISTICS

Morphine

Injection (sulfate) 10mg/ml in 1ml ampoule

Morphine

Tablets 10mg

Naloxone

Injection (hydrochloride) 0.4mg/ml in 1ml ampoule

Pethidine

Injection (hydrochloride) 50mg/ml in 1ml and 2ml ampoule

Pethidine

Capsules 50mg

6.0 ANTI-ALLERGIES/PRURITIC AND MEDICINES USED IN ANAPHYLAXIS AND CARDIOGENIC SHOCK

Chlorpheniramine

Tablets (maleate) 4mg

Chlorpheniramine

Injection (maleate10mg/ml in 1ml ampoule)

Chlorpheniramine

Elixir (maleate) 2mg/5ml

Loratadine

Tablet 10mg

Loratadine

Syrup 5mg/5ml

Cetrizine

Tablets (hydrochloride) 10mg

Cetrizine

Oral solution 5mg/5ml

Adrenaline (Epinephrine)

Injection (as hyrochloride or hydrogen tartarate) 1mg/1ml ampoule

Dopamine

Injection (hyrochloride) 40mg/ml in 5ml ampoule

Metolazone

Tablet 5mg

Torasemide

Tablets 10mg

Dobutamide Infusion

Ampoule 250mg/50ml

Hydrocortisone

Powder for injection (as sodium succinate) 100mg in vial

Promethazine

Tablets (hydrochloride) 25mg

Promethazine

Injection (hydrochloride) 25mg/ml in 2ml

Promethazine

Syrup 5mg/5ml

Dexamethasone

Tablets 1mg

Dexamethasone

Injection (phosphate as sodium salt) 4mg/ml

Calamine lotion

15g/100ml

7.0 ANTIDOTES

7.1 Antidotes (Non specific)

Ipecacuanha

Syrup, containing 0.14% Ipecacuanha alkaloid

Charcoal, activated

Tablets or Powder, 50g

Magnesium sulphate

Powder, 5g

Antivenom

7.2 Antidotes (Specific)

Acetylcysteine

Injection 200mg/ml in 10ml ampoules

Atropine

Injection (sulphate) 600mcg/ml in 1ml ampoule

Deferoxamine

Powder for Injection 500mg (Mesylate) in vial

Sodium bicarbonate

Injection

8.0 ANTI-EPILEPTICS AND ANTI-CONVULSANTS

Carbamazepine

Syrup 100mg/5ml

Carbamazepine

Tablets 200mg

Gabapentine

Capsules 100mg, 300mg

Diazepam

Tablets 5mg

Diazepam

Injection 5mg/ml in 2ml ampoule

Phenobarbital

Tablets (as sodium) 30mg, 100mg

Phenobarbital

Injection (as sodium salt), 100mg in 2ml ampoule

Phenytoin

Tablets/Capsules (as sodium salt) 50mg, 100mg

Phenytoin

Suspension (as sodium salt) 30mg/5ml

Magnesium sulphate

Injection 50mg/ml in 10ml vial

9.0 ANTI-INFECTIVE MEDICINES

9.1 Ameobicides

Metronidazole

Tablets 200mg

Metronidazole

Suspension (as benzoate) 200mg/5ml in 100ml

Tinidazole

Tablets 500mg

Secnidazole

Tablets 2g

9.2 Antihelminthes
Albendazole	Tablets 200mg, 400mg, chewable	A
Albendazole	Suspension 100mg/5ml in 30ml bottle	A

Ivermectin

Tablets 3mg, 6mg

Mebendazole

Tablets 100mg, chewable

Mebendazole

Suspension 100mg/5ml in 30ml bottle

Niclosamide

Tablets 500mg, chewable

Thiabendazole

Tablets 500mg, chewable

9.3 Antibacterial

Amikacin

Injection 250mg, 500mg powder for reconstitution

Amoxycillin

Capsules (as trihydrate) 250mg, 500mg

Amoxycillin

Dispersible tablets 250mg

Amoxycillin

Powder for suspension (as trihydrate), 125mg/5ml in 100ml bottle

Amoxycillin + Clavulanic acid

Tablets (as trihydrate) 500mg + 125mg clavulanic acid (as potassium salt)

Amoxycillin + Clavulanic acid

Powder for suspension (as trihydrate) 125mg+ 31.25mg (as potassium salt) in 5ml, 100ml bottle

Ampicillin

Powder for injection (as sodium salt) 250mg, 500mg in vial

Azithromycin

Capsules/Tablets (as dihydrate) 250mg, 500mg

Ceftazidime

Powder for injection (as pentahydrate) 250mg in vial

Cefixime

Capsules 200mg/ 400mg

Cefotaxime

Powder for Injection 500mg in vial

Ceftriaxone

Injection 250mg, 500mg, 1g in vial

Clarythromycin

Tablets 250mg, 500mg

Chloramphenicol

Capsules 250mg

Chloramphenicol

Powder for injection (as sodium succinate) 1g

Chloramphenicol

Oily injection (as sodium succinate) 1g in vial

Chloramphenicol

Suspension (as palmitate), 125mg/5ml injection (as phosphate), 150mg/ml in 2ml ampule

Ciprofloxacin

Tablets (as hydrochloride) 250mg, 500mg

Ciprofloxacin

IV solution (as lactate) 2mg/ml in 100ml bottle

Clindamycin

Capsules 150mg

Clindamycin

Injection (as phosphate) 150mg/ml in 2ml ampule

Cloxacillin

Capsules (as sodium salt), 250mg

Cloxacillin

Powder for injection (as sodium salt) 250mg, 500mg in vial

Cloxacillin

Powder for suspension (as sodium salt), 125mg/5ml in 100ml bottle

Co-trimoxazole

Tablets 480mg (sulphamethoxazole 400mg/trimethoprim 80mg)

Co-trimoxazole

Suspension (sulphamethoxazole 200 mg/5ml + trimethoprim 40mg/5ml in 100ml bottle

Doxycycline

Capsules (as hydrochloride), 100mg

Erythromycin

Tablets (as stearate or ethyl succinate), 250mg, film coated

Erythromycin

Powder for suspension (as ethylsuccinate), 125mg/5ml in 100ml bottle

Flucloxacillin

Capsule (sodium) 250mg

Flucloxacillin

Syrup 125mg/5ml

Flucloxacillin

Injection (sodium) 250mg

Gentamycin

Injection (as sulphate) 40mg/ml in 2ml ampoule

Levofloxacin

Tablets 250mg

Kanamycin

Powder for injection, 1g

Metronidazole

Tablets 200mg

Metronidazole

Suspension as (benzoate) 200mg/5ml in 100ml

Metronidazole

Injection (I.V) 5mg/ml in 100ml bottle

Nalidixic acid

Tablets 500mg

Nitrofurantoin

Tablets 100mg

Penicillin, benzyl

Powder for injection (as sodium or potassium salt) 3g ( 5,000,000 IU) in vial

Penicillin, benzathine benzyl

Powder for injection 1.44g (2,400,000 IU) in vial

Penicillin, phenoxy methyl-

Tablets (as potassium salt), 250mg

Penicillin, phenoxy methyl-

Powder for suspension 125mg/5ml in 100ml bottle

Sulphasalazine

Tablets 500mg

Sulphadiazine

Tablets 500mg

Pyrimethamine

Tablets 100mg

Tetracycline

Capsules 500mg

Vancomycin

Tablets 500mg

Vancomycin

Injection

9.4 Anti-filarials

Ivermectin

Tablets 3mg, 6mg.

Diethylcarbamazine

Tablets (dihydrogen citrate) 50mg

9.5 Anti-leishmaniasis

Pentamidine

Injection (di-isethionate) 200mg vial

Sodium stilbogluconate

Injection 10% (equivalent to pentavalent antimony 100mg/ml) in vial

9.6 Anti-malarial

Artemether/Lumefantrine (Alu)

Tablets 20mg/120mg

Artesunate Rectal

Suppositories 100mg

Dihydroartemisinin+Piperaquine (DPQ)

Tablets 40mg+320mg, 20mg+160mg

Chloroquine

Tablets 150mg base

Quinine

Tablets (as sulphate or bisulphate) 300mg

Quinine

Injection (as dihydrochloride) 300mg/ml in 2ml ampoule, 25ml vial

9.7 Anti-schistosomals

Praziquantel

Praziquantel Tablets 600mg

9.8 Anti-trypanosomals

Melarsoprol

Melarsoprol Injection 3.6% solution (in propylene glycol containing 5% water)

Suramin Sodium

Suramin sodium Powder for injection 1g in vial

9.9 Anti-leprosy

Clofazimine

Clofazimine Capsules 100mg, tablets 300mg

Dapsone

Dapsone Tablets 50mg, 100mg

Sodium Fusidate

Sodium fusidate Tablets 250mg

Sodium Fusidate

Sodium fusidate Suspension 250mg/5ml in 100ml bottle

9.10 Anti-tuberculosis

Cycloserine

Solid Oral dosage form 250mg (2ND LINE)

Ethambutol

Ethambutol Tablets (hydrochloride) 400mg

Ethambutol+Isoniazide

Ethambutol + Isoniazid Tablets 400mg + 100mg

Ethionamide

Tablets 125mg, 250mg(Second line anti TB)

Isoniazid

Isoniazid Tablets 100mg

Pyrazinamide

Pyrazinamide Tablets 500mg

Rifampicin+Isoniazid

Rifampicin + Isoniazid Capsules/Tablets 150mg + 75mg

Rifampicin+Isoniazid

Rifampicin + Isoniazid Capsules/Tablets 150mg + 150mg

Streptomycin

Streptomycin Powder for injection (as sulphate) 1g in vial

Rifampicin+Isoniazid+Pyrazinamide+Ethambutol

Rifampicin + Isoniazid + Pyrazinamide + Ethambutol Tablets 150mg + 75mg + 400mg + 275mg

9.11 Antiviral

Abacavir

Tablets 300mg

Abacavir

Syrup 20mg/ml, 240ml

Acyclovir

Tablets 200mg, 400mg,

Acyclovir

Cream 5%

Atazanavir

Tablets 300mg

Didanosine

Tablets 100mg, 200mg, 400mg

Efavirenz

Tablets 200mg, 600mg

Ganciclovir

Capsules 250mg

Ganciclovir

Powder for injection, 500mg/vial

Idoxuridine

Topical ointment 5%

Idoxuridine

Eye solution 5%

Indinavir

Capsule 400mg

Lamivudine

Tablets 150mg

Lamivudine

Syrup 10mg/ml, 100ml bottle

Lamivudine+ Zidovudine

Lamivudine + Zidovudine Tablets 150mg +

Lopinavir/Ritonavir

Lopinavir/Ritonavir Capsules/tablets 200mg, 400mg

Nelfinavir

Nelfinavir Tablets 250mg(mesylate)

Nelfinavir

Nelfinavir Oral powder (mesylate) 50mg/g

Nevirapine

Nevirapine Tablets 200mg

Nevirapine

Nevirapine Syrup 10mg/5ml

Ritonavir

Ritonavir Capsules 100mg,

Ritonavir

Ritonavir Syrup 600mg/7.5ml

Saquinavir

Saquinavir Capsules 200mg (mesylate)

Saquinavir/Ritonovir

Saquinavir/Ritonovir Capsules 200mg, 400mg

Stavudine

Stavudine Tablets/Capsules 15mg, 20mg, 30mg

Stavudine + Lamivudine + Nevirapine

Stavudine + Lamivudine + Nevirapine Tablets 30mg + 150mg + 200mg

Stavudine + Lamivudine + Nevirapine

Stavudine + Lamivudine + Nevirapine Tablets 40mg + 150mg + 200mg

Tenofovir

Tablets 300mg

Tenofovir+Lamivudine+Efavirenz

Tablets 300+150mg+600mg

Tenofovir+Emtricitabine+Efavirenz

Tablets 300mg+200mg+600mg

Tenofovir+Lamivudine+Nevirapine

Tablets 300mg+300mg+200mg

Zidovudine

Zidovudine Tablets 100mg, 300mg

Zidovudine

Zidovudine Syrup 10mg, 100ml bottle

Zidovudine+Lamivudine

Zidovudine 300mg+Lamivudine 150mg

9.12 (Fungicides (Systemic and Mucosal)

Amphotericin B

Amphotericin B Powder for injection 50mg in vial

Clotrimazole

Clotrimazole Vaginal cream (nitrate) 2%, 10%

Clotrimazole

Clotrimazole Pessaries 100mg

Fluconazole

Fluconazole tablets/Capsules 150mg, 200mg

Fluconazole

Fluconazole I.V infusion 2mg/ml in 100ml bottle

Griseofulvin

Griseofulvin Tablets 500mg

Griseofulvin

Griseofulvin Suspension 125mg/5ml

Ketoconazole

Ketoconazole Tablets 200mg

Ketoconazole

Ketoconazole Suspension 100mg/5ml in 30ml bottle

Miconazole

Miconazole Oral gel 2%

Nystatin

Nystatin Tablets 500,000 IU

Nystatin

Nystatin Suspension oral 100,000 IU/ml in 30ml bottle

9.13 Medicines for Opportunistic Infections

Co-trimoxazole

Co-trimoxazole Tablets 480mg

Dapsone

Dapsone Tablets 50mg, 100mg

Fluconazole

Fluconazole Tablets/Capsules 50mg, 150mg, 200mg

Fluconazole

Fluconazole Suspension 50mg/5ml

Fluconazole

Fluconazole I.V infusion 2mg/ml in 25ml and 100ml bottle

Itraconazole

Tablets/capsule 100mg

Flucytocine

Flucytocine I.V infusion 10mg/ml 250ml bottle

10.0 ANTI-NEOPLASTIC, IMMUNOSUPPRESSIVE AND RELATED MEDICINES

Cyclophosphamide

Tablets 50mg

Cyclophosphamide

Powder for injection 100mg, 500mg, in vilal

Rituximab

Injection 10mg/ml

Prednisolone

Tablets 5mg

11.0 ANTI-PARKINSONISMS

Benzhexol

Benzhexol Tablets (hydrochloride) 5mg

Biperidine

Biperidine Tablets 2mg/5ml injection 1ml ampoule

Bromocriptine

Tablets

Carbiodopa/Levodopa

Levodopa+Carbidopa Tablets 100mg + 25mg

12.0 MEDICINES AFFECTING THE BLOOD

Ferrous sulphate + folic acid

Ferrous sulphate + folic acid Tablets 200mg + 0.25mg

Ferrous fumarate

Ferrous fumarate Syrup 20mg/ml (equivalent to 6.5mg iron/ml)

Folic acid

Folic acid Tablets 5mg

Hydroxocobalamin (Vitamin B 12)

Hydroxocobalamin (Vit B12) Injection 1mg/ml in 1ml ampoule

Iron dextran

Iron dextran Injection 5% (equivalent to 50mg iron/ml) in 5ml and 20ml ampoule

13.0 ANTI-COAGULANTS AND ANTAGONISTS

Acetylsalicylic acid

Acetylsalicylic acid Tablets 75mg,

Activated Prothrombin

factor viii fraction

Enoxaparin Sodium

Injection (sodium salt) 100mg/ml

Heparin

Injection (sodium salt) 1,000 IU/ml in 5ml ampoule

Phytomenadione (Vit.K1)

Phytomenadione (Vit.K1) tablets 10mg

Phytomenadione (Vit.K1)

Phytomenadione (Vit.K1) Injection 0.5 mg/ml, 2mg/ml in 2ml ampoule

Protamine sulphate

Protamine sulphate Injection 10mg/ml in 5ml ampule

Streptokinase Infusion

Powder for injection: 1.5 million IU in vial.

Tranexamic acid

Tablets 500mg

Tranexamic acid

Injection 100mg/ml in 5ml ampoule

Tranexamic acid

Syrup 500mg/5ml in 300ml bottle

Warfarin

Tablets (sodium salt) 5mg

Streptokinase

Powder for injection 250,000 unit or 750,000 unit vial

Alteplase

Powder for injection 50mg-vial

Tenecteplase

Injection

Low molecular Heparin

Low molecular Heparin Injection, equivalence of Enoxaparin(sodium) 6000-8000 IU/ml

Low molecular Heparin

Low molecular Heparin Injection, equivalence of Edalteparin (sodium) 10,000IU/ml

Factor VIII concentrate

Factor VIII concentrate 500IU

Factor IX concentrate

Factor IX concentrate500 IU

Fresh frozen plasma (FFP)

Fresh frozen plasma (FFP) Bags

14.0 PLASMA SUBSTITUTES

Dextran 70

Dextran 70 IV solution 6% in sodium chloride bottle of 500ml

Polygeline

Polygeline IV solution 3.5%, 500ml bottles

15.0 CARDIOVASCULAR MEDICINES

15.1 Anti-anginal

Glyceryl trinitrate

Tablets 500 mcg sublingual

Isosorbide Mononitrate

Tablets 10mg, 20mg

Isosorbide Dinitrate

Tablets 10mg, 20mg

Nifedipine

Capsules/tablets 10mg, sublingual

Clopidegrol

Tablets 75mg

Propranolol

Tablets 40mg

15.2 Anti-arrhythmic

Amiodarone

Tablets (hydrochloride) 100mg

Amiodarone

Injection (hydrochloride) 30mg/ml in 10ml ampoule

Verapamil

Tablets 40mg 80mg Injection 2.5mg/ml, 2ml ampoule

Verapamil

Verapamil injection 2.5mg/ml, 2ml ampoule

Enalapril

Enalapril 5mg

Adenosine

Injection 3mg/ml in Saline

Lidocaine

Injection 2%; Lidocaine 20mg/ml

15.3 Anti-hypertensive Medicines

Methyldopa

Tablets 250mg

Captopril

Tablets 12.5mg, 25mg

Nifedipine

Tablets 10mg, sublingual

Nifedipine

Retard Tablets 20mg,

Atenolol

Tablets 50mg, 100mg

Propranolol

Tablets 40mg

Labetalol

Tablets 100mg

Labetalol

Injection 5mg/ml

Bisoprolol

Tablets 5mg

Bumetanide

Tablets 1mg, 5mg

Bumetanide

Injection 1mg/5ml

Perindopril

Tablets 4mg

Carvedilol

Tablets 6.25

Metoprolol

Tablets 50mg

Amlodipine

Tablets 5mg, 10mg

15.4 Hypetensive emergencies

Hydralazine

Powder for injection (hydrochloride) 25mg/ml ampoule

Hydralazine

Tablets 25mg

15.5 Cardiac Glycosides

Digoxin

Tablets 0.25mg (250mg)

Digoxin

Injection 250mg/ml in 2ml ampoule

15.6 Diuretics

Frusemide

Tablets 40mg

Frusemide

Injection 10mg/ml in 2ml ampoule

Hydrochlorthiazide

Tablets 25mg

Mannitol

-IV solution 10% in 200 ml bottle

Spironolactone

Tablets 25mg

Glycerol Syrup

Bendrofluazide

Tablets 5mg

15.7 Lipid Lowering Medicines

Simvastatin

Tablets 10mg

Atorvastatin

Tablets 10mg

16.0 Dermatological Medicines

16.1 Antiseptic/Disinfectants

Povidone iodine

Solution 10%

Potassium permanganate

Potassium permanganate Solution 1:4000 (prepare from raw materials)

16.2 Anti-inflamatory (steroidal) and Anti-pruritic Medicines

Bethamethasone

Bethamethasone Skin cream or ointment (valerate) 0.1% in 15g tube

Bethamethasone

Bethamethasone Lotion (valerate) 0.1% in 30ml bottle

Hydrocortisone

Hydrocortisone Cream 0.5%

Calamine

Calamine Skin ointment/lotion

Dithranol ointment

Ointment 0.1%

Calcipotriol 0.05%

Cream 0.05%

Clobetasol propionate

Ointment 0.05%or 0.01%

Para aminobenzoic Acid (PABA)

Cream/lotion 5%

Tretinoin acid

Tretinoin acid Topical cream 0.025%, Gel 0.01%

16.3 Fungicides (topical)

Benzoic acid Compound Ointment

Benzoic acid Compound Ointment (prepare from raw materials)(whitfied's)

Clotrimazole Cream

Clotrimazole Cream 1% in 20g tube

Clotrimazole Powder

Clotrimazole Powder 0.01g/g

Clotrimazole Vaginal pessaries

Clotrimazole Vaginal pessaries 100mg, 500mg

Nystatin Cream

Nystatin Cream 100,000 IU/g in 15g tube

Nystatin Pessaries

Nystatin Pessaries 100,000 IU

Miconazole Pessaries

Miconazole Pessaries (nitrate) 1.2g

Miconazole Vaginal cream

Miconazole Vaginal cream (nitrate) 2%

Miconazole

Miconazole Spray (nitrate) 0.16% + oral gel

Tolnaftate Solution

Tolnaftate Solution 1% 10mg/ml

Sodium Thiosulphate solution

Solution 20%

Terbinafine

Cream 1%, 15 and 30g Tube

16.4 Keratoplastic and Keratolytic Agent

Silver nitrate Stick

Podophylin Solution

Podophylin Solution 10-25% (prepare from raw materials)

Coal tar

Solution 5% (prepare from raw materials)

Salicylic acid

Salicylic acid Topical solution 5% (prepare from raw materials)

Emulsifying agent

Cream, the equivalent to E45 or softderm

Imiquimod

Cream 5%

Trichloracetic acid

Cream 80%

Sun screen Protecting Factor (SPF) 30+(Contains-Titanium Dioxide 9% , Zinc Oxide 8%) or equivalent.

Cream

16.5 Anti-infective Agent (topical)

Oxytetracycline + hydrocortisone Spray

Oxytetracycline + hydrocortisone Spray 150mg + 50mg

Oxytetracycline + hydrocortisone ointment

Oxytetracycline + hydrocortisone Ointment 3%+1%

Retinoic acid

Cream

Isotretinoin

0.05% cream

Benzoyl peroxide

Ointment/cream 2.5%, 5% and forte

Chloramphenicol

Ointment 1%

Mupirocin

Ointment 2%

Gentamycin

Cream 0.1%

17.0 GASTRO-INTESTINAL MEDICINES

17.1 Antacids and Anti-ulcers Agents

Cimetidine Tablets

Tablets 200mg

Cimetidine Injection

Injection 100mg/ml in 2ml ampoule

Famotidine Tablets

Tablets 40mg

Famotidine Injection

Injection 100mg/ml in 2ml ampoule

Lansoprazole

Capsule, 30mg

Magnesium trisilicate Tablets

Tablets (250mg magnesium trisilicate + 120mg dried aluminium hydroxide)

Omeprazole

Tablets 20mg

Ranitidine Tablets

Tablets 150mg

Ranitidine Injection

Injection 50mg/2ml

Esomeprazole

Tablets 20mg

17.2 Drugs affecting intestinal secretion and antispasmodics

Ursodeoxycholic acid

Tablets/capsule 300mg

Cholestyramine

Powder 4g per Sachet

Hyoscine butyl bromide Tablets

Hyoscine butyl bromide Tablets 10mg

Hyoscine butyl bromide Injection

Hyoscine butyl bromide Injection 20mg/ml; 1ml ampoule

17.3 Anti-emetics

Promethazine Tablets

Promethazine Tablets (hydrochloride/theoclate) 10mg, 25mg

Promethazine Injection

Promethazine Injection (hydrochloride) 25mg/ml in 2ml ampoule

Promethazine Elixir

Promethazine Elixir (hydrochloride) 5mg/5ml

Metoclopramide Tablets

Metoclopramide Tablets 10mg

Metoclopramide Injection

Metoclopramide Injection 5mg/2ml

Prochlorperazine Tablets

Prochlorperazine Tablets 5mg, 25mg

Prochlorperazine Injection

Prochlorperazine Injection (as mesylate) 12.5mg/ml ampoule

17.4 Cathartics

Bisacodyl

Tablets 5mg

Bisacodyl

Suppositories 5mg, 10mg

Lactulose

Solution 3.1 - 3.7g/5ml, 200ml bottle

17.5 Anti-Haemorrhoids

Local anaesthetic + astrigent and anti inflammatory Suppositories/ointment

Local anaesthetic + astrigent and anti inflammatory Suppositories/ointment (Bismuth oxide 25mg + Bismuth subgallate 59mg + Peru balsam 49mg+Zinc oxide 296mg) equivalent to Anusol suppositories

Local anaesthetic + astrigent and anti inti-inflammatory Suppositories

Local anaesthetic + astrigent and anti inflammatory Suppositories (Cinchocaine hydrochloride 5mg + Hydrocortisone 5mg) equivalent to ProctosedylR

Local anaesthetic + astrigent and anti anti-inflammatory Cream/ointment containing (Benzyl benzoate

Local anaesthetic + astrigent and anti inflammatory Cream/ointment containing (Benzyl benzoate +1.2%Bismuth oxide 0.875%+Hydrocortisone acetate 0.5%+Peru balsam 1.85%) equivalent to Anulgesic

Local anaesthetic + astrigent and anti inti-inflammatory Suppositories

Local anaesthetic + astrigent and anti inlfamatory Suppositories containing (benzyl benzoate 33mg+bismuth oxide 24mg+bismuth subgallate 59mg+hydrocortisone acetate 5mg+Peru balsam 49mg+bromocaine HCl 27mg+Zinc oxide 296mg) equivalent to Anugesic

17.6 Medicines used in Diarrhoea

Oral Rehydration Salts (ORS)

Oral Rehydration Salts (ORS) low osmolarity Sachet to make 1 litre of solution containing Sodium chloride 2.6g, Sodium citrate 2.9g, Potassium chloride 1.5g and Glucose 20.5g) repalcement solution

Loperamide Tablets/capsules

Loperamide Tablets/capsules (hydrochloride) 2mg

Zinc Tablets

Zinc Tablets dispersible (equivalent to 20mg elemental zinc)

18.0 HORMONES AND ANTIDIABETIC AGENTS AND RELATED MEDICINES

18.1 Adrenal Hormones and Synthetic Substitutes

Dexamethasone

Tablets 5mg

Dexamethasone

Injection (as sodium phosphate) 4 mg/ml in 1 ml ampoule

Hydrocortisone

Powder fo injection (as sodium succinate)

Prednisolone

Injection 100mg in vial

18.2 Oestrogens

Ethinyloestradiol

Tablets 50 mcg

18.3 Insulin and Anti- diabetic Agents

Chlorpropamide

Tablets 250mg

Glibenclalmide

Tablets 5mg

Gliclazide

Tablets 40mg

Tolbutamide

Tablets 500mg

Metformin

Tablets 500mg

Glucagon

Powder for reconstitution 10mg/vial

Glipizide

Tablets 2.5mg, 5mg

Insulin-short acting

Insulin-short acting (human) soluble100 IU/ml100

Insulin-intermediate acting

Insulin-intermediate acting (human) 100 IU/ml

Insulin-long acting

Insulin-long acting (human) lente100 IU/ml

18.4 Ovulation Inducers

Clomiphene

Tablets 50mg

18.5 Oral Contraceptives

Ethinyloestradiol + Norgestrel

Ethinyloestradiol + Norgestrel Tablets 0.03mg + 0.3mg

Ethinyloestradiol Levonorgestrel

Ethinyloestradiol Levonorgestrel Tablets 0.03mg + 0.15mg

Ethinyloestradiol Desogestrel

Ethinyloestradiol Desogestrel Tablets 0.03mg + 0.15mg

18.6 Barrier and Other Contraceptives

Intra Uterine Devices (IUD)

Intra Uterine Devices (IUD) Coper T 380A

Condoms male

Condoms male Latex

Condoms female

Condoms female Polyurathane sheet 15cm x 7cm

18.7 Progesterone

Levonorgestrel Tablets

Levonorgestrel Tablets 0.03mg, 0.07mg

Medroxyprogesterone

Medroxyprogesterone Injection acetate (depot) 150mg

Hydroxyprogesterone

Hydroxyprogesterone Injection (coproate) 200mg/ml in 1ml

Levonorgesterol

Levonorgesterol Implant 36mg (set)

Norethisterone

Norethisterone Tablets 5mg

18.8 Thyroid, Parathyroid hormones and Antagonists

Carbimazole

Carbimazole Tablets 5mg

Iodine (Lugol's solution) Solution

Iodine (Lugol's solution) Solution, Iodine 2mg + Potassium Iodide 4mg/g in water (prepare from raw material)

Levothyroxine

Levothyroxine Tablets (sodium salt) 0.05g

Iodized oil Capsules

Iodized oil Capsules with nipple 240mg/0.5ml and 480mg iodine/ml

19.0 SERA AND IMMUNOGLOBULINS

Gamma - Globulins Injection

Gamma - Globulins Injection I.V 500mg, 2.5g, 5g

Anti-D(Rho) Immunoglobulin Injection

Anti-D(Rho) Immunoglobulin Injection 0.25 mg/ml in set of 5ml

Anti-lymphocyte globulin

Anti-rabies Immunoglobulin Injection

Anti-rabies Immunoglobulin Injection 1000 IU/5ml ampoule

Anti-thymocyte globulin

Activated Prothrombin

Factor VII

Powder for reconstitution 2mg

Snake venom polyvalent Antiserum injeciton

Snake venom polyvalent Antiserum injeciton (|Central African type) in vila

Tetanus Immunoglobulin

Tetanus Immunoglobulin (human) - ATS Injection 1,500 IU in vial

Tetanus Immunoglobulin

Tetanus Immunoglobulin (human) - ATS Injection 10,000 I.U in vial

Tetanus Immunoglobulin

Tetanus Immunoglobulin (human) - ATS Injection 100,000 I.U in vial

Tetanus Immunoglobulin

Tetanus Immunoglobulin (human) - ATS Injection 500,000 I.U in vial

20.0 VACCINES

20.1 For Immunization

BCG Vaccine

BCG Vaccine (Bacillus Calmette Guerin) Injection 20 doses in 10ml vial

DPT Vaccine

DPT Vaccine (Diphtheria-Pertussis- Tetanus) Injection 20 doses in 10 ml vial

DPT Vaccine

DPT Vaccine (Diphtheria-Pertussis- Tetanus) + Hepatitis Injection Vaccine injection

Measles Vaccine

Measles Vaccine (Live attenuated) Injection 10 deses in vial

Poliomyelitis Vaccine

Poliomyelitis Vaccine (Live attenuated) Oral solution 20 doses in container

Tetanus (toxoid) Vaccine

Tetanus (toxoid) Vaccine Injection 20 doses in 10ml vial

20.2 For Specific Groups for Individuals

Hepatitis B Vaccine

Hepatitis B Vaccine 20mg/ml 1ml 1ml vials

Meningitis vaccine

Meningitis vaccine A & C Vaccine injection

Human Diploid Cell Rabies Freeze dried rabies vaccine

Yellow Fever Vaccine

Yellow Fever Vaccine Injection 10 doses in vial (with diluent)

Pneumococcal vaccine

Pneumococcal vaccine injection 0.5ml vial

21.0 OPHTHAMOLOGICAL PREPARATIONS

21.1 Anti- effective Agents

Acyclovir ointment

Acyclovir Eye ointment 3%

Chloramphenicol drops

Chloramphenicol Eye drops 0.5%, 1%

Chloramphenicol ointment

Chloramphenicol Eye ointment 1%

Gentamicin drops

Gentamicin Eye drops 0.3%

Povidone iodine

Eye drops 2.5 – 5%

Oxytetracycline ointment

Oxytetracycline Eye ointment 3%

Ciprofloxacin

Drops 0.3%

Dexamethasone+Chloramphenicol

Drops 0.1%, 0.5%

Dexamethasone +Gentamicin

Drops 0.1, 0.3%

Natamycin

Drops 5%

Econazole

Drops 1%

21.2 Steroidal Anti-infalamatory Agents

Dexamethasone

Drops 1%

Prednisolone

Drops 0.5% / Tabs 5mg

Methyl prednisolone sodium acetate

Injection

Triamcinolone Acetate

Cream

Triamcinolone Acetate

Injection 40mg/ml

21.3 Antinfective and Antinflamatory Agents

Cyclopentolate

Drops 0.5%, 1%

Atropine

Drops 1%

Timolol

Drops0.25%, 0.5%

Hydroxypropylmethylcellulose (Artificial tears)

Drops 0.75%

Iodoxamide tromethazine (Alomide)

Drops 0.5%

Sodium cromoglycate drops

Sodium cromoglycate 2%, 4% eye drops

Pilocarpine hydrochloride

Drops 2 or 4%

Zinc Sulphate

Drops 0.25%

Latanoprost

Drops 0.05%

Acetazolamide

Capsules 250mg

Glycerol Syrup

Triacenolone

Injection 20mg

Amethocaine

Drops 0.5%

Prostamide Bimatoprost

Drops 0.03%

Tropicamide

Drops o.5%, 1%

Tropicamide +Phenylephrine

Drops 0.8% / 5%

Bevacizumab

Injection 25mg/ml

Ranibizumab

Injection 0.05 ml

Hyaluronidase

Injection 150 USP Units

Fluorescein Sodium

Drops 2%

Ivermectin

Tablets 3mg, 6mg

21.4 Anti-allergy

Loratadine

Tablets 10mg

Cetirizine

syrup 5mg/5ml (100ml)

Sodium Cromoglycate

Tablets 10mg

Sodium Cromoglycate

Solution 5mg/ml (200ml)

Sodium Cromoglycate

Sodium Cromoglycate Eye drops

21.5 Drugs for Trachoma and Onchocerciasis

Azithromycin

Tablets 500mg

Azithromycin

Capsule 250mg

Ivermectin

Tablets 3mg, 6mg

22.0 MEDICINES USED IN EAR & NOSE DISEASES

21.1 Ear Drops

Chloramphenicol Ear drops

Ear drops 5% in 10ml

Dexamethasone + Neomycin Ear drops

Ear drops

Ciprofloxacin Ear drops

Ear drops

Aluminium diacetate Ear drops

Ear drops 3%

22.2 Oral Antiseptics

Chlorhexidine gluconate Solution

Chlorhexidine gluconate Solution 0.1%;prepare from concentrated solution

Potassium permanganate Solution

Potassium permanganate Solution 1:4000; prepare from powder/crystals

22.3 Nasal Preparations

Beclomethasone Spray

Spray 0.05% (50mcg/dose)

Ephedrine Nasal drops

Nasal drops 0.5% and 1%

23.0 OXYTOCICS, MYOMETRIAL RELAXANTS (TOCOLYTICS) AND RELATED MEDICINES

Salbutamol

Tablets 4mg

Salbutamol Injection

Injection 100mcg/ml, 10ml vial

Ergometrine Injection

Injection (maleate) 0.5mg/ml in 1ml ampoule

Oxytocin Injection

Injection 10 IU in 1ml ampoule

Misoprostol

Tablet 200mcg (rectal, sublingual)

Magnesium Sulphateinjection

Injection 50%

24. 0 PSYCHOTHERAPEUTIC AND RELATED MEDICINES

Carbamazepine tablets

Tablets 200mg, 400mg

Phenytoin Tablets

Tablets 50mg, 100mg

Phenobarbitone Tablets

Tablets 30mg, 100mg

Phenobarbitone Injection

Injection 200mg/ml in 1ml ampoule

Amitriptyline

Tablets (hydrochloride) 25mg

Fluvoxamine

Tablets 20mg

Citalopram

Tablets 20mg

Chlorpromazine

Tablets (hydrochloride) 25mg, 100mg

Chlorpromazine

Injection (hydrochloride) 25mg/ml in 2ml ampoule

Fluphenazine decanoate

Injection 25mg/ml in 1ml ampoule

Haloperidol

Tablets 1mg, 5mg

Haloperidol

Injection 5mg/ml in 1ml ampoule

Imipramine

Tablets 25mg, 50mg

Thioridazine

Tablets 25mg

Alprazolam

Tablets 250mcg

Lorazepam

Tablets 2mg

Fluoxetine

Capsule 20mg

Olanzapine

Tablets 5mg/10mg

Risperidone

Tablets 1mg/2mg

Benzhexol/ Trihexyphenidyl

Tablets 5mg

Procyclidine

Tablets 5mg

Lithium

Tablets 400mg

Naltrexone

Tablets 50mg

Carbidopa/levodopa

Tablets 25/100mg

Bromocriptine

Tablets 2.5mg

Sodium Valproate

Tablets 200mg, 500mg

Methadone

Powder

Chlordiazepoxide

Tablets 5mg

25.0 MEDICINES ACTING ON RESPIRATORY TRACT

25.1 Anti-asthmatics

Aminophylline

Tablets 100mg

Beclomethasone Inhalation

Inhalation (dipropionate) 0.05mg per dose (aerosol inhaler)

Cromoglycate Nasal spray

Nasal spray (di-sodium salt) 2% (sprayer with pump)

Salbutamol

Tablets (as sulfate) 4mg

Salbutamol Syrup

Syrup (as sulfate) 2mg/5mlmg

Salbutamol Inhalation

Inhalation (as sulfate) 0.1mg per dose (aerosol inhaler)

Salbutamol Nebulizer

Nebulizer solution 2.5 mg/ml

Salbutamol Nebulizer

Nebulizer solution 5 mg/ml

Ipratropium Bromide Aerosol

Inhalation (aerosol): 20microgram/metered dose

Adrenaline

Injection 1m/1ml ampoule

25.2 Antitussive

Cough Syrup/Linctus/Expectorants

Syrup/Linctus

26.0 SOLUTIONS, CORRECTING WATER ELECTROLTE AND ACID BASE DISTURBANCES

Dextrose 5%;

Dextrose 5%; 500ml, 1000ml

Dextrose 10%;

Dextrose 10%; 500ml

Dextrose 25%,

Dextrose 25%, 50ml, 100ml

Dextrose 50%,

Dextrose 50%; 50ml, 100ml

Sodium lactate compound (Ringer's solution)

Sodium lactate compound (Ringer's solution) 500ml, 1000ml. Each litre provides approximately Na+ 131 mmol, K+ 5mmol, Ca++2mmol, C1-111mmol and HCO3-(lactate) 29mmol

Sodium Chloride solution

0.9% Sodium Chloride 500ml, 1000ml

Sodium chloride+Dextrose

Sodium chloride+Dextrose 0.9%+5%; 500ml, 1000ml

Potassium chloride Solution

Potassium chloride Solution 7.4% 10ml Vial

Potassium citrate Oral solution

Potassium citrate Oral solution containing potassium citrate 30% + citric acid monohydrate 5%

Water for injection

5ml, 10ml vial

27.0 DISINFECTANTS AND ANTISEPTICS

Hydrogen peroxide Solution

Hydrogen peroxide Solution 3%

Hydrogen peroxide Solution

Hydrogen peroxide Solution 6%

Carbolic acid

5% equivalent to Lysol ®

Phenol

1-2% equivalent to phenol®

Alcohols

(60-90% ethyl, Isopropyl or Methylated spirit)

Alcohols based solutions(tinctures) of iodine or chlorhexidine

Chlorhexidine + Cetrimide Solution

Chlorhexidine + Cetrimide Solution concentrated containing chhlorhexidine digluconate 1.5%+ 15% cetrimide in 1litre and 5 litre

Chloroxylenol Solution

Chloroxylenol Solution 4.9% BP in litre and 5 litre

Cresol Solution

Cresol Solution 3% BP in litre and 5 litre

Formaldehyde solution

Formaldehyde solution 36 - 37% stabilised in 1 litre

Glutaraldehyde Activated solution

Glutaraldehyde Activated solution 2% in 1 litre, 5 litres for scopes sterilization)

Methylated spirit

70% in 1 litre,p 5 litre

Chlorhexidine

Solution 4% in litre and 5 litres

Sodium Dichloroisocyanurate Tablets

Tablets, 1.67g (equal to 1g available chlorine)

Povidone-Iodine Solution

Povidone-Iodine Solution 10%

Potassium permanganate Solution

Potassium permanganate Solution 1: 4000

28.0 VITAMINS/MINERALS

Retinol (Vitamin A) Capsules

Retinol (Vitamin A) Gelatin Capsules (with nipple to allow administration drop by drop) 50,000IU, 100,000IU 200, 000IU

Ascorbic acid (Vitamin C) Tablets

Ascorbic acid (Vitamin C) Tablets 100mg and 500mg

Calcium gluconate

Tablets 500mg

Calcium gluconate

Injection 100mg/ml in 10ml ampoule

Ergocalciferol (vitamin D)

Capsules 1.25mg (50, 000IU)

Ergocalciferol (vitamin D)

Oral solution 0.25mg/ml (10,000IU/ml)

Nicotinamide (Vitamin B3)

Tablets 50mg

Pyridoxine (Vitamin B6)

Tablets (hydrochloride) 25mg

Thiamine (Vitamin B1)

Tablets (hydrochloride) 100mg

Thiamine (Vitamin B1)

Injection (hydrochloride) 1000mg/ml in 1ml ampoule

Vitamin B12

Tablets (hydrochloride) 50mcg

Vitamin B complex

Vitamin B complex Tablets BP (contains per Tablet: nicotinamide 15mg, riboflavin 1mg, thiamine 1mg)

Vitamin B complex

Syrup (contains nicotinamide 15mg, riboflavin 1mg, thiamine 1mg/5ml)

Vitamin B complex

Injection BP in 10ml vial (contains nicotinamide 200mg, pantothenol 30mg, pyridoxine 20mg, riboflavine 20mg, thiamine 50mg per 1 ml)

Vit E

Suspension, alpha tocopheryl acetate 500 mg/5 mL

Vit K 10mg

Tablets 10mg

Selenium

As sodium selenite pentahydrate 50 micrograms/mL solution

Potassium chloride

Tablets (slow release) 600mg

29.0 Cytotoxic and Anti-Cancer Medicines

Cyclosporin

Injection: 50 mg/ml in 1-ml ampoule

Cyclosporin

Capsule: 25 mg.

Danazol

Capsule 100mg

Methotrexate

Tablets 2.5mg

Flurabine phosphate

Tablets 10mg

Flurabine phosphate

Injection

Vincristine

Injection 1mg/ml

Cisplatinum Infusion

Powder for injection 50 mg in vial

Actinomycin D

Powder for injection: 500 micrograms in vial

Etoposide

Capsule: 100 mg.

Etoposide

Injection: 20 mg/ml in 5-ml ampoule

Paclitaxel

Injection 6mg/mL in 5-mL ampoule

5-fluorouracil

Injection: 50 mg/ml in 5-ml ampoule

Adriamycin

Concentrate for infusion 2mg/ml, powder for reconstitution 50mg vial

Vincristine

Powder for injection: 1 mg; 5 mg (sulfate) in vial

Bleomycin

Powder for injection: 15 mg (as sulfate) in vial

Oxaliplatin

Powder for injection 50mg in vial

Epirubicin

Powder for injection 10mg in vial

Dacarbazine

Powder for injection: 100 mg in vial

Capecitabine 500mg

Tablets

Folinic acid

Tablets 15mg, injection 6mg

Tamoxifen

Tablets 20mg

Anastrozole

Tablets

Docetaxel

Concentrate for infusion 40mg/ml

Bezacizumab

Injection 25mg/ml

Session 9: Roles of Pharmaceutical Personnel

Total Session Time: 120 minutes

Prerequisites

· None

Students Learning Tasks

By the end of this session students are expected to be able to:

· Mention roles of pharmaceutical dispensers

· mention roles of pharmaceutical assistants

· Mention roles of pharmaceutical technicians

· Mention roles of a pharmacist

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Computer

· LCD Projector

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	30 minutes	Presentation Group Discussion	Roles of Pharmaceutical Dispensers
3	30 minutes	Presentation Group Discussion	Roles of Pharmaceutical Assistants
4	20 minutes	Presentation Group Discussion	Roles of Pharmaceutical Technicians
5	20 minutes	Presentation Group Discussion	Roles of Pharmacist
6	10 minutes	Presentation	Key Points
7	05 minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Roles of Pharmaceutical Dispensers (30 minutes)

Activity: Small Group Discussion ( 20 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the roles of pharmaceutical Dispenser?

ALLOW students to discuss for 10 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

· Assist the sale of pharmacy only and prescription only medicines under general sale

· Assist in compounding, manipulation or preparation of non sterile medicines or categorized substances according to a formula or standard operating procedures approved by a superintendent

· Assist the provision of information to individuals in order to promote health

· Assist in the distribution and control of stock of categorized medicines or categorized substances.

STEP 3: Roles of Pharmaceutical Assistants (30 minutes)

Activity: Small Group Discussion ( 20 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the roles of pharmaceutical assistants?

Refer students to The Pharmacy Practice Regulations, 2012, Part II Section 9 page 26

ALLOW students to discuss for 10 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

Pharmaceutical assistants enlisted may under supervision of a pharmacist, perform the following services or acts;

· Assist the sale of pharmacy only and prescription only medicines under general sale

· Assist in compounding, manipulation or preparation of non sterile medicines or categorized substances according to a formula or standard operating procedures approved by a superintendent

· Assist in manufacturing of sterile medicines or categorized substances according to formula and standard operating procedures approved by superintendent

· Assist in repackaging of medicines

· Assist in the distribution and control of stock of categorized medicine or categorized substances

· Assist the provision of information to individuals in order to promote health

· Undertake any other service or act as the council as the council may prescribe

STEP4: Roles of Pharmaceutical Technicians (20 minutes)

Activity: Small Group Discussion ( 15 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the roles of pharmaceutical technicians?

Refer students to The Pharmacy Practice Regulations, 2012, Part II Section 8 page 24

ALLOW students to discuss for 10 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

A pharmaceutical technician enrolled by the pharmacy council may, under the personal supervision of a pharmacist, perform the following activities

· Sale of pharmacy only and prescription only medicines under general sale

· Compounding, manipulation or preparation of non-sterile medicines or categorized substances according to a formula and standard operating procedures approved by a superintendent

· Assist in manufacturing of sterile or non sterile medicines or scheduled substances according to a formula and standard operating procedures approved by superintendent

· Repackaging of medicines in accordance with standard operating procedures approved by superintendent

· The distribution and control of stock of schedule medicines or categorized substances in the manner prescribed under any written law

· The ordering of medicine and scheduled substances upon review such medicine by an authorized practitioner in the manner prescribed under the Act or any other written law , or to purchase or obtain such medicine or categorized substance

· Interpretation and evaluation of prescription, selection, manipulation or compounding of medicine, labelling and supply of the medicine in an appropriate container

· Provision of instructions regarding the correct use of medicines supplied

· The provision of information to individuals in order to promote health

· Assist in data collection for research purposes

· Supervision of pharmaceutical Assistant

· Promotion of medical products and medical devices as per the Act

· Undertake any other Act or service as may be prescribed by the Council

STEP5: Roles of Pharmacist (20 minutes)

Activity: Small Group Discussion ( 15 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the roles of pharmaceutical technicians?

Refer students to The Pharmacy Practice Regulations, 2012, Part II Section 6 page 23

ALLOW students to discuss for 10 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

A pharmacist shall have regards to the following services pertaining the scope of his practice:

· Act pertaining to the professional of pharmacy as prescribed in regulation 5

· The formulation of any medicine for the purpose of registration as a medicine

· The distribution of any medicine or categorized substance

· The re-packing of medicines

· The initiation and conducting of pharmaceutical research and development

· The preparation and compilation of scientific dossiers of pharmaceutical products, cosmetics and medical devices for registration or other purposes as per the applicable law;

· The promotion of public health

· The promotion of medicines and medical devices

· Participating in the therapeutic management and pharmaceutical care and

· Any other service or act as may be prescribed by the council

STEP 6: Key Points (10 minutes)

· Pharmaceutical personnels have different roles depending on the level they belong

STEP 7: Evaluation (5 minutes)

· What are the roles of pharmaceutical dispensers?

· What are the roles of pharmaceutical assistants?

· What are the roles of pharmaceutical technicians

· What are roles of a Pharmacist?

ASK participants if they have any comments or need clarification on any points.

References

MoHSW (2011), The Pharmacy Act, 2011; Government Printer, Dar essalaam Tanzania

MoHSW (2005), The Pharmacy (Education and Training) Regulations; Government Printer, Dar essalaam Tanzania

Pharmacy Council of Tanzania. (2012). pharmacy act: the pharmacy practice regulations, 2012 (21-09-2012 ed.). DAR-ES-SALAAM: URT.

Session 10: Laws Relating to Storage and Distribution of Medicines and Medical supplies

Total Session Time: 60 minutes

Prerequisites

· None

Students Learning Tasks

By the end of this session students are expected to be able to:

· Define Terms Storage, Distribution, Good Storage Practices and Good Distribution Practices.

· Identify Sections in the Pharmacy Act 2011 Related to Storage and Distribution of Medicines and Medical Supplies

· Describe Sections in the Pharmacy Act 2011, Related to Storage and Distribution of Medicines and Medical Supplies

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Computer and LCD Projector

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Presentation of Session Title and Related Tasks
2	10 minutes	Presentation Brainstorming	Definitions of terms Storage, Distribution, Good Storage Practices(GSP) and Good Distribution Practices(GDP)
3	10minutes	Presentation Buzzing	Identification of Sections in the Pharmacy Act 2011,related to Storage and Distribution of Medicines and Medical Supplies
4	25minutes	Presentation Small group discussion	Description of Sections in the Pharmacy Act 2011,related to Storage and Distribution of Medicines and Medical Supplies
5	05 minutes	Presentation	Key Points
6	05 minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definitions of terms Storage, Distribution, Good Storage Practices (GSP) and Good Distribution Practices (GDP) (10 minutes)

Activity: Brainstorming (5 minutes)

ASK students to brainstorm on the following question according to their understanding

what is

Storage?
Good Storage Practices?
Distribution?
Good distribution practices?

ALLOW few students to respond and other pairs to add on points not mentioned

WRITE their responses on flip chart/ board

CLARIFY and SUMMERIZE using the content bellow

Definitions:

· Storage of medicines and medical supplies

o Storage means putting and safe keeping of medicines and medical supplies up to the point of use.

· Good Storage Practices (GSP) means part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof.

· Distribution

Distribution means a business of dealing in human medicines or medical devices in bulk or wholesale but does not include importers of human medicines, medical devices, food, cosmetics and veterinary medicines.

· Good distribution practices (GDP)

Are practices that ensure that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded pharmaceutical products

STEP 3: Identification of Sections in the Pharmacy Act 2011, related to Storage and Distribution of Medicines and Medical Supplies (10 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question

GIVE students the Pharmacy Act 2011copy of the book.

· What sections in the Pharmacy act relate to storage of medicines and medical supplies?

ALLOW few pairs to respond and other pairs to add on points not mentioned

WRITE their responses on flip chart/ board

CLARIFY and SUMMERIZE using the content bellow

· Section 34 Registration of premises

· Section 36 Application of permits

· Section 44 Conditions for body corporate to become authorized seller of medicines and pharmaceutical products

STEP 4: Description of Sections in the Pharmacy Act 2011, related to Storage and Distribution of Medicines and Medical Supplies (25 minutes)

Activity: Small Group Discussion (15minutes)

DEVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the descriptions of sections related to storage and distribution of medicine and medical supplies?

Refer students to The Pharmacy Act, 2011, Section 34, 36 and 44 ALLOW students to discuss for 10 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMERIZE using the contents bellow

· Section 34 Registration of Premises

o A person shall not sell, dispense or supply medicinal products except in premises registered under this Act.

o An application for registration or renewal of registration of premises shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Council may prescribe.

o The Registrar or any person in his behalf shall-

§ keep a register of all premises registered under this section;

§ register premises if he is satisfied that the requirements to be complied with by the applicant as prescribed by the Council from time to time have been complied with; or

§ have powers to approve the location and name of the proposed premises.

o The Council may, for good cause, refuse to register or cause to be removed from the register, any premises which is or has become unsuitable for purposes for which they were registered.

· Section 36 Application for Permits

A person shall not sell, dispense or supply medicinal products unless he has obtained a permit issued under this Act.
An application for a permit shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Minister may prescribe.
The Council shall not issue a permit to sell medicines and related medical supplies under this section unless the Council is satisfied

§ that the premises in respect of which the application relates shall be stored, meets the prescribed standards;

§ that the equipment are available for storing the medicines and related medical supplies;

§ with the suitability of the equipment and facilities which are used for distributing the medicines and related medical supplies; and

§ With the arrangements made or to be made for securing the safe keeping and the maintenance of adequate records in respect of medicines and related medical supplies stored in or distributed from those premises.

Section 44 Conditions for body corporate to become authorized seller of medicine and pharmaceutical products

· Anybody corporate carrying on business involving sale of drugs shall be an authorized seller of medicines within the meaning of this Act, if-

with regard to the keeping, selling, dispensing and compounding of medicines the business is under the management of a superintendent who-

§ is a Pharmacist;

§ has signed and submitted to the Registrar a statement in writing on behalf of the body corporate stating his name and specifying whether or not he is a member of that body; and

§ is not at that time acting in similar capacity for any other body;

in each set of premises for the sell of medicines, the business is carried on either under the personal supervision of the superintendent or subject to his directions under the personal control of another Pharmacist;
The name and certificate of registration of the superintendent or of some other Pharmacist having control of the business is conspicuously exhibited in the premises.

· Where-

a body corporate which is an authorized seller of drugs has been convicted of an offence under this Act; or
any member of the body corporate or any of its officer or any officer employed by it in carrying on the business, has been convicted of any criminal offence, or has been guilty of misconduct which, in the opinion of the Council, renders him or would, if he were a Pharmacist, render him unfit to be on the register, the Council may inquire into the matter and may, subject to this Act, direct that-

§ the body corporate cease to be an authorized seller of medicines, and be disqualified for a period to be specified in the directions from being an authorized seller of medicines; or

§ any or all of the premises of medicines and the body corporate be removed from the register of premises and be disqualified for such period as the Council may direct.

STEP 5: Key Points (5 minutes)

· According to the Pharmacy Act 2011, distribution means a business of dealing in human medicines or medical devices in bulk or wholesale but does not include importers of human medicines, medical devices, food, cosmetics and veterinary medicines.

· There are three sections in the Pharmacy Act 2011 related to storage and distribution of medicines and medical supplies which are sections 34, 36 and 44.

· Sections in the Pharmacy Act 2011, Section 34 Registration of Premises states that a person shall not sell, dispense or supply medicinal products except in premises registered under this Act. Section 36 Application for Permits addresses that a person shall not sell, dispense or supply medicinal products unless he has obtained a permit issued under this Act. Section44 addresses that anybody corporate carrying on business involving keeping, selling, dispensing and compounding of medicines should be an authorized seller of medicines within the meaning of the Pharmacy Act.

STEP 6: Evaluation (5 minutes)

· What is storage and distribution according to the Pharmacy Act 2011?

· What sections in the Pharmacy Act 2011 are related to storage and distribution of medicines and medical supplies?

· What do sections 34, 36 and 44 states relating to storage and distribution of medicines and medical supplies?

References

MoHSW (2011), The Pharmacy Act 2011. Sections 34, 36 and 44. 01, 20 & 25.

Dar-es-Salaam: Government Printer.

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act, Government Printer, Dar essalaam Tanzania

World Health Organization (2010) WHO Technical Report Series, WHO good distribution

practices for pharmaceutical products, No. 957, Annex 5.

Session 11: Procedures for Handling of Unfit Medicines and Cosmetic products

Total Session Time: 120 minutes

Prerequisites

· None

Students Learning Tasks

By the end of this session students are expected to be able to:

· Define the Terms “ Unfit Medicines and Cosmetic Products”

· Describe the Handling of Unfit Medicines and Cosmetic Products at Facility Level

· Describe the Procedures for Application to Dispose Off Unfit Medicines and Cosmetic Products

· Prepare the Format of the Register Book of Unfit Medicines/Cosmetic Products

· Prepare Model of Application Form for Disposal of Unfit Products

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Computer and LCD Projector

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Presentation of Session title and Related Tasks
2	20 minutes	Presentation Buzzing	Definition of Unfit Medicines and Cosmetic products
3	40 minutes	Presentation Small group discussion	Handling of Unfit Medicines and cosmetic products at facility level
4	25 minutes	Presentation	Procedures for Application to Dispose off Unfit Medicines and Cosmetic products
5	10 minutes	Presentation	Format of the Register Book of Unfit Medicines /Cosmetic products
6	10 minutes	Presentation	Model of Application Form for Disposal of Unfit products
7	05 minutes	Presentation	Key Points
8	05 minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Unfit Medicines and Cosmetic products (20 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

What are unfit medicines and cosmetic products?

ALLOW few pairs to respond and another pairs to add on points not mentioned

WRITE their responses on the flip chart/board

CLARIFY and SUMMERIZE using the content bellow

· Unfit medicines and cosmetic products

o Medicines and Cosmetic products shall be considered as unfit when they are:

§ expired

§ improperly sealed

§ damaged, unexpired and improperly stored

§ improperly labelled

§ counterfeit, substandard and adulterated

§ prohibited

§ unauthorized

· Prohibited drugs means any drug declared to be a prohibited drug in terms of the provisions of section 81 of this Act (TFDC Act).

· Counterfeit : a drug, medical device or herbal drug shall be deemed to be counterfeit if -

it is manufactured under a name which belongs to another drug; or
it is an imitation of, or is a substitute for, another drug, medical device or herbal drug resembles another drug or medical device likely to deceive or bears upon its label or container the name of another drug, medical device or herbal drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug, medical device or herbal drug; or
the label or container bears the name of an individual or company purporting to be a manufacturer of the drug, medical device or herbal drug; which individual or company is fictitious or does not exist; or
it has been substituted wholly or in part by another drug substances; or
it purports to be it is a product of manufacturer of whom it is not truly product.

· Expired: means a product should not be sold because of an expected decline in quality or effectiveness after a certain date.

· Substandard products are products that do not meet their quality standards and specifications.

· Adulterated drug product is a drug product whose composition has been affected by the addition thereto or subtraction therefrom of any substance; or which is not of the nature or quality demanded by the purchaser.

STEP 3: Handling of Unfit Medicines and Cosmetic Products at Facility Level (40 minutes)

Activity: Small Group discussion (20 minutes)

DEVIDE student into small manageable groups

ASK students to discuss on the following question

· What are the requirements for proper management of unfit medicines and cosmetic products at a facility level?

ALLOW students to discuss for 15 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMERIZE by using the contents bellow

Handling of Unfit Medicines and Cosmetic products at Facility level

· In order to manage properly unfit medicines and cosmetic products at a facility level, the following requirements shall be adhered to:

Maintain a register book (Annex I) for unfit medicines and cosmetic products
Keep them into different categories by dosage form such as:-

§ Solids, semi-solids and powders: capsules, powders for injection, tablets, granules, creams, gels, suppositories etc.

§ Liquids: Solutions, suspension, syrups, mixtures, lotions, aerosol, inhalers etc.

Keep separately medicines which fall under controlled drugs, antineoplastics, antibiotics and any other hazardous medicines or cosmetic products.
Keep in containers according to their dosage forms to facilitate verification exercise, sorting and selection of disposal method
Demarcate an area for keeping containers of unfit medicines and cosmetic products which shall be labeled conspicuously with words “Expired medicines/ cosmetic products – Not for Sale” or “Unfit medicines/cosmetics – Not for sale” or “Dawa/ Vipodozi hivi muda wake wa matumizi umekwisha – visiuzwe” au “Dawa/Vipodozi hivihavifai kwa matumizi – zisiuzwe” in red ink.

Maintain safe custody of unfit pharmaceutical products in registered premises until they are disposed off to avoid pilferage.
The decision of when to initiate disposal of unfit medicines and cosmetic products shall be made by regional, district or hospital pharmacist, owners, in-charge of facility, dispensers, and inspectors (including inspectors at ports of entry) to avoid accumulation of such products.
Application for disposal of unfit medicines from Government institutions shall be accompanied by an approval from Accountant General declaring that the product have been written off and that are subject to disposal as required by law under Section 256 of the Public Finance Regulations,2001.

STEP 4: Procedures for Application to Dispose off Unfit Medicines and Cosmetic products (25 minutes)

· Any person who intends to dispose off unfit medicines or cosmetic products shall adhere to the following procedures:

· Request in writing to the Director General of TFDA by using application for (Annex II) which is available at TFDA headquarter offices, TFDA zone offices, Regional and District Medical officer’s offices and TFDA website: www.tfda.ac.tz.

· A request shall be accompanied with a list of products to be disposed of and should state clearly trade name, generic name and strength (where applicable), dosage form, pack size, quantity, manufacturer, batch number and market value of product.

· Once the request has been received by TFDA, the Authority shall acknowledge and inform the applicant through a letter to contact Directorate of Medicines and Cosmetics to arrange or TFDA zone offices for verification of the product. In case of regions where there are no TFDA zone offices, applicant shall be informed to contact the Regional or District Medical officer’s offices for the same.

· TFDA-HQ or TFDA zone office/Regional/District Medical officer’s offices shall send inspectors to the premises to verify and authenticate the information submitted.

STEP 5: Format of the Register Book of Unfit Medicines /Cosmetic products (10 minutes)

Minimum important information in the Register book:

· Name of the product

o trade name

o generic name

· Strength of the product(where applicable)

· Dosage form: suspension, cream, ointment, tablet ...

· Pack size

· Quantity

· Batch number, and

· Value(Tshs.)

Figure 1.Register Book

S/N	Name of a product		Strength where applicable	Dosage form	Pack size	quantity	Batch number	Value (TZs)
	Trade name	Generic name	Strength where applicable	Dosage form	Pack size	quantity	Batch number	Value (TZs)

STEP 6: Model of Application form for Disposal of Unfit products (10 minutes)

Minimum important information in Application Form for Disposal

· Form number

· Postal address of TFDA

· Postal address of the applicant

· Specification of type of business of the applicant

· Type of products to be disposed

· License number

· Date of issue

· Location of business

· Name of in-charge and reg. number

· Reason for disposal

· Weight of the total products in Kg

· Value of the total products in Tshs

· Declaration by the applicant

· Name of the receiving officer, signature and official stamp.

Figure 2. Application form for disposal:

Form No……………

To: Director General

Tanzania Food and Drugs Authority

P.O Box 77150

Dar-es-Salaam

I/We..................................................................................................................

of (postal address)...........................................................undertaking the business of (specify)………………………………………………………………………………

……………………………………here by apply for disposal of unfit (specify type of products) ............................................. ………. License Number………..issued on………………….................................................

Location of Business……………………………………………………….........................

Name of In charge of the business……………………………………………Registration

Number (if applicable)……………………………………………………….

Reason for disposal............................................................................................

Weight (in Kg).....................................................................................................

Value (in Tshs)..................................................................................................

Attached herewith is the list of products to be disposed off.

Declaration:

I certify that the information provided in the application form is true and correct.

Date of application…………………………… Signature of Applicant..........................

Stamp…………………...........................

For official use only:

Received by: ...................................... Signature.............................................

Stamp..................................................

STEP 7: Key Points (5 minutes)

· Unfit medicines and cosmetic products are those expired, improperly sealed, damaged, unexpired and improperly stored, improperly labeled, counterfeit, substandard and adulterated, prohibited, unauthorized products.

· Unfit products are not safe for human consumption

· Proper handling of unfit products protects consumers against hazards associated with unfit medicines and cosmetic products.

· Before disposing off unfit medicines and cosmetic products, we must first apply to get permission from the Authority.

· Register book contains the following minimum important information: Name of the product (trade name, generic name),Strength of the product(where applicable), Dosage form: (suspension, cream, ointment, tablet ...), Pack size, Quantity, Batch number, and Value(Tshs.)

· Application Form for Disposal contains the following minimum information: Form number, Postal address of TFDA, Postal address of the applicant, Specification of type of business of the applicant, Type of products to be disposed, License number, Date of issue, Location of business, Name of in-charge and reg. number, Reason for disposal, Weight of the total products in Kg, Value of the total products in Tshs, Declaration by the applicant, Name of the receiving officer, signature and official stamp.

STEP 8: Evaluation (5 minutes)

· What is an unfit product?

· What are the procedures for application of unfit products disposal?

· What are the requirements for proper management of unfit medicines and cosmetic products?

References

MoHSW(2009),TFDA .Guidelines for safe disposal of unfit medicines and cosmetic

products. (1^ST ed.). Dar-es-Salaam: Government Printer.

MoHSW (2003), Tanzania Food, Drugs and Cosmetics Act section 99. Powers to seize

Forfeit, condemn and destruct unfit products, devices. 01, (pg71-72). Dar-es-Salaam:

Government printer.

WHO (2010), new definition for "substandard medicines" Retrieved from

www.who.int./medicines

Session 12: Sorting and Verification Exercise of Unfit Medicines and Cosmetic Products

Total Session Time: 120 minutes

Prerequisites

· None

Students Learning Tasks

By the end of this session students are expected to be able to:

· Define the term sorting of unfit medicines and cosmetic products

· Describe the sorting categories with their recommended disposal methods

· Describe sorting process of unfit medicines and cosmetic products

· Describe verification exercise of unfit medicines and cosmetic products

· Describe the Model of the Verification form(Annex III)

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard marker

· Computer and projector

· Handout 12.1: Verification Form

· Handout 12.2: Sorting Categories and their Recommended Methods of disposal

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Presentation of Session Title and Learning Tasks
2	10 minutes	Presentation Brainstorming	Definition of the term Sorting of Unfit Medicines and Cosmetic Products
3	60 minutes	Presentation Small Group Discussion	Sorting categories and their Recommended Disposal Methods
4	10 minutes	Presentation	Sorting process of Unfit Medicines and Cosmetic Products
5	15 minutes	Presentation	Verification Exercise of Unfit Medicines and Cosmetic Products
6	10 minutes	Presentation	Description of Model of Verification Form
7	05 minutes	Presentation	Key Points
8	05 minutes	Presentation	Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of the Term Sorting of Unfit Medicines and Cosmetic Products (10 minutes)

Activity: Brainstorming (5 minutes)

ASK students to brainstorm on the following questions

· What does sorting of unfit medicines and cosmetic products mean?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMERIZE by using the content bellow

Sorting of unfit medicines and cosmetic products

· Sorting of medicines and cosmetic products means to separate the medicines and cosmetic products into separate categories for which different disposal methods are required.

o The separation should be made into those that can be safely used and returned to the pharmaceutical supply system and those that require disposal by different methods. For example, controlled drugs (e.g. narcotics), antineoplastic drugs and antibiotics all require special methods of disposal. Substantial investment in human resources may be required for identifying and separating those products.

STEP 3: Sorting Categories and their Recommended Disposal Methods (60 minutes)

Activity: Small Group Discussion (30 minutes)

DIVIDE students into small manageable groups

ASK students to discuss in groups the following questions

· What are the sorting categories of medicines and cosmetic products for disposal?

· What are their recommended disposal methods for each sorting categories?

REFER Students to Handout 13.1 Sorting Categories and their Recommended Methods of disposal for reference

ALLOW students to read the Handout and discuss

ALLOW few groups to present for 15 minutes

CLARIFY and SUMMERIZE by using the content bellow

Sorting categories and their recommended methods

Some of the examples of category of products and their recommended disposal methods are highlighted on the table below:

S/N	Categories	Disposal methods
1.	Solids, semi-solids and Powders	Landfill, incineration and waste Immobilization
2.	Liquids	Sewer, high temperature incineration and treated waste
3.	Antineoplastics	Treated waste and landfill, high temperature incineration and return to manufacturer
4.	Controlled drugs	Treated waste and landfill, high temperature incineration
5.	Aerosols and inhalers	Landfill without waste inertization
6.	Disinfectants	Sewer or fast-flowing watercourse
7.	PVC plastics, glass (ampoules, bottles and vials)	Landfill and re-cycling
8.	Paper, cardboard	Recycle, burn, landfill

STEP 4: Sorting process of Unfit Medicines and Cosmetic Products (10 minutes)

· During verification exercise, the drug inspector shall supervise sorting exercise of unfit medicines and cosmetics products before determination of disposal method.

· Sorting should be done in an open or in a well ventilated area/building as close as possible to the stock pile in an orderly manner.

· Staff involved in sorting exercise shall be provided with protective gears such as gloves, boots, overalls and dust masks and shall be briefed on the sorting exercise, health and safety risks associated with handling the materials.

· Sorted medicines and cosmetics shall be carefully packed into steel drums or cardboard boxes or jute bags and information to be indicated outside the container shall include; dosage form(s) and proposed mode of destruction. The materials should be kept in a dry secure and preferably separate room to avoid being confused with in–date medicines or cosmetics until disposal is carried out.

STEP 5: Verification Exercise of Unfit Medicines and Cosmetic Products

(15minutes)

· After verification exercise is completed, a verification form (Annex III) shall be filled and signed by both parties.

· Verification process shall involve the following stages:

Identification of the product.
Separate medicines which fall under controlled drugs, antineoplastics, antibiotics and any other hazardous medicinal or cosmetic products.
Sort according to Destruction Method (Annex IV).

· After verification the applicant shall be informed by either TFDA-HQ or TFDA zone office, Regional or District Authorities through a letter on the proposed mode of destruction and shall be directed to arrange with the respective local authority e.g. Municipal/ District Medical Officer/ Pharmacist to determine disposal site, cost and date of destruction.

· The cost of destruction shall be borne by the owner of the product as stipulated under Section 99 of Tanzania Food, Drugs and Cosmetics Act of 2003.

STEP 6: Key Points (5 minutes)

· Sorting of unfit medicines and cosmetic products is separating of the medicines and cosmetic products into separate categories for which different disposal methods are required.

· Sorting categories: The priority of the sorting process is to separate out the unfit medicines that are categorized as controlled substances (e.g. narcotics), antineoplastic (cytotoxic-anti-cancer) drugs and any other hazardous non-pharmaceutical products that. These must all be stored in separate, secure designated areas prior to their separate, safe disposal. The remaining unwanted pharmaceuticals must be further sorted into different categories by dosage form, (capsules, powders, solutions, suppositories, syrups, tablets).

· Verification process involves identification of the product, separating medicines which fall under controlled drugs, antineoplastics, antibiotics and any other hazardous medicinal or cosmetic products and sorting according to disposal methods.

STEP 7: Evaluation (5 minutes)

· What is sorting of unfit medicines and cosmetic products?

· What are sorting categories and the recommended disposal methods?

· What important things are to be followed during sorting process of unfit medicines and cosmetic products?

· What are the stages of verification exercise of unfit medicines and cosmetic products?

· What are parts of the Model of the Verification form ?

References

MoHSW(2009),TFDA .Guidelines for Safe Disposal of Unfit Medicines and Cosmetic

Products. (1^ST ed.). Dar-es-Salaam: Government Printer.

MoHSW (2003), Tanzania Food, Drugs and Cosmetics Act section 99. Powers to seize

Forfeit, condemn and destruct unfit products, devices. 01, (pg71-72). Dar-es-Salaam:

Government printer.

World Health Organization (1999),Guidelines for Safe Disposal of Unwanted

Pharmaceuticals in and after Emergencies. 12-25. Retrieved from

http://www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf

Handout 12.1: Verification Form

Form No……………

TANZANIA FOOD AND DRUGS AUTHORITY

P.O. BOX 77150, DAR ES SALAAM

Email: info@tfda.or.tz

Telephone: 255 22 2450512, 2450751

Direct Line: 255 22 2450979

Fax No: 255 22 2450793

Name of applicant…………………………………………………………………………..

of (postal address)... ... ... ... ... ... ... ...... ... ... ... ... ... undertaking the business

of(specify)……………………………………………………………………………………....

Location of Business……………………………………………………….........................

Weight (in Kg)....................................................................................................

Value (in Tshs)..................................................................................................

Does the actual product(s) tally with the list of product(s) submitted to TFDA?

YES/NO

Other observation (s)..........................................................................................

..........................................................................................................................

Suggested mode of destruction...........................................................................

..........................................................................................................................

Name of Applicant..............................................................Signature.............

Date of verification.....................................

1. Name of Drug Inspector................................................Signature.................

2. Name of Drug Inspector................................................Signature..................

Handout 12: Sorting Categories and their Recommended Methods of disposal

Sorting categories:

· The objective of sorting is to separate the medicines and cosmetic products into categories that require different disposal methods.

· The appropriate safe disposal method recommended will depend principally on the pharmaceutical dosage form of the drugs. Segregated temporary storage areas or receptacles must be provided for each sorted category.

Practical advice on sorting

· Sorting involves an initial overall evaluation of the stockpile and subsequent division of pharmaceuticals into those suitable for use and those to be discarded. For those to be discarded a decision is made on the best method of disposal. To be efficient items should only be handled once. Pharmaceuticals suitable for use should remain in their packaging. The pharmaceuticals to be discarded should, when necessary, be separated from their packaging as late in the process as possible.

The sorting process includes:

· identifying each item;

· making a decision on whether it is usable;

· if usable, leaving packaging intact;

· if not usable, making a judgement on the optimal method of disposal and sorting accordingly;

· leaving packages and boxes intact until reaching their location, prior to definitive disposal or

· Transport to an institution for use.

Optimum conditions for sorting

· Sorting should be done in the open or in a well ventilated and, if necessary, heated covered structure designated by the local authority. Sorting should be done as close as possible to the stockpile in an orderly way, with all sorted material clearly labeled and separated at all times.

· Staff supplied with protective equipment (gloves, boots, overalls, dust masks, etc.), should work under the direct supervision of a pharmacist, and should receive training on the sorting criteria, and health and safety risks associated with handling the materials.

· Once sorted, the pharmaceuticals should be carefully packed into steel drums or into containers such as sturdy cardboard boxes, with the contents clearly indicated on the outside of the containers. The materials should be kept in a dry secure and preferably separate room to avoid being confused with in-date pharmaceuticals, until disposal is carried out.

Sorting categories

· The top priority of the sorting process is to separate out the pharmaceuticals that are categorized as controlled substances (e.g. narcotics), antineoplastic (cytotoxic-anti-cancer) drugs and any other hazardous non-pharmaceutical products that may have been mixed among the pharmaceuticals. These must all be stored in separate, secure designated areas prior to their separate, safe disposal.

· The remaining unwanted pharmaceuticals must be further sorted into different categories by dosage form, (capsules, powders, solutions, suppositories, syrups, tablets).

The following sorting categories and subcategories are suggested.

· Expired or unwanted pharmaceuticals

Pharmaceuticals that should never be used and should always be considered as unfit products are: all expired pharmaceuticals; all unsealed syrups or eye drops (expired or unexpired); all cold chain damaged unexpired pharmaceuticals that should have been stored in a cold chain but were not (for example: insulin, polypeptide hormones, gamma globulins and vaccines); all bulk or loose tablets and capsules. If unexpired these should only be used when the container is still sealed, properly labelled or still within the original unbroken blister packs; all unsealed tubes of creams, ointments, etc. (expired or unexpired).

· Sorted by active ingredient (special disposal needed):

controlled substances; e.g. narcotics, psychotropic substances;
anti-infective drugs;
antineoplastics;
cytotoxic-anti-cancer drugs, toxic drugs;
Antiseptics and disinfectants.

The last three groups require special consideration.

· Sorted by dosage form (all other pharmaceuticals):

solids, semi-solids and powders

§ tablets, capsules, granules, powders for injection, mixtures, creams, lotions, gels, suppositories, etc.;

liquids

§ solutions, suspensions, syrups, ampoules;

aerosol canisters

§ including propellant-driven sprays and inhalers.

Disposal Methods

· Landfill

This is a disposal method, which involves placing unfit medicines and cosmetic products directly into a land disposal site without prior treatment. The method is used in disposing off solid waste. Small quantities of unfit medicines and cosmetic products produced on a daily basis may be land filled provided that they are dispersed in large quantities of general waste. Cytotoxic, narcotic drugs and cosmetic products containing heavy metals such as mercury should not be land filled, even in small quantities.
Three types of landfill methods are recognized as outlined below:

§ Landfill for untreated unfit medicines and cosmetic products. The method is applicable to small quantities of unfit medicine and cosmetic products. It involves placing untreated waste medicine and cosmetic into an uncontrolled, non-engineered open dump. The unfit medicine and cosmetic products should be covered immediately with large quantities of other type of waste or soil/sand to prevent scavenging by unscrupulous people. Discarding of untreated unfit medicine and cosmetics into such a site is not recommended except as a last resort. They should preferably be discharged after immobilization by encapsulation or inertization. It should be noted that discarding in open uncontrolled dump with insufficient isolation from the aquifer or other watercourses can lead to pollution, with the risk of drinking water contamination in the worst cases. The disposal exercise should be done amid tight security by Police and be supervised by technical personnel. This method is applicable to solids, semi-solids, powders, medicines, waste dosage forms and cosmetics.

§ Engineered landfill: Such landfill has some features to protect from loss of chemicals into the aquifer. Direct deposit of medicines and cosmetics is second best to discharging immobilized unfit medicines and cosmetic products into such a landfill.

§ Highly engineered sanitary landfill: Properly constructed and operated landfill sites offer relative safe disposal route for unfit medicines and cosmetic products. An appropriate landfill consists of an evacuated pit isolated from watercourses and which is above water table. Once unfit medicine and cosmetic products are thrown into the pit, they are compacted and covered with soil to maintain sanitary environment. The term ‘safe sanitary landfill’ means a site that is adequately situated, constructed and managed. Limited quantities of untreated medicines and cosmetics waste in form of solids, semi-solids and powders are disposed of by this method.

· Landfill for treated unfit medicines and cosmetics (medicines and cosmetics waste immobilization).Immobilization of unfit medicine and cosmetics can be done in the following ways:

o Encapsulation:

§ In this process waste medicines and cosmetics are immobilized in a solid block within a plastic or steel drum. The drum should be cleaned before using them and they should not have contained explosive or hazardous materials previously.

§ The exercise starts by filling the drum to 75% of their capacity with solid and semi-solid waste medicines and cosmetics. The remaining space is filled by pouring in a medium such as cement or cement-lime mixture, plastic foam or bituminous sand. For ease and speed of filling, the drum lids should be cut open and bent back.

§ Once the drums are filled to 75% capacity, the mixture of lime, cement and water in the proportions 15:15: 5 (by weight) is added and drum filled to capacity.

§ Steel drum lids should then be bent back and sealed by seam or spot welding.

§ The sealed drum lids should be placed at the base of a landfill site and covered with fresh municipal solid waste.

§ The method is applicable to solids waste, semi-solids, powders, and liquids.

o Inertization

§ The method involves removing the packaging materials (inner and outer container). The unfit medicines and cosmetics are then ground and a mix of water, cement and lime added to form a homogenous paste. The paste is then transported in liquid state by concrete mixer truck to a landfill site and decanted into a normal municipal waste. The paste then sets as a solid mass dispersed within the municipal solid waste.

§ The main tools required for the operation are a grinder or road roller to crush the medicines/cosmetics, concrete mixer, cement, lime and water.

§ Medicines or cosmetics waste, lime, cement and water are mixed in the following ratios by weight 65%, 15%, 15% and 5% respectively. Water can be added more than the required amount when need arises to have satisfactory liquid consistency.

§ The method is applicable to solids, semi-solids, powders, antineoplastics controlled drugs of that nature and cosmetics containing heavy metals (e.g. mercury).

o Sewer

§ This is a method used whereby waste medicines and cosmetic products in liquid form e.g. syrups, lotions and intravenous fluids are diluted with water and flushed into a proper functioning sewerage system/sewers in small quantities over a period of time without causing serious public health or environmental effect. Fast flowing watercourses may likewise be used to flush small quantities of well-diluted liquid medicines/cosmetics or antiseptics.

o Medium temperature incineration

§ This method involves the use of medium temperature incinerators. Unwanted solid pharmaceuticals may be destructed by using a two-chamber incinerator that operates at the minimum temperature of 8500C, with a combustion retention time of at least two seconds in the second chamber. It is recommended that prior to destruction; pharmaceutical waste should be diluted with large quantities of municipal waste (approximately 1:1000).

§ Medium temperature furnaces may be used in absence of medium temperature incinerators. This type of incinerator is not suitable for incineration of halogenated compounds, as they need a more high temperature incinerator.

§ The method is applicable to solids, semi-solids, powders and controlled drugs of that nature.

o High temperature incineration

§ This involves the use high temperature incinerator, which operates at a temperature well in excess of 8500C. Our country does not possess such expensive and sophisticated incinerators so the uses of industrial plant such as cement kilns serve the purpose. Cement kilns can reach temperatures of 14500C – 20000C that is suitable for total destruction of organic waste component. These have long combustion retention times and disperse exhaust gases via tall chimneys, often to high altitudes thus reducing the risk of environmental effect.

§ It may be necessary prior to incineration to remove packaging materials to avoid clogging and blockage of incinerator or kiln.

o Burning in open containers

§ Paper and cardboard packaging materials, if they are not to be recycled, may be burnt. Polyvinyl Chloride (PVC) plastic however must not be burnt. Unfit medicines and cosmetics should not be destroyed by burning at low temperatures in open containers, as toxic pollutants may be released into the air. It is strongly recommended that only very small quantities of unfit medicines and cosmetics be disposed of in this way.

o Return to donor or manufacturer

§ Wherever practical the possibility of returning unfit medicines and cosmetic products for safe disposal by the manufacturer should be explored; particularly medicines and cosmetics which present problems, such as antineoplastics and heavy metals. For unwanted, unrequested donations, especially that arrive with past or unreasonably expiry dates, it may be possible to return them to the donors for disposal.

Session 13: Destruction of Unfit medicines and Cosmetic Products

Total Session Time: 60 minutes + 60 minutes assignment

Prerequisites

· Session 12

Students Learning Tasks

By the end of this session students are expected to be able to:

· Identify Different Participants Involved in the Destruction Process

· Describe the Procedures for Destruction of Unfit Medicines and Cosmetic Products

· Describe the Model of Drug Disposal Form of Unfit Medicines and Cosmetic Products

· Describe the Model of Certificate of Destruction of Unfit Medicines and Cosmetic Products

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Computer and LCD Projector

· Handout 13.1: Model Disposal Form

· Handout 13.2: Model of Certificate of Destruction

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Presentation of Session Title and Learning Tasks
2	10 minutes	Presentation	Identification of Different Participants involved in the Destruction Process
3	10 minutes	Presentation	Procedures for Destruction of Unfit Medicines and Cosmetic Products
4	10 minutes	Presentation	Description of Model of Drug Disposal Form of Unfit Medicines and Cosmetic Products
5	05 minutes	Presentation	Description of model of Certificate of Destruction of Unfit Medicines and Cosmetic Products
6	05 minutes	Presentation	Key Points
7	05 minutes	Presentation	Evaluation
8	10 minutes	Take home Assignment	Hazards associated with Improper Disposal of Unfit Medicines and Cosmetic Products

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Objectives (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Identification of Different Participants Involved in the Destruction Process (10 minutes)

· It is the responsibility of the Tanzania Food and Drug Authority to implement the guidelines in coordination with regional and local health authorities, as well as with the directors of health facilities that face the problems of drug disposal.

· A local task force or advisory committee should be established at an early stage to assess, analyze and address the problem of drug disposal, and to monitor activities. Furthermore, it is suggested that such a task force has a maximum of five members and that meetings are held as near to the site of the stockpile as possible.

· Members/supervisors are chosen from:

the drug regulatory authority
the ministry of health;
the police authority
institutional pharmacists;
A qualified hazardous waste expert may be appointed by the authority to be responsible for pharmaceutical waste disposal. If this is done the person appointed should become a member of the task force. The individual can be an expert in environmental management, a registered water chemist, hydro-geologist or sanitary engineer. The choice of expert depends on the technical problems to be faced.

· Therefore the destruction exercise shall be supervised by Health Officer, Environmental Officer, Policeman and Drug Inspector, and the owner/witness/superintended (pharmacist in charge) of the business.

STEP 3: Procedures for Destruction of Unfit Medicines and Cosmetic Products (10 minutes)

Destruction of unfit medicines and cosmetic products shall involve the following procedures:

· A Drug Inspector, Health Officer, Environmental Officer and Policeman shall supervise the transport of consignment from the owner’s premises to the disposal site for destruction exercise.

· The destruction exercise shall be supervised by Health Officer, Environmental Officer, Policeman and Drug Inspector.

· Unfit medicines and cosmetic products shall be transported in a closed motor vehicle to avoid pilferage.

· Supervisors shall wear protective gears such as overalls, gloves, masks, caps and boots during the exercise.

· Upon completion of the exercise, a Drug Disposal Form (Annex V) shall be duly filled in and signed by the supervisors and owner/owner’s representative.

· Drug Disposal Form shall be sent to TFDA headquarter offices.

· Once TFDA has received the form, a certificate of destruction of unfit medicines and cosmetic products (Annex VI) shall be prepared and sent to the consignee.

· Particular care shall be taken while handling anti cancer drugs, narcotic drugs and penicillins to avoid associated hazards.

STEP 4: Description of Model of Drug Disposal Form of Unfit Medicines and Cosmetic Products (10 minutes)

· Important information in the Disposal Form

· Name and address of the owner of the products destroyed

· Location/site where destruction exercise was conducted

· Date of the destruction exercise

· Methods of destruction used

· Total weight (Kg) and value(Tshs) of the products destroyed

· Name and signature of owner/in charge/representative of the organization

· Names, title and signatures of Drug Inspector, other supervisor(s) and witness of the disposal exercise.

REFER Students to Handout 13.1 Model of Disposal Form

STEP 5: Description of Model of Certificate of Destruction of Unfit Medicines and Cosmetic Products (10 minutes)

Important Information in the Certificate of Destruction

· Reference number of the certificate

· Date

· Name and postal address of owner

· Methods of destruction

· Place/site of destruction

· Serial number of the attached disposal form

· Weight(Kg) and value(Tshs) of products disposed

· Name and signature of Director General

REFER Students to Handout 13.2 Model of Certificate of Destruction

STEP 6: Key Points (5 minutes)

· Different Participants are involved in the Destruction process such are Drug Inspector, Health Officer, Environmental Officer, Policeman and a witness of the process.

· Procedures for Destruction of Unfit Medicines and Cosmetic products should be followed to avoid hazards associated with non-adherence to procedures.

· Drug Disposal Form of Unfit Medicines and Cosmetic products is filled and signed after completion of the exercise by supervisors and owner/owner representative involved in the destruction process and sent to the TFDA Headquarter offices.

· Certificate of Destruction of Unfit Medicines and Cosmetic products is prepared by the TFDA headquarter office and sent to the owner.

STEP 7: Evaluation (5 minutes)

· Who participates in the Destruction process of unfit medicines and cosmetic products?

· What are procedures for Destruction of Unfit Medicines and Cosmetic products

· What important information does Drug Disposal Form contain?

· What is the Certificate of Destruction of Unfit Medicines and Cosmetic products

STEP 8: Assignment (10 minutes)

Activity: Take home Assignment (10 minutes)

DEVIDE students in groups or individual.

ASK students to work on the following assignment

· Which hazards are associated with improper disposal of unfit medicines and cosmetic products?

ALLOCATE time for students to do the assignment and submit

REFER students to recommended references.

References

· MoHSW(2009),TFDA .guidelines for safe disposal of unfit medicines and cosmetic

products. (1^ST ed.). Dar-es-Salaam: Government Printer.

· MoHSW (2003), Tanzania Food, Drugs and Cosmetics Act section 99: powers to seize

forfeit, condemn and destruct unfit products, devices. 01, (pg71-72). Dar-es-Salaam:

Government printer.

· World Health Organization (1999),guidelines for safe disposal of unwanted

pharmaceuticals in and after emergencies. 12-25. Retrieved from

http://www.who.int/water_sanitation_health/medicalwaste/unwantpharm.

Handout 13.1: Model of Disposal Form

Model of Disposal Form

Form No………

(Pursuant to Section 99 of the Tanzania Food, Drugs and Cosmetics Act, 2003)

The Tanzania Food and Drugs Authority declares to have supervised the

disposal of unfit product (as per attached list) belonging to

M/S……………………………………………………………………………………………

of postal address……………………………………………………………………………

The destruction exercise was conducted at (location, site)

……………………………………………on this date ……………………………………...

by the following method(s) (state clearly):-

1……………………………………………………

2……………………………………………………

3……………………………………………………

The total weight of the products destroyed is ……………………………………… Kg

and value is ………………………………………. Tshs.

Name and signature of owner/in charge/representative of the organization:

…………………………………… …… …………………………………….

(Name) (Signature)

Names, title and signatures of Drug Inspector(s), other supervisor(s) and

Witness of the disposal exercise:-

Name: Title/Position: Signature & Date:

1………………………… ……. …………………….… ……………………

2……………………….... …………………. …………. ..…..………………

3………………………… …. ……………………. …… ……………………

4……………………….... . ……………………. ……… ……………………

5………………………... …. ……………………......... …………………….

Handout 13.2: Model of Certificate of Destruction

Model of Certificate of Destruction

Ref. No……………………………..… Date: ………………………..

THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003

CERTIFICATE OF DESTRUCTION

I, being the person in-charge with the administration of the law relating to the

Control of Pharmaceutical Products to which the Tanzania Food, Drugs and

Cosmetics Act, 2003 apply, hereby certify the destruction of expired

Pharmaceutical products belonging to..........................................................

of (Postal Address) ..................................................................... which took

place on.............................................................................................................

The said consignment was destroyed by............................................................

at........................................................... .....under the witness and supervision

of Drug Inspector, Environmental Officer, Health Officer and Police as

specified in the attached disposal form with S.No. .........................................

The weight of the whole lot disposed is ………………….. Kg and its value is

……………… Tshs.

..................................

Name and Signature of Director General

Background

Acknowledgment

Introduction

Target Audience

Organization of the Module

Preparation with Handouts and Worksheets

Using Students Manual When Teaching

Session1. Establishment, Functions, Organization Structure and Powers of the Pharmacy Council of Tanzania

Session 2: Requirements for Enlistment, Enrolment and Registration of Pharmaceutical Personnel

Handout 2.1: Enrolment of Pharmaceutical Technicians:

Handout 2.2. Requirements for registration of Pharmacist

Session 3: Requirements for Registration and Licensing of Premises for Pharmacy Business

Session 4: Historical Background of Pharmacy Practice

Session 5: Standards of Pharmacy Practice

Session 6: Code of Ethics and Professional Conduct for Pharmaceutical Practitioners

Session 7: Health Care Delivery and Referral System in Tanzania

Session 8: Medicines and Medical Supplies Provided at Different Levels of Health Care Delivery System

Handout 8.1: The National Essential Medicines List (NEMLIT)

Session 9: Roles of Pharmaceutical Personnel

Session 10: Laws Relating to Storage and Distribution of Medicines and Medical supplies

Session 11: Procedures for Handling of Unfit Medicines and Cosmetic products

Session 12: Sorting and Verification Exercise of Unfit Medicines and Cosmetic Products

Handout 12.1: Verification Form

Handout 12: Sorting Categories and their Recommended Methods of disposal

Session 13: Destruction of Unfit medicines and Cosmetic Products

Handout 13.1: Model of Disposal Form

Handout 13.2: Model of Certificate of Destruction

LCD ELCT CUHAS CEDHA	Liquid Crystal Display Evangelical Lutheran Church in Tanzania Catholic University Health and Allied Sciences Center for Educational Development in Health Arusha
MoHSW MoHCDGEC MUHAS	Ministry of Health and Social Welfare Ministry of Health, Community Development, Gender, Elderly and Children Muhimbili University Health and Allied Sciences
BRELA	Business Registrations and Licensing Agency
RP	Regional Pharmacist
DP	District Pharmacist
DLDM	Duka La Dawa Muhimu
FIN	Facility Identification Number
PIN	Person Identification Number
M²	Square meters
MTM MEMS	Medication Therapy Management Mission for Essential Medical Supplies
BC HKMU	Before Christ. Hurbert Kairuki Memorial University
WHO	World Health Organization
KCMC KSP	Kilimanjaro Christian Medical Centre Kilimanjaro School of Pharmacy
PPP NACTE	Describe public-Private Partnership National Council for Technical Education
NEMLIT	The National Essential Medicines List
USA UNHCR LZHRC	Unite State of America United Nations High Commissioner for Refugees Lake Zone Health Resource Center
I.V RuCU	Intra Venous Ruaha Catholic University
IU	International Unit
Alu	Artemether/Lumefantrine
DPQ	Dihydroartemisinin+Piperaquine
FFP	Fresh frozen plasma
PABA	Para aminobenzoic Acid
ORS	Oral Rehydration Salts
IUD JSI SIBS	Intra Uterine Devices John Snow Inc Spring Institute of Business and Sciences
BCG	Bacillus Calmette Guerin
DPT	Diphtheria-Pertussis- Tetanus
GSP	Good Storage Practices
GDP	Good Distribution Practices
TFDCA	Tanzania Food, Drug and Cosmetics Act
TFDA/HQ	Tanzania Food and Drug Authority Headquarter
TFDA	Tanzania Food and Drug Authority
PC	Pharmacy Council
PTIs	Pharmaceutical Training Institutions