Session 6: Prescription Errors

Total Session Time: 120 minutes + 1 hour assignment

Prerequisites

· None

Learning Tasks

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

· Define prescription error

· List common prescription errors

· Identify common prescriptions errors

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board chalk, and whiteboard markers

· Worksheet 6.1: Prescription Errors

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	10minutes	Presentation Brainstorming	Definition of Prescription Error
3	30 minutes	Presentation Buzzing	Common Prescription Errors
4	60minutes	Presentation Small Group Discussion	Identification of Common Prescription Errors
5	05 minutes	Presentation	Key Points
6	05 minutes	Presentation	Evaluation
7	05 minutes	Presentation	Assignment

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 Prescription Errors (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What is a prescription error?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

· Prescription errors encompass those related to the act of writing a prescription

· Prescribing faults encompass irrational prescribing, inappropriate prescribing, under prescribing, overprescribing, and ineffective prescribing

o These faults arise from erroneous medical judgement or decisions concerning treatment or treatment monitoring

STEP 3: Common Prescription Errors (30 minutes)

Activity: Buzzing (5 minutes)

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

· What are the common Prescription Errors?

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 the content below

The following are the common prescription errors:

· Omission error

· Wrong dose error

· Extra dose error

· Wrong dose form error

· Wrong time error

· Wrong drug

· Wrong route of administration

· Wrong frequency

· Wrong duration of treatment,

· Poor legibility of handwriting (unknown abbreviations)

· Unintended omissions

· Incomplete Medical Prescription (If any component of a Medical Prescription is not filled)

STEP 4: Identification of Common Prescription Errors (60 minutes)

Activity: Small Group Discussion ( 40 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the errors in the provided prescriptions?

REFER students to Worksheet 6.1 Prescription Errors SERIAL No. 001-005

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using the contents below

Students should be able to identify the following Prescription errors:

· Serial No.001

o Incomplete name of the patient

o No signature

o Duration of medicine missing (erythromycin)

o Wrong frequency of paracetamol

· Serial No. 002

o Name of the institution is not known

o Strength of paracetamol is not known

o Prescriber’s name is missing

· Serial No.003

o Age of the patient is missing

o Polypharmacy- no need to dispense two analgesics (paracetamol and aspirin)

o Atenolol strength is not 5.0 but there is 50 mg or 100 mg, mistake in writing

· Serial No.004

o Sex is not indicated (gender)

o Doxycycline and magnesium should not be given together, they interact each other

o Magnesium strength is not shown

· Serial No.005

o No date

o Tetracycline Bd ×2/52

o Wrong medicine for the indication i.e. amoebiasis is treated with Nitronidazole (Metronidazole, Ttinidazole, Secnidazole)

o Medicine does not tell the dosage form i.e. is it tablet, ointment capsule.

o Drug name should be generic and not trade name (Tulizamol should be written as Paracetamol)

STEP 5: Key Points (5 minutes)

· Medication errors are common in general practice and in hospitals.

· Both errors in the act of writing (prescription errors) and prescribing faults due to erroneous medical decisions can result in harm to patients

· Any step in the prescribing process can generate errors

· Inadequate knowledge or competence and incomplete information about clinical characteristics and previous treatment of individual patients can result in prescribing faults, including the use of potentially inappropriate medications

STEP 5: Evaluation (5 minutes)

· What are prescription errors?

· What are the common prescription errors?

References

Cornish, P.L, Knowles, S.R, Marchesano, R, Tam, V, Shadowitz, S, Juurlink, DN, Etchells, E, E. (2005). Arch Intern Med: Unintended medication discrepancies at the time of hospital admission. 2005;165:424–9.

Dean, B., Schachter, M., Vincent, C, Barber, N (202). Lancet: Causes of prescribing errors in hospital inpatients: a prospective study. 359:1373–8.

Dean, B., Vincent, C, Schachter, M., Barber, N (2005). Drug Saf:The incidence of prescribing errors in hospital inpatients: an overview of the research methods.. 28:891–900.

Knudsen, P., Herborg, H., Mortensen, A,R., Knudsen, M., Hellebek, A .(2007). Qual Saf Health Care:Preventing medication errors in community pharmacy: root-cause analysis of transcription errors. 16:285–290.

Lesar, T.S., Briceland, L., Stein, D, S. (1997). JAMA:Factors related to errors in medication prescribing.. 277:312–317.

Spinewine, A., Schmader, K,E., Barber, N., Hughes, C., Lapane, K,L., Swine, C., Hanlon, J,T. (2007). Lancet: Appropriate prescribing in elderly people: how well can it be measured and optimised? 370:173–184.

Tam, V,C., Knowles, S,R., Cornish, P,L., Fine., Marchesano, R., Etchells, E,E. (2005). CMAJ: Frequency, type and clinical importance of medication history errors at admission to hospital: a systematic review..173:510–5.

Velo, G, P., & Minuz, P. (2009). British Journal of Clinical Pharmacology: Medication errors: prescribing faults and prescription errors. 67:6

Worksheet 6 .1: Prescription Errors Serial No. 001-005

Serial Na. 002
Name:	Mariam Juma
Gender:	Me
Age:	20Yrs
Weight:	60kg
Rx	Amoxicillin 500mg tds 7/7
	Paracetamol Tabs 100g tds 3/7
qualification	CO
Signature	10/07/2015

Serial Na. 001 KIHESA HEALTH CENTER P.O. Box 558 IRINGA
Name:	John
Gender:	Me
Age:	20Yrs
Weight:	60kg
Rx	Erythromycin tabs 500mg q.i.d
	Paracetamol Tabs 1g Bd 3/7
Prescriber’s name qualification	Masige Kahwa Malimbo MO 11/09/2015

Serial Na. 003 KIHESA HEALTH CENTER P.O. Box 558 IRINGA
Name:	Salum Hussein
Gender:	Me
Weight:	60kg
Rx	Asprin 300mg tds 7/7
	Paracetamol Tabs 1g tds 3/7 Atenolol 5.0mg Od 1/30
Prescriber’s name qualification	Masige Kahwa Malimbo MO
Signature	20/04/2015

Serial Na. 004 KIHESA HEALTH CENTER P.O. Box 558 IRINGA
Name:	Kalunde Athuman
Age:	20Yrs
Weight:	60kg
Rx	Doxycycline100 Bd 7/7
	Magnisium Tricylicate tds 3/7
Prescriber’s name qualification	Ulimbo Ole MO
Signature	17/02/2015

Serial Na. 005 KIHESA HEALTH CENTER P.O. Box 558 IRINGA
Name:	John
Gender:	Me
Age:	20Yrs
Weight: Dx	60kg Amoeba
Rx	Tetracyclin Bd 2/52
	Tulizamol Tabs 1g tds 3/7
Prescriber’s name qualification	Masige Kahwa Malimbo MO

Session 7: Dispensing Procedures in Pharmacy

Total Session Time: 120 minutes

Prerequisites

· Session 1

Learning Tasks

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

· Define dispensing, dispenser, medicine and good dispensing procedures

· Explain good dispensing procedures

· Demonstrate good dispensing procedures

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk, and whiteboard markers

· Worksheet 7.1: Demonstration on Good Dispensing Procedures

· Worksheet 7.2: Sample Prescription Serial No. 001

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	10 minutes	Presentation	Definition of Dispensing, Dispenser, Medicine and Good Dispensing Procedures
3	35 minutes	Presentation Brainstorming	Good Dispensing Procedures
4	60 minutes	Presentation Role play	Demonstration of Good Dispensing Procedures
5	05minutes	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 tasks and clarify

ASK students if they have any questions before continuing.

Step 2: Define Dispensing, Dispenser, Medicine and Good Dispensing Procedures (10 minutes)

· Dispensing: The act of preparing medicines and/or medical supplies and distributing to users with adequate information, counseling and appropriate follow up

· Dispenser: Any person who is licensed or authorized by the appropriate body to dispense medicines and/or medical supplies

· Medicine: Any substance or mixture of substances used in the diagnosis, treatment, mitigation or prevention of a disease in human

o Medicines include narcotic drugs, psychotropic substances and precursor chemicals, traditional medicines, complementary or alternative medicine; poisons, blood and blood products, vaccine, radioactive pharmaceuticals, cosmetics and sanitary items and medical instruments

· Good Dispensing Procedures: Refers to the delivery of the correct medicine to the right patient, in the required dosage and quantities, in the package that maintains acceptable potency and quality for the specified period, clear medicine information counseling and appropriate follow up

STEP 3: Good Dispensing Procedures (35 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What procedures to follow in Good Dispensing?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

Dispensing Procedures

· Procedure 1: Evaluation and interpretation of a prescription

In this step a dispenser should do the following after welcoming and greeting the patient;

o Make sure that all important parts of the prescription are correct and complete (refer session 1)

o Arrange prescriptions in order so as to prevent possibility of confusion

o Dispenser should have knowledge of transcribing the prescription

o Make sure that the name of the medicine, dose, dosage, duration are correct

o The prescription should be in writing or typed but must be signed by the prescriber in ink

· Procedure 2: Selection and handling of the medicine. This includes:

o Select stock container of pre-pack reading the label and cross matching the medicine name and strength against the prescription

o Read the container label at least twice during the dispensing process.

o Do not select the prescribed medicine according to the color or location of container

o Do not open many stock containers at the same time

§ This trend will lead to errors and/or expose the medicines to air and eventually leads to deterioration in quality

o Open and close containers once at a time

o While counting, pouring or measuring, the following points should be noted:

§ Short and/or over counting should be avoided

§ Clean counting tray and/or spoon used

§ Graduated measuring cylinder and/or flask must be used for measuring liquid reduction

§ If small volume is to be measured, small measuring cylinder/flask has to be used (if compounding is performed in the pharmacy) provide appropriate bottles with caps for repackaging liquid preparations

o Dispense liquid preparations in suitable container

§ Do not use patient’s own bottle

§ Dispense each medicine in a different bottle

In dispensing tablets and capsules:

Do not use fingers to count tablets as this can lead to contamination of medicines
Use a spoon to put tablets and capsules onto a counting tray
Count and put them in a labeled medicine container or pack
Close stock containers tightly after dispensing
Keep the spoon clean at all times
Do not keep the spoon inside the container
Labeling of dispensed medicines should be clear and legible
Use separate plastic boxes for different patient's requirements of medicines

To avoid mix-ups of medicines of different patients, it is a good procedure to assemble medicines of different patients in separate/different boxes, till they are billed and packed

· Procedure 3: Labeling and packaging of the medicine in an appropriate container

The containers used for dispensing must be appropriate for the product dispensed
All containers intended for medicinal products must be protected and kept free from contamination
Medicines must be suitably contained, protected and labeled from the time of manufacture until they are used by the patient
The container must maintain the quality, safety and stability of the medicine throughout this period

· Procedure 4: The provision of information and instruction to client

All medicines should be dispensed with adequate and appropriate information and counseling. Information must be structured to meet the needs of individual patients and questions and answers should be used to check the patient understands.
Written information should be provided to supplement verbal communication as appropriate.

§ Counseling should ensure that the patient has an unequivocal understanding of the instructions for use, and any distinct characteristics or requirements of the medicine.

Counseling should cover matters that will enhance or optimize medicine therapy. The information in the form of verbal and/or written instructions should include the following:

§ How much and how often to take the medicine

§ When to take the medicine (e.g., before or after meals)

§ How long the treatment is to last (e.g., why the entire course of an antibiotic treatment must be taken)

§ How to take the medicine (e.g., with water, chewing or swallowing)

§ How to store the medicine (e.g., avoid heat, light and dampness, keep out of reach of children)

§ Not to share medicines with other persons

§ Which types of foods and beverages should avoid while taking the medicine

§ One has to demonstrate to the patient on how to administer the dispensed medications in case of inhaled administration and suppository application

§ Patients should also be informed not to stop treatment when side effects occur or in the absence of response without consulting the prescriber or dispenser

§ Finally, check whether patients have understood the information

· Procedure 5: Recording the transaction

o Prescriptions should be recorded and documented as proof of transaction between the patient and the dispenser

§ Prescriptions can therefore be traced back if any need arises

§ All dispensing units should have a standardized Prescription Registration Book (PRB) for recording every pharmaceutical issued to a patient

o A computerized dispensing and registration system may also be used, but should always be supported by paper back up

§ The registration book should be completed at the time of dispensing or at the close of the working day

o The prescription registration book should be used both when prescriptions are retained in the pharmacy and when they are returned to the patient

§ For a prescription which is returned to a patient because all the items in the original prescription could not be filled, the medicines that have been dispensed from the pharmacy should be copied on a blank prescription and the prescription should be filed appropriately

o On the original prescription, which is retained by the patient, the word “dispensed” should be stamped adjacent to those items which have been dispensed

o For prescriptions which are to be refilled on a later date, the dispensing information should be entered into the registration book before returning the prescription to the patient

§ The official seal of the pharmacy/Health institution, name and signature of the dispenser, the date of dispensing and the next refill date should be written on the back of the prescription

Source: FMHACA (2012)

Figure 1: Pictorial presentation of dspensing procedure

STEP 4: Demonstration of Good Dispensing Procedure (60 minutes)

Activity: Role Play (30 minutes)

EXPLAIN that this will be a role play between a patient and a dispenser. One volunteer student will play as dispenser and will demonstrate the necessary steps of Good Dispensing Procedures through and dispensing medicines to the patient, who will be another student volunteer.

ASK two students to volunteer playing as dispenser and patient respectively.

TELL the rest of students to observe carefully on the procedures of Good Dispensing

EXPLAIN that the patient will handle the prescription to the dispenser and wait for the medicine. The dispenser should follow all Good Dispensing procedures for dispensing medicine..

EMPHASIZE that the Dispenser should follow all the guides and steps of Good Dispensing procedures.

START the role play.

LEAD a discussion after the role play.

DE-ROLE all the students, once the role play is over.

ASK students if they have any questions about the role play.

Refer student volunteer to Worksheet 7.1: Demonstration so that he/she can read the description of the dispenser

Refer students to Worksheet 7.2: Sample Prescription Serial No. 001

STEP 5: Key Points (5 minutes)

· Dispensing refers to the process of preparing medicines and distributing to users with provision of an appropriate information, counseling and follow up

· Good dispensing procedures ensure that the correct medicine is delivered to the right patient, in the required dosage and quantities, with clear instructions, and in package that maintains an acceptable potency and quality of the medicine

· The medicine should be dispensed in a safe and hygienic manner, making sure that the patient or care provider understands and appreciates the value of taking specific medicines for specific indications

STEP 6: Evaluation (5 minutes)

· What is dispensing?

· What is Medicine ?

· Which are the Good Dispensing Procedures?

References

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS.

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia

GoT (1998). Tanzania National Formulary (1st ed.). Dar es salaam, Tanzania: MOHSW.

Worksheet 7 .1: Role Play Demonstration on Good Dispensing Procedures

Script:

Your role is to dispense the medicines to a patient who hands the prescription. you should follow all good dispensing procedures principles as you receive the prescription from the patient.

· Greet the patient

· Receive the prescription from the patient

· Read the prescription and interpret and understand

· Prepare and select medicines as per given prescription

o Erythromycin Tablets 500mg qid 7/7

o Paracetamol Tablets 1g tds 3/7

· Calculate total quantity of each medicine

o Erythromycin Tablets: 2 Tablets X 4 times a day X 7 days = Pack 56 Tablets

o Paracetamol Tablets: 2 Tablets X 3 times a day X 3 days = Pack 18 Tablets

· Write a label for each medicine then pack according to calculations above

· Record in dispensing register

· Call a patient by name and give instructions on how to use medicines

o Erythromycin Tablets: Take two tablets after every 6 hours for 7 days, swallow with water after meals.

o Paracetamol Tablets: Take two tablets after every 8 hours for 5 days, swallow with water.

o You may experience stomach upsets because of medicines given unless is severe report back to hospital

· Ask the patient to repeat information given for checking understanding

· Wish a patient quick recovery

Worksheet 7.2: Sample Pescription Serial No. 001

Serial Na. 001 KIHESA HEALTH CENTER P.O. Box IRINGA
Name:	John Kalunde
Gender:	Me
Age:	20Yrs
Weight:	60kg
Rx	Erythromycin tabs 500mg q.i.d 7/7
	Paracetamol Tabs 1g tds 3/7
Prescriber’s name qualification	Masige Kahwa Malimbo MO
Signature

Session 8: Determining Quantities of Medicine for Dispensing

Total Session Time: 120 minutes + 1 hours Assignment

Prerequisites

· Session 1, 5 and 6

Learning Tasks

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

· Interpret Information in the Prescription for Medicine Quantities for Dispensing

· Determine Quantities of Tablets/Capsules to be Dispensed

· Determine Eye/Ear/Nasal Preparations to be Dispensed

· Determine Quantities of Injectable Medicine to be Dispensed

· Determine Quantities of Ointment/cream to be Dispensed

· Determine Quantities of Syrup to be Dispensed

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and whiteboard markers

· Worksheet 8.1: Determine quantities of tablets and capsules to be dispensed

· Worksheet 8.2: Determine eye/ear/nasal preparations to be dispensed

· Worksheet 8.3: Determine quantities of injectable medicine to be dispensed

· Worksheet 8.4: Determine quantities of ointment and cream to be dispensed

· Worksheet 8.5: Determine quantities of syrup and solution to be dispensed

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	10 minutes	Presentation	Interpretation of Information for Medicine Quantities to be Dispensed
3	20 minutes	Presentation Case study	Quantities of Tablet and Capsule to be Dispensed
4	20 minutes	Presentation Case study	Quantities of Eye/Ear/Nasal Preparations to be Dispensed
5	20 minutes	Presentation Case study	Quantities of Injectable Medicines to be Dispensed
6	20 minutes	Presentation Case study	Quantities of Ointment/Cream to be Dispensed
7	15 minutes	Presentation Case study	Quantities of Syrup to be Dispensed
8	05 minutes	Presentation	Key Points
9	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 tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Interpretations of Information in the Prescription for Medicine Quantities to be Dispensed (10 minutes)

· Whenever a dispenser is required to dispense medicines, make sure always to;

· Identifying different information which provides information about medicines to be dispensed

· Interpret of information of the prescriber so you can get quantities of medicine to be dispensed

· Example: In a certain prescription of a specific patient the following medicines were prescribed:

· Paracetamol tabs 1g tds x 5/7

· Amoxicillin caps 500mg tds x 5/7

Interpretation:

· One Paracetamol tablet has a dosage strength of 500mg, so 1g means 2 tablets of Paracetamol

o Thus calculation is 2 tablets x 3 times a day x 5 days = 30 tablets of Paracetamol

o Therefore the patient will receive 30 tablets of Paracetamol

· One Amoxicillin capsule has dosage strength of 250mg, so 500mg means 2 capsules

o Thus 2 tablets of Amoxicillin x 3 times a day x 5 days = 30 tablets of Amoxicillin

o Therefore the patient will receive 30 capsules of Amoxicillin

STEP 3: Quantities of Drug to be Dispensed - Tablets and Capsules (20 minutes)

Activity: Case Study (15 minutes)

DIVIDE students into small manageable groups.

REFER students to Worksheet 8.1: Calculating quantities of tablets and capsules

READ or ASK one student to read the scenario in the worksheet and CLARIFY

ASK all groups to answer the three questions in the worksheet for 15 minutes.

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

CLARIFY and SUMMARIZE by using the content below

The Calculations

· A Paracetamol tablet has dosage strength of 500mg, so 1g means 2 tablets of Paracetamol

o One unit of Paracetamol tablet means one tablet, thus calculation for the total quantity Paracetamol tablets is 2 tablets x 3 times a day x 5 days = 30 tablets of paracetamol

o Thus dispense total of 30 tablets of paracetamol

· Ampiclox capsule has strength of 500mg, so 500mg means 1 capsule

o One unit of Ampliclox capsule means one capsule.

o Thus total quantity of Ampiclox Capsules to be dispensed is:

1 tablets x 3 times a day x 5 days = 15 capsules

o Therefore dispense a total of 15 capsules of Ampiclox Capsules

STEP 4: Calculation of Quantities of Drug to be Dispensed – Ear and Eye Preparations (20 minutes)

Activity: Case Study (15 minutes)

DIVIDE students into small manageable groups.

REFER students to Worksheet 8.2: Calculating quantities of ear and eye preparations

READ or ASK one student to read the scenario in the worksheet and CLARIFY

ASK all groups to answer the three questions in the worksheet for 15 minutes.

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

CLARIFY and SUMMARIZE by using the content below

· Information given: Prednisolone Eye drops 0.5% is available in 5ml bottle and assume 20 drops in 1ml

Calculation for Prednisolone:

o Firstly calculate total number of drops of prednisolone needed in 14 days as follows:

1drop x 4 times a day x 14 days = 56 drops

o Then calculate number of mLs containing 56 drops of prednisolone

Iml = 20 drops

? mls = 56 drops

= 56 drops/20drops x 1 ml

= 2.8mls

o Dispense one bottle of 5mls of prednisolone.

§ The patient should discard the remained prednisolone (2.2mls) after finishing the dose required (2.8ml)

· Information given: Sodium Cromoglycate 2% is available in 5ml bottle. Assume 20 drops is 1ml

Calculation for Sodium Cromoglycate:

o Firstly calculate total number of drops of Sodium Cromoglycate needed in 90 days as follows:

1drop x 4 times a day x 90 days = 360 drops

o Then calculate number of mLs containing 360 drops

Iml = 20 drops

? mls = 360 drops

= 360 drops/20drops x 1 ml

= 18mls

o Therefore 4 bottles of sodium cromoglycate, each of 5mls will be dispensed to Ana Kalunde for the total dose of 18ml to be completed, discarding the remainder

· Information given: Boric Acid Ear drops 0.5% is available in 2ml. Assume 20 drops is 1ml Calculation for Boric Acid:

o Firstly calculate total number of drops of boric acid needed in 7 days as follows:

1drop x 3 times a day x 7 days = 21 drops

o Then calculate number of mLs containing 21 drops of Boric Acid

Iml = 20 drops

? mls = 21 drops

= 21 drops/20drops x 1 ml

= 1.05mls

o Therefore dispense for Benard Sanga 1 bottle of Boric Acid Ear drop with information that he should discard remaining medicine after 7 days

· Ephedrine Nasal drops 0.5% is available in 2ml. Assume 20 drops is 1ml

Calculation for Ephedrine

Firstly calculate total number of drops of ephedrine needed in 7 days as follows:

1drop x 3 times a day x 7 days = 21 drops

Then calculate number of mLs containing 21 drops of ephedrine

Iml = 20 drops

? mls = 21 drops

= 21 drops/20drops x 1 ml

= 1.05mls

Therefore, dispense for Hadija Hamis 1 bottle of Ephedrine Nasal drop with information that he should discard remaining medicine after 7 days

STEP 5: Calculation of Quantities of Drug to be Dispensed-Injectables (20 minutes)

Activity: Case Study (15 minutes)

DIVIDE students into small manageable groups.

REFER students to Worksheet 8.3: Calculating quantities injectables

READ or ASK one student to read the scenario in the worksheet and CLARIFY

ASK all groups to answer the three questions in the worksheet for 15 minutes.

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

CLARIFY and SUMMARIZE by using the content below

· For Diclofenac Injection:

Information given: One ampoules of 3mls contains 75mg of Diclofenac injection, But the required prescription is 150mg od for 3 days
Calculation: 2 ampoules x once daily x 3 days
2 ampoules x 1 x 3
6 diclofenac ampoules

o Therefore dispense 6 diclofenac ampoules

· For Gentamicin injection:

Information given: One ampoule of 2ml contains 20mg of Gentamicin injection
But required prescription is 40 mg three times daily for five days
Calculations: 40mg x 3 times daily x 5days

2 ampoules x 3 x 5

= 30 ampoules

Thus dispense 30 ampoules of gentamicin

STEP 6: Calculation of Quantities of Drug to be Dispensed- Ointment and Cream (20 minutes)

Activity: Case Study (10 minutes)

DIVIDE students into small manageable groups.

REFER students to Worksheet 8.4: Calculating quantities of ointment and cream

READ or ASK one student to read the scenario in the worksheet and CLARIFY

ASK all groups to answer the two questions in the worksheet for 10 minutes.

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

CLARIFY and SUMMARIZE by using the content below

· The Calculations

§ Clotrimazole Ointment; Assuming the amount to be squeezed out of the tube for one application is 1g, and

§ The unit to dispense for Clotrimazole Ointment is a tube of 20g

§ Thus calculation for Clotrimazole Ointment for a single application is (1g) × 2 times a day x 7 days = 14g

§ Therefore the patient will be given 1 tube of Clotrimazole Ointment, as it contains 20g

STEP 7: Calculation of Quantities of Drug to be Dispensed-Syrup and Solutions (15 minutes)

Activity: Case Study (10 minutes)

DIVIDE students into small manageable groups.

REFER students to Worksheet 8.5: Calculating quantity of syrup and solutions

READ or ASK one student to read the scenario in the worksheet and CLARIFY

ASK all groups to answer the three questions in the worksheet for 10 minutes.

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

CLARIFY and SUMMARIZE by using the content below

· The Calculations:

§ Amoxicillin syrup has strength of 125mg/5ml, so 1 teaspoonful = 125mg syrup

§ Paracetamol syrup has strength of 120mg/5ml, so 1 teaspoonful = 120mg syrup

§ The unit to dispense for Amoxicillin syrup is a bottle of granules to be reconstituted to 100ml and a unit to dispense for Paracetamol syrup is a bottle of 100ml syrup

§ Thus calculation for Amoxicillin syrup is 5ml x 3 times a day x 5 days = 75ml and

§ Calculation for Paracetamol syrup is 5ml x 3 times a day x 5 days = 75ml

§ Therefore Pack for patient 1 bottle of reconstituted Amoxicillin syrup and 1 bottle of Paracetamol syrup

STEP 8: Key Points (5 minutes)

· In order to determine the quantities of medicines to be dispensed, it is important to understand the information which provided in a prescription that provides information about medicines to be dispensed

· The information must be interpreted correctly to lead a dispenser to correct calculation to get quantities of medicine to be dispensed

· The quantities to be dispensed are determined through correct calculation as given in different scenario done in this session

STEP 9: Evaluation (5 minutes)

· What are the information that will determine the total quantity of tablets and capsules to be dispensed?

· What are the information that will determine the total quantity of ear/eye/nasal preparations to be dispensed?

· What are the information that will determine the total quantity of injectables to be dispensed?

· What are the information that will determine the total quantity of creams and ointments to be dispensed?

References

Ansel, H. C. (2010). Pharmaceutical Calculations (13th ed.). Philadelphia, United States: LWW

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS.

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia

Worksheet 8.1: Calculating Quantities of Tablets and Capsules to be Dispensed

Scenario:

A patient Called Juma Said brought a prescription at a dispensing pharmacy which was written as follows;-

1. Ampiclox Caps 500mg tds 5/7

2. Paracetamol Tabs 1g tds 5/7

Students Leaning Tasks

By the end of the case study activity, students are expected to:

· Interpret the information given in a prescription

· Make decision of a unit to be dispensed that implies the correct amount of

· Calculate the total quantities of medicine to be dispensed

Questions

What is the total Ampiclox capsules should be dispensed?

___________________________________________________________

What is the total Paracetamol tablets should be dispensed?

___________________________________________________________

What dispensing unit will you dispense for Juma Said?

___________________________________________________________

Worksheet 8.2: Calculating Quantities of Eye/Ear/Nasal to be Dispensed

Scenario:

A patient Called Anna Kalunde brought a prescription at a dispensing pharmacy which was written as follows;-

1. 1 gtt Predinisolone 0.5% qid BE 2/52

2. 1 gtt Sodium Cromoglycate 2% qid BE 3/12

Another patient Called Benard Sanga brought a prescription at a dispensing pharmacy which was written as follows;-

1. 1 gtt Boric Acid 0.5% aur.dextr tds 7/7

Another patient Called Hadija Hamis brought a prescription at a dispensing pharmacy which was written as follows;-

1. 1 gtt Ephedrine 0.5% ad.aur tds 7/7

Students Leaning Tasks

By the end of the case study activity, student will be able to:

· Interpret the information given in a prescription

· Make decision of a unit to be dispensed that implies the correct amount of medicine.

· Calculate the total quantities of medicine to be dispensed

Questions

What is the amount of Predinisolone and Sodium Cromoglycate eye drops should be dispensed?

___________________________________________________________

What is the amount of Boric Acid Ear drops and Ephedrine Nasal drops should be dispensed?

___________________________________________________________

What dispensing unit will you dispense for Anna Kalunde, Benard Sanga and Hadija Hamis?

___________________________________________________________

Worksheet 8.3: Calculating Quantities of Injectables to be Dispensed

Scenario:

A Nurse has a file of patient Called Mwanaisha Kilimo with a prescription written as follows;-

1. Diclofenac 150mg od x3/7

2. Gentamycine 40mg x tds5/7

3. (you have Diclofenac ampule 75mg/3mil, Gentamycine 20mg/2mil)

Students Leaning Tasks

By the end of the case study activity, student will be able to:

· Interpret the information given in a prescription

· Make decision of a unit to be dispensed that implies the correct amount of medicine.

· Calculate the total quantities of medicine to be dispensed

Questions

What is the total amount of Diclofenac injection should be dispensed?

___________________________________________________________

What is the total amount of Gentamycine injection should be dispensed?

___________________________________________________________

What dispensing unit will you dispense for Mwanaisha Kilimo?

___________________________________________________________

Worksheet 8.4: Calculating Quantities of Ointments and Creams to be Dispensed

Scenario:

A patient Called Jumanne John brought a prescription at a dispensing pharmacy which was written as follows;-

1. Apply Clotrimazole Ointment b.d 7/7

Students Leaning Tasks

By the end of the case study activity, student will be able to:

· Interpret the information given in a prescription

· Make decision of a unit to be dispensed that implies the correct amount of medicine.

· Calculate the total quantities of medicine to be dispensed

Questions

What is the total amount of Clotrimazole Ointment should be dispensed?

___________________________________________________________

What dispensing unit will you dispense for Jumanne John?

___________________________________________________________

Worksheet 8.5: Calculating Quantities of Syrups and Solutions to be Dispensed

Scenario:

A Mother with a child called Anisha Juma brought a prescription at a dispensing pharmacy which was written as follows;-

1. Amoxicillin Syp 5 ml tds 5/7

2. Paracetamol Syp 5 ml tds 5/7

Students Leaning Tasks

By the end of the case study activity, student will be able to:

· Interpret the information given in a prescription

· Make decision of a unit to be dispensed that implies the correct amount of medicine.

· Calculate the total quantities of medicine to be dispensed

Questions

What is the total amount of Amoxicillin syrup should be dispensed?

___________________________________________________________

What is the total of Paracetamol syrup should be dispensed?

___________________________________________________________

What dispensing unit will you dispense for Anisha Juma?

___________________________________________________________

Session 9: Medicines Packaging Materials

Total Session Time: 120 minutes

Prerequisites

· None

Learning Tasks

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

· Define Packaging Material for Medicines to be Dispensed

· Explain Importance of Packaging Materials for Medicines to be Dispensed

· List Different types of Packaging Material for Medicines to be Dispensed

· Describe Features of Suitable Packaging Materials

· Select and Use Suitable Packaging Material for Medicines to be Dispensed

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and whiteboard markers

· Samples of Packaging Materials

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	05 minutes	Presentation	Definition of Packaging Material for Medicines
3	10 minutes	Presentation Buzzing	Importance of Packaging Materials for Medicines
4	15 minutes	Presentation Brainstorming	Types of Packaging Material for Medicine to be Dispensed
5	35 minutes	Presentation Small Group Discussion	Features of Suitable Packaging Material for Medicine
6	35 minutes	Presentation Small Group Discussion	Selection and Usage of Suitable Packaging Material for Medicines
7	05 minutes	Presentation	Key Points
8	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 Packaging Material for Medicine to be Dispensed (5 minutes)

· All medicinal products need to be protected and consequently need to be packaged in containers that conform to prescribed standards particularly with respect to the exclusion of moisture and light and the prevention of leaching of extractable substances into the contents and of chemical interaction with the contents

· Packaging material: Any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment

Primary packaging materials are those that are in direct contact with the product

· Packaging may be defined as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from the time of production until its use

· Prepackaging: Is the process by which the pharmacy professional transfers a medication manually from a manufacturer's original commercial container to another type of container in advance (before clients come to medicine retail out lets)

STEP 3: Importance of packaging materials for medicines (10 minutes)

Activity: Buzzing (5 minutes)

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

· What are the importances of packaging materials for medicine?

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 the content below

· Importance of medicine packaging material

§ Containment: This requires the packaging:

§ not to leak, nor allow diffusion and permeation of the product;

§ to be strong enough to hold the contents when subjected to normal handling

§ Not to be altered by the ingredients of the formulation in its final dosage form

§ Protection: The packaging must protect the product against all adverse external influences that may affect its quality or potency, such as:

§ Light

§ Moisture

§ Oxygen

§ Biological contamination

§ Mechanical damage

§ The compatibility: Of the packaging with the active pharmaceutical ingredients is very important in maintaining the integrity of the product

§ Stability: it is necessary to know the possible interactions between the container and the contents

§ The packaging itself should not interact with it so as to introduce unacceptable changes

§ Importance of closures is to prevent moisture to reach moisture-sensitive medicines and also prevent loss of moisture from creams and other water-containing medicines such as ointments and pastes

STEP 4: Types of Packaging Material for Medicine to be Dispensed (15 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What are the types of Packaging materials for medicines?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

The following are different types of packaging materials for medicines;

· Ampoule: A container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one occasion only

· Bag: A container consisting of surfaces, whether or not with a flat bottom, made of flexible material, closed at the bottom and at the sides by sealing; the top may be closed by fusion of the material, depending on the intended use

· Blister: A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses

o Strips are excluded

· Bottle: A container with a more or less pronounced neck and usually a flat bottom.

o They can be glass or plastic

· Cartridge: A container, usually cylindrical, suitable for liquid or solid pharmaceutical dosage forms; generally for use in a specially designed apparatus (e.g. a prefilled syringe)

· Injection needle: A hollow needle with a locking device intended for the administration of liquid pharmaceutical dosage forms

· Injection syringe: A cylindrical device with a cannula-like nozzle, with or without a fixed needle and a movable piston, used for the administration, usually parenteral, of an accurately measured quantity of a liquid pharmaceutical form

o The syringe may be prefilled, and can be for single-dose or multi-dose use

· Pressurized container: A container suitable for compressed, liquefied or dissolved gas fitted with a device that, after its actuation, produces a controlled spontaneous release of the contents at atmospheric pressure and room temperature

· Single-dose container: A container for single doses of solid, semi-solid or liquid preparations

· Strip: A multi-dose container consisting of two layers, usually provided with perforations, suitable for containing single doses of solid or semi-solid preparations. Blisters are excluded

· Tube: A container for multi-dose semi-solid pharmaceutical forms consisting of collapsible material and its contents are released via a nozzle by squeezing the package

· Vial: A small container for parenteral medicinal products, with a stopper and over seal and the contents are removed after piercing the stopper

o Both single-dose and multi-dose types exist

STEP 4: Features of Suitable Packaging Materials (35 minutes)

Activity: Small Group Discussion (15 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the desirable features of Packaging materials?

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using the contents below

The following are desirable features for packaging materials:

· The container should protect the contents from physical and mechanical hazards such as:

o Variation due to transportation

o Compression due to pressure applied during stacking or storage

o Shock due to impact, drops or rapid deceleration

o Puncture due to penetration from sharp objects or during handling operations

o Abrasion

· The container’s material should not interact with the product and vice versa.

o Interactions include migration, absorption, adsorption or extraction whereby ingredients either from the product or container are lost or gained. There are numerous possibilities of interactions between (primary) packaging materials and pharmaceutical products, such as:

§ the release of chemicals from components of the packaging materials

§ the release of visible and/or sub visible particles

§ the absorption or adsorption of pharmaceutical components by the packaging materials

§ Chemical reactions between the pharmaceutical product and the packaging materials

· The degradation of packaging components in contact with the pharmaceutical products

· Container should protect the contents from atmospheric gases

o Oxygen supports the growth of micro-organisms, as well as being involved in oxidation processes

o Carbon dioxide may cause pH shifts or a chemical reaction if absorbed by a liquid formulation

· The container must be capable of withstanding extremes of temperature and humidity.

o Protect the contents from both water loss and gain

§ Moisture gain may cause chemical reactions, encourage microbial growth or cause physical changes, e.g. softening of gelatin capsules

§ Moisture loss from a product may cause creams to contract and develop a rubbery feel, and solutions to concentrate

o Protect the contents from loss of volatile materials

o The loss of excipients such as alcohol and chloroform will concentrate the product or reduce its preservative content

· Protect the contents from light

o Many drugs are photosensitive and degraded in the presence of light

· Protect the contents from airborne particulate contamination

o contamination can be microbiological (bacteria, moulds or yeasts) or can be solid matter such as dirt, dust, hair, fibres

· Protect the product from animal contaminations, e.g. rodents and insects

· The container should not shed particles into the contents. E.g. spicules from glass bottles and metal flakes from metal ointment tubes

· The container should have a ‘pharmaceutically elegant’ appearance.

· Should be easy to label and thus to identify the product correctly.

· The container should be convenient and easy to use

o The container should be cheap and economical

STEP 6: Select and use suitable packaging material for medicines (35 minutes)

Activity: Small Group Discussion ( 15 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· Which packaging materials are suitable for packing of the following medicine?

o Tablets and capsules?

o Liquids?

o Ointment and creams?

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using the contents below

· The selection of packaging for medicines depends on:

Nature of the medicine
Type of patient
Dosage form
Method of administering the medicine
Required shelf-life
Use

The following are the types of packaging materials for medicines:

— Glass materials: Traditional packaging material widely used for both liquid and solid dosage forms

o Advantages:

§ It can be moulded to a rigid construction in a variety of shapes and sizes

§ It is available in clear or amber (light-resistant) forms

§ It can be sealed hermetically or by removable closures

§ It is impermeable to moisture and atmospheric gases

§ It is cheap and readily available

§ It is easily labelled

o Disadvantages:

§ It is fragile – easily breaking when dropped or knocked

§ It is heavy, which means transportation costs are high

§ It may release alkali to aqueous contents

· Plastic containers: Plastic is a collective term used for a variety of polymeric materials used for containers and closures

§ Advantages:

§ Flexible nature

§ Less brittle than glass

§ Lightweight –therefore transportation costs are cheaper than glass

§ Can be molded into a multiple of shapes and sizes

§ Suitable for both container and closure

§ Readily available

§ Disadvantages:

§ Few will withstand heat without softening or distorting

§ Permeability to water vapour and atmospheric gases

§ May interact with certain chemicals to cause softening or distortion

§ May sorb substances, particularly preservatives, from solution

§ Leaching out of plasticizers and stabilizers into solutions

§ Relatively expensive

· Metal Containers: Metals used as pharmaceutical packaging materials include aluminum, tin and tin-coated lead

§ Advantages:

§ Lightness

§ Robustness

§ Impermeable to light, moisture and gases

§ Can be made into rigid, unbreakable containers or into collapsible tubes or foil

§ Labels can be printed directly onto their surface

§ Disadvantages:

§ Their chemical and electrochemical activity

§ They may shed metal particles into the pharmaceutical product

§ Expensive

§ Not generally available for extemporaneous dispensing

· Unit dose packaging: Unit dose packaging has become increasingly common

§ Advantages:

§ Hygienic

§ Tamper evident

§ Lightweight

§ Child resistant

§ Protects solid dosage forms from moisture and abrasion

§ Available as calendar packs to aid patient compliance

§ Wastage is reduced

§ Accurate volume can be administered

§ Disadvantages:

§ Expensive

§ Patients may experience difficulty in use

§ Machinery is required which may be suitable for industrial or hospital use only.

§ Types of unit dose packaging for oral medicines include strip packaging, blister packaging, oral liquid containers and dispensers

STEP 7: Key Points (5 minutes)

· The materials used for repackaging include: glass bottles, plastic bottles, collapsible tubes, paper envelops, plastic envelops. original containers may contain large amount of medicines, therefore repackaging of medicines into another container may be necessary in order to dispense medicines for patients.

· The function of a container for a medical preparation is to maintain; the quality, safety, and stability of its contents

· Medicines must be suitably contained, protected and labeled from the time of manufacture until they are used by the patient

· The container must maintain the quality, safety and stability of the medicine

STEP 8: Evaluation (10 minutes)

· What is packaging, packaging material, repacking?

· What are the features of a suitable packaging material?

· What types of containers are used for medicine packaging?

· What are the factors contribute to the choice of packaging material?

· What are the importances of medicine packaging material?

· What are the advantages and disadvantages of different type of containers?

References

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS.

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia

Senya ,S. S., Mwasha, C.Y., Muyinga, A. M., Amiri,R. I., Mauga, E.A.K. (2011) Tanzania Pharmaceutical Handbook ( 2^nd ed. ) Dar eS Salaam, Tanzania: School of Pharmaceutical Sciences

Session 10: Medicines Label

Total Session Time: 120 minutes

Prerequisites

· None

Learning Tasks

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

· Define a label of a Dispensed Medicine

· List Essential Features of a Label

· Explain the Importance/ Purpose of a Label of Dispensed Medicine

· Design and prepare appropriate label

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and whiteboard markers

· Handout 10.1: General Labeling Requirements for Dispensed Medicines

· Worksheet 10.1: Label for Medicine to be Dispensed

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	15 minutes	Presentation Buzzing	Definition of a Label of Medicine to be Dispensed
3	30 minutes	Presentation Brainstorming	Essential Features of a Label
4	10 minutes	Presentation	Purpose/ Importance of a Label of Dispensed Medicine
5	40 minutes	Presentation Exercise	Design and Prepare Appropriate Label
6	10 minutes	Presentation	Key Points
7	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 a Label of Medicine to be Dispensed (15 minutes)

Activity: Buzzing (5 minutes)

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

· What is a label of a dispensed medicine?

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 the content below

· Label: Any material which is printed or affixed to a packing material which provides the necessary information about medicine, and includes an insert

· The main functions of a label on a dispensed medicine are to uniquely identify the contents of the container and to ensure that patients have clear and concise information about the use of the medicine

· Each dispensed medicine must be appropriately labeled to comply with legal and professional requirements

· All medicines to be dispensed should be labeled and the labels should be unambiguous, clear, legible and indelible

§ If possible lettering should be printed

STEP 3: Essential Features of a Label (30 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What are the essential features of a label of medicine to be dispensed?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

· The information on the labels of dispensed medicines should be:

§ Clear, accurate, and concise

§ To avoid misunderstanding and obtain greatest benefits from therapy

§ Abbreviations and unfamiliar expressions should not be used, especially for indications for use and dosage instructions

§ Legible

§ Easily readable, the print should not fade when exposed to water or sunlight

§ Manufacturers’ labels fulfill established criteria for good readability

§ Adequate and relevant

§ Care should be taken to avoid confusion

§ Too much information on the label may mean that none of it is noted

§ Intelligible

§ The information should be completely unambiguous and arranged to avoid confusion

§ The terms used should be readily understandable by the lay/unprofessional person

§ Graphic symbols for patient instruction should not be used alone but should always be combined with written instructions

· Label information should include the following:

§ Patient name

§ Generic name, strength and dosage form of the medicine

§ Dose, Frequency and Duration of use of the medicines

§ Quantity of the medicine dispensed

§ How to take or administer the medicine and cautionary statements, if applicable

§ Storage condition

§ The name and address of the dispenser

Figure 9.1: Sample Label of Medicine

STEP 4: Purpose/ Importance of a Label of Dispensed Medicine (10 minutes)

· The purpose of a label for medicine to be dispensed is:

§ To describe and identify a prescribed medicine

§ To contribute to optimal therapeutic outcome and to avoid medication errors

§ To achieve appropriate handling and storage

§ To allow the product to be traced if there are problems with either the manufacturing, prescribing or dispensing process

· The importance of label for medicine to be dispensed:

§ Label information for prescribed medicines should be considered to supplement and reinforce oral communication between the patient and healthcare provider

§ Label should provide the patient with all the information necessary so that the medicine may be taken or used appropriately

§ The presentation of label elements is important for patient understanding

§ Written instructions on the use of medicines are very important rather than verbal information

STEP 5: Design and Prepare Appropriate Label (40 minutes)

Activity: Exercise (20 minutes)

DIVIDE students into small manageable groups.

REFER students to Worksheet 10.1: Label for Medicine to be Dispensed

READ or ASK one student to read the scenario in the worksheet and CLARIFY

ASK all groups to answer the question in the worksheet for 15 minutes.

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

CLARIFY and SUMMARIZE by using the content below

Themi Pharmacy

P.O Box 3011

Arusha

Date: 15.01.2015

Name of Patient: Aisha Hassan

Paracetamol Syrup 120mg/5ml

2 teaspoonful x After every 8 hours for 5 days

Keep Away From Children Reach

Themi Pharmacy

P.O Box 3011

Arusha

Date: 15.01.2015

Name of Patient: Aisha Hassan

Amoxicillin Syrup 125mg/5ml

2 teaspoonful x After every 8 hours for 7 days

Keep Away From Children Reach

The label on the medicine packaging usually includes:

· The name of Patient

o the generic name for the active ingredient in your medicine (scientific name)

· the name and address of the pharmacy that dispensed medicine

· the date medicine dispensed

· the name of the medicine and the strength

· the dose should be taken, how to take it and how often and how long

· the amount of medicine in the container

· if necessary, any cautions or warning messages that apply to your medicine

§ Some examples are:

§ shake the bottle

§ store in a cool place

§ discard 28 days after opening

§ do not use after a certain date

STEP 6: Key Points (10 minutes)

· Medicine to be dispensed needs a label which is appropriately written to provide a good communication to a patient. It is to identify the medicine through its name and strength, provides information of how to take the medicines, the quantity and frequency of a dose and duration of that dose

§ It is also providing other information like storage condition and action to be taken before use of medicines

· The essential features of a label of medicines to be dispensed includes;- clear, accurate and concise written, the label written should be legible, the label should be adequately written and easy to interpret the information provided to a patient

STEP 7: Evaluation (10 minutes)

· What is a label for medicine to be dispensed?

· What informations are appropriate to be included in a label of medicine to be dispensed?

· What are the essential features of a label of medicine to be dispensed?

References

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS.

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia

WHO (2002). Technical Report Series No. 902. (Annex 9). Geneva

· Handout 10.1: General Labeling Requirements for Dispensed Medicines

Worksheet 10.1: Label for Medicine to be Dispensed

Scenario:

You are a dispenser at Themi Pharmacy P.O Box 3011, Arusha today. A Mother with a child called Aisha Hassan gives you a prescription written as follows;-

1. Amoxicillin Syp 250mg tds 5/7

2. Paracetamol Syp 240mg tds tds 5/7

At Themi Pharmacy you have in stock bottles Amoxicillin Dry Suspension 100ml with strength of 125mg/5ml and Paracetamol syrup 100ml with strength of 120mg/5ml.

Design and prepare an appropriate label for the two medicines prescribed.

Session 11: Generic and Brand Names of Medicines

Total Session Time: 120 minutes

Prerequisites

· None

Learning Tasks

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

· Define Generic (non-proprietary) and Brand (proprietary) Medicines

· Explain Global and National Initiatives on Generic and Brand Medicines

· Distinguish between Generic and Brand Medicines

· List Advantages and Disadvantages of Generic and Brand Medicines

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and whiteboard markers

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	10 minutes	Presentation	Definition of Generic (non-proprietary) and Brand (proprietary) Medicines
3	25 minutes	Presentation	Global and National Initiatives on Generic and Brand Medicines
4	30 minutes	Buzzing Presentation	Generic and Brand Medicines
5	30 minutes	Brainstorming Presentation	Advantages and Disadvantages of Generic and Brand Medicines
6	10 minutes	Presentation	Key Points
7	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 Generic (Non-Proprietary) and Brand (Proprietary) Medicines (10 minutes)

Generic medicine

· The generic or scientific or non proprietary name is the term given to the active ingredient in the medicine that is decided by an expert committee and is understood and used internationally

o Thus, paracetamol/acetaminophen is the non-proprietary name (generic name) while Crocin/Metacin/Meftal/Tylenol etc are brand names

Brand medicine

· A brand name drug is a medicine that’s discovered, developed and marketed by a pharmaceutical company

o This name is given to a medicine by the pharmaceutical company that makes it

o This is also called the "proprietary name"

· A generic drug is a chemically equivalent, lower-cost version of a brand-name drug, costing 30-80% less!

· A brand-name drug and its generic version must have the same active ingredient, dosage, safety, strength, usage directions, quality, performance and intended use

STEP 3: Explain Global and National Initiatives on Generic and Brand Medicines (25 minutes)

· Once a new drug is discovered, the company files for a patent to protect against other companies making copies and selling the drug

· At this point the drug has two names: a generic name that’s the drug’s common scientific name and a brand name to make it stand out in the marketplace

o This is true of prescription drugs as well as over-the-counter drugs

· An example is the pain reliever Tylenol®. The brand name is Tylenol® and the generic name is acetaminophen

o Generic drugs have the same active ingredients as brand name drugs already approved by the Food and Drug Administration (FDA)

o Generics only become available after the patent expires on a brand name drug

o Patent periods may last up to 20 years on some drugs

· The same company that makes the brand name drug may also produce the generic version or a different company might produce it

· It is a well-known fact that generic drugs are “drugs that are usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights”

· When it is said that doctors should prescribe generic drugs, it means that they should prescribe drugs manufactured by other companies after expiry of patent of parent drug of the innovator company

· The patent for paracetamol expired in 2007 after which numerous generic versions have been developed and sold under various “brand names.”

o If one were to prescribe it only by the name “paracetamol” (generic name), it is up to the pharmacist to select and dispense a particular brand.

§ A simpler and better alternative for cost reduction would be to prescribe the cheapest “brand” of paracetamol.

· Thus, a better way to prescribe would be to prescribe the cheapest brand of the drug and include the generic name of the drug in parenthesis, in case that particular brand is not available.

STEP 4: Distinguish Between Generic and Brand Medicines (30 minutes)

Activity: Buzzing (5 minutes)

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

· What are the differences between Generic name (Non-proprietary name) and Brand name (Proprietary name) of medicine?

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 the content below

· Although the active ingredients are the same, the excipients (inactive ingredients) may differ

o This is only important in rare cases when a patient has an allergy or sensitivity to one of the excipients

· The product may also be slightly different in:

Colour
Shape or markings
Taste
Preservatives
Packaging

· The biggest difference is cost; generic drugs are generally less expensive than brand name comparators

STEP 5: Advantages and Disadvantages of Generic and Brand Medicines (30 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What are the advantages and disadvantages of generic names (Non-proprietary names) and Brand names (Proprietary names)?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

· Generic drugs cost less than Branded drugs

o The generic drug manufacturer does not have the incurred costs of discovery, research and development, preclinical and clinical tests as well as advertising/marketing and promotion

o Therefore it can offer the generic drug at a much lower cost to you/patient

· Generic drugs are more available than Branded drugs

· Generic drugs can be manufactured locally while Branded drugs cannot be manufactured locally

STEP 6: Key Points (10 minutes)

· A generic drug is identical or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

· Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price

· Generic drugs are essentially the same as brand name drugs since the differences are on other ingredients other than active ingredient which are binders, coloring agents, and flavorings but is same in the therapeutic and medicinal portion as well as dose, strength, route of administration, safety, efficacy and intended use.

STEP 7: Evaluation (10 minutes)

· What are the generic names (Non-proprietary name) and brand names (Proprietary names)?

· What are the differences between generic names and brand names?

· What are the advantages and disadvantages of generic names and brand name?

References

Cameron A., Mantel-Teeuwisse A., Leufkens H., Laing R. (2012). Value Health: Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved? 15, 664–673 PubMed

Davit et al. (2009). Ann Pharmacother:Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. 2009;43(10):1583-97

Kesselheim et al. (2008). JAMA: Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis. 300(21)2514-2526

Session 12: Giving Appropriate Medicine Information to Patients

Total Session Time: 120 minutes

Prerequisites

· None

Learning Tasks

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

· Define Interaction, Side effects, Precaution and Contraindication

· Give Appropriate Instructions on the Use of Prescribed Medicine(s)

· Give Appropriate Information on Precautions, Interactions, Side effects and Storage of Dispensed Medicines

· Check Patient Understanding on the Use and Precautions of Dispensed Medicine(s)

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and whiteboard markers

· Handout 12.1: Warnings/cautions to Patients

· Worksheet 12.1: Sample Prescriptions

· Worksheet 12.2: Giving appropriate instructions on the use of prescribed medicine

· Worksheet 12.3: Giving appropriate precautions, interactions, side effects and storage of medicines

· Worksheet 12.4: Checking patient understanding on the use and precautions of dispensed medicines

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	10 minutes	Presentation	Definitions of Drug Interaction, Side effects, Contraindication and Precautions of Medicines
3	30 minutes	Presentation Role play	Appropriate Instructions on the Use of Prescribed Medicine(s)
4	30 minutes	Presentation Role play	Appropriate Information on Precautions, Interactions, Side effects and Storage of Dispensed Medicines
5	30 minutes	Presentation Role play	Patient Understanding on the Use and Precautions of Dispensed Medicine(s)
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 tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definitions of Drug Interaction, Side effects, Contraindication and Precautions of Medicines (10 minutes)

· Drug Interaction: is a situation in which a substance (usually another drug) affects the activity of a drug when both are administered

o However, the effect of medicine may be modified by food, smoking, alcohol or environmental pollutants

o A drug interaction may occur when one drug potentiates or diminishes the action of another drug

o These actions may be desirable or undesirable

o Drugs may also interact with various foods, alcohol, tobacco, and other substances

· Side effect: is an action or effect of a drug (medicine) other than that desired

§ Commonly it is undesirable effect such as nausea, headache, insomnia, rash, confusion, dizziness, or an unwanted drug-drug interaction

· A side effect is an undesirable action of the drug and may limit the usefulness of the drug

· Contraindication: is something which suggests that someone should not be treated with a specific drug or not continue with a specific treatment because circumstances make that treatment unsuitable

· Precaution: is an action taken in advance to protect against danger, harm, or possible failure

STEP 3: Give Appropriate Instructions on the Use of Prescribed Medicine(s) (30 minutes)

Activity: Role Play Demonstration on giving appropriate information on the use medicine (20 minutes)

EXPLAIN that this will be a role play demonstration between a patient and a health care provider. You (the tutor) will play the Dispenser and lead the conversation of the instructions on the use of medicines prescribed to the patient, who will be a student volunteer.

ASK a student to volunteer to play the patient role.

Refer student volunteer to Worksheet 12.2: Role Play Demonstration so that he/she can read the description of the patient.

Refer students to Worksheet 12.1: Sample Prescription Serial No. 001190

TELL the rest of students to observe carefully

EXPLAIN that the patient will listen carefully and provide answers to dispenser as will be asked to do so.

EMPHASIZE that the Dispenser should concentrate on presenting the instructions on how to use the prescribed medicines.

START the role play.

LEAD a discussion after the role play.

DE-ROLE yourself and the student, once the role play is over.

ASK students if they have any questions about the role play.

· At a stage of giving information to the patient, a dispenser must instruct and counsel the patient on the following information:

§ Why the patient needs to take medication

§ If a patient understands why the medication was given then he/she will be tempted to take medication

§ Drug name, strength and dosage formation and route of administration

§ Dose of medicine

§ Dose interval/ frequency

§ For example after every 6 or 8 hours

§ Dosage of medication

§ Duration of taking medication

§ Any other special instructions, such as there are some drugs which work efficiently if taken before or after food, for examples:

§ Magnesium sulphate anti acids will work effectively if taken one or two hours after food

§ Alcohol reduce potency of different medicines so patient should be advised not to take alcohol when under medication and it should not be taken with medicines such as metronidazole, phenobarbitone and antihistamines.

§ Patients should be told on cautions of different medicines

Storage of medicines: Patient should be advised to keep medicines away from the reach of children as some drug colors might attract children's attention

o The Direct observed treatment (DOT) Strategy

§ This is the treatment strategy that emphasizes the use of the most effective standardized, short-course regimen, and of fixed-dose drug combinations (FDCs) under observation to facilitate adherence to treatment and to reduce the risk of the development of drug resistance

§ This means a supervisor watches the patient when swallowing tablets

§ It ensures that a patient takes the right drugs, in the right doses and at the right time intervals.

§ Examples of drugs given under DOT strategy are methadone and anti-tuberculosis medicines.

STEP 4: Give Appropriate Precautions, Interactions, Side effects and Storage of Dispensed Medicines (30 minutes)

Activity: Role Play Demonstration (30 minutes)

EXPLAIN that this will be a role play demonstration between a patient and a health care provider. One volunteer student will play the Dispenser and lead the conversation of the instructions on the use of medicines prescribed to the patient, who will be another student volunteer.

ASK the students to volunteer to play the dispenser role and the patient role.

Refer student volunteer to Worksheet 12.3: Role Play Demonstration so that he/she can read the description of the patient.

Refer students to Worksheet 12.1: Sample Prescription Serial No. 001191.

TELL the rest of students to observe carefully

EXPLAIN that the patient will listen carefully and repeat the information provided when asked.

EMPHASIZE that the Dispenser should concentrate on presenting the instructions on how to use the prescribed medicines as well as telling about precautions to a patient, common side effect of medicines dispensed and the storage condition of medicine

START the role play.

LEAD a discussion after the role play.

DE-ROLE all the students, once the role play is over.

ASK students if they have any questions about the role play.

The dispenser must give the following information to a patient:

· Effects of the drug: Which symptoms will disappear; and when; how important is it to take the drug; what happens if it is not taken;

§ Dosage and administration, whether the medicine can be given with food, before or after food, with more water or at night only

§ Drug Interactions: two basic interactions are important in medication administration; - drug-drug interactions and drug-food interactions

§ Drug-drug interaction occurs when one drug interacts with or interferes with the action of another drug. For example taking anti-acid with oral Tetracycline causes a decrease in the effectiveness of tetracycline.

§ Drug-food interaction is when drug is given orally, food may impair or enhance its absorption

§ A drug taken on an empty stomach is absorbed into the bloodstream at a faster rate than when drug is taken with food in the stomach

§ Some drugs must be taken on an empty stomach for example Captopril to achieve optimal effect

· Side effects: Which side effects may occur; how to recognize them; how long will they remain; how serious they are; what to do if they occur

Warnings: What not to do (driving, machinery); maximum dose (toxic drugs); need to continue treatment (antibiotics)

Refer students to Handout 12.1: Warnings/Cautions to Patients for further reading

STEP 5: Check Patient Understanding on the Use and Precautions of Dispensed Medicine(s) (30 minutes)

Activity: Role Play Demonstration (30 minutes)

ASK the students to volunteer to play the dispenser role and the patient role.

Refer student volunteer to Worksheet 12.4: Role Play Demonstration so that he/she can read the description of the patient.

Refer students to Worksheet 12.1: Sample Prescription Serial No. 001192

TELL the rest of students to observe carefully

EXPLAIN that the patient will listen carefully and repeat the information provided when asked. The dispenser should present the instructions on how to use the prescribed medicines as well as telling about precautions to a patient, common side effect of medicines dispensed and the storage condition of medicine

EMPHASIZE that the Dispenser should concentrate on checking the patient understanding on the use of medicines and the precautions given.

START the role play.

LEAD a discussion after the role play.

DE-ROLE all the students, once the role play is over.

ASK students if they have any questions about the role play.

· Checking if everything is understood: Everything is clear to patient or else repeat the information; let the patient ask any more questions.

§ When to take medicine

§ The right dose and dosage

§ In relation to food and other medicines

§ How to take the medicine

§ Chewing/swallowed whole

§ Taken with plenty of water

§ How to store medicine

§ Warnings in case of possible common side effect but harmless like nausea, mild diarrhoea, urine changing colour

§ Reporting back in case of an unfavourable or harmful effect of medicine

STEP 6: Key Points (10 minutes)

· The dispenser should give information to the patient about when to take; how to take; how to store; how long to continue the treatment, what to do in case of problems and wheather the medicine therapy needs Direct Observed Therapy (DOT)

· The dispenser should also give opportunity to the patient to repeat instructions given

· It is also important to ask questions for further checking of understanding on how to take medication

· The necessity of reporting back in case of an unfavourable or harmful effect caused by medicine

STEP 7: Evaluation (5 minutes)

· Which instructions are important to be given to patient while dispensing medicines?

· What information would a dispenser want to know if a patient has understood the medication taking instructions?

· Which condition(s) are necessary for patient to report back to prescriber?

· What is DOT?

References

Rice, J. (2011). Principles of pharmacology for medical assisting (5th ed.). Boston, United States of America: Cengage Learning.

Roach, S. S., & Ford, S. M. (2008). Introductory clinical pharmacology (8th ed.). Philadelphia, United States of America: Lippincott Williams & Wilkins.

Taber, C. W., & Thomas, C. L. Taber's cyclopedic medical dictionary (pp. v.). Philadelphia, United States of America: F.A. Davis Co.

Walker, R., & Whittlesea, C. (2012). Clinical pharmacy and therapeutics (5th ed.). Edinburgh, United Kingdom: Churchill Livingston

Handout 12.1: Warnings/Cautions to Patients

WARNINGS/CAUTIONS TO PATIENTS

1. Warning. May cause drowsiness

To be used on preparations for children containing antihistamines, or other preparations given to children where the warnings of label 2 on driving or alcohol would not be appropriate.

2. Warning. May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink

To be used on preparations for adults that can cause drowsiness, thereby affecting the ability to drive and operate hazardous machinery; label 1 is more appropriate for children. It is an offence to drive while under the influence of drink or drugs.

Side-effects unrelated to drowsiness that may affect a patient's ability to drive or operate machinery safely include blurred vision, dizziness, or nausea. In general, no label has been recommended to cover these cases, but the patient should be suitably counselled.

3. Warning. May cause drowsiness. If affected do not drive or operate machinery

To be used on preparations containing monoamine-oxidase inhibitors; the warning to avoid alcohol and dealcoholized (low alcohol) drink is covered by the patient information leaflet.

Also to be used as for label 2 but where alcohol is not an issue.

4. Warning. Avoid alcoholic drink

To be used on preparations where a reaction such as flushing may occur if alcohol is taken (e.g. metronidazole and chlorpropamide). Alcohol may also enhance the hypoglycaemia produced by some oral antidiabetic drugs but routine application of a warning label is not considered necessary.

5. Do not take indigestion remedies at the same time of day as this medicine

To be used with label 25 on preparations coated to resist gastric acid (e.g. enteric-coated tablets). This is to avoid the possibility of premature dissolution of the coating in the presence of an alkaline pH.

Label 5 also applies to drugs such as ketoconazole where the absorption is significantly affected by antacids; the usual period of avoidance recommended is 2 to 4 hours.

6. Do not take indigestion remedies or medicines containing iron or zinc at the same time of day as this medicine

To be used on preparations containing Ofloxacin and some other quinolones, doxycycline, minocycline, and penicillamine. These drugs chelate calcium, iron and zinc and are less well absorbed when taken with calcium-containing antacids or preparations containing iron or zinc. These incompatible preparations should be taken 2-3 hours apart.

7. Do not take milk, indigestion remedies, or medicines containing iron or zinc at the same time of day as this medicine

To be used on preparations containing ciprofloxacin, norfloxacin or tetracyclines that chelate calcium, iron, magnesium, and zinc and are thus less available for absorption; these incompatible preparations should be taken 2-3 hours apart. Doxycycline and minocycline are less liable to form chelates and therefore only require label 6 (see above).

8. Do not stop taking this medicine except on your doctor's advice

To be used on preparations that contain a drug which is required to be taken over long periods without the patient necessarily perceiving any benefit (e.g. antituberculosis drugs).

Also to be used on preparations that contain a drug whose withdrawal is likely to be a particular hazard (e.g. clonidine for hypertension). Label 10 (see below) is more appropriate for corticosteroids.

9. Take at regular intervals. Complete the prescribed course unless otherwise directed

To be used on preparations where a course of treatment should be completed to reduce the incidence of relapse or failure of treatment.

The preparations are antimicrobial drugs given by mouth. Very occasionally, some may have severe side-effects (e.g. diarrhoea in patients receiving clindamycin) and in such cases the patient may need to be advised of reasons for stopping treatment quickly and returning to the doctor.

10. Warning. Follow the printed instructions you have been given with this medicine

To be used particularly on preparations containing anticoagulants, lithium and oral corticosteroids. The appropriate treatment card should be given to the patient and any necessary explanations given.

This label may also be used on other preparations to remind the patient of the instructions that have been given.

11. Avoid exposure of skin to direct sunlight or sun lamps

To be used on preparations that may cause phototoxic or photoallergic reactions if the patient is exposed to ultraviolet radiation. Many drugs like phenothiazines and sulphonamides) may, on rare occasions, cause reactions in susceptible patients. Exposure to high intensity ultraviolet radiation from sunray lamps and sunbeds is particularly likely to cause reactions.

12. Do not take anything containing aspirin while taking this medicine

To be used on preparations containing probenecid and sulfinpyrazone whose activity is reduced by aspirin.

Label 12 should not be used for anticoagulants since label 10 is more appropriate.

13. Dissolve or mix with water before taking

To be used on preparations that are intended to be dissolved in water (e.g. soluble tablets) or mixed with water (e.g. powders, granules) before use. In a few cases other liquids such as fruit juice or milk may be used.

14. This medicine may colour the urine

To be used on preparations that may cause the patient's urine to turn an unusual colour. These include phenolphthalein (alkaline urine pink), triamterene (blue under some lights), levodopa (dark reddish), and rifampicin (red).

15. Caution flammable: keep away from fire or flames

To be used on preparations containing sufficient flammable solvent to render them flammable if exposed to a naked flame.

16. Allow to dissolve under the tongue. Do not transfer from this container. Keep tightly closed. Discard eight weeks after opening

To be used on glyceryl trinitrate tablets to remind the patient not to transfer the tablets to plastic or less suitable containers.

17. Do not take more than . . . in 24 hours

To be used on preparations for the treatment of acute migraine except those containing ergotamine, for which label 18 is used. The dose form should be specified, e.g. tablets or capsules.

It may also be used on preparations for which no dose has been specified by the prescriber.

18. Do not take more than ... in 24 hours or ... in any one week

To be used on preparations containing ergotamine. The dose form should be specified, e.g. tablets or suppositories.

19. Warning. Causes drowsiness which may continue the next day. If affected do not drive or operate machinery. Avoid alcoholic drink

To be used on preparations containing hypnotics (or some other drugs with sedative effects) prescribed to be taken at night. On the rare occasions (e.g. nitrazepam in epilepsy) when hypnotics are prescribed for daytime administration this label would clearly not be appropriate. Also to be used as an alternative to the label 2 wording (the choice being at the discretion of the pharmacist) for anxiolytics prescribed to be taken at night.

It is hoped that this wording will convey adequately the problem of residual morning sedation after taking 'sleeping tablets'.

20. ...with or after food

To be used on preparations that are liable to cause gastric irritation, or those that are better absorbed with food.

Patients should be advised that a small amount of food is sufficient.

21. ...half to one hour before food

To be used on some preparations whose absorption is thereby improved. Most oral antibacterials require label 23 instead (see below).

22. ...an hour before food or on an empty stomach

To be used on oral preparations whose absorption may be reduced by the presence of food and acid in the stomach.

23. ...sucked or chewed

To be used on preparations that should be sucked or chewed.

The pharmacist should use discretion as to which of these words is appropriate.

24. ...swallowed whole, not chewed

To be used on preparations that are enteric-coated or designed for modified-release.

Also to be used on preparations that taste very unpleasant or may damage the mouth if not swallowed whole.

25. ...dissolved under the tongue

To be used on preparations designed for sublingual use. Patients should be advised to hold under the tongue and avoid swallowing until dissolved. The buccal mucosa between the gum and cheek is occasionally specified by the prescriber.

26. ...with plenty of water

To be used on preparations that should be well diluted (e.g. chloral hydrate), where a high fluid intake is required (e.g. sulphonamides), or where water is required to aid the action (e.g. methylcellulose). The patient should be advised that 'plenty' means at least 150 mL (about a tumblerful). In most cases fruit juice, tea, or coffee may be used.

27. To be spread thinly . . .

To be used on external preparations that should be applied sparingly (e.g. corticosteroids, dithranol).

28. Do not take more than 2 at any one time. Do not take more than 8 in 24 hours

To be used on containers of dispensed solid dose preparations containing paracetamol for adults when the instruction on the label indicates that the dose can be taken on an 'as required' basis. The dose form should be specified, e.g. tablets or capsules.

This label has been introduced because of the serious consequences of over dosage with paracetamol.

29. Do not take with any other paracetamol products

To be used on all containers of dispensed preparations containing paracetamol.

30. Contains aspirin and paracetamol. Do not take with any other paracetamol products

To be used on all containers of dispensed preparations containing aspirin and paracetamol.

31. Contains aspirin

To be used on containers of dispensed preparations containing aspirin when the name on the label does not include the word 'aspirin'.

32. Contains an aspirin-like medicine

To be used on containers of dispensed preparations containing aspirin derivatives.

Worksheet 12.1: Sample Prescriptions

Serial Na. 001 KIDIA HEALTH CENTER P.O. Box 58 IRINGA
Name:	Amina Salehe
Gender:	Fe
Age:	17 Yrs
Weight:
Rx	Cotrimoxazole tabs 480mg bd 5/7
	Paracetamol Tabs 1g 5/7
Prescriber’s name qualification	Hamis Juma Mgenja C/O
Signature	12/6/2015

Serial Na. 002 KIGOMA HOSPITAL P.O. Box 5 KIGOMA
Name:	Peter John
Gender:	Me
Age:	25 Yrs
Weight:
Rx	Erythromycin tabs 500mg qid 5/7
	Paracetamol Tabs 1g tds 5/7
Prescriber’s name qualification	Kisa Mwanjela MO
Signature	12/6/2015

Serial Na. 003 HASSANALI HOSPITAL P.O. Box 5118 MTWARA
Name:	Miriam Kilimilimi
Gender:	Fe
Age:	43 Yrs
Weight:
Rx	Erythromycin tabs 500mg qid 7/7
	Paracetamol Tabs 1g 5/7 Diazepam Tabs 5mg o.d nocte 3/7
Prescriber’s name qualification	Kilimani Kajengeni AMO
Signature	12/6/2015

Worksheet 12.2: Role Play Demonstration: Giving Appropriate Instructions on the Use of Prescribed Medicine

Script:

REFER Worksheet 7.1: Role Play Demonstration on Good Dispensing Practice

· You act as a Dispenser to give instructions to a patient on how to use medicines as prescribed.

· Cotrimoxazole Tablets is taken 2 tablets after every 12 hours for 5 days

· Paracetamol Tablets is taken 2 tablets after every 8 hours for 5 days.

· Make sure you emphasize the 12hourly and 8 hourly well to a patient

· After receiving prescription and properly prepare the medicine, when dispensing follow the following tips;

o Communicate to the patient the correct way to take medication. Give verbal instructions. Use symbolic instructions in case of illiteracy. Use auxiliary labels if required.

o In case of illiterate patients or patients familiar with only the regional language, devise a system of pasting specific colored labels/stickers on strips/ bottles to take it easier to identify the product.

o Repeat orally the labeled instructions, if possible, in laymen's terms. Do not disturb any other pharmacy staff person, dispensing or preparing a bill.

o Make the patient repeat the advice to ensure that he/she has understood them. Emphasize the need for adherence. Inculcate awareness in patients about the importance of therapy.

o Patient information leaflets can be provided along with a particular medicine or for a particular illness. Provide warnings and cautions. Give special attention to certain cases-

§ Those with visual impairment

§ Illiterates.

§ Those taking multiple medications.

§ Special group of patients (pregnant, children and elderly patients,

§ patients with liver and kidney problem)

o OTC medicines are requested, the pharmacy professionals can evaluate if the product requested, is appropriate for the patient's condition, and advise accordingly.

· Worksheet 12.3: Role Play Demonstration: Giving appropriate precautions, interactions, side effects and storage of medicines

Script:

REFER Worksheet 7.1: Role Play Demonstration on Good Dispensing Practice

· You act as a Dispenser to give instructions to a patient on how to use medicines as prescribed.

· Erythromycin Tablets is taken 2 tablets after every 6 hours for 5 days

· Paracetamol Tablets is taken 2 tablets after every 8 hours for 5 days.

· Make sure you emphasize the 6 hourly and 8 hourly well to a patient

· You must tell the patient about common side effect of Erythromycin Tablets which is stomach discomfort. It is also enteric coated to avoid stomach discomfort but it should be stored at a cool and dry place out of children reach. Keeping medicines out of children reach should apply for Paracetamol also.

· Remember to ask a patient to repeat instructions as given

· Worksheet 12.4: Role Play Demonstration: Checking patient understanding on the use and precautions of dispensed medicines

Script:

REFER Worksheet 7.1: Role Play Demonstration on Good Dispensing Practice

· You act as a Dispenser to give instructions to a patient on how to use medicines as prescribed.

· Erythromycin Tablets is taken 2 tablets after every 6 hours for 7 days

· Paracetamol Tablets is taken 2 tablets after every 8 hours for 5 days.

· Diazepam Tablets is taken 1 tablet once a day at night before sleeping for 3 days

· Make sure you emphasize the 6 hourly and 8 hourly and at night before sleeping well to a patient

· You must tell the patient about common side effect of Erythromycin tablets which is stomach discomfort.

· It is also enteric coated to avoid stomach discomfort but it should be stored at a cool and dry place out of children reach.

· Keeping medicines out of children reach should apply for Paracetamol and Diazepam also

· Emphasize on Erythromycin is causing stomach discomfort;

· Diazepam is causing drowsiness on the next day.

· Precaution to a patient not to drive in case of drowsiness

· Remember to ask a patient to repeat instructions as given

· Put more emphasis to patient understanding on the instructions given

Session 13: Adverse Drug Reactions, Drug Overdose and Intoxication

Total Session Time: 120 minutes

Prerequisites

· None

Students Learning Tasks

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

· Define ADRs, Drug Overdose and Intoxication

· Identify suspected adverse drug reactions (ADRs), drug overdose and intoxication

· Report suspected adverse drug reactions (ADRs)

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and whiteboard markers

· Handout 13.1 Adverse Drug Reactions Cases

· Worksheet 13.1 TFDA ADR form

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	05 minutes	Presentation	Definition of Adverse Drug Reactions, Drug Overdose and Intoxication
3	35 minutes	Presentation Brainstorming	Identification of Adverse Drug Reactions (ADRs), Drug Overdose and Intoxication
4	60 minutes	Presentation Small Group Discussion	Reporting Adverse Drug Reactions (ADRs)
5	10 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 tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Adverse Drug Reactions (5 minutes)

· Adverse Reaction is a situation where someone experiences harmful effects from the application of a drug

or is an unfavourable or harmful unintended action of a medicine

· Serious adverse drug reaction: any reaction that is fatal, life-threatening, permanently/significantly disabling, requires or prolongs hospitalization, causes a congenital anomaly, or requires intervention to prevent permanent impairment or damage

· Drug Overdose describes the ingestion or application of a drug or other substance in quantities greater than are recommendedor generally practiced

§ An overdose may result in a toxic state or death

· Combined drug intoxication (CDI), also known as multiple drug intake (MDI) or lethal polydrug/polypharmacy intoxication is due to the simultaneous use of multiple drugs, whether the drugs are prescription, over-the-counter, recreational, or some other combination

STEP 3: Identification of Adverse Drug Reactions (ADRs) (35 minutes)

Activity: Buzzing (5 minutes)

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

· How will one identify Adverse Drug Reactions?

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 the content below

· Patients may experience one or more adverse reactions when they are given medicines Adverse reactions (Side effect) are undesirable drug effects which may be common or may occur infrequently

· They may be mild, severe, or life-threatening. They may occur after the first dose, after several doses, or even after many doses

· An adverse reaction often is unpredictable, although some drugs are known to be cause certain adverse reactions in many patients

· For example the drugs used in the treatment of Cancer and those used in treating HIV/AIDS, commonly known as Anti-Retralviral Therapy(ART) are very toxic and are known to produce adverse reactions in many patients receiving them

· Other medicines produce adverse reactions in fewer patients

· Some adverse reactions are predictable, but many adverse drug reactions occur without warning

· When dealing/ dispensing medicines that are suspected to have ADRs:

o Counsel all patients regarding the possibility of ADRs

o Inform patients of signs and symptoms that may indicate an ADR

o Instruct patients that in the event of an ADR, they should return to the clinic/hospital immediately if the reaction is life-threatening or contact the MO as soon as possible in all other instances

o Refer all patients with suspected ADRs to the MO

o After a period to be determined by the ART Eligibility Committee, complete one ADR form for each ADR reported

§ Refer patients with suspected serious ADRs or patients requiring treatment to the MO

o Work with the Records Officer and the nursing staff to make sure that the original ADR form is placed in the patient record and the duplicate is received by the pharmacist

o Maintain a file of all completed ADR forms and related reports

o Review ADR forms on an ongoing basis and alert the ART Eligibility Committee of unusual trends or findings

o Provide verbal feedback at ART Eligibility Committee meetings, or written feedback to staff regarding outcomes of referred ADRs so as to encourage continued reporting

o Prepare ADR Summary Report

o Present the ADR Summary Report and findings to the ART Eligibility Committee

· Signs and symptoms of drug overdose vary depending on the drug or toxin exposure

o The substance that has been taken may often be determined by asking the person

o For patients with altered level of consciousness, questioning of their friends and family may be helpful in order to get information of the drug involved

Refer students to Worksheet 13.1: TFDA ADR FORM

STEP 4: Reporting Adverse Drug Reactions (ADRs) (60 minutes)

Activity: Small Group Discussion (30minutes)

DIVIDE students into small manageable groups.

REFER students to Worksheet 12.1: TFDA ADR FORM

READ the form and CLARIFY

ASK all groups to discuss about the following question for 15 minutes.

Where to report in case of ADR?
What to report on ADR form?
Who should report?
How to report?

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

CLARIFY and SUMMARIZE by using the content below

Where to report

· The National ADRs monitoring centre: This is under the Tanzania Food and Drugs Authority (TFDA), with offices near EPI-Mabibo, Dar es Salaam.

§ The Centre collects and evaluates ADR reports and feedbacks its findings to the healthcare professionals and the general public.

§ Reported information is also communicated to the World Health Organisation (WHO).

· Zonal Drug Information Centres: Four Zonal Drug information Centres located at;

o Muhimbili National Hospital (Dar es salaam)

o Bugando Medical Centre (Mwanza)

o Kilimanjaro Christian Medical Centre and Mbeya Consultant Hospital

§ are responsible with co-ordinating the collection of ADR reports at respective hospitals and zones.

What to report

· All suspected adverse reactions should be reported whether known or unknown, serious or not, including minor ones.

· Reports on the new drugs are of great interest because they make easier to monitor the performance of these drugs in the country for any suspected adverse drug reactions.

Who should report

· All health care providers including specialists, doctors, dentists, pharmaceutical personnel and nurses can report ADRs

· All affected consumers are encouraged to report ADRs directly to their healthcare professionals and zonal Drug Information centers

How to report

· Adverse drug reaction forms may be obtained from TFDA headquarters, Zonal Drug Information Centres, offices of Regional Medical Officers or Regional Pharmacists and healthcare facilities

o The form can be filled online or downloaded from the website

· Suspected adverse reactions for drugs marketed in Tanzania should be reported using a standardised form which is postage pre-paid and self adhesive

· The reports should be sent to the Director General, TFDA, P.O. Box 77150, Dar es Salaam, fax +255 22 2450793 email adr@tfda.or.tz

· The forms or reports should contain the following elements:

o Patient information including Patient’s name, Age/Date of birth, Sex, Weight and relevant medical history

o Description of the adverse reaction including date of onset

o Suspected drug(s): name (including brand name, if known), dosage, route, start and stop dates and reasons for use.

o Treatment given for the reaction(s)

o Other relevant history, including pre-existing medical conditions

o Outcome of reactions

o Name, date, signature and address of the reporter

· All sections of the form should be dully filled prior submission

o A separated form should be used for each patient

STEP 5: Key Points (10 minutes)

· Adverse reaction is a response to a medicine that is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or the modification of physiological function

· All suspected adverse reactions should be reported whether known or unknown, serious or not, including minor ones

· The word "overdose" implies that there is a common safe dosage and usage for the drug; therefore, the term is commonly only applied to drugs, not poisons, though even poisons are harmless at a low dosage

· Reports on the new drugs are of great interest because they make easier to monitor the performance of these drugs in the country for any suspected adverse drug reactions

· The reports should be sent to the Director General, TFDA, P.O. Box 77150, Dar es Salaam, fax +255 22 2450793 email adr@tfda.or.tz

· Adverse drug reaction forms may be obtained from TFDA headquarters, Zonal Drug Information Centres, offices of Regional Medical Officers or Regional Pharmacists and healthcare facilities

· All sections of the Yellow form should be dully filled prior submission

STEP 6: Evaluation (5 minutes)

· What is adverse drug reaction?

· When adverse drug reaction occur?

· Why is it important to report adverse drug reaction?

· What is drug overdose?

· What is intoxication?

· Where should the report be sent?

· Who should fill the ADR (Yellow Form) for a patient?

· Why is it important to keep a copy of complete ADR (Yellow Form) for your record?

References

Malestrom.(2004) Dictionary of Medical Terms (4th ed.). London, United Kingdom: A & C Black.

Rice, J. (2011). Principles of pharmacology for medical assisting (5th ed.). Boston, United States of America: Cengage Learning.

TFDA, (2006). Guidelines for Monitoring and Reporting Adverse Drug Reactions – ADRs. Dar; MoH&SW

Worksheet 13.1: TFDA ADR FORM

Session 14: Documentation of Medicines and Medical Supplies

Total Session Time: 120 minutes

Prerequisites

· None

Learning Tasks

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

· Explain the Dispensing Medicine Records and Electronic Records

· Mention Components of Dispensing Register/Prescription Record Book/Sales Book

· Report Information of Dispensed Medicines/Medical Supplies to Dispensing Register/ Prescription Record Book/Sales Book

· Retain and File Prescriptions of Dispensed Medicines and Mdical Supplies

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and /whiteboard markers

· Worksheet 14.1 Dispensing Register

· Worksheet 14.2 Prescriptions for Dispensing Records

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	20 minutes	Presentation	Dispensing Medicine Records and Electronic Records
3	25 minutes	Presentation Brainstorming	Components of Dispensing Register/ Prescription Record Book/Sales Book
4	30 minutes	Presentation Exercise	Information of Dispensed Medicines into Dispensing Register
5	30 minutes	Presentation Buzzing	Retention and Filling of Prescriptions of Dispensed Medicines
6	05 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 tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Dispensing Medicine Records and Electronic Records (20 minutes)

· Prescriptions should be recorded and documented as proof of transaction between the patient and the dispenser

o Prescriptions can therefore be traced back if any need arise

· All dispensing units should have a standardized Prescription Registration Book (PRB) for recording every pharmaceutical issued to a patient

· A computerized dispensing and registration system may also be used, but should always be supported by paper back up

· The registration book should be completed at the time of dispensing or at the close of the working day

· Importance of documentation of dispensed medicine

o Can be used as back up data when needed

o Is the source of information on the monitoring and evaluation of the daily activities done in the unit

o Can act as the proof and show the source of purchase of medicine

o Simplify payment of revenue

· Electronic Records

Electronic Document and Records Management Systems are computer based systems designed to store a wide range of electronic documents and file types
These systems can store documents/files created from variety of programs including Microsoft Office applications and emails

· The following are the Importance of electronic records in pharmacy:

Providing accurate, up-to-date, and complete information about patients at the point of care
Enabling quick access to patient records for more coordinated, efficient care
Securely sharing electronic information with patients and other clinicians
Helping providers more effectively diagnose patients, reduce medical errors, and provide safer care

Improving patient and provider interaction and communication, as well as health care convenience
Enabling safer, more reliable prescribing
Helping promote legible, complete documentation and accurate, streamlined coding and billing
Enhancing privacy and security of patient data
Reducing costs through decreased paperwork, improved safety, reduced duplication of testing, and improved health
Help in effective inventory management

STEP 3: Components of Dispensing Register/ Prescription Record Book/Sales Book (25 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What are the components of Dispensing Register?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

· Date

o Make sure you write the new date every day

o You are not required to repeat writing the same date for every patient on the same day but if you have shift on the same day, you should skip one line and write new date

o Start new page for new month

· Serial Number

o Each patient should be given serial number

This number has no other meaning than just numbering all customers that have been attended at the particular day

· Full name of a patient

Write the full name of the patient who will use the medicine as it appears in the Prescription and not of the one who has collected the medicine

· Age: Write the age of a patient by years but if you cannot get the exact age be sure to indicate whether is a child or adult

· Address of the patient ( Ward/street): Write the street and the ward from which the patient is living

· Sex: Indicate if patient is male or female

· Generic name of the medicine: Record generic name of the medicine and not trade name

o For example: Write Paracetamol and not Panadol.

· Direction for use: Write direction for use as indicated in the prescription.

o For example: 2 x 3 x 5/7 Meaning "take 2 tablets after every 8 hours for 5 days"

· Quantity of medicine dispensed: Record the amount of drug dispensed

· Signature of the Dispenser: Themedicine dispenser should sign in the dispensing register so as to recognize who dispensed medicines on a particular day

· Name of the Health Facility: Dispenser must record the health facility from which the prescription was written

o This is very important in case of tracking errors at any stage from prescription writing to dispensing

Refer students to Worksheet 14.1: Dispensing register

STEP 4: Information of Dispensed Medicines into Dispensing Register (30 minutes)

Activity: Exercise ( 15 minutes)

DIVIDE students into small manageable groups

ASK students to discuss the following question

What informations are to be filled in the Dispensing register provided?

REFER students to the Worksheet 14.2 Prescriptions for Dispensing Records Serial No. 00660-00664

REFER students to the Worksheet 14.1 Dispensing Register

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using table 1 below

The following is the example of filled dispensing register :

Table 1: Dispensing register with filled medicine information

Name of Institution MADUKANI PHARMACY Page No 1

S/ No	Date	Patient name	Addre	Sex	Age	Diagnosis	Drug Generic Name	Dosage	Total Quantity	Name of Health Facility	Sign
1	15/1/15	Ibrahim Kimongo	-	Me	39	-	Metronidazole tabs Paracetamol Tabs	2x3x7 2x3x3	42 tabs 18 tabs	Kihesa HC
2	15/1/15	Joyce Kamau	-	Fe	18	-	Miconazole Cream Griseofluvin tabs Paracetamol tabs	1x2x28 1x1x90 2x3x3	2 tube 90 tabs 18 tabs	Kihesa HC
3	20/1/15	Steven Nnyamayao	-	Me	56	-	Mebendazole tabs Phenytoin tabs	1x5x1 1x1x3	5 tabs 3 tabs	Kihesa HC
4	20/1/15	Marystella Ndauka	-	Fe	65	-	Tetracycline Eye Oint Paracetamol tabs	1x4x7 2x3x3	2 tube 18 tabs	Kihesa Hc
5	13/1/15	Mariam Abubakari	-	Fe	4	-	Metronidazole Syp Paracetamol Syp	1x3x7 1x3x	1 bottle 1 bottle	Kihesa HC

STEP 5: Retaining and Filing Prescriptions of Dispensed Medicines (30 minutes)

Activity: Buzzing (10 minutes)

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

· Which dispensing records are to be retained?

· How long the dispensing records can be retained?

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 the content below

· The prescription registration book should be used both when prescriptions are retained in the pharmacy and when they are returned to the patient

· For a prescription which is returned to a patient due to some of the medicines to be out of stock the copy of the prescription should be retained

o The word “dispensed” should be stamped/written adjacent to those items which have been dispensed

o For prescriptions which are to be refilled on a later date, the dispensing information should be entered into the registration book before returning the prescription to the patient

§ The official seal of the pharmacy/Health institution, name and signature of the dispenser, the date of dispensing and the next refill date should be written on the back of the prescription

· Prescriptions should be filed sequentially by day in a single container/carton or box for each month

§ The box/container should be labelled with the month and year

§ Containers/boxes should be arranged on a monthly basis

· Normal prescriptions should be filed securely for two years and special prescriptions for 5 years

§ Thereafter, they should be disposed carefully in the presence of appropriate body

· Prescriptions, patient and medication related records and information should be documented and kept in a secure place that is easily accessible only to the authorized personnel

STEP 6: Key Points (5 minutes)

· Prescription shall be documented separated by day, month and year dispensed and archive for minimum of two years

· Electronic Records Management (ERM) ensures your organization has the records it needs when they are needed

· Prescriptions should be recorded and documented as proof of transaction between the patient and the dispenser

· All dispensing units should have a standardized Prescription Registration Book (PRB) for recording every pharmaceutical issued to a patient

STEP 7: Evaluation (5 minutes)

· What is a dispensing register?

· What information is filled in a dispensing register?

· What is the importance of keeping records?

· What is the importance of electronic records?

References

Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of pharmaceutics (8th ed.). London, United Kingdom: Bailliere Tindall.

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia

Rees, J. A., Smith, I., & Watson, J. Pharmaceutical practice (5th ed.). London, United Kingdom: Churchill Livingstone

Worksheet 14.1: Dispensing Register

Dispensing Register

Name of Institution……………………………………………………………… Page No.. ………………………

Date

Patient name

Address

Sex

Age

Diagnosis

Drug Generic Name

Dosage

Total Quantity

Name of Health Facility

Signature

Worksheet 14.2: Prescriptions for Dispensing Records

Serial Na. 00660 KIHESA HEALTH CENTER P.O. Box IRINGA
Name:	Ibrahim Kimongo
Gender:	Me
Age:	39Yrs
Weight:	65kg
Rx	Paracetamol tabs 1g t.d.s 3/7
	Metronidazole Tabs 480 mg tds 7/7
Prescriber’s name qualification	Masige Kahwa Malimbo MO
Signature	15/1/15

Serial Na. 00661 KIHESA HEALTH CENTER P.O. Box IRINGA
Name:	Joyce Kamau
Gender:	Fe
Age:	18Yrs
Weight:	40kg
Rx	Miconazole cream 2% p.a.a b.i.d 4/52 Griseofulvin tabs 500 mg p.c od 3/12
	Paracetamol Tabs 1g tds 3/7
Prescriber’s name qualification	Masige Kahwa Malimbo MO
Signature	15/1/15

Serial Na. 00662 KIHESA HEALTH CENTER P.O. Box IRINGA
Name:	Steven Nnyamayao
Gender:	Me
Age:	56Yrs
Weight:	74kg
Rx	Mebendazole tabs 500mg stat Phenytoin 10mg nocte OD x 3/7

Prescriber’s name qualification	Masige Kahwa Malimbo MO
Signature	20/1/15

Serial Na. 00663 KIHESA HEALTH CENTER P.O. Box IRINGA
Name:	Marystella Ndauka
Gender:	Fe
Age:	65Yrs
Weight:	80kg
Rx	Occul tetracycline oint RE 6hrly 1/52
	Paracetamol Tabs PO 1g tds 3/7
Prescriber’s name qualification	Masige Kahwa Malimbo MO
Signature	20/1/15

Serial Na. 00664 KIHESA HEALTH CENTER P.O. Box IRINGA
Name:	Marium Abubakar
Gender:	Fe
Age:	4Yrs
Weight:	10kg
Rx	Metronidazole syrup 1 tsp tds 7/7 Paracetamol syrup 1tsp prn

Prescriber’s name qualification	Masige Kahwa Malimbo MO
Signature	13/1/15

Session 15: Rational Use of Medicines (RUM)

Total Session Time: 120 minutes

Prerequisites

· None

Learning Tasks

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

· Define Rational Use of Medicine

· List Components of Rational Use of Medicine

· List the Consequences of Irrational Use of Medicines

· Outline importance of Rational Use of Medicine

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and whiteboard markers

· Worksheet 1.1 Sample Prescription

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	05 minutes	Presentation	Definition of Rational Use of Medicine
3	20 minutes	Presentation Brainstorming	Components of Rational Use of Medicines
4	40 minutes	Presentation Small Group Discussion	Consequences of Irrational Use of medicines
5	40 minutes	Presentation Small Group Discussion	Importance of Rational Use of Medicines
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 tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Rational Use of Medicine (5 minutes)

· Rational Use of Medicine: Refers to patients receiving medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time and at the lowest cost to them and the community

STEP 3: Components of Rational Use of Medicines (20 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What are the components of Rational Use of Medicines?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

· The following are the components of Rational Use of Medicines

o Appropriate indication: The decision to prescribe drug(s) is entirely based on medical rationale and the drug therapy is an effective and safe treatment

o Appropriate drug: The selection of drugs is based on efficacy, safety, suitability, and cost considerations

o Appropriate patient: No contraindications exist, the likelihood of adverse reactions is minimal, and the drug is acceptable to the patient

o Appropriate patient information: Patients are provided with relevant, accurate, important and clear information regarding their conditions and the medication(s) that are prescribed

o Appropriate evaluation: The anticipated and unexpected effects of medications are appropriately monitored and interpreted

STEP 4: Causes and Consequences of Irrational Use of Medicines (40 minutes)

Activity: Small Group Discussion ( 20 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the causes and consequences of irrational use of medicine?

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using the contents below

The following are the causes of Irrational Medicine Use

o Diagnosis

§ Inadequate examination of patient

§ Incomplete communication between patient and doctor doctor

§ Lack of documented medical history

§ Inadequate laboratory Resources

o Prescribing

§ Extravagant prescribing

§ Over-prescribing

§ Incorrect prescribing

§ Under-prescribing

§ Multiple prescribing/ers

o Dispensing:

§ Incorrect interpretation of the prescription

§ Retrieval of wrong ingredients

§ Inaccurate counting, compounding, or pouring pouring

§ Inadequate labeling

§ Unsanitary procedures

§ Packaging:

- Poor quality packaging materials

- Odd package size, which may require repackaging repackaging

- Unappealing package

o Patient adherence:

§ Poor labeling

§ Inadequate verbal instructions

§ Inadequate counseling to encourage adherence adherence

§ Inadequate follow-up/support of patients

· The following are consequences of irrational use of medicines:

o Ineffective and unsafe treatment

o Prolongation of illness

o Distress and harm to patient

o Increase the cost of treatment

o Lead to antimicrobial resistance

STEP 5: Importance of Rational Use of Medicines (40 minutes)

Activity: Small Group Discussion ( 20 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What is the importance of Rational Use of Medicine?

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using the contents below

Importance of Rational Use of Medicines:

· Reducing the incidences of drug resistance

· Improving patience adherence to medicines

· Reducing unnecessary cost of drug acquisition

· Reducing incidences of treatment failure

· Reducing the incidences of drug adverse reaction

STEP 6: Key Points (5 minutes)

· Improving the use of medicines by health workers and the general public is crucial both in reducing morbidity and mortality from communicable and non-communicable diseases, and to containing drug expenditure curtail

· Therapeutically sound and cost-effective use of medicines by health professionals and consumers should be at all levels of the health system, in the public and the private sectors

STEP 7: Evaluation (5 minutes)

· What is Rational Use of Medicines?

· What are the Components of Rational use of Medicines?

· What are the Concequences of Irrational Use of Medicine?

· What is the importance of Rational Use of Medicines?

References

Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of pharmaceutics (8th ed.). London, United Kingdom: Bailliere Tindall.

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia

Rees, J. A., Smith, I., & Watson, J. Pharmaceutical practice (5th ed.). London, United Kingdom: Churchill Livingstone

Senya ,S. S., Mwasha, C.Y., Muyinga, A. M., Amiri,R. I., Mauga, E.S.K.(2011). Tanzania Pharmaceutical Handbook ( 2nd ed.). Dar eS Salaam, Tanzania: School of Pharmaceutical Sciences

Session 16: Irrational Prescribing of Medicines

Total Session Time: 120 minutes

Prerequisites

· None

Learning Tasks

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

· Define irrational prescribing

· Distinguish types of irrational prescribing practices

· Describe common patterns of irrational prescribing

· Identify irrational prescriptions

· Explain factors contributing to Irrational Prescribing

· Describe Measures to alleviate Irrational Prescribing

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Worksheet 16.1 to 16.5: Irrational Prescriptions

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	05 minutes	Presentation	Definition of Irrational Prescribing
3	30 minutes	Small group Discussion	Types of Irrational Prescribing Practices
4	20 minutes	Presentation Brainstorming	Common Patterns of Irrational Prescribing
5	30 minutes	Presentation Exercise	Identification of Irrational Prescriptions
6	10 minutes	Presentation Brainstorming	Factors Contributing to Irrational Prescribing
7	10 minutes	Presentation Buzzing	Measures to Alleviate Irrational Prescription
8	05 minutes	Presentation	Key Points
9	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 tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Irrational Prescribing (5 minutes)

· Medicines should be prescribed only when they are necessary, and in all cases the benefit of administering the medicine should be considered in relation to the risk involved

· Irrational use of Medicines may be defined as: Patients receive medications inappropriate to their clinical needs, in doses that do not meet their own individual requirements, for inadequate period of time, and the highest cost to them and their community

STEP 3: Types of Irrational Prescribing Practices (30 minutes)

Activity: Small Group Discussion ( 15 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the types of irrational prescribing practices?

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using the contents below

· The following are the types of irrational prescribing:Extravagant Prescribing: This occurs when:

A less expensive drug would provide comparable efficacy and safety
Symptomatic treatment of mild condition diverts funds from treating serious illness
A proprietary product is used where less expensive generic equivalent is available

· Over prescribing: This occurs when:

The drug is not needed
The dose is too large
The treatment period is too long
The quantity dispensed is too much for the current course of treatment

· Incorrect prescribing: This occurs when:

The drug is given for an incorrect diagnosis
A wrong drug is selected for the indication

· Multiple prescribing: This occurs when a drug is prescribed when:

Two or more medication are used where one or two would achieve virtually the same effect
Several related conditions are treated when one or two would achieve virtually the same effects
Several related conditions are treated where treatment of the primary condition will improve or cure the other conditions

· Under prescribing: This occurs when a drug is prescribed when:

Dosage is inadequate
length of treatment is too brief
Need medications are not prescribed

STEP 4: Common Patterns of Irrational Prescribing (20 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What are the common patterns of irrational prescribing?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

Irrational prescribing may be manifested in the following ways:

Over-prescribing

This occurs if a drug is prescribed when:

The drug is not needed
The dose is to large
The treatment period is to long
The quantity dispensed is too great for the current course treatment

Incorrect Prescribing

The drug is given for the incorrect diagnosis
The wrong drug is selected for the indication
The prescription is prepared incorrectly
Adjustments are not made for co-existing medical, genetic, environmental, or other
factors

Multiple Prescribing

Two or more medications are used where one or two would achieve virtually the same

effect

Several related conditions are treated where treatment of the primary condition would

alleviate or cure the other conditions

Under-prescribing

Dosage is inadequate
Length of treatment is too brief
Needed medications are not prescribed

STEP 5: Irrational Prescriptions (30 minutes)

Activity: Exercise (20 minutes)

DIVIDE students into small manageable groups.

REFER students to Worksheet 16.1 to 16.5: Irrational Prescriptions

READ or ASK one student to read and then comment on the following prescription orders and CLARIFY

· Prescription 16.1

o A patient came with prescription written as Septra tabs 960 mg bd 7/7, Panadol tabs 1 gm tds 3/7 and Cough syrup 10 ml tds 5/7. The diagnosis Cough with chest pain. Comment

o Answer

This is Extravagant Prescribing: Septra is a brand of cotrimoxazole tabs. It cost more than generic drug. The prescription should have been prescribed using generics. Panadol is a trade name too, instead it should have been written paracetamol which is cheaper than panadol

· Prescription 16.2

o A patient aged 55 years, came with prescription written as Paracetamol tabs 1 gm tds 7/7,Metronidazole tabs 400 mg tds 1/12, Diagnosis tooth extraction

o Answer

This is over prescription: Duration for paracetamol is too long, proper is just 3days or as needed Metronidazole duration is too long it should have been 5-7 days. For tooth extraction another antibiotic is needed, ampiclox, Flucamox.

· Prescription 16.3

A patient aged 23 years came with prescription written as BBE 25% w/v od 3/7

Diagnosis scabies

o Answer

This is incorrect prescription: The instruction are not correct BBE 25% od x 3/7 does not tell route of administration. BBE is a topical medication. Need to apply after bath whole body except face and head. Patient should not shower until after 24hrs. Should be applied after every one day (repeat on the third day, and then on fifth day). That means the course is three times

· Prescription 16.4

A patient came with prescription written as Flucamox caps 500 mg tds 10/7, Pen V tabs 500 mg tds 5/7, Ampiclox 500mg tds 5/7, Diagnosis tonsillitis, typhoid, and boils.

o Answer

This is multiple prescription/polypharmacy: The three diseases; tonsillitis, boils and typhoid can well be treated with flucamox. Is a wide antibiotic which is indicated for all the three diseases. There was no need of prescribing ampiclox and Pen V

· Prescription 16.5

A patient aged 10 years came with prescription written as Paracetamol syrup 5mL tds 3/7 ( available paracetamol syrup 125mg/5mL) Co-trimoxazole syrup 5mL bd 3/7 ( available co-trimoxazole syrup 240mg/5mL). Diagnosis pneumonia

o Answer

This is under prescribing : For a child of that age, the dose is too small and the treatment will not be achieved. That is a dose for below 6 years child.

ASK all groups to answer the above 5 questions for 15 minutes.

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

CLARIFY if there are any questions

STEP 6: Factors Contributing to Irrational Prescribing (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What factors contribute to Irrational Prescribing?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

The following are factors contributing to irrational Prescribing:

· Inadequate training in clinical pharmacology and therapeutics

· Lack of continuing education and supervision

· practitioner's inappropriate desire for prestige

· promotional activities of company representatives

· Lack of time due to heavy patient load

· Pressure from patient

· Incorrect generalization about a drug from limited experience

STEP 7: Measures to Alleviate Irrational Prescribing (10 minutes)

Activity: Buzzing (5 minutes)

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

· What are the Measures to alleviate Irrational Prescribing?

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 the content below

· Measures to alleviate irrational prescribing

o Proper use of Standard Treatment Guideline

o Regular supervision of subordinates

o Participating in developing standard treatment protocols

o Participate in continuing education programs through informal one-to-one teaching and through hospital seminars

o Make appropriate use of available laboratory investigations to confirm diagnosis and hence appropriate treatment

o Availability of current drug information through reference manuals and drug news periodical

o Use of hospital formulary to provide scientific justification for appropriate therapeutic intervention

o Educate and counsel patients on proper use of medicine

o Promotion of cost consciousness among prescribers

STEP 8: Key Points (5 minutes)

· In developed and developing world, medically inappropriate, ineffective, and economically inefficient use of pharmaceuticals commonly occurs in health care facilities

· The costs of such irrational drug use are enormous in terms of both scarce resources and the adverse clinical consequences of therapies that may have real risks but no objective benefits

· Promoting appropriate use of drugs in the health care system is needed not only because of the financial reasons but also quality of care which is the most concern to practitioners

· Actions or intervention programs to promote the appropriate use of drugs should, therefore, be continuously implemented and systematically incorporated as an integral part of the health care system

STEP 7: Evaluation (5 minutes)

· What are the commonly encountered irrational prescribing practices?

· What is irrational prescribing?

· What are the types of irrational prescribing?

· What factors contribute to irrational prescribing?

· What are the Measures to alleviate irrational prescribing?

References

Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of pharmaceutics (8th ed.). London, United Kingdom: Bailliere Tindall.

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia

Rees, J. A., Smith, I., & Watson, J. Pharmaceutical practice (5th ed.). London, United Kingdom: Churchill Livingstone

Management Sciences for Health (1988). Health Center Prescribing and Child Survival in East Java and West Kalimantan, Indonesia. Boston: United States of America

Quick, J.D., Foreman, P., Ross-Degnan, D., et al. Where Does the Tetracycline Go?

Ross-Degnan, D., Laing, R.O., Quick, J,D., et al. (1992). Soc Sci and Med:A strategy for promoting improved pharmaceutical use: The International Network for Rational Use of Drugs. 35 (11) 1329–41.

Senya ,S. S, Mwasha, C.Y, Muyinga, A. M, Amiri,R. I. and Mauga E.A.S.K. (2011) Tanzania Pharmaceutical Handbook ( 2^nd ed. ) Dar eS Salaam, Tanzania: School of Pharmaceutical Sciences

Vance, M.A., Millington, W.R., (1986). Int J Health Serv: Principles of irrational drug therapy. 1986;16(3):355–61.

Session 17: Irrational Dispensing of Medicine

Total Session Time: 120 minutes

Prerequisites

None

Learning Tasks

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

· Define Irrational Dispensing

· Identify Irational Dispensing Practices

· Describe Factors Contributing to Irrational Dispensing

· Determine Measures to Alleviate Irrational Dispensing

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board and chalk/whiteboard markers

· Handout 17.1: Factors contributing to Irrational Dispensing

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	10 minutes	Presentation Brainstorming	Definition of Irrational Dispensing
3	55 minutes	Presentation Small Group Discussion	Irrational Dispensing Practices
4	15 minutes	Presentation	Factors Contributing to Irrational Dispensing
5	20 minutes	Presentation Brainstorming	Measures to Alleviate Irrational Dispensing
6	05 minutes	Presentation	Key Points
7	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 Irrational Dispensing (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What is Irrational Dispensing?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

· Irrational dispensing refers to dispensing practices resulted from errors occurring during the dispensing process in the pharmacy

o They are different from prescribing errors or errors during consumption of medicine

STEP 3: Irrational Dispensing Practices (55 minutes)

Activity: Small Group Discussion ( 20 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

· What are the Different Practices of irrational dispensing observed from Dispensers?

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using the contents below

· Misreading the prescription

· Misinformation to the patient (wrong or failure to give proper information)

· Picking wrong medication (picking errors)

· Overcharging (billing error)

· Mistake in packing and labeling

· Mistaken delivery of medicine i.e giving medicine to a wrong person

· Dispensing Expired Medicine

· Error in dispensing similarly pronounced medicine (similarity errors)

· Errors in counting medicine for dispensing

Activity: Exercise ( 25 minutes)

DIVIDE students into small manageable groups

ASK students to Discuss and Comment on cases 17.1-17.3 below

Case 17.1

Mary James, pharmacist, has filled some prescriptions for carbimazole on one working day. On the same day a customer, epileptic patient, presented him a prescription for carbamazepine. Glancing at it, Abebe thinks it is carbimazole once again, and that is what he dispensed. The patient went to his prescriber with complaints of no improvement. Comment on this case.

Discussion: Mary James, the pharmacist, failed to read and understand the prescription correctly. This has led to failure of treatment regimen prescribed for the epileptic patient. Because of the existence of similarity with the names of some medicines, it is important to read and understand the prescribed medicines carefully and correctly.

Case 17.2

Frank Chacha, went to a medicine shop and made verbal request for ampicillin and cough syrup for her 8 years old daughter with complaints of cough and poor appetite. As she did not have enough amount of money, she wanted to purchase only ten capsules of ampicillin and one bottle of cough syrup suspension. The dispenser fulfilled her request. Comment.

Discussion: Frank chacha made a verbal request for a prescription medicine (ampicillin) and an OTC cough syrup. The dispenser should have asked her a prescription at least for ampicillin. Secondly, dispensing inadequate quantity of ampicillin even with prescription is irrational. Such clients should be referred to authorized prescribers. prescription at least for ampicillin. Secondly, dispensing inadequate quantity of ampicillin even with prescription is irrational. Such clients should be referred to authorized prescribers.

Case 17.3

A prescription that calls for atenolol 50 mg tablets is presented to a pharmacy. The total quantity to be dispensed is not indicated. One Tab. BID po for 4 weeks is written after Sig. All other information is complete. The pharmacy professional dispensed 28 atenolol 50 mg tablets. Comment.

Discussion: The total quantity dispensed is not correct. According to the prescription, 56 tablets (2 tablets a day for 4 weeks or 28 days) should be dispensed.

ALLOW students to discuss for 15 minutes

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

CLARIFY if there is any question.

STEP 4: Factors Contributing to Irrational Dispensing (15 minutes)

The following are factors contributing to irrational dispensing practices:

· Dispensing:

o Incorrect interpretation of the prescription

· Retrieval of wrong ingredients

o Inaccurate counting, compounding, or pouring

o Inadequate labeling

o Unsanitary procedures

o Packaging:

§ Poor-quality packaging materials

§ Odd package size, which may require repackaging repackaging

§ Unappealing package

o Inadequate verbal instructions

o Inadequate counseling to encourage adherence

o Inadequate follow-up/support of patients

o Treatments or instructions that do not consider the consider the patient’s beliefs, environment, or culture or culture

Refer students to Handout 17.1: Factors contributing to Irrational Dispensing

STEP 5: Measures to Alleviate Irrational Dispensing (20 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

· What are the measures to alleviate irrational Dispensing?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

· Dispensing should be done by Pharmaceutical personnel

· Dispenser should follow good Dispensing Practice and abide to dispensing policy

· The dispenser or dispensing team should have knowledge, skills and attitudes to carry out the dispensing process rationally. These includes

o Knowledge about the medicines being dispensed (common use, usual dosage, precautions about the method of use, common side effects, common interactions with other medicines or food, storage condition)

o Good calculation and arithmetic skills

o Skills in assessing the quality of preparations

o Attributes of cleanliness, accuracy and honesty

o Attitudes and skills required to communicate effectively with patients,

o Sufficient training according to the level of the health institution and medicine retail outlet

o Knowledge about national polices and working guidelines

o Good knowledge of societal norms and cultural values

o Good working relation with other health care professionals

o Good knowledge on medicine supply management

· Maintain a register/chart to record dispensing errors occurring in your pharmacy, with the possible cause/reason for the error

o Try to work out systems/processes, to avoid such errors in future

· Do not dispense any doubtful prescription if:

o Essential information is missing or doubtful, and the prescriber cannot be contacted

o Safety of the medicines is doubtful

o The prescription does not conform to legal requirements

STEP 6: Key Points (5 minutes)

· Irrational dispensing refers to dispensing practices resulted from errors occurring during the dispensing process in the pharmacy. Improper attention, careless attitude while dispensing, not checking carefully before dispensing are among the factors that contribute to irrational dispensing

· The dispenser or dispensing team should have knowledge, skills and attitudes to carry out the dispensing process rationally

STEP 7: Evaluation (10 minutes)

· What is Irrational Dispensing?

· What are the different practices of irrational dispensing observed from Dispensers?

· What are factors that contributing to Irrational Dispensing?

· What are the measures to alleviate Irrational Dispensing?

References

Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of pharmaceutics (8th ed.). London, United Kingdom: Bailliere Tindall.

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia

Rees, J. A., Smith, I., & Watson, J. Pharmaceutical practice (5th ed.). London, United Kingdom: Churchill Livingstone

Management Sciences for Health (1988). Health Center Prescribing and Child Survival in East Java and West Kalimantan, Indonesia. Boston: United States of America

Quick, J.D., Foreman, P., Ross-Degnan, D., et al. Where Does the Tetracycline Go?

Senya ,S. S, Mwasha, C.Y, Muyinga, A. M, Amiri,R. I. and Mauga E.A.S.K. (2011) Tanzania Pharmaceutical Handbook ( 2^nd ed. ) Dar eS Salaam, Tanzania: School of Pharmaceutical Sciences

Vance, M.A., Millington, W.R., (1986). Int J Health Serv: Principles of irrational drug therapy. 1986;16(3):355–61.

Handout 17.1 Factors Contributing to Irrational Dispensing

Session 18: Sections in a Pharmacy Department

Total Session Time: 120 minutes

Prerequisites

· None

Learning Tasks

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

· List Different Sections of Pharmacy Department

· Explain Activities Carried out and Services Offered in Department

· Describe the Requirements for a Functional Dispensing Unit

Resources Needed:

· Flip charts, marker pens, and masking tape

· Black/white board, chalk and whiteboard markers

SESSION OVERVIEW

Step	Time	Activity/ Method	Content
1	05 minutes	Presentation	Introduction, Learning Tasks
2	05 minutes	Presentation Buzzing	Different Sections of a Pharmacy Department
3	60 minutes	Presentation Small Group Discussion	Activities Carried Out and Services Offered in a Pharmacy Department
4	40 minutes	Presentation	Requirements for a Functional Dispensing Unit
5	05 minutes	Presentation	Key Points
7	05 minutes	Presentation Question and answers	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: Sections/Units of a Pharmacy Department (5 minutes)

Activity: Buzzing (5 minutes)

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

· What are the sections of hospital pharmacy?

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 the content below

· For good pharmaceutical practice, the hospital pharmacy department is organized into the following sections/area:

o Pharmacy administration section

o Dispensing section

o Compounding section

o Strong room

o Sterile preparations section

o Storage section/main store room

o Drug information section

STEP 3: Activities carried out and services offered in pharmacy department (60 minutes)

Activity: Small Group Discussion ( 20 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

What are the activities that are carried out and services offered in pharmacy department?

ALLOW students to discuss for 15 minutes

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

CLARIFY and SUMMARIZE by using the contents below

· The following are activities/services offered by pharmacy department:

o Receiving, Storage and distribution of medicines

o Compounding of sterile and non-sterile products

o Dispensing of medicines

o Therapeutic consultations

o Patient counselling

o All other activities associated with the patient’s drug therapy

Step 4: The requirements for a functional dispensing unit (40 minutes)

The following are the requirements of a functional dispensing unit:

· The premises:

o Should inspire confidence in the users of the service

o Should be clean and hygienic

o Well designed and organized

o Regularly monitored

o Tidy, accessible and secure

o Should provide suitable environmental conditions for both personnel and products

· Dispensing and compounding equipments:

Should be of appropriate design
Suitable, well maintained and adequate for the work to be undertaken
All equipment must be maintained in accurate working order
Checked for cleanliness prior to each use
A range of glass and plastic beakers and conical flasks
graduated glass and plastic measuring cylinders
A range of graduated glass and plastic pipettes
A pipette filler
Stainless steel & plastic spatulas
containers for each type of dosage form
A suitable range of labels
Spoons & Counting trays for tablets and capsules
Appropriate information sources, for examplespharmacopoeias

· Quality assurance procedures.

To assure the quality of all medicines prepared or supplied, control procedures are necessary; these measures include:

quality of raw materials
supervision, documentation
packaging and labelling
labelling for stock
Storage conditions and expiry date

· Accessible sources of Drug information

Competency in the use of information sources is an essential part of pharmacy practice.
It is advised to become familiar with these different sources of drug information so that the required information of various types can be readily retrieved.
Sources of drug information can be obtained from either of the following:

§ Internet source e.g : www.cdnphar , www.which.net/health

§ Subscription source or (e.g pharmaceutical journal, bulletin)

§ Textbook sources e.g Pharmacopoeia

· The personnel:

Should be adequately trained and motivated personne
Pharmacists, Pharmaceutical technicians and Pharmaceutical Assistants together with appropriate support staff
Standards of personal hygiene and politeness should be high
Appropriate protective clothing worn during working hours
Eating, drinking and smoking should not be permitted in any area where medicines are prepared or supplied

Dispensing Balance

Figure 1: Dispensing Aids

Counting Triangle

STEP 6: Key Points (5 minutes)

· The premises on which a dispensing service is provided should reflect the quality of service and inspire confidence on patients in the nature of pharmaceutical service delivered

· Maintaining a clean environment requires a regular routine of cleaning shelves and a daily cleaning of floors and working surfaces

· For good pharmaceutical practice in dispensing and compounding, the hospital pharmacy department is organized into the following sections/areas; pharmacy administration section, dispensing section, compounding section, strong room, sterile preparations section, storage section/main store room, drug information section

· Pharmaceutical personnel working in pharmacy department must be well trained with necessary knowledge, skills and caring attitude to perform activities of pharmaceuticals

STEP 7: Evaluation (5 minutes)

· What are the sections of a pharmacy department?

· What are the activities offered in a pharmacy department?

· What are the requirements for a functional dispensing unit?

References

Abraham G/Giorgis (2004). Drug smuggling and counterfeiting in Ethiopia. Masters Dissertation, University of Bradford, UK

Amanda, L.E., et al.(1999). Intervention research in rational use of drugs. Health policy and planning 14(2):89-102

Management Sciences for Health (1997). Managing drug supply. West Hartford, United States of America; Kumarian press

Tietze, K.J., (1997). Clinical skills for pharmacists: a patient focused approach. Philadelphia, United States of America: Mosby, Inc.

World Health Organization (1997). Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Geneva, Vol.1

Bentley, A. O., & Rawlins, E. A. (1977). Bentley's textbook of pharmaceutics (8th ed.) London, United Kingdom: Bailliere Tindall

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's dispensing for pharmaceutical students (12th ed.). New Delhi, India: CBS

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices. (2nd ed.). Ethiopia


Symbols	Definition	Abbreviation
I	One	o.d.	once a day
Ii	Two	b.i.d.	twice a day
Iii	Three	t.i.d.	three times a day
Iv	Four	q.i.d.	four times a day
5X	five times a day	q.h.s.	everynight at bedtime
Rx	Take this
		q.4h	every four hours
		q.6h	every six hours
		q.o.d	every other hour
		Prn	as needed
		gtt.	Drop
		a.c.	before meals
		p.c.	after meals

Abbreviation	Interpretation
p.o.	By mouth, orally (per oral)
SL	Sublingual, under the tongue
ID	Intradermal
IM	Intramuscular
IV	Intravenous
IV PB	Intravenous piggyback
SC	Subcutaneous.
GT	Gastrostomy tube
NJ	Naso-jejunal tube
p.r	Per rectum
p.v	Per vagina
O.D (RE)	Right eye
O.S (LE)	Left eye
O.U BE)	Both eyes
A.D	Right ear
A.S	Left ear
A.U	Both ears

Abbreviation	From the Latin	Meaning
Aa	Ana	of each
Ad	Ad	up to
a.c	ante cibum	before meals
a.d	aurio dextra	right ear
ad lib	ad libitum	use as much as one desires; freely
admov	Admove	Apply
Agit	Agita	stir/shake
alt. h	alternis horis	every other hour
a.m	ante meridiem	morning, before noon
Amp		Ampule
Amt		Amount
Aq	Aqua	Water
a.l., a.s	aurio laeva, aurio sinister	left ear
A.T.C		around the clock
a.u	auris utrae	both ears
Bis	Bis	Twice
b.i.d	bis in die	twice daily
B.M		bowel movement
bol	Bolus	as a large single dose (usually intravenously)
B.S		blood sugar
B.S.A		body surface areas
cap., caps	Capsula	Capsule
C	Cum	with (usually written with a bar on top of the "c")
C	Cibos	Food
Cc	cum cibos	with food, (but also cubic centimetre)
Cf		with food
comp		Compound
cr., crm		Cream
D5W		dextrose 5% solution
D5NS		dextrose 5% in normal saline (0.9%)
D.A.W		dispense as written
dc, D/C, disc		Discontinue
dieb. alt	diebus alternis	every other day
Dil		Dilute

disp.		Dispense
div.		Divide
d.t.d.	dentur tales doses	give of such doses
D.W.		distilled water
elix.		Elixir
e.m.p.	ex modo prescripto	as directed
emuls.	Emulsum	Emulsion
ex aq	ex aqua	in water
fl., fld.		Fluid
ft.	Fiat	make; let it be made
G		Gram
Gr		Grain
gtt(s)	gutta(e)	drop(s)
H		Hypodermic
h, hr	Hora	Hour
h.s.	hora somni	at bedtime
ID		Intradermal
IM		intramuscular (with respect to injections)
inj.	Injection	Injection
IP		Intraperitoneal
IV		Intravenous
IVP		intravenous push
IVPB		intravenous piggyback
L.A.S.		label as such
LCD		coal tar solution
Lin	Linimentum	Liniment
Liq	Liquor	Solution
lot.		Lotion
M.	Misce	Mix
m, min	Minimum	a minimum
Mcg		Microgram
mEq		Milliequivalent
Mg		Milligram
mist.	Mistura	Mix
Mitte	Mitte	Send

mL		Millilitre
Nebul	Nebula	a spray
N.M.T.		not more than
noct.	Nocte	at night
non rep.	non repetatur	no repeats
NS		normal saline (0.9%)
1/2NS		half normal saline (0.45%)
N.T.E.		not to exceed
o_2		both eyes, sometimes written as o₂
o.d.	oculus dexter	right eye
o.s.	oculus sinister	left eye
o.u.	oculus uterque	both eyes
Oz		Ounce
Per	Per	by or through
p.c.	post cibum	after meals
p.m.	post meridiem	evening or afternoon
Prn	pro re nata	as needed
p.o.	per os	by mouth or orally
p.r.		by rectum
pulv.	Pulvis	Powder
Q	Quaque	Every
q.a.d.	quoque alternis die	every other day
q.a.m.	quaque die ante meridiem	every day before noon
q.h.	quaque hora	every hour
q.h.s.	quaque hora somni	every night at bedtime
q.1h	quaque 1 hora	every 1 hour; (can replace "1" with other numbers)
q.d.	quaque die	every day
q.i.d.	quater in die	four times a day
q.o.d.		every other day
Qqh	quater quaque hora	every four hours
q.s.	quantum sufficiat	a sufficient quantity
R		Rectal
rep., rept.	Repetatur	Repeats
		"s")
		"s")
		Page 3 of 4

Background

Acknowledgment

Introduction

Target Audience

Organization of the Module

Preparation with Handouts and Worksheets

Using Students Manual When Teaching

Abbreviations/Acronym

Session 1: Introduction to Dispensing

Session 2: Medical Prescription

Session 3: Interpretation of Various Medical Symbols and Abbreviations in a Prescription

Session 4: Guidelines on Prescribing Medicines

Session 6: Prescription Errors

Session 7: Dispensing Procedures in Pharmacy

Session 8: Determining Quantities of Medicine for Dispensing

Session 9: Medicines Packaging Materials

Session 10: Medicines Label

Session 11: Generic and Brand Names of Medicines

Session 12: Giving Appropriate Medicine Information to Patients

Session 13: Adverse Drug Reactions, Drug Overdose and Intoxication

Session 14: Documentation of Medicines and Medical Supplies

Session 15: Rational Use of Medicines (RUM)

Session 16: Irrational Prescribing of Medicines

Session 17: Irrational Dispensing of Medicine

Session 18: Sections in a Pharmacy Department

s.a.	secundum artum	use your judgement
SC, subc, subq,		Subcutaneous
Subcut		Subcutaneous
Subcut
Sig		write on label
SL		sublingually, under the tongue
Sol	Solution	Solution
s.o.s., si op. sit	si opus sit	if there is a need
Ss	Semis	one half
Stat	Statim	Immediately
Supp	suppositorium	Suppository
Susp		Suspension
Syr	Syrupus	Syrup
Tab	Tabella	Tablet
tal., t	Talus	Such
Tbsp		Tablespoon
Troche	Trochiscus	Lozenge
Tsp		Teaspoon
t.i.d.	ter in die	three times a day
t.d.s.	ter die sumendum	three times a day
t.i.w.		three times a week
top.		Topical
T.P.N.		total parenteral nutrition
tr, tinc., tinct.		Tincture
u.d., ut. dict.	ut dictum	as directed
ung.	Unguentum	Ointment
U.S.P.		United States Pharmacopoeia
Vag		Vaginally
W		With
w/o		Without
X		Times

Serial Na. 002 KIHESA HEALTH CENTER P.O. Box 56 IRINGA
Name:	Joyce Kamau
Gender:	F
Age:	18Yrs
Weight:	40kg
Rx	Miconazole cream 2% p.a.a b.i.d 4/52 Griseofulvin tabs 500 mg p.c od 3/12
	Paracetamol Tabs 1g tds 3/7
Prescriber’s name qualification	Masige Kahwa Malimbo MO
Signature