Labelling and Dispensing of Prepared Liquid – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209

Labelling and Dispensing of Prepared Liquid

Compounding of Pharmaceutical Preparations • Source Session/Topic 12
Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 12: Labelling and Dispensing of Prepared Liquid

Dosage Form

Total Session Time: 60 minutes

Prerequisites

• None

Learning Tasks

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

• Label Prepared Preparations
• Dispense Prepared Preparations into Suitable Containers and Closures

Resources Needed:

• Flip charts, marker pens, and masking tape
• Black/white board ,chalk/whiteboard markers,
• LCD projector and computer

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

35 minutes Presentation

2 Labeling of Prepared Preparations

Demonstration

10 minutes Dispensing of Prepared Preparations into

3 Presentation

Suitable Containers

4 05 minutes Presentation Key Points

5 05 minutes Presentation Evaluation

CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide

Session X: ———— -(Title)———————- 82

SESSION CONTENTS

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

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Labelling of Prepared Preparations (35 minutes)

• Label means any tag, brand, mark, pictorial or other descriptive matter, written, printed,

stencilled, marked, embossed or impressed on or attached to a container of any food,

drug, cosmetics or medical devices

o A label is an important, integral part of a drug preparation

o A label gives clear instructions on how and when to take or use the medication

o The label contributes a good appearance of dispensed medicine, thus increasing the

confidence of the patient

o The label should be written in a legible, neat, and well balanced way

o The size of the label should be appropriate to that of the container

• The main label should clearly state the following:

o The name (underlined) and quantity of the preparation

o The patient‟s name

o The date of dispensing (preparation date)

o Dose and instruction for use.

o The expiry date, where applicable and/ or manufacturing date

o Storage condition

o The name of the dispenser (initial)

o The name and address of the dispensing institution.

o Required dispensing information, such as Shake well before use.

• Preparations intended for application to the skin should be labelled “for External Use

Only” in red; those to be used in the mouth but not to be swallowed, get an auxiliary label

“Not to be Swallowed”. “Not to be Taken” is used for liquid preparations which are not

administered orally and which are not applied to skin surfaces such as ear drops, eye-

drops, nasal drops, enemas and for solid dosage forms which might, by error, be

administered orally such as inhalation capsules, pessaries and solution tablets.

Alternatively, such preparations can be labelled with instructions on the restricted use e.g.

“For Use in the Eye Only” or “Rectal Use only” or “For Vaginal Use Only”. All

heterogeneous liquid preparations such as emulsion and suspensions, must carry the

instruction “Shake before use”. Special storage conditions are also given on the auxiliary

label such as “Store at a Cool Place” or more precise instructions like “Store between 20

C and 80C”. Preparations containing easily inflammable liquids are labelled “Highly

Inflammable” or “Keep away from Open Flames”

• All dispensed medicines should have the instruction: “Keep out of Reach of Children”.
• A label have the following important characteristics

o Neat (orderly and in a clean condition)

o Clear (easily deliver a well-defined message in a simple language)

CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide

Session X: ———— -(Title)———————- 83

o Fit the container (not too large or too small)

o Attractive (pleasing or appealing to the senses)

Activity: Demonstration (25 minutes)

DIVIDE students in small manageable groups.

PREPARE equipment and materials needed for demonstration

POSITION students so that everyone can see and hear

REVIEW steps of writing a label

REFER students to the important things required to appear on the label.

DEMONSTRATE on how to write a good label

ALLOW one student from each group to do a return demonstration and let others comment

on it

CLARIFY and SUMMARIZE by using the content below

INFORM the students that “every student will practice in the skills laboratory under

supervision until is competent”

• Example of labels:

For External Use Only

CALAMINE LOTION PCx

100 mL

Apply to the affected parts at night until cured.

The name of the dispenser and the name and address of the dispensing Institution

Preparation date

Expiry date

SHAKE THE BOTTLE BEFORE USE

Keep Out of Reach of Children

CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide

Session X: ———— -(Title)———————- 84

STEP 3: Dispensing of Prepared Preparations into Suitable Containers (10

minutes)

• Selection of a suitable container is more crucial, because container forms an integral part

of dispensed medicines and should maintain the quality, safety and stability of its

contents. Therefore it should comply with the following requirement:

o Be strong enough to protect the contents from normal mechanical hazards of

handling and transport.

o Prevent leakage

o Provide protection from environmental conditions, such as moisture,

microorganisms, oxygen, carbon dioxide and light.

o Be sufficiently transparent to inspect liquid preparation.

o Do not react with the contents.

• Some general guidelines on selection of container for preparations made in small scale

compounding are:

o Liquid medicines. Preparations for external use, for application to the mouth and

throat, and for instillation into body cavities should be dispensed in fluted bottles,

whereas those for internal use should be dispensed in plain bottles, as officially

recommended.

o This difference gives warning to user of the medicine. When someone touches a

bottle which is fluted will be cautioned that the medicine should not be

swallowed. Even though this is not more practicable now a days.

o Medicines which are sensitive to light or which have ingredients which are

sensitive to light should be dispensed in colored bottles.

o Semi-solid medicines. Ointments, Creams, Pastes, gels, and Poultices are usually

dispensed in wide mouthed plastic or glass containers or suitable metal or plastic

tubes.

Figure 1.1: Plain amber medicine bottles.

Source: Pharmaceutical Compounding and Dispensing (2008).

CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide

Session X: ———— -(Title)———————- 85

• Figure 1.2: Fluted amber medicine bottles.

Source: Pharmaceutical Compounding and Dispensing (2008).

• Figure 1.3: Ointment jars.

Source: Pharmaceutical Compounding and Dispensing (2008).

STEP 4: Key Points (5 minutes)

• Label means any tag, brand, mark, pictorial or other descriptive matter, written, printed,

stencilled, marked, embossed or impressed on or attached to a container of any food,

drug, cosmetics or medical devices

• Preparations intended for application to the skin should be labelled “for External Use

Only” in red; those to be used in the mouth but not to be swallowed, get an auxiliary label

“Not to be Swallowed”. “Not to be Taken” is used for liquid preparations which are not

administered orally and which are not applied to skin surfaces such as ear drops, eye-

drops, nasal drops, enemas and for solid dosage forms which might, by error, be

administered orally such as inhalation capsules, pessaries and solution tablets.

CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide

Session X: ———— -(Title)———————- 86

• Requirements for a good Container are:

o Be strong enough to protect the contents from normal mechanical hazards of

handling and transport.

o Prevent leakage

o Provide protection from environmental conditions, such as moisture,

microorganisms, oxygen, carbon dioxide and light.

o Be sufficiently transparent to inspect liquid preparation.

o Do not react with the contents.

STEP 5: Evaluation (5 minutes)

• What is a label?
• What are the important characteristics of a good label?
• What are the important information that should appear on the label?
• What type of a container is used to dispense liquid preparations intended for internal use?
CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide

Session X: ———— -(Title)———————- 87

References

Langley, C. A., & Belcher, D. (2008). Pharmaceutical Compounding and Dispensing. London:

Pharmaceutical Press.

Peter Bakker, H. W., Vincent Gooskens, Ben Naafs, Rachel Van der Kaaij, Nicolien Wieringa.

(2012). Dermatology Preparations for the Tropics (2nd ed.).

Pharmaceutical Society of Great Britain., & Pharmaceutical Society of Great Britain. Department

of Pharmaceutical Sciences. (1994). The Pharmaceutical Podex, Principles and Practice

of Pharmaceutics (W. Lund Ed. 12th ed.). London,: Pharmaceutical P.

School of Pharmaceutical Sciences, I. o. A. H. S., Muhimbili University of Health and Allied

Health Sciences. (2011). Tanzania Pharmaceutical Handbook (2nd ed.). Dar es salaam:

School of Pharmaceutical Sciences, Institute of Allied Health Sciences, Muhimbili

University of Health and Allied Health Sciences.

MoHSW (2003), Tanzania Food, Drugs and Cosmetics Act. Dar-es-Salaam:

Government printer.

CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide

Session X: ———— -(Title)———————- 88

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