PHARMACY PRACTICE MPHA 2501

GOOD PHARMACEUTICAL PRACTICE IN COMPOUNDING AND DISPENSING

NURULUMI AHMAD
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Learning Outcomes
At the end of the session, students should be able to: Identify the resources needed in compounding and dispensing. Know the equipment used and choose the appropriate equipment to be used in extemporaneous compounding and dispensing. Apply the knowledge in practical session.
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Resources
The resources that are required for good compounding and dispensing practice include: Suitable, well-maintained premises, An adequate supply of equipment, Well-trained personnel, Strict control procedures, Readily accessible information sources.
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1. 2. 3. 4. 5.

1. The Premises
The premises from which a pharmaceutical service is provided should inspire confidence in the users of the service. Clean and hygienic, well-organized, tidy, accessible and secure. Provide suitable environmental conditions for both personnel and products (medicines, etc.) e.g. controlled temperature, acceptable noise level for concentration.
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2. The Equipment
The equipment in the pharmacy should be suitable and adequate for the work to be undertaken. The equipment required include a means of counting tablets and capsules, a suitable range of labels, working surface of adequate size, sink, refrigerator, suitable balance and weights, mortars and pestles, etc. All equipment must be maintained in accurate working order (calibration!!!) and checked for cleanliness prior to each use. Log books and user manuals attached if appropriate.
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Tablet counting tray

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Tablet Counting Machine

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Pharmaceutics 1: GDP 8

A. Weighing and Measuring

Balance: Electronic Balances

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 Balance: Triple Beam Balances

Learn how to use the balance at: http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202

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Weighing: Balances
Important equipment in pharmaceutical formulation. Torsion and electronic balances. Recognize maximum capacity (including the weight of tares weighing boat/paper/beaker used) and sensitivity requirement. Use balance that is appropriate for a particular task.
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Sensitivity Requirement (SR) and Min. Weighable Quantity (MWQ) of a Balance

All balances have a point below which they cannot measure accurately, e.g. 6 mg for a standard prescription balance. Fancy electronic balances can measure as little as 10 mg, 1 mg, or even 0.1 mg (100 micrograms). The number below which they cannot measure reliably is usually inversely proportional to the price of the balance! This cut off point is called the sensitivity requirement (SR). The sensitivity requirement will tell two things: the minimum amount of drug that can be weighed on that balance and the increments of the balance measure. 12

Sensitivity Requirement (SR) and Min. Weighable Quantity (MWQ) of a Balance

In pharmacy, weighing error of 5% or less is acceptable (some potent drugs require up to 98% accuracy in weighing). Therefore, to keep the error below 5%, the minimum amount of substance that can be weighed using a balance should be 20 times its SR. i.e. MWQ = (SR 0.05) or, (SR 20). Any amount smaller than MWQ should be obtained by aliquot method.
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B. Volumetric Apparatus
Graduated cylinders, beakers, burettes, pipettes. As general rule, choose graduates with capacity equal or just exceeding the volume to be measured higher accuracy.

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 Measuring equipment for small volumes.

Micropipette

Syringe

Pipettes

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Meniscus reading technique.

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C. Mortar and Pestle

For particle size reduction, mixing & making emulsions. Made of porcelain or glass. Porous, unglazed interiors (porcelain) shearing action for making emulsion, should not be used for drugs that stain.
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D. Pellet Knives
Stainless steel spatula with wooden or hard plastic handles. Hard rubber or Tefloncoated stainless steel spatula. Flexible rubber spatulas or rubber scrapers. Used for levigation and spatulation in compounding ointment.
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E. Spatulas

Spatula and micro spatula.

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F. Glass and Plastic Funnels

Used to transfer solutions from one vessel or bottle to another. Also used with filter paper in filtering solution.

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G. Ointment Slab

Used as a surface for levigation and spatulation in compounding ointment. Also be used as a clean, hard surface for rolling semisolid material when making hand rolled suppositories or lozenges.

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H. Glass Stirring Rods

Useful for stirring liquid preparations. Spatulas are not to be used as stirring rods.

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I. Heating Devices
1. Hot Plate Offer fast and direct sources of heat, but required careful monitoring to avoid overheating of ingredients. Must have a carefully controlled temperature.
2. Water Bath For desired temperature at 100oC or less.
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3. The Personnel
Most defects in manufactured medicinal products arise through human error or carelessness!!! There should be an adequate number of trained personnel i.e. pharmacists and technicians together with appropriate support staff. Standards of personal hygiene should be high and appropriate clothing worn. Personnel with potentially infectious disease or open wounds should NOT be involved in compounding process. Eating, drinking and smoking should not be permitted in any area where medicines are prepared or supplied. 25
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4. Strict Control Procedures

In order to assure the quality of all medicines prepared or supplied, stringent control procedures are necessary. Supervision: The compounding and dispensing of medicines should be carried out by a pharmacist or by other suitable personnel under the personal supervision of a pharmacist. Packaging and labeling: Suitable containers should be used. Containers should be labeled immediately after filling. Storage and expiry date: Appropriate storage conditions should be maintained 26 and out-of-date stock safely disposed. 26

4. Strict Control Procedures

Documentation Good documentation of the procedures involved in production of pharmaceutical products is essential. All documents must be clearly written. Do what you document, document what you do

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5. Information Sources
United States Pharmacopoeia (USP) British Pharmacopoeia (BP) British National Formulary (BNF) Medical Information Management System (MIMS) Martindale: The Extra Pharmacopoiea British Pharmaceutical Codex (BPC)

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 Pharmacopoiea is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. The British Pharmacopoeia (BP) is the authoritative annual published collection of standards for UK medicinal substances and the official source of all UK pharmaceutical quality standards.

British Pharmacopoeia (BP)

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British Pharmacopoeia (BP)

Essential reference for anyone involved in pharmaceutical research, development, manufacture and testing, and plays a vital role in ensuring that all medicinal substances on the UK market (and other countries market using the title BP, e.g. simple syrup BP) meet standards of safety, quality and efficacy. The BP comprises monographs, which set out the mandatory standards for active substances, excipients and formulated preparations, together with supporting General Notices, Appendices (test methods, reagents, etc) and Reference Spectra.
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British Pharmacopoeia (BP)

Other Pharmacopoieas include: European Pharmacopoeia (EP), United States Pharmacopoeia (USP), Indian Pharmacopoeia (IP), International Pharmacopoeia (Ph.Int.) etc.

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British National Formulary (BNF)

A very useful and widely used reference. The British National Formulary (BNF) contains a wide spectrum of information on prescribing and pharmacology, among others indications, side effects and costs of the prescription of all medications available on the National Health Service.

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British National Formulary (BNF)

It is used by general practitioners and specialist practitioners, and by other prescribers (such as pharmacists, nurses and paramedics) to help them select appropriate treatments for their patients; as a general reference book on the wards by nurses who administer medications; and by patients and others seeking an authoritative source of pharmacological advice.
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Pharmaceutics 1: References 40

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Pharmaceutics 1: References 41

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Pharmaceutics 1: References 42

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Pharmaceutics 1: References 43

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Pharmaceutics 1: References 44

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Pharmaceutics 1: References 45

Medical Information Management System (MIMS)

MIMS is a pharmaceutical prescribing reference guide containing information about all drugs in the UK formulary. The title is published monthly, being sent gratis to all UK general practitioners and on a paid basis to subscribers. An electronic version, eMIMS, is part of the Healthcare Republic website. MIMS also serves as a medical advertising medium and has been published in various forms since the 1960s by unrelated organizations in China, Europe, Hong Kong, India, the Middle East, Ireland, Australia, New Zealand and Malaysia (MIMS Malaysia).
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 MIMS Malaysia contains information (brand and generic names, indications, dosages, contraindications, special precautions, adverse reactions, drug interactions, presentations and packings, and prices) about drugs available in the Malaysian market.
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THANK YOU

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Discussion
Explain why using proper techniques and weighing ingredients with accuracy are important while preparing special compounds in the pharmacy.

QUESTIONS
1. Define compounding. 2. Define dispensing. 3. List factors required for good pharmacy practice in compounding. 4. List factors required for good pharmacy practice in dispensing.

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QUESTIONS
5. You are the new pharmacist incharge of the in patient pharmacy department. Your head of pharmacist asked you to prepare standard operating procedures for compounding and dispensing. With relevant examples, discuss the important points necessary to produce the document.

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