PY4030-5130 - Extemp prep booklet - 2019-20 - Student copy with Coshh PDF

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FACULTY OF SCIENCE, ENGINEERING AND COMPUTING SCHOOL OF PHARMACY & CHEMISTRY

MASTER OF PHARMACY & FOUNDATION DEGREE IN PHARMACEUTICAL AND CHEMICAL SCIENCES PRACTICAL EXTEMPORANEOUS PREPARATIONS GUIDE

LEVEL 4 & 5 Making Medicines/The Science of Medicines PY4030 / PY5130

2

MODULE CODE: PY4030 Table of contents Introduction

3

Specials

4

Standards in the Professional Practice Laboratory

5

How to complete the worksheets

6

Definitions and guidance

7

Important notices

9

Extemporaneous preparation practical worksheet

10

Practical 1: Preparation and labelling of a solution

13

Practical 2: Preparation and labelling of a ointment and a cream

20

Practical 3: Preparation and labelling of an emulsion

31

Practical 4: Preparation and labelling of a suspension and solution

38

Appendix 1: Good Dispensing Practice

44

Appendix 2: Good Manufacturing Practice

46

Appendix 3: List of Risk and Safety Phrases

48

Appendix 5: Label example

63

Appendix 6: Methodology for Potassium Citrate BP

64

Appendix 4: COSHH forms

65

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Introduction This practical course augments the lectures and workshops in the Making Medicines module. The main aim of the practical classes is to familiarise you with the equipment and techniques used in the extemporaneous compounding of medicinal products. These sessions will involve the small-scale preparation of medicines from basic ingredients. You will analyse prescriptions, locate appropriate formulae, perform pharmaceutical calculations, manufacture, label and package medicines accordingly and keep suitable records of your activities. What do we mean by extemporaneous compounding of a medicinal product? The Oxford Dictionary of English defines extemporaneous as ‘spoken or done without preparation’ and compounding as ‘something made by mixing, especially a medicinal preparation’. In pharmacy practice, the phrase extemporaneous compounding is used in order to refer to the preparation of a medicinal product from its basic ingredients by some process of manipulation prior to dispensing. When is extemporaneous compounding warranted? In contemporary practice, most medicines dispensed by pharmacists have been premanufactured on a site that holds a manufacturer’s licence (usually the ‘pharmaceutical industry’) and the medicines themselves have a marketing authorisation (previously called a ‘product licence’). In the UK, manufacturer’s licences and marketing authorisations are issued by the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medicinal products for human use in accordance with The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789), The Medicines Act (1968), and regulations made there under. The legislation provides a regulatory framework in respect of the safety, quality and efficacy of medicinal products to be sold, supplied or administered to patients. Medicines that meet the standards of safety, quality and efficacy are granted a marketing authorisation, which is normally necessary before they can be prescribed or sold. The Royal Pharmaceuticals Society’s (RPS) “Good practice guidance on the procurement and supply of pharmaceutical specials” published in 2010 states that where a UK product with a marketing authorization is available, it has to be supplied. A “special” is an unlicensed medicine and is supplied only when there is no available licensed medicine which fully meets the patient’s clinical needs. A special can be manufactured in MHRA licensed facilities or extemporaneously prepared under the direction of a pharmacist in registered premises. However extemporaneously dispensing under the direction of a pharmacist in registered premises is not performed under licensed facilities and may or may not have written quality assurance protocols and procedures. Consequently extemporaneously dispensed medicines are “higher risk” according to the RPS hierarchy of risk table (www. rpharms.com).

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Specials Majority of medical treatment is delivered by prescription of licensed medicines which have been approved for sale in the UK by a Marketing Authorisation (MA), from the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA). The core purpose of licensing and regulatory process is rigorous assessment of quality, safety and efficacy. All licensed medicines must have an MA before they can be placed on the UK market. For some conditions such as psoriasis and eczema, the range of appropriate licensed medicines may be limited and prescribing can rely significantly on unlicensed creams and ointments (known as ‘Specials’) containing ingredients like tars, dithranol, salicylic acid, steroids and other active constituents in a range of concentrations and bases. Similarly, the range of licensed medicines such as oral liquids for groups of patients including babies, young children and older people unable to swallow tablets or capsules, or for whom the available strengths are not appropriate, is relatively limited. The small size of the potential market is a key factor. Investment in the development of licensed forms of these preparations is discouraged by the prohibitively high cost of development and because manufacturers view such products as unlikely to be profitable. When suitable licensed medicines aren’t available, the Medicines Act allows doctors to prescribe and specify the formulation of any medicine which they judge to be essential to meet the patient’s “special clinical need”. Prescribers have a professional and ethical responsibility to prescribe an unlicensed medicine only when there is no available licensed product which meets the patient’s clinical need. There is significant clinical experience and circumstantial evidence of the efficacy of Specials in dermatological practice. Almost all practising clinicians will be familiar with patients having had a Special prescribed previously who have found it extremely effective, such that they and the patient are keen to continue treatment with it, in the continuing absence of a directly equivalent licensed product.

Batch Size Safety, efficacy

Price

Licensed medicine

Special

Large batches rigorously tested for quality, safety & efficacy. Cheap

Small batches Tested for quality but not for safety or efficacy Expensive

Extemporaneous preparations Single packs not tested

Very expensive

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Standards in the Professional Practice Laboratory Pharmacists are trusted by patients for their knowledge, skills and professional judgement. This requires high standards of personal and professional conduct. As a pharmacy undergraduate, you are required to adhere to the following standards at all times in the Professional Practice Laboratory. 1. Please use the lockers provided to store all your personal belongings; bring only necessary items into the laboratory with you. 2. Wear a white laboratory coat, reserved for Professional Practice practicals. Ensure that the lab coat is clean, professional in appearance, and wear it buttoned up. 3. Switch off your mobile phone and do not use it at any time. 4. Do not consume food or drinks. Similarly, chewing gum is not allowed. (If you need to consume food for a medical reason or take medication during the course of the practical class, talk to a member of staff and if possible please leave the lab to do so.) 5. Please keep your behaviour professional and limit non-professional discussions. 6. Keep your preparation area clean and tidy before, throughout and after your compounding. Wash, dry and replace all glassware (and other equipment as appropriate) once you have completed each task. Similarly, wash and dry your hands before and after you prepare each product. 7. Work to Good Dispensing Practice (GDP) (see Appendix 1) and Good Manufacturing Practice (GMP) (see Appendix 2) at all times.

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How to complete the worksheets During the course of each practical you will be asked to prepare and label one or more products, in accordance with a prescription, by extemporaneous compounding.  Analyse the prescription for legal, ethical, good-practice, and clinical considerations, as directed (you will be asked to do more of this as the course progresses). Record your comments in the appointed section and use extra sheets where needed  Read and sign the COSHH form provided at the back of the practical guide  Use the reference sources available to find a master formula for the preparation unless it is already provided in your worksheet or practical guide.  Write a label for each product on an adhesive label (your tutor will affix this to your practical guide at the end of the session)  Record the following information on a worksheet: o Your name and the date o The product’s name, the batch number you have assigned it, and its expiry date o The original (master) formula used together with its reference source o The quantities used for preparing the amount stated on the prescription o The source, batch number and expiry date of the ingredients used o The working of all calculations o The equipment, containers and closures used o The recommended storage conditions for the product o The shelf life you have assigned the product o Record your methodology  Sign the worksheet after you have completed it  Ensure that you obtain a signature from the lab technician or one of the tutors to indicate that you have cleaned up your work station and have washed and tidied away all glassware and equipment as appropriate  Make sure your completed worksheet is checked by a colleague or by an instructor before you leave the practical session

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Definitions and guidance Expiry of extemporaneous products Products prepared by extemporaneous compounding are normally assigned a short shelf life. The British Pharmacopeia (BP) directs that such preparations must be either freshly prepared or recently prepared. The direction that a preparation must be freshly prepared indicates that it must be made not more than 24 hours before it is issued for use. The direction that a preparation should be recently prepared indicates that deterioration is likely if the preparation is stored for longer than about 4 weeks at 15–25°C. In practice: freshly-prepared products are assigned as expiry of 2 weeks including the date of manufacture; recently-prepared products are assigned as expiry of 4 weeks including the date of manufacture. Information about whether a product is freshly or recently prepared can be found with the ‘master formula’ e.g. in the British Pharmacopoeia, or will be stated on your worksheet. Make sure that you know how many days are in each month. There are two ways to remember this: A rhyme: 30 days has September, April, June and November. All the rest have 31 except February alone which has 28 or 29 on a leap year. Or this second method……. Clench your fists and put your knuckles together side by side. The first knuckle on the left of your left hand is January, then moving to the right there is a dip, this is February, then there is the next knuckle, March, etc. until you get to December on the middle of your right hand. All the knuckles are 31 days and all the dips are 30 (except February, which is an exception, as above)

Potable water The term water used without qualification means either potable water, freshly drawn direct from the public supply and suitable for drinking, or freshly boiled and cooled purified water. Freshly boiled and cooled purified water should be used if the public supply is from a local storage tank or if the potable water is unsuitable for a particular preparation.

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Latin abbreviations The British National Formulary recommends that directions on prescriptions should preferably be in English without abbreviation. However, it is recognised that some Latin abbreviations are used when prescribing. The following is a list of commonly used abbreviations: a. c. = ante cibum (before food) b. d. = bis die (twice daily) o. d. = omni die (every day) o. m. = omni mane (every morning) o. n. = omni nocte (every night) p. c. = post cibum (after food) p. r. n. = pro re nata (when required) q. d. s. = quater die sumendus (to be taken four times daily) q. q. h. = quarta quaque hora (every four hours) stat = immediately t. d. s. = ter die sumendus (to be taken three times daily) t.i.d. = ter in die (three times daily) a. m. = ante meridiem (before noon) p. m. = post meridiem (afternoon) m. = mane (in the morning) n. = nocte (at night) m. d. = more dicto (as directed) m. d. u. = more dicto utendus (to be used as directed) mist. = mistura (a mixture) mitt. / mitte = mittatur (send) Rx = recipe (take) Sig = signa (write/label) supp. = suppositorium (suppository) syr. = syrupus (syrup) inj. = injectio (injection) liq. = liquor (solution) lot. = lotio (lotion) ocul. = oculo (to/for the eye) p. o. = per os (by mouth/orally) p. r. = per rectum (into the rectum) p.v = per vaginam (into the vagina) ung. = unguentum (ointment) guttae = drops

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Important notice in case (or suspected case) of pregnancy

Pregnant students should be aware that it is their responsibility to inform their module leader where practical classes are scheduled. In order to exclude the possibility of any risk to their developing child, a risk assessment will be undertaken and it is likely that such students will not be permitted to undertake experimental work on this module. Since in modules with a practical element, this element makes up a significant proportion of the coursework marks, any affected student would need to carry out the practical work at a later date, normally when the module next runs.

Alternatively, a pregnant student may wish to discuss their options with their Course Director and consider the alternatives, such as suspending their studies for a suitable period. Advice can be obtained from the SEC Faculty Student Support Office.

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Kingston University – Faculty of Science, Engineering and Computing School of Life Sciences, Pharmacy and Chemistry – Department of Pharmacy Extemporaneous Preparation Practical Worksheet Name of Student:

Date:

Product:

Expiry date:

Batch No.: Original Formula: Ingredients Quantity

Working Formula: Quantity Manufacturer

Batch no.

Expiry

Dispenser

Source of Formula: Calculations:

Equipment:

Size

Quantity

Comments:

Checker

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Container(s)/closure(s):

Size

Quantity

Comments:

Labelling Information: Storage: Shelf Life: Copy of Label:

Tutor to affix label

Methodology:

Legal, ethical, good-practice and clinical considerations

Signature of Student:

Signature of technician/tutor to confirm cleaning completed:

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Comments from Tutor

Professional appearance- e.g. hair out of face, no chewing gum Health and Safety e.g. COSHH, gloves

Correct weighing and measuring of ingredients Product correctly dispensed e.g correct method and techniques used Product appearance e.g. label written clearly, bottle / jar not greasy

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Practical 1: Preparation and labelling of a solution This is the first of a set of four practicals to introduce the extemporaneous preparation of pharmaceuticals. Guidance One of the reference books you will use throughout your Pharmacy degree course and in your career as a pharmacist is the British National Formulary. The BNF is published jointly by the Royal Pharmaceutical Society and the British Medical Association. It aims to provide healthcare professionals with sound and up-to-date information about the use of medicines. The main body of the BNF is its 15 Chapters, arranged according to systems of the body (e.g. Chapter 1 is the Gastro-intestinal system) or an aspect of medical care (e.g. Chapter 15 is Anaesthesia), and its 5 Appendixes. In addition, the first 30 or so pages of the BNF are dedicated to guidance on prescribing and the emergency treatment of poisoning. PLEASE TAKE THE TIME TO FAMILIARISE YOURSELF WITH THE LAYOUT AND FORMAT OF THE BNF. YOU MAY FIND SECTION X OF THE BNF: “HOW TO USE THE BNF” USEFUL. Each of the 15 Chapters of the BNF is divided into sections that begin with ‘notes for prescribers’. These are followed by details of relevant drugs and preparations, otherwise known as the drug monographs*. Each drug monograph is headed by the approved drug name followed by some standard subheadings. The following describe the common subheadings in the BNF drug monographs; the descriptions are intended to help you when using the BNF in this practical and in general.

DRUG NAME Indications: lists details of uses and indications for the drug. Dose: lists the dose and frequency of administration (and the maximum dose) for the drug; CHILD and ELDERLY lists the details of the dose for specific age groups Contra-indications: lists circumstances when a drug should be avoided Cautions: lists details of precautions required and also any monitoring required when using the drug. Interactions: when one drug changes the effect of another drug, explained in Appendix 1 Side-effects: lists details of common and more serious side-effects associated with the drug. Pregnancy: advice on the use of the drug during pregnancy Breast- feeding: advice on the use of the drug during breastfeeding Hepatic impairment: advice on the use of the drug in hepatic impairment. Renal impairment: advice on the use of the drug in renal impairment. * In general the doses, indications, cautions, contra-indications and side-effects in the BNF reflect those in the manufactures’ data sheets or Summaries of Product Characteristics (SPCs), which in turn reflect those in the corresponding Marketing Authorisations for the products. However, the editorial staff at the BNF also uses information from medical/clinical literature, regulatory and professional authorities, national guidelines, and expert advice when constructing the BNF.

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Extemporaneous compounding of Potassium Citrate Mixture BP 

Watch the demonstration on “How to prepare Potassium Citrate Mixture BP”. This will be delivered by one of the tutors. IMPORTANT: make notes as you watch the demonstration since you will not be given a method to work from.



Examine the following prescription.



Complete the extemporaneous worksheet below (see also the section “How to complete the worksheets”, page 5 of this booklet). You can use one of the reference sources available in the lab to find the formula.



Transcribe the formula onto the worksheet and state the reference used.



Reduce or increase the original formula according to the volume prescribed. Show all working for your calculations in the space indicated.



IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS IN THE FORMULA, PLEASE TELL ONE OF THE TUTORS BEFORE PROCEEDING FURTHER.



Please read and sign the COSHH assessment form number 1 in Appendix 4.



Proceed to make the product by extemporaneous compounding. As you weight and measure each ingredient, sign the appropriate cell in the worksheet (in the column entitled ‘dispenser’) and ask your assigned ‘lab partner’ to check your work*.



Make up the mixture as demonstrated by the tutor at the sta...