Extemporaneous Dispensing 1 Flashcards
Knowledge
- Commonly encountered preparation types
- Official and unofficial formulae
- Legal requirements
- Documentation
- Labelling of preparations
- Containers
- Methods for compounding
Skills
- Accuracy of weights and measures
- Use of equipment
- Mixing techniques
- Team working to ensure safety of patient
Attitudes and values
- Professionalism – applying knowledge of pharmacy law and scientific principles
- Responsibility – you are responsible for the quality of the end product and the documentation associated with it
Definitions
• Extemporaneous
– From Latin ‘ex tempore’ – ‘on the spur of the moment’
– OED ‘spoken or done without preparation’
• In practice it is the preparation of small quantities of medicines from constituent ingredients
Exemption from the Medicines Act 1968
and Human Medicines Regulations 2012
• Allows pharmacists to prepare and dispense unlicensed medicines
– Includes extemporaneously prepared medicines
Section 10 exemption for Pharmacists - 1
- Preparing or dispensing a medicinal product in accordance with a prescription given by a practitioner, or preparing a stock of medicinal products for this purpose (this exemption also applies to anything done in a hospital or health centre);
Section 10 exemption for Pharmacists - 2
- Preparing or dispensing of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is to be sold, where the product is prepared or dispensed for administration to that person or to a person under his care;
Section 10 exemption for Pharmacists - 3
- Preparing or dispensing a medicinal product for administration to a person when the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required and, that person is present in the pharmacy at the time of the request.
DSCW Assessment Failure
- Incorrect calculation from master formula to required quantity
- Quantities not checked by another person
- What steps should have been followed to avoid this mistake?
Changes to the use of DSCW
• Thirty five monographs have been omitted from the British Pharmacopoeia 2016.
• In line with recommendations from the Commission on
Human Medicines and the BP Commission, reference to chloroform as an ingredient in licensed medicines has been removed from all affected monographs in this publication. This has been through either removing the monograph from the publication or deleting the formula and/or method of preparation.
Problems with extemporaneous
preparations
• Unlicensed products and therefore no safety data
– No clinical trials conducted
• Lack of evidence of efficacy
• Risks during compounding process
– Errors in weighing and measuring
– Problems with raw ingredients
• Products often given to the most vulnerable patients
– Neonates, children, elderly patients, stroke victims, patients with feeding tubes
• Following the ‘peppermint water case’, community
pharmacies rarely, if ever, extemporaneously prepare
medicines
• Slightly larger scale manufacture in hospitals
• Previous RPS guidance has stated “Appropriately licensed specials manufacturers should be used wherever possible in preference to pharmacists preparing products extemporaneously”
Hierarchy of risk?
- Licensed UK medicine
- Off-label use of UK licensed medicine
- Imported product licensed in country of origin
- UK manufactured special made in MHRA licensed facilities
- Extemporaneously dispensed medicine
- Imported product not licensed in the country of origin
GPhC Guidance
• GPhC Guidance for registered pharmacies preparing unlicensed medicines
• By following this guidance the pharmacy will:
– demonstrate that it meets our standards, and
– provide assurances that the health, safety and wellbeing of patients and the public are safeguarded. Responsibility for making sure this guidance is followed lies with the pharmacy owner
• Pharmacy owners and superintendent pharmacists should make sure that all staff, including non-pharmacists, involved in preparing unlicensed medicines are familiar with this guidance.
GPhC Guidance
• Individual pharmacy professionals are key to ensuring the safe preparation and supply of unlicensed medicines. Pharmacists and pharmacy technicians involved in preparing unlicensed medicines have a responsibility to provide medicines safely to patients, maintain the quality
of their practice, keep their knowledge and skills up to date, and work within their professional competence
• To prepare an unlicensed medicine from ingredients, staff need expertise and skill over and above that needed to dispense a licensed medicine. Many pharmacists and pharmacy technicians should have acquired this knowledge and skill during their initial education and training leading to registration.
