Legal and Ethics of Small Scale Manufacture Flashcards
(12 cards)
What does specials and unlicensed medicines include?
Medicines licensed in Europe or elsewhere but not on sale in this country
Medicines for a specified patient in accord with a prescriber’s instructions
Medicines obtained from holders of a manufacturer’s ‘specials’ license e.g. in a hospital or a commercial - liquid formulations, low dose products for children, colour or allergen free
Re-packed medicines - generally in accordance with the license - changing the packaging means it is no longer licensed
Product is not a medicine but used to treat a rare condition
Prepared under section 10 exemption
Give examples of section 10 exemption
Medication prepared for a specified patient in accordance with prescribers instructions
i.e. extemporaneous dispensing, including crushed tablets for suspension, novel formulations
What did The Medicines Act 1968 state?
Introduced a licensing system to regulate the manufacture, distribution, and importation of medicinal products
What does section 10 exempt pharmacists from the licensing requirements in the following circumstances?
Medicinal product is prepared and dispensed in a hospital or health centre by or under the supervision of a pharmacist and in accordance with a doctors prescription
Assembling a medicinal product in a hospital or health centre by or under supervision of a pharmacist
Preparing a stock of medicinal products in a hospital or health centre by or under the supervision of a pharmacist with a view to dispensing them.
Describe the differences between licensed and specials
If medicine is used within the terms if the license any untoward effects are the legal responsibility of the manufacture
if a patient experiences a side effect then patient would have the grounds to prosecute the manufacture
THIS is not the case for a pharmaceutical special
As there is no SmPC the prescriber takes full responsibility in law of any adverse effects caused by the medicine
What does the Human Medicines Regulation 2012 state?
All Medicines are licensed - before they are sold or supplied in the UK
Some exemptions:
- Under section 10 of the Medicines Act 1968 - pharmacists and pharmacies are permitted to manufacture medicines without the need for manufacturing authorisations (license), subject to certain conditions, i.e. to fulfil special needs
What are the legal conditions as a pharmacist?
Must have - Bona fide unsolicited order
Product is formulated for a specifiefd patient in accordance with the requirement of a practitioner registered in the UK
Prescriber is expected ‘in law’ to detail:
- exact pharmaceutical need and
- how that should be addressed
Must make sure:
- Product is for use by your individual patients on their direct personal responsibility
broadly includes any form of extemporaneous dispensing, including TPN compounding, IV additives and cytotoxic reconstitution
if a ‘special’ is manufactured in the UK the manufacture must hold a manufactures license from the MHRA and/or an Investigative Medicinal Products License
Pharmacies must have the appropriate equipment and facilities available to produce a high quality, safe product
A ‘special’ may not be supplied if an equivalent licensed product is available which could meet the patient’s needs
Essential records must be kept
What are the risks with preparation of unlicensed medicines?
Not common
Less skill
Wrong facilities
High risk
What are risk assessments?
Legal requirement
A risk assessment should be specific to the individual pharmacy, the staff working on it, each medicine to be made
Risks should be considered before deciding whether to make or whether another option for supply is best
Risk assessments should be reviewed regularly and when circumstances change
Should state what the risks are and whether an equivalent relevant licensed product exists and is available
What should a risk assessment include?
Formula from a recognised source e.g. pharmacopeia
Method validation
Calculation verification
need/use of specialist equipment
Contamination and hygiene measures
Product-specific risks
Assurances around ingredients and starting materials
Suitability of premises
Staff skills/ knowledge/ training/ competence
Circumstances that would trigger a new risk assessment
What essential records should be kept?
name of product
specification
prescribers name if appropriate
manufactures and if different supplier
date ordered
quantity ordered
batch number received
Keep record of supply for a period of at least 5 years
What does the policy detail?
Responsibilities of all staff involved in the commissioning, purchase and supply of unlicensed medicines
Records should be kept, e.g. product, specification, prescriber, supplier, date and quantity ordered, when received, batch number
A system for handling complaints is required - concerns are made when you suspect the medicines are not ft for purpose
