Legal and ethical issues Flashcards
What are specials and unlicensed medicines?
Those medicinal products that are prescribed for specific indications in cases for which a licensed product does not exist or is no longer available on the marker.
Which regulations requires all medicines are licensed before they may be sold or supplied in the UK?
Human medicines regulations 2012
Why can’t ‘specials’ be offered for sale by a manufacturer?
They have no product licence
What can specials manufacturers advertise?
Their service but not their products
Which regulation allowed price lists of specials to be published?
The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010
What is a risk assessment?
A careful and through look at what, in your work, could cause harm to patients (and what needs to be done to prevent this)
What should risk assessments be specific to?
the individual pharmacy
the staff working in it
each medicine to be made
What should a risk assessment include?
What the risks are Formula Method validation Calculation verification Specialised equipment Contamination measures Product-specific risks Assurance around ingredients Suitability of premises Staff training/competence Circumstances that would trigger a new risk assessment
What risks assessment records should be kept?
Name of product Specification Prescribers name Manufacturer Date ordered Quantity ordered Batch number
How long should a record be kept when selling or supplying an unlicensed medicine?
5 years
What does TSE guideline stand for?
Trnansmissible spongiform encephaopathies
What are three measures to minimise contamination?
There should b enough space
Environment is suitable for medicine preparation
Steps taken to ensure risk of chemical contamination is eliminated or minimised
What are 3 examples of contamination disasters?
Manchester Incident 1994
Fungal Meningitis 2012
French Alps Baby Deaths 2013-2014
What is a policy?
Information giving detail about the responsibilities of all staff involved in commissioning, purchase and supply of unlicensed medicines
What does good practice include?
Verification Quarantine Inspection Certificate Formal recorded approval
