Lecture 9 - Pharmacy Laws & Regulations Flashcards
What happened with thalidomide?
it was not tested for teratogenesis
12,000 affected
What was put in place because of thalidomide?
medicines act put in laws and legislations for how drugs are tested, made, distributed etc
What does medicinal product mean?
any substance of combination of substances present as having properties of preventing or treating disease in human beings OR
any substance of combination of substances that may be administered to human beings with a view to
i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action or
ii) making a medical diagnosis
What does humans medicines regulations part 12 cover?
the rules relating to the sale supply and administration of medicinal products related to their classification as GLS, P or POM
it also creates a number of exemptions from the basic rules for hospitals, certain professionals and supply under patient group directions (PGD)
When can medicines not subject to general sale be supplied?
a person lawfully conducting a retail pharmacy business
the product is sold, supplied or offered for sale or supply on premises that are a registered pharmacy
the transaction is carried out on behalf of a pharmacist or under the supervision of a pharmacist
When can we not accept a prescription?
for dispensing that has been received by a pharmacy not on a pharmaceutical list
Where can we only supply NHS Rx?
from a registered pharmacy included in the pharmaceutical list
What can happen if there are details missing from the Rx?
the pharmacist can supply medication considered most appropriate
If there is no quantity on a Rx what should be given?
5 days supply, or minimum pack size
What must all drugs/appliances conform to?
standard (BP, BPC, DT) or not be of a lower grade than that used for medicinal purposes
What must not be supplied?
product listed in Schedule 10 Medical Services regulations (blacklist)
What must a pharmacy be?
open as shown in pharmaceutical list and must display a notice containing opening hours
When did the public bodies joint working act come into effect?
April 2016
