Medicines Legislation Flashcards
What are the main features of HMR, 2012? (5)
Single legal framework applicable to all medicinal products for human use at every stage of development, production, licensing and supply to public.
Px protection legislation.
Applies to substances when used as medicines or as ingredients in medicines.
Operation of the Act monitored and enforced by MHRA.
Outline the administration of HMR 2012. (4)
Government Health Ministers
CHM
MHRA
Other committees e.g. BP commission.
Explain the role of CHM. (7)
Replaced the CSM.
Comprises of members with variet of professional expertise.
Chairman and members appointed by appointment commission.
Advises ministers policy matters relating to medicines legislation.
Give independent advice to MHRA about safety, quality or efficacy of medicines.
Promotes collection and investigation of information relating to ADR.
Advising on impact of new safety issues on balance of +/- of licensed medicines e.g. adding warnings, restricting/suspending use of a medicines.
Explain the role of MHRA. (5)
Ensuring medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy.
Ensuring supply chain for medicines, medical devices and blood components is safe and secure.
Promotes international standardisation and harmonisation to assure effectiveness and biological medicine safety.
Educate public and. HCP about the +/- of medicines, medical devices and blood components leading to safer and more effective use.
Supporting innovation, research and development that’s beneficial to public health.
Influencing UK, EU and international regulatory frameworks so they’re effective at protecting public health.
Collects/investigates information relating to ADR for human medicines via yellow card scheme (post-marketing surveillance)
Investigating sale of medicines on internet/counterfeit medicines.
Explain the importance of drug safety update. (1)
Contains new warnings and reminders.
Define medicinal products. (1)
Any substance or combination of substances presented as having properties of preventing/treating disease in humans.
Define administer. (1)
To give to a human: Orally, injection or by introduction into the body in other way/external application.
Define hospital. (1)
Clinics, nursing home or similar institutions.
Define food + cosmetics. (1)
Not all products are considered as foods/cosmetics.
If it doubt, product should be regulated as medicine.
Food which are Rx under the NHS are listed in BNF as Borderline substances. Approved by Advisory Council on Borderline Substances for NHS reimbursement
What is glucosamine? (5)
Natural substance.
Available as food supplements and widely used for joint health (OA)
Classified as less suitable for Rx.
MHRA all glucosamine products containing >= 1178mg/day = medicine.
Products below this level = food supplement.
What are the 3 types of medical devices? (3)
Active implantable (cardiac pacemaker catheters)
General (bandages, contact lenses)
In-vitro diagnostic (IVD); (pregnancy testing kits, BP machines, BM monitors)
What are the main features of medical devices? (4)
Should have UKCA logo on the packaging (meets safety and performance requirements)
CE = EU logo (UK no longer in EU.) MHRA still accepts the use of CE mark until 30th June 2030. UKCA not accepted in EU.
MHRA keen to receive reports of defective devices or ADR from medical devices via yellow card scheme.
MHRA issues medical devices alerts.
What are the main features of HIV Home testing kits? (3)
Approved HIV self-testing kits that carry CE/UKCA mark after proper regulatory processes and when used in accordance with instruction can be used safely.
Unregulated kits can be purchased over internet but their quality isn’t guaranteed.
All packaging for any near px testing kits should be checked for CE/UKCA logo
Any issues relating to medical devices reported to MHRA via yellow card scheme.
Explain the main features Medicines + Medical Devices Act 2021. (4)
Allows government to amend medicines legislation.
Act also been used to create px safety commissioner.
Medicines manufacturers may also be required to signpost px to updated statutory information about certain medicines on variety digital platforms rather than hard copy PILs.
Act also allows Rx for low-risk medicines.
What are the main duties of the patient safety commissioners? (2)
Promote px safety regarding the use of medicines/medical devices
Promotes the importance of px/members of the public views relating to medicine/medical devices safety.
