Medicines Regulation Flashcards
T/F: The term ‘medicine’ is not defined in the Human Medicines Regulations 2012?
TRUE
no legal definition
T/F: A condom is a medicinal product?
FALSE
a medicinal device
T/F: All shampoos are cosmetics and are therefore exempt from the HMR 2012?
FALSE
not all, some for medical conditiions (sebhorrhic dermatitic, dermatitis)
T/F: A salbutamol MDI is classified as a medical device?
FALSE
medicinal product, MDI contains the medicinal product and plastic
T/F: Packaging for medical devices should be marked with the letters ‘EC’?
FALSE
should be CE
T/F: Folic acid tablets 400mcg can be licensed as a medicinal product?
TRUE
can also be sold as a food supplement, not a med product
T/F: Liquid nitrogen can be classified as a medicinal product?
TRUE
can also be a gas or not a medicinal product, med product more expensive/more licencing
T/F: Emulsifying Ointment BP contains no active ingredient and is therefore not a medicinal product?
FALSE
is a med product, just because it doesn’t have active ingredients doesn’t mean can’t be licenced as med product
T/F: A tinzaparin pre-filled syringe is classified as a medicinal product?
TRUE
has medicine in it
(an empty syringe diepensed to patient is med device)
T/F: It is possible for eye drops and nasal drops to be classified as medical devices?
TRUE
unusual, some eye drops/nasal sprays can be medical devices, usually med products that don’t contain recognised active ingredients
What was the reason for the Medicines Act 1968?
the thalidimide problem
3 pieces of legislation relating to drugs/meds in UK
- The Medicines Act 1968
- The Misuse of Drugs Act 1971
- The Poisons Act 1972
What was the Medicines Act 1968 replaced by?
Human Medicines Regulations 2012
What type of law is HMR 2012?
criminal law
Who enforces HMR 2012?
MHRA
medicines and healthcare regulatory agency
- some aspects relating to pharmacy monitored by GPhC
What is the HMR 2012?
- Single legal framework applicable to ALL medicinal products for human use at EVERY stage of development, production, licensing & supply to the public
- Patient protection legislation
- Only applies to substances when they’re used as medicines or as ingredients in medicines
who does MHRA advise
CHM
commission on human medicines
who does CHM advise
government health ministers
What is the CHM (commission on human medicines)?
- composed of members with wide range of clinical/scientific/professional expertise
- advises ministers on matters relating to medicines regulation
- gives advice to the MHRA about the safety/quality/efficacy of med products
- promotes collection & investigation of info relating to ADRs
- advises on new safety issues, risks & benefits of licensed meds (adding warnings, restricting/suspending use of a med)
What is the MHRA? - Medicines and Healthcare Products Regulatory Agency
- ensures meds, devices, blood components for transfusion meet applicable standards of safety/quality/efficacy
- safeguards the public’s health
- ensures supply chain for meds/devicesblood components is safe and secure
- assures effectiveness & safety of biological medicines
- educates the public & hc professionals about risks/benefits of meds/devices/blood components
- issues drug alerts
- recalls
- supports R&D
- collects & investigates ADRs via yellow card scheme
- investigates sale of meds on internet and counterfeit meds
definition of a medicinal product
a) any substance/combination of substances presented as having properties of preventing/treating disease in human beings
OR
b) any substance/combination of substances that may be used by or administered to human beings with a view to
1. restoring, correcting or modifying a physiological fxn by exerting a pharmacological, immunological or metabolic action
2 making a medical diagnosis.
definition of administer
means to administer to a human being:
a) orally, by injection, or by introduction into the body in any other way
OR
b) by external application (whether or not by direct application to the body) either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with a substance used as a vehicle
products exempt from med legislation
food
cosmetics
doubt if product comes under med legislation
should be regulated as a medicine - stricter regulation
foods that can be prescribed under the NHS, what are the listed as?
Borderline Substances
Who approves foods licenced as medicinal products?
ACBS - advisory council on borderline substances
foods are reinbursed on NHS Rx even though not medicinal products
glucosamine
routinely- natural substance found in mucopolysaccharides, mucoproteins and chitin
- glucosamine products available as food supplements
- used for joint health (OA)
- limited evidence, should not be routinely prescribed
- glucosamine products containing > 1,178mg/day of MUST licensed as a medicine
- below this available as a food supplement
legislation that regulates medical devices
Medical Devices Regulation 2002
definition of medical device
does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means
3 types of medical devices
- Active implantable medical device (pacemaker, catheter)
- General medical devices (bandages, contact lenses)
- In vitro diagnostic medical devices IVDs (pregnancy test, BP machines, BM monitors, strips for BMs)
logo/letters on packaging for medical device
‘CE’
- Conformité Européenne
- EU symbol
- used until 30/6/23
UKCA
- UK Conformity Assessed
- will now be this in UK
- mandatory from 1/7/23
What does CE/UKCA mean?
medical device meets safety and performance requirements (fit for its stated use)
Who receives reports about medical devices and how?
MHRA
via yellow card scheme
what are medical apps classed as
medical devices
What regulates home testing kits?
regulated under medical device legislation
if device doesn’t have CE/UKCA what does it mean?
quality is not guaranteed
unregulated
How to report issues with medical devices?
to MHRA via yellow card scheme
new act when UK left EU
Medicines and Medical Devices Act 2021
What did the Medicines and Medical Devices Act 2021 do/mean?
- allows the Government to amend medicines legislation
- used to create a Patient Safety Commissioner
duties of the Patient Safety Commissioner
- promote safety of pts with regard to use of medicines & medical devices
AND - promote importance of the views of patients/members of public in relation to the safety of medicines and medical devices
