ms 1 Flashcards
what replaced the medicines act 1968?
HMR Human medicines regulation 2012
what is the definition of a medicine/medicinal product according to the human medicines regulation 2012?
medicinal product means
- any substance or a combination of substances having properties to prevent disease in human beings
- medicines or a combination of substances that may be administered to a human being with a view to restoring, correct, and modify a physiological function by exerting a pharmacological, immunological, or metabolic action
define human med regulation 2012?
HMR 2012 govern all the medicines that are sold, supplied and prescribed in the UK including those supplied by the NHS and private healthcare.
HMR regulate all aspects of the medicinal product
does the NHS legislations apply to the HMR 2012 only?
no, HMR control the legislations of the NHS and private practice
does the HMR regulate all aspects of the medicinal product
yes
what does the HMR regulate of a medicinal product?
marketing manufacture advertising and promotion packaging labelling sale supply and prescribing safety and quality post marketing surveillance
what is post-marketing surveillance called?
pharmacovigilance
who licenses all the medicines in the UK?
MHRA
what does MHRA Stand for?
medicines health and regulation agency
what is the function of the MHRA?
MHRA Provide licenses to the medicinal product. The government has set up MHRA to safeguard the public from harm and ensures medicinal products are safe from any ill side effects are brought forward
what is needed before a medicine can be sold in the UK?
before a medicine can be sold in the UK, a number of licenses are essential
- marketing authorization (aka product license)
- manufacturers and wholesale dealer license
who is responsible for issuing licenses?
MHRA
what is marketing authorisation?
what does a marketing authorisation include
includes information such as
-indication of use
-dosage
-recipients (maybe specific age ranges or restricted to adults)
-cautions that apply and possible contraindications
routes of administration
how can we search for a marketing authorisation of a product?
searching for marketing authorization is not user friendly, so we can use the SPC as it is a more user-friendly version of the marketing authorization
what does spc stand for
summary of product characteristics
what does a off-licensed product mean?
medicinal product which has a marketing authorisation but the use of product is outside the marketing authorisation
i.e. marketing authorisation states product used for eye but you use it for the ear
what does an unlicensed product mean?
when a product does not have a marketing authorisation
product could be made according to Rx in a specials unit
what are the classes of medicinal product?
POM
GSL
P MED
what does P medicine mean?
pharmacy only medicines
what does gsl mean?
general sales list
what medicines can be sold otc?
pharmacy only and GSL
define gsl meds
general sales list medicines are otc medicines which have reasonable safety which does not have to be supplied and sold under the supervision of a Pharmacist
can be picked up from the shop floor
is gsl found in pharmacy outlets only?
no, pharmacy and non pharmacy outlets have gsl product
what medicines are not examples of gsl
- alhelminietics,
- parenteral products i.e. IV SC
- ememas, products used for wholely or mainly for irrigation of wounds, products used in the bladder/vagina/rectum
- aloxpirin or aspirin products for administration wholet or mainly for children,
- products stated in schedule 15 unless stated limits,
- eye ointments
P medicines have a general marketing authorisation? t/f
F- p medicines have a marketing authorisation only available in the Pharmacy
what are the laws about the conditions of selling a P med?
- only by a person conducting a retail pharmacy business can sell P med
2/ only sold under the supervision of a Pharmacist - only sold from a registered pharmacy premises
definition of pom?
pom are medicines siupplied by an Rx and specified as being POM by their marketing authourisation
examples of pom
parenterals cds cynogenic substances meds which emit radiation meds without marketing authorisation and specified as being pom in the pom order
what are the nhs contractual categories of medicines?
- black list meds
- borderline substances
- SLS select list schemes
what is a drug tariff?
drug tariff contains sections which lists meds which cannot be supplied by the NHS in order to reduce the burden
what section is the blacklist meds in the drug tariff?
section XVIIA 7a
when was the black list introduced?
1985
what is the outcome of a pharmacist dispensing a blacklisted med?
breach of the NHS contract, pharmacists will not be reimbursed with the item on the blacklist as it breaches their terms of service
examples of blacklisted products?
branded meds calpol, augmentin
what is borderline substances
Borderline substances are nutritional or dermatological products that have been specially formulated to manage medical conditions. The ACBS reviews applications for borderline substances made by manufacturers. Products approved and recommended by the ACBS are listed in Part XV of the Drug Tariff
examples of borderline substances?
cosmetics used for covering disfigured skin lesions or to treat photodermatosis
foods for used in conditions such as coelic disease
food supplements e.e. vitamin preparations not used for deficiencies
what does acbs stand for?
advisory committee of borderline substances
what does the abcs do?
advise when certain non medicinal product such as food which are specially formulated for people with medicinal conditions can be prescribed on a nhs prescription
what section of the drug tariff is the abcs found?
part XV 15
what are sls?
drug that is prescribed for patients with a certain condition such as certain erectile disfunction medication is prescribed for a diabetic patient by the NHS
what part of the sls in thedrug tariff?
XVIIB 17b
is sls normally prescribed by the NHS?
not normally prescribe by tge NHS, mainly private Rx
what list of meds can a dentist prescribe?
part XVIIA dental prescribing formulary
what list of meds can a community nurrse prescriver prescribe?
part XVIIB i 17b
what are the sections of the borderline substances?
list A list of products a-z
LIST B list of medical conditions a-z
LIST C list of meds which have been moved to the black list. no longer prescribed by the NHS
who has full prescribing rights of POM?
doctors, dentists, nurse independant prescriber, pharmacist ip
Who has restricted prescribing rights?
chropodisr, optometrist IP, community nurse prescriber, supplementary prescriber
who is an appropriate prescriber?
doctors, dentists, nurse independant prescriber, pharmacist ip
who is a supplementary prescriber?
works in all areas of med can be appropriate prescriver i.e. mental health
