Regulation, Introduction and Monitoring of Medicines Flashcards
Committee for Safety of Medicines (CSM)
formulated in 1963 following thalidomide saga
Commission on Human Medicines (CHM)
Formerly Committee for Safety of Medicines (CSM)
Advises Ministers on matters relating to human medicinal products
Advises Licensing Authority (LA)
Considers representations by an applicant or MA holder
Promotes collection and investigation of information relating to adverse Drug Reactions to human medicines.
with all new drugs what questions should be asked
Does it work?
What dose is therapeutic?
What dose is toxic?
Is it safe?
Is it necessary?
Medicines & Healthcare products Regulatory Agency (MHRA) –Executive Agency of DoH
Post-marketing surveillance – ADRs and incidents
Assessment & Authorisation of medicinal products for sale in UK
Devices
Quality control
Internet sales & counterfeiting
Clinical Trials regulation
Statutory controls
Promotion of safe use
Manage British Pharmacopoeia & Clinical Practice Research Database
Andexanet alfa
A drug to reverse apixaban and rivaroxaban in patients who have a life threatening bleed
Approved for use for intracerebral haemorrhage in Scotland (SMC) but not in England (NICE).
Recent study called Annexa-I shows superior haemostatic efficacy to usual care (which might include concentrated clotting factors)
yellow card role
if patient has an adverse event in the time period following administration of a drug - pharm industry, healthcare workers, patients or carers
GcMAF (globulin component Macrophage Activating Factor)
Company: Immuno Biotech
Unlicensed human blood product
Treatment for autism, HIV and cancer
Unlicensed
Sold to 10000 people online
was then arrested
European Medicines Agency
European equivalent of FDA
Was based in London, but now Amsterdam.
Decentralised scientific assessment to ~4,500 experts throughout EU
in 40 National Competent authorities
Committee for Medicinal Products for Human Use (CHMP)
Quality
Safety
Efficacy
Food and Drug Administration
Regulates:
US$1 trillion worth of consumer goods
$466 billion food sales
$275 billion pharmaceutical drugs
$60 billion cosmetics
$18 billion vitamin supplements
Budget for Fiscal Year 2014 = $4.7 billion
Scottish Medicines Consortium
3 month assessment process at time of launch
Submission by manufacturer
Health economic analysis
Cost per QALY central
Attempt to be fair and reasonable
Patient Access Schemes Assessment Group (PASAG)
Remit is to Advise on acceptability of Patient Access Schemes within NHS Scotland.
Convened by Secretary of State for Health within National Services Division of NHS Scotland, and reporting to SMC.
Clinicians
Pharmacists
Legal advisors
Administrators
Pharma representative
Why local Formularies?
Local ownership of decisions
(but much common ground in Scotland)
familiarity with limited range
effectiveness
value
primary/secondary care issues
new technology
intranet/websites
hyperlinks to guidelines
electronic prescribing
GPASS, EMIS, Vision etc
Role of ADTCs
development of regional formularies
implementation of SMC advice
implementation of NICE/QIS appraisals
implementation of SIGN guidelines
dealing with drugs not on SMC agenda
dealing with unlicensed products
rationing new and expensive drugs
regional “shared care/interface” issues
education & communication
prescribing errors
“out of line” prescribers
antimicrobial policies
Patient Group Directives
“Disinvestment”
Recommend removal from Grampian Joint Formulary
[a] evidence for superior efficacy/safety/kinetics
now available for alternative product
[b] evidence from major outcome studies now favour
an alternative product
[c] evidence of superior cost/benefit now available
for an alternative product
[d] evidence that this product is of limited clinical effectiveness
Antibiotic policies
changing resistance patterns
hospital acquired infections
MRSA
HIV
Hepatitis C
consistency
