Management of Medicines Flashcards
1
Q
Role of Scottish Medicines Consortium
A
- DECISION on COST EFFECTIVENESS of NEW/EXISTING PHARMACEUTICAL PRODUCTS used in NHS Scotland
- Representation from all AREA DRUGS and THERAPEUTICS COMMITTEES: pharmacists, health economists, pharmaceutical representatives, lay representatives, physicians, NHS management
- Manufacturer submits application - HEALTH ECONOMIC ANALYSIS + COST per QALY central○ ATTEMPT to be FAIR + REASONABLE○ PROBLEM w/ V. EXPENSIVE DRUGS - political overtones
3 OUTCOMES: APPROVED for USE, APPROVED for RESTRICTED USE, NOT RECOMMENDED
2
Q
Role of Medicines & Healthcare products Regulatory Agency
A
Regulate SAFETY, QUALITY, EFFICACY of medicines
* Post-marketing surveillance - ADRs + incidents * Assessment + authorisation of medicinal products for UK sale * Devices * Quality Control * Internet sales + counterfeiting * Clinical trials regulation * Statutory controls * Promoting safe use * Manage British Pharmacopoeia + Clinical Practice Research Database * Monitoring drug production + drug standard
3
Q
Role of Area Drugs & Therapeutics Committees
A
RESPONSE to SMC APPRAISAL - local formularies that decide how to implement SMC recommendations in their region
* Development of regional formularies * Implementation of SMC advice, NICE/QIS appraisals, SIGN guidelines * Dealing w/ drugs not on SMC agenda * Dealing w/ unlicensed products * Rationing new & expensive drugs * Regional 'shared care/interface' issues e.g. cyclosporin for transplantation, epoetin for anaemia in CRF, bisoprolol/carvedilol for HF * Education + communication * Prescribing errors * 'out of line' prescribers * Antimicrobial policies * Patient group directives
4
Q
Why do we have local formularies?
A
• LOCAL OWNERSHIP of DECISIONS
* FAMILIARITY w/ LIMITED RANGE * EFFECTIVENESS * VALUE * PRIMARY/SECONDARY ISSUES * NEW TECHNOLOGY - intranet/websites, hyperlinks to guidelines * ELECTRONIC PRESCRIBING - GPASS, EMIS, Vision etc.
