Clinical Pharmacology: Medicine Management Flashcards
What does the commission on human medicines (CHM) do?
- 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.
What is the medicines and healthcare products regulatory agency responsible for?
- 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
How can adverse effects of a medication be reported?
Yellow card scheme
How do you know is a signal detected via the yellow card scheme is significant?
A= drug and adverse event of interest B= drug of interest and all other adverse events C= other drugs and adverse event of interest D= other drugs and all other adverse events
Significant if:
A/(A+B) > C/(C+D)
What does the committee for medicinal products for human use ensure?
Drug:
- Quality
- Safety
- Efficacy
Why are drugs so expensive?
Once drugs are on the market, companies can charge whatever the market will bear
What is the main role of the Scottish Medicines Consortium?
Principal remit is to make decisions on the cost effectiveness of
new/existing pharmaceutical products in respect of their use in
NHS Scotland
What does the SMC allow opportunity for?
- Comprehensive assessment
- Rapid response
- Uniformity within Scotland
- Minimise ‘Post code prescribing’
- Education
What threats does the SMC pose?
- Pharmaceutical freedom
- Funding
How does the SMC assess cost/effectiveness?
- 3 month assessment process at time of launch
- Submission by manufacturer
- Health economic analysis
- Cost per QALY central
- Attempt to be fair and reasonable
What are the 3 labels that the SMC can assign to medicines?
- Approved for use
- Approved for restricted use
- Not recommended
Why may the SMC not recommend a drug?
- Clinical effectiveness not convincing
- Cost-effectiveness not demonstrated
- No submission by manufacturer
What can happen is a drug is deem not recommended by the SMC?
- Resubmission
- Appeal
- individual patient treatment requests
What is the purpose of the 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.
- Includes: clinicians, pharmacists, legal advisors, administrators, pharmacy representative
End of life medicine
A medicine used to treat a condition at a stage
that usually leads to death within 3 years with
currently available treatments
Orphan medicine
A medicine with EMA designated orphan status
(ie conditions affecting fewer than 2,500 people in a
population of 5 million) or a medicine used to treat an
equivalent size of population irrespective of whether
It has designated orphan status
Ultra-orphan medicine
A medicine used to treat a condition with a prevalence of
1 in 50,000 or less (or around 100 people in Scotland
What are the challenges of enhancing access to new medicines?
-Company engagement – expected to improve
-Current QALY “threshold” may already be over generous
(£13,000 per QALY may be more appropriate)
-Incentive to propose PAS may be reduced
-Net budget impact in year 1 may be £70M
-Equivalent changes in England & Wales may have
inflated drugs budget by an estimated 7.5%
SMC: Approved for use
-Expected to approve for local use, unless equally
effective alternative available locally.
-Local preference taken into account
-Cost may be a consideration
SMC: Not recommended
- Default position is not to approve for local use
- IPTR may apply
Why are local formularies used?
- Local ownership of decisions
- Familiarity with limited range
- Effectiveness
- Value
- Primary/secondary care issues
- New technology (intranet/websites, hyperlinks to guidelines)
- Electronic prescribing
What is the 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
What must happen or be true of a new addition to a formulary?
Unequivocal evidence of efficacy:
- Available for general use
- Available for restricted use/specialist supervision
- Restricted funding approved by NHS Grampian Tto support protocol under strict use
- Approved by SMC, cost effective alternatives available, not recommended for use in Grampian
When may disinvestment from a formulary occur?
Recommend removal from Grampian Joint Formulary
- Evidence for superior efficacy/safety/kinetics, now available for alternative product
- Evidence from major outcome studies now favour an alternative product
- Evidence of superior cost/benefit now available for an alternative product
- Evidence that this product is of limited clinical effectiveness
