Clinical Pharmacology: Medicine Management

Question 1

What does the commission on human medicines (CHM) do?

Answer 1

• 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.

Question 2

What is the medicines and healthcare products regulatory agency responsible for?

Answer 2

• 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

Question 3

How can adverse effects of a medication be reported?

Answer 3

Yellow card scheme

Question 4

How do you know is a signal detected via the yellow card scheme is significant?

Answer 4

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)

Question 5

What does the committee for medicinal products for human use ensure?

Answer 5

Drug:

• Quality
• Safety
• Efficacy

Question 6

Why are drugs so expensive?

Answer 6

Once drugs are on the market, companies can charge whatever the market will bear

Question 7

What is the main role of the Scottish Medicines Consortium?

Answer 7

Principal remit is to make decisions on the cost effectiveness of
new/existing pharmaceutical products in respect of their use in
NHS Scotland

Question 8

What does the SMC allow opportunity for?

Answer 8

• Comprehensive assessment
• Rapid response
• Uniformity within Scotland
• Minimise ‘Post code prescribing’
• Education

Question 9

What threats does the SMC pose?

Answer 9

• Pharmaceutical freedom

- Funding

Question 10

How does the SMC assess cost/effectiveness?

Answer 10

• 3 month assessment process at time of launch
• Submission by manufacturer
• Health economic analysis
• Cost per QALY central
• Attempt to be fair and reasonable

Question 11

What are the 3 labels that the SMC can assign to medicines?

Answer 11

• Approved for use
• Approved for restricted use
• Not recommended

Question 12

Why may the SMC not recommend a drug?

Answer 12

• Clinical effectiveness not convincing
• Cost-effectiveness not demonstrated
• No submission by manufacturer

Question 13

What can happen is a drug is deem not recommended by the SMC?

Answer 13

• Resubmission
• Appeal
• individual patient treatment requests

Question 14

What is the purpose of the patient access schemes assessment group (PASAG)?

Answer 14

• 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

Question 15

End of life medicine

Answer 15

A medicine used to treat a condition at a stage
that usually leads to death within 3 years with
currently available treatments

Question 16

Orphan medicine

Answer 16

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

Question 17

Ultra-orphan medicine

Answer 17

A medicine used to treat a condition with a prevalence of

1 in 50,000 or less (or around 100 people in Scotland

Question 18

What are the challenges of enhancing access to new medicines?

Answer 18

-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%

Question 19

SMC: Approved for use

Answer 19

-Expected to approve for local use, unless equally
effective alternative available locally.
-Local preference taken into account
-Cost may be a consideration

Question 20

SMC: Not recommended

Answer 20

• Default position is not to approve for local use

- IPTR may apply

Question 21

Why are local formularies used?

Answer 21

• Local ownership of decisions
• Familiarity with limited range
• Effectiveness
• Value
• Primary/secondary care issues
• New technology (intranet/websites, hyperlinks to guidelines)
• Electronic prescribing

Question 22

What is the role of ADTCs?

Answer 22

-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

Question 23

What must happen or be true of a new addition to a formulary?

Answer 23

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

Question 24

When may disinvestment from a formulary occur?

Answer 24

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