Medicines Management and Drug Safety

Question 1

roles of the commission on human medicines

Answer 1

1. advises ministers on matters relating to human medicinal produces
2. advises licensing authority
3. considers representations by an applicant or MA holder
4. promotes collection and investigation of information relating to adverse drug reactions to human medicines

Question 2

roles of the MHRA

Answer 2

• post-marketing surveillance – ADRs and incidents
• assessment and authorization of medicinal products for sale in the UK
• devices
• quality control
• internet sales and counterfeiting
• clinical trials regulation
• statutory controls
• promotion of safe use
• manage British Pharmacopoeia and Clinical Practice Research Database
yellow card

Question 3

roles of the SMC

Answer 3

• Principal remit is to make decisions on the cost effectiveness of new/existing pharmaceutical
products in respect of their use in NHS Scotland
• Representation from all area drugs and therapeutic committees
o Pharmacists
o Health economists
o Pharma representatives
o Lay representatives
o Physicians
o NHS management
• Opportunities
o Comprehensive assessment
o Rapid response
o Uniformity within Scotland
o Minimise post code prescribing
o Education
• Threats
o Pharmaceutical freedom
o Funding
• 3-month assessment process at time of launch
• Submission by manufacturer
• Health economic analysis
• Cost per QALY central
• Attempt to be fair and reasonable
• Problem with very expensive drugs – political overtones
• Categories
o Approved for use
o Approved for restricted use
o Not recommended
§ Clinical effectiveness not convincing
§ Cost effectiveness not demonstrated
§ No submission by manufacturer
§ Resubmission
§ Appeal
§ Individual patient treatment requests

Question 4

role of area drug and therapeutic committees

Answer 4

• 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 produces
• Rationing new and expensive drugs
• Regional shared care/interface issues
• Education and communication
• Prescribing errors
• Out of line prescribers
• Antimicrobial policies
• Patient group directives

Question 5

patients most at risk of medicine errors

Answer 5

• Those undergoing cardiothoracic surgery, vascular surgery or neurosurgery
• Those with complex conditions
• Those in the emergency room
• Those looked after by inexperienced doctors
• Older patients

Question 6

factors that could increase the rate of medication errors

Answer 6

• More rapid throughput of patients
• New drug developments, extending medicines into new areas
• Increasing complexity of medical care
• Increased specialisation
• Increased use of medicines generally
• Sicker and older patients are more vulnerable to adverse effects

Question 7

people related causes of medication incidents

Answer 7

• Fatigue
• Hunger
• Concentration lapses
• Stress
• Distraction
• Lack of training
• Lack of access to information
• Alcohol, drugs, illness