Medicines Management Flashcards
What is the MHRA and what is their role in management of medicines?
MHRA = Medicines & Healthcare products Regulatory Agency
MHRA does the following:
Ensures that human medicines meet acceptable standards on safety, quality and efficacy.
Ensures that the sometimes difficult balance between safety and effectiveness is achieved.
What is the role of SMC in the management of medicines?
SMC = Scottish Medicines Consortium
- Makes decisions on cost effectiveness of new/existing pharmaceutical products w.r.t. their use in NHS Scotland
- How well the new medicine works
- Is the newer medicine better than current medicine
What are positive opportunities provided by the SMC?
- Comprehensive assessment
- Rapid response
- Uniformity within Scotland
- Education
What are the threats to the SMC?
Pharmaceutical freedom
Funding
What is the process followed by the SMC when assessing a new drug?
- 3 month assessment process at time of launch
- Manufacturer submits proposal
- Health economic analysis
What are the possible outcomes of the assessment of a new pharmacological agent by the SMC?
1) Approved for use
2) Approved for restricted use
3) Not recommended
What are the possibl reasons for a ‘not recommended’ outcome from the SMC?
- Clinical effectiveness not convincing
- Cost-effectiveness not demonstrated
- No submission by manufacturer
What can be done following a ‘not recommended’ outcome for a new pharmacological agent?
- Resubmission
- Appeal
- Individual patient treatment requests
Using Cystic Fibrosis as an example, explain how availability of treatments has been controlled by the SMC?
- CF is a life-threatening condition with a childhood onset
- Mutation occurs in CF transmembrane regulator (CFTR)
- Drug Ivacaftor (Kalydeco) helps treat those with CFTR mutation (10% improvement in FEV1)
- SMC decided to ‘not recommend’ Ivacaftor based on its costs.
- Scottish Government overuled SMC and set up a ‘rare conditions medicine fund’ to allow provision of Ivacaftor to CFTR mutations
Under what conditions will a drug be added to the formulary?
Unequivocal evidence of efficacy:
1) Available for general use
2) Available for restricted use
3) Approved by SMC
4) Restricted funding approved by NHSG
Under which conditions could a medication be removed, or ‘disinvested’ from the formulary?
1) Evidence for superior efficacy/safety/kinetics now available for alternative products
2) Evidence from major outcome studies favour an alternative product
3) Evidence of superior cost/benefit available for alternative product
4) Evidence that the product is of limited clinical effectiveness
What are the 2 main categories medicines are classified under?
Prescription-only medicine
Over the counter
What are the constiuent components of OTC medicines?
Pharamacy medicines
General sales list medicines
Where can general sales list medicines be sold?
Supermarkets
Petrol stations etc.
Under which age should a patient be for their age to be written on their prescription?
Under 12 years old
