Regulation, introduction and monitoring of medicines Flashcards
Pharma direct to consumer advertising - positive (5)
- Empowers patients
- Disease education
- Prompts patients to seek more timely medical advice and support
- Better adherence
- Mary result in earlier diagnosis and treatment
Pharma direct to consumer advertising - negative (4)
- Consumers think it increases prices
- Disease education
Reduces authority of the doctor
-Inflates demand for new/expensive drugs even if not appropriate - Off patent use (eg surgical glue)
drug for RA that revolutionised treatment?
Humira
With all new drugs: what do you need to know (5)
- Does it work?
- What dose is therapeutic?
- What dose is toxic?
- Is it safe?
- Is it necessary?
who regulates new drugs?
Committee for Safety of Medicines (CSM)
What committee advises ministers and licensing authorities ?
Commission on Human Medicines (CHM)
what does the Medicines & Healthcare products Regulatory Agency (MHRA) –Executive Agency of DoH DO???
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
Another role is monitoring drug production IS?
standard of the drug
main role of the SMC
- Scottish Medicines Consortium
- make decisions on the cost effectiveness of
new/existing pharmaceutical products in respect of their use in
NHS Scotland
SMC- opportunities (4)
- comprehensive assessment
- rapid response
- uniformity within Scotland
- minimise “post code prescribing” education
SMC - threats (2)
pharmaceutical freedom
funding
Scottish Medicines Consortium - when drugs are not recommended , why may this be? (6)
- Clinical effectiveness not convincing
- Cost-effectiveness not demonstrated
- No submission by manufacturer
- Resubmission
- Appeal
- Individual Patient Treatment Requests (IPTRs)
what is CF caused by?
mutation in cystic fibrosis transmembrane
regulator (CFTR)
what drug selectively potentiates CFTR? - what patients does this work in
Ivacaftor - G551D mutation
what is an 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
what is an ‘orphan’ medicine?
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.”
what is an ‘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.”
Why local Formularies? (5)
- Local ownership of decisions
- familiarity with limited range
- effectiveness
- value
- primary/secondary care issues
- new technology
Antibiotic policies? (What is considered)
- changing resistance patterns
- hospital acquired infections
- MRSA
- HIV
- Hepatitis C
- consistency
