Regulation, introduction and monitoring of medicines

Question 1

Pharma direct to consumer advertising - positive (5)

Answer 1

• Empowers patients
• Disease education
• Prompts patients to seek more timely medical advice and support
• Better adherence
• Mary result in earlier diagnosis and treatment

Question 2

Pharma direct to consumer advertising - negative (4)

Answer 2

• 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)

Question 3

drug for RA that revolutionised treatment?

Answer 3

Humira

Question 4

With all new drugs: what do you need to know (5)

Answer 4

• Does it work?
• What dose is therapeutic?
• What dose is toxic?
• Is it safe?
• Is it necessary?

Question 5

who regulates new drugs?

Answer 5

Committee for Safety of Medicines (CSM)

Question 6

What committee advises ministers and licensing authorities ?

Answer 6

Commission on Human Medicines (CHM)

Question 7

what does the Medicines & Healthcare products Regulatory Agency (MHRA) –Executive Agency of DoH DO???

Answer 7

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 8

Another role is monitoring drug production IS?

Answer 8

standard of the drug

Question 9

main role of the SMC

Answer 9

• Scottish Medicines Consortium
• make decisions on the cost effectiveness of
  new/existing pharmaceutical products in respect of their use in
  NHS Scotland

Question 10

SMC- opportunities (4)

Answer 10

• comprehensive assessment
• rapid response
• uniformity within Scotland
• minimise “post code prescribing” education

Question 11

SMC - threats (2)

Answer 11

pharmaceutical freedom

funding

Question 12

Scottish Medicines Consortium - when drugs are not recommended , why may this be? (6)

Answer 12

• Clinical effectiveness not convincing
• Cost-effectiveness not demonstrated
• No submission by manufacturer
• Resubmission
• Appeal
• Individual Patient Treatment Requests (IPTRs)

Question 13

what is CF caused by?

Answer 13

mutation in cystic fibrosis transmembrane

regulator (CFTR)

Question 14

what drug selectively potentiates CFTR? - what patients does this work in

Answer 14

Ivacaftor - G551D mutation

Question 15

what is an 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

what is an ‘orphan’ medicine?

Answer 16

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

what is an ‘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

Why local Formularies? (5)

Answer 18

• Local ownership of decisions
• familiarity with limited range
• effectiveness
• value
• primary/secondary care issues
• new technology

Question 19

Antibiotic policies? (What is considered)

Answer 19

• changing resistance patterns
• hospital acquired infections
• MRSA
• HIV
• Hepatitis C
• consistency