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Year 3 - Pharmacology > Clinical Pharmacology - Regulation, Introduction and Monitoring of Medicines > Flashcards

Clinical Pharmacology - Regulation, Introduction and Monitoring of Medicines Flashcards

1
Q

Who is going to be interested in your healthcare/prescribing?

A
  • Public
  • MPs (if you are a democracy)
  • Industry
  • Doctors/Pharmacists
  • Media
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2
Q

You are dictator-for-life!

How are you going to Structure your health Care system?

what questions do you need to think about?

A

Who is going to be interested in your healthcare/ prescribing?

Who will you allow to prescribe?

Can your prescribers prescribe whatever they want to prescribe?

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3
Q

Drug companies have hiked _____ exorbitantly over the past several years

A

prices

Generic drugs should be cheaper once patent ends

Mylan pharmaceuticals: 548% increase in price of EpiPen

Isuprel and Nitropress: Valeant Pharmaceuticals increased costs of:

  • Isuprel: $180 to $1,472 a vial, a 718 percent increase.
  • Nitropress ($215 a vial to $881) a 300% increase

Valeant: bought ‘old’ drugs and increased their prices precipitously

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4
Q

how has spending on presciption drugs changed?

A

Number of drugs being prescribed for older people or more conditions is increased

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5
Q

what is the price difference of drugs like between he US and UK?

A

Same drug in us cost much more than it would in Europe and uk

Another drug showing the difference in price in the UK and Switzerland compared to the US

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6
Q

Pharmaceutical advertising - Direct to consumer advertising - what is it?

A

the pahrma companies advertising directly to comsumers

very expensive

Only 2 countries you can advertise direct to the consumers in the US and New Zealand

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7
Q

Pharma direct to consumer advertising - what are the advantages?

A

Empowers patients

Disease education

Prompts patients to seek more timely medical advice and support

May result in earlier diagnosis and treatment

May improve adherence

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8
Q

Pharma direct to consumer advertising - what are the disadvantages?

A

Consumers think it increases prices (Consumers think it increases price as the 5.4 billion dollars has to be paid somewhere)

Reduces authority of the doctor (as patient more empowered)

Inflates demand for new/expensive drugs even if not appropriate

Off patent use (eg surgical glue)

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9
Q

Advertising to doctors:

Things are now very ________ regulated in the UK in terms of the amount of advertising and promotion that companies can do to your _______ professionals

A

tightly

medical

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10
Q

what are the statistics for prescribing in scotland? (2011-2012)

A

Total spend on the NHS is up to around 13 billion which is the same as the deficit

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11
Q

With all new drugs being considered for use in the general population you need to know what?

A
  • Does it work?
  • What dose is therapeutic?
  • What dose is toxic?
  • Is it safe?
  • Is it necessary?
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12
Q

Who regulates drugs/devices in the UK?

A

Commission on Human Medicines (CHM)

Formerly Committee for Safety of Medicines (CSM)

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13
Q

what do Commission on Human Medicines (CHM) do?

A

Advises Ministers on matters relating to human medicinal products

Advises Licensing Authority (LA)

Considers representations by an applicant or MA (Marketing authorisation) holder

Promotes collection and investigation of information relating to adverse Drug Reactions to human medicines.

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14
Q

CMH sits within a bigger organisation called the MHRA

Medicines & Healthcare products Regulatory Agency (MHRA) –Executive Agency of DoH

what is their role?

A

Post-marketing surveillance – ADRs and incidents

Assessment & Authorisation of medicinal products for sale in UK

Devices

Quality control

Internet sales & counterfeiting (drugs coming to the UK that are made elsewhere)

Clinical Trials regulation

Statutory controls

Promotion of safe use

Manage British Pharmacopoeia & Clinical Practice Research Database

They will ask for a report of the first prescriptions of the drug to see how its been

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15
Q

Why is pharmacovigilance needed?

A

Rarer the side effects may not be identified in the RCT

So you do need post marketing surveillance of a drug to see how it is doing once it has came into the world

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16
Q

how do you report an ADR?

A

yellow card scheme

17
Q

Where have all the yellow card reports came from?

A

Need to be looked at to see if they are truly related to the drug or if they are part of a wider sickness profile of the patient

18
Q

how does the yellow card shceme work?

A
19
Q

How do you know when a signal is significant?

A
20
Q

•Another role is monitoring drug ___________, ________ of the drug

Careful regulation of where did the drug ____ ____, what is it, and does it do what it _____ on the tin

A

production

standard

come from

says

21
Q

what is the European Medicines Agency? and what is their role?

A

European equivalent of FDA (food & drug administration in the US)

Ensure quality, safety and efficacy of drug

Marketing Authorisation (MA) or License Valid for whole of EU

Committee for Medicinal Products for Human Use (CHMP):

  • Quality
  • Safety
  • Efficacy
22
Q

Once drugs are on the ______, companies can ______ whatever the market will ____; prices for cancer therapies now routinely top $100,000 a year.

A

market

charge

bear

23
Q

So who decides whether a drug can be used?

(In the US, insurance companies)

A

Scottish Medicines Consortium (SMC)

24
Q

what is the role of the Scottish Medicines Consortium (SMC)?

A

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

They will all get together and discuss and look at the evidence for the specific drug and decide if it should be available for the general population in Scotland

25
Q

who makes up the Scottish Medicines Consortium (SMC)?

A

Representation from all Area Drugs and Therapeutics Committees:

  • Pharmacists
  • Health economists
  • Pharma representatives
  • Lay representatives
  • Physicians
  • NHS management
26
Q

whata re the good things about the SMC?

A

comprehensive assessment (of new drugs)

rapid response

uniformity within Scotland

minimise “post code prescribing”

education

27
Q

what are the threats of the SMC?

A

pharmaceutical freedom

funding

28
Q

what do SMC do with submissions?

A

3 month assessment process at time of launch

Submission by manufacturer

Health economic analysis

Cost per QALY (quality adjusted life years) central

Attempt to be fair and reasonable

Problem with very expensive drugs – Political overtones

29
Q

what are the 3 different outcomes from the SMC?

A
  • Approved for use
  • Approved for restricted use
  • Not recommended
30
Q

why may a drug by not recommened by the SMC?

A
  • Clinical effectiveness not convincing
  • Cost-effectiveness not demonstrated
  • No submission by manufacturer
  • Phamasuticals are allowed to:
  • Resubmission
  • Appeal
  • Individual Patient Treatment Requests (IPTRs) – if a particular consultant wants a drug for a patient
31
Q

Cycstic fibrosis:

Life-threatening, Childhood onset, Caused by mutation in cystic fibrosis transmembrane regulator (CFTR)

G551D-CFTR occurs in ~12% cases in Scotland

Ivacaftor selectively potentiates CFTR in those with G551D mutation

Two key studies to date - Aged 6-11 years and 12+

Both showed 10% improvement in FEV1

Some improvement in respiratory symptoms and weight

Not clear how/if this translates into survival

Substantial extrapolation

A

“Not recommended”

Weakness of economic case

Balance of cost/benefit unfavourable

veyr expensive

“Not recommended” advice from SMC

Huge publicity in National Press

Politically unacceptable

Scottish Government overruled SMC by setting up an “Rare Conditions Medicines Fund” (RCMF) to facilitate provision of ivacaftor to CF patients with G551D-CFTR mutation (£25M)

Review of SMC processes

32
Q

Enhancing access to new medicines:

what is an end of life medicine?

A

“A medicine used to treat a condition at a stage

that usually leads to death within 3 years with

currently available treatments.”

33
Q

Enhancing access to new medicines:

what are orphan and ulta-orphan medicines?

A

Orphan medicines - “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.”

Ultra-orphan medicines - “A medicine used to treat a condition with a prevalence of 1 in 50,000 or less (or around 100 people in Scotland.”

34
Q

what are the challanges of enhancing access to new medicine

A

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%

35
Q

Area Drugs & Therapeutics Committees - what is their role?

A

Response to SMC appraisal

“Approved for use” - Expected to approve for local use, unless equally effective alternative available locally. (“Me too” scenario). Local preference taken into account. Cost may be a consideration

“Not recommended” - Default position is not to approve for local use, IPTR may apply

(individual patient treatment requests)

36
Q

Why local Formularies?

A
  • Local ownership of decisions
  • (but much common ground in Scotland)
  • familiarity with limited range
  • effectiveness
  • value
  • primary/secondary care issues
  • new technology - intranet/websites, hyperlinks to guidelines
  • electronic prescribing - GPASS, EMIS, Vision etc
37
Q

what is the role of ADTCs?

A
  • 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
38
Q

disinvestment - Recommend removal from Grampian Joint Formulary

why may this happen?

A

[a] evidence for superior efficacy/safety/kinetics now available for alternative product

[b] evidence from major outcome studies now favour an alternative product

[c] evidence of superior cost/benefit now available for an alternative product

[d] evidence that this product is of limited clinical effectiveness

Year 3 - Pharmacology (4 decks)

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