Ensuring the gap between science and practice is filled safely - MHRA

Transcription

1 Safeguarding public health Ensuring the gap between science and practice is filled safely - MHRA Diane Leakey Head of Information and Communications, MHRA April 2012

2 Agenda Who is MHRA? Why we have regulation? How we regulate? Possible roles for pharmacists

3 WHO IS THE MHRA?

4 Who is MHRA? Agency of Department of Health Negotiate European and agree national legislation Advise industry, healthcare professionals, patients groups Employ over 900 staff (600 scientists & pharmacists) Created 2003 (medicines and devices) MCA and MDA

5 Why are we here aims of MHRA MHRA s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe. Protecting public health through regulation, with acceptable risk:benefit profiles for medicines and devices Promoting public health by helping people who use these products to understand their risks and benefits Improving public health by encouraging and facilitating developments in products that will benefit people

6 What does MHRA Regulate? Medicines for human use? Medical Devices? Cosmetics? Veterinary medicines? Herbal and natural medicines? Food supplements? Inspection of medicines production? Inspection of pharmacy shops? Pharmacists? Advertising?

7 Why Control Medicines and Devices?

8 1914 select committee on patent medicines Control of medicines should be a ministerial responsibility Need for Medicines Division within the Department of Health All drugs should be approved by a Medicines Commission prior to their registration Provision should be made for analysis of drugs by the Government Chemist Ingredients of preparations should be put on labels Inspectors should examine advertisements for drugs

9 Thalidomide What was it? - Harmless Sedative and for morning sickness in late 50 s and early 60 s. But what did it also do? - Teratogenicity - Phocomelia What was the outcome: - Extra safeguards with clinical trials and post marketing - Drug withdrawn And now? - Currently under research - Lenalidomide a derivative used in Myelomas

10 Clothier report What was it? - Report into deaths from Glucose injection Why did that happen? - Lack of sterility - Temperature monitoring at steam inlets of autoclave What was the outcome: - Medicines Inspectorate And now? - Medicines Inspectorates worldwide

11 How are medicines regulated? SAFETY, benefit / risk QUALITY EFFICACY Not effectiveness Not cost

12 HOW WE REGULATE MEDICINES?

13 How to control medicines? Pre-marketing Regulation of clinical trials Licensing approval before marketing Inspection of sites, GLP/GCP/GMP/GDP/GPvP Approval of all licensing activities Standard setting of pharmaceutical substances (API)

14 How to control medicines Post-marketing surveillance Literature scanning Adverse drug reaction monitoring Acting on safety issues, pseudoephedrine Better access to medicines, chloramphenical Maintaining up to date market authorisations

15 How to control medicines? Regulation Enforcement and intelligence gathering Setting of medicines policy, who can prescribe Red Tape Challenge, regulations Working with Europe, pharmacovigilance Advertising regulations, braille

16 20,000 medicines Reclassification Labels, leaflets, advertising, patient information leaflets Education internet Recall defective medicines, transplant solution Medicines testing Publish standards e.g British Pharmacopoeia Enforce the law relating to medicinal products Attempt to stop counterfeit medicines Inspections

17 Inspection Good Laboratory Practice Good Clinical Practice Good Manufacturing Practice - Orange Guide Good Distribution Practice - Turquoise Guide Good Pharmacovigilance Practice - Purple Guide (GLP) (GCP) (GMP) (GDP) (GPvP)

18 Counterfeiting Near Infra-Red Spectroscopy Non-destructive technique Minimal sample preparation Rapid measurement (< 1 minute) Chemical and physical data Differentiate between different manufacturing sites for the same product Samples analysed by nir spectroscopy Data comparison with library samples

19 Counterfeit Surveillance Project 20 mg tablets Market Samples (black) Reference samples (red) Counterfeit samples (green, blue) SIMCA-P /03/ :26:

20 Recent new stories PIP implants metal on metal hips internet drugs rat advert cough and cold treatments in children pseudoephedrine Suicide deaths from smoking cessation medicines Dangerous tanning injections Barbie drug

21 Current Issues merging with NIBSC development of CPRD, medicnal information counterfeit medicines Internet sales managing (raising) awareness of medical devices encouraging adverse drug reaction reporting Enforcement control of the supply chain Public and patient engagement

22 Types of roles at MHRA

23 Roles in Medicines Assessment clinical trial assessment marketing authorisations variations European liaison

24 Roles in post marketing surveillance adverse drug reaction reporting literature monitoring safety variations patient information

25 Roles for balancing access to medicines reclassification Co-proxamol Pseudoephedrine Chloramphenicol eye drops Azithromycin

26 Roles in maintaining and publishing the standards Inspection GMP GCP GPvP GDP GLP Defective medicine reporting centre Medicines testing scheme British Pharmacoepia

27 Roles in Device Evaluation

28 Other roles Medicines information Communications IT Development Policy development Senior management

29 Information available MHRA s WEB SITE ADDRESS: INFORMATION CENTRE: info@mhra.gsi.gov.uk MHRA 151 Buckingham Palace Road London SW1W 9SZ