Regulation of Medicines in UK

We learned about the history of medicines regulation from Professor Bill Inman who wrote extensively in his book 'Don't Tell the Patient  - Behind the Drug Safety Net.

Obituary for Bill Inman

Millie Kieve was priviledged to meet Bill Inman and he kindly donated boxes of his books to APRIL, to enable us to share the information it contained. He worked for 30 years for the NHS in the area of drug safety, having recovered from Polio when he was a medical student in 1947, he was confined to a wheelchair. He later conducted a study to produce evidence that the contraceptive pill could cause fatal thrombosis.

The Thalidomide disaster led to Sir Derrick Dunlop who was the first Chairman of the Committee on Safety of Drugs (CSD) asking Bill Inman to start a national early warning system for detecting adverse drug reactions (ADRs). The system is known as the 'yellow card system'

Professor Bill Inman established the Drug Safety Research Unit (DSRU in Southampton to monitor  adverse effects of specific medicines after they have been licensed with the cooperation of GPs who send questionairs to groups of patients in order to find if the drugs had caused any problems. It seems this system is not run today in the way Bill Inman intended so the effectieness of the system to improve patient safety may no now be so effective as when Bill Inman or Dr Ronald Mann werer in control, unfortunately.

The Prescription-Event Monitoring (PEM) system was launched in January 1981

One example of a missed opportunity was to warn patients of their finding from a DRSRU PEM study, about an antidepressant mirtazapine / zispin. Unlabled possible side effects found in a PEM study were reported by patients as aggression and agitation among other possible ADRs.

When Millie asked Prof Shakir, chair of the DSRU and one of the authors of the study why he did not insist the MHRA push the manufacturer to list these unlabled side effects, he replied " I am an academic scientist, I did the research and published it and that is what I do". Millie told him she thought if Prof Inman was involved something would have been done in a more proactive manner. The DSRU may be more influenced by the requirements of industry than we would wish, in terms of the best resource for patient safety.

1997 The European Medicines Agency directive that all drugs should have a patient information, led eventually to patients being supplied with a patient information leaflet (PIL) unless the drugs were taken from a large pot of bulk supply. However long discussions over the right of pharmacists to copy the data, may have been resolved.

The patient should request a leaflet in any circumstances from the pharmacy or hospital where the drugs are dispensed as it is their right to have this information. This can also be found for UK medicines at www.medicines.org.uk  The SPC (Summary of Product Characteristics) has more information than the PIL.

  • Many people wrongly believe that if a drug is licensed it must be safe for them to take. Sadly this is far from the truth.
  • Many drugs prescribed to women have never been tested on women
  • Drugs prescribed to children may be lower doses of drugs tested on mature men
  • Clinical trials may be swayed in favour of the drug and eliminate data about harm patients' suffered during the trials.

This article in The Guardian explains more:

The Tamiflu scandal not only shocked many people but

 the UK regulator of medicines the Medicines and Healthcare Products Regulatory Agency (MHRA) were due to issue a similar warning as the FDA have, according to an article in The Guardian newspaper November 2006

It was however not easy to find such warnings on the MHRA web site. The fact that Roche have taken opportunities to promote Tamiflu direct to the public which is against the UK and EU law, was mentioned if you put Tamiflu in the search box on the MHRA web site: This data is now unavailable in the .Gov archive of MHRA information

Post licensing data about adverse drug reactions is vital for many side effects and withdrawal problems will not be evident until the drug has been used by many people for months or years.

Reporting Adverse Drug Reactions (ADRs)
If you have suffered psychiatric adverse reactions please report them. There may be side effects not mentioned on the data sheets. You can request a list of drugs used pre surgery and during surgery. You should be given patient information for all drugs prescribed as you are discharged from hospital.

If you have suffered psychiatric, neurological or physical adverse drug reactions (ADRs) please report them. There may be adverse effects not mentioned on the patient leaflets (PILs) or data sheets. (SPCs)

You should be given a patient information leaflet (PIL) for all drugs prescribed, either as you are discharged from hospital, or if the pharmacy supplies you from a bulk supply of pills. (EU Directive 1997)

Please report Adverse Drug Reactions (ADRs) to:

UK - Yellow Card Reporting for Patient and Health Professional reports of Adverse Drug Reactions you can report to the MHRA using the link above or call them 0808 100 3352 10am - 2pm Monday to Friday

USA and worldwide - to the Food and Drug Administration for Patients and Healthcare Professionals

Universal free, independent drug safety website - Rxisk

 

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