Archive for the 'Publications' Category

MMR vaccine and autism

admin February 15th, 2010

A member of our staff has written an editorial on the story of MMR vaccine and autism for The Pharmaceutical Journal.

Patient reporting of adverse drug reactions

admin January 19th, 2009

A member of our unit has written an article on patient reporting of adverse drug reactions at The Pharmaceutical Journal.

Evidence that patient reports complement professional reports of ADRs is growing. Differences in the types of report exist. In particular neuropsychiatric reactions appear to be a particular concern of patients, and it may be that healthcare professionals have been dismissive of this type of report in the past, or that patients may have been less comfortable in reporting such symptoms.

Regulators do value reports from patients, and there is evidence that such reports have contributed to drug safety signals and regulatory decisions, which is the primary purpose of spontaneous reporting schemes such as the yellow card scheme.

Assessing, managing and reporting ADRs

admin April 21st, 2008

Our unit has recently had a brief guide to the assessment, management and reporting of ADRs.

Cox AR. Assessing, managing and reporting adverse drug reactions may better equip us to minimise medicines-related harm. Pharmacy in Practice 2008;18(2):57-61

A PDF version is here, courtesy of Medicom. (Note this version contains a correction referred to in the following edition of Pharmacy in Practice.

Over the counter medicines: proceed with caution

admin March 28th, 2008

Our director has an editorial in the BMJ this week on the subject of over the counter medication.

Both overuse and underuse of effective medicines can cause serious harms. The benefits of self treatment probably apply to only a small subset of medicines. There is little evidence in the UK that the current policy governing the change from prescription-only to over the counter medicines has exacerbated the harm of overuse. Although we can take heart from the fact that major disasters such as thalidomide have been avoided by stringent licensing regulations, the global outlook is rather more sombre. Much of the world has little or no effective regulation of medicines once licensed, and the internet makes these medicines, or counterfeit versions of them, available worldwide. The Royal Pharmaceutical Society proposes a “seal of approval” for legitimate internet pharmacies, but many people seem prepared to risk fake drugs, often for erectile dysfunction or obesity, rather than confide in a prescriber and present the prescription at a recognised pharmacy. The society’s initiative is unlikely to plug the internet loophole, and we face the uninviting prospect that medicines regulation will become ineffective everywhere.

The safety of over the counter medicines has to be continually reviewed, even though this is difficult in practice. Since healthcare professionals may not be involved, we have to rely on patients to report adverse effects. The UK regulatory agency’s new simplified yellow card system inviting patients to report adverse drug reactions could therefore be helpful. When safety concerns are raised regulators should investigate. Since efficacy is also important, regulators should ask for clearer evidence of benefit at the over the counter dose if this is lower than the dose usually prescribed. Given the concerns, it would be wise to avoid any wholesale rush to reclassify medicines. Whole communities might lose out in the long run if indiscriminate overuse of widely available medicines were to lead to large numbers of avoidable but irreversible adverse effects.

Also reported at the BBC.

New re:action 33

admin March 20th, 2006

The new edition of re:action (No 33 PDF) is now available on our website. Topics include vigilance with oseltamivir, forgetfulness with statins, African herbal medicines, Kelp and thyroid activity, and a big thank you to our reporters.

Our latest bulletin is published

admin December 21st, 2004

Our Christmas edition of re:Action 31 has just been published (pdf). It contains articles on drug-induced hallucinations, drug-induced gambling addiction, isotretinoin and neuropathy, and moxifloxacin and bronchospasm, and a thank you to reporters for making 2004 one of our best years for reports.

The index for re:Action has also been updated to include all issues 1-31.