Black Triangle

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Pharmaceutical related talk about medicines, adverse drug reactions. medication errors and marketing...

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Friday, May 30, 2003

WHIMSical thoughts: "The Food and Drug Administration (FDA) said today that the results of a Women's Health Initiative (WHI) study on the effects of combined estrogen with progestin therapy on the incidence of dementia and memory impairment do not at this time dictate any changes to the FDA-approved uses of these drug therapies. FDA is reviewing the new information and will determine whether labeling should be updated so that women and prescribers are fully informed about use of these therapies."
FDA

"In contrast to most of the earlier research on the effects of hormone replacement therapy on dementia, the WHIMS study unexpectedly demonstrated that HRT doubled the risk of dementia in women over the age of 65 and did not prevent mild cognitive impairment. The effect on dementia became apparent after one year of treatment and continued throughout the 5-year duration of the study. The additional risk due to HRT was found to be relatively small (1 case in 500 women per year) and was only statistically significant in women over the age of 75." MCA [PDF] 83KB
posted by Anthony Cox at 11:15 PM | permalink


Patient Pack Campaign: The Pharmaceutical Journal's campaign for patient packs is gathering a head of steam.
posted by Anthony Cox at 2:17 PM | permalink


Drug Driving: "Over-the-counter medicines have inconsistent and inaccurate labels that pose a danger to drivers, the Department of Transport says.

The Department commissioned research from Loughborough University as part of a programme of research into the effects of drugs on driving. It found that British National Formulary recommended labelling is not always followed by manufacturers and that different manufacturers give differing advice regarding the potential for drowsiness of the same active ingredients."
More details at The Pharmaceutical Journal

Full Department of Transport report [PDF] 328KB
posted by Anthony Cox at 2:12 PM | permalink


What's in a Name: Quite a lot really. Choosing the wrong name for a product can be disastrous in terms of patient safety. Look-a-like and sound-a-like names are all too common, and continue to produced. Combined with poor handwriting the dangers are multiplied. A recent review in Drug Safety is worth a read.

Hoffman JM, Proulx SM. Medication Errors Caused by Confusion of Drug Names Drug Safety, 2003, vol. 26, no. 7, pp. 445-452(8)
posted by Anthony Cox at 12:34 PM | permalink


No More Free Lunches: The BMJ have an excellent themed issue on the interaction between industry and healthcare professionals.

"Free pens and pizza lunches. Sponsored conferences and compromised medical education. Courtesy golf and unaffordable holidays. Thought leaders and ghost writers. These are the trappings of doctors and drug companies being entwined in an embrace of avarice and excess, an embrace that distorts medical information and patient care. An article in this theme issue of the BMJ identifies 16 ways in which doctors are entangled with the drug industry.1 You can probably identify more. The issue explores the extent of this relationship, its effects on research, its influence on prescribing, and the consequences for patients. Our central argument is that doctors, drug companies, and most importantly patients would all benefit from greater distance between doctors and drug companies."
Kamran Abbasi, deputy editor and Richard Smith, Editor.
posted by Anthony Cox at 8:38 AM | permalink

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Friday, May 23, 2003

Absolute Junk on MMR: Stephen Evans at the Problems and Perils of Prescription Medicines conference at the Royal College of Physicians on the 22nd of May, discussing the recent paper on MMR by Geier and Geier.:
"The absolute junk that was published recently in the Journal of International Paediatrics in the June Issue, you can go and look at it on the web, by Geier and Geier on MMR, comparing rates of adverse reactions to MMR and other vaccines in the America spontaneous reporting database is the most scientific nonsense I have ever seen in a particular published paper. I just can't believe it. That anyone with any intelligence could possibly use that kind of thing for comparative purposes. At the same time you can't use spontaneous reporting to say there is an absence of a problem, as some people have tried to say. Spontaneous reporting can't demonstrate the presence of a problem, it gives you a signal of a problem."
Meanwhile the benefits of vaccination seem clear.

UPDATE August 2003: The Geier paper is no longer available on the International Paediatrics website. It used to be in this Table of contents.
posted by Anthony Cox at 8:38 AM | permalink


The Safety of Patients is in the Palm of your Hand?: "New information technologies, particularly personal digital assistants (PDAs), are able to provide readily accessible medical information at the point-of-care. Although definitive studies are still necessary, the bedside use of these portable electronic devices, equipped with relevant, reliable and accurate drug, medical reference and calculator software, can help reduce the prevalence of medical errors, particularly for children. "
Rosenbloom M. Medical Error Reduction and PDAs. International Pediatrics 2003;18(2):69-77 [PDF]
posted by Anthony Cox at 8:22 AM | permalink

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Wednesday, May 21, 2003

MMR and the media: The BBC report some evidence that the public debate about MMR is skewed to the detriment of the children's health:

"People have been misled by media reports that the measles, mumps and rubella vaccine could be unsafe, according to new research. A survey by Cardiff University claims that more than half of the British public wrongly believe that medical science opinion was split down the middle on the subject.

But in fact almost all scientific experts rejected the claim of a link between the measles, mumps and rubella (MMR) vaccine and autism, said the research. "


The same day the BBC run a story saying that:

"A US study has re-ignited the debate about the safety of the MMR vaccine by suggesting it may raise the risk of neurological problems. Leading experts - who have repeatedly stressed the vaccine is safe - have expressed doubts about the validity of the study, claiming it is deeply flawed. They are concerned that continuing suspicion about the safety of the vaccine - despite overwhelming scientific evidence to the contrary - will see vaccination rates dip to levels which make a measles epidemic more likely. Last year there were 310 cases of measles in the UK - the highest number since MMR was introduced in 1988."

Full credit to the BBC for underlining the mainstream view that the MMR vaccine is safe, but I do wonder whether pressure groups, who are referred to in the story, get media attention far in excess of that they deserve.
posted by Anthony Cox at 2:33 PM | permalink

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Monday, May 19, 2003

Not So Complementary: Confidence in Australia's complementary medicines industry has been shaken after the Therapeutic Goods Administration (TGA) suspended the production licence of Pan Pharmaceuticals-Australia's leading manufacturer of complementary medicines.

After a 3-month audit, the TGA suspended Pan's licence for 6 months on April 28. The audit found evidence of manipulation of test results, substandard manufacturing processes, and substitution of ingredients. The TGA also ordered an urgent recall of 1546 products made by Pan.

The TGA first became aware of Pan Pharmaceuticals after reports of adverse reactions to its anti-travel sickness product, Travacalm, in January. Faulty batches of the product were responsible for 19 people being admitted to hospital and 68 people having serious adverse reactions. The TGA subsequently found that some batches of the tablets contained up to seven times the amount of the active ingredient--hyoscine hydrobromide.
The Lancet 17th of May.
posted by Anthony Cox at 4:10 PM | permalink

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Saturday, May 17, 2003

Seroxat: Back in the news again, Seroxat (Paroxetine). Panorama broadcast another Seroxat programme, E-mails from the edge, to complement their previous programme, The Secrets of Seroxat. A paper by Andrew Herxheimer, Charles Medawar and two BBC journalists based on an analysis of patient experience's was also published recently [PDF]. MIND and the Seroxat user group are calling for seroxat to be withdrawn for new patients.

Interesting review in the BMJ "Some of the second round confrontations were as fruitless as those of the first. Paroxetine is accused of provoking suicide or outbursts of violence. But the game of charge and countercharge got nowhere; when talking of particular cases, those making the allegations are no more able to prove the link than the company is to deny it."

The Chairman of CSM Professor Gordon Duff said "The CSM fully understands the importance of listening to the experiences of patients who have taken Seroxat and is keen that the patient's voice is represented on the expert working group on SSRIs. One of the key outputs of the expert group will be revised information for patients taking SSRIs. We consider it vital that the new information is user tested by patients and will be convening a panel specifically for this purpose."

SSRIs are an important group of medicines, which help patients who suffer from depression, anxiety, panic disorder and obsessive compulsive disorder. These serious conditions can cause severe suffering and the availability of effective treatments is essential. The health benefits of SSRIs are still considered to outweigh the risk of adverse drug reactions.


Question and Answer sheet from MHRA.[PDF]
posted by Anthony Cox at 12:23 AM | permalink

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Thursday, May 15, 2003

Error Reporting"Roll out of the National Patient Safety Agency's reporting system for adverse incidents is expected this summer. Sue Osborn, joint chief executive of the NPSA, said last week that a nine-month pilot study of the reporting system had identified shortfalls in the reporting form and had clarified what data will be needed by the NPSA. "
The Pharmaceutical Journal
posted by Anthony Cox at 10:48 PM | permalink

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Friday, May 09, 2003

Regional CSM units: If you live near one, use them.
posted by Anthony Cox at 5:25 PM | permalink

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Thursday, May 08, 2003

Drug advertising: The pharmaceutical industry sometimes plays on very marginal differences between drugs. This one takes the biscuit:

"The Danish drug company Lundbeck breached the UK industry code of practice in the way it advertised the successor to its top selling product, the antidepressant citalopram (Cipramil), the drug industry's watchdog has ruled. The company claimed that its new offering, escitalopram (Cipralex), was more effective than citalopram, even though the two drugs have exactly the same active ingredient ".
posted by Anthony Cox at 11:35 PM | permalink


Co-proxamol, more reason to avoid: Co-proxamol, although widely prescribed, has always had it's detractors. A new study draws attention to it's potential as a drug of choice for suicide. Hawton K. Simkin S, Deeks J. Co-proxamol and suicide: a study of national mortality statistics and local non-fatal self poisonings BMJ 2003;326:1006-1008

What this study adds:

Fatal overdoses due to co-proxamol are the second most frequent means of suicide with prescribed drugs in England and Wales.
The risk of death associated with co-proxamol overdose seems to be higher than for either tricyclic antidepressants or paracetamol

posted by Anthony Cox at 11:29 PM | permalink


No-blame culture: James Reason argued for a systems approach to errors, but the NHS is still some way from the ideal system. William Gaine in the BMJ puts the case forward for a no-fault system:

In the United Kingdom a no-fault system would increase compliance with the mandatory reporting of adverse clinical events and would facilitate the culture of openness demanded by clinical governance, the NHS Plan, and the modern approach to look for errors in the organisations instead of blaming individuals. It should be introduced on a limited pilot basis and monitored closely for some years.
posted by Anthony Cox at 10:37 PM | permalink


Combination vaccines: "Combining vaccines into one product does not increase the overall rate of adverse events, and with some combinations, such as DTaP, the rates are lower than when the component vaccines are given separately.4 Schmitt et al compared antibody responses in children receiving DTaP-HBV-IPV-Hib as one injection with children receiving the same antigens but with the Hib given at a different site. No difference was found in adverse events associated with the different regimens." Elliman and Bedford in the BMJ.
posted by Anthony Cox at 10:33 PM | permalink


Vitamins: "Following the publication of a report by an expert group the FSA said that it is to seek a ban on the inclusion of chromium picolinate in food supplements because it can cause cancer. It has also warned that taking more than 1g of vitamin C, 1.5g of calcium or 17mg of iron a day can cause reversible abdominal pain and diarrhoea. Other supplements - beta-carotene, nicotinic acid, zinc, manganese and phosphorus - can have irreversible harmful effects if taken at high doses for long periods."" www.pharmj.com

Full report as a PDF 1.4mb.

Dr Wendy Doyle of the British Dietetic Association, said (in The SUN of all places): "If you have a balanced diet you don't need supplements. People who don't eat properly or who are pregnant may benefit from an all-round vitamin supplement but should avoid high individual vitamin doses."
posted by Anthony Cox at 4:12 PM | permalink

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Wednesday, May 07, 2003

I'm a celebrity, get me a prescription: Mike Lascelles on another recruit: And today's celebrity drug pusher is Magic Johnson, who takes the dollar from GlaxoSmithKline. This is the company that sued another famous black guy who wouldn't push their expensive HIV drugs - Nelson Mandela:
posted by Anthony Cox at 4:03 PM | permalink


Patient reporting: More from the BMJ. " Chrys Short, nursing director for NHS Direct in southeast London, said: 'The system will initially involve simply recording possible adverse reactions to drugs, but as it progresses the assessment of side effects may become more refined - in collaboration with the Medicines Control Agency - to improve the quality of information collected.' "
It looks more like professionally facilitated reporting.
posted by Anthony Cox at 3:56 PM | permalink


GSK opposes controls on bupropion: Leading researchers have attacked the pharmaceutical giant GlaxoSmithKline for trying to block proposed new controls on the smoking cessation treatment bupropion (Zyban) in Australia.

The plan, which requires that patients have a second GP consultation to get a full prescription, was developed in response to concerns about costly waste of the treatment. BMJ
posted by Anthony Cox at 3:52 PM | permalink


Errors still common: "Medical mistakes, inefficiency and poor communication between doctors and their patients are still common in the NHS, according to a survey comparing patients' experiences in the UK with those in the US, Australia, New Zealand and Canada.

The UK has a better record on medical mistakes than the other four countries, but 20% of patients surveyed reported that they had been the victim of a medication or other medical error in the last two years."
The Guardian.
posted by Anthony Cox at 3:42 PM | permalink


Hal 9000?: "The hospital of the future could have beds that monitor patients and drugs that warn you if you are taking the wrong pill." according to the rather scary sounding Center for Pervasive Computing. See BBC story.
posted by Anthony Cox at 3:37 PM | permalink

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Monday, May 05, 2003

Record Linkage: Having been involved in some studies using pharmacy data and laboratory data, I concur with the first sentence of this:

"A myriad of errors and lost improvement opportunities result from failure of clinical laboratory and pharmacy information systems to effectively communicate. Pharmacotherapy could benefit from enhanced laboratory-pharmacy linkage with respect to (1) drug choice (laboratory-based indications and contraindications), (2) drug dosing (renal or hepatic, blood level-guided adjustments), (3) laboratory monitoring (laboratory signals of toxicity, baseline and ongoing monitoring), (4) laboratory result interpretation (drug interfering with test), and (5) broader quality improvement (surveillance for unrecognized toxicity, monitoring clinician response delays). Linkages can be retrospective or real-time. Many organizations could benefit now by linking existing pharmacy and laboratory data."
Schiff GD, Klass D,Peterson J, Shah G, Bates DW. Linking Laboratory and Pharmacy: Opportunities for Reducing Errors and Improving Care Arch Intern Med. 2003;163 :893-900.
posted by Anthony Cox at 10:48 PM | permalink

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Friday, May 02, 2003

WHOs Viewpoint: "For the first time in a widely distributed publication, the issues and questions surrounding the safety of drugs will be discussed in a simple and accessible way for the general and specialist reader. "

The WHO Uppsalal Monitoring Centre have produced a book deisgned to appeal to experts and lay people about drug safety. I hope you have broadband though... It's 3.2mb in size [PDF] The summary sheet is smaller.
posted by Anthony Cox at 1:54 PM | permalink

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