Black Triangle
Welcome to Black Triangle, homepage of Anthony Cox.
Pharmaceutical related talk about medicines, adverse drug reactions. medication errors and marketing...
Of course you may be looking for the world famous Weapons of Mass Destruction 404 error page or the T-shirt of Mass Destruction. Did I hack Google to accomplish this feat? No, it's more interesting than that.
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Blog
Wednesday, April 30, 2003
Re:action 27: The West Midlands CSM release their latest bulletin. Main issues, General Practitioner reports plummet, SSRI'd and bleeding, confusion with COX-II's, nicorandil anal-ulceration and angioedema with clopidogrel.posted by Anthony Cox at 8:09 AM | permalink --------------------
Tuesday, April 29, 2003
Highlight of 2003?: Well this has to be the extension of ADR reporting to the public via NHS Direct. In the past the concern has been that such reports would lead to increased noise in surveillance systems from poor quality ADR reports. A recent review [van Grooheest K, de Graaf L, de Jong-van den Berg LTW. Consumer Adverse Drug Reaction Reporting: A new Step in Pharmacovigilance? Drug Safety 2003;26(4):211-217] suggests that present data might not demonstrate an additional benefit for consumer reporting. However, perhaps this will be a valuable opportunity to see what benefits can come from a patient reporting scheme and if nothing else it will be seen by the public as increasing openness in regulatory systems. This scheme does seem to make use of a "learned intermediary"."Patient reporting via NHS Direct will offer an important step in involving patients in monitoring drug safety with the support of our trained staff. I am pleased that the centre here at Beckenham has been chosen as the first centre to pilot this major initiative. We will be able to offer advice to deal with the problems a patient is experiencing as well as completing the Electronic Yellow Card to be sent to the MHRA."
Just as an aside, there is nothing to stop patients reporting adverse drug reactions to the MHRA via their local pharmacist who is well-trained and highly accessible in the community to discuss management of adverse drug reactions face-to-face with the patient. In addition, they may well have better background information on regular patients to their pharmacy within their patient medication record systems.
posted by Anthony Cox at 12:57 PM | permalink
Highlights of the Yellow Card Scheme: The MHRA has released some highlights of the Yellow Card Scheme this year. My own personal favourite bit is "This year has seen a rise in reporting from hospital and community pharmacists, resulting in a significant increase of 8% on 2001. ", but then I'm biased. Nice to see the reporter base expanding with increasing pharmacist involvement and now nurse involvement. I hope that it does not come at the expense of a fall in General Practitioner reports, which the West Midlands CSM sadly report are plummeting. [PDF]
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Friday, April 25, 2003
Failures of Drug Treatment: "The following are only some examples of failures in drug treatment. In 2001 the top five best selling medicines globally were atorvastatin, omeprazole, simvastatin, lansoprazole, and amlodipine, although available evidence indicates that only two of these drugs are first choice in their class. In recent years, various non-essential non-innovative drugs had to be withdrawn from the market because of serious adverse effects after a few years of growth in sales. One of these drugs, troglitazone, was associated with a risk of liver failure, which had been played down by the manufacturing company. More recently, serious flaws in the published pivotal trial that served as the basis for the global promotion of celecoxib were made public, and alosetron was reapproved by FDA amid accusations that the FDA had become a servant of the drug industry"Albert Figueras and Joan-Ramon Laporte in the BMJ.
posted by Anthony Cox at 1:19 PM | permalink
CSM West Midlands Bulletin published: Reaction 27 now on-line in PDF format.
posted by Anthony Cox at 10:25 AM | permalink
Telithromycin and Myasthenia Gravis: "Recent reports, including one fatal case, indicate aggravation of myasthenia gravis or severe respiratory failure in patients treated with Ketek (telithromycin)"
Full Public Statement [PDF] from EMEA
posted by Anthony Cox at 10:21 AM | permalink
Disease Awareness Campaigns: The MHRA have published DISEASE AWARENESS CAMPAIGNS GUIDELINES [PDF]
"The primary purpose of a DAC must be to increase awareness of a disease or diseases and to provide health educational information on that disease and its management. It should not promote the use of a particular medicinal product or products. Campaigns which aim to stimulate demand by the public for a specific medicine or specific medicines, are likely to be considered promotional"
posted by Anthony Cox at 9:33 AM | permalink --------------------
Thursday, April 24, 2003
More on drug-related admissions: More on drug related admissions in a PDF format...Bhalla N, Duggan C, Dhillon S. The incidence of drug-related admissions to hospital. The Pharmaceutical Journal 2003; 270: 583-58610% of admissions related to drug use. Of these 18% related to drug-therapy failures, 52% Adverse Drug Reactions and 30% to overdose or abuse.
posted by Anthony Cox at 10:49 PM | permalink
The Empire Strikes Back: A while back I reported an editorial critical of current Pharma policies on funding of patient groups.
"Is it too much to expect the professional journal of all pharmacists in Britain to support the aims and efforts of the pharmaceutical industry, rather than demeaning and criticising it?" The Pharmaceutical Journal
Yep, the pharmaceutical industry is a poor persecuted industry on the edge of viability as a business. Really?
posted by Anthony Cox at 10:26 PM | permalink --------------------
Wednesday, April 23, 2003
Celebrity endorsement: Watching the Who wants to be a Millionaire Major 'cough' Fraud program, I was hardly surprised to see a Benylin Advert at the first advertisement break. Michael Lascelles on celebrity endorsement:"Watching the TV weather bimbo reporting from the Red Cross Blood Donor centre this morning, I had to admit that celebrities can be a good thing for health. Sometimes. But I'm glad we don't have direct to consumer advertising. Look what happens in the US, where every disease now has to have its own celeb to lobby for funding and also promote the drugs on TV. In the old days diseases were named after the doctors who discovered them. Maybe now we should have diseases named after the celebrities who promote them. Let's change Rett syndrome to Julia Robert's disease. Parkinsons can become Michael J. Fox-Muhammed Ali syndrome. And impotence can be termed Pele-ism."
Do we need Direct to Consumer Advertising in the UK? I'd phone a friend, but I suspect the answer would be, as Tecwen Whittock put it: "HarrumpNOrhh"
posted by Anthony Cox at 3:50 PM | permalink
Intravenous errors: A while back I mentioned a study in the BMJ about intravenous errors in hospitals. Taxis and Barber found errors in 49% of prepared intravenous doses and suggested that pharmacists could reduce the number of errors by preparing intravenous doses in the pharmacy, rather than nurses on the ward. However in a follow-up electronic response Anton et al. report the results of a prospective study of the preparation of acetylcysteine infusions, that shows that errors still occur when pharmacists are involved.
Whoever makes up these drugs, there has got to be a system to report known errors, and the National CIVAS group has started a reporting scheme. There may be a danger that the number of differing schemes for reporting errors may be counterproductive in the long term, people are not going to know who to report what to if care isn't taken to centrally co-ordinate reporting. A job for the NPSA if ever there was one.
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Saturday, April 19, 2003
Links: I've updated the links page, which has been a little bare to be honest, additions are mainly about medical error and pharmaceutical marketing...posted by Anthony Cox at 8:16 PM | permalink --------------------
Friday, April 18, 2003
Nurse Reporters: Morrison-Griffiths S, Walley TJ, Park BK, Breckenridge AM, Pirmohamed M. Reporting of adverse drug reactions by nurses. Lancet 2003; 361: 1347-48"Schemes for spontaneous reporting of adverse drug reactions are important to post-marketing safety surveillance worldwide. In the UK, doctors, dentists, coroners, and pharmacists are allowed to report through the yellow card scheme, but nurses were not until October, 2002. We used a similar programme to assess the role of community and hospital nurses in reporting of adverse drug reactions. The proportion and quality of reports received from nurses was similar to that of those received from doctors: we received reports from one in seven nurses eligible to report, compared with one in eight doctors; 137 of 177 nurse reports and 676 of 984 doctor reports were judged to be appropriate according to regulatory authority criteria (95% CI for difference between proportions 1.4-15.0, z=2.3,p=0.02). Our findings suggest that nurses, who form the largest proportion of health-care staff in the UK, can play a valuable part in improvement of pharmacovigilance."
posted by Anthony Cox at 12:07 PM | permalink
Constructing Drug Names: Choosing the wrong name for a drug can lead to future errors.
"The British National Formulary, under the authority of the Joint Formulary Committee, has developed a procedure for constructing names for non-proprietary medicinal products. This procedure will be used only when the British Pharmacopoeia Commission is not minded to coin a name" Details at the BNF site.
posted by Anthony Cox at 8:21 AM | permalink
Musical Chairs: Professor Gordon Duff has been appointed chairman of the Committee on Safety of Medicines. CSM press release [PDF]
posted by Anthony Cox at 8:11 AM | permalink --------------------
Thursday, April 17, 2003
Adverse Drug Events: Gandhi TK, Weingart SN, Borus J. Adverse Drug Events in Ambulatory Care. NEJM 348:1556-1564.A prospective cohort study at four adult primary care practices in Boston (two hospital-based and two community-based) involving 1202 patients during a four-week period.
" The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors (10 percent), beta-blockers (9 percent), angiotensin-converting enzyme inhibitors (8 percent), and nonsteroidal antiinflammatory agents (8 percent). On multivariate analysis, only the number of medications taken was significantly associated with adverse events. "
posted by Anthony Cox at 8:11 PM | permalink --------------------
Tuesday, April 15, 2003
Reminder: It is not too late to attend Problems and Perils of Prescription Medicines on Thursday 22 May 2003 at the Royal College of Physicians. This meeting is sponsored by the MCA and covers topics such as adverse drug reactions and medication errors. The standard of speakers is very high and one I'll be interested to hear is James Reason.Perhaps I'll see you there?
posted by Anthony Cox at 4:02 PM | permalink
Advertising: A Review of Advertising Therapeutic Products in Australia and New Zealand. This review is part of the process which will ultimately lead to the creation of a new regulatory body to replace the Therapeutic Goods Administration in Australia and Medsafe in New Zealand.
posted by Anthony Cox at 11:13 AM | permalink --------------------
Friday, April 11, 2003
Industry motives: "Executives in pharmaceutical companies are sophisticated operators and, however altruistic their stated aims, the reasons they struggle and strive is to make their shareholders happy and their bottom lines healthy. Along the way, people's health may be improved but anybody who has any dealings with pharmaceutical companies should have no illusions about their motives." The Pharmaceutical JournalWhat brought this on? Well, Which? has suggested that patient organisations should publish details of who their sponsors are and should make their funding policies widely available. One example they cite is the National Eczema Society who receive funding from 14 companies. The National Eczema Society has "run a successful campaign to have eczema guidelines removed from general practitioners' computer-based prescribing systems. The NES had concerns that guidelines did not include details of the most up-to-date treatments. However, Which? suggests that this campaign has left GPs without consistent guidance and says that some of the treatments not listed in the guidelines were likely to have been made by the sponsors of the NES." [link]
Are patients the winners here?
posted by Anthony Cox at 5:24 PM | permalink
Safer Packaging of Drugs: "Product packaging and labelling should serve only one purpose: the clear unambiguous identification of the drug. By all means, encourage professionals to read labels, but let us also encourage manufacturers to make it easier for them to do so safely. " Let's start to take account of the fact we are all human.
On a similar note, when will bar codes deliver?
posted by Anthony Cox at 4:36 PM | permalink
Transparency in Regulation: "The number of patients who die or have serious adverse reactions because of drugs is small relative to their use and their effectiveness. But what is an acceptable risk and to whom? Regulators try to answer this question on behalf of the public when they withdraw a drug, but it is a task with a huge subjective component. There is even a controversy about the concept of regulators doing comparative analyses between therapies, which would at least add some objectivity. Often, early information on safety is based on case reports, which are difficult to interpret for causality even when they contain adequate information. Even with complete epidemiological information, how can risks be compared? For instance, the greater chance of dying from an overdose of a tricyclic antidepressant versus a drug which is safer in overdose but sometimes causes liver damage? Such basic information is still not easy to find, and takes a long time to assemble for a new drug on the market. Regulatory decisions are still made in secret: there is no scientific account of the information and logic that supports them. It is urgent that safety regulation is made transparent, so that the arguments by regulators in different settings can be weighed." Ralph Edwards in The Lancet.
posted by Anthony Cox at 9:01 AM | permalink --------------------
Tuesday, April 08, 2003
Pointing out the bleedin' obvious: Is not such a bad thing says The Institute of Safe Medical Practice: In discussing the dilemma between evidence-based medicine and obvious patient safety strategies, Leape, Berwick, and Bates noted that, "A common theme... is that they make sense. To a lay person and to most physicians these things sound like obvious things to do. That is basically how aviation and anesthesia made progress: they did what seemed to be the obvious right thing to do."posted by Anthony Cox at 9:19 PM | permalink --------------------
Monday, April 07, 2003
Cervical Cancer and the Pill: A study published in The Lancet recently Smith JS et al. (361:9364:1159-67) confimed that long-termb use of hormonal contraceptives is associated with an increased risk of cervical cancer. The MHRA has produced two documents on this subject. The information sheet [PDF] has the key point:"A new review, which evaluates all research that has been published worldwide on the long-term use of oral contraceptives and risk of cervical cancer, has just been published in The Lancet. The findings of this review suggest that women who use oral contraceptives for more than 5 years are slightly more likely to develop cervical cancer than those who have never used them and that using OCs for 10 or more years means you may be twice more likely to develop cervical cancer. However, your overall likelihood of getting cervical cancer is extremely low whether you use long-term oral contraceptives or not. "
A question and answer sheet [PDF] addresses similar concerns. Let's hope headlines like "Pill 'can double risk of cancer' " Women who take the contraceptive pill could be doubling their risk of suffering cervical cancer, a major scientific study has found. " do not cause a surge in unwanted pregnancies. The day when newspaper editors choose a absolute risk instead of an exciting relative risk is going to be a longtime coming.
posted by Anthony Cox at 4:23 PM | permalink --------------------
Friday, April 04, 2003
Health Canada: Health Canada have a issued their latest Bulletin. [PDF]. Main topics: Withdrawal reactions with paroxetine and other SSRIs, adverse drug reaction reporting rates, case presentation of divalproex, safe use of products containing acetaminophen [Paracetamol], and hormone replacement therapy. Health Canada have also issued a dear doctor letter about severe cutaneous reactions associated with the use of amifostine. [PDF]posted by Anthony Cox at 10:30 PM | permalink
ADRAC Bulletin: The latest Australian Adverse Drug Reactions Bulletin has been published. This edition's main items are fluticasone and adrenal crisis, early experience with the glitazones, interstitial nephritis with the proton pump inhibitors, and new information about interactions with grapefruit juice.
posted by Anthony Cox at 10:20 PM | permalink
Smallpox vaccine: "Reports of myocardial infarction, angina, and myopericarditis in people who have recently received smallpox vaccination as part of a US government bioterrorism preparedness campaign have prompted US officials to halt vaccinations of anyone with a history of heart disease or who has cardiovascular risk factors. " The Lancet
posted by Anthony Cox at 3:12 PM | permalink
Statins and myopathy: An article on myopathy underlines the point that trials do not always find serious adverse reactions.
"The literature review found that reports of muscle problems during statin clinical trials are extremely rare. The FDA MEDWATCH Reporting System lists 3339 cases of statin-associated rhabdomyolysis reported between January 1, 1990, and March 31, 2002. Cerivastatin was the most commonly implicated statin. Few data are available regarding the frequency of less-serious events such as muscle pain and weakness, which may affect 1% to 5% of patients. "
posted by Anthony Cox at 1:21 PM | permalink
Drug Interactions: JAMA has an interesting article on drug interactions: "During the 7-year study period, 909 elderly patients receiving glyburide were admitted with a diagnosis of hypoglycemia. In the primary analysis, those patients admitted for hypoglycemia were more than 6 times as likely to have been treated with co-trimoxazole in the previous week (adjusted odds ratio, 6.6; 95% confidence interval, 4.5-9.7). Patients admitted with digoxin toxicity (n = 1051) were about 12 times more likely to have been treated with clarithromycin (adjusted odds ratio, 11.7; 95% confidence interval, 7.5-18.2) in the previous week, and patients treated with ACE inhibitors admitted with a diagnosis of hyperkalemia (n = 523) were about 20 times more likely to have been treated with a potassium-sparing diuretic (adjusted odds ratio, 20.3; 95% confidence interval, 13.4-30.7) in the previous week."
posted by Anthony Cox at 1:14 PM | permalink
DTCA via the BBC: A new drug is hyped once again. Ximelagatran, a possible replacement for warfarin, is covered by the BBC. Warfarin does cause problems, but the BBC's comment that "research shows it is at least as safe and effective as warfarin, a drug more commonly known for its use as rat poison." may be premature since it has been used in only around 3,500 patients so far.
The BBC page says that ximelagatran "does not increase the risk of bleeding." . Compared to warfarin this may be true, but ximelagatran is associated with bleeding. The recent SPORTIF II trial showed that "The combined rate of major and minor bleeding events was found to be significantly lower for Exanta [ximelagatran] than warfarin (475 vs 554 events p=0.007)" . In addition the incidence of liver enzyme (ALT) elevations was 6.5% with ximelagatran, although no specific clinical symptoms have been associated with this rise yet.
posted by Anthony Cox at 12:59 PM | permalink
Aspirin and Reye's syndrome: The MHRA's first act is the decision that from 1 October 2003 all products containing aspirin will be required to include a statutory label warning: "Do not give to children under 16 years, unless on the advice of a doctor". Fact sheet [PDF] and question and answers [PDF].
posted by Anthony Cox at 12:41 PM | permalink
The MHRA has been born: This week has seen the birth of the new Medicines and Healthcare Products Regulatory Agency (MHRA) at http://www.mhra.gov.uk/.
Hazel Blears said: "The establishment today of the Medicines and Healthcare products Regulatory Agency will give the public even greater confidence in the safety of healthcare. We have brought together the work of the MCA and MDA because of the increasing convergence in the fields of pharmaceuticals and medical devices. The MHRA will be well-placed to respond to this changing world."
The new agency's first chairman is Professor Alasdair Breckenridge, who has wide experience of the regulation of pharmaceutical products through his chairmanship since 1999 of the Committee on the Safety of Medicines. Professor Breckenridge will be responsible for representing the new agency and its decisions in public, for overseeing the agency's board and the strategic management of the MHRA.
posted by Anthony Cox at 12:37 PM | permalink --------------------
Notice:Black Triangle is not an official site of the MHRA.
