Black Triangle

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

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Blog

Saturday, March 29, 2003

Dispensing Errors: Dispensing errors in have had relatively little scrutiny in the UK, and most of the research is in the hospital sector. Arguments have been made for increased reporting and dissemination of dispensing errors in order to improve safety. However, an acceptance of no-blame culture is needed and in community pharmacy dispensing errors are either seen in the statutory committee proceedings of pharmacists regulatory body, or remain anecdotal stories. Linda Dodds has written a paper on the East Kent no-blame system for reporting errors, near misses and potential errors to community pharmacists in The Pharmaceutical Journal [PDF]. Let's hope similar schemes can be set-up nationally and integrate with the NPSA.
posted by Anthony Cox at 9:11 AM | permalink

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Friday, March 28, 2003

Marketing: Corporate sponsorship of "independent" lay groups.
posted by Anthony Cox at 11:18 PM | permalink


Medication errors: Intravenous this time. Published in the BMJ and reported by the BBC as 'Dangers of drug errors exposed' this is an interesting piece of work involving disguised observation of intravenous administration of drugs. About half of intravenous drugs were incorrect and a third of those potentially harmful.
posted by Anthony Cox at 11:14 PM | permalink


Paediatrics: A call for improved post-marketing safety monitoring of children's medicines.
posted by Anthony Cox at 11:03 PM | permalink


Scaremongering: Again the dangers of sending wrong ideas out about risk are highlighted. A letter in The Lancet [registration required] discusses the case of an alarmist letter about Coenzyme Q10 and statins, which suggests that statins may cause cardiovascular deaths. In fact, statins have been shown to reduce death in clinical trials. On the same subject of dangerous scaremongering, Helen Bedford and David Elliman have written an excellent critique of Melanie Phillips' hyped series about MMR in the Daily Mail:

'Phillips rubbishes epidemiological studies, even though such studies have been the tools used in many major medical discoveries, such as the link between smoking and lung cancer. The reviews she quotes have quite correctly concluded that the evidence does not support a link between autism and MMR, but it can never rule out the possibility that the occasional case is associated with the vaccine. Phillips interprets this as distortion, which demonstrates her lack of understanding of one of the fundamental tenets of epidemiological researchthat one can never totally prove a negative. However, she refers to an "epidemic of autism." If there is one, then epidemiological studies should have no problem in picking up a major factor in its causation. '

More on this in Spiked-Online by Michael Fitzpatrick, who co-incidently has written an interesting piece in the Lancet about the home front [registration required].
posted by Anthony Cox at 10:43 PM | permalink


Pharmacovigilance: While regulatory agencies in the developed world protect their populations from serious adverse effects of drugs, in the developing world things are a little different. A letter in the BMJ highlights the life-threatening hepatotoxicity of nimesulide. Attention is drawn to the lack of education about adverse effects and inadaquate reporting of adverse effects. The authors hope that Indian authorities do not wait any longer to withdraw the drug. The Lancet [registration required] highlights the question about whether drug companies should continue to market drugs in developing countries that have been withdrawn in other countries.
posted by Anthony Cox at 10:27 PM | permalink

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Wednesday, March 26, 2003

SSRIs: According to The Guardian the MCA have disbanded the expert committee for the review of SSRI anti-depressants.

'We can confirm that we have now decided to dissolve the original group and appoint a new expert group to conduct the review. The membership of this new expert group has yet to be decided, and individuals' interests in the pharmaceutical industry will be taken into account when considering the appropriate membership. The timescale for completion of the review is uncertain.'
posted by Anthony Cox at 9:53 AM | permalink


Smallpox: Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report 'During January 24 to February 14, 2003, smallpox vaccine was administered to 4,213 civilian health-care workers in 27 jurisdictions. No potentially life threatening or moderate-to-severe adverse events have been reported.'
posted by Anthony Cox at 12:04 AM | permalink


Ephedra: More in JAMA about Ephedra, in an accompanying editorial [registration required]to the paper reported here recently.

'The reports by Shekelle et al, along with other studies documenting the increased risk of adverse reactions associated with ephedra, are sufficient evidence to restrict the use of this agent. However, the most important lessons from the new information on ephedra are demonstration of the inadequate nature of the current system of regulation of dietary supplements and recognition that much more rigorous oversight of these biologically active agents is necessary to protect the health and safety of the public. '
posted by Anthony Cox at 12:02 AM | permalink

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Tuesday, March 25, 2003

Corticosteroids: DrugInfoZone report that 'long-term treatment with high doses of anti-inflammatory steroids appear to be at increased risk of developing heart disease.' This was restricted to oral steroids. No evidence suggests that inhaled or topical steroids are a risk. The story is also reported by the BBC with the rather simplistic 'Asthma drug raises heart risk'.
posted by Anthony Cox at 10:48 AM | permalink

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Monday, March 24, 2003

Dispensing errors: One of the solutions to prevent dispensing errors is increasing the use of automated systems. An interesting news report, though brief and not explaining the systems involved in detail, does show that technology may not eliminate all errors. CNN reports how a power-outage at a hospital chain's computer center led to thousands of patients potentially receiving the wrong drug labelled correctly.
posted by Anthony Cox at 1:22 PM | permalink

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Saturday, March 22, 2003

Flu Vaccine: The US Institute of Medicine's immunisation safety review committee has been investigating whether the influenza vaccine might carry a risk of the demyelinating disorder Guillain-Barré syndrome.
posted by Anthony Cox at 12:18 AM | permalink


Medication errors: The US Pharmacopeia, an independent non-governmental organisation that monitors drug safety, has now made a series of recommendations aimed about medication errors.
posted by Anthony Cox at 12:15 AM | permalink


Paroxetine: More from BMJ about the SSRI review.
posted by Anthony Cox at 12:09 AM | permalink


Deceptive Practices: Seemingly threatening behaviour from a pharmaceutical company. Dr Franklin, 41, said he had been working as a "medical liaison" employee for Parke-Davis for only four months when a company executive warned that he "couldn't guarantee what is going to happen to you or your career" if Dr Franklin continued to challenge the marketing scheme. From BMJ
posted by Anthony Cox at 12:05 AM | permalink

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Thursday, March 20, 2003

Anthrax Vaccine: As coalition forces prepare to liberate Iraq, there is the potential of undeclared anthrax being deployed against them. Unfortunately almost half of UK service personal choose not receive the vaccine, due to fears that it may have been responsible for Gulf War Syndrome. However, a recent study suggests just 11% of military personnel immunised against anthrax develop reactions, mainly confined to localised injection site reactions. This compares favourably to many routine vaccines, such as the meningitis C vaccine, and the link with possible Gulf War Syndrome seems unlikely.
posted by Anthony Cox at 2:37 PM | permalink

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Wednesday, March 19, 2003

Safety of Ephedra and Ephedrine A meta-analysis in JAMA studies the safety of Ephedra and Ephedrine for weight loss and athletic performance. 'Use of ephedra or ephedrine and caffeine is associated with increased risk of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations.'
posted by Anthony Cox at 2:31 PM | permalink

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Tuesday, March 18, 2003

BAYCOL VERDICT:It took two and a half days for the jury to return a verdict, but Bayer have been cleared in a court case regarding the withdrawal of cerivastatin (know as Lipobay in the UK). The first of 8,000 cases was lost by an 82 year-old engineer, Mr Haltom, who claimed that Bayer did not adaquately warn doctor's about the dangers of the drug before it was pulled from the market. Mr Haltom claimed he had leg weakness caused by the drug, but he also suffered from diabetes and vascular disease which the company suggested may have lead to Mr Haltom's symptoms.

Bayer did acknowledge the link between the drug and rhabdomyolysis, but said they acted responsibly by withdrawing the drug in August 2001.
posted by Anthony Cox at 10:44 PM | permalink


The CSM has published guidance on the SOURCING OF PLASMA AND URINARY DERIVED MEDICINAL PRODUCTS [PDF] which lists 7 precautionary principles to guard agaisnt the possibility that plasma-derived medicinal products might transmit vCJD.
posted by Anthony Cox at 3:33 PM | permalink

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Monday, March 17, 2003

The MCA has had to respond to adverse comments in The Guardian. The article expresses concern about the links of some members of a review of SSRI anti-depressants with the pharmaceutical industry. An additional concern is that some of the members of the review committee have previously been on a 1996 CSM committee looking at SSRIs. The MCA has responded by maintaining its rules about conflict of interest are robust and that "All members of committees and associated working groups are professionals of the highest standing in their fields and there has never been any evidence that members have acted other than with the highest integrity,"

I'm no fan of industry, a fan of nofreelunch.org in fact, but should the MCA hamstring itself by not using experts in the field because of links to the industry? Any criticism of the review should perhaps focus on the science of the issue, rather than on Ad Hominem attacks on the committee members. Having been involved with previous reports seems more of a qualification, rather than a disqualification. All of this does illustrate the ability of internet based groups, like the Seroxat User Group, to increasingly influence the agenda of the media and respond quickly to events.
posted by Anthony Cox at 5:13 PM | permalink


The FDA has issued revised warnings for Avonex (Interferon beta-1a) [Updated safety information includes a cautionary note regarding use in patients with depression and other severe psychiatric symptoms.]
posted by Anthony Cox at 2:23 PM | permalink

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Friday, March 14, 2003

A two week study of accident and emergency attendees in a UK hospital has shown that 4 percent present with a drug-related problem. One-third of these problems were due to adverse drug reactions, and a third of these patients had used illicit drugs. Welcome information given the relative lack of studies on drug-related problems in the UK.
posted by Anthony Cox at 1:04 PM | permalink


Ever reported an adverse drug reaction on a Yellow Card? Many professionals feel it is pointless reporting well-known, yet serious, reactions to established drugs. Warfarin is a prime example. 'Everyone knows warfarin causes bleeding' I hear you cry. Here is an argument for why you should report these serious reactions.
posted by Anthony Cox at 11:20 AM | permalink


The FDA appear to be having an argument about the safety of leflunomide. An Office of Drug Safety report advised the drug should be withdrawn, as the 'risks of leflunomide greatly exceeded its benefits.' , but others in the FDA argue that reports linking the drug with acute liver injury were "confounded, inconclusive, or incomplete." and that no clear pattern of toxcity is emerging.
posted by Anthony Cox at 11:15 AM | permalink


Case reports of Bilateral anterior toxic optic neuropathy associated with the use of infliximab in the BMJ. There is also an interesting editorial on the controversy of albumin use in the critically ill.
posted by Anthony Cox at 11:09 AM | permalink

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Wednesday, March 12, 2003

Professionals may be interested in attending 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.
posted by Anthony Cox at 4:31 PM | permalink


Methotrexate: The use of internet references is becoming more common, however some websites move pages, move domains or even more disruptively close. One example of a well-used and oft-quoted document that has disappeared into the ether is the report on the death of a patient who was using methotrexate, which was published by Cambridgeshire Health Authority in 2000.

It is still less than 2 years since the document was published and already the document has disappeared from the web, as the health authority is no more.

The report is now hosted on this site. It is now only a 200k PDF file and there is a link to the ARC booklet which was responsible for the previously large file size of over 3mb.
posted by Anthony Cox at 12:12 AM | permalink

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Monday, March 10, 2003

Regional Response teams have been issued with a Smallpox Vaccination Pack, which details how adverse reactions should be reported:

'Adverse reactions to the vaccine must be reported to the Medicines Control Agency and Committee on the Safety of Medicines in the usual way via the Yellow Card system. Serious reactions [should also] be reported to the Communicable Disease Surveillance Centre.'
posted by Anthony Cox at 5:37 PM | permalink


Eli Lilly and the FDA advise about the reports of cardiac valvulopathy involving one or more hearts valves in patients receiving pergolide therapy.

'Based on Lilly safety data and scientific publications, the pathological assessment of valves that were surgically removed was consistent with the valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs. While a clear causal relationship between pergolide and the valvulopathy seen in these patients can not be established, given the nature of the lesions and known similar effects of other ergots, the Warnings section of the US Package Insert for Permax will be modified to reflect these reports. '
posted by Anthony Cox at 3:17 PM | permalink


Spontaneous reporting schemes for adverse drug reactions suffer from under-reporting. It is thought that only around 5% of possible reactions are reported. A simple guide to reporting is available in the UK, as well as an electronic submission system.
posted by Anthony Cox at 3:10 PM | permalink

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Saturday, March 08, 2003

Interesting perspective linking fears about MMR to the current Iraqi Crisis:

'The obsession with avoiding risk informs the position of just about every protest movement today, whether the object of their fears is the MMR triple vaccination, GM crops or whatever else. All exhibit a deeply conservative better-safe-than-sorry siege mentality. From this point of view, the new anti-war movement appears to be modelled on the anxious outlook of the anti-MMR lobby, projected on to the Middle East.'

From: Spiked On-line
posted by Anthony Cox at 3:18 PM | permalink

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Friday, March 07, 2003

Campaign to ban Direct to Consumer advertising in New Zealand starts. This follows a report about Direct to Consumer Advertising in New Zealand.
posted by Anthony Cox at 1:50 PM | permalink


Manufacturers pledge to supply to provide whatever dilutions of Potassium Choride the National Health Service requests, following the patient safety alert that came into effect at the end of October 2002. [PDF]
posted by Anthony Cox at 10:13 AM | permalink


More debate on advertising pharmaceuticals at The Lancet and The Pharmaceutical Journal.
posted by Anthony Cox at 9:59 AM | permalink


Obituary published in the Lancet of David Margerison Davies. 'One of the first physicians in the UK to see the importance of detecting and preventing harm from drugs. Devoted himself to spreading this gospel to practising doctors through his pioneering Adverse Drug Reaction Bulletin and Textbook of Adverse Drug Reactions.'
posted by Anthony Cox at 9:55 AM | permalink


Bayer have been told to release documents about cerivastatin's withdrawal to the US courts.

'The plaintiff's lawyers argue that these documents show that Bayer was aware of problems associated with Baycol since its approval by the FDA in 1997. However, occasional adverse reactions often occur with a new drug, and although these may be of concern they are not necessarily grounds for withdrawal. More serious is a suggestion that not all adverse events were reported to the FDA, but Bayer says it kept the FDA fully informed.'

The Lancet also has an interesting article about the consequences of the cerivastatin withdrawal for Bayer. Their share price has plummeted following the withdrawal. Bizarrely they sent a letter to 2000 residents in Corpus Christi, Texas "reminding them that it employs nearly 2000 people in Texas and contributes about US$185 million to the state's economy in payroll, taxes, and support of local groups. In its letter, Bayer lumped all statins together when discussing the potential for serious side-effects in a "small segment" of the population, but failed to mention the FDA comparative data for rhabdomyolysis and statins, alone or with gemfibrozil--which, of course, would show cerivastatin outlying the other drugs in the class. "

However it must be remembered that statins DO SAVE LIVES! Again, the dangers of advertising are underlined:

"These drugs are highly effective in the prevention of heart attacks--indeed, some experts advocate much wider use of statins. But the message following the cerivastatin disaster is of the law of unintended consequences. In the enthusiasm for wider use of a class of drugs, all must remember that rarer side-effects are unlikely to be seen in clinical trials before a drug is approved. Post-marketing surveillance can teach salutary lessons about the need for caution when new drugs are promoted to physicians."
posted by Anthony Cox at 9:34 AM | permalink

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Thursday, March 06, 2003

EMEA has also recently published a concept paper entitled The Conduct of Pharmacovigilance for medicines used by Children [PDF]. Medicine-use in children presents special problems and the EMEA paper proposes establishing guidelines for the pharmacovigilance in children.
posted by Anthony Cox at 5:44 PM | permalink


Health Canada has updated safety information in Sibutramine. They have concluded that sibutramine continues to meet the requirements for sale in Canada. This follows an EMEA opinion that sibutramine has a favourable risk/benefit profile.[Large PDF file]
posted by Anthony Cox at 12:17 PM | permalink


Yet another news item about the wonders of aspirin. Researchers suggest that the use of aspirin can cut the risk of cancers of the mouth, throat and oesophagus. Of course the news item does not mention the risks of aspirin. About 1 in 100 patients taking aspirin over a 28 month period will experience a gastrointestinal haemorrhage, so shouldn't news items like this be given a health warning? If you are considering taking aspirin, then at least ask a health professional's advice.
posted by Anthony Cox at 10:29 AM | permalink

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Tuesday, March 04, 2003

Adverse Drug Events Gurwitz et al. Incidence and Preventability of Adverse Drug Events Among Older Persons in the Ambulatory Setting. JAMA. 2003;289:1107-1116.

Cohort study of elderly care patients in an ambulatory care setting examining incidence and preventability of adverse drug events (ADEs). The incidence was 50.1 per 1000 person-years and substantial numbers of ADEs were deemed preventable. The more serious events had a higher rate of preventability. Errors associated with preventable ADEs were mostly related to prescribing, monitoring and patient adherence. The authors suggest a number of strategies to reduce the risk of adverse events. Well worth a read.
posted by Anthony Cox at 10:04 PM | permalink


Sometimes in order to reduce a defined risk, we have to change practice. However, one would do well to remember this maxim:

Pitz's Cyncism Principle
"In the real world one does not solve problems, one merely exchanges them for other problems."

However, coping with risk is about choosing between options, and avoiding, delaying or delegating a decision is in itself a decision. Having mechanisms to monitor for "unintended consequences" is crucial to being able to make changes in practice.
posted by Anthony Cox at 3:23 PM | permalink


The Medicines control agency has published Best Practice Guidance on the labelling and packaging of medicines [PDF] . "Medicines management plays an important role in the way in which medicines are used and clear labelling of medicines is part of the safe use of all medicines. As part of a wider impetus to reduce medication errors, the Committee on Safety of Medicines has reviewed the factors that are involved in labelling and packaging and as a result of their work, have agreed the principles that should be used when labelling for medicines is drawn up." This work builds upon a process set in train by Building a Safer NHS and MLX 275 [PDF]. An important point is that this guidance has been shared with Europe who have contributed to the document. It is hoped that this document will help reduce medication errors related to labelling and improve patient packs. This is a working document and will be reviewed on an annual basis which is important given that research in this area is still limited.
posted by Anthony Cox at 2:45 PM | permalink

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Monday, March 03, 2003

The Therapeutic Goods Administration of Australia has issued an update of it's 1998 Review of Non-prescription Analgesics. It addresses issues such as paracetamol poisoning, liver disease. children's analgesic doses and labelling, and aspirin and Reye's Syndrome. They say "There are alternatives to aspirin for children with pain or fever and a new message, consistent with that proposed in the UK [PDF], would be shorter and simpler; label clutter would also be reduced."
posted by Anthony Cox at 5:33 PM | permalink

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