Volume 199 - Issue 11
Systematic postmarketing surveillance needed for misused psychoactive pharmaceutical drugs
Authors: Angela C Rintoul and Malcolm D H Dobbin
Med J Aust 2013; 199 (11): 747. || doi: 10.5694/mja13.11017
Published online: 16 December 2013
Published online: 16 December 2013
In reply: We thank Soh for her letter providing further evidence of harm relating to alprazolam misuse,
which highlights deficiencies in postmarketing surveillance systems for pharmaceutical drugs. Reports
of adverse drug reactions typically originate from therapeutic use; they seldom identify problems arising from misuse. Detection of misuse-related harm currently relies on ad-hoc epidemiological studies such as ours and that of Frei and colleagues, who documented ...
In reply: We thank Soh for her letter providing further evidence of harm relating to alprazolam misuse, which highlights deficiencies in postmarketing surveillance systems for pharmaceutical drugs. Reports of adverse drug reactions typically originate from therapeutic use; they seldom identify problems arising from misuse. Detection of misuse-related harm currently relies on ad-hoc epidemiological studies such as ours and that of Frei and colleagues, who documented problems with over-the-counter codeine–ibuprofen analgesics.1 Given that pharmaceutical drug misuse and its consequences are becoming more prevalent in Australia,2 a more systematic approach to identifying harm from misuse is required.
In the 1950s, several reports of aplastic anaemia associated with oral chloramphenicol emerged in the literature, but it was difficult to define the extent of the problem from these spontaneous reports.3 An American Medical Association blood dyscrasia registry found that, while this was a rare adverse effect, the denominator of use was very high and the number affected was unacceptable. Oral chloramphenicol was removed from the market.
This example shows how a registry enables description of low-prevalence conditions. Other examples include the study by Frei et al1 and the monitoring of uncommon diseases in children by the Australian Paediatric Surveillance Unit. A professional body such as the Royal Australasian College of Physicians Australasian Chapter of Addiction Medicine might serve to administer a funded registry for emerging pharmaceutical drug misuse problems.
Moylan highlights the inconsistency between alprazolam prescribing and treatment guidelines. Although alprazolam is not recommended as first-line treatment for anxiety or panic disorders, and despite significant risks of misuse and dependence, it remains widely prescribed for these conditions.
Regulatory and administrative changes can be effective in controlling pharmaceutical drug misuse problems. For example, flunitrazepam was moved to Schedule 8 of the Standard for the Uniform Scheduling of Medicines and Poisons in 1998,4 and temazepam capsules were removed from the Australian market in 2004.5 The 2010 report of the Victorian Illicit Drug Reporting System showed that benzodiazepine injection among people who inject drugs decreased from 40% in 2001 to 4% in 2010.6
We were encouraged to learn that as a result of many submissions to the Therapeutic Goods Administration describing harm from alprazolam misuse, alprazolam will also move to Schedule 8 in February 2014.
Competing interests
Malcolm Dobbin has received honoraria from Pfizer for lectures, which he donated to charity.
References
- Frei MY, Nielsen S, Dobbin MD, Tobin CL. Serious morbidity associated with misuse of over-the-counter codeine–ibuprofen analgesics: a series of 27 cases. Med J Aust 2010; 193: 294-296. CHDHFDFJ
- Rintoul AC, Dobbin MD, Drummer OH, Ozanne-Smith J. Increasing deaths involving oxycodone, Victoria, Australia, 2000–09. Inj Prev 2011; 17: 254-259. i1142877
- Wright C, Schnoll S, Bernstein D. Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective. Ann N Y Acad Sci 2008; 1141: 284-303. CBBCCIDG
- Rintoul AC, Nielsen S, Drummer OH, Dobbin MD. Benzodiazepine supply and heroin-related deaths in Victoria: the success of flunitrazepam regulation compared with escalating deaths involving alprazolam [abstract]. Drug Alcohol Rev 2010; 29 Suppl 1: 62. CBBDBHIH
- Degenhardt L, Roxburgh A, van Beek I, et al. The effects of the market withdrawal of temazepam gel capsules on benzodiazepine injecting in Sydney, Australia. Drug Alcohol Rev 2008; 27: 145-151. i1142886
- Reddel SE, Horyniak D, Dietze P, McElwee P. Victorian drug trends 2010: findings from the Illicit Drug Reporting System (IDRS). Sydney: National Drug and Alcohol Research Centre, University of New South Wales, 2011. i1142887