Topics
Pharmacology
Off-label prescribing
Off-label prescribing (to patient groups or for indications not listed in a medicine's product information) is okay if supported by evidence
J Paul Seale MB BS, PhD, FRACP
Reducing off-label prescribing in psychiatry
Consider the evidence before prescribing medications off-label and use non-pharmacological treatments where possible
Ian B Hickie MD
Pharmacometrics: an underused resource in Australian clinical research
To the Editor: Pharmacometrics is an emerging field in Australia, with use in a wide range of therapeutic areas including cardiovascular disease, critical patient care, diabetes and paediatrics.1-4 The results of pharmacometric analyses are often referred to in Therapeutic Goods Administration-approved product information; however, for many clinicians, pharmacometrics remains a mysterious area of research. Therefore, we seek to promote the discipline of pharmacometrics in clinical ...
Vidya Perera · Michael J Dolton · Andrew J McLachlan · Vaughan J Carr · Richard O Day
Systematic postmarketing surveillance needed for misused psychoactive pharmaceutical drugs
To the Editor: I would like to thank Rintoul and colleagues for bringing together data from varied sources to highlight an important public health issue.1 The 1426% increase in supply of alprazolam they identified over the 20-year period from 1990 to 2010 was particularly striking. Alprazolam is indicated as a second-line treatment for panic disorder where other therapies are ineffective, or for short-term treatment of anxiety disorder. As ...
Tracy W Soh
Systematic postmarketing surveillance needed for misused psychoactive pharmaceutical drugs
To the Editor: Rintoul and colleagues showed that alprazolam is being increasingly detected in heroin-related deaths.1 One explanation provided is increased rates of alprazolam misuse among people who inject drugs. My colleagues and I recently reviewed the role of alprazolam in Australian clinical practice,2 focusing on the sole supported Pharmaceutical Benefits Scheme (PBS) indication: treatment of “panic disorder where other treatments have failed or are inappropriate”. ...
Steven Moylan
Systematic postmarketing surveillance needed for misused psychoactive pharmaceutical drugs
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 ...
Angela C Rintoul · Malcolm D H Dobbin
Inadvertent dispensing of Coumadin instead of Coversyl
the Editor: In August 2012, a 43-year-old woman presented to her general practitioner with extensive spontaneous bruising. Her only medications were Coversyl (perindopril) 5 mg daily for hypertension and Rhodiola rosea extract. Laboratory testing revealed prolonged coagulation times (Box 1). Mixing studies (50 : 50 patient and normal plasma) showed complete correction of the activated partial thromboplastin time and international normalised ratio (INR) and no evidence of a ...
Duncan P Carradice · Ellen L Maxwell
Sotalol-associated cardiogenic shock in a patient with asymptomatic transient rate-related cardiomyopathy
The prescribing information for sotalol does not warn of the risk of life-threatening cardiogenic shock when this drug is used in patients with left ventricular dysfunction, and should probably be amended.
Simon D Leslie
Psychotropic medication in pregnancy
The increasing use of psychotropic medicines has led to a need to understand the safety of antipsychotics in pregnancy.
Roisin N Worsley · Heather Gilbert · Jayashri Kulkarni
Low awareness of adverse drug reaction reporting systems: a consumer survey
Although consumers have been able to directly report possible adverse drug reactions to the Therapeutic Goods Administration since 1964, most such reports still come from health professionals and pharmaceutical companies. It seems that lack of awareness of the reporting mechanisms is a major limiting factor for consumers, and promotion and education of reporting systems are required.
Jane Robertson BPharm, MMedSc, PhD · David A Newby BPharm, GradDipEpi, PhD
Pregabalin-associated rhabdomyolysis
The case of a woman who developed severe rhabdomyolysis shortly after the addition of pregabalin to a stable atorvastatin regimen serves as a reminder to clinicians to be aware of possible adverse drug reactions.
Roshan Gunathilake MB BS, MD · Laura E Boyce BPharm · Anne T Knight MB BS(Hons), FRACP
Pharmacological treatment approaches to difficult-to-treat depression
Summary In the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial of almost 3000 patients with depression in the United States, 50% responded to the initial trial of a selective serotonin reuptake inhibitor antidepressant, but only a third achieved remission (nil or minimal depressive symptoms). The final remission rate, even after four potential treatment steps, was only 70%. This finding reflects the reality of ...
Herng-Nieng Chan MB BS, MMed(Psych) · Philip B Mitchell AM, MD, FRANZCP, FRCPsych · Colleen K A Loo MB BS(Hons), MD, FRANZCP · Samuel B Harvey MB BS, MRCPsych, PhD
Khat-associated hepatitis
We report a case of khat-associated hepatitis in a 32-year-old Somali man living in Australia. This is the first case of hepatoxicity related to khat ingestion reported in Australia.Clinical recordA 32-year-old Somali man with no prior medical history presented to the emergency department with a 1-week history of dark urine, pruritus and jaundice, on a background of a month of malaise and reduced appetite. He ...
Malcolm P Forbes MB BS · Ashok S Raj MB ChB, FRACP · Jennifer Martin MB ChB, FRACP, PhD · Guy Lampe MB BS, FRCPA · Elizabeth E Powell FRACP, FRCP, PhD
The after-life of drugs: a responsible care initiative for reducing their environmental impact
It is time that the environmental cost of doing medicine is brought into the whole equation; that Big Pharma are brought on board; and that doctors are educated to give this some priority.
Peter M J Fisher BSc(Hons), PhD · David A Smith BSc · Peter J Collignon MB BS(Hons), BSc(Med)
Vitamin D and health in adults in Australia and New Zealand
Vitamin D3 in oral supplements is derived from animal sources, so it is important to address this when recommending vitamin D supplementation to a person who adheres to a vegetarian diet.
Bettina Douglas
Vitamin D and health in adults in Australia and New Zealand
In reply: People requiring a purely vegetarian source of vitamin D should use vitamin D2 (ergocalciferol), which is produced by ultraviolet irradiation of the plant sterol ergosterol, and not vitamin D3 (cholecalciferol), which is derived from animal sources. As cholecalciferol is derived from sheep’s wool, which does not involve the sheep being killed, several cholecalciferol supplements are certified as halal. Some capsules contain gelatine (an animal ...
Caryl A Nowson · Rebecca S Mason
Severe symptomatic hypocalcaemia following a single dose of denosumab
First-line monoclonal antibody therapy to prevent bone loss in bone-metastatic breast and prostate cancers is delivered subcutaneously, often by general practitioners who need to be aware that this treatment in patients with low vitamin D levels, impaired renal function and poor calcium absorption (all often seen in older patients) can lead to serious hypocalcaemia.
Jennifer M McLachlan · Gavin M Marx · Margaret Bridgman
Trials and tribulations in the removal of dextropropoxyphene from the Australian Register of Therapeutic Goods
Does the appeal process against TGA decisions appropriately serve the Australian public interest?
Nick A Buckley MD, FRACP · Thomas A Faunce BA/LLB(Hons), BMed, PhD
How can we improve access to new (and old) antibiotics in Australia?
With very few new antibiotics in the pipeline, promoting their development is important, as is balancing priorities when treating patients
Allen C Cheng FRACP, MPH, PhD · Roger L Nation PhC, MS, PhD
Rethinking psychotropics in nursing homes
The problem of excessive psychotropic drug use in Australian nursing homes is well known, but where are the solutions?
Juanita L Westbury · Gregory M Peterson
Rethinking psychotropics in nursing homes
To the Editor: The article by Hilmer and Gnjidic1 raises issues about the management of behavioural and psychological symptoms of dementia (BPSD)2 in residential aged care facilities (RACFs). It is important to remember the context in which RACF residents’ care is provided. The federally managed aged care system is politically and organisationally perceived as supported accommodation, which is geared toward supporting or substituting for residents’ performance ...
Ludomyr J Mykyta
Rethinking psychotropics in nursing homes
In reply: We thank Westbury and Peterson, and Mykyta for highlighting some of the issues raised in our article.1 While we acknowledge the important contribution of providing education programs to existing staff, staff education alone is insufficient to address the complex issues affecting psychotropic drug use in nursing homes.1 Better access to appropriately trained staff in nursing homes, including general practitioners, geriatricians, psychogeriatricians, psychologists, pharmacists, nurses ...
Sarah N Hilmer · Danijela Gnjidic
The case for CBT over antidepressants
THIS BOOK is by a doctor with an abiding interest in the philosophy of medicine. Paul Biegler is an Australian Research Council Postdoctoral Fellow at the Centre for Human Bioethics, Monash University, and a recipient of the 2011 Australian Museum Eureka Prize for Research in Ethics.The book describes the therapeutic use of antidepressant medication (ADM) versus cognitive behaviour therapy (CBT), and concludes that it is unethical ...
Kay A Wilhelm
Is there really misuse and abuse of dabigatran?
We have a continued responsibility to ensure that the benefits of new drugs demonstrated in randomised controlled trials are translated into clinical practice.
John W Eikelboom MB BS, MSc · Graeme J Hankey MD, FRACP, FRCP
Mass or molar? Recommendations for reporting concentrations of therapeutic drugs
Clinical errors may occur if a result in one unit is interpreted using information expressed in a different unit. The working party recommends using mass units for reporting therapeutic drug concentrations, with the litre (L) as the denominator.
Graham R D Jones MB BS, DPhil, FRCPA · Stewart Bryant MB BS, FRCPA, FAMM · Robert Fullinfaw MSc · Ken Ilett BPharm, PhD · John O Miners PhD, DSc · Raymond G Morris PhD, FFSc(RCPA) · Matthew P Doogue MB ChB, FRACP