Re: Margaret McCartney: Forever indebted to pharma—doctors must take control of our own education
Thank you, Dr McCartney, for acknowledging that the sweet temptations gifted with education by the pharmaceutical companies are never ‘free’.
I work in a tertiary teaching hospital, in psychiatry. The pathology of disease and mechanism of actions of many medicines in psychiatry are still unknown. This can further inflate the wonders of new medicines.
An example I would like to share is the recent addition of Aripiprazole Long-Acting Injection (ALAI) (Abilify Maintana®) to our Pharmaceutical Benefits Scheme (PBS) in Australia. A pharmaceutical company representative (rep) was given an opportunity to educate the prescribers on this medicine at the weekly medical meeting at my hospital. The rep was kind enough to provide lunch.
Her opening statement of ‘I’m not here to sell anything, I am just here to present the facts’ led into a presentation of specifically chosen pieces of data, whilst omitting to complete the picture, which would help prescribers be guided by evidence to understand ALAI place in therapy.
Her key points (as the drug rep) were:
• That aripiprazole has been available for years as the oral form and is ‘unique’
• Side-effects which antipsychotics commonly cause but ALAI did not, such ALAI being weight-neutral (suggesting no weight gain) and ‘no-effect’ on QTc intervals which can precipitate cardiac events.
• And suggestion that failure to respond to ALAI is likely to be due to a sub-therapeutic oral coverage during initiation.
The director of psychiatry allowed me to have 5 minutes at the end of the presentation to clarify the evidence-based for ALAI place in therapy and local implications. I tried to ensure the ‘take home’ messages for the prescribers in my area, were not negative but a balanced informed view of ALAI, mindful of the drug rep being present to listen to my advice.
My key points (as a clinical pharmacist):
• Currently no head-to-head trials to compare ALAI to other antipsychotic long acting injection. Hence, suggestions regarding the use of one long-acting injection over another cannot be readily made.1
• Although aripiprazole has a different side-effect profile, it is not immune to side effects and is still considered a second generation antipsychotic. The main reported side-effects from the clinical trials have been akathesia/restlessness and insomnia2. These are important to note particularly in unwell patients, prescribers often expect sedation to occur with the initiation of an antipsychotic. With the use of aripiprazole this will not be the case and may lead to a prescribing cascade to facilitate sleep. Changes to QTc can occur and has with the oral form as a Treatment Emergent Adverse Event and is listed within the product information (PI)3, metabolic monitoring (which includes weight changes and cardiac) needs to be a priority for all patients treated with antipsychotics to ensure we are not causing harm.
• Aripiprazole is only listed on the PBS for schizophrenia. As antipsychotics can be indicated for other psychiatric conditions, such as bipolar, if it is not approved for those indications on the PBS it will have a large financial impact to our patients increasing cost of treatment from $6.90 per month (if they are a concession card holder) to $399.95 plus dispensing fees.4
• Within Australia the PI recommends that treatment with oral aripiprazole, or other oral antipsychotics, should be continued for 14 consecutive days to maintain therapeutic antipsychotic levels during initiation.3 Other countries where ALAI is licenced have specified aripiprazole oral to be used which clinically ensures patients are showing a response, but also prevents the use of multiple antipsychotics, especially if the oral is also being used for its sedating properties. The main studies showing non-inferiority data are for patients stabilised first on oral aripiprazole, meaning they have responded to the therapeutic agent prior to trialling the Long-acting form.5
• ALAI is currently not on our hospital formulary, this means that it has not yet gone through our local drugs and therapeutics committee which is again a chance for independent review and also addressing the cost: benefit for our patients. It also means that ALAI is not currently stocked at the hospital and therefore a delay may be expected in treatment until it is sourced, this leads to increasing costs of prolonged admissions.
The pharmaceutical rep added her input throughout my summary as a ‘right of reply’ such as ‘there is a head to head trial against another antipsychotic’ and that ‘another hospital in Australia is also awaiting formulary approval but they have been keeping a “stash of stock” so there is no delay when it is required.’ Again blurring the lines for prescribers and when questioned about the head to head trial, we discovered it has not yet been published, leading to questions of the quality, the results and if the research had been peer reviewed. Disregarding the drugs and therapeutics committee’s process encourages prescribers to work around our hospital policies and prohibits the quality use of medicines principles.
The constant denial by prescribers of being influenced by pharmaceutical reps and their ability to ‘see-through’ the biased information has been held under a magnifying glass in my organisation. Exactly one week after the reps presentation the psychiatric ward which currently has 25 admitted patients, had 10 patients prescribed oral aripiprazole. 7 of these have transitioned to the long-acting injection form. Of the remaining 15 patients 7 were admitted for mood disorders (such as suicidal ideation) and therefore ariprazole is not indicated.
I am not anti-aripiprazole by any means and it is good to have another option for our patients, however I do have a duty of care as a pharmacist to help promote quality use of medicines and evidence based practices. The change needs to occur from doctors, such as Dr McCartney, promoting the importance of independent information. Above all the change needs to be by the policy makers. The government needs to support education such as the National Prescribing Service, and allow time for clinical pharmacists to do what they do best, help prescribers and patients make informed decisions about medicines.
1. Aripiprazole modified release (Abilify Maintena) for the treatment of Schizophrenia. NPS RADAR April 2015. NPS Limited.
2. Motiwala et al. Review of depot aripiprazole for schizophrenia. Patient Preference and Adherence 2013:7 1181–1187.
3. Lundbeck Australia Pty Ltd. Abilify Maintena Product Information. 25 July 2014.
4. Australian Government Department of Health, Pharmaceutical Benefits Scheme, 2014. http://www.pbs.gov.au/pbs/home (accessed 24 Sept 2014).
5. Fleischhacker WW, Sanchez R, Perry PP, Jin N, et al. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Psychiatry. 2014 Jun 12. pii: bjp.bp.113.134213.
Competing interests: No competing interests