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THE proposal for a pharmacy-based Minor Ailments Scheme (MAS) should be seen for what it is — a push by the pharmaceutical industry and pharmacy business to increase drug sales under the guise of health innovation.
The government is correct to insist on a formal trial to investigate the feasibility of a pharmacy-based MAS, but should go further and investigate the industry to determine whether further regulatory measures are needed to protect patients. Unless integrity within the pharmacy industry is improved, MAS programs will simply become another mechanism to increase drug use in the community.
Touted as a cheaper solution to managing minor presentations in general practice, MAS programs have been developed and promoted in the UK and Canada. Despite availability for years, there is a paucity of high-quality evidence supporting or evaluating MAS programs.
A recent systematic review has shown that the quality of reporting in MAS evaluations is often poor, and the assessment of bias is often difficult. The authors concluded that there was some positive evidence for MAS programs, but that results needed to be interpreted with caution and may be unique to the UK system. Ominously, the broader issue of drug utilisation was not considered in any of the evaluations; for example, deregulating the use of the antibiotic chloramphenicol in the UK led to a 48% increase in its use through substantial prescribing by pharmacists.
Despite this, Australian pharmacy groups and drug company organisations have been advocating for an MAS in Australia. Submissions to the federal government and Victorian Government have led to commencement of MAS trials in Australia.
Publicly, the justification for an MAS is that it reduces pressure on GPs, provides GPs with time to care for patients with more serious illnesses and is a more efficient way to manage minor ailments. This is despite evidence that access to GPs is not a problem, and a lack of evidence on effectiveness of current advice and treatments given to patients by pharmacists.
Privately, within the industry, the arguments are quite different. Competition and perceived income loss from Pharmaceutical Benefits Scheme (PBS) changes has prompted a renewed focus on broadening pharmacy income streams. Despite the 6th Community Pharmacy Agreement providing an extra $3.2 billion to deliver PBS medications, the pharmacy sector is looking to broaden revenue streams through the provision of clinical services and increasing sales of S3 medications (pharmacist only) and S2 medications (over the counter [OTC]).
Profit from drug sales is the common goal of pharmacy groups and the pharmaceutical industry. Pharmaceutical companies and pharmacy banner groups are becoming increasingly involved in providing pharmacy-based services. The relationships between these groups in Australia are not well known, and certainly not well studied. The so-called “Coke and fries” arrangement between the Pharmacy Guild and Blackmores to coprescribe complementary medicines with routine medical prescriptions is a good example of agreements that arguably put profit before consumer benefit.
Drug companies are now delivering a wide range of clinical services in pharmacies. For example, Apotex uses nurses and nurse practitioners and advertises delivery of health services in more than 800 Australian pharmacies. Sigma Pharmaceuticals and Probiotec have different arrangements. These collaborative arrangements in the pharmacy sector have developed without critical oversight and examination. There is doubt that consumers would know of the implications of services delivered by drug companies.
The Australian Self Medication Industry (ASMI), a multiple drug company-based organisation, has acted with the Pharmacy Guild to change restrictions to access and advertising of S3 (pharmacist only) medications (pages 3 and 6) to promote S3 drug sales. ASMI believes increasing consumer self-care is a key driver of pharmacy growth. A different perspective would suggest a profit motive from sales of OTC medication.
Some pharmacists are following the Guild’s transformation scheme in broadening revenue streams by involvement in educational courses to boost profits by sales of S2 and S3 drugs. Training includes the promotion of sales tactics via “pick-up lines” to engage consumers in minor ailment consultations. Concerningly, this has also been associated with sales of pseudoephedrine, yet there has been no ethical challenge to this practice from within pharmacy groups. It appears sales tactics are being normalised as professional behaviour.
Technological tools to augment drug sales have also been developed and implemented. The Pharmacy Guild software “GuildSmart” actively promotes boosting profits from medication sales as a key function. It alerts pharmacists in real time to sales opportunities with OTC drugs, companion drugs (that’s Coke-and-fries again) and generic medication. It is only a small technological step to automate drug protocols to address minor ailments and further enhance profits for pharmacies.
Business arrangements and clinical practices that promote drug sales have flourished in the community pharmacy sector in the absence of regulatory oversight or clinical evaluation. Marketing and sales practices promoting drug sales are now common. OTC drug sales are big business in Australia, but OTC medicine misuse is also a problem well known in the literature.
From a patient safety perspective, this is a worrying trend, and arguably it is not an environ in which an MAS should be implemented. If an MAS is to be implemented, the government should also undertake a comprehensive review of drug company influence and business activity in the pharmacy sector, as well as examining the marketing practices within pharmacies that inappropriately promote sales of drugs and products rather than benefiting consumers.
At the very least, there should be regulatory change to provide transparency regarding arrangements between pharmacies and the pharmaceutical sector. There are transparency rules regarding relationships between the medical profession and pharmaceutical companies, so similar standards should apply to pharmacy.
In a period of health reform, innovations should be accepted only if they lead to global benefits in patient and population health. Unless there is integrity within the pharmacy sector, MAS programs will become just another mechanism for industry to increase drug use in the community.
Dr Evan Ackermann is a GP at the University Medical Centre, Southern Cross University, Gold Coast, Queensland, and the chair of the Royal Australian College of General Practitioners National Standing Committee – Quality Care.
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Now that Chlorsig (chloramphenicol) eye drops and eye ointment are no longer subsidised by the PBS the general public are more likely to skip the review by a doctor and head straight to the pharmacy to purchase these products. There is already a problem with staff at childcare centres directing parents to buy chloramphenicol eye drops for every case of “sticky eye” so that the baby or child can return to daycare. When sale is refused by a pharmacist parents go elsewhere to buy it with a different story. Maybe RANZCO needs to undertake a public education campaign. The other risk of inappropriate use of chloramphenciol eye drops/ointment is the rare but serious risk of aplastic anaemia.
The Royal Australian and New Zealand College of Ophthalmologists urges caution in regard to the dispensation of chloramphenicol by pharmacists. Many ophthalmic diagnoses involve interpretation of subtle ophthalmic signs that can only be elicited by practitioners with appropriate training. There are documented cases in both the UK and Australia of delays in diagnosis of vision threatening microbial keratitis while patients were inappropriately treated with chloramphenicol. Patients with minor ocular symptoms may progress rapidly to a problem sufficiently severe or sight threatening to require prolonged intensive antibiotic treatment with full ophthalmic supervision. Most general practitioners are aware of these issues and are able to triage care appropriately at the outset and so prevent delayed treatment
I am very concerned about the widening of pharmacist’s powers to supply any medications, because of the delegation that already exists to untrained pharmacy assistants. When in the local pharmacies it is not unusual to hear pharmacy assistants being ‘consulted’ about various ailments, and the conversation invariably ends with a product being sold – whether suitable or not. The sale appears to be all that matters, and the pharmacist is not even involved with OTC products, which can be wasteful, expensive and delay proper assessment. Yesterday my elderly mother was sold some cream that would not work and she had already at home, when I’d encouraged her to show the rash to her GP on Monday. Assistants also supervise blood pressure testing, and I recently overheard a discussion about a BP that sounded high enough to warrant proper assessment, but no suggestion of seeing a doctor was made. Can there at least be some insistence that the pharmacist properly supervise any discussion of a ‘minor ailment’?
Pharmacists undergo training in the treatment of minor ailments throughout their university and intern year. They follow protocols e.g. for the use of choramphenicol and have robust treatment pathways.
The analogy of the upward trend of the use of choramphenicol in the UK is an interesting one and I am sure Dr Ackerman is well aware of why this trend occured. The patients that presented to pharmacy for tteatment of minor eye conditions were never going to see a GP unless pushed very hard by a pharmacist. As we are all very aware treatment of many minor eye conditions has a limitation and will resolve whatver you do e.g. cold packs, lubricating eye drops etc. In the past these patients were probably given items such as brolene or Golden Eye Ointment and their condition resolved in 3-5 days. When Choramphenicol became available in pharmacy we had a better tool to use for treating minor eye ailments and pharmacy followed the gudielines and used this product. The use of Brolene and Golden eye ointment fell away so badly that both products have now disappeared from the market.
The minor ailments program has been in pharmacy forever. To make it into an actual program where we can monitor the p[resentations and products recommended assists with research and product development.
This program is a normal part of the normal practice of pharmacy. Please do not demean the role of pharmacists. If a problem is not minor we have definite referal processes to send a patient to a GP. We have taught these processes to graduates and registered pharmacists since the beginning of pharmacy. If you want to see every stubbed toe and splinter that I see you are welcome to them.
At present many patients already present to pharmacies with minor ailments. There are many reasons for this. Some patients want to seek an opinion as to whether something requires a visit to the doctor or not. The pharmacist is freely available – no appointment necessary and no fee for advice. Their GP is not available after hours and the pharmacy is open extended hours. They don’t want t bother their GP with something minor. They can’t get an appointment at their GP (particularly in regional areas). The patient may believe that they can treat a condition with a specific product which they may have used before or the product has been recommended by someone else. Pharmacists undertake five years of training prior to registration and are experts in medication. Their training covers the management of minor ailments and when to refer. Pharmacists are registered health professionals with similar requirements for CPD to medical practitioners. Pharmacists have a code of ethics. In addition pharmacists are trusted by the public (the polls show them second place to nurses above medical practitioners). Pharmacists often refuse sales of over the counter medication, they have to work within tight guidelines. It is also not uncommon for a patient to be upset when a sale is refused as they wrongly belive that is is their right to purchase any over the counter product. They may go elsewhere with a different story.
The development of a MAS would formalise what already occurs and also provide more structure and more scrutiny. Hopefully the MAS would also formalise reporting and communication between the various health care practitioners involved in the care of each patient.
I think that the crux of the problem is “What is a Minor Ailment?” Who is to decide if the ailment is minor – the pharmacist or the patient? Neither are trained to do so.
An example: I attended my dermatologist for the usual six-month burnoff and he observed a small mole on my forehead which had been present for a month or two. It was 2-3 mm across, round, regular colour etc etc; nothing that aroused any suspicion in me. The dermatologist was suspicious and did a shave biopsy; result, malignant melanoma in situ, now dealt with.
I can think of many other examples from my far-off days as a GP where a symptom or a lesion might be thought minor; a case of early leprosy comes to mind.