I do wonder how much of this consultation is a serious attempt to engage with anyone other than the profession to which it applies.
The Pharmacy Board of Australia is currently seeking feedback on a proposal to endorse the registration of “suitably qualified pharmacists” under section 94 of the National Law.
The consultation is limited – a Hobson’s choice of supporting one of two statements:
- Option A: An endorsed pharmacist is qualified to administer, obtain, possess, prescribe, sell, supply and/or use Schedule 2, 3 and 4 medicines; or
- Option B: An endorsed pharmacist is qualified to administer, obtain, possess, prescribe, sell, supply and/or use Schedule 2, 3, 4 and 8 medicines.
The consultation paper states that the Board will not consider patient safety outside of these two options, nor will they publish any responses they perceive to be outside the scope of the consultation.
Therefore, there is no opportunity to discuss structural weaknesses in the regulatory process that impact patient safety when either of these statements are endorsed.
Although the Board claims to have already consulted stakeholders prior to this consultation, the GPs who attended did not feel their feedback was heard, acknowledged or valued. This is a consistent pattern, echoed by NACCHO who felt their concerns were not heard, acknowledged or valued in the North Queensland Pharmacy Pilot.
This article is my attempt to make my concerns available to others, assuming it is unlikely to be included in the Board’s consultation process. To date, I can see no evidence that any feedback has been taken seriously by the Guild or the pharmacy profession as a whole.
Limitations of the consultation
There is no discussion of what the pharmacists are planning to do with these medications they are “authorised to prescribe”.
The fundamental problem in this consultation, ironically, is its scope. Health professionals are not there to manage medications, they are there to manage patients.
The question should be whether an endorsed pharmacist is able to manage certain patients with certain conditions at certain times and places, rather than whether they can “administer, obtain, possess, prescribe, sell, supply and/or use” medications.
The Board is also trying to endorse all “current and future initiatives” in pharmacy prescribing as “determined by state and territory governments”, meaning they are intending to open prescribing to unknown patient groups with unknown conditions.
Without knowing what pharmacists are going to be asked to do, it is difficult to assess whether pharmacists are qualified to do it.
There is no discussion of which drugs will fall under this scheme and which will not.
There are medications and investigations that are limited in general practice and require support from specific specialities, (eg, high-dose proton pump inhibitors). There are some that are not able to be prescribed by GPs at all (eg, roaccutane). Some medications are never used outside of hospitals, while others can be purchased at Colesworth.
While this consultation is clear that “prescribing by endorsed pharmacists would be limited by the authorisation to prescribe granted in the state or territory of practice and by their scope of prescribing practice”, there is no mention of any limits placed around capacity to prescribe more specialised drugs.
It is easy to imagine pharmacists prescribing drugs that are restricted in general practice, provided there is state government endorsement. Pharmacists are already prescribing the oral contraceptive pill, despite repeated warnings from the Therapeutic Goods Administration who opposed the change.
If pharmacy is to be uniquely exempt from national governance, it should be clearer in their code of conduct.
It is deeply uncomfortable to consider that a health minister could, in the interest of political or economic expediency, enable pharmacists to prescribe whatever they like. When politicians can override clinical safety to meet political, economic or social goals, health regulation becomes dangerously irrelevant.
There is no discussion of where drugs will be prescribed, and the influence of context on prescribing safety.
Interns can prescribe in hospitals, but not in the community. Pharmacists in palliative care teams, with all the multidisciplinary support teams provide, may manage opiates safely. Pharmacists in community pharmacies may not.
Individual training does not create patient safety. Hospitals have extensive governance, safety and quality improvement processes embedded in their systems, but community pharmacies do not have the same regulatory and governance oversight.
Where the drug is prescribed influences whether it is “safe” and whether the pharmacist can be considered “qualified” to prescribe it.
There is no discussion of who they prescribing for.
The model of care that is replicated throughout the pharmacy prescribing “pilots” is to take an average recommendation, expressed in a particular guideline, and turn it into a protocol.
The problem is equity.
Outliers, who do not benefit from the average treatment, are more likely to be people from marginalised communities.
In all the celebration of improving “access”, there has been little comment on the fact that most participants in the pharmacy trials are privileged and urban. In the NSW trials, there were three people in MM 6-7, making the Guild’s claims of access in rural and remote communities somewhat optimistic.
Of more concern is the fact that those likely to experience harm are those who would never have been included in the research that grounded the guidelines. This includes people from Aboriginal and Torres Strait Islander communities who are likely to miss out on the benefits of this industrial approach to treatment, and be at higher risk of harm.
It is deeply concerning to see the lack of Aboriginal and Torres Strait Islander engagement embedded in pharmacy training. GP registrars have been required to undertake at least 15 hours of Aboriginal and Torres Strait Islander specific training, with a team of Aboriginal and Torres Strait Islander cultural educators and mentors, for at least three decades.
This part of training has always been highly valued.
As far as I am aware, there is no such requirement in pharmacy training. The Pharmacy Council requires students to be “aware” of Aboriginal Medical Services, and pharmacy prescriber programs should “include” Aboriginal and/or Torres Strait Islander input “where possible”. This is not sufficient, in my view, to ensure cultural and clinical safety.
Pharmacy is now undertaking women’s health care, an area that requires considerable cultural sensitivity.
Cultural sensitivity was clearly lacking in the UTI trials in North Queensland, which went ahead after NACCHO withdrew their support. At the time, NACCHO Deputy CEO Dr Dawn Casey said:
“There has been insufficient consultation with the community-controlled sector on the proposed trial. Furthermore, the proposed trial will fragment care and result in missed opportunities for comprehensive team-based primary care.”
The pharmacy trial went ahead anyway, with no acknowledgement or consideration of these concerns.
Related
In the NSW oral contraception trials, the research team undertook a genuine consultation with Aboriginal and Torres Strait Islander community members to seek their opinion on the model of care. However, in the trials themselves, only eight participants identified as Aboriginal and/or Torres Strait Islander, four were redirected to general practice and all gave markedly lower satisfaction scores.
If consultation with communities is taken so lightly, what faith should the community have in the ethics and professionalism of a self-regulated, government-sponsored profession?
There is no discussion of how the profession will ensure prescribing remains safe across the multiple contexts in which it occurs.
It is critical to recognise that regulation is there to protect the most vulnerable patients from the least qualified professionals.
High performers in any industry are likely to perform well. However, the Board is there to protect the public from the least trained, least competent members of the profession.
There is a reason why medicine has had its right to self-regulate curtailed. The community decided self-regulation was unsafe.
I doubt pharmacists are uniquely able to graduate perfectly ethical health professionals, so I expect their profession has the same weaknesses and public threats as doctors, nurses and physiotherapists.
There is no discussion around conflicts of interest.
I always find it interesting when health professionals raise concerns about the inherent conflicts of interest present when pharmacies sell medications in a retail environment.
The Guild usually deflects such arguments using the rhetoric of the “turf war” – an interesting response from an industry with the strongest anti-competitive behaviours in the contemporary market.
The language of capital, markets, competitive advantage, market segmentation, profitability and strategic stocking sits uncomfortably with evidence-based, patient-centred healthcare.
Unlike most other health professions, retail sales constitute a substantial proportion of a pharmacist’s business. Pharmacists and pharmacy owners use a variety of marketing strategies to increase profits, including loyalty programs.
I suspect there are few other health professionals who discuss concepts like basket size in their trade journals. Floor plans can be designed to increase profits, including strategies to keep “consumers” in the retail aisles for a longer period of time to stimulate impulse buying. This must be the only circumstance in which increasing waiting time is seen to be beneficial.
The pharmacy profession sees this combination of healthcare and retail as “a harmonious blend of healthcare and business, where each aspect supports and enhances the other”. Perhaps this is so, but there is certainly the potential for the two goals to compete.
After the oxycontin epidemic, drug advertising was increasingly restricted and heavily regulated to control potential conflicts. There is ample evidence that doctors are influenced by branded pens and Post-It notes, so I see no reason to doubt the impact of rows of branded products on a pharmacists’ prescribing choices. Companion selling is certainly promoted as a business strategy.
In developing a specific code of conduct, it will be important to explicitly address the conflict of interest inherent in running a retail business beside a healthcare business. It will also be important to address the ethical problem of combining prescribing and dispensing.
By combining the two, pharmacy has removed a layer of protection for the public, and the Code should address how this added risk will be managed ethically.
In the next article, I will discuss what will be necessary when pharmacy develops its own Code of Conduct. At the moment, it relies on a shared code, which is increasingly out of step with its own practice.
Public safety depends on the community understanding what can and can’t be done by health professionals. Before this consultation ends, it will be critical to bed down prescribing in a framework of governance.
But then again, I do wonder how much of this consultation is a serious attempt to engage with anyone other than the profession to which it applies. Regardless, I would encourage others to add their voices to the discussion. You can add your comments here.
Professor Louise Stone is a GP in Canberra and an academic at Adelaide University. A collection of her research, policy and teaching materials can be found at drlouisestone.com.
