Why down-scheduling medicines is fraught with danger

The Government has recently directed the Therapeutic Goods Administration (TGA) to propose a new schedule for more medicines to be available over the counter.
 
While the move is ostensibly to improve access to these medicines, I – and many others – have serious questions.
 
The effect has been that the TGA has created a new group between Schedule 4 (prescription-only) and Schedule 3 (pharmacy-only) drugs, labelled Schedule 3 Appendix M (Schedule 3M). In effect, this is Schedule 3½.
 
The TGA briefly sought input on its proposal, which outlines the principles and rules around this new group of medicines. Once the principles and rules are set, pharmacists, patient groups, politicians and drug companies will be able to request medicines be included in the new group.
 
It appears, however, that no evidence review has been conducted about the need for down-scheduling. In short, it is not clear what problem Appendix M is trying to address.
 
External pressures are continually at play for Australia to down-schedule drugs and commercialise healthcare.
 
These pressures come from a number of sources, including comparisons with other countries (which may have very different health systems), pharmacy, patient advocates, and drug companies.
 
Unfortunately, many of these pressures run counter to efforts to ensure the quality use of medicines and maintain good stewardship in medicine.
 
There are many risks to our patients and the health system that I believe have not been adequately examined by the TGA.
 
More evidence is needed to demonstrate any need for down-scheduling of medications, and more investigation is also required to model any unintended consequences of down-scheduling.
 
Profits over patients?
Pharmacists have a glaring conflict of interest on such matters because they stand to profit from the proposal by selling medicines to patients. There are pressures on pharmacists from owners to maximise profits, and it is difficult to imagine effective exploration of non-drug alternatives.
 
Pharmacy owners and the Pharmacy Guild have a long history of objecting to any suggestions that might harm profits, even when there is clear evidence of patient harm or inconvenience – consider the pushback on up-scheduling of codeine or 60-day pack sizes.
 
Another issue is patient education, which starts with identifying prior knowledge, and is informed by the prescriber’s knowledge of that patient’s individual risk profile and health literacy. This information and the privacy to talk are not available at the front counter of a pharmacy.
 
Clinicians have explicit training in health communication that is intense and tested as part of medical school and professional examinations. Such training is minimal in pharmacy degrees, and the influence of pharmaceutical companies is likely to outshine evidence-based patient education.
 
Even worse, many pharmacies also employ largely untrained pharmacy assistants, who have been known to provide pseudo-medical advice.
 
Anecdotal evidence exists that many of the complementary and alternative medicines and devices are sold after advice from pharmacy assistants. I consider this a breach of trust, in that patients are entering what they think is a regulated health-provider space.
 
For all pharmacy-only medications, the TGA should ensure that there can be no delegation of medical history-taking, patient assessment and patient education to pharmacy assistants.
 
We need a process to monitor the impacts of changes to scheduling that considers societal costs of overuse of medications and a shift from lifestyle interventions to pharmaceutical interventions. In short, we need to weigh the costs versus the benefits.
 
For instance, chloramphenicol for topical treatment of conjunctivitis was down-scheduled in Australia in 2010. While there was no monitoring of the impact of this shift, a similar down-scheduling in the UK led to a 48% increase in use. Yet, sticky, sore eyes are commonly caused by viral infections. No treatment results in recovery for 74% of people, while antibiotic treatment increases this only marginally to 80%.
 
I have concerns regarding the provisions and safeguards proposed for Schedule 3M, as there is no effective system in place to ensure pharmacists comply with the recommendations.
 
Fragmentation of care
I am further concerned there will be a tokenistic shift of responsibility back to the GP via some form of communication informing the GP that the pharmacist has prescribed and sold a down-scheduled medication.
 
Responsibility for monitoring side effects, interactions, providing follow-up and access to after-hours cover typically rests with the prescriber. It is far from certain that pharmacies are adequately resourced to provide this level of care.
 
GPs do not have the time or resources to provide daily, continuous monitoring of a patient’s medication safety outside of consultations.
 
GPs also use the prescription and numbers of repeats as a way to schedule periodic medical reviews according to individual clinical need (eg during medication titration). This individual review frequency is lost when medicines can be purchased directly from pharmacies as S3 or 3M, and is an example of how fragmentation of care leads to poorer care.
 
When patients are seen for inter-current illness there is an opportunity to check which medicines are overdue for prescription, which is often the first indicator that a patient has stopped taking a medication. This adherence check is lost when the patient can purchase medicines directly from a pharmacist and further demonstrates how fragmentation of care can lead to poorer health outcomes.
 
The TGA proposal is to define quantity and duration limits on the newly down-scheduled medicines as a method of ensuring patient safety.  
 
I disagree with this approach. Only medicines so safe that there is no need for follow-up, and medicines treating benign and stable conditions, should be available over the counter.
 
Patient safety
The TGA has recommended that pharmacists use checklists to confirm no contraindications or medication interactions. This is inadequate.
 
As GPs we know that our patients can easily forget or choose not to mention important medication and medical history. GPs use information and pathology results in their clinical records to supplement patient memory. Pharmacists do not have access to this information. They will only have access to static information from My Health Record and, even then, only for patients who have not opted out.
 
In addition, the perceived importance of medicines will be lower when patients see little difference between the purchase of vitamins and vital preventive medications. For example, if statins become available without prescription, patients might stop or change the dose without reference to their doctor.
 
RACGP members regularly see patients stopping or starting low-dose aspirin because it is available without prescription and without adequate exploration in the pharmacy.
 
Real-time prescription monitoring is not yet in place at a national level, meaning patients may be able to circumvent rules around duration and quantity by visiting different pharmacies.
 
Are there better ways to improve patient safety, convenience and costs?
 
Certainly. We could move away from one-month pack sizes for low-risk ongoing medications, given
the evidence of patients deferring medications because of dispensing costs.
 
We could ensure face-to-face assessment between a registered health professional and patient before medicines are dispensed, and monitor the impacts of any changes to scheduling.
 
And we could pilot GP dispensing of common medicines rather than supporting monopoly supply in
pharmacies.

down-schedule medicines TGA Therapeutic Goods Administration