Regulation and innovation in practice – Not a “drug interaction”?

Introduction

Recently there has been a lot of discussion about establishing a full scope of pharmacy practice as the new standard.¹ A full scope includes identifying the need for, selecting and prescribing, monitoring, optimizing and discontinuing drug therapy. This comprehensive practice, which includes prescribing, ordering laboratory tests, administering injections and disease management, is not the reality in most provinces. Some pharmacists claim that pharmacy regulators (the “Colleges” of Pharmacy) are holding back the profession. Is it really the Colleges that are holding us back, or is that merely yet another excuse put up by pharmacists? What is the role of our Colleges in practice innovation? Are you surprised to see the words “regulation” and “innovation” in the same sentence? Let’s examine the role of regulation and pharmacy practice.

The role of the Colleges

The Colleges govern the profession of pharmacy in the public interest. The Colleges’ mandate is to protect the health of the public. This role is different from advocacy for the profession of pharmacy. Colleges fulfil their mandate by governing the profession through the development and application of various rules and standards of practice, discipline, practice reviews and continuing education requirements.

We fundamentally believe that access to a full scope of pharmacy practice will significantly enhance the health of the public.

In fact, we believe that it is the Colleges that have stimulated innovation in Canadian pharmacy practice. For example, it was the Alberta College of Pharmacists that spearheaded the effort to get pharmacists prescribing in Alberta. The BC College of Pharmacists drove the establishment of PharmaNet, and the requirement for pharmacists to review all drugs before dispensing any prescription, and now, have applied to the Minister of Health for authorization to prescribe.

Modern regulatory philosophy is exemplified by movements like “Right-Touch” regulation,² which aims to protect the public, while avoiding the over-regulation of professionals (Box 1). This approach fosters and supports practice innovation that can not only protect, but enhance, public health. It allows the professional latitude to determine the best path to a positive therapeutic outcome, rather than limiting to a single option.

Box 1 Right-touch regulation.

Right-touch regulation is a term coined by Harry Cayton, formerly the CEO of the Professional Standards Authority in the United Kingdom.² The principles state that regulation should aim to be:

• Proportionate: Regulators should only intervene when necessary. Remedies should be appropriate to the risk posed, and costs identified and minimized.

• Consistent: Rules and standards must be joined up and implemented fairly.

• Targeted: Regulation should be focused on the problem and minimize side effects.

• Transparent: Regulators should be open and keep regulations simple and user-friendly.

• Accountable: Regulators must be able to justify decisions, and be subject to public scrutiny.

• Agile: Regulation must look forward and be able to adapt to anticipate change.

A somewhat more radical approach has been put forward by Robert Thierer—“Permissionless Innovation.”³ The general concept behind this is that when innovators must seek and obtain the blessing of public officials before developing new services, innovation is curtailed. Thierer suggests that unless there is compelling evidence that a new service will cause harm, innovators should generally be able to try new models of care and services, which will stimulate more innovation. Pretty radical for pharmacy, eh?

Furthermore, a recent paper published in CPJ by Foong et al.⁴ reviewed disciplinary actions by Canadian Colleges of Pharmacy and found that it was exceedingly rare for disciplinary action to be taken for clinical errors. And there were no instances of disciplinary actions for innovations in practice. It is clear that pharmacy regulators are not standing in the way of innovations in practice.

The way forward

If the Colleges are not holding us back, then who is? Is it government? Certainly, when a new service requires a change in legislation, then, yes, that is a barrier. But not an insurmountable one. Is it our culture? Is it the pharmacy corporations? Is it our ambivalence? Soon we will run out of scapegoats and excuses.

Look in the mirror. More often than not, we pharmacists are the ones standing in the way.⁵ Studies have shown that some pharmacists have a poorly developed sense of responsibility and lack confidence,⁶ find very elaborate and impressive strategies for not taking responsibility,⁷ blame corporations for holding us back, etc., etc. The fact is, many of us don’t practise to the scope of practice that we currently do have. For example, MacCallum et al. reviewed Diabetes MedsChecks in Ontario.^8,9 While approximately half of patients with diabetes received a MedsCheck review, 2/3 only received one annual review over the study period of 4 years (despite being eligible for yearly full reviews, paid for by government payors), and 97% never received any follow-up visits over 4 years (despite being eligible for up to 4 paid follow-ups per year). Should governments expand the scope of practice of a profession that doesn’t currently use the scope it actually has?

Our patients could be our greatest advocates. If we provided the fullest scope of care possible to all of our patients consistently; if we changed our culture to make it unacceptable to just dispense; if we used the full extent of the scope of practice we have; if we took the time to explain to our patients what we are doing for them; if we didn’t just wait around for someone else to change things, then it would be easier for governments to unequivocally believe that expanding pharmacists’ scope of practice to a full scope would improve the health of the public. This would become the standard, rather than the exception in the country. It certainly isn’t the Colleges that are standing in the way. ■