Understanding the BC Court’s Decision on Pharmacy Incentive Bans

July 31, 2014
Reward card used for a sale on the computer

The BC Supreme Court decision in Sobeys West Inc. v. College of Pharmacists of British Columbia has found that the ban on pharmacy inducements and incentives (such as loyalty points) by the BC College of Pharmacists is unreasonable and outside of the scope of authority of the College. The College had enacted bylaws that banned the granting of incentives in conjunction with the provision of prescription sales or other pharmacy services. The ban was absolute, and made only limited exceptions for pharmacies to provide free parking or delivery, or to accept credit cards with attached incentive programs. The judge’s reasons for finding unreasonableness centred primarily on the bylaws being too broad for their proposed purpose.

The court began by recognizing that as a self-regulating body, the College of Pharmacists draws its authority from statute. Any bylaws it puts into effect must be in line with the purposes for which it was established. The court acknowledged that the College had a duty to regulate the activities of pharmacies and pharmacists to protect the public under the Health Professions Act. The court recognized that the bylaws were subject to a test of whether they were reasonable in carrying out the College’s mandate. The court also accepted the 5 potential harms as articulated by the College that the banning of inducements was meant to address.

  1. The use of “bonus days” where on certain days, a multiple of the usual reward would be given for purchases was thought to potentially cause an unmanageable increase in workload for on-duty pharmacists which could increase the likelihood for them to make errors in filling prescriptions;
  2. Bonus days might encourage a customer to defer filling a needed prescription until the next bonus day;
  3. Incentive programs could cause customers to repeatedly transfer their prescriptions from one pharmacy to another, thus undermining their continuity of care;
  4. Incentive programs could encourage customers to procure more drugs than required in order to obtain the incentive reward; and
  5. The need for a pharmacist to explain the incentive program reduces the time available for pharmacists to counsel customers on medication therapy.

Reasonableness of a regulatory body’s bylaws is highly context-specific, and the court stated that it would accept a range of reasonable alternatives from the College to address the above concerns. However, an important consideration in assessing the reasonableness of the bylaws is the level of evidence supporting the bylaws and — where there was little or low quality evidence proffered — whether the bylaws were therefore overbroad and failed to address competing public concerns, such as reducing the burden of prescription drug costs. (Loyalty point programs have the net effect of reducing the overall burden of prescription drug costs, even if they do not lower prices directly.) It was not enough that the College held a bona fide reasonable belief that there is some risk of harm to the public or to the standards of the profession. An outright ban that fails to balance patient health and safety with the need for reducing prescription drug cost burdens, especially in the absence of direct evidence of harm, would fail the reasonableness test.

Since Ontario has had a similar ban in place for 10 years, one might expect the College to be able to produce evidence of patient harms in the province because it lacked such a policy over the same time period. Admittedly, demonstrating actual harm to a patient from an incentive program is difficult, and the court was careful to state that the mere absence of any evidence that such programs were harmful did not mean that they weren’t. Moreover, the College does have the mandate to enact proactive bylaws to limit the risk of harm to the public even in the absence of such evidence. The lack of evidence likely constrains the range of reasonable alternatives available to the College.

The court proceeded to discuss how an outright ban was unreasonable in light of the College’s 5 objectives. First, Sobeys had already agreed to eliminate bonus day offerings, and the court seemed to suggest that a ban on bonus days (similar to the one provided in Manitoba) would not be unreasonable. Second, a ban on incentives for prescription transfers would address the concerns arising from the third objective. And third, the fifth objective regarding the time available for counseling patients on their medications was already addressed by the College’s ethical code and standards of practice. Moreover, the court considered the breadth of the ban in light of other mechanisms in place to prohibit the use of incentives for vulnerable populations, such as those receiving methadone treatment or those covered by the provincial drug plan.

Perhaps the most problematic issue was the court’s addressing of the fourth objective. To begin, the court could find no reason that cash-paying customers would be incentivized to obtain more drugs than necessary simply on the basis of incentives provided by the pharmacy. Then, for prescriptions paid for by third party insurers, the court pointed to other safeguards — namely, the quantity authorized by the prescription and the directions for use — which ought to ensure the proper use of medication. Electronic health records (in BC, PharmaNet) would also help pharmacists to ensure patients were refilling their prescriptions at the appropriate time intervals and to dispense only when appropriate. Beyond the practical challenges, the court ignores the important implication for “PRN” medications — medications prescribed and used by patients on an as needed basis. Such prescriptions may be filled at regular intervals even if the patient is not using them, simply to obtain the incentives of loyalty points that are subsidized by third-party insurers. In such cases, a real and rational connection between patient behaviours and incentive programs is demonstrable, and raises significant public health concerns such as medication hoarding inside the home (which may pose a danger, for example, to children or seniors with visual impairment); medication misuse, abuse and diversion (given that many prn medications can be opioid narcotics); nationwide prescription drug shortages; and the increasing problem of pharmaceutical waste, which patients may or may not dispose of appropriately and end up in landfills.

Even if these concerns are considered, an outright ban may still be considered unreasonable. Instead, limiting loyalty points to be awarded only in proportion to the amounts that patients pay out-of-pocket would bring the incentives in line with cash-paying customers. This would also keep in line with the court’s desire to ensure that patients are able to reduce the prescription drug cost burden in proportion to their out-of-pocket contribution. The court left open to the College the right to amend the bylaws and address the court’s concerns.

There are two additional points of interest to consider in the evolving pharmacy practice environment. First, the College did not propose to ban incentives on the sale of over-the-counter products. That distinction seems arbitrary, but was not raised by either side in reference to the objectives of the bylaws. It would seem that the potential patient harms apply equally for both drug categories. Moreover, if the College chooses to amend the bylaws to limit incentive programs to the portion a patient pays out-of-pocket, it is bolstered by having a consistent approach across all drug sales from the pharmacy.

Second, and more importantly, the initiatives by both the BC and Alberta colleges to ban pharmacy inducements demonstrates a deepening conflict within the Colleges — a conflict between regulating prescription drug sales by pharmacies and the expansion of professional services offered by pharmacists. Unfortunately, numerous times throughout the BC Board members’ affidavits, the award of loyalty points by pharmacies was equated to the award of those points by pharmacists, and therefore contrary to their code of ethics. But it is pharmacists, not pharmacies or pharmacy operators, that are required to uphold a code of professional ethics. Pharmacies are regulated only to the extent that their commercial practices do not risk patient health. The failure of the Colleges to distinguish between the two diverging entities in modern pharmacy practice — an artifact, perhaps, reflecting the environment in which the Colleges were established — does not bode well for those pharmacists who hope to see their practices emerge from behind the dispensary. Pharmacists should be loath to the conflation of their professional services with the sales and value-added services of pharmacy operators. It is a pharmacist’s professional services that ought to conflict with a pharmacist’s professional code of ethics and which threatens the standards, and the Colleges’ confusion of the two — here, and in the context of pharmacy ownership requirements — only serves to emphasize the role of the pharmacist as intimately connected to the sale of drug products in the eyes of the public.

Sunnybrook offers hospital staff a choice: donate blood or designate a stand-in

July 21, 2014
Event to mark World Blood Donor Day 2011 at WHO HQ in Geneva, Switzerland.

Sunnybrook Health Sciences Centre will require doctors, nurses and other hospital staff and volunteers to either donate blood or find a substitute donor during periods of low blood supply, according to a memo to employees obtained by Opined.

Sunnybrook is introducing the new policy this fall in an attempt to improve the levels of dangerously low blood stores that afflicts thousands of Canadians. About 3,500 people die every year from blood loss, according to the Public Health Agency of Canada.

The new policy is an acknowledgement that voluntary blood donation campaigns are not that effective. Only one of every four health-care workers donates blood, even though a blood transfusion is one of the best methods of treating low blood volume. Each pint of blood may save up to 4 lives, including children and adults, according to medical studies.

It just seems to be the responsible thing to do to have our staff who are caring for sick and vulnerable people to donate blood.” Sunnybrook spokesman Craig DuHamel said.

Sunnybrook is introducing a donate-or-designate directive along with other major teaching hospitals in Toronto, says the memo sent to employees on Thursday. The hospitals will not make donations mandatory for health-care workers. Rather, they will offer employees the choice of either donating or finding a willing substitute during periods of low blood supply. Such policies result in substantial increases in blood donation rates among health-care workers, according to a recent Canadian Medical Association Journal article.

Sunnybrook is far from the first hospital to put in place a donate-or-designate policy. Hospitals and long-term care homes in British Columbia, as well as 13 hospitals in Ontario, have adopted such measures. Still, the decision is expected to provoke a backlash from the Ontario Nurses’ Association, the union that represents 60,000 nurses and other health-care workers in the province. The ONA has threatened to file grievances against other hospitals that have forced would-be donor nurses to find substitutes.

Donating blood needs to be a choice and should be part of a more comprehensive, evidence-based infection control plan,” Linda Haslam-Stroud, president of the ONA, said in a statement. “Outing nurses that do not choose to donate blood with mandatory designating a substitute does nothing but provide our patients with a false sense of security.”

The Registered Nurses’ Association of Ontario, which spearheads professional development and political lobbying on behalf of nurses, disagrees with the ONA’s stance, saying hospitals have a responsibility to do everything possible to protect patients, including forcing non-donating staff and visitors to find designated donors. “We are in support of it. Simple as that,” said Doris Grinspun, the chief executive officer of RNAO. “The only thing we would say is that it has to apply to everybody, not only the nurses, of course, [but to] all the health professionals and to visitors.”

Ms. Grinspun said that even among nurses, unfounded concerns about the safety of blood donation persist. “I think that there are still a lot of myths of, ‘Oh, I donated blood today and now I feel weak.’ I think that’s [true] for the public and also for health professionals,” she said. “To me that’s an issue of education.”

This has been a re-write of an article in the Globe and Mail. I only changed terms and phrases relating to mandatory vaccination, masking, and influenza outbreaks to ones about blood donation, finding a substitute donor, and low blood supplies. Many will point to the differences between mandating an influenza vaccine and mandating a blood donation, and they’d be right, but in terms of the encroachment of a person’s bodily autonomy I believe the analogy is strong. All arguments in favour of mandatory vaccination of healthcare workers can be equally applied to mandatory blood donation. In fact, the evidence that blood transfusions saves lives may even be stronger than that for the influenza vaccine. The question to ask is whether the balancing of a patient’s rights with a healthcare worker’s rights pushes us to favour the patient in all analogous circumstances. Hopefully this example using blood donation sheds a different light on that debate.

Is it time to recognize a right to the birth control pill?

July 8, 2014

Recently, there was a report in Calgary of a doctor posting a notice to patients coming into the clinic that she was unwilling to prescribe the birth control pill (BCP) to patients. This follows on a similar incident in Ottawa earlier this year, and Kelly Grant has reported that the CPSO is looking to update its policy on conscience clauses. The policy was last updated in 2006 when the issue of conscience-conflicting activities arose in the context of pharmacists dispensing emergency contraception pill (ECP), sometimes called the morning-after pill. The hope was to make ECP more accessible by having pharmacists dispense the medication from behind the counter. It has since gone over-the-counter in all provinces.

The debate then, as now, has focused on balancing the rights of healthcare practitioners (HCP) to practice their beliefs with the rights of the patient to have timely access to care. The main mechanism of the ECP is to block a newly fertilized egg from implantation. The BCP works primarily to prevent ovulation. In either case, the moral objection stems from the HCP not wanting to be: 1) an abetter to terminating a life (as defined at the moment of conception); or, 2) to enabling a person to make immoral choices, either intrinsically or by allowing them to avoid consequences that would have otherwise motivated them to choose a moral path. In both cases, by prescribing or dispensing the pill, the HCP feels he is drawn into immoral activity of the other person’s choices.[1] There may even be a small hope that the objection will give the patient pause to reconsider their position — a sort-of micro-awareness campaign.[2] Moreover, the “patient” seeking a BCP or ECP prescription is not even viewed as a patient because they are not suffering any symptoms or seeking treatment for a medical condition. In that sense, a HCP may feel that turning people away is not the same as denying access to medical care. Ovulating, after all, is not a disease.

The patient, unsurprisingly, takes a very different view. Physicians and pharmacists are trained to provide health services to those in need. It seems unconscionable to turn away any patient on the basis of moral or ethical beliefs. Especially when access is a concern, there is potential harm to the patient. It may be more pronounced in rural areas, but even in urban settings where patients may have to take time off work or take public transit to visit a physician or pharmacist, being turned away on arrival can be a source of undue pressure. Also, whatever the HCP’s moral objections, imposing those values on the patient or attempting to influence their personal behaviour is beyond their duties as caregivers. So yes, the patient claims, HCP must not practice their religion in a manner that hampers their professional relationship.

Is this actually an issue of competing rights, or is it instead a part of a broader problem of our healthcare system? The ECP has gone OTC in Canada (not in the US) and many have called for the same for regular BCP. But oral contraceptives are not without their risks. It remains reasonable to ensure that patients (especially young teenagers) access these drugs through a healthcare practitioner. However, physicians are seen as the gatekeepers to these medications, which skews their role in this context and the broader healthcare delivery model.

So is refusing to prescribe oral contraceptives the same as refusing medical services? I would argue that the patient seeking a medical consultation is asking her physician to assess whether an oral contraceptive is medically appropriate. Once that medical assessment is completed, prescribing is as-of-right. In other words, the patient wants the physician to answer the questions: Are there medical reasons why I should not use OC? And if not, can you recommend a specific one? In the case of a reassessment, the question is whether continued use is appropriate, or whether further investigation is merited.

I’m not suggesting that all drugs should be prescribed as-of-right. But viewing the role of the physician this way would seem to remove any moral objection in the physician-patient relationship. It defines the physician-patient relationship in terms of an expert in medical care providing a patient with the information she needs to make safe and healthy choices. Perhaps instead of a “prescription”, the physician could provide the patient with a medical note stating that there are no medical contraindications to taking oral contraceptives. The patient could hand that into her pharmacy who could then provide her with the appropriate product.

If we need to create a special regulatory framework to make this clear, then so be it. It’s better than shoehorning an especially sensitive area of healthcare into a paradigm meant for something totally different. And perhaps some physicians will still feel their freedoms are being compromised. But as far as the current arguments go, conversations about competing rights of a physician’s freedom of religion and a woman’s bodily autonomy seem like a distraction. By properly understanding the roles of healthcare practitioners, as facilitators and advocates to better health rather than gatekeepers, we may be able to avoid such conflicts and maybe even transform other areas of healthcare.

  1. Unfortunately, the argument is muddied with the bad analogy of handing a psychopath a gun. Let’s just all agree that whatever the stance of the moral objecter, this is not the same thing, and only distracts from the legitimate arguments on both sides.  ↩

  2. Or micro-evangelism, in some cases.  ↩