Re: Bill 33, Safeguarding our Communities Act (Fentanyl Patch for Patch Return Policy), 2015

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1 November 30, 2015 Mr. Peter Tabuns Chair, Standing Committee on Social Policy 99 Wellesley Street West, Room 1405 Whitney Block Queen's Park Toronto, ON M7A 1A2 Dear Mr. Tabuns: Re: Bill 33, Safeguarding our Communities Act (Fentanyl Patch for Patch Return Policy), 2015 The Ontario Pharmacists Association (the Association, OPA ) appreciates the opportunity to present commentary on behalf of the profession of pharmacy to the Standing Committee on Social Policy on Bill 33, Safeguarding our Communities Act (Fentanyl Patch for Patch Return Policy), OPA advocates for the profession of pharmacy in Ontario, where more than 20,000 pharmacists, pharmacists-in-training and pharmacy technicians who actively practice in community pharmacies, family health teams, long term care facilities, and hospital clinical settings, as well as for those in industry, private businesses, insurance, and government. Consistent with the core objectives of inspiring excellence in the profession and its practices, advocating for the wellness of the patients we serve, and the daily experiences of more than 9,500 members practicing in close to 4,000 clinical settings, we are pleased to provide the following comments for your consideration of the proposed bill. The scourge of drug abuse, including drug diversion, continues to threaten safety and security in every Ontario community, and indeed the country, and the Ontario Pharmacists Association acknowledges the many efforts made at the local, municipal, provincial and federal levels to curb such activities for the protection of Ontarians and indeed all Canadians. Most notable at the front lines in this war on drug abuse, misuse and diversion are Ontario s community pharmacists and pharmacy technicians who, as vigilant gatekeepers of our drug supply, protect our communities as they ensure that narcotic, controlled and targeted substances are provided to the right patient, at the right dose, at the right time and for the right purpose and in accordance with rigid protocols and standards of practice. They are perhaps the most at risk of all healthcare providers in this war as they alone physically stand between the substances of choice and the users, many of whom have and will continue to resort to threats and violence when their drugseeking strategies are thwarted. On November 1, 2011, the Narcotics Safety and Awareness Act, 2010 ( NSAA ) came into effect with the aim to improve the health and safety of Ontarians by promoting appropriate prescribing 1

2 and dispensing practices for narcotics and other controlled substances, identifying and reducing the abuse, misuse and diversion of these drugs and reducing the risk of addiction and death from the abuse or misuse of these drugs. Among the first strategies to be put in place with the Act was the implementation of a narcotic monitoring system ( NMS ) that was intended to track the dispensing of prescription narcotic, controlled and targeted substances while collecting information to better support appropriate prescribing and dispensing behaviours. OPA is on record with its support of the NSAA, but recognized that the NMS while being a good first step in the fight against abuse, misuse and diversion was an information tracking system at best. To be truly effective, OPA s position was that information needs to be evaluated, shared and corresponding best practices developed in order to drive appropriate prescribing and dispensing. Such information sharing with pharmacy and medical practitioners has yet to occur since the electronic NMS became fully functional in April Nonetheless, with the NMS tracking in place, a strong message was sent to drug users and diverters that they were under scrutiny and it would become more and more difficult to obtain prescriptions for narcotic, controlled or targeted substances. With the discontinuation of OxyContin (oxycodone) in early 2012 and its replacement with tamper-resistant OxyNEO, an even stronger message was sent, and while tamper-resistance did not imply tamper-proof, the switch in formulation triggered a shift to an alternative substance of choice of users; aside from the escalation in heroin use, fentanyl patches became the new OxyContin. For an overview of fentanyl and its formulation, please refer to Appendix A. The Association commends the Member from Nipissing, Mr. Victor Fedeli, for acknowledging through Bill 33 the severity of fentanyl abuse and its devastating impact on Ontario communities and taking a step to mitigate diversion of new and used patches. As with all government or regulatory initiatives that potentially impact the profession of pharmacy, OPA carefully examined Bill 33 for both its intended and potential unintended consequences. On first glance, the concept of introducing greater controls on the dispensing through a mandated patch-for-patch ( P4P ) program seemed plausible, but on further analysis, the Association identified some challenges and concerns that need to be raised with both the Standing Committee on Social Policy and the Ministry of Health and Long-Term Care. The challenges and concerns with a mandated P4P program as expressed in Bill 33 touch on matters related to provider health and safety, societal influences, legislative process, professional judgment and professional misconduct, and operational impact. Health and Safety Concerns: In the matter of dispensing narcotic, controlled and targeted substances, OPA is particularly concerned with the inherent risks for pharmacists and pharmacy technicians. Integral to the P4P programs in place voluntarily across the province comes the risk of fentanyl toxicity and potential contamination associated with the physical inspection of returned used patches. In many cases, patches are returned in ways that do not permit close or even accurate visual inspection. They may be placed back loosely within the pouch from the manufacturer, stuck or stapled to a piece 2

3 of paper, wrapped in plastic wrap, or encased in clear tape or foil. Through Bill 33, clause 3(1)(4) requires the dispenser to inspect every used fentanyl patch collected from the patient or his or her authorized representative. Users and diverters have become quite adept at rendering the used patches more difficult to scrutinize, thereby leaving the pharmacist to question the authenticity of the returned product. In addition to the serious health and safety risks of toxicity and contamination comes the risks associated with finding a counterfeit product within the return or where a patch has been lost, tampered with or destroyed beyond recognition and is incapable of being authenticated. Clause 3(1)(5) indicates that the dispenser is only permitted to dispense patches in accordance with the contingency plan established under the regulations. Irrespective of any regulatory contingency plan that results in the dispensing of fewer patches than the patient/agent anticipates, it is not unreasonable for said patient/agent to become hostile and possibly violent. Personal safety and security for pharmacists and technicians is of paramount importance to OPA, and mandating pharmacy team members to act as police, judge and jury with respect to patch validation will undoubtedly place them at increased risk of harm, and is not consistent with their training as health care providers. Linked to risks associated with challenging a patient or agent on patch authenticity is the very real potential for P4P programs to shift users/diverters to more crude and extreme behaviours of pharmacy break-ins and armed robberies. Both are happening with increased frequency, and it is speculated that this may be due in part to the introduction of barriers such as narcotic monitoring systems and P4P programs, which make access to and diversion of targeted substances through the traditional prescription pathway more difficult. Societal Influence: The Association is very concerned with the unintended consequence of a mandated P4P program that is very product specific. As explained earlier in the document, this serious fentanyl problem was largely influenced by strong scrutiny on oxycodone prescribing and dispensing and the shift toward tamper-resistant formulations. It is therefore very reasonable to assume that stringent oversights on the prescribing and dispensing of fentanyl will surely shift behaviours toward yet another targeted substance without the same levels of scrutiny. This is not to suggest that nothing be done. Rather, it is the Association s recommendation that each initiative under consideration should be extremely well thought-out with input from all stakeholders and significant efforts undertaken to predict what the next new substance of choice will be. From the patient perspective, OPA has heard from our members that some patients are refusing to participate in regional P4P programs due to the social stigma associated with them. Should this program be mandated, many of those patients who truly need to be using fentanyl, will certainly be asking their prescriber to switch them to another medication so that they would not feel stigmatized by that process, which is concerning to OPA as this would prevent those legitimate patients from achieving their desired health outcomes. 3

4 Legislative Process: While the Association acknowledges the need for legislative intervention to address the serious concern of drug diversion and abuse, we are concerned that Bill 33 would be setting a precedent for drug-specific legislations, which will only have a short-term effect simply lasting until another drug becomes the new abused drug of choice. We suggest that a more effective approach would be to focus on tackling the issue of drug abuse and diversion in general, rather than focusing on one drug/medication at a time. This proposed approach would require ongoing, transparent and structured collaboration between prescribers, dispensers and law enforcement. OPA therefore suggests forming a task force which involves representatives from each of those sectors with the goal to explore and implement long-term sustainable solutions. Professional Judgment and Professional Misconduct: With the evolving needs of our patients, along with the expanding scope of practice, as pharmacy professionals, we continuously exercise professional judgment based on assessing each patient s unique needs and each situation s own facts and circumstances. Exercising professional judgment means that one pharmacist s assessment and decision may differ, not only from another colleague s, but also from one patient to another. In doing so, pharmacists ensure that their actions and decisions are always in the patient s best interest. This is an integral element of our everyday practice. OPA is therefore concerned that the proposed Bill could hinder a pharmacist s ability to exercise their professional judgment. Since neither legislations nor regulations could ever cover each possible exception that a pharmacist may encounter, OPA therefore questions how the regulatory College would view cases where pharmacy professionals might decide to exercise their judgement to contravene some aspects of the Patch for Patch program, when that decision is made solely in the best interest of the patient. Operational Impact: Pharmacy professionals strive to provide excellence in practice and care to their patients on a daily basis. While doing so, they constantly exercise zero tolerance for drug diversion and abuse. OPA supports community pharmacies that voluntarily choose to participate in the P4P program in their municipality. However, OPA is concerned that mandating such a program would put added strains on those pharmacies that do not have the capacity and/or resources to manage the additional administrative workload and logistics necessary to comply with the program s policies, such as drafting and maintaining individual patients contracts, inspecting used patches, ensuring required documentation is completed, denaturing and discarding of returned patches, etc. The Association therefore suggests that should a Bill like this one be enacted, adequate remuneration should be in place to support pharmacies in delivering on those administrative 4

5 requirements. OPA would welcome the opportunity to provide further breakdown of the anticipated costs and the suggested corresponding remuneration value. The Ontario Pharmacists Association appreciates the opportunity to present commentary on Bill 33, Safeguarding our Communities Act (Fentanyl Patch for Patch Return Policy), While we do applaud the initiative, we question whether there is any data collated or studies conducted that prove the efficacy of diversion programs. OPA believes that a broader strategy for tackling drug abuse, overdose and diversion is more warranted than the narrow-focused approach in the proposed Bill, and we therefore welcome the opportunity to be involved, and spearhead, such initiatives with the Ministry of Health and Long-Term Care, other health care providers, and law enforcement. The Association also strongly recommends that the Ontario government invests in technology, including the implementation of a comprehensive electronic prescribing system and a more robust and functional narcotic monitoring system. Yours truly, Dennis A. Darby, P.Eng., ICD.D Chief Executive Officer 5

6 Appendix A FENTANYL Overview Fentanyl is a powerful synthetic opiate analgesic similar to but more potent than morphine. It has typically been used to treat patients with severe pain, or to manage pain after surgery. It is also sometimes used to treat people with chronic pain who are physically tolerant to opiates. In its most commonly available format, fentanyl is delivered through a transdermal patch system and is intended to be used only on skin that is not irritated or injured. Each patch comes in an individually sealed pouch; once opened, care must be exercised so as not to touch the adhesive surface since it contains some of the active ingredient. Fentanyl is rapidly absorbed into the body via the skin of the hand. If accidental contact requires immediate rinsing of the area with plenty of clear water. Patches are never intended to be placed in the mouth, chewed, or swallowed. Each patch is a controlled delivery system designed to release a steady amount of medication over a 72-hour time period; damage to a patch may cause fentanyl to pass into the skin too quickly, leading to overdose. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, fentanyl patches should only be used in patients for whom alternative treatment options are ineffective or not tolerated (e.g., non-opioid analgesics), or would be otherwise inadequate to provide sufficient management of pain (e.g., immediaterelease opioids). Fentanyl patches pose risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Each patient s risk should be assessed prior to prescribing, and all patients should be monitored regularly for the development of these behaviours or conditions. All patients should be instructed to store their patches securely to avoid theft or misuse. 6