2017 November 7 Michelle Boudreau Director General Legislative and Regulatory Affairs Controlled Substances Directorate Healthy Environments and Consumer Safety Branch Health Canada Address Locator: 0302A 150 Tunney s Pasture Driveway Ottawa, Ontario K1A 0K9 Email: ocs_regulatorypolicy-bsc_politiquereglementaire@hc-sc.gc.ca. Re: Non-prescription availability of low-dose codeine products Dear Ms. Boudreau, Thank you for the opportunity to provide feedback regarding the proposed changes to the regulations to the Controlled Drugs and Substances Act requiring all products containing codeine to be sold by prescription only. Members of the Canadian Society of Hospital Pharmacists (CSHP) were invited to provide comments on the proposal. I am pleased to share the comments received, in summary and detailed form. (The details are provided as an attachment.) Patient safety is paramount. Non-prescription access to low-dose codeine products can increase the risk exposure to patients. The opportunity to selfmedicate (regardless of whether the product contains codeine) without routine follow-up places patients at a higher risk of preventable adverse drug reactions. The risks associated with low-dose codeine products could be better managed if they are available only by prescription. And so, there is agreement among members who responded that additional restrictions on the sale of codeine products are needed. Some members want codeine products to be available only by prescription, while others want a further step to be taken: remove codeine products from the market. It was suggested that information be obtained from the provincial poison centres to help evaluate the risk-versus-benefit profile of codeine-containing preparations. The opioid crisis is a system-wide problem. A move to prescription-only status for codeine products will not fix the current situation, but it stands to
help. The following anticipated unintended, undesirable consequences were mentioned: o A shift to other (potentially more potent, expensive, or illicit) opioids o A shift to non-prescription analgesics that could be harmful to the patient (and are available without the intervention of a pharmacist) o Increased burden in the healthcare system (arising from an increase in appointments with practitioners authorized to prescribe a codeinecontaining product), possibly causing delays in accessing required medication Changes made to the Act regarding the sale of codeine products should reflect what has been learned about the effectiveness of efforts to curb the sale of codeine preparations in other countries and Canadian provinces. Continued dialogue with healthcare professionals was requested. If you have any questions about the information provided herein, please do not hesitate to contact me at 613.736.9733, or via email at clyder@cshp.ca. Sincerely, Cathy Lyder Director, Members and Programs Cc Patrick Fitch, CSHP President Douglas Doucette, CSHP President Elect and External Liaison Myrella Roy, CSHP Executive Director
Consultation on non-prescription availability of lowdose codeine products I think all codeine products and doses should require a physician s prescription. I agree that we need to address the opioid (fentanyl) crisis. But removing an abused substance from the market place will not stop the problem. It just redirects it to another area. We have created the current fentanyl crisis by removing oxycodone from the provincial formularies. We didn t offer all the people using oxycodone rehab therapy and as a result they filled the void we created. Switching codeine products to prescription status will not fix the opioid crisis and may possibly have an unintended consequence. Please urge government and Health Canada to sit down with front line health care practitioners before making any decisions. I am fully supportive of Health Canada changing the regulatory status of codeine to only be available via prescription. This proposed change is in the best interest of patient safety. As a practising pharmacist, I am aptly positioned to comment on this important regulatory change. I have practiced both in community and hospital settings. As a community pharmacist, it can be difficult to identify individuals who may potentially abuse codeine products. From my experience, many patients know how to work the system by accurately answering the questions regarding appropriate use. As well, as a healthcare professional you do not want to deny any patient access to a therapy that they may require for a legitimate reason (e.g., pain control for an acute injury), and many patients that abuse codeine can be very convincing. In my province, we do not have a mechanism to track the sale of codeine products. Thus, it is impossible to know if a patient is buying multiple codeine products by going from pharmacy-to-pharmacy. Another scenario I have encountered was a patient with complex chronic pain who was self-prescribing over-the-counter combination codeine-acetaminophen products. Every time she made a purchase, we discussed at length the appropriate use of codeine-acetaminophen, and availability of more effective/less toxic alternatives via prescription. However, she did not have a regular primary care provider, and it was much easier for her to purchase codeine over-the-counter. We
tracked her usage and tried to limit her use, but she still ended up with an acute liver injury from acetaminophen because she escalated her dose on her own. I still remember this patient vividly I tried to do everything in my power to prevent her from harming herself, but was ultimately unsuccessful. I acknowledge this incident may not have been prevented if codeine was only available via prescription, but it would at least have forced her to access a primary care provider (even at a walk-in clinic), and she may have been stabilized on a safer chronic therapy. Finally, in my pharmacy practice I have a great deal of experience providing consultative pharmacy services for patients with chronic pain on opioid therapy including the provision of take home naloxone kits. There are numerous patients with opioid misuse disorder at the clinic, and the number of opioid-related overdose deaths in this province continues to rise at an alarming rate. Therefore, if we can prevent even a small number of patients from developing opioid misuse disorder by limiting access to codeine, this regulatory change will be worthwhile. First of all, I applaud Health Canada for proposing restrictions of sales to these products. I would suggest going one step further, and eliminating them all together. I am very proud to say we have successfully removed all codeine-containing products from our hospital formularies at our adult and pediatric hospitals. Codeine as an analgesic: Codeine is a weak opioid with 200-fold less affinity for the mu-opioid receptor compared with morphine. Codeine is considered to be a prodrug and the analgesic properties of codeine are attributed to its conversion to morphine and morphine-6-glucuronide via a minor metabolic pathway. The transformation to morphine occurs via CYP2D6, a genetically highly polymorphic drug metabolizing enzyme that is subject to marked inter-individual variability in the amount of morphine produced. The administration of codeine is essentially equivalent to the administration of and UNKNOWN dose of morphine. My comments: codeine should NOT be licensed for sale in Canada as an analgesic. Codeine for suppressing cough: Codeine is widely regarded as the gold standard cough suppressant drug however, very few studies have investigated the antitussive efficacy of codeine. My comments: codeine as a cough suppressant lacks good data to support this claim. Codeine and patient harm: Patient harm from codeine can occur via its lack of metabolism to morphine (i.e., lack of efficacy) or via its metabolism to morphine (as
an opioid agonist). In addition many of the products were also combined with a fixed dose of acetaminophen (liver toxicity). I would encourage Health Canada to obtain some statistics on exposures to these products from the 5 provincial Poison Centres (if they have not already done this). In my opinion this type of data is essential in order to evaluate the risk vs benefit of these formulation to the Canadian population. My comments: low-dose codeine products are more likely to cause patient harm than patient benefit. They should NOT be licensed for sale in Canada. Concerns regarding patient accessing health care systems for products they would otherwise have accessed without the intervention of a prescriber: Healthcare providers should welcome this potential intervention. The move to prescription-only access for low-dose codeine products is welcome as a first step. However, I would prefer the complete removal of codeine from the market. Given the availability and greater pharmacological predictability of morphine over codeine, codeine is not needed. Such changes would come with unintended, undesirable consequences which would need to be managed. There would likely be an increase in the number of visits to obtain a prescription from a practitioner who is authorized to prescribe those products. While that is not necessarily undesirable, the system is not sufficiently resourced to handle the increased demand in a timely manner. Pharmacists currently have a role in the sale of low-dose codeine products and an expansion of their role to include prescribing of controlled substances should not be overlooked. There could be higher migration from low-dose codeine products to illicit drugs or to higher doses of codeine-containing products that are currently available only with a prescription. (Overtime the usage of low-dose codeine will likely decline significantly.) For many reasons (e.g., avoiding the time for a medical appointment), patients may choose to self-medicate with either an illicit drug, someone else s analgesic, or with a non-prescription drug whose use is approved in Canada but contraindicated for the patient s condition. The incidence of doctor-shopping or double-doctoring will likely not decline, and stands to increase.
The information in the Gazette refers to countries and Canadian provinces that have restricted access to low-dose codeine products, but does not describe the outcome of such changes. It would be helpful to healthcare professionals to know the experiences and outcome the changes in those areas.