Prescribing Drugs

Approved by Council: December 2012
Reviewed and Updated: February 2016; September 2016; September 2017, December 2019

Companion Resource:

• Advice to the Profession
• Patch-for-Patch Fentanyl Return Program: Fact Sheet

Other References: "New legislation aims to curb abuse of fentanyl patches," Dialogue, Issue 3, 2016

Policy

1. Physicians must comply with the requirements for prescribing that are set out in this policy, as well those contained in any other relevant CPSO policies¹ and legislation².

Before Prescribing

2. Physicians must only prescribe a drug if they have the knowledge, skill, and judgment to do so safely and effectively.³
3. Before prescribing a drug, physicians must:
   1. undertake an appropriate clinical assessment of the patient (limited exceptions are set out in provisions 4 and 5 of this policy);⁴
   2. make a diagnosis or differential diagnosis and/or have a clinical indication based on the clinical assessment and any other relevant information;
   3. consider the risks and benefits of prescribing the chosen drug, including the combined risks and benefits when prescribing multiple drugs and the risks and benefits when providing long-term prescriptions; and
   4. obtain valid consent.⁵

CPSO is aware that some patients face financial difficulties that limit their ability to afford the drugs prescribed to them. For more information about prescribing drugs in a way that reflects the patient’s ability to pay, please see the CPSO’s Advice to the Profession: Prescribing Drugs document.

Relying on an Assessment Undertaken by Someone Else / Prescribing with no Prior Assessment

4. Physicians are permitted to prescribe on the basis of an assessment conducted by someone else.⁶ When doing so, physicians must:
   1. have reasonable grounds to believe that the person who conducted the assessment had the appropriate knowledge, skill, and judgment to do so;⁷ and
   2. evaluate the assessment and judge it to be appropriate.
5. If no prior assessment of the patient has been undertaken, physicians must only prescribe:
   1. for the sexual partner of a patient with a sexually transmitted infection who would not otherwise receive treatment and where there is a risk of further transmission;
   2. prophylaxis as part of a public health program operated under the authority of a Medical Officer of Health; and/or
   3. post-exposure prophylaxis for a health-care professional following potential exposure to a blood borne virus.

Content of Prescriptions

6. Physicians must ensure that written prescriptions are legible.
7. Physicians must ensure that the following information is included on every written or electronic prescription:
   1. the prescribing physician’s printed name, signature⁸ (or electronic signature), and CPSO registration number;
   2. the prescribing physician’s practice address;
   3. the patient’s name;
   4. the name of the drug;
   5. the drug strength and quantity;
   6. the directions for use;
   7. the full date the prescription was issued (day, month, and year);
   8. refill instructions, if any;
   9. if the prescription is for a monitored drug⁹, an identifying number for the patient¹⁰ (unless certain conditions set out in regulation are met)¹¹;
   10. if the prescription is for a fentanyl patch, additional requirements apply (these are set out in provision 36 and 37 of this policy); and
   11. any additional information required by law.
8. Physicians must use their professional judgment to determine whether it is necessary to include any additional information on the prescription (g., the patient’s weight where this information would affect dosage or the patient’s date of birth where this information would assist in confirming the patient’s identity).

Authorizing and Transmitting Prescriptions

9. When providing prescriptions, physicians must authorize each prescription in one of three ways: with a written signature, electronically, or verbally¹².
   1. When authorizing prescriptions electronically, physicians must authorize the prescription themselves. Physicians must not permit other members of staff to authorize a prescription unless there is a direct order or medical directive in place, and if so, there must be a mechanism within the system to identify who authorized the prescription and under what authority. 
10. Regardless of the method of transmission, physicians must ensure that patient privacy and confidentiality are protected.¹³

Duplicate Prescriptions

11. Physicians must not create duplicate copies of a prescription except for the purposes of retaining a copy in the patient’s medical record or to replace a lost or damaged prescription.
12. If physicians wish to provide a copy of the prescription to their patients for information purposes, physicians must provide this information in a format that does not resemble a prescription (e.g. a written summary).

Respecting Patient Choice When Choosing a Pharmacy

13. Physicians must respect the patient’s choice of pharmacy.
14. Physicians must not attempt to influence the patient’s choice of pharmacy unless doing so is in the patient’s best interest and does not create a conflict of interest for the physician.

Communicating with Pharmacists

15. Physicians must respond in a timely manner when contacted by a pharmacist or other health-care provider involved in the care of a patient. The timeliness of the communication will depend on a variety of factors, including the degree to which a delay may impact patient safety.

Documentation

16. In addition to complying with the general requirements for medical records¹⁴, physicians must specifically document all relevant information regarding the drugs they prescribe. Physicians must do this by either retaining a copy of the prescription in the patient’s medical record or by specifically documenting the information contained in the prescription (as set out in provision 7, a-k of this policy).
17. Physicians must also document the type of prescription it is (e.g. verbal, handwritten, or electronic) and comply with any applicable requirements for the documentation of patient consent, as set out in CPSO’s Consent to Treatment policy.

Monitoring Drug Therapy

18. Physicians must ensure that appropriate monitoring protocols are in place as-needed to identify emerging risks or complications arising from the drugs they prescribe.
19. Physicians must inform patients of:
    1. the follow-up care required to monitor whether changes to the prescription are necessary; and
    2. the patient’s role in safe medication use and monitoring effectiveness.
20. If patients do not comply with an agreed-upon plan for prescription monitoring, physicians must consider whether continued prescribing is safe and appropriate by weighing the risks of continuing prescribing against the risks of discontinuing prescribing.
21. If, in the physician’s judgment, drug therapy is not effective or the risks outweigh the benefits, physicians must consider discontinuing the prescription.¹⁵
22. Whenever possible, physicians must only discontinue prescribing following discussion with the patient.

Prescription Refills (also known as Repeats or Renewals)

23. Physicians must review all requests to refill a prescription and authorize any refills provided unless these tasks are delegated to staff¹⁶ or the person authorizing the refill is a regulated health professional with the authority to prescribe.
24. Physicians must ensure that all requests for refills and all authorized refills are documented in the patient’s medical record.
25. Physicians must ensure that procedures are in place to monitor the ongoing appropriateness of the drug when prescribing refills (e.g., by conducting periodic re-assessments).
26. Physicians must not adopt blanket “no refill” policies.¹⁷ While some physicians may rarely, if ever, write prescriptions with refills, physicians must decide whether or not to prescribe refills on a case-by-case basis, with consideration for the circumstances of each patient.

Redistributing Returned Drugs

27. Because the integrity of the drugs cannot be ensured, physicians must not redistribute drugs that have been returned by a patient.
28. Physicians must dispose of returned drugs in a safe and secure manner.¹⁸

Drugs That Have Not Been Approved for Use in Canada (‘Unapproved Drugs’)

29. Physicians must not prescribe drugs that have not been approved for use in Canada (i.e., drugs for which Health Canada has not issued a Notice of Compliance) except in the limited circumstances permitted by Health Canada.¹⁹

Distributing Drugs without a Prescription (e.g. Drug Samples)

30. When providing drugs to patients without a formal prescription²⁰ (e.g. drug samples), physicians must continue to meet all of the relevant requirements that apply to prescribing and dispensing drugs generally²¹, including those related to patient assessment, documentation, and prescription monitoring.
31. When providing drugs to patients without a prescription, physicians must ensure that no form of material gain is obtained for the physician or for the practice with which they are associated (this includes selling or trading).

Narcotics and Controlled Substances

Narcotics and controlled substances²² can help support the safe, effective, and compassionate treatment of many conditions, including acute or chronic pain and addiction. When prescribing these drugs; however, special consideration is necessary given that they are susceptible to diversion, misuse, and/or abuse, and many carry a risk of dependence and overdose.

Before Prescribing Narcotics and Controlled Substances

32. Before initiating a prescription for a narcotic or controlled substance (or continuing a prescription initiated by another prescriber), physicians must:
    1. consider whether the narcotic or controlled substance is the most appropriate choice for the patient;
    2. if prescribing opioids for chronic pain, physicians must document in the patient’s medical record that there are no appropriate or reasonably available alternatives;
    3. consider the potential risks associated with prescribing, and take reasonable steps to mitigate those risks, consistent with any relevant practice standards, quality standards, and clinical practice guidelines;²³
       1. Where these do not exist (e.g., in areas of medicine that are less developed), physicians must consider any available indirect evidence, clinical trials, evidence-based research or consensus recommendations, and general best practices;
    4. review any previous interventions the patient has undergone and develop a comprehensive treatment plan that includes:
       1. realistic treatment goals;
       2. a plan for discontinuing prescribing should the risks outweigh the benefits;
       3. a plan for minimizing risks and unintended consequences (e.g. diversion); and
       4. a plan for managing withdrawal, where applicable;
    5. take reasonable steps to review the patient’s prescription history as it relates to narcotics and controlled substances (e.g., by contacting the patient’s other treating physicians or by reviewing electronic sources of information regarding the patient’s prescription history, where available²⁴); and
    6. obtain valid consent as required by applicable legislation²⁵and the CPSO's Consent to Treatment policy;
       1. when prescribing narcotics and controlled substances, physicians must inform patients of the risks and harms associated with the drug being prescribed, including any risk of dependence, addiction, withdrawal, diversion, and overdose.

When Prescribing Narcotics and Controlled Substances

33. When prescribing narcotics or controlled substances (or continuing a prescription initiated by another prescriber) physicians must:
    1. meet the general requirements for prescribing that are set out in this policy, as well as any other relevant policies and/or legislation;
    2. consider any relevant practice standards, quality standards, and clinical practice guidelines, and apply them as appropriate;
       1. where these resources do not exist (e.g., in areas of medicine that are less developed), physicians must consider any available indirect evidence, clinical trials, evidence-based research or consensus recommendations, and general best practices;²⁶ and
    3. inform patients of how to safely secure, store, and dispose of any unused medication (especially in circumstances where locked storage is considered critical, such as prescription opioids and methadone).

Tapering and Discontinuing Narcotics and Controlled Substances

34. Physicians must not taper patients inappropriately or arbitrarily. Physicians are reminded that it is not always possible or appropriate to taper below a specific dose, nor is it usually appropriate to suddenly or rapidly taper prescriptions.
35. When tapering or discontinuing narcotics and controlled substances, physicians must:
    1. proceed with consideration for the safety and well-being of the patient;
    2. consider and apply, as appropriate, relevant practice standards, quality standards, and clinical practice guidelines;²⁷
    3. explain to the patient the rationale for tapering or discontinuation, and provide an opportunity for discussion;
    4. discuss a strategy to treat withdrawal symptoms, where applicable;
    5. whenever possible, make decisions with respect to tapering or discontinuation in collaboration with the patient; and
    6. carefully document decision-making and any discussions with the patient.

Prescribing Fentanyl Patches

36. When prescribing fentanyl patches, physicians must include the following additional information on every prescription:²⁸
    1. the name and address of the pharmacy where the patient has chosen to fill the prescription; and
    2. a notation that it is the patient’s first prescription for fentanyl patches when the following conditions are met: 1) the physician has not previously prescribed fentanyl patches to that patient, and 2) the physician is reasonably satisfied²⁹ that the patient has not previously obtained a prescription for fentanyl from another prescriber.
37. Physicians must also notify the pharmacy directly. Notification is automatically achieved if the prescription is faxed directly to the pharmacy; however, if the prescription is provided to the patient directly then physicians must notify the pharmacy separately (e.g. via telephone).

“No Narcotics” Prescribing Policies

While some physicians may rarely, if ever, prescribe narcotics or controlled substances in practice³⁰, arbitrarily refusing to prescribe these drugs without consideration for the circumstances of each patient may lead to inadequate patient care.

38. Unless the prescribing of narcotics and controlled substances falls outside of the physician’s scope of practice or clinical competence³¹, or the physician has a restriction imposed by CPSO prohibiting prescribing, physicians:
    1. must not adopt a blanket policy³² refusing to prescribe narcotics and controlled substances, and
    2. must make prescribing decisions on a case-by-case basis with consideration for each patient.

Reporting the Loss or Theft of Narcotics or Controlled Substances

39. Physicians must report the loss or theft of narcotics and/or controlled substances from their possession to the Office of Controlled Substances, Federal Minister of Health³³, within 10 days.³⁴

Drug Storage

40. Where physicians stock narcotics and controlled substances, they must be securely and appropriately stored in the office to prevent theft/loss.

Endnotes

^1. Other relevant policies include (among others): Protecting Personal Health Information, Consent to Treatment, Medical Records Management, and Virtual Care.

^2. Relevant legislation includes, but may not be limited to: the Food and Drugs Act, R.S.C, 1985, c. F-27 (hereinafter FDA); the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (hereinafter CDSA); the Narcotics Safety and Awareness Act, 2010, S.O. 2010, c. 22 (hereinafter NSAA); and the Drug and Pharmacies Regulation Act, R.S.O.1990, c. H.4 (hereinafter DPRA).

^3. Sections 2(1)(c), 2(5), O. Reg. 865/93, Registration, enacted under the Medicine Act, 1991, S.O. 1991, c.30; Ensuring Competence: Changing Scope of Practice and/or Re-entering Practice policy; CPSO's Essentials of Medical Professionalism.

^4. An appropriate clinical assessment includes an appropriate patient history as well as any other necessary examinations or investigations.

^5. For more information on consent, please refer to CPSO’s Consent to Treatment policy.

^6. The prescribing physician is ultimately responsible for how they use the assessment information, regardless of who conducted the assessment.

^7. In most circumstances, this will require that the physician know the person conducting the assessment and be aware of their qualifications and training. In some limited circumstances, such as large health institutional settings, the physician may be able to rely upon knowledge of the institution’s practices to satisfy him or herself that the person conducting the assessment has the appropriate knowledge, skill, and judgment.

^8. Signatures must be authentic and unaltered. Electronic signatures may be acceptable if they meet the requirements of the Ontario College of Pharmacists. For more information, see the Ontario College of Pharmacists’ website: http://www.ocpinfo.com/regulations-standards/policies-guidelines/unique-identifiers/.

^9. See Section 2 of the NSAA for the definition of “monitored drug.” For a complete list of monitored drugs, see the Ministry of Health and Long-Term Care’s website at: http://health.gov.on.ca/en/pro/programs/drugs/monitored_productlist.aspx. 

^10. For example, a Health Card number. See the full list of approved forms of identification here: http://www.health.gov.on.ca/en/public/programs/drugs/ons/publicnotice/identification_list.aspx.

^11. See Sections 3 and 6 of the General, O. Reg., 381/11, enacted under the NSAA.

^12. There are some limitations on the use of verbal prescriptions (for example, narcotics cannot be authorized verbally). Physicians can contact the pharmacist if they are uncertain about whether a particular prescription is permitted. The Ontario College of Pharmacists (OCP) created a summary of federal and provincial laws governing prescription requirements which can be found here:
https://www.ocpinfo.com/wp-content/uploads/2019/05/Prescription-Regulation-Summary-Chart-Summary-of-Laws.pdf.

^13. Obligations with respect to the security of personal health information are set out in Sections 12 and 13 of PHIPA. For more information on the security of faxed prescriptions, see the Information and Privacy Commissioner of Ontario’s “Guidelines on Facsimile Transmission Security”.

^14. Sections 18-21 of the Medicine Act, General Regulation. For full details of the requirements concerning medical records, see CPSO’s Medical Records Management policy.

^15. Specific expectations for discontinuing narcotics and controlled substances are set out in provisions 34 – 35 of this policy.

^16. If physicians are delegating this responsibility to staff, they must do so in accordance with CPSO’s Delegation of Controlled Acts policy.

^17. A blanket “no-refill policy” means that a physician will not authorize refills for any patient, for any drug, in any circumstances. A blanket no-refill policy is an arbitrary, inflexible position that prevents physicians from exercising independent clinical judgment that takes into account the circumstances of the individual patient. This approach is not consistent with patient-centered care and has no clinical basis.

^18. For more information about the safe disposal of drugs, please see CPSO’s Advice to the Profession: Prescribing Drugs document.

^19. For more information, see Health Canada’s Notice of Compliance webpage: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/database.html. There are two circumstances when access to an unapproved drug can be obtained for patient use: the first is when drugs have been authorized by Health Canada for research purposes as part of a clinical trial and the second is when drugs have been authorized under Health Canada’s Special Access Programme.

^20. Small amounts of drugs are sometimes provided to patients without a formal prescription for the immediate treatment of acute symptoms or to evaluate the clinical effectiveness of the treatment.

^21. For more information about dispensing, see CPSO’s Dispensing Drugs policy.

^22. For the purposes of this policy, “Narcotics and Controlled Substances” includes Narcotic Drugs, Narcotics Preparations, and Benzodiazepines and Other Targeted Substances as defined in the Regulations made under the CDSA, Controlled Drugs as defined in the Regulations made under the FDA, and Monitored Drugs as defined in the NSAA. Examples include narcotic analgesics (e.g. Tylenol 3 and OxyNEO), methadone, and non-narcotic controlled drugs such as methylphenidate (e.g. Ritalin), benzodiazepines (e.g. Valium), and barbiturates (e.g. phenobarbital).

^23. With respect to the prescribing of opioids for chronic non-cancer pain, relevant guidelines and standards include the 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain, the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain, and any applicable Quality Standards developed by Health Quality Ontario. Relevant guidelines for the clinical management of opioid use disorder include, among others: the CRISM National Guideline for the Clinical Management of Opioid Use Disorder, the British Columbia Centre for Substance Use: A Guideline for the Management of Opioids Use Disorder, and National Guidelines on the Treatment of Opioid Use Disorder.

^24. For more information about accessing patient’s electronic prescription histories, please see CPSO’s companion Advice to the Profession: Prescribing Drugs document.

^25. Applicable legislation includes the Health Care Consent Act, 1996 (HCCA).

^26. With respect to the prescribing of opioids for chronic non-cancer pain, relevant guidelines and standards include the 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain, the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain, and any applicable Quality Standards developed by Health Quality Ontario. Relevant guidelines for the clinical management of opioid use disorder include the CRISM National Guideline for the Clinical Management of Opioid Use Disorder.

^27. With respect to the prescribing of opioids for chronic non-cancer pain, relevant guidelines and standards include the 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain, the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain, and any applicable Quality Standards developed by Health Quality Ontario. Relevant guidelines for the clinical management of opioid use disorder include the CRISM National Guideline for the Clinical Management of Opioid Use Disorder.

^28. Safeguarding our Communities Act, 2015. Physicians can find more information about their obligations under the Act in CPSO’s “Patch-for-Patch Fentanyl Return Program: Fact Sheet”, which is a companion to CPSO’s Prescribing Drugs policy.

^29. A physician may be reasonably satisfied based on his or her discussions with the patient as well as any other information available to the physician.

^30. For example, because the physician practices in an emergency room setting and feels unable to provide necessary follow-up care and monitoring.

^31. Physicians with primary care practices are reminded that given their broad scope of practice, there are few occasions where scope of practice would be an appropriate ground to refuse to prescribe all narcotics and controlled substances.

^32. A blanket “no prescribing” policy means that a physician will not prescribe narcotics or controlled substances for any patient in any circumstances. A blanket “no-prescribing” policy is an arbitrary, inflexible position that prevents physicians from exercising independent clinical judgment that takes into account the circumstances of the individual patient.

^33. https://www.canada.ca/en/health-canada/corporate/contact-us/office-controlled-substances.html

^34. Section 55(g) of the CDSA, Narcotic Control Regulations; Sections 7(1) and 61(2) of the Benzodiazepines and Other Targeted Substances Regulations, S.O.R./2000-217, enacted under the CDSA. These requirements are also set out in CPSO’s Guide to Legal Reporting Requirements.