CPSO, in consultation with the Ontario College of Pharmacists (OCP), has developed the Dispensing Drugs policy for those physicians who dispense drugs. The aim of the policy is to help physicians meet the same standards as pharmacists when dispensing drugs. This companion Advice document is intended to provide guidance to physicians on how to interpret and effectively discharge their obligations as set out in the policy.

What is dispensing?

The OCP’s Dispensing Components Included in the Usual and Customary Fee guideline describes dispensing as involving both technical and cognitive components. Technical components may include drug selection, verification, and quantity determination, applying appropriate labelling, and documentation. Cognitive components (which may overlap with a physician’s responsibilities when prescribing) may include assessing the appropriateness of drug therapy, considering drug interactions and contraindications, providing patient communication and counselling, and offering follow-up advice.

Does this policy apply if I am distributing drug samples?

The policy is intended to set expectations for physicians dispensing in limited circumstances in a role that is comparable to a pharmacist. It does not apply to the distribution of drug samples. However, relevant expectations for drug samples can be found in the Medical Records Documentation, Prescribing Drugs, and Physicians Relationships’ with Industry: Practice, Education and Research policies, such as keeping relevant documentation of the drug name, dose, directions for use, quantity, and lot number in the patient’s medical record

Some of the expectations articulated in the Dispensing Drugs policy are also informative and may help guide appropriate conduct when it comes to distributing samples. This includes not distributing expired medications. Further guidance around samples can be found in the OCP’s Distribution of Medication Samples policy.

How can I determine what dispensing fee to charge?

A dispensing fee may incorporate the cost of the drug and reasonable handling costs, such as shipping and secure storage for the drug. Further guidance on charging for uninsured services more generally can be found in the Uninsured Services: Billing and Block Fees policy. In line with this policy, you must consider the patient’s ability to pay when charging for uninsured services. The Ontario Medical Association also publishes an annual Physician’s Guide to Uninsured Services which provides recommendations to help physicians set their fees.

What information do I need to provide to a patient when dispensing a drug?

Many aspects of patient counselling may overlap with the responsibility to obtain informed consent from a patient or substitute decision-maker for treatment and before prescribing a drug. Information to provide a patient can include directions for using the drug, the expected therapeutic effect, potential side effects, drug contraindications and precautions, and information about the drug therapy as it relates to the patient’s condition. You can also communicate with patients to evaluate their ability to comply with the therapeutic regimen. You can exercise judgment as to what is discussed when dispensing repeats or refills.

What information do I need to include on labels for dispensed drugs?

Subsection 156(3) of the Drug and Pharmacies Regulation Act sets out the information which must be recorded on the container of the dispensed drug, including, not limited to, the identification number on the prescription; drug name, strength, and manufacturer; the date the prescription is dispensed; the name of the prescriber; the name of the person for whom it is prescribed; and the directions for use as prescribed.

Under the Food and Drug Regulations, physicians who dispense Class A opioids are required to apply a warning sticker to the prescription bottle, container, or package, and provide a patient information handout to accompany the drug. A sticker or handout is not required if the drug is being administered under the supervision of a practitioner (for example, a physician or nurse practitioner). For more information about these requirements, see Health Canada’s FAQ.

What do I need to know about procuring drugs?

Physicians must use proper methods of procurement and keep documentation of each sale or product transaction (e.g., with a packing slip from the manufacturer or wholesaler). Physicians can meet this expectation by procuring drugs from reliable sources and in accordance with federal legislation, such as from manufacturers or wholesalers who have been issued drug establishment licences by Health Canada.

For controlled substances, physicians must keep purchase/receiving records that contains information about the name and quantity of the substance received; the date the substance was received; and the name and address of the person from whom the substance was received.

Additional guidance can be found in the OCP’s policy on medication procurement and inventory management and fact sheet on federal purchase and sales record requirements, and Health Canada’s Recommended guidance in the areas of security, inventory, reconciliation and record-keeping for community pharmacists.

What do I need to do to store drugs securely and appropriately?

Physicians need to implement practices that enable storing drugs in a clean and organized area, with appropriate temperature, light, humidity, ventilation, regulation, security, and safety controls. It is important to store drugs in areas appropriate to their classification and which are accessed only by designated and appropriately trained personnel.

With respect to controlled substances, the regulations do not define what is considered reasonable or necessary to ensure security nor do they establish specific storage requirements. A combination of methods can be used, such as physical security measures (e.g., alarm system, locks, video surveillance, restricted access), inventory management (e.g., physical counts, accurate record-keeping), operational processes, audits, and inventory reconciliation.

In March 2023, the OCP approved updated policies requiring the use of time-delayed safes to store narcotics and associated signage in all community pharmacies. These updates were introduced as a new security measure in response to a rise in reports of pharmacy robberies across Ontario. Physicians dispensing drugs are required to store drugs securely. A dispensing physician may consider adopting the use of time-delayed safes as a best practice but may not need to depending on the circumstances of their practice (e.g., the quantity and/or type of drugs stored on site). More information on this requirement can be found on the OCP’s website.

Additional guidance can be found in the OCP’s policy on medication procurement and inventory management and fact sheet on security and reconciliation of controlled substances, and Health Canada’s Recommended guidance in the areas of security, inventory, reconciliation and record-keeping for community pharmacists.

How can I minimize dispensing errors?

Dispensing errors can include providing the wrong drug, strength, quantity, or dosing regimen; not identifying potential drug interactions; or mislabelling drugs. You can minimize errors by instituting standardized dispensing procedures (including labelling, instructions, and documentation), using a checklist or other mechanisms to ensure the dispensing process is accurately completed and the correct drug dispensed, and using technology to assist with workflow. The Advice to the Profession: Prescribing Drugs outlines what to do in the case of a medication incident.