Health Canada no longer requires pre-authorization requests for the local destruction of unserviceable narcotics and controlled drugs. This means that pharmacists may proceed with destruction without notifying and receiving acknowledgment from Health Canada in advance.
Local (on site) destruction is one option available to pharmacists and persons in charge of hospitals when destroying unserviceable narcotics and/or controlled drugs. It is important to note that any record or written order required to be retained under the regulations made under the Controlled Drugs and Substances Act (CDSA) or any relevant CDSA exemption must be retained in a manner that permits an audit to be made pursuant to sections 41 and 64 of the Narcotic Control Regulations and sections G.03.011 and G.05.002 of Part G of the Food and Drug Regulations). With respect to appropriate record keeping and destruction, Health Canada recommends the following:
1. Before any destruction, the pharmacist should record information with respect to the destruction, such as the destruction date, name, strength per unit, and quantity of the controlled substance to be destroyed. This information should be kept for a period of two years. Beyond the two-year period, it is up to the hospital administrators, pharmacists or practitioners to determine if these records should be kept for a longer period based on other regulatory requirements such as provincial or professional practice regulations.
2. The pharmacist should destroy the drugs in the presence of another health professional. Both witnesses should record their names and destruction date on a statement indicating they witnessed the destruction. For these purposes, a health professional could be a pharmacist, practitioner, nurse, pharmacy intern, regulated pharmacy technicians (in those provinces where they are registered with the pharmacy licensing authority) or an inspector from the provincial pharmacy licensing authority.
3. The controlled substance should be destroyed using a method of destruction that conforms with applicable federal, provincial and municipal environmental legislation.
4. The controlled substance should be altered or denatured to such an extent that its consumption has been rendered impossible or improbable.For the regulatory requirements for the destruction of benzodiazepines and other targeted substances, please refer to sections 2, 55 and subsection 65(1) of the Benzodiazepines and Other Targeted Substances Regulations.
Pharmacists and persons in charge of hospitals who do not wish to destroy narcotics or controlled drugs on site may, through an exemption under section 56 of the Controlled Substances and Drugs Act, sell or provide these substances, to a licensed dealer who is licensed to destroy narcotics or controlled drugs.
No. However, you must:
- Record, before the destruction, the name, strength per unit, and quantity of the targeted substance to be destroyed;
- Ensure the method of destruction conforms with federal, provincial and municipal environmental legislation;
- Record the date of the destruction;
- Have the destruction witnessed by a pharmacist or a practitioner; and,
- Immediately after the destruction, ensure you and the witness sign and print your names on a joint statement indicating you have witnessed the destruction, and the targeted substance destroyed has been altered or denatured to such an extent that its consumption has been rendered impossible or improbable.
These records must be kept for two years.
Yes. When doing so, you must first verify the identity of the person who is giving the order. Before filling the prescription, you must record:
- The name and address of the individual or animal for whose benefit the prescription is issued;
- The date of the verbal prescription;
- The specified name or brand name of the targeted substance, as specified in the prescription;
- The quantity and, if applicable, the strength per unit of the targeted substance;
- The name of the recording pharmacist, and the name of the practitioner who issued the prescription;
- The handwritten initials or signature of the pharmacist who reduced the verbal prescription to writing;
- The directions for use as specified by the practitioner; and
- If applicable, the number of refills authorized, and, if specified, the interval between refills.
You must also keep a hard copy or create a written record of the verbal prescription. These records must be kept for two years.
Yes, you may refill a prescription for a targeted substance if:
- The practitioner who prescribed it expressly directs that the prescription may be refilled and specifies the number of refills;
- The pharmacist makes a record of each refill;
- Less than one year has elapsed since the day on which the prescription was issued by the practitioner;
- At least one refill remains on the prescription; and
- In the case where an interval between refills has been specified by the practitioner, the interval has expired.
When you receive a targeted substance from a licensed dealer, another pharmacist or a hospital, you must keep a record of:
- The brand name;
- The quantity and strength per unit;
- The number of units per package, and the number of packages;
- The name and address of the licensed dealer, pharmacist or hospital that supplied it; and,
- The date on which it was received.
You must record:
- The date of the transfer,
- The name of the pharmacist to whom the prescription is transferred,
- The name and address of the pharmacy where the prescription is being transferred, and
- If applicable, the number of refills being transferred.