TARGETED SUBSTANCES - GUIDANCE DOCUMENT FOR COMMUNITY PHARMACISTS

The Benzodiazepines and Other Targeted Substances Regulations have been published in Canada Gazette, Part II, on June 21, 2000 .They will come into force on September 1, 2000. They are available on the Therapeutic Products Programme website at the following location:
http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/schedule/

The following information is provided to explain to pharmacists regulatory requirements that will come with the promulgation of these regulations. For pharmacists practicing in hospitals, please refer to the guidance document prepared for these establishments. Attached is a list of targeted substances to whose the regulations will apply.

Record keeping for the receipt of targeted substances
A pharmacist receiving a targeted substance from a licensed dealer, another pharmacist or a hospital must keep a record of the following information:
• the brand name of the targeted substance received,
• the quantity and strength per unit of the targeted substance received, 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.


Prescription required
The new regulations do not introduce any change to current practice with regard to prescription requirement. A targeted substance can only be sold or provided to an individual or for the benefit of an animal upon receipt of a prescription issued by a practitioner either in writing or verbally. If the prescription is transmitted verbally, the following information must be recorded by the pharmacist before filling it:
• the name and address of the individual or animal for whose benefit the prescription is issued,
• the date that the verbal prescription was provided,
• 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 directions for use, as specified by the practitioner,
• if applicable, the number of refills authorized and, if specified , the interval between refills.

The pharmacist must also keep a hard copy or create a written record of the verbal prescription.

Refills
A prescription for a targeted substance can be refilled if the practitioner specified on the prescription the number of refills. Conditions applicable to refills are described in the Regulations.

Records
When a pharmacist fills or refills a prescription for a targeted substance, the following information must be recorded:
• the date the prescription was filled or refilled,
• the quantity of the targeted substance provided,
• the pharmacist’s name or initials,
• the number assigned to the prescription.

For refills, copies of the original prescription are not required as long as the above mentioned informationis recorded.

Prescriptions for targeted substances do not have to be filed in the special prescription files used for narcotics and controlled substances.

Authorized transfers
A pharmacist can transfer a prescription for a targeted substance to another pharmacist, except if that prescription has already been transferred.
Before selling or providing a targeted substance under a prescription that has been transferred, a pharmacist must:
• in the case of a verbal transfer, record the required information as per verbal prescription issuance,
• in the case of a written transfer, obtain from the transferring pharmacist a copy of either the written prescription issued by the practitioner or the record of the verbal prescription,
• the name and address of the transferring pharmacist,
• the number of authorized refills remaining and, if specified, the intervals between refills
• the date of the last refill.

The transferring pharmacist 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 that are being transferred.

Activities without a prescription
A pharmacist may sell, provide, send, deliver, transport a targeted substance without a prescription to one of the following persons upon receipt of an order from that person specifying the name and quantity of the targeted substance:
• the licensed dealer who sold or provided the targeted substance or one who is licensed to destroy targeted substances other than those produced, made, assembled, sold or provided by him
• a practitioner
• a pharmacist
• a hospital
• the Minister
• a person to whom an exemption with respect to the targeted substance has been granted under Section 56 of the Controlled Drugs and Substances Act.

For transactions with a licensed dealer, the Minister or an individual to whom an exemption has been granted, the order must be written.
Transactions with another pharmacist are authorized only if the targeted substance is required by that other pharmacist because of a delay or shortfall in an order for the targeted substance placed with a licensed dealer.
Details pertaining to information that must be recorded upon receipt of a verbal order are described in the Regulations.

Storage
A pharmacist may only store a targeted substance in an place that is used for the purpose of conducting their business or professional practice and in an area in that place where only authorized employees have access. The pharmacist must take any reasonable steps to ensure the security of the targeted substances and to prevent their loss or theft.

Loss or Theft Report
A pharmacist must report to the Minister any loss or theft of a targeted substance within 10 days of its discovery. Loss and Theft Report forms are available at the Office of Controlled Substances

Change of Location
A pharmacist who closes the premises in which a targeted substance is stored must inform the Minister of the date of the closure, the location to which the targeted substance was moved and the quantity of the targeted substance that has moved. The pharmacist has 10 days after the closure to provide the Minister with the required information.

Destruction
A pharmacist may destroy a targeted substance if the following conditions are met:
• the pharmacist records, before the destruction, information with respect of the destruction including the name, strength per unit and quantity of the targeted substance to be destroyed,
• the method of destruction is in conformity with federal, provincial and municipal environmental legislation
• the date of the destruction is recorded
• the destruction is witnessed by a pharmacist or a practitioner
• immediately after the destruction took place, the pharmacist and the witness sign and print their names on a joint statement, indicating that they 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.

There will be no authorization or approval document issued by the Office of Controlled Substances with respect to this activity.

Notification
As for narcotics and controlled drugs, the Minister will issue a notice to licensed dealers and other pharmacists to inform them that they must not sell or provide targeted substance to the pharmacist named in the notice whenever the circumstances for issuing such a notice exist.
Those circumstances are:
• upon request from the pharmacist
• upon request from the licensing authority of a province in which the pharmacist is practising and that pharmacist has contravened a rule of conduct established by that licensing authority
• the pharmacist has been found guilty in a court of law of a designated drug offence or an offence under these Regulations

Other circumstances under which the Minister may issue a notice are:
• the pharmacist has contravened a provision of the Controlled Drugs and Substances Act or the regulations,
• the pharmacist has, on more than one occasion, self-administered a targeted substance under a self-directed order, or, when there is no such order, contrary to accepted pharmaceutical practice,
• the pharmacist has, on more than one occasion, provided a targeted substance to a spouse, parent or child, contrary to accepted pharmaceutical practice
• the pharmacist is unable to account for any quantity of targeted substance for which he/she was responsible under these Regulations.


This notice will be issued to:
• all licensed dealers
• all pharmacies within the province in which the pharmacist is registered and practising
• the licensing authority of the province in which the pharmacist named in the notice is registered or entitled to practice
• any interested licensing authority in another province
• any pharmacies in an adjacent province in which an order from the pharmacist named in the notice may be filled.

TARGETED SUBSTANCES: GUIDANCE DOCUMENT FOR HOSPITAL PHARMACISTS
Orders
Only a pharmacist or a practitioner practising in the hospital and authorized by the person in charge of the hospital may order a targeted substance on behalf of the hospital.
Administration or provision to a patient
A targeted substance may only be sold, provided or administered to a patient or an animal under treatment as an in-patient or a out-patient of the hospital pursuant to a prescription or authorization issued or given by a practitioner practising in the hospital.
Supply to non-patients
A targeted substance may be sold or provided to the following persons, without a prescription, upon receipt of an order specifying the name, quantity and, if applicable, the strength per unit of the targeted substance:

• a licensed dealer who sold or provided the targeted substance or who is licensed to destroy targeted substances other than those that he produced, made, assembled, sold or provided,
• a practitioner or a pharmacist if the order states that the targeted substance is required because of a delay or shortfall in an order placed for the substance,
• another hospital, if the order is placed by a pharmacist or practitioner practising in the other hospital and authorized by the person in charge of that hospital to order targeted substances on behalf of that hospital and if the order states that the targeted substance is required because of a delay or shortfall in an order placed for the targeted substance,
• the Minister, if the order is written and signed on the Minister’s behalf,
• a person to whom an exemption with respect to the targeted substance has been granted under Section 56 of the Controlled Drugs and Substances Act and that person is an employee of or associated with the hospital and the order is written and accompanied by a copy of the exemption.


Orders from a licensed dealer, a pharmacist, a practitioner or another hospital can be verbal. In such cases, the following information must be recorded before filling the order:
• date on which the order was received,
• name and address of the person placing the order,
• brand name of the targeted substance or if the substance has no brand name, the specified name,
• quantity of the targeted substance ordered,
• the name of the person recording the information . This person should be a pharmacist practising in the hospital or an individual authorized by the person in charge of the hospital to fill orders on behalf of the hospital.

Records
The following information must be recorded:

• the brand name or, if the targeted substance has no brand name, the specified name, the quantity of any targeted substance received by the hospital and the date on which it was received,
• the name and address of the licensed dealer, pharmacist or other hospital that sold or provided the targeted substance,
• the disposition of the targeted substance ( transactions such as distribution to a ward, supply to non-patients, returns to licensed dealers, destruction, etc...) and the date of its disposition,
• the name and address of any out-patient to whom a targeted substance is sold or provided.


Destruction
The person in charge may destroy a targeted substance if the following conditions are met:
• the hospital records, before the destruction, information with respect to the destruction, including the name, strength per unit and quantity of the targeted substance to be destroyed,
• the targeted substance is destroyed using a method of destruction that conforms with all applicable federal, provincial and municipal environmental legislation,
• the person records the date of destruction,
• the destruction is witnessed by a pharmacist or a practitioner,
• immediately after the destruction, the person who destroyed the targeted substance and the witness sign and print their names on a joint statement, indicating that they witnessed the destruction and that the targeted substance has been altered or denatured to such an extent that its consumption has been rendered impossible or improbable.

There will be no authorization or approval document issued by the Office of Controlled Substances with respect to this activity.

Open Ampoule
The remainder of an open ampoule containing a targeted substance, the partial contents of which have been administered to a patient, may be destroyed by a hospital employee who is a licensed health professional without a witness.

Closure
Whenever a hospital closes or the pharmacy department within a hospital closes, the person in charge of the hospital must inform the Minister of the date of the closure, the location to which the targeted substance was moved and the quantity of the targeted substance that was moved. This has to be done no later than ten days after the closure.

Storage
The person in charge of a hospital must store a targeted substance in a place used for the purpose of conducting their business or professional practice and in an area in that place where only authorized employees have access. The person in charge of the hospital must take any reasonable steps to ensure the security of the targeted substances and to prevent their loss or theft.

Loss and Theft
The person in charge of the hospital must report to the Minister any loss or theft of a targeted substance no later than 10 days after its discovery. Loss and Theft Report forms are available at the Office of Controlled Substances.

Since this document is only intended to summarize the main points of the content of the new Benzodiazepines and Other Targeted Substances Regulations, please refer to the regulations in their entirety. Should you have any question on this document or on the Regulations, do no hesitate to contact us at (613) 954-1541.
Carole Bouchard, B. Pharm, M.A.P.
Director
Office of Controlled Substances
Healthy Environments and Consumer Safety Branch
Health Canada

List of Benzodiazepines and other targeted substances:

1. Policy Handbook, Pg. 5



1. Benzodiazepines, their salts and derivatives, including 1. Alprazolam 2. Bromazepam 3. Brotizolam 4. Camazepam 5. Chlordiazepoxide 6. Clobazam 7. Clonazepam 8. Clorazepate 9. Cloxazolam 10. Delorazepam 11. Diazepam 12. Estazolam 13. Ethyl Loflazepate

14. Fludiazepam 15. Flurazepam 16. Halazepam 17. Haloxazolam 18. Ketazolam 19. Loprazolam 20. Lorazepam 21. Lormetazepam 22. Medazepam 23. Midazolam 24. Nimetazepam 25. Nitrazepam 26. Nordazepam 27. Oxazepam 28. Oxazolam 29. Pinazepam 30. Prazepam

31. Quazepam 32. Temazepam 33. Tetrazepam 34. Triazolam 35. Flunitrazepam 36. Clotiazepam 37. Ethchlorvynol 38. Ethinamate 39. Fencamfamin 40. Fenproporex 41. Mazindol 42. Mefenorex 43. Meprobamate 44. Methyprylon 45. Pipradol