Controlled Substances Regulations: Prescribing, adapting, transferring, and providing for care for patients

Background

Controlled substances are subject to additional federal requirements that may affect how pharmacists and pharmacy technicians provide patient care. Activities that may be permitted for other drugs, such as adapting a prescription, transferring a prescription, receiving a verbal order, or ordering and receiving drugs may be subject to additional considerations or limitations when a controlled substance is involved.

When providing professional services involving controlled substances, you must always consider the complete legislative framework including the federal Controlled Substances Regulations (CSR), relevant Alberta legislation, and the requirements of the standards.

This advice highlights some of the practical considerations involved when common professional services involve controlled substances.

Advice

1. Prescribing controlled substances
   1. Limitations on prescribing
      1. Prescribing activities involving controlled substances are subject to additional federal restrictions under the CSR that limit the prescribing you may do. The CSR does not authorize pharmacists to prescribe a controlled substance at initial access or to manage ongoing care.
   2. Adapting a prescription
      1. The CSR does allow you to adapt an existing prescription for a controlled substance when permitted by the Standards of Practice for Pharmacists and Pharmacy Technicians (SPPPT).
      2. As with any prescribing activity, you must complete an appropriate assessment, apply your professional judgement, and document your decision.
   3. Renewing a prescription
      1. The CSR refers to renewing a prescription to ensure continuity of care as “extending” a prescription. For practical purposes, you can consider these activities equivalent.
      2. When you renew a prescription for a controlled substance, note that the CSR places limits on how long the prescription is valid for renewal. The renewed days of supply that you authorize cannot extend beyond two years from the date the original prescription was first received by the original pharmacist, not the date you received the prescription. 
   4. Transferring a prescription
      1. If a prescription for a controlled substance is transferred to your pharmacy, remember that the CSR limits validity a two-year period calculated from the date the original prescription was first received by any pharmacy, not the date it was transferred to your pharmacy.
   5. Therapeutic substitution
      1. You may substitute a controlled substance identified in a prescription with another controlled substance that is expected to have a similar therapeutic effect.
      2. If you have a valid prescription for a controlled substance, you may also substitute a non-controlled substance when appropriate. However, the CSR does not permit you to substitute a controlled substance when the original prescription is for a non-controlled substance.
   6. Deprescribing
      1. A pharmacist with additional prescribing authority who has completed a patient assessment may deprescribe a prescription for a controlled substance in accordance with the CSR and the SPPPT.
      2. Because controlled substances may be associated with additional risks (e.g., dependence, withdrawal), always consider how deprescribing these drugs may impact the patient and if any additional monitoring, follow up, or support is required.
2. Verbal prescriptions
   1. If you are a pharmacist or pharmacy technician, you may accept a verbal prescription for a controlled substance from an authorized practitioner.
   2. Because verbal prescriptions do not include a written order from the prescriber, take extra care to ensure all required information is obtained and accurately documented when the prescription is received. Given the potential for diversion and increased risk associated with verbal prescriptions, consider whether additional steps are needed to verify and authenticate the prescription before proceeding.
3. Transferring prescriptions
   1. A pharmacist or pharmacy technician may transfer a prescription for a controlled substance to another pharmacist or pharmacy technician in Canada.
   2. There are no limitations on the number of times a prescription may be transferred but the CSR requires that the transfer must occur within two years after the date the prescription was received.
   3. When transferring a prescription for a controlled substance, ensure sufficient information is communicated to allow the receiving pharmacy to accurately determine the prescription’s status. This is particularly important because the two-year transfer period is calculated from the date the original prescription was first received, regardless of how many times the prescription has been transferred between pharmacies.
4. Receiving controlled substances
   1. A pharmacist or pharmacy technician may receive controlled substances on behalf of a pharmacy.
   2. As the regulated member receiving the controlled substance, the CSR and the standards both require that records are created and maintained and that the controlled substance is appropriately secured.
5. Ordering controlled substances
   1. The CSR only authorizes pharmacists to order controlled substances.
6. Delivering and transporting controlled substances
   1. You may deliver, send, or transport controlled substances when permitted by the CSR.
   2. Controlled substances are at greater risk of loss, theft, or diversion while in transit. If you are involved in delivering or transporting controlled substances, consider whether the transportation method, packaging, and chain of custody are appropriate to maintain the security and integrity of the drug.
7. Destruction of controlled substances
   1. Both pharmacists and pharmacy technicians are authorized to destroy controlled substances. When you participate in the destruction of controlled substances, be aware that the CSR establishes specific requirements for how destruction must occur, including applicable witnessing and record-keeping requirements.
   2. Controlled substances continue to present a risk of diversion until destruction is complete. Take steps to ensure they remain secure throughout the destruction process, including during storage before destruction occurs, as this may be a particularly vulnerable point for diversion.
8. Record keeping
   1. The CSR establishes record-keeping requirements for activities involving controlled substances, including
      1. receiving controlled substances;
      2. dispensing and providing controlled substances;
      3. receiving verbal prescriptions;
      4. extending and adapting prescriptions;
      5. transferring prescriptions;
      6. delivering or transporting controlled substances; and
      7. destroying controlled substances.
   2. Accurate and complete records are an important component of accountability for controlled substances. They demonstrate compliance with regulatory requirements and assist in identifying and investigating potential losses or diversion.
   3. Federal record-keeping requirements apply alongside ACP’s requirements for pharmacy records. When more than one requirement applies, you must meet all applicable requirements.

Further reading

ACP resources

• Standards of Practice for Pharmacists and Pharmacy Technicians

External resources

• Controlled Substances Regulations – Government of Canada