Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019
by Ciara H Guiney

Prescription and supply under the Cannabis
for Medical Use Register

Part 2 of the Regulations provides for the prescription and supply of cannabis under the Cannabis for Medical Use Register (CMUR):

 

  • Under Section 4 of the Regulations, a practitioner prescribing cannabis must be a medical consultant, must include their name and address on the prescription, and must continue to be responsible for and supervise the patient while being treated. In addition, only a person named on the CMUR who has been given a CMUR number from the Health Service Executive (HSE) can be issued a prescription.
  • Under Section 4(6), when a prescription is being issued for the first time:

-     It must be intended to treat the person for a specific condition.

-     The HSE must be provided with the person’s name, address, date of birth, and the name of the condition being treated; the notifying practitioner’s name, registration number, and medical speciality; and any other information required by the HSE.

  • Section 5 of the Regulations provides for the establishment and maintenance of the CMUR. The CMUR records the information provided by the practitioner under Section 4(6). The HSE can alter or delete an entry; however, it may need additional information from the medical consultant supervising the treatment. The HSE is also responsible for assigning the CMUR number to each person entered in the register.

 

  • Under Sections 6 and 7, only a pharmacist or a person operating a retail pharmacy business shall supply a specified controlled drug to a practitioner. These suppliers must maintain records of the following:

-     Date of supply

-     Name of drug, quantity, and dosage

-     Name, address, and registration number of the prescriber

-     CMUR number

-     Name and address of the person who is being prescribed the drug

-     Date of prescription.

 

Commercial supply under licence

Part 3 of the Regulations provides for the commercial supply of cannabis under licence.

 

  • Under Sections 11 and 12, a specified controlled drug should only be supplied to a pharmacist, retail pharmacy business, or hospital. For each consignment supplied, the supplier must maintain a record of each consignment received and supplied for a minimum of five years. The following information should be recorded:

-     Name of the drug, including the brand name

-     Dosage form of the drug

-     Quantity of drug received and supplied

-     Batch number of the drug received

-     Name and address of the producer of that specified controlled drug in the form it was received

-     Name and address of the supplier of each consignment.

 

This information should be made available to the Minister for Health when requested for review.

  • Section 13 prohibits the exportation of imported specified controlled drugs outside of the State.

This legislation provides for the operation of the Medical Cannabis Access Programme on a pilot basis for five years.

 

 

 

 

Reporting, enforcement, and advertising

Part 4 of the Regulations provides for the reporting, enforcement, and advertising of a specified controlled drug within the scope of Part 2 or Part 3. Under Section 15, a person shall report suspected adverse reactions and quality defects to the Health Products Regulatory Authority (HPRA) within 15 days of being provided with the information. Where there are quality or safety issues relating to a specified controlled drug or batch, HPRA can authorise the withdrawal or recall of the product (Section 16). If notice is received from the Minister for Health or HPRA to stop prescribing, supplying, or importing a specified drug, the specified controlled drug should no longer be supplied or imported (Section 17). Under Section 18, the advertisement or supply of information related to a specified controlled drug to the general public is restricted.

 

Ciara H Guiney

 

1  Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. Available online at:
http://www.irishstatutebook.ie/eli/2019/si/262/made/en/print