Closed Public Consultation: Designated Drugs Regulation
Note: This public consultation is now closed.
On May 30, 2019, the College of Midwives of Ontario (College) received a letter from the Health Minister Christine Elliott requesting that the College amend its Designated Drugs Regulation made under the Midwifery Act, 1991 to include categories of drugs and substances.
The College’s current Designated Drugs Regulation includes lists of individual drugs and substances that can be prescribed or administered by injection or inhalation on midwife’s own authority.
The College was requested to undertake this work immediately with a view that the formal submission to the Ministry should be made no later than December 31, 2019.
What will change?
The College is proposing the following amendments to the Designated Drugs Regulation:
- Rescind lists of drugs and substances in the current Designated Drugs Regulation and include categories of drugs and substances in accordance with the American Hospital Formulary Services (AHFS) pharmacologic-therapeutic classification categories.
- Make it a condition of registration that all members and midwifery applicants must successfully complete, within a time period specified by Council, a mandatory training approved by Council relating to the safe, effective, and ethical prescription and administration of controlled substances.
- Enable midwives, in the course of engaging in the practice of midwifery, to prescribe any drug and administer any substance by injection or inhalation on the order of a physician and a nurse practitioner.
The College’s Council has reviewed the proposed draft of the Designated Drugs Regulation at its September 20, 2019, meeting and made a decision to circulate the draft for a 60-day consultation.
What are the AHFS pharmacologic-therapeutic classification categories?
The Ministry requested that the College propose categories using the AHFS pharmacologic-therapeutic classification. The AHFS is a system of organizing drugs developed and maintained by the American Society of Health-System Pharmacists (ASHP) and has been used for organizing drugs in institutional, governmental, and other settings since 1959. The classification system is based on a hierarchical numeric structure and the drugs are classified together with other drugs with similar pharmacologic, therapeutic, and/or chemical characteristics in a 4-tier hierarchy. The hierarchy begins with Tier 1 as the broadest category whereas Tier 4 consists of specific categories that fall under Tiers 1 to 3. There are 31 classifications in the first tier, 200 in the second tier, 285 in the third tier, and 112 in the fourth tier.
What AHFS categories does the College propose to include in the amended regulation?
The Ministry requested that the College propose categories at a Tier 3 level citing both flexibility and specificity that can be achieved at this level. For instance, in the below example, Cephalosporins is a Tier 3 category of anti-infective agents.
In some categories, the College has requested Tier 1 or Tier 2 rather than Tier 3. This was done either because there were no Tier 3 categories (e.g. there are no Tier 3 categories in Electrolytic, Caloric and Water Balance but only Tier 1 and Tier 2) or because many of the drugs or categories in Tier 1 or Tier 2 a midwife requires access to (e.g. Anti-infective agents).
The below table provides the categories of drugs and substances that the College proposes to include in the amended regulation. We have also included, for your reference, individual drugs and substances to show what individual drugs and substances fit into the AHFS categories.
Note that the regulation itself will only contain the categories listed in the category column (in light blue). The regulation WILL NOT CONTAIN the Tier Requested (column 2) or individual drugs and substances (column 3). The information in columns 2 and 3 has been included for your reference only.
When will the regulation be approved?
Once the consultation closes, the results will be brought back to Council in December for its final review and approval. If approved, the regulation will be formally submitted to the Ministry at the end of December, as requested by the Minister. Based on our preliminary discussion with the Ministry, it is expected that the regulation will be approved in the winter of 2020.
What happened to the College’s previous submission requesting broad prescribing and administering?
In January 2018, the College made a submission to the Ministry requesting that the list of drugs and substances in the current Designated Drugs Regulation be rescinded to instead allow midwives access to any drug or substance approved by Health Canada, within the scope of midwifery practice. At this stage, however, the Ministry is not willing to move from lists to broad prescribing and will only consider including categories of drugs and substances in the drug regulation.
While the College still believes that the public will be best served by midwifery care when clients receive the treatments that are in their midwives’ scope of practice, we acknowledge that rescinding the current list in the Designated Drugs regulation and moving to the category approach will bring positive change as midwives and their clients will have more access to up-to-date treatments than they currently have.
We invite midwives, stakeholders, and members of the public to comment on the proposed changes to the Designated Drugs Regulation below.
You are welcome to share any comments you might have. It will be helpful if in addition to your general comments, you could also address the following question:
After reviewing the proposed categories (and individual drugs and substances that fall under these categories), what additional drugs or substances should be included and what will they be used to treat?
Our consultation is open until Friday, November 22, 2019, and all members of the public, stakeholders, and midwives are invited to share their thoughts below.
Thank you for taking the time to read and provide your comments. We will carefully consider your feedback. We greatly appreciate your participation and contribution to this initiative.
Please note that all comments are reviewed before being posted publicly to ensure they meet the Posting Guidelines. If you prefer to provide feedback via email, please email email@example.com with “Proposed Amendments to the Designated Drugs Regulation” in the subject line.