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The previous Drug Regulation has been expanded to improve client care through more direct access to necessary drugs and substances. On May 3, 2024, the government announced that a new Designated Drugs and Substances Regulation had come into effect, setting out a list of drugs midwives can prescribe and substances that midwives can administer by injection or inhalation on a midwife’s own authority within the scope of midwifery practice.
The new regulation adds additional drugs and substances to the list that midwives may prescribe and/or administer on their own authority. Access to these new drugs and substances will reduce the need for midwifery clients to seek care outside midwifery for treatment that is within the midwifery scope of practice, improving the quality and timeliness of care for clients.
The changes to the list include hormonal contraceptives, expanded analgesia, additional antibiotics, updates to the vaccines that a midwife can administer to include many routine vaccines clients receive during pregnancy, and other additions to align with current best practices. With the new regulation, midwives will be able prescribe and administer all items on the expanded list as long as they have the knowledge, skill, and judgment to do so safely and effectively.
The College of Midwives of Ontario worked with the Ministry of Health over the past few years to find the right path forward for Ontarians. We are happy to see this expansion to the list of drugs and substances that midwives can prescribe and administer on their own authority. These changes will provide improved access to treatments within the midwifery scope of practice.
While we are pleased with this expansion to the list, the College recognizes that specified lists of drugs and substances are at risk of becoming outdated as new drugs and substances become available and practice standards change. We will continue to work with the Ministry to find a sustainable solution for clients to continue to receive optimal care by midwives as medication treatment evolves.
What is new?
Categories
Hormonal contraceptives and vitamins, minerals, and fluid replacements are listed as categories in the updated regulation. In these two instances, midwives can prescribe and administer any drug or substance that falls under the category.
Vitamins, Minerals, and Fluid Replacements
Midwives can prescribe and administer vitamins, minerals, and fluid replacements, for example intravenous iron sucrose.
Hormonal Contraceptives
Hormonal contraceptives include: oral contraceptives such as the combination and progestin-only pills; the patch; the contraceptive ring; and hormone-releasing IUD. Nexplanon, the injectable long-acting contraceptive is also included in this list for midwives to prescribe, although midwives will require a delegation from a physician or nurse-practitioner in order to insert this device as midwives do not currently have the controlled act of performing a procedure under the dermis for this purpose.
Of note, the copper IUD (which does not release any medication) is classified as a device and not a drug, therefore it does not appear on the list of drugs. Prescribing and inserting this method of birth control continues to be within the scope of midwives.
Vaccines
Changes in the new regulation permit midwives to administer several adult vaccines, including Varivax (for the prevention of varicella or chicken pox), Tdap, Influenza, and Covid-19, as well as several others listed in the regulation. In addition, midwives will be able to administer several newborn vaccines should they continue to care for infants at eight weeks, including Rot-1 (for rotovirus infection prevention), and Pneumococcal conjugate (Pneu-C-13).
It is important to note that not all vaccines require a prescription; at this time, Tdap, influenza, and COVID-19 vaccines are available to midwives through the publicly funded vaccine program.
Midwives can find a complete list of vaccines contained within the regulation, under the category vaccines.
Opioid Analgesics
The new regulation permits midwives to prescribe and administer (in hospital settings only) four controlled substances: fentanyl citrate, meperidine, morphine sulfate, and nalbuphine. This means that midwives will no longer have to obtain a physician’s order to administer these drugs for intrapartum pain management.
Midwives are not permitted to prescribe opioids other than for the purpose of being administered in the hospital. Midwives must complete specified education and training before prescribing or administering opioids on their own authority. (Please see Registrar’s Policy on Controlled Drugs and Substances Education and Training or Course Requirement below)
Misoprostol
In the previous regulation, misoprostol was restricted for the treatment of postpartum hemorrhage only. This restriction is no longer in place. Midwives can now use misoprostol for other uses within the midwifery scope of practice, including, for example, inductions of labour or for the treatment of early pregnancy loss.
Misoprostol-Mifepristone (Mifegymiso)
The new regulation permits midwives to prescribe Misoprostol-Mifepristone (Mifegymiso) for the management of early pregnancy loss. Midwives may continue to use this medication on the order of a physician or a nurse-practitioner for the purpose of termination of pregnancy.
Antimicrobials
Many new antimicrobial medications have been added to the regulation. These include antibacterials such as antibiotics, antifungal medications, and antivirals, found under the related categories. In the updated regulation, it is now possible for midwives to prescribe and administer medications for treating several sexually transmitted and blood-borne infections. These medications have been added to permit midwives to treat many conditions which fall under the midwifery scope of practice.
Oral antibiotic medications can now be prescribed by midwives for the treatment of a variety of infections, including some urinary tract infections, sexually transmitted and blood-borne infections (STBBIs). These are listed under Schedule 1.
Injectable antibacterial medications are also included in the new regulation, and the list of these substances can be found in Schedule 3.
Haemostatics
Another new addition to the regulation is the haemostatic tranexamic acid. This medication is found under Schedule 3, for administration by injection.
Administering a Medication on the Order of a Nurse Practitioner
Since the new regulation continues to specify lists of drugs and substances, midwifery clients may need access to necessary medications that are not on the list. In the past, midwives could access these medications on the order of a physician. Now, midwives can receive these orders from nurse practitioners (NPs) as well as physicians.
Additional Emergency Drugs
The new regulation includes drugs and substances that are used to provide routine midwifery care, as well as drugs and substances that midwives use to manage emergencies in the home, hospital, and birth centre settings.
Midwives can also use additional emergency drugs, not listed in the regulation, by way of the exception granted in subsection 29(1)(a) of the Regulated Health Professions Act, 1991 (RHPA). The RHPA grants an exception to the prohibition on performing any controlled act (including the controlled acts of prescribing a drug or administering a substance by injection or inhalation) to any person in the course of providing first aid or temporary assistance in an emergency. This means that in emergencies where the midwife is the most appropriate person with the required knowledge, skill, and judgment to provide temporary assistance, the midwife can access any drug necessary.
Please see our Scope of Practice document, section 2.2.2 Exceptions to Controlled Acts under the RHPA for additional information.
Frequently Asked Questions
Prescribing a medication includes giving written instructions for dispensing a medication by a pharmacist, and self-administration of that medication by a client. As well, the act of prescribing can include prescribing for the purpose of administering a medication. Drugs that may be prescribed by a midwife fall under Schedule 1 and Schedule 4 of the regulation.
In addition, midwives may prescribe any drug that may lawfully be purchased or acquired without a prescription, as set out in Section 6.
Administering medication is giving a medication through the correct route to a client. The regulation specifies which drugs can be administered by inhalation and which drugs can be administered by injection as these procedures are controlled acts authorized to midwives. Midwives can administer any medication that they are authorized to prescribe. Drugs that may be administered by inhalation by a midwife fall under Schedule 2. Drugs that may be administered by injection by a midwife fall under Schedule 3 and Schedule 4. Midwives can also administer by injection any drug on the order of a physician or nurse practitioner.
In addition, midwives may administer any substance that may lawfully be purchased or acquired without a prescription, as set out in Section 6.
Ordering a medication is the way that midwives prescribe a medication to be administered by a nurse in the hospital. This can be a verbal or written order; or may be part of a set of medications that midwives order in a group based on hospital protocols. In addition, midwives can receive orders from physicians or nurse practitioners to administer medications by inhalation or injection that are not included in the regulation.
In addition, midwives may order any drug or substance that may lawfully be purchased or acquired without a prescription, as set out in Section 6.
Using a medication means administration of a medication by any means other than inhalation or injection. This includes oral, vaginal, topical, or rectal routes of administration. Midwives can administer any medication that they are authorized to prescribe. Midwives can receive orders from physicians and nurse practitioners to use medications that are not included in the regulation.
Midwives will be required to declare, in the College’s Registrant Portal during the 2024 Registration Renewal period, that they understand and are in compliance with the requirements that must be met in order to prescribe and administer by injection a controlled drug or substance set out in Schedule 4 of the Designated Drugs and Substances Regulation.
Midwives must be competent in all areas of their practice including prescribing and administering drugs and substances.
As such, prior to initiating any drug therapy, midwives must have sufficient knowledge, skill, and judgment to use the drug or substance safely and effectively. Anything less may constitute professional misconduct. Midwives are expected to seek out the resources, courses, and training they need to be competent at prescribing or administering drugs and substances.
No. The laboratory tests that midwives may order are listed in Schedule 2 of the General Regulation under the Laboratory and Specimen Collection Centre Licensing Act, 1990.
The Ministry of Health held a public consultation on proposed changes to General Regulation under the Laboratory and Specimen Collection Centre Licensing Act, 1990 that closed on May 25, 2024.
There are many new additions to the list of laboratory tests that midwives will be able to order, including point of care tests like the Group B Strep rapid screen, and genetic screening tests like Non-invasive Prenatal Testing (NIPT). To see the proposed changes, click here.
The proposed expansion encompasses most of the tests that midwives might order in the scope of midwifery practice and includes tests that can facilitate timely consultations with other care providers when required. The College believes the proposed changes will:
- Ensure clients have access to routine tests during pregnancy, birth, and postpartum directly through their midwife.
- Decrease the number of unnecessary consultations with physicians for routine tests.
- Facilitate timely consultations with physicians by providing a more complete clinical picture.
- Ensure healthy, pregnant people can receive the care they need without unnecessary additional primary care or hospital visits.
Unlike previous versions, the new Designated Drugs and Substances Regulation does not specify indications for use, or limitations of use of particular medications or substances. The important exception to this is the medication Mifegymiso (or Misoprostol-Mifepristone), and other oxytocic and prostaglandins, which do have specified indications for use in the regulation.
All medications require that a midwife have the knowledge, skills, and judgement to prescribe and/or administer it, medications must be used to treat a condition that is within the midwifery scope of practice, and the medication’s use must be clinically indicated.
Midwives who hold leadership roles within the hospital, such as lead midwives or head midwives, are primarily responsible for notifying hospital administration of changes to the Designated Drugs and Substances Regulation under the Midwifery Act, 1991. Lead midwives should be open to collaboration with hospital leaders such as the Chief of Medicine, the Medical Advisory Committee, and the Chief of Obstetrics to adapt any current processes that would need to change in light of the new regulation. The College of Midwives of Ontario has prepared a letter notifying hospitals to the changes contained within the Designated Drugs and Substances Regulation, which can be provided to midwives in order for them to communicate with their hospitals about these updates.
The College of Midwives of Ontario has also sent a letter to other health regulatory colleges, including the College of Physicians and Surgeons of Ontario, the College of Nurses of Ontario, and the Ontario College of Pharmacists, advising these regulators of changes to the Designated Drugs and Substances Regulation, with a request for them to share this information with their registrants.
The College’s Policy on Controlled Drugs and Substances Education and Training or Course Requirement refers specifically to Schedule 4, controlled drugs and substances, i.e. opioid analgesics. Each midwife will have unique education requirements dependent on their route of entry into midwifery practice and their background education. Midwives can consult the Policy on Controlled Drugs and Substances Education and Training or Course Requirement to understand exactly which education requirements apply to them.
For all other drugs and substances listed in the new regulation, it is the midwife’s responsibility to ensure that they have the knowledge, skills, and judgment to prescribe and administer medications contained within the list. Midwives will find a variety of clinical resources through the Association of Ontario Midwives and through other education centres to renew, refresh, or review their understanding of each drug or substance and their use.
The Designated Drugs and Substances Regulation, section 4(1) reads:
Section 4 (1) For the purposes of paragraph 5 of section 4 of the Act, a member may, in a public hospital, on the member’s own responsibility, administer by injection a substance set out in Schedule 4 to this Regulation…
Schedule 4 lists controlled drugs and substances fentanyl citrate, meperidine, morphine sulfate, and nalbuphine, which are all opioid analgesics.
All medications in the regulation must be used to treat a condition that is within the midwifery scope of practice, and the medication’s use must be clinically indicated. As such, the only use for the opioid analgesics listed above is for intrapartum pain management in a hospital setting.
College of Midwives of Ontario Safe Prescribing and Administration of Controlled Drugs and Substances Course
Completion of this online module satisfies the requirements set out in the Designated Drugs and Substances Regulation for Ontario midwives to prescribe and administer in public hospitals, on their own authority, the following controlled drugs and substances: fentanyl citrate, meperidine, morphine sulphate, and nalbuphine.
Section 1 Links
For more information on the legislative and regulatory frameworks pertaining to the Designated Drugs and Substances Regulation, please visit the following links.
- CDSA
- The Regulated Health Professions Act
- Controlled Acts Regulation
- The Midwifery Act
- The Designated Drugs and Substances Regulation
Section 2 Links
For more detailed information on the standards of practice referenced in this course, please visit the following links.
Section 3 Links
For more information, please visit the provided links to resources on the opioid crisis, the College’s Standards of Practice, and the Association of Ontario Midwives website which provide comprehensive resources including clinical practice guidelines and a pharmacology app.
- Health Canada
- Canadian Centre on Substance Use and Addiction
- Standards of Practice
- The Association of Ontario Midwives (clinical practice guidelines and pharmacology app)
Policy on Controlled Drugs and Substances Education and Training or Course Requirement
Webinar on the changes to the Designated Drugs and Substances Regulation
Thank you to everyone who joined the College of Midwives of Ontario webinars on the Designated Drugs and Substances Regulation. We have posted the webinar for all midwives to our website here. Included in this webinar is the College of Midwives of Ontario Safe Prescribing and Administration of Controlled Drugs and Substances Course.
Please note that the when the webinar was recorded the College’s Prescribing and Administering Standard was still in effect. The standard was rescinded on July 15, 2024. There may be other documents that still refer to the rescinded standard, the College is currently working to update older materials to reflect this change.