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Home News RSV Monoclonal Antibody Added to Designated Drugs and Substances Regulation

RSV Monoclonal Antibody Added to Designated Drugs and Substances Regulation

On Friday, October 31, the government advised the College of Midwives of Ontario that an amendment to O. Reg 188/24, the Designated Drugs and Substances Regulation under the Midwifery Act, 1991 had come into force.

The amendment includes the addition of a single substance, RSV monoclonal antibody to the existing regulation, permitting midwives to both prescribe and administer by injection an additional immunization to prevent respiratory syncytial virus (RSV) transmission in newborns. This amendment to the Designated Drugs and Substances Regulation is in force effective October 31, 2025.

Access to the RSV monoclonal antibody, which protects against virus transmission, 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.

In the regulation, the previous heading “Vaccines and Immune Globulins” has been replaced by the broader term, “Immunizations.” Substances which fall under this category will represent different types of immunizations, including vaccines, immune globulins, and monoclonal antibodies.

The College of Midwives worked with the Ministry of Health to prioritize this timely regulatory amendment, which will enable more newborns to be protected as we enter the 2025-26 RSV season. We are pleased to see this addition to the list of drugs and substances that midwives can prescribe and administer on their own authority.

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M4T 1L9
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