Easing restrictions on abortion capsule drastically improved entry to care in Canada

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The lifting of restrictions on the prescription and dispensing of mifepristone – the medical abortion drug – in Canada has greatly improved access to abortion, especially in rural communities across the country.

This is one of the key findings of new research, led by the University of British Columbia, published today in the Annals of Family Medicine.

"Access to family planning health services has long been inadequate and unfair in Canada," said Sarah Munro, lead author of the study and assistant professor in the Department of Obstetrics and Gynecology at UBC Medical School. "The approval of mifepristone helped reduce these inequalities, but it may not have been successful if Health Canada hadn't removed many of the early restrictions required on the drug's prescription and dispensing."

In Canada, mifepristone is packaged together with the drug misoprotol. Together they are marketed as Mifegymiso, a combination product that contains both drugs that are taken sequentially for the medical termination of a pregnancy.

For the study, researchers worked closely with Health Canada, the Society of Obstetricians and Gynecologists of Canada, the College of Family Physicians of Canada, the College of Physicians and Surgeons, and the College of Pharmacists – both nationally and in provinces and territories in Across Canada – Use the results to advance Canada's medical abortion guidelines and improve abortion access and justice in Canada.

The researchers say the results may be relevant to other nations struggling with access to family planning services, as Canada became the first country in the world to introduce evidence-based deregulation of all additional restrictions on the supply and administration of mifepristone.

Early regulations made mifepristone difficult to access

Access to abortion in Canada has been historically unequal, with few options for drug-induced abortion – the preferred method of terminating pregnancy during the first trimester in the US and many European countries.

One possible solution appeared in 2015 when Health Canada approved mifepristone, the medical abortion drug that is considered the international standard. However, with many dispensing and administration restrictions initially associated with approval, there were concerns that availability of the drug may not improve access to abortion care as hoped.

The initial requirements included:

  • Doctors need to watch the patient taking the medication
  • Prescribers must complete mandatory training
  • Patients must sign a consent form from the manufacturer
  • Only doctors, not pharmacists, can dispense the drug directly to the patient
  • Prescribers must register with the manufacturer
  • Mandatory pre-prescription ultrasound
  • Medication could only be used up to seven weeks of pregnancy (instead of nine weeks, which is the standard outside of Canada).

During the course of the study, Health Canada lifted these restrictions on the drug.

However, the researchers found that the regulatory change during the first year of mifepristone's availability caused confusion among healthcare providers, which persisted even after the drug was deregulated.

Postponement regulations caused confusion among prescribers

For the study, researchers sought to understand perceptions of mifepristone barriers in primary care during the first two years of availability in Canada.

They interviewed 90 people – 55 health care providers and 35 stakeholders – who were involved in planning and delivering abortion services across Canada.

"During the interviews, healthcare providers told us that the initial restrictions on prescribing and dispensing mifepristone made the drug more complicated than necessary, which in turn limited patient access," said Munro. "The requirement for ultrasound made it difficult, for example, for clinicians in remote or rural areas where access to timely ultrasound was a challenge."

Healthcare providers unanimously criticized the original requirement that they must observe the patient taking the drug and stated that they could not come up with a legitimate security reason for the requirement. A number of participants also still believed they needed to watch their patients take the drug, although this requirement was eliminated early.

Overall, however, the researchers found that health care providers felt that mifepristone was the new standard for medical abortion in Canada and as part of primary care.

The research provides lessons for the U.S. approach to mifepristone

The researchers say their findings have important implications for other countries that have difficulty accessing family planning services, such as the United States.

Many of the restrictions on mifepristone lifted by Health Canada are still required nationwide in the United States. For example, pharmacists cannot dispense the drug directly to patients there, prescribing doctors must be registered with the drug distributor and patients must sign a declaration of consent.

"Our research found that Canadian doctors believed that these elements would not improve safety, but rather deter doctors from prescribing the drug and limit access to abortion," said Dr. Wendy Norman, senior study author and associate professor, UBC's Department of Family Practice. "Canada's experience of deregulating mifepristone could be useful for countries like the US to bring drug labeling into line with current international practice and evidence."

Canada approves abortion pill and joins 60 other countries

More information:
Annals of Family Medicine (2020). DOI: 10.1370 / afm.2562

Provided by
University of British Columbia

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