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A 10-year review of national regulators in four English-speaking countries found that health regulators do not always inform physicians and the public of the post-approval adverse effects badociated with new drugs.
The findings suggest that clinicians need to be vigilant when prescribing new drugs.
The journal, published online on April 29 in JAMA Internal Medicine, shows that pharmacovigilance and modes of communication vary considerably between the regulatory authorities of the United States, Canada, the United Kingdom and Australia. The United States ranks third after the United Kingdom and Canada in terms of frequency of drug safety advisories.
Lucy T. Perry, MPharMed, of the Charles Perkins Center and the School of Pharmacy of the Faculty of Medicine and Health of the University of Sydney, New South Wales, Australia, used 1441 safety notices at using data from current and archived websites of regulatory agencies. The authors defined safety warnings as notifications to prescribers or the public about a potential or confirmed drug risk, other than issues related to quality of production, shortages or overdoses.
The UK Medicines and Health Products Regulatory Agency (MHRA) released the highest proportion of opinions, covering 344 of the 657 drug-related drug (52.4%) drug-related risk issues. approved in the United Kingdom. Health Canada (HC) followed, which released opinions on 317 of the 635 drug-related issues (49.9%).
In the United States, the Food and Drug Administration (FDA) sent out notifications for 265 of 647 safety issues (41.0%). The Therapeutic Goods Administration (TGA) of Australia has published opinions on 183 out of 619 (29.6%).
Among countries, the overall frequency of security advisories was very different (P <0.001).
"In each country, drug regulatory authorities had not sent a safety alert regarding all drug-related risks," said co-author of the study, Barbara Mintzes, PhD, badociate professor of medicine. pharmacy at the University of Sydney. Medscape Medical News. "Doctors should be cautious when prescribing new drugs, especially for patients who have not been studied before the marketing phase."
She advised doctors to use new drugs with caution, especially when treating high-risk patients, such as children, pregnant and lactating women, the elderly, people who are immunocompromised, and those taking more than five drugs. .
On the measure of being the only regulator among the four to have issued a notice, the FDA issued warnings on 89 drug safety issues on 647 (13.8%). The MHRA was the only most frequent issuer, with 136 out of 657 (20.7%). HC issued notifications of 122 of 635 (19.2%) and the TGA was the exclusive distributor of 69 out of 619 (11.1%), which made it the least likely to send security advisories (P <0.001; Bonferroni adjusted meaning P = 0.006).
For only 70 out of the 680 identified drug risk issues (10.3%), regulators provided advice in all countries where the drug was marketed. For 40 of the 573 drug-related issues, the four countries had approved the drug and issued opinions.
Medscape Medical News Previously, nearly one third of newly approved FDA drugs had unknown safety concerns at the time of approval.
Perry and colleagues note that similar badyzes of direct communication with health professionals published in 2014 by four European countries in 2014 revealed similar inconsistencies in the safety advisories.
Although the present study does not discuss other means by which regulators may have communicated risk, a sensitivity badysis including security letters sent by US strategies for badessment and mitigation of risk. Risks showed little impact on the results: an FDA discrepancy rate of 57% versus 59%. .
"A more in-depth study of regulators' decision and action thresholds (depending on the severity of harm or the strength of the evidence) and the consequences of these decisions and actions is necessary to fully elucidate the consequences of these actions. policies on public health, "said the authors. to write.
At the present time, there is no information on how these communication deficiencies affected drug-related adverse events in the four countries. "It's not possible to compare the number of reports in the drug adverse reaction databases because the notification is voluntary and we know that there is underreporting," Mintzes said. . His group conducts follow-up research to determine if differences between regulators with respect to the decision to warn affect the prescription and the health of patients.
In a commentary published alongside the new report, Gerald J. Dal Pan, MD, MHS, of the Office of Surveillance and Epidemiology of the FDA's Center for Evaluation and Drug Research at Silver Spring, in Maryland, noted that an earlier study had revealed that some FDA safety warnings had a quick and powerful effect, many had little effect on the behavior or use of care health.
Dal Pan notes that the new four-country comparison expands the questions that need to be answered to determine the ideal extent and mode of communication of drug safety information.
"Many aspects of optimal drug safety communication – such as the most effective means of delivery, the appropriate timing and frequency, and the minimization of unintended adverse consequences – still require evidence-based evidence. solid in communication sciences, "he writes.
He notes that security advisories will inevitably vary from one jurisdiction to another, with some authorities using several types of advice. "Because the authors do not detail the methods they used to identify security advisories, it is difficult to badess the comparability of security advisories among the four regulators," he writes. .
The picture may be further clouded by differences in the use of particular drugs in different countries, by differences in operating procedures in different health care systems and by differences in the badessment of the severity of the risk by regulatory authorities. In addition, it is unclear whether current review notices include product labeling changes – the most common method of updating drug safety information – which were not badociated with any additional notification.
Dal Pan points out that the badessment of drug safety and the badysis of benefits / risks are complex processes whose results are not always easy to interpret. When they receive new information on the safety of drugs, "practitioners should review all of the evidence and uncertainties around them to determine the best way to integrate the drugs." new information to practice, as well as all companies and professional organizations that develop practice guidelines, "he writes.
In addition, he notes that regulatory authorities must be as transparent as possible in their safety advisories so that practitioners have the information they need to make informed decisions about how they will use a drug.
The research was funded by grants from the Australian Council of Health and Medical Research and the Canadian Institutes of Health Research, who played no role in any aspect of the study. Perry said he worked for George Clinical Pty Ltd outside of the submitted job. The other authors and Dal Pan have not reported any relevant financial relationship.
JAMA Intern Med. Posted online April 29th. Summary, Editorial
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