MHRA reports big increase in serious adverse blood reactions in annual report

The agency says the increase can be attributed to changes in the way the reports are collected.

Medicines and Healthcare Products Regulatory Agency

The UK’s medicines safety watchdog investigated 17,484 adverse incidents last year and issued 24 medical device alerts, according to the Medical and Health products Regulatory Agency’s (MHRA) annual report for 2016–2017, published in July 2017.

The MHRA dealt with 3,779 serious adverse blood reactions and events — a “large” increase on the 2,470 in the previous 12 months, it said. The rise, according to the report, is attributed to changes in the way the reports are collected.

It also investigated 1,351 defective medicines reports, issued 22 drug alerts and supported nine company-led drug alerts, the report revealed.

The MHRA highlighted its first ever sustained public health campaign to discourage people from buying fake medical products.

The campaign included fake slimming products, condoms, sexually transmitted disease self-testing kits and medication for erectile dysfunction. The initiative was supported by the Royal Pharmaceutical Society and will run for the next three years.

The report also revealed the impact in the past year of the new European Union tobacco products directive, which came into force in May 2016.

Under the directive the MHRA had to establish a notification scheme for electronic cigarettes and refills; producers have to inform the agency if they intend to launch a new product.

The report revealed that the UK has “received thousands more notifications than any other member state”, adding: “The agency is now regarded positively by key stakeholders across the industry as having been inclusive and pragmatic in our approach to implementation.”

“Our focus is on safety in use and we have added a new entry point to our Yellow Card reporting portal to accept reports about safety and health effects of these products.”

Outside the UK the MHRA continued to play a significant role in helping to secure the global medicines supply chains and crack down on the illegal trade of medicines and devices.

It was involved in the month-long Operation Pangea IX, which resulted in the seizure of potentially dangerous medical products worth £13.6 million, led to 393 arrests worldwide, and the closure or suspension of 4,700 websites.

The annual report also reiterated the MHRA’s intention to maintain its role in ”retaining protection of public health and patient safety” whatever the impact of the Brexit negotiations.

Last updated
The Pharmaceutical Journal, MHRA reports big increase in serious adverse blood reactions in annual report;Online:DOI:10.1211/PJ.2017.20203289

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