Report sus­pected side ef­fects to help make medicines safer: Malta Medicines Au­thor­ity

Malta Independent - - NEWS -

The Malta Medicines Au­thor­ity is run­ning a so­cial me­dia cam­paign to pro­mote re­port­ing of sus­pected medicines side ef­fects be­tween 7th -19th Novem­ber, as part of an EU-wide aware­ness ini­tia­tive.

At the cen­tre of the cam­paign is an an­i­ma­tion show­ing the story of a pa­tient who has a sus­pected ad­verse re­ac­tion. It shows the medicine be­ing pre­scribed, a sus­pected side ef­fect be­ing ex­pe­ri­enced and, fi­nally, how re­ports are made by pa­tients or health­care pro­fes­sion­als to the medicines reg­u­la­tor.

Medicines reg­u­la­tors rely on the re­port­ing of sus­pected side ef­fects to help make sure medicines on the mar­ket are ac­cept­ably safe. Un­for­tu­nately, all re­port­ing sys­tems suf­fer from un­der re­port­ing, and this is why our cam­paign is im­por­tant to both raise aware­ness and help strengthen the sys­tem.

Re­port­ing side ef­fects has re­cently led to:

• the for­mer obe­sity drug Ri­mon­a­bant be­ing with­drawn af­ter new ev­i­dence which meant the risks were con­sid­ered to out­weigh any ben­e­fitsin­ter­ac­tion be­tween War­farin and cran­berry juice – a warn­ing is­sued that pa­tients tak­ing the medicine should limit or avoid drink­ing cran­berry juice

• in many EU coun­tries the ad­vice not to pre­scribe Aspirin to chil­dren vir­tu­ally elim­i­nat­ing cases of Reye’s syn­drome, a se­ri­ous, and of­ten fa­tal con­di­tion, that causes swelling in the liver and brain, prob­a­bly pre­vent­ing thou­sands of cases since. Prof. An­thony Ser­ra­cino In­glott, Chair­per­son of the Medicines Au­thor­ity stated:

“The most im­por­tant part of our work is mak­ing sure the medicines you and your fam­ily take are of high qual­ity, safe and ef­fec­tive. Our cam­paign will help the pub­lic; pa­tients and health­care pro­fes­sion­als report po­ten­tial side ef­fects and have con­fi­dence that their re­ports are mak­ing a dif­fer­ence. You can help make medicines safer by re­port­ing any sus­pected side ef­fects eas­ily and quickly on­line through www.medici­ne­sauthor­ .”

The cam­paign is part of the Strength­en­ing Col­lab­o­ra­tion for Op­er­at­ing Phar­ma­covig­i­lance in Eu­rope Joint Ac­tion project. One of its main aims is to raise aware­ness of na­tional re­port­ing sys­tems for sus­pected side ef­fects in medicines.

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