LONG-TERM users of medication may at some point suffer from side effects, big or small, but a little known scheme that has been running for years allows patients and doctors to report side effects that are later disseminated in EU and world bodies, stakeholders said yesterday.
Patients or doctors can submit a confidential report online via pharmaceutical services on www.moh.gov.cy/phs (click on the yellow card banner) in either Greek or English to report what medication they take, what reactions they believe the drugs are having, and their medical history and background.
Three bodies issued a news release yesterday to raise awareness: the Thalassaemia international federation, the Cyprus alliance for rare disorders and the Pancyprian thalassaemia association.
The pharmaceutical services said the reporting scheme has been set up for years, but the head of the Thalassaemia international federation, Androulla Eleftheriou, said patients and doctors are not necessarily aware of it.
“Patients are either misinformed or not aware of their rights and responsibilities to report possible adverse reactions that may be related to the drugs they take,” Eleftheriou said.
And because the scheme is not mandatory, not all doctors make use of, or even know about the scheme, she said.
But pharmacovigilance or monitoring medicine safety is a “very important issue for the European Union because it is a way of monitoring chronic reactions that are important on patients who depend on lifelong treatment”, Eleftheriou said.
Patient reporting is part of a system in place in the EU to monitor medicine safety, reduce risks and increase benefits by acquiring input across thousands of patients. A reporting template for patients alone is due this June and will be disseminated across member states, an official from pharmaceutical services said.
Direct reporting from patients needs to be sorted by medical specialists and evaluated on a national and international level. An official from the pharmaceutical services looks at a report, decides whether any action needs to be taken on a national level and passes on the information to the Eudravigilance network, the EU’s mandatory data processing network on adverse drug reactions launched in late 2011.
There is a host of classifications for perceived side effects, from definite connections between a drug and its side effects to a looser correlation between drugs and side effects, or factors relating to drug interactions.
Treating thalassaemia for example, the blood disorder that requires regular blood transfusion in some cases, may lead to adverse reactions from the drugs taken to regulate iron accumulation. Patients may suffer from allergies, stomach problems, or suffer from liver and other organ ailments.
“So it is very important to see what (side effects) are related to drugs,” Eleftheriou said.
“From the feedback we are getting we can see that reporting (side effects) is weak,” she said urging patients and doctors to become proactive.