Tell people how to take pills, Commission urged

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Health specialists urged  the European Commission to include provisions to its revised proposal for the controversial Information to Patients directive, expected for early October, so that patients are fully instructed on how to take medicine properly.

The European Parliament voted on the proposals in October last year, calling for obligatory industry information on medicinal products and for no comparative details available on packs, as this could be seen as promotional.

MEPs also requested links between the information given in packs and internet databases, allowing patients to obtain further information relating to the testing of their medicines.

Health Commissioner John Dalli last year welcomed the Parliament's suggestions, but rejected calls to connect patient information with online data, saying such a move could ostracise patients who do not have access to the internet.

Spelling out the risks

However, at a lunch debate in the Parliament this week, health sector delegates urged the Commission to take the proposals a step further.

The meeting was called to discuss methods of helping patients 'adhere' to therapies – to take the medicines prescribed to them properly – and delegates called for patient information to include advice on what the effects of non-adherence would be, and repeated calls for links between packs and online information.

The meeting heard estimations that 20% to 30% of European patients do not follow medication regimens, and 30% to 40% fail to abide by regimens designed to prevent health problems.

Almost 200,000 deaths occur in the EU each year due to mis-dosing and non-adherence to prescribed medication, which is estimated to cost the European Union €1.25 billion annually, delegates were told.

Older people more likely to 'forget' to take medicine

Failure to take medicine affects some illnesses more than others, such as cardiovascular disease, for which up to 50% of hospital admissions may be due to poor adherence. Older people often take multiple medications and are at greater risk of adverse drug reactions through failure to understand their medicine regimens.

Professor Przemyslaw Kardas, the head of family medicine at the University of Lodz, told the meeting: "I would like to see the patient information contain information enabling patients to adhere and telling them what to do if they failed to carry on taking the medicine properly. At the moment this kind of information is only provided for contraceptives, but it is needed for a whole range of other disorders such as hypertension."

Richard Bergström, the director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said that the European Parliament's proposals for patient information were "a good starting point" for the Commission to use, but he added: "We need to take a look at how we provide patient information with packaging. It could be something that is uploaded online."

Jeremy Fleming

"There is still a lack of coordination between health professionals, patients and the industry," said MEP Cristian Silviu Bu?oi (Liberals & Democrats; Romania).

He added: "The European Innovation Partnership on Healthy and Active Aging will be an excellent opportunity to explore potential innovative solutions that can support individual patients and carers, improve data sharing and communication between health professionals, and improve the integration of care."

Health professionals should engage with patients as equal partners in the prescribing process, really listening to and taking account of their views, according to Christos Sotirelis, a representative from the European Patients' Forum.

"We need to empower patients and educate health professionals in order to create such an environment and promote meaningful dialogue," he concluded.

proposal to change the rules on providing medicine information to patients was included in the 'pharmaceutical package' presented by the European Commission in December 2008. 

The controversial measures, which would allow pharmaceutical companies to provide information directly to consumers for the first time, was partly to blame for repeated delays to the long-awaited pharma package. 

Critics said allowing companies to provide factual information on their own products would open the door to advertising of prescription drugs. Proponents of the plan say quality information in all EU languages should be provided so that consumers are not taken in by poor quality online information.

The European Parliament voted in a draft report by Swedish MEP Christofer Fjellner last year which highlighted the importance of providing information in a consumer-friendly format. The Commission will publish its second draft proposal in October.

  • 10-14 Oct. 2011: Commission expected to publish new draft Information to Patients Directive.

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