Recalls of medical products in the Republic increased by 20 per cent between 2004 and 2005, according to figures from the Irish Medicines Board (IMB). Reports of adverse drug reactions rose by 8 per cent last year.
Some 163 product recalls were initiated by the IMB in 2005; of these 89 involved medical devices. While 68 recalls related to human medicines, just six product recalls involved veterinary medicines.
The IMB is responsible for the quality, safety and efficacy of human and veterinary medicines and medical devices available or manufactured in the State. In a statement outlining its performance for 2005, the IMB said packaging and labelling defects and the distribution of unlicensed products were the main reasons why it recalled products. Packaging issues include incorrect information in patient leaflets.
Among the unlicensed products recalled last year was a batch of illegally imported condoms bearing the Tulip brand name. The condoms did not carry the quality CE mark in line with 1994 European Communities (Medical Devices) Regulations. A subsequent investigation found the condoms had defects and could not be guaranteed to prevent the transmission of sexually transmitted diseases or work as an effective means of contraception.
The IMB said yesterday "the company involved in the importation and distribution [ of the condoms] was successfully prosecuted".
The board's compliance department initiated 561 cases involving breaches of medicines and medical devices legislation in 2005. "These enforcement investigations led to the seizure of 65,044 tablets, 17,456 capsules, 2,971 millilitres of liquids and 6,525g of creams," the IMB said.
During 2005, the IMB received 1,861 adverse drug reaction (ADR) reports from healthcare professionals and pharmaceutical companies. Under a voluntary reporting system, doctors, dentists, pharmacists and nurses are requested to report all suspected reactions to new medicines and serious suspected reactions to established drugs.
Pharmaceutical companies reported 856 ADRs, while the number of ADRs occurring during clinical trials fell from 190 in 2004 to 127 last year. ADR reports from hospital pharmacists almost doubled in 2005.
The number of human medicines applications processed by the IMB rose from 16,669 in 2004 to 18,082 in 2005.
The IMB said it continued to collaborate with international medicines regulatory agencies. It signed agreements during 2005 with the US Food and Drugs Administration (FDA) and the UK Medicines and Healthcare Regulatory Agency (MHRA) to facilitate the early sharing of information on the safety of medicines. IMB staff made "a significant contribution" by participating at management and scientific committees of the European Medicines Evaluation Agency (EMEA).
An EU Cells and Tissue Directive comes into force on Friday. It sets out guidelines for the donation, procurement, testing, storage and distribution of human cells and tissues in the EU. Once the directive becomes law here, the IMB will be empowered to inspect any process by which stem cells or other human tissue are stored or distributed.
