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• W2079267637 abstract "Primidone is licensed for the treatment of epilepsy and essential tremor. In April, 2003, AstraZeneca informed the UK Department of Health (DoH) that they were planning globally to discontinue Mysoline, the only primidone licensed in the UK, due to low volume of use. This decision would affect about 10000 individuals in England alone. In June, 2003, the company told regional medicines information centres and the pharmaceutical press in the UK that Mysoline supply would be stopped in December. Further information, cascaded from purchasing pharmacists in hospitals and Primary Care Trusts to individual hospital and family doctors, stated that primidone could be withdrawn and replaced but warned that abrupt withdrawal could cause seizures. After complaints from several professional and patients' groups, AstraZeneca reviewed their decision and announced on Aug 12, that the drug would be continued into 2004. Astra- Zeneca announced in June, 2004, that the production and supply of Mysoline was secure for the foreseeable future. The discontinuation of medicines is not regulated by legislation, but by a set of best-practice guidelines drawn up by the DoH and the Association of the British Pharmaceutical Industry (ABPI).1Association of the British Pharmaceutical Industry and Department of Health Ensuring best practice in the notification of product discontinuations: best practice guidelines.http://www.dh.gov.uk/assetRoot/04/06/70/45/04067045.pdfGoogle Scholar Adherence is voluntary. The DoH has no legal means of stopping the discontinuation of a licensed drug. AstraZeneca followed the guidelines, but this did not protect some patients with epilepsy (see panel for examples). The guidelines imply that the DoH will consult relevant professional and patients' groups before the decision to discontinue a drug is publicly announced. How this consultation was done in this case is unclear, but the process did not involve the Association of British Neurologists, the British Chapter of the International League Against Epilepsy, Epilepsy Action, the National Society for Epilepsy, or the Joint Epilepsy Council.PanelTwo examples of patients affected by discontinuation of MysolineCase 1A 65-year-old man with epilepsy treated with primidone was invited by his doctor for a review of his medication in September, 2003. The patient was started on primidone after two generalised tonic clonic seizures (GTCS) in 1963, and subsequently had only one further GTCS after an attempt to withdraw primidone in 1973. Although the patient was concerned about making any changes to his treatment, his doctor instructed him to switch to phenytoin over 2 weeks. A fortnight after taking the last tablet of primidone the patient, who lives in an isolated rural location, had a cluster of three GTCS, resulting in the loss of his driving licence for a year.Case 2A 53-year-old woman with epilepsy with GTCS treated with primidone and valproate saw her family doctor for a check-up in November, 2003. She developed epilepsy after a febrile convulsion at age 5 years. Her seizures proved refractory to several drugs before she started primidone monotherapy in 1967, and stopped after valproate was added to primidone in 1977. Valproate monotherapy was abandoned because of recurrent seizures in 1978. At her check up, she was informed of the discontinuation of primidone and told that her treatment would be tapered over 2 months. Less than a month after stopping primidone she had a GTCS, causing her to fall down some stairs. She developed problems with concentration and lightheadedness, which meant she was unable to work. Case 1 A 65-year-old man with epilepsy treated with primidone was invited by his doctor for a review of his medication in September, 2003. The patient was started on primidone after two generalised tonic clonic seizures (GTCS) in 1963, and subsequently had only one further GTCS after an attempt to withdraw primidone in 1973. Although the patient was concerned about making any changes to his treatment, his doctor instructed him to switch to phenytoin over 2 weeks. A fortnight after taking the last tablet of primidone the patient, who lives in an isolated rural location, had a cluster of three GTCS, resulting in the loss of his driving licence for a year. Case 2 A 53-year-old woman with epilepsy with GTCS treated with primidone and valproate saw her family doctor for a check-up in November, 2003. She developed epilepsy after a febrile convulsion at age 5 years. Her seizures proved refractory to several drugs before she started primidone monotherapy in 1967, and stopped after valproate was added to primidone in 1977. Valproate monotherapy was abandoned because of recurrent seizures in 1978. At her check up, she was informed of the discontinuation of primidone and told that her treatment would be tapered over 2 months. Less than a month after stopping primidone she had a GTCS, causing her to fall down some stairs. She developed problems with concentration and lightheadedness, which meant she was unable to work. What lessons can be learned? The DoH and ABPI should review their guidelines; they might offer better protection if the consultation process about planned drug discontinuations was improved and clear standards for the dissemination of information were laid down. The DoH could also review its policy on informing interested parties on the procurement of discontinued medicines from abroad. Pharmaceutical companies should liaise with professional and patients' groups before discontinuing a drug, and Primary Care Trusts should review how they disseminate information received from pharmaceutical companies or the DoH to family doctors. Finally, doctors who are not experts in the treatment of epilepsy should not change drug regimens without obtaining specialist advice. Copies of all dated correspondence from AstraZeneca are available from the author." @default.
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• W2079267637 date "2004-10-01" @default.
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• W2079267637 title "Discontinuation of Mysoline: lessons to be learned" @default.
• W2079267637 doi "https://doi.org/10.1016/s0140-6736(04)17306-6" @default.
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