The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Retigabine (Trobalt®) has been accepted for restricted use as an adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above. The restriction limits use to individuals with refractory epilepsy with treatment initiated by clinicians who have appropriate experience in the treatment of epilepsy.
Prucalopride (Resolor®) has been rejected for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. The manufacturer failed to provide a sufficiently robust clinical and economic analysis. The National Institute for Health and Clinical Excellence (NICE) has previously recommended the product provided that at least two different types of laxatives at the highest possible recommended doses for at least 6 months without success and invasive treatment is being considered.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The British National Formulary for Children 2011-2012 has been updated, published and made available online.
Hard copies can be ordered from the publishers however many NHS staff will receive a free hard copy through usual channels and can also access the online version.
Update prescribing information in this revision include:
- The addition of symbols indicated the schedule for all controlled drugs throughout the BNFC
- Updated guidance on the use of antiepileptic medication in pregnancy
- Updated guidance on the pre-hospital management of bacterial meningitis
- Updated guidance on the treatment of HIV infection
- Updated advice on the interactions of combined hormonal contraceptives and progestogen-only contraceptives
- Updated advice on the management of nocturnal enuresis
- A revised set of cautionary and advisory labels
- A new look for table summarising antibacterial therapy
Action: BNFC is the primary source of prescribing information when prescribing to all children up to the age of 18 years.
The Prescription Medicine Code of Practice Authority (PMCPA) has reprimanded Bayer and ruled that they have brought discredit onto the pharmaceutical industry after the social media site twitter was used to post information about vardenafil (Levitra®) and delta-9-tetrahydrocannabinol and cannabidiol (Sativex®).
A journalist reported the 'tweets' to the PMCPA and asked whether action would be taken and what concerns the PMCPA had regarding the use of social media sites to promote pharmaceutical products.
The PMCPA have responded strongly and ruled a breach of clause 2 of the voluntary Code of Practice. The PMCPA also referred to Digital Communication Guidance issued in April 2011 which specifically discusses the application of the current Code of Practice to the rapidly evolving use of social media and digital communications.
Action: Clinicians should be aware of this first ever case of a pharmaceutical company being reprimanded for promoting products using social media sites. The PMCPA obviously consider that the Code of Practice extends to all forms and methods of communication.
Thank to Kevin Ashworth for spotting this reprimand
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2011 (PDF).
This issue contains drug safety information advising clinicians of updated dosing information for paediatric paracetamol liquids. The dosing recommendations have been revised to narrower age bands with a single dosing option per band.
For children aged 3 months to 6 years paracetamol 120mg/5ml is recommended at the following doses:
- 3-6 months: 2.5ml up to four times a day
- 6-24 months: 5ml up to four times a day
- 2-4 years: 7.5ml up to four times a day
- 4-6 years: 10ml up to four times a day
For children aged 6 to 12 years paracetamol 240mg/5ml or 250mg/5ml is recommended at the following doses:
- 6-8 years: 5ml up to four times a day
- 8-10 years: 7.5ml up to four times a day
- 10-12 years: 10ml up to four times a day
This edition also contains a hot topic section that discusses two recent reports that were commissioned by the Department of Health to review prescribing of benzodiazepines and over-the-counter (OTC) analgesics containing codeine. The reviews noted an increase in use of anxiolytics between 1991 and 2009 while hypnotic prescribing declined. Use of OTC codeine containing medicines has also been rising since 2006. Large variations in regional prescribing are also noted in these reports but it remains unclear why the variations exist.
Healthcare professionals are reminded that:
- benzodiazepines should be prescribed the lowest effective dose for the shortest time possible, up to a maximum of 4 weeks including a dose tapering phase
- OTC codeine containing medicines should be used for the short-term (3 days) treatment of acute, moderate pain which is not relieved by simple analgesia
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The manufacturer of leuprorelin (Prostap®) injections has written to healthcare professionals advising that the current presentation will be replaced with effect from the 4th of July 2011 and with a dual chamber syringe (DCS) system.
The one month (Prostap SR) and three month (Prostap 3) presentations are both affected by this change with the product license and price remaining unchanged. The manufacturer reports that the DCS system is simple to use and that the existing products will be discontinued in October 2011.
Action: Clinicians should be aware of this product presentation change. Clinicians who use Prostap products should ensure that usage instructions for the new product are followed.