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Off-label Prescribing (off-label + prescribing)
Selected AbstractsAdverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in SwedenPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2004Mike Ufer MD Abstract Purpose To investigate the extent and characteristics of off-label prescribing for paediatric outpatients among drugs reported to have caused an adverse reaction. Methods A retrospective, cross-sectional, observational analysis of spontaneous adverse drug reaction (ADR) reports in Sweden in the year 2000. We included all reports concerning drugs prescribed for outpatients younger than 16 years. Each ADR was classified with respect to its causality, seriousness and type of reaction. Off-label prescribing was evaluated with respect to age, dose, indication, formulation and route and frequency of administration. Results We identified 112 patient-linked reports corresponding to 158 ADRs of which 31% were serious. Antiasthmatic drugs were most frequently suspected as a cause of almost every third adverse reaction. The average proportion of off-label drug prescribing amounted to 42.4%. It was more frequently associated with serious than non-serious ADRs and mostly due to a non-approved age or dose. The most common clinical manifestations were psychiatric disorders and mucocutaneous inflammatory reactions. Conclusions Off-label prescribing for paediatric outpatients is common among drugs reported to have caused an ADR. It is suggested to further identify unlabelled drugs frequently contributing to, in particular serious ADRs in children for a proper benefit-risk assessment of off-label drug use. Copyright © 2003 John Wiley & Sons, Ltd. [source] Latest news and product developmentsPRESCRIBER, Issue 17 2007Article first published online: 6 NOV 200 Drug information stilllacking for mentally ill Half of people with mental illness still have no say in the medication they are prescribed and one-third are not informed about side-effects, according to the latest report by the Healthcare Commission and the Commission for Social Care Inspection (www.health-carecommission.org.uk). The annual national review of adult mental health services found overall improvement among local intervention teams in 2005/06 compared with the preceding year, though all could improve further and the performance of 46 per cent were rated as only fair or weak. A survey of 7446 people with schizophrenia also showed that only 46 per cent had access to psychological treatments. More incentives for shift of care in Scotland Scotland has made good progress on shifting NHS care into the community but joined-up thinking, better information and incentives are needed to overcome barriers to better management of long-term conditions in adults, says Audit Scotland (www.audit-scotland.gov.uk). Reviewing progress on the 2005 strategy document Delivering for Health, Audit Scotland found good progress on asthma and diabetes services , partly due to the effects of the GMS contract. Better information about clinical activity, costs and effectiveness is needed to help redesign services. Patients with more than one long-term condition do not receive co-ordinated care and many want greater involvement in their care, the report concluded. Acorn, QOF and Guy Rotherham awards Entries are invited for the 2007 annual Acorn, QOF and Guy Rotherham Awards. The awards are run in association with the NHS Alliance, Improvement Foundation, British Cardiac Society, British Cardiac Patients Society and Prescriber. The CHD QOF Award, sponsored by Schering-Plough, recognises the achievement of an individual practice that gains maximum points in the CHD and heart failure QOF domains, and a second award is given to the primary care organisation (PCO) that achieves the best average scores across its practices. The entry form can be found at www.escriber.com. The closing date is 12 October. Entries are also invited for the Guy Rotherham Award from PCOs that can demonstrate they have delivered a high-impact change resulting in better outcomes and services for patients. For online entry go to www.improvementfoundation.org/guy rotherhamaward. Closing date is 5 October. Award winners will receive free entry for three to the NHS Alliance conference and the conference dinner. The winner of the Guy Rotherham Award will also receive £3000. NICE scores five out of six NICE acted unreasonably in relying solely on the Mini-Mental State Examination (MMSE) to define severity of Alzheimer's disease in its updated technology appraisals, with the effect of discriminating against people with learning or language difficulties, the High Court has ruled. The five other claims by Eisai that NICE acted unreasonably and irrationally were not upheld. This was the first court action against NICE in its eight-year history. It has now promised to publish revised appraisals on its website on 7 September and is consulting with Eisai, Shire Pharmaceuticals and the Alzheimer's Society on the best approach. PPRS reform follows Office of Fair Trading report The Government is to renegotiate the Pharmaceutical Price Regulation Scheme (PPRS) following the critical report by the Office of Fair Trading (OFT). In February, the OFT recommended renegotiation of the PPRS to reward innovation and obtain better value for patients. In particular, it called for a pricing scheme based on value for patients, ie effectiveness, rather than profit controls. The DoH, acknowledging the report's complexity, says it will take four principles into account in its negotiations during the forthcoming months: value for money, promoting innovation, assisting the uptake of new cost-effective medicines and promoting market stability. MHRA launches e-bulletin The MHRA (www.mhra.gov.uk) has next issue can be downloaded. The launched an electronic bulletin to August bulletin includes items on provide health professionals with antidepressants and suicide, updates about the safe use of medi-adverse effects of dopamine ago-cines. Users need to sign up to nists and information about smokreceive an e-mail alert when the ing cessation and isotretinoin. DURG call for abstracts The Drug Utilisation Research Group is calling for abstracts for its 19th annual meeting ,Target-driven medicine , is this the end of prescribing freedom?' to be held on 7 February 2008 at the Royal Society of Medicine, London. Abstracts are requested on any aspects of drug utilisation research. A bursary of £500 will be awarded for the best abstract received. The closing date for receipt of abstracts is 26 November. Further information about abstract submission is available at www.durg.org.uk. GP prescribing up by half Prescription volume and costs in England increased by approximately half over the decade to 2006, according to data published by the Information Centre for Health and Social Care (www.ic.nhs.uk). The number of items dispensed per year increased by 55 per cent and the cost by 60 per cent in real terms. The average number of items per head of population was 10.0 in 1996 and 14.8 in 2006; older people received 21.2 items per head in 1996 but 40.8 in 2006. MR morphines similar Modified-release preparations of morphine are equivalent in the treatment of severe pain, according to a new review by Bandolier (www.jr2.ox.ac.uk). The analysis of 54 randomised trials, which reviewed the release mechanisms and clinical data for four brands, showed these preparations provide effective analgesia for malignant and nonmalignant pain; about 4 per cent of patients were unable to tolerate the adverse effects of morphine. NSAIDs compared in OA Etoricoxib (Arcoxia) and naproxen are equally effective in the long-term treatment of osteoarthritis (Ann Rheum Dis 2007;66:945,51). Extension studies for two one-year trials showed that, after a total of 138 weeks, the two drugs had almost identical effects on pain and function assessments. All treatments were generally well tolerated, but serious cardiovascular effects were more common with etoricoxib and serious GI effects more common with naproxen. CPN nystatin allowed Community practitioner nurses (CPNs) may now prescribe oral nystatin (Nystan) to treat oral thrush in neonates, following a special amendment to the regulations limiting their prescribing to licensed indications. CPNs may now prescribe oral nystatin at the dose recommended in the BNF for Children provided they are sure of the diagnosis. In doing so, they accept clinical and medicolegal responsibility for their actions. There are no other exceptions to the prohibition of off-label prescribing. Copyright © 2007 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 7 2007Article first published online: 11 JUL 200 Poor asthma control with off-licence prescribing Children who are prescribed off-licence medications are more likely to have poor asthma control, according to an analysis from Dundee (Br J Gen Practice 2007;57:220-2). The review of 17 163 consultations identified 1050 (6.1 per cent) who received a prescription for an unlicensed use (defined as not licensed for children or the particular age group, or dose not licensed). High doses (4.5 per cent) were more frequent than unlicensed indications (1.9 per cent). Children who received off-label prescriptions reported statistically significantly more symptoms in the day or night, symptoms during activity, and increased use of daily short-acting beta2-agonists. The authors note that off-label prescribing appears to be increasing. Atkins diet most effective over one year? The ultra low-carbohydrate, high-protein Atkins diet achieved greater weight loss than other popular diets in overweight women over one year, say US investigators (J Am Med Assoc 2007;297:969-77). The study compared the Atkins diet with three diets designed as low- or very high-carbohydrate, or based on USA nutritional guidance, in 311 women with body mass index 27-40. After one year, mean weight loss was 4.7kg with the Atkins diet , significantly greater than with the low- carbohydrate diet (1.6kg) but not compared with very high-carbohydrate (2.2kg) or the nutrition-based diet (2.6kg). Metabolic endpoints were comparable or more favourable in women using the Atkins diet. Androgen therapy linked to gum disease The majority of men treated with androgen deprivation therapy for prostate cancer are more likely to have periodontal disease (J Urol 2007;177:921-4). After controlling for risk factors, the prevalence of periodontal disease was 80.5 per cent among treated men compared with 3.7 per cent in matched controls not receiving treatment. There was no difference in bone mineral density between the groups but plaque scores were significantly higher among treated men. Food Commission rebuts MHRA on additives An independent watchdog has not accepted the MHRA's justification for including certain additives in medicines for children. The Food Commission (www.foodcomm.org.uk) found that most medicines for children contained additives, some of which , including azo dyes and benzoates , are not permitted in food. The Commission called on the pharmaceutical industry to stop using ,questionable additives'. The MHRA stated that the licensing process takes into account the likely exposure to excipients that are considered essential to make medicines palatable to children. Colouring helps children to identify the correct medicine, and preservatives ensure a reasonable shelf-life. A list of additives is included in the product's summary of product characteristics and patient information leaflet. In response, the Commission states: , , it is quite possible to flavour medicines with natural oils or extracts, and natural colourings such as beetroot and beta-carotene can be used instead of azo dyes. If parents were advised to give these medicinal products at mealtimes the manufacturers could also add a little sugar to sweeten their products, rather than relying on artificial sweeteners.' All triptans the same? There is no economic case for choosing one triptan over another and no evidence for preferring a particular triptan for adults, a systematic review has concluded. The Canadian Agency for Drugs and Technologies in Health (www.cadth.ca) found that published trials had compared most triptans with sumatriptan but not with one another, and most economic evaluations were flawed. New drug for HIV Janssen-Cilag has introduced darunavir (Prezista), a new protease inhibitor for the treatment of HIV infection. Licensed for highly pre- treated patients in whom more than one other pro- tease inhibitor regimen has failed, darunavir must be co-administered with ritonavir (Norvir). A month's treatment at the recommended dose of 600mg twice daily costs £446.70. Variation in liquid captopril for children The NHS uses a wide range of liquid formulations of captopril to treat children with heart failure , with no assurance of their bioequivalence (Arch Dis Child 2007; published online 15 March. doi: 10.1136/adc.2006.109389). Specialists in Leicester surveyed 13 tertiary paediatric cardiac centres and 13 hospitals that referred patients to them. Only three tertiary centres supplied the same liquid for-mulation of captopril as their referring hospitals. Four hospitals supplied tablets for crushing and dissolving in water; the other hospitals and centres used a total of nine different formulations. The authors say the formulations had widely varying shelf-lives, determined empirically in all but one case, and were used interchangeably despite a lack of quality control data to establish their bioequivalence. QOF CVD targets not good enough for GPs Two-thirds of GPs want Quality Outcome Framework (QOF) targets for cardiovascular disease brought into line with those of the Joint British Societies latest guidance (JBS2), according to a survey by doctor.net.uk. The survey of 1000 GPs showed that 88 per cent were aware of the JBS2 guidelines and most were already implementing the targets for lipids, blood pressure and blood glucose in some form; however, only 55 per cent were implementing the JBS2 obesity target and 14 per cent were implementing screening for the over-40s. The JBS2 target for lipids in at-risk patients is <4mmol per litre total cholesterol and <2 mmol per litre LDL-cholesterol, compared with <5 and <3mmol per litre respectively in QOF and the NSF. The survey was commissioned by Merck Sharp & Dohme and Schering- Plough. Fracture warning Following warnings in the US that rosiglitazone (Avandia) is associated with an increased risk of fractures in women, Takeda has advised prescribers that pioglitazone (Actos) carries a similar risk. An analysis of the company's clinical trials database has revealed an excess risk of fractures of bones below the elbow and knee. The incidence was similar to the excess risk associated with rosiglitazone and also confined to women. Scottish approvals The Scottish Medicines Consortium (www.scottish medicines.org.uk) has approved for use within NHS Scotland the sublingual tablet formulation buprenorphine/naloxone (Suboxone) for the treatment of opioid dependence. It has also approved the combined formulation of valsartan and amlodipine (Exforge) and the restricted use of the If inhibitor ivabradine (Procoralan). [source] Off label and unlicensed prescribing in a specialist oncology center in AustraliaASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 4 2009James D MELLOR Abstract Aim: Oncology is an area with a high prevalence of off-label and unlicensed prescribing. A previous audit conducted in 2001 at the Peter MacCallum Cancer Centre, a specialist oncology hospital, showed that 22% of all prescriptions were either off-label or unlicensed. This study aimed to determine if the rates of off-label and unlicensed prescribing in oncology had changed between 2001 and 2008. Methods: All prescriptions at the Peter MacCallum Cancer Centre were reviewed on a single day in March 2008. Each prescription was classified as licensed, off-label or unlicensed by comparing to the Approved Product Information (API). Results: The medications of 132 patients were assessed. Among the 1094 prescriptions, 382 (35%) were off-label and 44 (4%) were unlicensed. 112 (85%) patients received at least one off-label or unlicensed drug. Conclusion: The results of the audit suggest that the level of off-label prescribing increased by 17% since 2001. This study confirmed the extensive off-label and unlicensed drug usage as suggested by the literature and demonstrated a higher rate of off-label prescribing than the previous audit in 2001. The results demonstrate that 85% of all cancer patients in the study were prescribed at least one drug that had not been fully tested by the regulatory approval process. [source] | ||||||||||