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Background: Because of relatively small treatment numbers together with low adverse drug reaction (ADR) reporting rates the timely identification of ADRs affecting children and young people is problematic. The primary objective of this study was to assess the utility of unplanned medication discontinuation as a signal for possible ADRs in children and young people., Methods: Using orlistat as an exemplar, all orlistat prescriptions issued to patients up to 18 years of age together with patient characteristics, prescription duration, co-prescribed medicines and recorded clinical (Read) codes were identified from the Primary Care Informatics Unit database between 1st Jan 2006-30th Nov 2009. Binary logistic regression was used to assess association between characteristics and discontinuation., Results: During the study period, 79 patients were prescribed orlistat (81% female, median age 17 years). Unplanned medication discontinuation rates for orlistat were 52% and 77% at 1 and 3-months. Almost 20% of patients were co-prescribed an anti-depressant. One month unplanned medication discontinuation was significantly lower in the least deprived group (SIMD 1-2 compared to SIMD 9-10 OR 0.09 (95% CI0.01 - 0.83)) and those co-prescribed at least one other medication. At 3 months, discontinuation was higher in young people (≥17 yr versus, OR 3.07 (95% CI1.03 - 9.14)). Read codes were recorded for digestive, respiratory and urinary symptoms around the time of discontinuation for 24% of patients. Urinary retention was reported for 7.6% of patients., Conclusions: Identification of unplanned medication discontinuation using large primary care datasets may be a useful tool for pharmacovigilance signal generation and detection of potential ADRs in children and young people.

Background: Little is known about the impact of British asthma management guideline revisions. Concerns about the use of high dose inhaled corticosteroids (ICS) in children have resulted in the promotion of add-on therapy., Aims: To assess prescribing patterns of asthma medication in children in the primary care setting., Methods: Retrospective observational study of asthma prescribing in children aged 0-18 years using primary care database from 2001 to 2006., Results: The proportion of children prescribed oral corticosteroids increased significantly (from 6% in 2001-2002 to 16% in 2005-2006, p<0.001), while the proportion of children prescribed an ICS dose of >400 mcg decreased from 16.2% to 11.7% (P<0.001). The proportion of children prescribed an add-on therapy and an ICS dose >400 µg, increased from 38.8 % in 2001-2002 to 61.2% in 2005-2006 (p<0.001)., Conclusions: Although adherence with asthma management guidelines is not optimal, this study has identified improved adherence in primary care.

Aims: To assess the level of paracetamol off label prescribing in the community and the potential for paracetamol under or overdosing., Methods: The Scottish Practice Team Information (PTI) database containing prescribing data for approximately 35,839 children aged (0-12 years) was analysed for paracetamol prescriptions for the year 2006. Off label prescribing was defined as prescribing outside the BNFc age and dose recommendations., Results: Two thousand seven hundred and sixty-one children aged 0-12 years were issued with 4423 prescriptions for paracetamol. (1446 males). Children 1-5 years (1329, 42.2%) accounted for 48.9% (2164) of all paracetamol prescriptions. Eighteen per cent (793) of individual prescriptions were off label and after accounting for repeat prescriptions 625 (22.75%) individuals were exposed to off label prescriptions. A further 15% (668) of prescriptions contained insufficient dosage data to determine their status, 13.3% (368) being underdosed and 4.4% (121) overdosed at least once during the study year. In total 11.3% (502) of all prescriptions were classified as underdose, 2.9% (127) as overdose and 15% (667) had no dosage instructions. Age was significantly related to non recommended dosage (χ(2) test, P < 0.001). Children 1-3 months old were at highest risk of being overdosed; 27% of prescriptions recommended actual or potential overdosage and 25% (354) of children aged 6-12 years were prescribed an actual or potential underdose. Overall 57.2% of all prescriptions failed to comply with current BNFc recommendations., Conclusion: Paracetamol off label prescribing is common in primary care, with relatively high levels of potential overdosing in the youngest children and potential underdosing in the oldest children., (© 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.)

Background and Objective: Warfarin is commonly involved in drug-related hospital admissions. The drug is most commonly prescribed to elderly patients in whom polypharmacy is common and, when administered in combination with other drugs such as NSAIDs, aspirin (acetylsalicylic acid) or macrolide antibacterials, is associated with increased bleeding risk. The aim of this study was to investigate the prevalence of prescriptions that might give rise to clinically relevant drug-drug interactions in a warfarinized population., Methods: Primary care prescribing of warfarin and potentially interacting medicines was assessed between 1 April 2005 and 31 March 2006 using computerized prescribing data retrieved from 321 primary care practices in Scotland., Results: A total of 17,861 registered patients were prescribed warfarin in the study year, of whom 68% (n=12,107) were concomitantly issued with a prescription for at least one potentially interacting medicine. For short-term use, 'one-off' prescriptions for antibacterials (sulfonamides, ciprofloxacin, and macrolides), nonselective NSAIDs and antithrombotics (fibrinolytics) were the most frequently prescribed drug groups with potential for interaction, being prescribed to 12.7%, 5.3%, and 1.4% of warfarinized patients, respectively. Macrolide antibacterials were prescribed in significantly fewer warfaranized patients than standardized population (3.84% vs 4.41%; p<0.001). For long-term use, nonselective NSAIDs and antithrombotics were the most frequently prescribed drug groups, being prescribed to 21.0% and 21.1% of warfarinized patients, respectively. When compared with a standardized population, NSAIDs and antithrombotics were prescribed to a significantly smaller proportion of the warfarin population, whereas selective cyclo-oxygenase 2 inhibitors were prescribed to a significantly greater proportion. Nevertheless for the whole warfarinized population 26.3% were prescribed nonselective NSAIDs and 22.5% antithrombotic agents., Conclusions: The lower 'one off' use of macrolide antibacterials and long-term use of antithrombotics and NSAIDs in warfarinized patients observed in this study might suggest awareness among general practitioners of the increased risks for bleeding associated with concomitant use of these agents with warfarin therapy. However, despite this, the majority of warfarinized patients in this study were issued with a repeat prescription for at least one potentially interacting medicine.

Aim: To identify community pharmacist experiences of, and attitudes towards paediatric off-label prescribing., Methods: A prospective questionnaire-based study, with a 21-item questionnaire issued to 1500 randomly selected community pharmacies throughout the UK during 2005 on three separate occasions., Results: Four hundred and eighty-two (32.1%) completed questionnaires were returned. Over 70% of respondents were familiar with the concept of off-label prescribing, primarily through dispensing experience rather than education, although only 40% were aware of having dispensed a paediatric off-label prescription within the previous month. The reasons given for a prescription being off label were younger age than recommended (84.6%, 297/351), primarily for antihistamines, analgesics and beta(2)-agonists, and higher (73.9%, 229/310) or lower than (41%, 103/258) recommended dose, primarily antibiotics and analgesics. Over 60% of respondents had been asked by the public to sell paediatric over-the-counter medicines, such as antihistamines, analgesics and steroid preparations for off-label use. The majority of respondents used the British National Formulary or the Pack Insert rather than specialist formularies or guidelines as a source of specialist paediatric information. Although 78% of respondents believed they had a responsibility to inform the prescriber that a medicine was off label, only 66% believed that they had a similar responsibility to inform parents., Conclusion: The community pharmacists who responded to this questionnaire appear to be aware of and concerned by the issues which surround paediatric off-label prescribing. Despite this, most gained relevant knowledge through work experience rather than undergraduate or postgraduate training or professional development.

Aims: To investigate the current levels of homoeopathic and herbal prescribing in Scottish general practice., Methods: Prescribing of homoeopathic and herbal remedies in primary care was assessed in 1891 669 patients for the year 2003-2004, using computerized prescribing data retrieved from 323 general practices in Scotland., Results: Forty-nine percent of practices prescribed homoeopathic and 32% herbal remedies. A total of 193 homoeopathic and 17 herbal remedies were prescribed, with 5% of practices accounting for 46% of patients and 50% of remedies. Four thousand one hundred and sixty patients (2.2/1000 registered patients) were prescribed at least one homoeopathic remedy during the study period, with the highest prevalence to children under 12 months of age (9.5/1000 children of that age). Children under the age of 16 made up 16% of the population prescribed homoeopathic remedies (2.2/1000 registered patients of that age). Three hundred and sixty-one patients (0.2/1000 registered patients) were prescribed at least one herbal remedy during the study period, 44 of whom were children < 16 years old. Patients prescribed a homoeopathic or herbal remedy were also prescribed a median of four and five conventional medicines, respectively. Of patients prescribed an oral herbal remedy, 4% were also concomitantly prescribed a conventional medicine with which a drug-herb interaction has been documented., Conclusions: Our study reports that a substantial number of Scottish general practitioners prescribe homoeopathic and herbal remedies, with an approximate doubling in the number of children prescribed homoeopathic remedies. The level of homoeopathic and herbal prescribing raises questions about homoeopathic/herbal provision in the National Health Service and should prompt critical review.

Aims: To investigate the extent of homoeopathic prescribing in primary care for childhood diseases and assess GP attitudes towards the use of homoeopathy in children., Methods: Homoeopathic prescribing in primary care was assessed in 167 865 children aged 0-16 years for the year 1999-2000. Computerized prescribing data were retrieved from 161 representative general practices in Scotland. Medical attitudes towards homoeopathic prescribing to children were also assessed via a questionnaire survey., Results: During the year 1999-2000 22% (36) of general practices prescribed homoeopathic medicines to 190 (1.1/1000 registered) children. The majority of such prescriptions were issued to children under 1 year of age (8.0/1000 registered children). The most frequently prescribed medicines were for common self-limiting infantile conditions such as colic, cuts and bruises, and teething. A total of 259 completed questionnaires were returned by GPs, giving a response rate of 75%. GPs who frequently prescribed homoeopathic medicines to children (more than 1 per month) were more likely to claim an interest in homoeopathy, have had a formal training and keep up to date in the discipline, and refer on to a homoeopath (P < 0.001 for all variables) than those GPs who prescribed less than once a month or never. The majority of GPs who prescribed homoeopathic medicines did so when conventional treatments had apparently failed (76%), while 94% also perceived homoeopathy to be safe. Frequent prescribers reported a more positive attitude towards homoeopathic medicines than those who prescribed less frequently. Non-prescribers reported a lack of proven efficacy and lack of training as the main reasons for not prescribing homoeopathic medicines (55% and 79%, respectively). However non-prescribers from within homoeopathic prescribing practices reported a more favourable attitude in general towards homoeopathy and less resistance towards prescribing in the future than non-prescribers from practices where none of the partners practiced homoeopathy., Conclusions: In primary care paediatric prescribing of homoeopathic medicines most commonly occurs for self-limiting conditions in infants less than 1 year of age. Although the current level of homoeopathic prescribing is low, the widespread use in the community suggests that at least some knowledge of the main indications for homoeopathy and the preparations used would be of benefit to registered medical practitioners.

Objectives: To investigate the extent and pattern of off-label prescribing to children in primary care throughout Scotland., Design: Assessment of prescribing to 167,865 children aged 0-16 years during the period November 1999 to October 2000 using data from 161 general practices using the national Scottish primary care computer system General Practice Administration System for Scotland., Setting: One hundred and sixty one general practices in Scotland., Results: During the study period, at least one off-label prescription was issued to 17,715 (26.1%) children aged 0-16 years. Off-label prescribing due to lower than the recommended dose was the most common form of off-label prescribing (40-50%), with antibiotics and antihistamines making up the majority. Off-label prescribing due to higher than the recommended dose was also common (35% of all off-label prescribing), with antiasthmatics, topical corticosteroids and laxatives making up the majority. Off-label prescribing with respect to age was less common (6-16%) affecting mainly young children (less than 2 years old) and adolescents. Off-label prescribing with respect to formulation was the least common cause accounting for 5-10% of off-label prescribing., Conclusions: This is the largest and most detailed study to date of paediatric off-label prescribing in primary care within the UK. Such off-label prescribing likely occurs as the result of several factors including a failure to update licensing information with currently accepted practice and confusion or unawareness of the licensing recommendations, further compounded by a lack of clinical trials data and suitable formulations for medicines commonly prescribed to young children and adolescents.

Aims: To investigate the extent of dose-related off-label antibiotic paediatric prescribing in primary care and to identify any potential clinical effects, particularly of lower than recommended dose prescribing., Methods: Assessment of antibiotic prescribing in 168 396 children aged 0-16 years for the year 1999-2000 from data retrieved from 158 general practices using the national Scottish primary care computer system GPASS. The setting was general practices in Scotland., Results: During the study period at least one course of antibiotics was prescribed to 23 911 children (14.2%). A total of 4582 (19.2%) children were prescribed an antibiotic dose of less than that recommended in the Summary of Product Characteristics (SPC). The number of children prescribed an antibiotic at less than recommended dose increased with age from 1154 (11.8%) aged 0-4 years to 1827 (30.0%) in the 12-16 years age group. For each antibiotic, prescribing lower than recommended dose occurred most frequently at those ages at which a dose increase was recommended in the SPC. Antibiotic prescribing at less than the recommended dose was not associated with an increased return rate for further antibiotic prescriptions during the following month, but in 5-11-year-olds was associated with a significant 48% increase in the total number of antibiotic courses prescribed during the study year [mean = 2.09 [95% confidence interval (CI) 1.79, 2.39]vs. 1.41 [95% CI 1.35, 1.47]]. Antibiotic prescribing at doses higher than recommended occurred less frequently (1.6%) and decreased steadily with age., Conclusions: Off-label prescribing of antibiotics at less than the recommended dose in children is common in primary care and occurs primarily as the result of a failure to increase antibiotic dosage with age in line with SPC recommendations. Adoption of a uniform approach to SPC age banding for antibiotic dose increments would reduce the frequency of dose-related off-label antibiotic prescribing in children and help minimize the potential for the development of antibiotic resistance.