Inappropriate oral formulations and information in paediatric trials

Previously, quality of formulations information provided for oral medications used in paediatric clinical trials published in 10 highly cited journals between 2002 and 2004 raised concerns. This short report explores if there was any subsequent improvement on how the formulations used in trials involving children

Cross-sectional studies in prescribing research

A cross-sectional study aims to describe the overall picture of a phenomenon, a situational problem, an attitude or an issue, by asking a cross-section of a given population at one specified moment in time. This paper describes the key features of the cross-sectional survey method. It begins by highlighting the main principles of the method, then discusses stages in the research process, drawing on two surveys of primary care pharmacists to illustrate some salient points about planning, sampling frames, definition and conceptual issues, research instrument design and response rates. Four constraints in prescribing studies were noted. First the newness of the subject meant a low basis of existing knowledge to design a questionnaire. Second, there was no public existing database for the sampling frame, so a pragmatic sampling exercise was used. Third, the definition of a Primary Care Pharmacist (PCP) [in full] and respondents recognition of that name and identification with the new role limited the response. Fourth, a growing problem for all surveys, but particularly with pharmacists and general practitioners (GP) [in full] is the growing danger of survey fatigue, which has a negative impact on response levels.

Development of a prescribing indicator for objective quantification of antibiotic usage in secondary care

Objectives: To compare the recognized defined daily dose per 100 bed-days (DDD/100 bed-days) measure with the defined daily dose per finished consultant episode (DDD/FCE) in a group of hospitals with a variety of medicines management strategies. To compare antibiotic usage using the above indicators in hospitals with and without electronic prescribing systems. Methods: Twelve hospitals were used in the study. Nine hospitals were selected and split into three cohorts (three high-scoring, three medium-scoring and three low-scoring) by their 2001 medicines management self-assessment scores (MMAS). An additional cohort of three electronic prescribing hospitals was included for comparison. MMAS were compared to antibiotic management scores (AMS) developed from a questionnaire relating specifically to control of antibiotics. FCEs and occupied bed-days were obtained from published statistics and statistical analyses of the DDD/100 bed-days and DDD/FCE were carried out using SPSS. Results: The DDD/100 bed-days varied from 81.33 to 189.37 whilst the DDD/FCE varied from 2.88 to 7.43. The two indicators showed a high degree of correlation with r = 0.74. MMAS were from 9 to 22 (possible range 0-23) and the AMS from 2 to 13 (possible range 0-22). The two scores showed a high degree of correlation with r = 0.74. No correlation was established between either indicator and either score. Conclusions: The WHO indicator for medicines utilization, DDD/100 bed-days, exhibited the same level of conformity as that exhibited from the use of the DDD/FCE indicating that the DDD/FCE is a useful additional indicator for identifying hospitals which require further study. The MMAS can be assumed to be an accurate guide to antibiotic medicines management controls. No relationship has been found between a high degree of medicines management control and the quantity of antibiotic prescribed. © The British Society for Antimicrobial Chemotherapy; 2004 all rights reserved.

Documentation of antibiotic prescribing controls in UK NHS hospitals

Objectives: To identify the types, prevalence and nature of antibiotic prescribing control documents within NHS hospitals in the UK. Methods: A self-completion postal questionnaire was sent to each Chief Pharmacist at 465 NHS hospitals in 2001/2002. This contained questions covering hospital demographics, and hospital antibiotic prescribing control documentation, including format, dissemination, approval and review processes. Results: In total, 253 (54%) completed questionnaires were returned. Of these, 168 respondents' hospitals had an antibiotic formulary, 107 had a policy for antibiotic prescribing and 216 had guidelines on antibiotic use. All three types of antibiotic prescribing documents were used by 82 hospitals but 18 did not have any documents; 44% of formularies, 45% of policies and 35% of guidelines were available electronically. The Drug and Therapeutics Committee was the most frequently cited body for document approval and approximately one-third of documents had been approved during the current year of the questionnaire. Only about one-half of responding hospitals had an annual review of documents. Conclusions: Despite publication of high-profile national guidance in response to growing concerns regarding antimicrobial resistance, there has been little increase in the use of antibiotic prescribing control documents in NHS hospitals over the past decade. It is clear that appropriate controls for antibiotic prescribing are not yet universally applied in the UK and recommendations for action have been proposed. © The British Society for Antimicrobial Chemotherapy 2004; all rights reserved.

An evaluation of quinolone prescribing in a group of acute hospitals:Development of an objective measure of usage

Objectives: To develop an objective measure to enable hospital Trusts to compare their use of antibiotics. Design: Self-completion, postal questionnaire with telephone follow up. Sample: 4 hospital trusts in the English Midlands. Results: The survey showed that it was possible to collect data concerning the number of Defined Daily Doses (DDD's) of quinolone antibiotic dispensed per Finished Consultant Episode (FCE) in each Trust.. In the 4 trusts studied the mean DDD/FCE was 0.197 (range 0.117 to 0.258). This indicates that based on a typical course length of 5 days, 3.9% of patient episodes resulted in the prescription of a quinolone antibiotic. Antibiotic prescribing control measures in each Trust were found to be comparable. Conclusion: The measure will enable Trusts to objectively compare their usage of quinolone antibiotics and use this information to carry out clinical audit should differences be recorded. This is likely to be applicable to other groups of antibiotics.

Control of antibiotic prescribing in UK NHS hosptials. Available in 2 volumes.

This thesis is an evaluation of practices to control antibiotic prescribing in UK NHS hospitals. Within the past ten years there has been increasing international concern about escalating antibiotic resistance, and the UK has issued several policy documents for pmdent antibiotic prescribing. Chief Pharmacists in 253 UK NHS hospitals were surveyed about the availability and nature of documents to control antibiotic prescribing (formularies, policies and guidelines), and the role of pharmacists and medical microbiologists in monitoring prescribers' compliance with the recommendations of such documents. Although 235 hospitals had at least one document, only 60% had both an antibiotic formulary and guidelines, and only about one-half planned an annual revision of document(s). Pharmacists were reported as mostly checking antibiotic prescribing on every ward whilst medical microbiologists mostly visited selected units only. Response to a similar questionnaire was obtained from the Chief Medical Microbiologists in 131 UK NHS hospitals. Comparisons of the questionnaires indicated areas of apparent disagreement about the roles of pharmacists and medical microbiologists. Eighty three paired-responses received from pharmacists and medical microbiologists in the same hospital revealed poor agreement and awareness about controls. A total of 205 institutional prescribing guidelines were analysed for recommendations for the empirical antibiotic prescribing of Community-Acquired Pneumonia (CAP). Variation was observed in recommendations and agreement with national guidance from the British Thoracic Society (BTS). A questionnaire was subsequently sent to 235 Chief Pharmacists to investigate their awareness of this new guidance from the BTS, and subsequent revision of institutional guidelines. Documents had been revised in only about one-half of hospitals where pharmacists were aware of the new guidance. An audit of empirical antibiotic prescribing practices for CAP was performed at one hospital. Although problems were experienced with retrieval of medical records, diagnostic criteria were poorly recorded, and only 57% of prescribing for non-severe CAP was compliant with institutional guidelines. A survey of clinicians at the same hospital identified that almost one-half used the institutional guidelines and most found them useful. However, areas for improvement concernmg awareness of the guidelines and ease of access were identified. It is important that hospitals are equipped to react to changes in the hospital environment including frequent movement of junior doctors between institutions, the employment of specialist "infectious diseases pharmacists" and the increasing benefits offered by information technology. Recommendations for policy have been suggested.

The impact of drug information on the prescribing of drugs

Using prescription analyses and questionnaires, the way drug information was used by general medical practitioners during the drug adoption process was studied. Three new drugs were considered; an innovation and two 'me-too' products. The innovation was accepted by general practitioners via a contagion process, information passing among doctors. The 'me-too' preparations were accepted more slowly and by a process which did not include the contagion effect. 'Industrial' information such as direct mail was used more at the 'awareness' stage of the adoption process while 'professional' sources of information such as articles in medical journals were used more to evaluate a new product. It was shown that 'industrial' information was preferred by older single practice doctors who did not specialise, had a first degree only and who did not dispense their own prescriptions. Doctors were divided into early and late-prescribers by using the date they first prescribed the innovatory drug. Their approach to drug information sources was further studied and it was shown that the early-prescriber issued slightly more prescriptions per month, had a larger list size, read fewer journals and generally rated industrial sources of information more highly than late-prescribers. The prescribing habits of three consultant rheumatologists were analysed and compared with those of the general practitioners in the community which they served. Very little association was noted and the influence of the consultant on the prescribing habits of general practitioners was concluded to be low. The consultants influence was suggested to be of two components, active and passive; the active component being the most influential. Journal advertising and advertisement placement were studied for one of the 'me-too' drugs. It was concluded that advertisement placement should be based on the reading patterns of general practitioners and not on ad-hoc data gathered by representatives as was the present practice. A model was proposed relating the 'time to prescribe' a new drug to the variables suggested throughout this work. Four of these variables were shown to be significant. These were, the list size, the medical age of the prescriber, the number of new preparations prescribed in a given time and the number of partners in the practice.

Influences on general practitioner prescribing with particular reference to community pharmacy

Influences on general practitioner prescribing of drugs continue to be of interest and importance as cost containment becomes central to Government health policy. This thesis employs a plurality of research methods including quantitative and qualitative survey techniques for example, questionnaires, interviews and prescription analyses to investigate some of the factors which may influence GP prescribing such as information sources, hospital consultants and in particular the community pharmacist. When the use and influence of drug information sources by GPs was examined, the community pharmacist was given a relatively low rating as a source but a high rating, similar to that of the consultant, for helpfulness. Influences are needed to improve prescribing and reduce the incidence of iatrogenic disease for the benefit of the patient. The education and expertise of pharmacists and their familiarity with local prescribing habits places them in a unique position to meet the needs of local GPs. As 96.5% of the public always or nearly always take their prescriptions to the same pharmacy, patient medication records, now kept by 77.5% of pharmacies, provide a valuable check on the appropriateness and safety of patients' medication. The barriers to the pharmacist's greater involvement were shown to be suspicion by GPs of pharmacists' motivation, isolation of many community pharmacists, difficulties in leaving the pharmacy for domiciliary visits, residential home care and GP practice meetings. These barriers must be lowered if the pharmacist is to have a greater influence and involvement. It was concluded that changes are necessary in pharmaceutical education, staff training, organisation and remuneration. Some changes in the targeting of remuneration to the pharmaceutical care services provided and registration of patients with pharmacies would contribute greatly to these aims.

A pharmacy led program to review anti-psychotic prescribing for people with dementia

Background: Anti-psychotics, prescribed to people with dementia, are associated with approximately 1,800 excess annual deaths in the UK. A key public health objective is to limit such prescribing of anti-psychotics. Methods: This project was conducted within primary care in Medway Primary Care Trust (PCT) in the UK. There were 2 stages for the intervention. First, primary care information systems including the dementia register were searched by a pharmacy technician to identify people with dementia prescribed anti-psychotics. Second, a trained specialist pharmacist conducted targeted clinical medication reviews in people with dementia initiated on anti-psychotics by primary care, identified by the data search. Results: Data were collected from 59 practices. One hundred and sixty-one (15.3%) of 1051 people on the dementia register were receiving low-dose anti-psychotics. People with dementia living in residential homes were nearly 3.5 times more likely to receive an anti-psychotic [25.5% of care home residents (118/462) vs. 7.3% of people living at home (43/589)] than people living in their own homes (p?prescribing of anti-psychotics to people with dementia.

Professionals' awareness of operational antibiotic prescribing controls in UK NHS hospitals

In recent years, there have been increasing recommendations for multidisciplinary collaboration between clinical pharmacists and medical microbiologists in an attempt to control the quality (and quantity) of antibiotic prescribing. A questionnaire addressing the utilization of antibiotic prescribing controls was sent to the chief pharmacist and medical microbiologist in UK NHS hospitals. Responses were received from both the chief pharmacist and the medical microbiologist employed in the same hospital from 83 hospitals (a 30% response rate from two independent studies). A high level of disagreement and poor awareness was identified between the interprofessional staff groups regarding the existence of antibiotic formulary (with disagreement between the two groups, or not known by one or both respondents, in 46% of the paired hospitals, N=38) and guideline documents (13%, N=11), performance of antibiotic prescribing audits (40%, N=33), and whether pharmacists (52%, N=43) and medical microbiologists (77%, N=64) monitored physician compliance with antibiotic prescribing control documents. This study has identified poor knowledge of the existence of basic antibiotic prescribing control mechanisms and the role of professional colleagues. It is suggested that there is some way to go before 'Agenda for Change' principles of flexible and collaborative roles are met. © 2004 The Hospital Infection Society. Published by Elsevier Ltd. All rights reserved.

Medicines management strategies to improve antibiotic prescribing

A systematic review was conducted to explicitly identify interventions that alone, or in combination, were effective in improving antibiotic prescribing. The citation search strategy used in the present review provided a database of 365077 studies, of which only twenty-five were included in the final review (“review studies”). Analysis of the interventions used within the review studies indicated that a combination of “guidelines” and “pharmacy” interventions have the greatest potential to improve antibiotic prescribing. Two types of qualitative research were conducted, semi-structured interviews and the collection of naturally occurring data. Semi-structured interviews were conducted in order to determine NHS managers? perceptions of current policies used to improve antibiotic prescribing within selected Primary Care Trusts and highlighted the importance of pharmacy intervention, formularies or guidelines and improved prescribing analysis (IT based intervention) on improving antibiotic prescribing. This was supported by the collection of naturally occurring data, which was used to provide further insight into interventions used to improve antibiotic prescribing. The Specialist Antibiotic Pharmacist (HD) produced and implemented an innovative electronic antibiotic prescribing analysis tool (the Antibiotic Database) to analyse and improve antibiotic prescribing in a consistent manner. The key advantage of the Antibiotic Database was the time and money saved on producing visual electronic outputs containing an inaccurate outcome measure or time period for analysis. The results concluded that an IT based intervention, such as the Antibiotic Database should be used, in addition to the use of antibiotic guidelines and pharmacy intervention, within all sectors of the NHS in order to improve antibiotic prescribing and its analysis.

Children's views on unlicensed/off-label paediatric prescribing and paediatric clinical trials

Objectives - To explore the views and perspectives of children on the unlicensed/off-label use of medicines in children and on the participation of children in clinical trials. Methods - Focus-group discussions, involving school children, were carried out in a range of primary and secondary schools in Northern Ireland. A purposeful sample was chosen to facilitate representation of various socioeconomic groupings. Results - A total of 123 pupils, aged from 10 to 16 years, from six schools, participated in 16 focus groups. In general, pupils viewed the unlicensed/off-label use of medicines in children as unsafe and unethical and felt it is necessary to test medicines in children to improve the availability of licensed products. The majority felt that older children should be told, and that parents should be told, about the unlicensed/off-label use of medicines in children, yet they recognised some implications of this, such as potential medication non-adherence. Conclusions - This is the first study to explore the views of healthy children on unlicensed medicine use in children. Children were able to recognise potential risks associated with the unlicensed use of medicines and felt it is necessary to test and license more medicines in children. Practice implications - Health care professionals should consider the views of children in decisions that affect their health.