No description available.

Abstract A recent World Health Organisation study conducted in 26 countries found substantial disagreement in the prescribing information available in those countries, as well as significant disparity between brands within the same country. This appears to be a common experience in other countries. This may mislead prescribers, patients and those comparing drug-use patterns across countries, and have serious safety implications. This study was carried out to investigate the variability of prescribing information currently available within South Africa, comparing generic and originator brands. It also investigated the extent of variability between the Standardised Package Insert (SPI) mandated by the Medicines Control Council, versus internationally approved prescribing information for given drug substances. Five drug substances were selected that are widely used in South Africa. The package inserts of the originator product were compared in terms of the indications, dosage, cautions, side-effects and drug interactions versus five generic brands of each drug substance registered in South Africa, using a comprehensive method adapted from the WHO study. The SPI was also compared against the South African originator brand package insert and those approved in four international MCC Reference Countries (ie. USA, EU, Canada & Australia) for each drug substance. Substantial disagreement was found between the originator and generic products for each drug substance, which may be due, in part, to the absence of a mandatory periodic updating requirement for package inserts in the post-registration phase in South Africa. This may result in divergence between materials from companies that voluntarily submit safety updates over the life of the product, and those that do not. There was also substantial disagreement between the SPI and the originator and international reference country materials. The reason is less simple to explain. The SPI project is in its early stages, and requires validation to ensure that the texts are in fact, entirely in line with latest best clinical practice and with the reference countries with which MCC aligns itself. These findings are comparable with those found in international WHO study. Regulatory authorities have key responsibility in ensuring that prescribing information is current and consistent across originator, generic and international materials. It is recommended that the MCC implement a mandatory updating requirement for all registered medicines with specified timelines. Secondly, a validation step should be introduced in the MCC SPI project to ensure consistency with international materials. Additional recommendations are made to improve the quality and practicality of prescribing information to ensure that it remains relevant in the South African and regional context. vThese findings are comparable with those found in international WHO study. Regulatory authorities have key responsibility in ensuring that prescribing information is current and consistent across originator, generic and international materials. It is recommended that the MCC implement a mandatory updating requirement for all registered medicines with specified timelines. Secondly, a validation step should be introduced in the MCC SPI project to ensure consistency with international materials. Additional recommendations are made to improve the quality and practicality of prescribing information to ensure that it remains relevant in the South African and regional context.

Prescribing accounts for 11% of the total NHS budget. In the UK, there is an aging population who receive nearly half of all prescriptions, with the increasing age of the population, the prevalence of long-term conditions, cost and complexity of prescribing is likely to rise. Prescribing is influenced by numerous factors such as new drugs; aging populations; polypharmacy; and increased concern about adverse reactions. Although numerous initiatives are targeted at general practitioners to encourage application of research evidence the significant variation in prescribing quality and cost is difficult to explain. Previous studies have explored the influences of type of drug, focused clinical area, guidelines and the doctor/patient relationship. No study was found which has explored the details of the prescribing process using the ethnographic approach. This ethnographic study of three different general practices, involved participant observation, documentary review and semi-structured interviews. Analysis was an iterative process conducted in Atlas.ti by borrowing on grounded theory techniques and interpretative description. Practices were selected using prescribing quality indicators developed by Audit Scotland via PRISMS (Prescribing Information System for Scotland), which collects prescribing data for all practices in Scotland. Two practices which were ranked highly and one practice which was ranked low were observed. Practices made two different kinds of prescribing decision; macro and micro. Macro prescribing decisions are strategic, influenced by EBM and practice data, and consider the „average patient?. Micro prescribing decisions are made with an individual patient, considering their unique biology, context and perspectives. Practice pharmacists were instrumental in leading prescribing quality improvement in the larger practices and had an important role interpreting practice level data in light of the changing evidence. In the high ranking practices these changes were formulated into macro prescribing policy to rationalise and standardise their prescribing. The lower ranking practice suggested practices had to value collective decision-making and consistency in their prescribing behaviour to formulate a macro prescribing policy. Consistency in prescribing behaviour was facilitated by effective communication, which was important for shared values and practice identity. Practice identity influenced practice values, communication and organisation thus had a direct impact on their macro prescribing policy formulation and implementation. GPs used mindlines when making prescribing decisions at the micro prescribing level. GPs did not refer to explicit sources when seeking information but used personal prescribing formularies. These mindlines were iteratively developed from social networks with colleagues, secondary care and patient specific information from the practice pharmacist and from past experience. Through effective communication with colleagues these mindlines were shared.In conclusion, practices made two different kinds of prescribing decision; macro and micro. Both types of prescribing were dependent on effective communication channels, organisation, values and practice identity, illustrating the importance of communication for shared values, collective behaviour and prescribing decision-making.

Abstract not available

No description available.

A longitudinal study was carried out on a population of 4,922 patients served by a general practice surgery with three doctors. The purpose was to investigate the opportunity which domiciliary care of elderly and infirm patients offers to UK pharmacists working in primary care. The aims of the study were: - 1) To identify indicators that could be used to identify patients in the community who might benefit from domiciliary pharmaceutical care, and which do not leave patients excluded. 2) To identify specific issues that would lead to better pharmaceutical care 3) To deliver a package of pharmaceutical care to these most "at risk" patients in the population over approximately a year. 4) To evaluate the interventions made considering the viewpoints of all parties found to be stakeholders. 5) To measure the scale of the challenge of domiciliary managed pharmaceutical care in relation to the population in the study. 6) To provide indicators for the development of pharmaceutical care including cost/ benefit and potential training requirements. A simple qualitative study design was pursued, based upon semi-structured interviews and field notes. A cohort of patients (n=149) identified as candidates for domiciliary visiting, represented 3% of the surgery population. After de-selection of unsuitable candidates, visits were made to 100 patients. Three concepts for the organisation of information and three clusters of criteria were identified and developed which would identify 94 out of 100 patients visited. A large number of indicators for pharmaceutical care were identified and described qualitatively under 14 headings. Though typical, these were not claimed as a comprehensive set of issues which could have been encountered. It was generally perceived that more of the pharmacist's interventions produced positive effects than those that were neutral or actually did harm. Some of the interventions were accepted by the GPs as very important, and developing the extended role to include for instance a cardiovascular review clinic; "in house" medication reviews was discussed. Domiciliary visits were deemed useful though the GPs pointed out that making visits was time consuming and, by implication, expensive. Patients reported a high level of satisfaction with the visiting programme. Satisfaction was explored in an attempt to differentiate sociometric issues from professional ones. Rating satisfaction with a domiciliary pharmaceutical service required that specific issues were identified and dealt with which reflected the main concerns of patients about their medicines. Most of the patients' concerns appeared to be centred around multiple medication, widely perceived (in this cohort) to have potential to cause harm. The author recommends that PCGs consider allocating part of the prescribing budget to fund a domiciliary pharmaceutical care service to a small targeted population through community pharmacies. This could be a first step in offering new professional opportunities through community pharmacies and might revitalise some which are currently in decline.

This research aimed to measure the effect on health outcomes of implementing selected recommendations of the Grampian Joint Drug Formulary in primary care. Antibiotics used in the treatment of uncomplicated lower urinary tract infections (UTIs), ulcer healing agents and peripheral vasodilators were selected for study, thereby reflecting both acute and chronic prescribing. For the UTI study, 12 randomly selected high and low prescribers of trimethoprim, the recommended agent, each agreed to distribute 20 patient questionnaires. Following a period of 18 months and despite repeated contact with the GPs, only 89/480 (19%) questionnaires had been distributed. Patient response was, however, very high with 80 (90%) questionnaires returned. Health outcome measures identified that trimethoprim resulted in no or mild symptoms in 40/45 (91 %) of patients. These findings must be interpreted with caution due to the low level of questionnaire distribution and thus cannot be extrapolated to the total population of patients. In addition, the poor questionnaire distribution did not permit comparison between trimethoprim and non-recommended therapy. One hundred and eighty four patients receiving repeat prescriptions for ulcer healing agents were identified from one general practice. Therapy in 95 patients did not adhere to formulary recommendations. Changes to therapy were considered inappropriate in 11 patients due to factors such as severe depression and a further 8 were deemed unsuitable for participation for non-clinical reasons. The remaining 76 patients were contacted with 19 (25%) refusing to participate. Fifty seven patients were interviewed using the Glasgow Dyspepsia Severity Score and Short Form 36 (SF-36). Changes in health outcomes were measured for 21 patients where a change in therapy had taken place. These results were difficult to interpret due to the diversity of changes recommended and the lack of data relating to those patients not participating. Work involving peripheral vasodilators aimed to determine the effect on health outcomes of cessation of therapy. Forty five patients receiving these agents in 2 practices were identified, although 8 had not requested a prescription in the previous year. Two further patients were excluded from the study due to cancer and old age. The remaining 35 agreed to be interviewed using the Walking Impairment Questionnaire and SF-36. All patients were subsequently instructed to stop therapy for 2 months, although 6 (17%) refused to follow this instruction, one patient was seriously ill thus was excluded and 3 refused to be reinterviewed. Of the remaining 25 patients, no significant differences were observed in the domains studied. Seventeen patients (68%) expressed no desire to restart therapy, generating considerable savings. These results must be interpreted with caution since those not stopping therapy or refusing re-interview are likely to have responded differently to those completing the study. The measurement of health outcomes following formulary implementation deserves further work.

The elderly are increasingly retaining natural teeth into old age and many require regular long-term medication for chronic medical problems. If these medicines contain sugars and have a prolonged clearance time from the mouth, they may threaten dental health. The extent of regular and long-term use of these medicines in the elderly was the subject of this study comprising five surveys. A general medical practice survey identified 2002 elderly patients aged ≥60 years taking 143 prescribed medicines with prolonged oral clearance (POC) long-term representing a prevalence of use of 9.8%, with females aged ≥75 years more likely to be taking POC medicines long-term (p<0.001). The main medical problems reported were cardiovascular and musculoskeletal, however antacids, laxatives and minor analgesics were the most commonly prescribed POC medicines. The prevalence of over-the-counter POC medicine use long-term was 1.1%. Analysis of prescription numbers and quantities of medicines dispensed in primary care identified 613 POC medicines representing 13% of the 457 million items dispensed in England in 1994, of which 30.4 million items (51%) were for medicines potentially used regularly and longterm by the elderly. POC medicines prescribed in primary care represented the main area of use; secondary care accounted for only 1% of the overall quantities prescribed in the Northern Region and the contribution of OTC medicines to overall consumption of POC medicines was also low (<1 %). The influence of generic prescribing and dose form on the sugar content of the medicines dispensed was substantial; over 80% of generic liquid oral medicines were sugars-containing compared with 7% of proprietary liquid oral medicines. Efforts should be made to draw the attention of government, manufacturers, prescribers and dispensers as well as consumers to the major influences of dose form and specificity of prescribing on the sugars content of medicines. This is crucial in those increasing number of dentate individuals whose dental health is at risk through regular and long-term use of POC medication.

Thesis (M.S.)--University of Hawaii at Manoa, 2005. / Includes bibliographical references (leaves 29-31). / x, 31 leaves, bound 29 cm

The prescribing rights of non-medical healthcare professionals in the United Kingdom (UK) are some of the most extensive in western medical practice. Nurses, pharmacists, physiotherapists, optometrists, chiropodists, podiatrists, therapeutic and diagnostic radiographers and dieticians, with appropriate training have the authority to prescribe. They are often referred to as non-medical prescribers (NMPs). These non-medical healthcare professionals should have a specified number of years of post-registration experience in order to undertake specific training in prescribing. There has been a limited amount of research exploring how non-medical healthcare professionals acquire their expertise during the prescribing programme. In addition, there is a gap in the literature on how NMPs apply their acquired expertise during the process of making clinical prescribing decisions. A programme of research was conducted to explore the learning processes and decision-making skills of pharmacist and nurse independent prescribers working in secondary care. The research used current literature on pharmacist and nurse independent prescribing by conducting a systematic review to assess how their expertise development is reported in the literature. In addition, the learning experiences of secondary care pharmacists and nurses undertaking the independent prescribing programme was explored by employing a novel audio-diary technique followed by semi-structured interviews on 7 nurses and 6 pharmacists. Students were mainly recruited via their non-medical prescribing programme leaders at a number of accredited universities across the UK. There was little opportunity in this study to explore the clinical reasoning processes of students as they were learning to prescribe. Therefore, the final study aimed to explore how secondary care pharmacist and nurse independent prescribers make clinical prescribing decisions. A total of 21 independent prescribers working in secondary care took part in this study, mainly recruited via their non-medical prescribing lead and social media. This study employed a think-aloud protocol method using validated clinical vignettes followed by semi-structured interviews. Students and NMPs occupied a wide range of roles. Ethical approval from the University of Manchester Research Ethics Committee (UREC) and governance approvals from a number of National Health Service (NHS) hospitals were obtained before conducting the research. NMPs were influenced by a number of intrinsic and extrinsic factors during the process of learning to prescribe and when making prescribing decisions. Students also experienced an affective phase of transition in which students became highly metacognitive as they began to form their identities as prescribers and reflect on their confidence and competence. There were notable differences between how pharmacists and nurses learned to prescribe, which were also seen during the process of clinical decision-making as independent prescribers. Despite this, pharmacists and nurses revealed a similar pattern in their decision-making processes as prescribers. Findings from this programme of research provide further insight into the specific training and support requirements of these healthcare professionals. Additional research with NMPs would be beneficial to contribute to the currently limited understanding of the learning and clinical reasoning processes of NMPs.