Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes

Objectives: To assess the extent of teaching about the Committee on Safety of Medicine's Yellow Card scheme and adverse drug reactions within UK Schools of Medicine and Pharmacy. Methods: A self-completed questionnaire sent to all heads of undergraduate schools of medicine and pharmacy within the UK. Results: The majority of undergraduate syllabuses feature the Yellow Card Scheme. Knowledge of the Yellow Card Scheme was assessed in 79% of pharmacy programmes and 57% of medical schools. Specialist speakers on the Yellow Card Scheme were infrequently used. Fewer than half of respondents provided students with a guide to reporting ADRs (43% pharmacy and 43% medical). There is some disagreement about the value of supplying students with printed material about the Yellow Card Scheme. Half of medical Schools did not think that supplying 'Current Problems In Pharmacovigilance' would be useful. Conclusions: It was found that in both medicine and pharmacy, courses differed substantially in teaching about the Yellow Card Scheme and adverse drug reactions (ADRs). There is scope for increased involvement of the Medicines and Healthcare products Regulatory Agency in undergraduate education, in line with recommendations from the National Audit Office.

Increased potential of a cationic liposome-based delivery system:enhancing stability and sustained immunological activity in pre-clinical development

The combination of dimethyl dioctadecyl ammonium bromide (DDA) and the synthetic cord factor trehalose dibehenate (TDB) with Ag85B-ESAT-6 (H1 fusion protein) has been found to promote strong protective immune responses against Mycobacterium tuberculosis. The development of a vaccine formulation that is able to facilitate the requirements of sterility, stability and generation of a vaccine product with acceptable composition, shelf-life and safety profile may necessitate selected alterations in vaccine formulation. This study describes the implementation of a sterilisation protocol and the use of selected lyoprotective agents in order to fulfil these requirements. Concomitantly, close analysis of any alteration in physico-chemical characteristics and parameters of immunogenicity have been examined for this promising DDA liposome-based tuberculosis vaccine. The study addresses the extensive guidelines on parameters for non-clinical assessment, suitable for liposomal vaccines and other vaccine delivery systems issued by the World Health Organisation (WHO) and the European Medicines Agency (EMEA). Physical and chemical stability was observed following alteration in formulations to include novel cryoprotectants and radiation sterilisation. Immunogenicity was maintained following these alterations and even improved by modification with lysine as the cryoprotective agent for sterilised formulations. Taken together, these results outline the successful alteration to a liposomal vaccine, representing improved formulations by rational modification, whilst maintaining biological activity.

Pharmaceutical compounding and dispensing

This is a detailed and practical guide to the theory and practice of extemporaneous compounding and dispensing, and a source of reference to extemporaneous formulae. Pharmacists have been responsible for compounding medicines for centuries and there is currently a dearth of current information on the topic, yet it is still taught in schools of pharmacy and required in community and hospital departments and by "specials" manufacturers and in development of new products in industry. This is a modern, detailed and practical guide to the theory and practice of extemporaneous compounding and dispensing, which will equip readers with the knowledge required for producing extemporaneous formulations safely and effectively.

Development and validaton of an indicator to compare antibiotic usage in secondary care in England

The use of antibiotics was investigated in twelve acute hospitals in England. Data was collected electronically and by questionnaire for the financial years 2001/2, 2002/3 and 2003/4. Hospitals were selected on the basis of their Medicines Management Self-Assessment Scores (MMAS) and included a cohort of three hospitals with integrated electronic prescribing systems. The total sample size was 6.65% of English NHS activity for 2001/2 based on Finished Consultant Episode (FCE) numbers. Data collected included all antibiotics dispensed (ATC category J01), hospital activity FCE's and beddays, Medicines Management Self-assessment scores, Antibiotic Medicines Management scores (AMS), Primary Care Trust (PCT) of origin of referral populations, PCT antibiotic prescribing rates, Index of Multiple Deprivation for each PCT. The DDD/FCE (Defined Daily Dose/FCE) was found to correlate with the DDD 100beddays (r = 0.74 p

The use of anticholinergic agents to treat excessive oropharyngeal and tracheal secretions in palliative care

Palliative care involves a multi-professional team approach to the provision of active, holistic care for patients and their families when the patient's disease is no longer responsive to curative treatment. Patient care encompasses medical and pharmacological intervention for symptom control, together with psychological, spiritual and social support for patients and families. Care is provided by teams in hospice, hospital or community environments. Although traditionally associated with providing care for cancer patients, palliative care services are increasingly providing for patients with non-malignant disease. Symptoms commonly associated with terminal phase of disease include pain, nausea, agitation, respiratory symptoms and general fatigue. During the last few days of life, patients may become weak, resulting in difficulty taking oral medication and have periods of unconsciousness. Some patients may require drug administration via subcutaneous infusion. A proportion of patients may develop difficulty clearing respiratory secretions causing a characteristic ‘death rattle’, which although not generally considered to be distressing for the patient, is often treated with a variety of anticholinergic drugs in an attempt to reduce the ‘noisy breathing’ for the benefit of relatives and others who may be closely associated with the patient.This study examined treatment of death rattle in two Hospices focusing on objective and subjective outcome measures in order to determine the efficacy of anticholinergic regimens in current use. Qualitative methods were employed to elicit attitudes of professionals and carers working closely with the patient. The number of patients recruited and monitored were small, many confounding factors were identified which questioned firstly the clinical rationale for administering anticholinergic drugs routinely to treat death rattle and secondly, the ethics of administering drug regimens to patients to treat death rattle with the primary aim of relieving distress for others. Ethnical issues, including those of consent are discussed in relation to their impact on the methodology of end of life studies in medicines management in palliative care.

Sedation in paediatric intensive care

Paediatric intensive care is an expanding specialty that has been shown to improve the quality of care provided to critically ill children. An important aspect of the management of critically ill children includes the provision of effective sedation to reduce stress and anxiety during their stay in intensive care. However, to achieve effective and safe sedation in these children, is recognised as a challenge that is not without risk. Often children receive too much or too little sedation resulting in over sedation or under sedation respectively. These problems have arisen owing to a lack of information regarding altered pharmacokinetics and pharmacodynamics of medicines administered to critically ill children. In addition there are few validated sedation scoring systems in practice with which to monitor level of sedation and titrate medication appropriately. This study consisted of two stages. Stage 1 investigated the reproducibility and practicality of two observational sedation assessment scales for use in critically ill children. The two scales were different in design, the first being simple in design requiring a single assessment of the patient. The second was more complex in design requiring assessment of five patient parameters to obtain an overall sedation score. Both scales were found to achieve good reproducibility (kappa values 0.50 and 0.62 respectively). Practicality of each sedation scale was undertaken by obtaining nursing staff opinion about both scales using questionnaire and interview technique. It was established that nursing staff preferred the second, more complex sedation scale mainly because it was perceived to give a more accurate assessment of level of sedation and anxiety rather than merely level of sedation. Stage 2 investigated the pharmacokinetics and pharmacodynamics of midazolam in critically ill children. 52 children, aged between 0 and 18 years were recruited to the study and 303 blood samples taken to analyse midazolam and its metabolites, I-hydroxyrnidazolam (I-OR) and 4-hydroxymidazolam (4-0H). Analysis of plasma was undertaken using high performance liquid chromatography. A significant correlation was found between midazolam plasma concentration and sedative effect (r=0.598, p=O.OI). It was found that a midazolam plasma concentration of 223ng/ml (±31.9) achieved a satisfactory level of sedation. Only a poor correlation was found between dose of midazolam and plasma concentration of midazolam. Similarly only a poor correlation was found between sedative effect and dose of midazolam. Clearance of midazolam was found to be 6.3mllkglmin (±0.36), which is lower than that reported in healthy children (9.Il-13.3mllkg/min). Age related differences in midazolam clearance were observed in the study. Neonates produced the lowest clearance values (l.63mllkg/min), compared to children aged 1 to 12 months (8.52mllkg/min) who achieved the highest clearance values. Clearance was found to decrease after the age of 12 months to values of 5.34mllkglmin in children aged 7 years and above. Patients with renal (n=5) and liver impairment (n~4) were found to have reduced midazolam clearance (1.37 and 0.74ml/kg/min respectively). Plasma concentrations of I-OH and 4-0H ranged from 0-5 1 89nglml and 0-27 Inglml respectively. All children were found to be capable of producing both metabolites irrespective of age, although no trend was established between age and extent of production of either metabolite. Disease state was found to affect production of l-OH. Patients with renal impairment (n=5) produced the lowest I-OH midazolam plasma ratio (0.059) compared to patients with head injury (0.858). Patients with severe liver impairment were found to be capable of manufacturing both metabolites despite having a severely damaged liver.

Innovation in the pharmaceutical industry:a study of the effects of regulation on the U.K. pharmaceutical industry

A history of government drug regulation and the relationship between the pharmaceutical companies in the U.K. and the licensing authority is outlined. Phases of regulatory stringency are identified with the formation of the Committees on Safety of Drugs and Medicines viewed as watersheds. A study of the impact of government regulation on industrial R&D activities focuses on the effects on the rate and direction of new product innovation. A literature review examines the decline in new chemical entity innovation. Regulations are cited as a major but not singular cause of the decline. Previous research attempting to determine the causes of such a decline on an empirical basis is given and the methodological problems associated with such research are identified. The U.K. owned sector of the British pharmaceutical industry is selected for a study employing a bottom-up approach allowing disaggregation of data. A historical background to the industry is provided, with each company analysed or a case study basis. Variations between companies regarding the policies adopted for R&D are emphasised. The process of drug innovation is described in order to determine possible indicators of the rate and direction of inventive and innovative activity. All possible indicators are considered and their suitability assessed. R&D expenditure data for the period 1960-1983 is subsequently presented as an input indicator. Intermediate output indicators are treated in a similar way and patent data are identified as a readily-available and useful source. The advantages and disadvantages of using such data are considered. Using interview material, patenting policies for most of the U.K. companies are described providing a background for a patent-based study. Sources of patent data are examined with an emphasis on computerised systems. A number of searches using a variety of sources are presented. Patent family size is examined as a possible indicator of an invention's relative importance. The patenting activity of the companies over the period 1960-1983 is given and the variation between companies is noted. The relationship between patent data and other indicators used is analysed using statistical methods resulting in an apparent lack of correlation. An alternative approach taking into account variations in company policy and phases in research activity indicates a stronger relationship between patenting activity, R&D Expenditure and NCE output over the period. The relationship is not apparent at an aggregated company level. Some evidence is presented for a relationship between phases of regulatory stringency, inventive and innovative activity but the importance of other factors is emphasised.

A study of the role of the community pharmacist in responding to symptons

Factors affecting the current role of the community pharmacist in responding to symptoms are investigated. Communication and collaboration with general medical practitioners (GPs), and the competency of pharmacists and counter assistants to perform the role of responding to symptoms, are examined. A national survey of GPs, conducted by postal questionnaire, explores attitudes towards the role of the community pharmacist in the treatment of patients' symptoms, and towards future extension of such a role. A majority (over 90%) of respondents thought that the counter prescribing activities of the pharmacist should be maintained or increased. Doctors supported treatment of most minor illnesses by pharmacists, but there was relatively little support for the deregulation of selected Prescription Only Medicines. Three quarters of respondents were in favour of joint educational meetings for pharmacists and doctors. Most GPs (85%) expressed support for a formal referral route from pharmacists to doctors, using a "notification card". A pilot study of the use of a notification card was conducted . Two thirds of the patients who were advised to see their doctor by the pharmacist subsequently did so. In most cases , the GP rated the patients' symptoms " significant" and the card "helpful". Pharmacists' and counter assistants' competency in responding to symptoms was assessed by a programme of pharmacy visits, where previously-defined symptoms were presented. Some pharmacists' questioning skills were found to be inadequate, and their knowledge not sufficiently current. Counter assistants asked fewer and less appropriate questions than did pharmacists, and assistants ' knowledge base was shown to be inadequate. Recommendations are made in relation to the education and training of pharmacists and counter assistants in responding to symptoms .

The corporatization of community pharmacy:implications for service provision, the public health function, and pharmacy's claims to professional status in the United Kingdom

Background Pharmacy has experienced both incomplete professionalization and deprofessionalization. Since the late 1970s, a concerted attempt has been made to re-professionalize pharmacy in the United Kingdom (UK) through role extension—a key feature of which has been a drive for greater pharmacy involvement in public health. However, the continual corporatization of the UK community pharmacy sector may reduce the professional autonomy of pharmacists and may threaten to constrain attempts at reprofessionalization. Objectives The objectives of the research: to examine the public health activities of community pharmacists in the UK; to explore the attitudes of community pharmacists toward recent relevant UK policy and barriers to the development of their public health function; and, to investigate associations between activity, attitudes, and the type of community pharmacy worked in (eg, supermarket, chain, independent). Methods A self-completion postal questionnaire was sent to a random sample of practicing community pharmacists, stratified for country and sex, within Great Britain (n = 1998), with a follow-up to nonresponders 4 weeks later. Data were analyzed using SPSS (SPSS Inc., Chicago, IL, USA) (v12.0). A final response rate of 51% (n = 1023/1998) was achieved. Results The level of provision of emergency hormonal contraception on a patient group direction, supervised administration of medicines, and needle-exchange schemes was lower in supermarket pharmacies than in the other types of pharmacy. Respondents believed that supermarkets and the major multiple pharmacy chains held an advantageous position in terms of attracting financing for service development despite suggesting that the premises of such pharmacies may not be the most suitable for the provision of such services. Conclusions A mixed market in community pharmacy may be required to maintain a comprehensive range of pharmacy-based public health services and provide maximum benefit to all patients. Longitudinal monitoring is recommended to ensure that service provision is adequate across the pharmacy network.

The impact of ageing on the barriers to drug delivery

Generally, we like to see ageing as a process that is happening to people older than ourselves. However the process of ageing impacts on a wide range of functions within the human body. Whilst many of the outcomes of ageing can now be delayed or reduced, age-related changes in cellular, molecular and physiological functionality of tissues and organs can also influence how drugs enter, distribute and are eliminated from the body. Therefore, the changing profile of barriers to drug delivery should be considered if we are to develop more age-appropriate medicines. Changes in the drug dissolution and absorption in older patients may require the formulation of oral delivery systems that offer enhanced retention at absorption sites to improve drug delivery. Alternatively, liquid and fast-melt dosage systems may address the need of patients who have difficulties in swallowing medication. Ageing-induced changes in the lung can also result in slower drug absorption, which is further compounded by disease factors, common in an ageing population, that reduce lung capacity. In terms of barriers to drug delivery to the eye, the main consideration is the tear film, which like other barriers to drug delivery, changes with normal ageing and can impact on the bioavailability of drugs delivery using eye drops and suspensions. In contrast, whilst the skin as a barrier changes with age, no significant difference in absorption of drugs from transdermal drug delivery is observed in different age groups. However, due to the age-related pharmacokinetic and pharmacodynamic changes, dose adaptation should still be considered for drug delivery across the skin. Overall it is clear that the increasing age demographic of most populations, presents new (or should that be older) barriers to effective drug delivery. © 2012 Elsevier B.V. All rights reserved.

Pharmaceutical compounding and dispensing

This is a modern, detailed and practical guide to the theory and practice of extemporaneous compounding and dispensing. Fully revised and updated, this new edition will be an indispensable reference for pharmacy students and practicing pharmacists. Pharmacists have been responsible for compounding medicines for centuries. Although most modern medicines are not compounded in a local pharmacy environment, there are still occasions when it is imperative that pharmacists have this knowledge. Pharmaceutical Compounding and Dispensing provides a comprehensive guide to producing extemporaneous formulations safely and effectively.

Applied pharmaceutical practice

Applied Pharmaceutical Practice is an invaluable resource and will guide the student pharmacist and pharmacy technician through the main stages involved in pharmaceutical dispensing. As a core reference text, it is ideal as a companion to the compulsory dispensing courses found in all undergraduate MPharm programmes and the equivalent technical training courses. Contents include: •medicines classification and standard operating procedures •NHS supply in the community and within hospitals •non-NHS supply •controlled drugs •emergency supply •patient counselling and communication •poisons and spirits This practical textbook contains useful exercises with an answers section and numerous examples and is written by authors with extensive experience within the field. This is a comprehensive guide through the main stages of pharmaceutical dispensing.The textbook is designed to guide student pharmacists or pharmacy technicians through the main stages involved in pharmaceutical dispensing. It provides students with a core reference text to accompany the compulsory dispensing course found in all pharmacy undergraduate programmes, highlighting and explaining all key concepts behind the processes involved in pharmaceutical dispensing.

Medication error in mental health:implications for primary care

Medication errors are associated with significant morbidity and people with mental health problems may be particularly susceptible to medication errors due to various factors. Primary care has a key role in improving medication safety in this vulnerable population. The complexity of services, involving primary and secondary care and social services, and potential training issues may increase error rates, with physical medicines representing a particular risk. Service users may be cognitively impaired and fail to identify an error placing additional responsibilities on clinicians. The potential role of carers in error prevention and medication safety requires further elaboration. A potential lack of trust between service users and clinicians may impair honest communication about medication issues leading to errors. There is a need for detailed research within this field.

Measuring the assessment and counselling provided with the supply of non-prescription asthma reliever medication: a simulated patient study

BACKGROUND: Over one quarter of asthma reliever medications are provided without prescription by community pharmacies in Australia. Evidence that community pharmacies provide these medications with sufficient patient assessment and medication counseling to ensure compliance with the government's Quality Use of Medicines principles is currently lacking. OBJECTIVE: To assess current practice when asthma reliever medication is provided in the community pharmacy setting and to identify factors that correlate with assessment of asthma control. METHODS: Researchers posing as patients visited a sample of Perth metropolitan community pharmacies in May 2007. During the visit, the simulated patient enacted a standardized scenario of someone with moderately controlled asthma who wished to purchase a salbutamol (albuterol) inhaler without prescription. Results of the encounter were recorded immediately after the visit. Regression analysis was performed, with medication use frequency (a marker of asthma control) as the dependent variable. RESULTS: One hundred sixty community pharmacies in the Perth metropolitan area were visited in May 2007. Pharmacists and/or pharmacy assistants provided some form of assessment in 84% of the visits. Counseling was provided to the simulated patients in 24% of the visits. Only 4 pharmacy staff members asked whether the simulated patient knew how to use the inhaler. Significant correlation was found between assessment and/or counseling of reliever use frequency and 3 independent variables: visit length (p < 0.001), number of assessment questions asked (p < 0.001), and the simulated patient who conducted the visit (p < 0.02). CONCLUSIONS: Both patient assessment and medication counseling were suboptimal compared with recommended practice when nonprescription asthma reliever medication was supplied in the community pharmacy setting. Pharmacy and pharmacist demographic variables do not appear to affect assessment of asthma control. This research indicates the need for substantial improvements in practice in order to provide reliever medication in line with Quality Use of Medication principles of ensuring safe and effective use of medication.

Monocytes in coronary artery disease and atherosclerosis:where are we now?

Despite improvements in interventional and pharmacological therapy of atherosclerotic disease, it is still the leading cause of death in the developed world. Hence, there is a need for further development of effective therapeutic approaches. This requires better understanding of the molecular mechanisms and pathophysiology of the disease. Atherosclerosis has long been identified as having an inflammatory component contributing to its pathogenesis, whereas the available therapy primarily targets hyperlipidemia and prevention of thrombosis. Notwithstanding a pleotropic anti-inflammatory effect to some therapies, such as acetyl salicylic acid and the statins, none of the currently approved medicines for management of either stable or complicated atherosclerosis has inflammation as a primary target. Monocytes, as representatives of the innate immune system, play a major role in the initiation, propagation, and progression of atherosclerosis from a stable to an unstable state. Experimental data support a role of monocytes in acute coronary syndromes and in outcome post-infarction; however, limited research has been done in humans. Analysis of expression of various cell surface receptors allows characterization of the different monocyte subsets phenotypically, whereas downstream assessment of inflammatory pathways provides an insight into their activity. In this review we discuss the functional role of monocytes and their different subpopulations in atherosclerosis, acute coronary syndromes, cardiac healing, and recovery with an aim of critical evaluation of potential future therapeutic targets in atherosclerosis and its complications. We will also discuss technical difficulties of delineating different monocyte subpopulations, understanding their differentiation potential and function.