James McElnay

Benefits and Risks of Self Medication

Self medication is becoming an increasingly important area within healthcare. It moves patients towards greater independence in making decisions about management of minor illnesses, thereby promoting empowerment. Self medication also has advantages for healthcare systems as it facilitates better use of clinical skills, increases access to medication and may contribute to reducing prescribed drug costs associated with publicly funded health programmes. However, self medication is associated with risks such as misdiagnosis, use of excessive drug dosage, prolonged duration of use, drug interactions and polypharmacy. The latter may be particularly problematic in the elderly. Monitoring systems, a partnership between patients, physicians and pharmacists and the provision of education and information to all concerned on safe self medication, are proposed strategies for maximising benefit and minimising risk.

Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care: a multicentre study in seven European countries.

ObjectiveThis study aimed to measure the outcomes of a harmonised, structured pharmaceutical care programme provided to elderly patients (≥65 years of age) by community pharmacists in a multicentre international study performed in 7 European countries.Design and settingThe study was a randomised, controlled, longitudinal, clinical trial with repeated measures performed over an 18-month period. A total of 104 intervention and 86 control pharmacy sites participated in the research and 1290 intervention patients and 1164 control patients were recruited into the study.Main outcome measures and resultsA general decline in health-related quality of life over time was observed in the pooled data; however, significant improvements were achieved in patients involved in the pharmaceutical care programme in some countries. Intervention patients reported better control of their medical conditions as a result of the study and cost savings associated with pharmaceutical care provision were observed in most countries. The new structured service was well accepted by intervention patients and patient satisfaction with the services improved during the study. The pharmacists involved in providing pharmaceutical care had a positive opinion on the new approach, as did the majority of general practitioners surveyed. The positive effects appear to have been achieved via social and psychosocial aspects of the intervention, such as the increased support provided by community pharmacists, rather than via biomedical mechanisms.ConclusionsThis study is the first large-scale, multicentre study to investigate the effects of pharmaceutical care provision by community pharmacists to elderly patients. Future research methodology and implementation will be informed by the experience gained from this challenging trial.

Pharmaceutical care of patients with congestive heart failure : Interventions and outcomes

We evaluated a structured pharmaceutical care program for elderly patients (> 65 yrs) with congestive heart failure (CHF) based on objective measures of disease control, quality of life, and use of health care facilities in a randomized, controlled, longitudinal, prospective clinical trial. The 42 patients in group A received education from a pharmacist on the disease and its treatment, and lifestyle changes that could help control symptoms. Patients also were encouraged to monitor their symptoms and comply with prescribed drug therapy. If necessary, dosage regimens were simplified in liaison with hospital physicians. The 41 control patients (group B) received standard care. The following outcome measures were assessed in all patients at baseline (before the start of the trial) and at 3, 6, 9, and 12 months: 2‐minute walk test, blood pressure, body weight, pulse, forced vital capacity, quality of life [disease‐specific (Minnesota Living with Heart Failure questionnaire) and generic (SF‐36)], knowledge of symptoms and drugs, compliance with therapy, and use of health care facilities (hospital admissions, visits to emergency room, emergency calls). Patients in group A showed improved compliance with drug therapy, which in turn improved their exercise capacity compared with those in group B; education on management of symptoms, lifestyle changes, and dietary recommendations were also of benefit. Group A patients significantly improved knowledge of their drug therapy over the 12‐month study and had fewer hospital admissions compared with group B patients. They also had improved outcomes compared with group B, despite the small samples. An extension of this trial to other sites with pooling of results would provide additional evidence of the value of this structured program in elderly patients with CHF.

Assessment of a community pharmacy-based program for patients with asthma.

Study Objective. To implement and assess a community‐based pharmaceutical care program for patients with asthma.

Modelling the impact of antibiotic use and infection control practices on the incidence of hospital-acquired methicillin-resistant Staphylococcus aureus: a time-series analysis

OBJECTIVES Methicillin-resistant Staphylococcus aureus (MRSA) is a major nosocomial pathogen worldwide. A wide range of factors have been suggested to influence the spread of MRSA. The objective of this study was to evaluate the effect of antimicrobial drug use and infection control practices on nosocomial MRSA incidence in a 426-bed general teaching hospital in Northern Ireland. METHODS The present research involved the retrospective collection of monthly data on the usage of antibiotics and on infection control practices within the hospital over a 5 year period (January 2000-December 2004). A multivariate ARIMA (time-series analysis) model was built to relate MRSA incidence with antibiotic use and infection control practices. RESULTS Analysis of the 5 year data set showed that temporal variations in MRSA incidence followed temporal variations in the use of fluoroquinolones, third-generation cephalosporins, macrolides and amoxicillin/clavulanic acid (coefficients = 0.005, 0.03, 0.002 and 0.003, respectively, with various time lags). Temporal relationships were also observed between MRSA incidence and infection control practices, i.e. the number of patients actively screened for MRSA (coefficient = -0.007), the use of alcohol-impregnated wipes (coefficient = -0.0003) and the bulk orders of alcohol-based handrub (coefficients = -0.04 and -0.08), with increased infection control activity being associated with decreased MRSA incidence, and between MRSA incidence and the number of new patients admitted with MRSA (coefficient = 0.22). The model explained 78.4% of the variance in the monthly incidence of MRSA. CONCLUSIONS The results of this study confirm the value of infection control policies as well as suggest the usefulness of restricting the use of certain antimicrobial classes to control MRSA.

An evaluation of the impact of antibiotic stewardship on reducing the use of high-risk antibiotics and its effect on the incidence of Clostridium difficile infection in hospital settings

OBJECTIVES To evaluate the impact of a high-risk antibiotic stewardship programme on reducing antibiotic use and on hospital Clostridium difficile infection (CDI) incidence rates. A secondary objective was to present the possible utility of time-series analysis as an antibiotic risk classification tool. METHODS This was an interventional, retrospective, ecological investigation in a medium-sized hospital over 6.5 years (January 2004 to June 2010). The intervention was the restriction of high-risk antibiotics (second-generation cephalosporins, third-generation cephalosporins, fluoroquinolones and clindamycin). Amoxicillin/clavulanic acid and macrolides were classified as medium-risk antibiotics based on time-series analysis findings and their use was monitored. The intervention was evaluated by segmented regression analysis of interrupted time series. RESULTS The intervention was associated with a significant change in level of use of high-risk antibiotics (coefficient -17.3, P < 0.0001) and with a borderline significant trend change in their use being reduced by 0.156 defined daily doses/100 bed-days per month (P = 0.0597). The reduction in the use of high-risk antibiotics was associated with a significant change in the incidence trend of CDI (P = 0.0081), i.e. the CDI incidence rate decreased by 0.0047/100 bed-days per month. Analysis showed that variations in the incidence of CDI were affected by the age-adjusted comorbidity index with a lag of 1 month (coefficient 0.137051, P = 0.0182). Significant decreases in slope (coefficient -0.414, P = 0.0309) post-intervention were also observed for the monitored medium-risk antibiotics. CONCLUSIONS The restriction of the high-risk antibiotics contributed to both a reduction in their use and a reduction in the incidence of CDI in the study site hospital. Time-series analysis can be utilized as a risk classification tool with utility in antibiotic stewardship design and quality improvement programmes.

Influence of pharmaceutical care on health outcomes in patients with Type 2 diabetes mellitus

AIMS To examine the influence of a pharmaceutical care programme on disease control and health-related quality of life in Type 2 diabetes patients in the United Arab Emirates. METHODS A total of 240 Type 2 diabetes patients were recruited into a randomized, controlled, prospective clinical trial with a 12-month follow-up. A range of clinical measures, medication adherence and health-related quality of life (Short Form 36) were evaluated at baseline and up to 12 months. Intervention group patients received pharmaceutical care from a clinical pharmacist, whereas control group patients received their usual care from medical and nursing staff. The primary outcome measure was change in HbA(1c). British National Formulary and Framingham scoring methods were used to estimate changes in 10-year coronary heart disease risk scores in all patients. RESULTS A total of 234 patients completed the study. Significant reductions (P < 0.001) in mean values (baseline vs. 12 months; 95% confidence interval) of HbA(1c)[8.5% (8.3, 8.7) vs. 6.9% (6.7, 7.1)], systolic [131.4 mmHg (128.1, 134.7) vs. 127.2 mmHg (124.4, 130.1)] and diastolic blood pressure [85.2 mmHg (83.5, 86.8) vs. 76.3 mmHg (74.9, 77.7)] were observed in the intervention group; no significant changes were noted in the control group. The mean Framingham risk prediction score in the intervention group was 10.56% (9.7, 11.4) at baseline; this decreased to 7.7% (6.9, 8.5) (P < 0.001) at 12 months but remained unchanged in the control group. CONCLUSIONS The pharmaceutical care programme resulted in better glycaemic control and reduced cardiovascular risk scores in Type 2 diabetes patients over a 12-month period.

Community pharmacy based provision of pharmaceutical care to older patients.

Aim: To measure the outcomes of a harmonised, structured pharmaceutical care programme provided to elderly patients by community pharmacists.Method: A randomised, controlled, longitudinal, clinical trial with repeated measures was performed over an 18‐month period, involving community pharmacies (5 intervention and 5 control) in Northern Ireland. Elderly, ambulatory patients (≥ 65 years), taking 4 or more prescribed medications were eligible for participation. Patients attending an intervention pharmacy received education on medical conditions, implementation of compliance strategies, rationalising of drug regimens and appropriate monitoring; patients attending control sites received normal services. A battery of clinical, humanistic and economic outcomes were assessed.Results: A significantly higher proportion of intervention patients were compliant at the end of the 18‐month study and experienced fewer problems with medication compared to control patients (P < 0.05). There was little impact on quality of life and health care utilisation.Conclusions: Pharmaceutical care provision to community‐dwelling patients resulted in an improvement in medication compliance and evidence of cost‐savings. Future pharmaceutical care studies may benefit from a more focussed selective approach to data collection and outcomes measurement.

Pharmacogenomic studies of the anticancer and immunosuppressive thiopurines mercaptopurine and azathioprine.

AIMS To examine the allelic variation of three enzymes involved in 6-mercaptopurine/azathioprine (6-MP/AZA) metabolism and evaluate the influence of these polymorphisms on toxicity, haematological parameters and metabolite levels in patients with acute lymphoblastic leukaemia (ALL) or inflammatory bowel disease (IBD). METHODS Clinical data and blood samples were collected from 19 ALL paediatric patients and 35 IBD patients who were receiving 6-MP/AZA therapy. All patients were screened for seven genetic polymorphisms in three enzymes involved in mercaptopurine metabolism [xanthine oxidase, inosine triphosphatase (C94-->A and IVS2+21A-->C) and thiopurine methyltransferase]. Erythrocyte and plasma metabolite concentrations were also determined. The associations between the various genotypes and myelotoxicity, haematological parameters and metabolite concentrations were determined. RESULTS Thiopurine methyltransferase variant alleles were associated with a preferential metabolism away from 6-methylmercaptopurine nucleotides (P = 0.008 in ALL patients, P = 0.038 in IBD patients) favouring 6-thioguanine nucleotides (6-TGNs) (P = 0.021 in ALL patients). Interestingly, carriers of inosine triphosphatase IVS2+21A-->C variants among ALL and IBD patients had significantly higher concentrations of the active cytotoxic metabolites, 6-TGNs (P = 0.008 in ALL patients, P = 0.047 in IBD patients). The study confirmed the association of thiopurine methyltransferase heterozygosity with leucopenia and neutropenia in ALL patients and reported a significant association between inosine triphosphatase IVS2+21A-->C variants with thrombocytopenia (P = 0.012). CONCLUSIONS; Pharmacogenetic polymorphisms in the 6-MP pathway may help identify patients at risk for associated toxicities and may serve as a guide for dose individualization.

Clinical and economic impact of contaminated blood cultures within the hospital setting

Blood cultures have an important role in the diagnosis of serious infections, although contamination of blood cultures (i.e. false-positive blood cultures) is a common problem within the hospital setting. The objective of the present investigation was to determine the impact of the false-positive blood culture results on the following outcomes: length of stay, hotel costs, antimicrobial costs, and costs of laboratory and radiological investigation. A retrospective case-control study design was used in which 142 false-positive blood culture cases were matched with suitable controls (patients for whom cultures were reported as true negatives). The matching criteria included age, comorbidity score and month of admission to the hospital. The research covered a 13-month period (July 2007 to July 2008). The findings indicated that differences in means, between cases and controls, for the length of hospital stay and the total costs were 5.4 days [95% CI (confidence interval): 2.8-8.1 days; P<0.001] and £5,001.5 [