Risk assessment of neonatal excipient exposure: lessons from food safety and other areas.

Newborn babies can require significant amounts of medication containing excipients intended to improve the drug formulation. Most medicines given to neonates have been developed for adults or older children and contain excipients thought to be safe in these age groups. Many excipients have been used widely in neonates without obvious adverse effects. Some excipients may be toxic in high amounts in which case they need careful risk assessment. Alternatively, it is conceivable that ill-founded fears about excipients mean that potentially useful medicines are not made available to newborn babies. Choices about excipient exposure can occur at several stages throughout the lifecycle of a medicine, from product development through to clinical use. Making these choices requires a scalable approach to analysing the overall risk. In this contribution we examine these issues.

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 [$7,502.2; 95% CI: £3,283.9 ($4,925.8) to £6,719.1 ($10,078.6); P<0.001], respectively. Consequently, and considering that 254 false-positive blood cultures had occurred in the study site hospital over a one-year period, patients with false-positive blood cultures added 1372 extra hospital days and incurred detrimental additional hospital costs of £1,270,381 ($1,905,572) per year. The findings therefore demonstrate that false-positive blood cultures have a significant impact on increasing hospital length of stay, laboratory and pharmacy costs. These findings highlight the need to intervene to raise the standard of blood-culture-taking technique, thus improving both the quality of patient care and resource use.

A HRG-based costing model for estimating pharmacy costs associated with surgical procedures.

OBJECTIVE: The present study addresses pharmacy expenditure within a surgical directorate in a UK hospital. The aim of the study was to develop a health care resource group (HRG)-based costing model that can be used to forecast pharmacy expenditure based on surgical casemix. Such a model will be of benefit as an expenditure projection tool at a time when hospitals are developing accelerated operation programmes in an attempt to decrease hospital waiting times. METHOD: During the period February-April 2000, nursing staff recorded all pharmacy sourced items for each individual operation in the theatres used for general surgery, ENT surgery and gynaecological procedures; each operation was also classified according to its HRG. The associated costs of the items per HRG were identified and the average pharmaceutical cost per HRG calculated and included in the costing model. The model derived costs over the study period were compared with the actual pharmacy expenditure which was obtained from the pharmacy computer system. Finally HRG data for operations carried out in February 2002 were costed using the model for validation purposes. RESULTS: The estimated pharmaceutical cost for surgery items for February-April 2000 was 121,235 UK pounds. This figure was 3.92% over the actual pharmaceutical expenditure as determined from computer records. The February 2002 casemix varied considerably from that of 2000. However, the model estimated pharmaceutical cost of surgery performed in February 2002 (38,054 UK pounds) was again very similar to the computer logged expenditure (1.09% under the actual expenditure for that period) indicating the robustness of the HRG-based costing approach.

Management of Helicobacter pylori eradication--the influence of structured counselling and follow-up.

AIMS: Helicobacter pylori (H. pylori) eradication rate varies according to the treatment regimen used and other factors, e.g. antimicrobial resistance and patient compliance. The aim of the present study was to evaluate the influence of patient counselling and follow-up on H. pylori eradication rates and to document the effectiveness of a 1 week eradication regimen consisting of lansoprazole (30 mg once daily), amoxicillin (1 g twice daily) and clarithromycin (500 mg twice daily). METHODS: Seventy-six dyspeptic patients, who at endoscopy were found to have gastritis, duodenitis or ulceration, and a positive H. pylori urease test, were recruited. Patients were randomly assigned to an intervention group (n = 38) or a control group (n = 38). Intervention patients received their medicines via the hospital pharmacy and were counselled (and followed up) by a hospital pharmacist. Control patients were given a standard advice sheet and referred to their GP who prescribed the same therapy. RESULTS: Intervention patients exhibited a statistically significant improvement in the H. pylori eradication rate (94.7% vs 73.7%; P = 0.02) and compliance (92.1% vs 23.7; P < 0.001). Of the 64 H. pylori eradicated patients, 62 were able to eliminate their antisecretory medication compared with only 12 of the H. pylori persistent patients (P < 0.001). A pharmacoeconomic evaluation indicated that counselling and follow-up reduced the direct costs of eradication by approximately 30 UK pounds per patient. CONCLUSIONS: Structured patient counselling and follow-up can have a significant effect on H. pylori eradication rates and should be a routine part of therapy.

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.

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. DESIGN: Prospective, randomized, controlled trial. SETTING: Community pharmacies (11 control, 11 intervention) in Malta. PATIENTS: Community-dwelling patients with asthma. INTERVENTIONS: A comprehensive asthma education and monitoring program was implemented. Intervention patients received verbal counseling, an educational video, an information leaflet, and subsequent monitoring with reinforcement; control patients received routine dispensing services. MEASUREMENTS AND MAIN RESULTS: Parameters assessed at baseline and at 4, 8, and 12 months were health-related quality of life, peak expiratory flow (PEF), inhaler technique, compliance with therapy, hospitalization rates, days lost from work, asthma symptoms, and patient satisfaction. Health-related quality of life of the intervention patients improved at 12 months (p=0.044). In the same time period, PEF significantly decreased in control patients compared with intervention patients (p=0.009) whereas inhaler technique improved in the intervention group (p=0.021). There were significantly fewer self-reported hospitalizations in intervention patients. CONCLUSIONS: A community-based pharmaceutical care program was appreciated by the participants and had a positive impact on the vitality of patients with asthma, inhaler technique, and PEE.

Clostridium difficile-associated diarrhoea in hospitalised patients.

OBJECTIVE: The aim of the present study was to evaluate the incidence, risk factors and cost implications of Clostridium difficile-associated diarrhoea (CDAD) in hospitalized adult patients. METHODS: Eighty-seven hospitalized adult patients, positively identified as having CDAD, were reviewed retrospectively to determine the risk factors and cost implications of CDAD. RESULTS: The clinical manifestations, in addition to diarrhoea, included elevated temperature (= 37.8 degrees C; 42.5%), abdominal pain (63. 2%) and leucocytosis (=12 x 109 cells/l; 52.9%). Eight patients underwent endoscopy, and pseudomembranous colitis was confirmed in all of these patients. Nine patients died during their hospital stay. Cefotaxime and cefuroxime were the agents most commonly associated with CDAD. There was a significant difference (P < 0.001) between the sex distribution of CDAD patients and adult hospital patients (69% of CDAD patients were female vs. 52% of general adult hospital population). Significantly (P < 0.001) more patients with CDAD were admitted from the nursing home (NH) setting. The mean age of patients with CDAD admitted from NHs (n = 19) was older than those cases admitted from the community (n = 68) by 14 years (P < 0.001). The length of hospital stay was significantly (P < 0.001) longer for patients with CDAD (16.9 vs. 3.89 days). No differences (P = 0.306) were found in the response times for CDAD patients treated with either oral metronidazole (n = 39) or oral vancomycin (n = 48). The mean response time was, however, significantly longer in the CDAD patients admitted from NHs (4.2 days) compared with those admitted from the community (2.5 days), although the former patients were older and had significantly more comorbidity (P < 0.001). The mean cost per one treated-case of CDAD (bed, laboratory requests and treatment therapy) was calculated as pound2860. CONCLUSION: Patients admitted from NHs are at increased risk of development of CDAD; receiving cefotaxime or cefuroxime axetil (oral form), being elderly and being female are risk factors for the development of CDAD. Treatment of CDAD with oral metronidazole or oral vancomycin gives rise to similar response times and efficacy.

Use of a treatment protocol in the management of community-acquired lower respiratory tract infection.

The aim of the present study was to examine the impact of an antimicrobial prescribing protocol on clinical and economic outcome measures in hospitalized patients with community-acquired lower respiratory tract infection (LRTI). The study was performed as a prospective controlled clinical trial within the medical wards at Antrim Area Hospital, Northern Ireland. Data were collected on all hospitalized adult patients with a primary diagnosis of LRTI during the period December 1994 to February 1995 (normal hospital practice; control group; n = 112). After an LRTI management protocol (medical, microbiological and pharmacy staff) had been developed, all hospitalized adult patients with a primary diagnosis of LRTI over the period December 1995 to February 1996 formed the intervention group (treated according to the protocol; n = 115). The results showed a statistically significant impact of the protocol in terms of clinical and economic outcome measures. Patients treated using the algorithmic prescribing protocol had significant reductions in length of hospital stay (geometric mean 4.5 versus 9.2 days), iv drug administration (34.8% versus 61.6%), duration of iv therapy (geometric mean 2.1 versus 5.7 days) and treatment failures (7.8% versus 31.3%). Healthcare costs were also significantly reduced. The use of the protocol was a major factor in streamlining the prescribing of antimicrobial therapy for community-acquired LRTI and led to more cost-effective patient management.

Sequential antimicrobial therapy: treatment of severe lower respiratory tract infections in children.

Although there have been a number of studies in adults, to date there has been little research into sequential antimicrobial therapy (SAT) in paediatric populations. The present study evaluates the impact of a SAT protocol for the treatment of severe lower respiratory tract infection in paediatric patients. The study involved 89 paediatric patients (44 control and 45 SAT). The SAT patients had a shorter length of hospital stay (4.0 versus 8.3 days), shorter duration of inpatient antimicrobial therapy (4.0 versus 7.9 days) with the period of iv therapy being reduced from a mean of 5.6 to 1.7 days. The total healthcare costs were reduced by 52%. The resolution of severe lower respiratory tract infection with a short course of iv antimicrobials, followed by conversion to oral therapy yielded clinical outcomes comparable to those achieved using longer term iv therapy. SAT proved to be an important cost-minimizing tool for realizing substantial healthcare costs savings.

A self-reported work sampling study in community pharmacy practice.

Lack of time to implement pharmaceutical care has been cited as a barrier to the routine provision of this extended patient-care service. Using self-reported work sampling methodology, this study investigated how community pharmacists utilise their time. Pharmacists working in community pharmacies in the Greater Belfast area were found to spend approximately 49% of their time engaged in professional activities, 29% in semi-professional activities and 22% involved in non-professional activities. The activity to which pharmacists devoted the majority of their time was product assembly and labelling, this being a task which can be performed by trained technical staff. Only 9.5% of community pharmacists' time was devoted to counselling patients on their prescription medicines. Wide variation in the amount of time apportioned to each activity was observed between the participating community pharmacists (n = 30). Staffing levels within the community pharmacy were found to significantly influence pharmacists' involvement in a number of activities, with pharmacists who worked in pharmacies employing multiple pharmacists devoting more time to the assembly and labelling of products and less time to administrative tasks, non-professional encounters and to miscellaneous professional activities. Pharmacists working in pharmacies with a high prescription turnover were found to devote significantly less time to counselling patients regarding OTC products and in responding to patient symptoms.

Costs and effects associated with a community pharmacy-based smoking-cessation programme.

OBJECTIVE: The aim of the study was to determine the costs and effects associated with a community pharmacy-based smoking-cessation programme in Northern Ireland, using the perspective of the payer in the main analysis. DESIGN AND SETTING: Data from a pilot study conducted in 2 community pharmacies in Northern Ireland were used as the basis of the current study, which examined the cost effectiveness of a formal counselling programme for smoking cessation by community pharmacists throughout Northern Ireland. A number of assumptions were made in the baseline analysis (e.g. annual rate of smoking cessation in the absence of the programme; lifetime relapse rate), and these were varied in the sensitivity analysis. PATIENTS AND PARTICIPANTS: The pilot study upon which the main analysis was based was carried out in 2 Belfast pharmacies over a 2-year period. 52 people entered the smoking-cessation programme (group 1), 48 bought nicotine gum and gave their address so that additional information could be sent and they could be followed-up (group 2), and 60 people who expressed a wish to stop smoking were chosen on the basis that they matched, by age, gender, social status and disease status, those in group 1. Thirty-five of those in group 1 requested to use nicotine gum. A statistically significant difference (p < 0.01) was found in cessation rates between intervention and control patients. INTERVENTIONS: The Pharmacists Action on Smoking (PAS) model was the only active intervention used in the study. The model was developed by the PAS group in association with the National Pharmaceutical Association (NPA) in the UK in 1994, and was designed specifically for use by community pharmacists to provide advice and motivation to help smokers stop smoking. The 4-stage model involves a written 'contract' between the patient and pharmacist (including a 'stop date'), and a series of brief counselling meetings over a period of approximately 6 months. MAIN OUTCOME MEASURES AND RESULTS: Our findings indicate that the cost per life-year saved when using the PAS programme ranges from 196.76 pounds sterling (Pounds) to 351.45 Pounds for men and from 181.35 Pounds to 772.12 Pounds for women (1997 values), depending on age. This compares favourably with other disease prevention medical interventions such as screening for hypertension or hypercholesterolaemia. CONCLUSIONS: These findings provide an argument for adoption and remuneration of the PAS model in the community pharmacy (primary healthcare) setting.

Audit of antibiotic usage in medium-sized general hospital over an 11-year period. The impact of antibiotic policies.

The objective of the present study was to evaluate trends in antibiotic expenditure over an 11-year period (1982-1992) in a 370-bed district general hospital in Northern Ireland and to examine the impact of two separate antibiotic policies on antibiotic usage. A further objective was to examine the attitudes of prescribers to the second policy. Drug utilization review was used to collect information on antibiotic expenditure and usage before and after introduction of separate antibiotic policies in 1985 (not intensively monitored) and 1989 (intensively monitored). A main questionnaire was used to determine the attitudes of prescribers. The first policy (1985) showed no benefits with regard to the number of antibiotic entities stocked (45 before, 45 after), number of dosage units issued (9.3% increase) or expenditure (33.3% increase). The 1989 policy led to significant reductions in the number of antibiotic entities stocked (28.9%), number of antibiotics issued (11.9%) and expenditure (6.1%). Expenditure began to spiral upwards when active monitoring of the second policy was suspended. The majority of prescribers (87.2%) who responded to the questionnaire (56.5% response rate) felt that the 1989 policy made a positive contribution to antibiotic usage in the hospital.

Drug-antacid interactions: assessment of clinical importance.

Antacids and adsorbents are commonly used preparations that are generally considered to be pharmacologically inert and free from adverse effects. They may, however, interact with a diverse range of primary drugs and the sequelae can be disadvantageous to the efficacy of the primary medication. Many such reports in the literature are based on animal experiments, or on single-dose studies in healthy subjects. Some reports are anecdotal and are unconfirmed; others are based solely on in vitro evidence. Potentially important interactions have been suggested for a relatively small group of drugs: tetracyclines, phenytoin, digoxin, chloroquine, cimetidine, quinidine, nonsteroidal antiinflammatory drugs, and beta-blocking agents. The evidence for these has been critically evaluated, as well as for antacid-anticoagulant and antacid-nitrofurantoin interactions that have been wrongly emphasized in the literature. The majority of literature reports on interactions with antacids have been overemphasized; only ferrous sulfate-, isoniazid-, and tetracycline-antacid interactions fall into a category I importance (scale I-III of descending importance). This category is for those interactions with good evidence of actual or potential importance in patients or in relevant studies on normal subjects.