Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

INTRODUCTION: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. METHODOLOGY: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. RESULTS: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. CONCLUSION: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe.

Time spent by Belgian hospital pharmacists on supply disruptions and drug shortages: An exploratory study.

INTRODUCTION: Supply problems of drugs are an increasing and worldwide problem, also in Belgium. Hospital pharmacists try to manage drug supply problems to minimize the impact on patient care. This study aims to quantify in a detailed manner how much time employees of 17 Belgian hospital pharmacies spend on drug supply problems. METHODS: During six months, employees of Belgian hospital pharmacies filled in the daily time spent on drug supply problems using a template containing all steps which can be executed to manage drug supply problems. Additionally, Belgian hospital pharmacists were asked to report the drugs which experienced drug supply problems together with the solution for this problem. RESULTS: Hospital pharmacists spent a median of 109 minutes a week on drug supply problems, with a minimum of 40 minutes per week and a maximum of 216 minutes per week. Fifty-nine percent of the total time spent on drug supply problems was executed by hospital pharmacists, 27% by pharmacy technicians; the rest was performed by logistic or administrative personnel. About one third of the total time spent was invested in gathering information on the supply problem. About two third of the supply disruptions caused drug shortages, meaning there was a need to switch to another (generic) therapeutic alternative. For most drug shortages, a Belgian generic medicine could be found. However in some cases, the alternative had to be ordered abroad or for some drug shortages, no alternative was available. CONCLUSION: These exploratory results on time spent by hospital pharmacists on drug supply problems in Belgium highlight the economic impact of drug supply problems for hospital pharmacies. A fully reliable, daily updated list on the federal agencies websites would be a major help to hospital pharmacists.

Appropriateness of Acid Suppression Therapy.

BACKGROUND: The inappropriate startup of long-term acid suppressive therapy (AST) can have clinical and pharmacoeconomic impacts on ambulatory care. OBJECTIVE: To assess the proportion of patients with appropriate initiation of long-term AST in non-critically ill patients. To describe possible risk factors for nonappropriate AST. To calculate the potential savings when eliminating the nonappropriate startup of AST. METHOD: This observational, retrospective study evaluated the appropriateness of startup of long-term AST in medical records using a broad variety of international criteria and guidelines and using a validated screening instrument. RESULTS: A sample of 597 patients was included in the analysis. In 57% of them, AST was appropriately initiated. No specific risk profile could be defined. There was some indication that the availability of a clinical pharmacist and the use of standing orders were correlated to the outcome. Extrapolation to the total population (ie, 2836 patients) led to a total cost of €8880 during hospital stay plus an extra €40 391 per month after discharge. Avoiding inappropriate initiation of AST could lead to a saving of €3805 plus €17 441 per month. CONCLUSION: In all, 43% of initiation of long-term AST in the hospital was inappropriate. The potential savings from avoiding this could be substantial from a health care payer perspective. No patient characteristics that could predict for inappropriate initiation of AST were identified. A correlation between inappropriate initiation and medical disciplines using standing orders that include AST was seen.

Early versus late parenteral nutrition in ICU patients: cost analysis of the EPaNIC trial.

INTRODUCTION: The EPaNIC randomized controlled multicentre trial showed that postponing initiation of parenteral nutrition (PN) in ICU-patients to beyond the first week (Late-PN) enhanced recovery, as compared with Early-PN. This was mediated by fewer infections, accelerated recovery from organ failure and reduced duration of hospitalization. Now, the trial's preplanned cost analysis (N = 4640) from the Belgian healthcare payers' perspective is reported. METHODS: Cost data were retrieved from individual patient invoices. Undiscounted total healthcare costs were calculated for the index hospital stay. A cost tree based on acquisition of new infections and on prolonged length-of-stay was constructed. Contribution of 8 cost categories to total hospitalization costs was analyzed. The origin of drug costs was clarified in detail through the Anatomical Therapeutic Chemical (ATC) classification system. The potential impact of Early-PN on total hospitalization costs in other healthcare systems was explored in a sensitivity analysis. RESULTS: ICU-patients developing new infection (24.4%) were responsible for 42.7% of total costs, while ICU-patients staying beyond one week (24.3%) accounted for 43.3% of total costs. Pharmacy-related costs represented 30% of total hospitalization costs and were increased by Early-PN (+608.00 EUR/patient, p = 0.01). Notably, costs for ATC-J (anti-infective agents) (+227.00 EUR/patient, p = 0.02) and ATC-B (comprising PN) (+220.00 EUR/patient, p = 0.006) drugs were increased by Early-PN. Sensitivity analysis revealed a mean total cost increase of 1,210.00 EUR/patient (p = 0.02) by Early-PN, when incorporating the full PN costs. CONCLUSIONS: The increased costs by Early-PN were mainly pharmacy-related and explained by higher expenditures for PN and anti-infective agents. The use of Early-PN in critically ill patients can thus not be recommended for both clinical (no benefit) and cost-related reasons. TRIAL REGISTRATION: ClinicalTrials.gov NCT00512122.

Economic effects of clinical pharmacy interventions: a literature review.

PURPOSE: Economic evaluations of clinical pharmacy interventions are reviewed. SUMMARY: A variety of clinical pharmacy interventions have been assessed, but the body of evidence relating to any particular type of intervention is small. Cost-saving interventions comprise a small percentage of clinical pharmacy interventions, but they generated substantial savings. Clinical pharmacists provided added value by participating in multidisciplinary teams attending rounds. Clinical pharmacy interventions reduced preventable adverse drug events and prescribing errors, thereby yielding savings related to cost avoidance. Interventions relating to antibiotic therapy lowered costs of care without adversely affecting clinical outcomes. The results of cost-benefit analyses suggested that general clinical pharmacy interventions are associated with cost savings. Most economic evaluations of clinical pharmacy interventions suffered from a number of methodological limitations relating to the absence of a control group without clinical pharmacy interventions, limited scope of costs and outcomes, focus on direct health care costs only, exclusion of pharmacist employment cost, use of intermediate outcome measures, exclusion of health benefits, and absence of incremental cost analysis. Some avenues for designing future economic evaluations include the use of a control group, detailed descriptions of the interventions provided, evaluations conducted from a societal perspective, consideration of patients' health benefits when assessing economic effect of interventions and hospital costs, and the inclusion of sensitivity and incremental analyses. CONCLUSION: Most pharmacoeconomic evaluations of clinical pharmacy interventions demonstrated limitations in their methodological quality and applicability to current practice. Future evaluations should use a comparative study design that includes the incremental cost-effectiveness or cost:benefit ratio of clinical pharmacy interventions from a societal perspective.