The development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines.

BACKGROUND: Falsely labelled, falsified (counterfeit) medicines (FFCm's) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm's is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool. METHODS: The tool consists of a questionnaire referring to a watch-list of FFCm's identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under "real-life conditions" in 371 patients in 5 ambulatory and in-patient care sites ("sub-studies"). The physicians participating in the study scored the patients and classified their risk of harm as "unlikely" or "probable" (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool's value. RESULTS: In 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm's. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels: a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm's): LR + 4.9/LR-0, post-test probability: 35%; b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm's) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%. In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm's. The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors. CONCLUSIONS: This "decision aid" is a systematic tool which helps find in medical practice patients harmed by FFCm's. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups. The establishment of systematic communication between authorities and the medical community concerning FFCm's, current patterns of use and case reports may sustain positive public health impacts.

The evaluation of patient self-completion concordance forms used in community pharmacy: a comparison of two European countries.

OBJECTIVES: To evaluate the use of patient self-completion concordance forms in Dutch and Bulgarian pharmacies. Second, to show any differences in pharmacy practice and patient behaviour in two European countries: the Netherlands and Bulgaria. METHODS: A random sample of 500 pharmacies were approached per country. Patients at the start of a chronic treatment were invited to participate. At the first dispensing patients received a self-completion concordance form (SCCF). Patients were asked to fill in the SCCF at home and bring it to the appointment for their consultation at the second dispensing. After the consultations patients and pharmacists were asked to fill in a questionnaire. KEY FINDINGS: Twenty-four Dutch pharmacies (99 patients) and 41 Bulgarian pharmacies (241 patients) sent back study results. A higher proportion of Bulgarian patients answered questions on the SCCF compared to Dutch patients. Patients from both countries are satisfied with the SCCF, consultation and newly started medicine. CONCLUSIONS: Although differences between pharmacies from the Netherlands and Bulgaria exist, the SCCF can be used at the start of chronic treatment. More research in other European countries will be necessary to further develop the use of the SCCF in community pharmacies. Eventually this could be used to develop indicators to measure patient involvement in pharmaceutical care.

[Patterns of alcohol consumption: a cluster analytic study of the Trierer Alcoholism Inventory (TAI) in an Austrian clinical sample]. / Differentielle Alkoholkonsummuster: Eine typologische Untersuchung mit dem Trierer Alkoholismusinventar (TAI) in einer österreichischen klinischen Untersuchungsgruppe.

OBJECTIVE: The Trierer Alcoholism Inventory (TAI) assesses differential patterns of alcohol consumption in patients with alcohol use disorders. Previous cluster analytic studies with the TAI identified four distinct patterns of alcohol consumption. The aim of the present study was to replicate the cluster profiles of the TAI in an Austrian clinical sample. The discriminative validity of the TAI cluster profiles was evaluated with several external independent socio-demographic and clinical variables. A practical method to determine the similarity between an individual and a group profile of the TAI was also explored. METHODS: The TAI was administered to N = 238 patients who were admitted to an inpatient unit for alcohol withdrawal. Data were submitted to k-means cluster analysis with different starting partitions. Different cluster solutions were compared with regard to their stability, similarity (Rand-Index) and the consistency of the within-cluster profiles. RESULTS: A five-cluster solution was found to be stable. The five cluster represent different and distinctive alcohol consumption patterns: 1) Socially integrated alcohol consumption; 2) Excessive consumption, loss of self-control and severe psychosomatic consequences of long-term alcohol abuse; 3) Isolated and hidden alcohol consumption, 4) Inconspicuous alcohol consumption; 5) Residual cluster of non-classifiable cases. The discriminative validity of the cluster solution was supported with regard to age, gender, unemployment, living-situation, problems with partner, symptoms of psychological distress, and number of withdrawal treatments within the last five years. CONCLUSIONS: The study found further evidence for distinct patterns of alcohol consumption as measured by the Trierer Alcoholism Inventory. The development of clinical treatment concepts for patients with alcohol use disorders can be expected to benefit from the information obtained by the administration of the TAI-typology of alcohol consumption patterns.

[Evaluation of the short-form social support questionnaire (SOZU-K-22) in clinical and non-clinical samples]. / Evaluation der Kurzform des Fragebogens zur Sozialen Unterstützung (SOZU-K-22) in klinischen und nichtklinischen Stichproben.

Three versions (22-item, 10-item, and 7-item) of the social support questionnaire (F-SOZU) were psychometrically evaluated in two clinical and three non-clinical Austrian samples. The distribution of sum scores in all three versions was negatively skewed; means on the item-level were in the upper region of the five-point scale (M > 4.0) in all non-clinical samples. Internal consistency estimates were found to be satisfying for the total test scores (alpha > 0.85). The 10-item and the 7-item forms correlated highly with the 22-item form total score (r > 0.90). Principal components analysis supported a one dimensional solution in all forms. The discussion focuses on the problem of the highly skewed test scores. It is also argued that the use of the 7-item version might be preferable and more efficient if the researcher is only interested in obtaining a global score for perceived social support.