Pharmacovigilance and the Null Hypothesis Do We do Much for Public Health?

ArticleinDrug Safety 34(2):93-6 · February 2011with20 Reads
DOI: 10.2165/11588420-000000000-00000 · Source: PubMed
    • "It is important to demonstrate that PV is an essential public health function with sound processes and the ability to improve health outcomes. It is also essential to demonstrate that the level or scale of PV is cost effective [3]. However, even in high-income countries where PV is well developed, systematic assessments of the economic value of PV are not routine or even generally available. "
    [Show abstract] [Hide abstract] ABSTRACT: Pharmacovigilance (PV) programs are an essential component of national healthcare systems. Well-functioning PV programs can improve population health by identifying and reducing medicines-related problems (MRPs). Many low- and middle-income countries lack functional PV systems, but this deficiency has not been described in terms of the potential economic value of strengthening PV systems. The assessment of economic value for PV can support rational decision making at the country level. We propose a framework for assessing the economic value of PV. We divide national PV systems into four levels: (1) no PV, (2) basic PV, (3) semi-functional PV, and (4) functional PV. These categories represent increasing levels of investment in PV capacity at the national or health facility level for all available medicines, including vaccines. The proposed framework can be used to estimate the costs of PV (including the value of investments to increase PV capacity and the costs of managing MRPs) and outcomes associated with PV (including improvements in morbidity, mortality, and quality of life as a result of the reduction in MRPs). The quantitative approach proposed for assessing costs and benefits uses a decision-analytic modeling framework that would estimate the value of the consequences of MRPs adjusted for their probability of occurrence. This allows the quantification of value using monetary outcomes (cost-benefit analysis), natural units (cost-effectiveness analysis), or mortality adjusted for quality of life or disability (cost-utility analysis). Evidence generated using this framework could assist policy makers, program managers, and donors in evaluating investments that aim to increase the capacity and efficiency of national and facility-level PV programs in low- and middle-income countries.
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  • [Show abstract] [Hide abstract] ABSTRACT: Drug-induced pro-arrhythmia is a serious and unexpected event. Large administrative and claims databases can potentially identify drugs or interactions leading to cardiac arrhythmias. The purpose of this study is to evaluate the evidence supporting the validity of algorithms or codes to identify ventricular arrhythmias using administrative and claims data. A search of MEDLINE database is supplemented by manual searches of bibliographies of key relevant articles. We selected all studies in which an administrative and claims data algorithm or code was validated against a medical record. We report the positive predictive value (PPV) for ICD-9 codes compared to medical records. Our search strategy yielded 664 studies, of which only seven met our eligibility criteria. Two additional studies were identified by peer reviewers. The most commonly included databases were Medicare and Medicaid, and the most commonly evaluated ICD-9 codes were 426.x and 427.x. The individual use of ICD-9 codes 427.x yielded a high PPV (78%-100%). The highest PPV was seen when both ICD-9 codes 427.x and 798.x were used (92%). The same codes yielded the highest PPV when found in the principal diagnosis position (100%). The use of ICD-9 codes 427.x, alone or in combination with code 798.x, in the principal position is appropriate for the identification of ventricular arrhythmias in administrative and claims databases.
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