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Development and pilot testing of a prescription quality index for Ayurveda.

ABSTRACT: BACKGROUND:Prescription quality can be a direct predictor of the net outcome of a health care delivery effort. Quality of prescription may be considered as a cumulative matrix of multiple components of a prescription on the basis of their relative importance. Prescription quality index is a recognized tool in clinical medicine for multiple purposes including the prediction of health care intervention outcome. OBJECTIVES:Considering the importance of prescription quality among every system of medicine, an attempt was made to design a prescription quality index for Ayurveda. MATERIALS AND METHODS:The Prescription Quality Index for Ayurveda was designed through item selection following a thorough literature search and was validated through multiple peer group discussions. Final draft of index containing 38 individual items carrying different scores as per their importance in the prescription was subjected to a pilot test upon 1576 indoor prescriptions generated in 2015 at State Ayurvedic College Hospital, Lucknow. RESULTS:The study revealed large information gaps in the components of the prescription where it was supposed to be noted by the prescribers. These gaps in the Ayurvedic prescriptions were most significant in the areas pertaining to Ayurvedic fundamentals of clinical examination, disease diagnosis and Ayurvedic drug intake methods. CONCLUSION:Prescription Quality Index for Ayurveda was found useful in underlining the gaps between the ideal and generated prescriptions. This can be utilized as a useful tool to evaluate the quality of Ayurvedic prescriptions by seeing their adherence to the standard prescription template.

SUBMITTER: Rastogi S

PROVIDER: S-EPMC6938884 | biostudies-literature | 2019 Oct - Dec

REPOSITORIES: biostudies-literature

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Development and pilot testing of a prescription quality index for Ayurveda.

Rastogi Sanjeev S

Journal of Ayurveda and integrative medicine 20171107 4

<h4>Background</h4>Prescription quality can be a direct predictor of the net outcome of a health care delivery effort. Quality of prescription may be considered as a cumulative matrix of multiple components of a prescription on the basis of their relative importance. Prescription quality index is a recognized tool in clinical medicine for multiple purposes including the prediction of health care intervention outcome.<h4>Objectives</h4>Considering the importance of prescription quality among ever ...[more]

PMID: 29122455

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Project description:ImportanceHealth care practitioners and patients must have information to support their confidence in the quality of prescription pharmaceuticals.ObjectiveTo determine whether there were clear and substantive differences in major quality attributes between difficult-to-make solid oral dosage form pharmaceutical products marketed in the US.Design, setting, and participantsThis quality improvement study analyzed US Food and Drug Administration-collected samples of 252 drug products marketed in the US and manufactured in the US, Canada, Europe, India, and the rest of Asia. These drug products were immediate-release solid oral dosage forms considered difficult to make on the basis of product quality history. This sampling included 35 innovator and 217 generic drug samples manufactured by 46 different firms containing 17 different active ingredients. Statistical analysis was performed from February to November 2019.Main outcomes and measuresAll products were tested within their shelf life on the basis of the legally recognized tests of the US Pharmacopeia for the major quality attributes of dosage unit uniformity and dissolution. These tests measure dosage consistency and drug release, respectively. The consistency of either attribute was used to calculate a process performance index to describe the variability in manufacturing.ResultsAll 252 drug product samples met the US market standards for dosage unit uniformity and dissolution, although the process performance index (Ppk) for dissolution fell below the level of 4-sigma capability (ie, <1 error per 1600) for 11 different manufacturers and for generics in 4 of 5 regions, including the US. As part of a retrospective analysis, manufacturers performing above the median Ppk for either dissolution or dosage unit uniformity submitted fewer product quality defect reports (mean field alert reports of 0.22 and 0.63, respectively) than those falling at or below the median Ppk for these attributes (mean field alert reports of 2.1 and 1.7, respectively).Conclusions and relevanceAll samples met the US market standards for dosage unit uniformity and dissolution, indicating acceptability for use by patients regardless of manufacturer or region. To our knowledge, this is the largest sampling study of pharmaceutical manufacturers for the US market and these data provide objective insight into the quality of prescription drugs with high manufacturing risks.

Dataset Information

Development and pilot testing of a prescription quality index for Ayurveda.

Publications

Development and pilot testing of a prescription quality index for Ayurveda.

Similar Datasets

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