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Machine Learning Results for High Utilizers
Published in Chengliang Yang, Chris Delcher, Elizabeth Shenkman, Sanjay Ranka, Data-Driven Approaches for Health care, 2019
Chengliang Yang, Chris Delcher, Elizabeth Shenkman, Sanjay Ranka
We designed multiple features as the input variables of the predictive models. For each previous time period consistent with the desired forecast time period: Diagnostic codes (ICD-9-CM) grouped into CCS categories (283 categories) [2].Procedures codes (CPT and HCPCS) grouped into CCS [2] categories (231 categories).Medication information represented by National Drug Codes (NDC). These are grouped by pharmacy classes (893 classes) provided by the U.S. Food and Drug Administration (FDA)’s NDC Directory (Updated Oct. 20, 2015).Demographic variables such as age, sex, race/ethnicity (White, Black, Hispanic, American Indian or Alaskan, Asian, Unknown/Other), and disabled status.
Packaging and Labeling Control
Published in Graham P. Bunn, Good Manufacturing Practices for Pharmaceuticals, 2019
In the Federal Register of February 26, 2004 (69 FR 9120), the FDA published a final rule requiring certain human drug and biological products to have on their labels a linear bar code that contains, at a minimum, the drug’s NDC number (21 CFR 201.25). The rule also requires the use of machine-readable information on blood and blood component labels (21 CFR 606.121[c][13]). The guidance6 states: “Bar codes will allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings.” The FDA issued the Guidance for Industry “Bar Code Label Requirements Questions and Answers”6 in August 2011 and amended/incorporated previous guidances. Exemptions to the requirements are covered in the guidance.
Regulatory Affairs
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Many additional regulatory activities must be completed during the product life cycle, some before and others after product registration. Several examples are as follows:Establishment registration: Establishments manufacturing any drug or biopharmaceutical or medical device, whether U.S. or foreign, must be registered with the FDA.Licensing issues: Divided, shared, or contract manufacturing. To accommodate the complex and sometimes specialized manufacturing schemes required for biopharmaceuticals, the FDA allows manufacturing of one product at two or more sites. For example, a biopharmaceutical might be produced by fermentation at one site, then shipped to a second site for purification, formulated at a third site, and filled and labeled at a fourth site. Such divided or shared manufacturing, generally done largely by contractors for the sponsor, is allowed if it is carefully controlled and defined and if each site is a registered establishment.Proprietary name: A sponsor wishes to have a unique name, apart from the often long and confusing chemical name, for their biopharmaceutical. To avoid duplication for confusion in labeling, the FDA is responsible for approving the proprietary name for each biopharmaceutical.National drug code: In addition to the unique name, the FDA issues with marketing approval a unique drug number, a National Drug Code (NDC), and this is clearly marked on all labeling.
The effect of adherence on antihypertensive therapy plans in patients with diabetes
Published in IISE Transactions on Healthcare Systems Engineering, 2021
Saeideh Mirghorbani, Sharif Melouk, John Mittenthal
Adherence transition probabilities were obtained from the study of Nichol et al. (2009). This study is based on a publicly available 20% sample of California Medicaid (Medi-Cal) fee-for-service claims data from January 1995 through December 2003. Medi-Cal administrative data houses a computerized database of eligibility, pharmacy, and physician/medical claims of each patient. The pharmacy and physician claims data include specific drug dispensed (National drug codes [NDC]), quantity dispensed, number of days’ supply, service dates, and disease diagnoses based on codes from the International Classification of Diseases, Ninth Revision (ICD-9). Patients were included in the analyses if they were 40years or older on the date of the first prescription fill on record for either a Lipid Lowering (LL) or an Antihypertensive (AH) medication; a primary or secondary diagnosis of hypertension (ICD-9 codes 401.x to 404.x) on any claim; and a prescription for both LL and AH medications within 180days of each other. This study defines the index date as the first prescription fill for an LL or AH, whichever occurred later on record, to ensure that medications have the same starting point to calculate compliance. All patients were required to have continuous eligibility, 6months before the first AH or LL prescription and at least 24months after the index prescription to allow for an adequate observation period.