Medication errors are among the most common medical errors, harming at least 1.5 million people every year. The extra medical costs of treating drug-related injuries occurring in hospitals alone are at least to $3.5 billion a year, and this estimate does not take into account lost wages and productivity or additional health care costs.
Drug utilization review (DUR) is defined as an authorized, structured, ongoing review of prescribing, dispensing and use of medication. DUR encompasses a drug review against predetermined criteria that results in changes to drug therapy when these criteria are not met.
The purpose of outcomes research per the Patient Centered Outcomes Research Institute (PCORI) is to assist patients, clinicians, purchasers and policy makers in making informed health decisions by advancing quality and relevance of evidence. The Agency for Healthcare Research and Quality (AHRQ) defines the purpose of outcomes research as a tool to provide evidence about benefits, risks, and results of treatments so clinicians and patients can make more informed decisions.
Disease management is the concept of reducing health care costs and improving quality of life for individuals with chronic conditions by preventing or minimizing the effects of the disease through integrated care. Disease management programs are designed to improve the health of persons with chronic conditions and reduce associated costs from avoidable complications by identifying and treating chronic conditions more quickly and more effectively, thus slowing the progression of those diseases.
E-prescribing is the use of health care technology to improve prescription accuracy, increase patient safety, and reduce costs as well as enable secure, real-time, bi-directional, electronic connectivity between clinicians and pharmacies. This is achieved by providing prescribers with a secure means of electronically accessing health plan formulary, patient eligibility, and medication history at the point of care and securely transmitting the prescription electronically into the pharmacy’s computer system.
Congress passed the Health Insurance Portability and Accountability Act (HIPAA) in 1996. Within that Act are privacy provisions with which covered entities (including all health plans, health care providers and health care clearinghouses [e.g. PBMs] that transmit any health information in electronic form must comply. HIPAA rules provide guidance to covered entities about how to comply with the Act.
AMCP Format 4.1 includes new sections describing the evidence needs of HCDMs for unapproved products nearing the end of the product development pipeline, as well as unapproved uses of existing products for which FDA approval is being sought.