Page:United States Statutes at Large Volume 104 Part 2.djvu/561

 PUBLIC LAW 101-508—NOV. 5, 1990 104 STAT. 1388-153 "(cc) Special directions and precautions for preparation, administration and use by the patient. "(dd) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur. "(ee) Techniques for self-monitoring drug therapy. "(ff) Proper storage, "(gg) Prescription refill information, "(hh) Action to be taken in the event of a missed dose. "(11) A reasonable effort must be made by the pharmacist to obtain, record, and maintain at least the following information regarding individuals receiving benefits under this title: "(aa) Nsmie, address, telephone number, date of birth (or age) and gender. "(bb) Individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices. "(cc) Pharmacist comments relevant to the individuals drug therapy. Nothing in this clause shall be construed as requiring a pharmacist to provide consultation when an individual receiving benefits under this title or caregiver of such individual refuses such consultation. "(B) RETROSPECTIVE DRUG USE REVIEW.— The program shall provide, through its mechanized drug claims processing and information retrieval systems (approved by the Secretary under section 1903(r)) or otherwise, for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care, among physicians, pharmacists and individuals receiving benefits under this title, or associated with specific drugs or groups of drugs. "(C) APPLICATION OF STANDARDS.— The program shall, on an ongoing basis, assess data on drug use against explicit predetermined standards (using the compendia and literature referred to in subsection (1)(B) as the source of standards for such assessment) including but not limited to monitoring for therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, and clinical abuse/misuse and, as necessary, introduce remedial strategies, in order to improve the quality of care and to conserve program funds or personal expenditures. "(D) EDUCATIONAL PROGRAM. —The program shall, through its State drug use review board established under paragraph (3), either directly or through contracts with accredited health care educational institutions, State medical societies or State pharmacists associations/societies or other organizations as specified by the State, and using data

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