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Drug Utilization Review (DUR) Program Prospective Drug Utilization Review (DUR) Federal law requires that Rhode Island Pharmacies participating in the Medicaid Program must provide prospective Drug Utilization Review (prospective DUR). The Federal Department of Health and Human Services (HHS) has issued guidelines to assist pharmacies in implementing the prospective DUR process. Adherence to these guidelines enables pharmacists to comply with Federal requirements. General Requirements In general, the Federal rules pertaining to prospective DUR require the following: Before each prescription is filled or delivered to the patient or the patient's caregiver, the pharmacist must screen for potential drug therapy problems. The pharmacist must offer to counsel the patient or the patient's caregiver on matters related to the prescribed drug which, in the pharmacist's professional judgment, are deemed significant. To assist in the screening of the prescription and the counseling of each patient, the pharmacist must make a reasonable effort to originate and maintain a patient profile (medication record). On the following pages are guidelines for pharmacies issued by HHS as they apply to the Medicaid Program. Prospective DUR Screen Federal Statutory Requirement: Section 1927(g)(2)(A) of the Social Security Act (the Act) requires prospective DUR at the point of sale or distribution before each prescription is filled or delivered to a Medicaid Program recipient. This review shall include screening for potential drug therapy problems due to: Therapeutic duplication Drug disease contraindications Drug interactions Incorrect dosage or duration of drug treatment Drug allergy interaction Clinical abuse/misuse Prospective DUR screening must use predetermined standards which are based upon the peer-reviewed medical literature and the following compendia: American Hospital Formulary Service Drug Information United States Pharmacopoeia Drug Information American Medical Association Drug Evaluations Impact on Pharmacies Conducting prospective DUR screening is the sole responsibility of each Medicaid Program participating pharmacy. Pharmacies may use commercially available DUR database packages to assist with prospective DUR. Such data base packages must be able to screen for the therapeutic problems specified in the statute listed above and do so based on explicit standards. It is not expected that these commercial data bases will contain patient-specific diagnosis or allergy information. When, in the pharmacist's professional judgment, obtaining such information is essential, he or she should consult the patient or the patient's health care provider. Pharmacies without computers, or those which choose not to use prospective DUR data base packages, must undertake prospective DUR screening based on Medicaid Program policy guidelines issued by EOHHS. Patient Counseling Federal Statutory Requirement: Section 1927(g)(2)(ii)(I) of the Act requires that the pharmacist offer to discuss with each Medicaid Program recipient or a caregiver, in person whenever practicable, or by toll-free telephone for long distance calls, matters which, in his/her professional judgment the pharmacist deems significant. Such counseling is subject to standards for counseling to be established under State law (State Pharmacy Practice Act). Such counseling is to be provided unless refused by the Medicaid Program recipient or caregiver. The statute lists the following subjects for inclusion in counseling: The name and description of the medication Dosage form, dosage, route of administration and duration of drug therapy Special directions and precautions for preparation, administration and use by the patient Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including how they may be avoided and the actions required if they occur Techniques for self-monitoring drug therapy Proper storage Prescription refill information Action to be taken in the event of a missed dose Impact on Pharmacies Pharmacy providers must observe the following guidelines regarding counseling: The pharmacist is responsible for personally conducting the counseling in accordance with the requirements of the Rhode Island State Board of Pharmacy. Pharmacies whose primary patient population is accessible through local measured or toll-free exchange are not required to offer toll-free service for long distance calls. Pharmacists are required to at least document refusal by the patient or the patient's agent to accept an offer of counseling. Counseling requirements apply to both new and refill prescriptions. The content of counseling is governed solely by the professional judgment of the pharmacist. Patient Profiles (Medication Records) Federal Statutory Requirement: Section 1927(g)(2)(A)(ii)(II) of the Act requires the pharmacist to make a reasonable effort to obtain, record and maintain for Medicaid Program recipients the following information: Name, address, phone number, age (or birth date) and gender Individual history, where significant, including disease state(s), known allergies, drug reactions, a comprehensive list of medications and relevant devices Pharmacist's comments relevant to the individual's drug therapy Impact on Pharmacies The pharmacist is responsible for collecting, recording and maintaining the above patient medication record information in accordance with the requirements of the Rhode Island State Board of Pharmacy. The pharmacist may rely upon ancillary personnel to collect, record and obtain patient information for his/her medication record, but the pharmacist must review and interpret that information and clarify confusing or conflicting information. It is expected that the pharmacist will be guided by professional judgment as to whether and when individual history information should be sought from the patient's physician or other health care providers.