Omnibus Budget Reconciliation Act of 1990
While most federal laws provide the pharmacist with guidance on handling pharmaceuticals, the Omnibus Budget Reconciliation Act of 1990 (OBRA-90) placed expectations on the pharmacist in how to interact with the patient. While the primary goal of OBRA-90 was to save the federal government money by improving therapeutic outcomes, the method to achieve these savings was implemented by imposing on the pharmacist counseling obligations, prospective drug utilization review (ProDUR) requirements, and record-keeping mandates.
The OBRA-90 ProDUR language requires state Medicaid provider pharmacists to review Medicaid recipients' entire drug profile before filling their prescription(s). The ProDUR is intended to detect potential drug therapy problems. Computer programs can be used to assist the pharmacist in identifying potential problems. It is up to the pharmacists' professional judgment, however, as to what action to take, which could include contacting the prescriber. As part of the ProDUR, the following are areas for drug therapy problems that the pharmacist must screen:
- Therapeutic duplication
- Drug–disease contraindications
- Drug–drug interactions
- Incorrect drug dosage
- Incorrect duration of treatment
- Drug–allergy interactions
- Clinical abuse/misuse of medication
OBRA-90 also required states to establish standards governing patient counseling. In particular, pharmacists must offer to discuss the unique drug therapy regimen of each Medicaid recipient when filling prescriptions for them. Such discussions must include matters that are significant in the professional judgment of the pharmacist. The information that a pharmacist may discuss with a patient is found in the enumerated list below.
- 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 effects or adverse effects or interactions and therapeutic contraindications that may be encountered.
- Techniques for self-monitoring of drug therapy.
- Proper storage.
- Refill information.
- Action to be taken in the event of a missed dose.
Under OBRA-90, Medicaid pharmacy providers also must make reasonable efforts to obtain, record, and maintain certain information on Medicaid patients. This information, including pharmacist comments relevant to patient therapy, would be considered reasonable if an impartial observer could review the documentation and understand what has occurred in the past, including what the pharmacist told the patient, information discovered about the patient, and what the pharmacist thought of the patient's drug therapy. Information that would be included in documented information are listed below.
- Name, address, and telephone number.
- Age and gender.
- Disease state(s) (if significant)
- Known allergies and/or drug reactions.
- Comprehensive list of medications and relevant devices.
- Pharmacist's comments about the individual's drug therapy.
While OBRA-90 was geared to ensure that Medicaid patients receive specific pharmaceutical care, the overall result of the legislation provided that the same type of care be rendered to all patients, not just Medicaid patients. The individual states did not establish 2 standards of pharmaceutical care-one for Medicaid patients and another for non-Medicaid patients. The end result is that all patients are under the same professional care umbrella requiring ProDUR, counseling, and documentation.
- Pharmacy Times, A Review of Federal Legislation Affecting Pharmacy Practice, Virgil Van Dusen , RPh, JD and Alan R. Spies , RPh, MBA, JD, PhD, https://secure.pharmacytimes.com/lessons/200612-01.asp
- Strauss's Federal Drug Laws and Examination Review, Fifth Edition (revised), Steven Strauss, CRC Press, 2000