OBRA '90 and Patient Counseling Responsibilities
Congress enacted the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) requiring pharmacists to conduct prospective drug use reviews (ProDUR) and to provide patient counseling for all Medicaid patients. These new rules took effect January 1, 1993. OBRA ’90 was a key piece of legislation and its requirements have encouraged pharmacists to practice pharmaceutical care. Studies have shown that 30-50% of all prescriptions fail to produce the desired results because they are improperly used. OBRA ’90 mandates that pharmacists perform the following three duties when dispensing a prescription:
- Make a reasonable effort to obtain, record, and maintain a patient medication record (PMR) on each patient.
- Examine the PMR and conduct a prospective drug use review (ProDUR) when filling or refilling a prescription.
- Following the ProDUR, counsel the patient or the patient’s agent about the drug dispensed.
Counseling is required for new prescriptions only, unless problems are noted in the PMR and ProDUR review on refill prescriptions. At that time, the pharmacist must exercise clinical judgment and proceed with patient counseling if needed. Maintaining or updating the PMR and conducting ProDUR reviews are required for new and refill prescriptions.
The PMR should contain the patient information below. This patient information must be maintained for two years.
- Full name, address, and telephone number
- Drug profile
- Pharmacist comments
- Chronic conditions, allergies, drug reactions
ProDUR should consist of the specific reviews noted below. The pharmacist must examine the PMR to determine if any of the potential conflicts exist. If conflicts are present, the pharmacist must use clinical judgment as to whether the prescription should be dispensed, contacting the physician or discussing the conflict with the patient, if necessary.
- Over/under utilization
- Therapeutic duplication
- Drug-disease, drug-drug, drug-pregnancy interactions
- Incorrect dosage or duration of treatment
- Drug-allergy interactions
- Clinical abuse-misuse
- Early refill conditions
- Ingredient duplication
- Drug-age contraindications
The pharmacist must cover many points when counseling the patient or his agent on new prescriptions. These points are outlined below. The offer to counsel must be made verbally. A written statement suggesting that counseling is available if needed will not satisfy the requirements of OBRA ’90.
- Name of medication (trade name, generic name, or other descriptive name)
- Intended use and expected action
- Route, dosage form, dosage and administration schedule
- Special directions for preparation, proper storage
- Special directions for administration, precautions to be observed during administration
- Common side effects that may be encountered, including their avoidance and the action required if they occur
- Techniques for self-monitoring of drug therapy
- Potential drug-drug or drug-food interactions or other therapeutic contraindications
- Prescription refill information
- Actions to be taken in the event of a missed dose
- Any other information peculiar to the specific patient or drug
ACS’ prescription claims processing software transmits ProDUR messages to pharmacy providers that are specially designed to provide precise conflict and alert information in support of appropriate patient counseling. When a DUR message is sent, pharmacists are instructed to review the enrollee’s prescription in conjunction with the patient profile information maintained in the pharmacy and use their professional judgment to determine if the medication should be dispensed.
The ACS Help Desk and clinical pharmacy staff are available to support pharmacy providers when they have questions about ProDUR messages or override procedures. The toll-free contact number for the ACS Help Desk is 877-439-0803. Also, pharmacists should contact the ACS Help Desk immediately if they suspect clinical misuse or abuse of drugs by enrollees.