(a) General. Except as provided in §456.703 (b) and (c), the State plan must provide for a review of drug therapy before each prescription is filled or delivered to a beneficiary, and applicable State law (including State Board policy incorporated in the State law by reference) must establish standards for counseling of the beneficiary or the beneficiary's caregiver. The State must provide pharmacies with detailed information as to what they must do to comply with prospective DUR requirements, including guidelines on counseling, profiling, and documentation of prospective DUR activities by the pharmacists. The pharmacies, in turn, must provide this information to their pharmacists. This information is to be based on guidelines provided by this subpart and by other sources that the State may specify.

(b) Point-of-sale or point-of-distribution review. Except as provided in §456.703 (b) and (c), the State plan must provide for point-of-sale or point-of-distribution review of drug therapy using predetermined standards before each prescription is filled or delivered to the beneficiary or the beneficiary's caregiver. The review must include screening to identify potential drug therapy problems of the following types:

(1) Therapeutic duplication, that is, the prescribing and dispensing of two or more drugs from the same therapeutic class such that the combined daily dose puts the beneficiary at risk of an adverse medical result or incurs additional program costs without additional therapeutic benefit.

(2) Drug-disease contraindication, that is, the potential for, or the occurrence of—

(i) An undesirable alteration of the therapeutic effect of a given drug because of the presence, in the patient for whom it is prescribed, of a disease condition; or

(ii) An adverse effect of the drug on the patient's disease condition.

(3) Adverse drug-drug interaction, that is, the potential for, or occurrence of, a clinically significant adverse medical effect as a result of the beneficiary using two or more drugs together.

(4) Incorrect drug dosage, that is, the dosage lies outside the daily dosage specified in predetermined standards as necessary to achieve therapeutic benefit. Dosage is the strength multiplied by the quantity dispensed divided by day's supply.

(5) Incorrect duration of drug treatment, that is, the number of days of prescribed therapy exceeds or falls short of the recommendations contained in the predetermined standards.

(6) Drug-allergy interactions, that is, the significant potential for, or the occurrence of, an allergic reaction as a result of drug therapy.

(7) Clinical abuse/misuse, that is, the occurrence of situations referred to in the definitions of abuse, gross overuse, overutilization, and underutilization, as defined in §456.702, and incorrect dosage and incorrect duration, as defined in paragraphs (b)(4) and (b)(5) of this section, respectively.

(c) Drug counseling.

(1) As part of the prospective drug review program, standards for counseling by pharmacists of beneficiaries or the beneficiaries' caregivers must be established by State law or other method that is satisfactory to the State agency. A State agency's counseling standards must address special situations where the patient or the patient's representative, is not readily available to receive the offer to counsel or the actual counseling, for example, prescriptions delivered offsite or through the mail. The State agency, at a minimum, must also address the following issues in their counseling standards:

(i) Whether the offer to counsel is required for new prescriptions only, or for both new and refill prescriptions;

(ii) Whether pharmacists must make the offer to counsel or auxiliary personnel are authorized to make the offer;

(iii) Whether only a patient's refusal of the offer to counsel must be documented, or whether documentation of all offers is required;

(iv) Whether documentation of counseling is required; and

(v) Whether counseling is required in situations where the patient's representative is not readily available to receive a counseling offer or the counseling itself.

(2) The standards must meet the following requirements:

(i) They must require pharmacists to offer to counsel (in person, whenever practicable, or through access to a telephone service that is toll-free for long-distance calls) each beneficiary or beneficiary's caregiver who presents a prescription. A pharmacist whose primary patient population is accessible through a local measured or toll-free exchange need not be required to offer toll-free service. Mail order pharmacies are required to provide toll-free telephone service for long distance calls.

(ii) They need not require a pharmacist to provide consultation when a Medicaid beneficiary or the beneficiary's caregiver refuses that consultation.

(iii) They must specify what documentation by the pharmacy of refusal of the offer of counseling is required.

(3) The standards must specify that the counseling include those matters listed in paragraphs (c)(3)(i) through (c)(3)(viii) of this section that, in the exercise of his or her professional judgement (consistent with State law regarding the provision of such information), the pharmacist considers significant as well as other matters the pharmacist considers significant.

(i) The name and description of the medication;

(ii) The dosage form, dosage, route of administration, and duration of drug therapy;

(iii) Special directions and precautions for preparation, administration, and use by the patient;

(iv) 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;

(v) Techniques for self-monitoring drug therapy;

(vi) Proper storage;

(vii) Prescription refill information; and

(viii) Action to be taken in the event of a missed dose.

(d) Profiling. The State agency must require that, in the case of Medicaid beneficiaries, the pharmacist make a reasonable effort to obtain, record, and maintain patient profiles containing, at a minimum, the information listed in paragraphs (d)(1) through (d)(3) of this section.

(1) Name, address, telephone number, date of birth (or age), and gender of the patient;

(2) Individual history, if significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and

(3) Pharmacist's comments relevant to the individual's drug therapy.

[57 FR 49408, Nov. 2, 1992, as amended at 59 FR 48824, Sept. 23, 1994]