1. A. Patient medication profile. On and after January 1, 1993, pharmacists shall make a reasonable effort to maintain a patient medication record system for persons covered under Title XIX of the Social Security Act for whom prescriptions are dispensed. For purposes of this regulation, a reasonable effort shall have been made if the information set forth in subdivision 1 of this subsection is requested by the pharmacist or the pharmacist's designee from the patient or the patient's agent.

   1. 1. A reasonable effort shall be made by the participating pharmacist to obtain, record, and maintain at least the following information on each patient's profile:

      1. a. Patient's name, address, telephone number;
      2. b. Date of birth (or current age) and gender;

      3. c. Medical history

         1. (1) Significant patient health problems known to the pharmacist,
         2. (2) Prescription drug reactions or known allergies,
         3. (3) A comprehensive list of prescription and nonprescription medications and legend drug administration devices known by the pharmacist to have been used by the patient; and
      4. d. Prescriber information to include, but not necessarily be limited to, name, address, and Medicaid and Drug Enforcement Agency (DEA) provider numbers.
      5. e. Pharmacist's comments relevant to the patient's drug use, including any failure to accept the pharmacist's offer to counsel.
   2. 2. Such information may be recorded in any system of records and may be considered by the pharmacist in the exercise of his professional judgment concerning both the offer to counsel and content of counseling. DMAS or its designated agent is authorized to survey pharmacists' patients in order to determine compliance with and report on the mandates of federal and state law and regulations.
   3. 3. The information for patient profiles may be obtained from a patient's prescribing physician, hospital medical records, interviews with the patient, patient's family or agent, or a combination of the above.
   4. 4. Patient medication profiles shall be maintained for a period of not less than two years from the date of last entry or as necessary to comply with state or federal law.

2. B. Pharmacist's responsibilities. Upon receipt of each prescription and before dispensing the medication, a pharmacist shall perform prospective DUR based on his professional knowledge and the criteria and standards approved by the DUR Board, using the information contained in the patient's profile.

   If an exception to one or more prospective DUR criteria is identified, a message will be transmitted to the pharmacist. Claims may be rejected due to the exceptions to one or more criteria. Pharmacists may be required to obtain prior authorization, defined as the process of reviewing drugs to determine if medically justified prior to the submission of a claim for payment by Medicaid, in order to dispense the medications.

   Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

3. C. Patient counseling. Consistent with federal law and regulation a pharmacist must offer to discuss in person, whenever practicable, or through access to a telephone service which is toll-free for long-distance calls with each individual receiving benefits or the caregiver of such individual who presents a prescription, matters which in the exercise of the pharmacist's professional judgment are deemed to be significant. The offer to counsel shall be made consistent with the requirements in § 54.1-3319 B of the Code of Virginia.

   1. 1. Name and description of the medication;
   2. 2. Dosage form and amount, route of administration, and duration of therapy;
   3. 3. Special directions for preparation, administration and use by the patient as deemed necessary by the pharmacist;
   4. 4. Common or severe side or adverse effects or interactions that may be encountered which may interfere with the proper use of the medication as was intended by the prescriber, and the action required if they occur;
   5. 5. Techniques for self-monitoring drug therapy;
   6. 6. Proper storage;
   7. 7. Prescription refill information;
   8. 8. Action to be taken in the event of a missed dose.

   9. 9. Any other matters the pharmacist considers significant.

      Alternative forms of patient information may be used to supplement, but not replace, oral patient counseling.

      A pharmacist shall not be required to provide oral consultation when a patient or a patient's agent refuses the pharmacist's attempt to consult.

      When prescriptions are delivered to the patient or patient's agent who resides outside of the local telephone calling area of the pharmacy, the pharmacist shall either provide a toll free telephone number or accept collect calls from such patient or patient's agent.

      Patient counseling as described in this part shall not be required for inpatients of a hospital or institution where a nurse or other person authorized by the Commonwealth is administering the medication.

   The specific areas of counseling shall include those matters listed below that, in the exercise of his professional judgment, the pharmacist considers significant:

4. D. Compliance monitoring. An ongoing program shall be developed for the purpose of monitoring pharmacists' compliance with the prospective DUR requirements of this part.

   1. 1. On-site inspections,
   2. 2. Patient surveys,
   3. 3. Desk audits, or
   4. 4. Retrospective pharmacy profile reviews.
   5. 5. Electronic messages as well as rejection or denial of claims until there is resolution of the conflict with DUR criteria.

   The director may establish the compliance monitoring program through agreements with other state agencies, the DUR Board or other organizations.

   As determined to be appropriate by DMAS, the methods used to monitor compliance shall include but shall not be limited to:

Statutory Authority

§§ 32.1-324 and 32.1-325 of the Code of Virginia.

Historical Notes

Derived from VR460-04-4.2600 § 5, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005.