OBRA and counseling

Omnibus Budget Reconciliation Act (OBRA) ‘90: Overview

• First federal law directly regulating pharmacy practice standards

• Primary goal to save money

• Adopts the “pharmaceutical care” or “pharmacist care” model that pharmacy developed for itself

• The law establishes minimal requirements that states must adopt and requires that states must actually establish the standards in order to continue receiving federal funds for Medicaid.

OBRA ‘90: Basic Framework

• Rebates

  • Requires manufacturers to provide drug products to the Medicaid program at their “best price”

  • “Best price” is the lowest price at which they sell the product to any customer.

  • Accomplished by requiring manufacturer to rebate to the state the difference between the average manufacturer’s price and the “best price”

• Demonstration projects

  • OBRA funded demonstration projects to evaluate whether the DUR requirements would result in improved patient care and decreased costs.

OBRA ‘90: Drug Use Review (DUR)

• Establishes two types of DUR programs:

  • Retrospective review

  • Prospective DUR

Retrospective DUR

• Each state must establish a DUR board composed of physicians and pharmacists to oversee retro-DUR.

• The board reviews medication use data and compares to target criteria.

• The board has authority to recommend and establish educational programs for providers who are not meeting target criteria.

Prospective DUR (Pro-DUR)

• Provides opportunity to evaluate the prescribed drug therapy before the Rx is dispensed

• The DUR board can examine data generated from pro-DUR to determine if drug use problems are being resolved or continuing.

Components of Pro-DUR

• Screening

  • Pharmacists must detect potential drug use problems before Rx is dispensed.

  • OBRA lists seven general categories of potential problems that should be screened.

  • Computer software does not replace the professional judgment of a pharmacist.

• Counseling

  • Requires an “offer to counsel” patient or caregiver

  • Lists several points of information counseling could include, but allows pharmacist to determine the content of the counseling based on professional judgment

  • Meaning of phrase “common severe side effect” generally believed to mean common or severe

  • An offer to counsel may be made by ancillary personnel or other means in some states, while some states require counseling.

  • Patient has the right to waive counseling.

• Patient profile

  • Requires pharmacy to obtain, record, and maintain a record of specified information about the patient

  • Review of the patient profile prior to dispensing is critical to effective screening and counseling.

MGL Chapter 94C Section 21A

Prescriptions: Prospective Drug Review and Counseling by Pharmacist

Section 21A. A pharmacist shall conduct a prospective drug review before each new prescription is dispensed or delivered to a patient or a person acting on behalf of such patient. Such review may include, but not be limited to, screening for potential drug therapy problems due to therapeutic duplication, drug disease contraindication, drug interactions, including serious interactions with nonprescription or over-the-counter drugs, incorrect drug dosage, duration of drug treatment, drug allergy interactions and clinical abuse or misuse.

A pharmacist shall offer to counsel any person who presents a new prescription for filling. Such offer shall be made either by face to face communication between the pharmacist or the pharmacist's designee and the patient, or by telephone, except when the patient's needs or availability require an alternative method of counseling.

If a person elects delivery of a prescription drug at a location other than a pharmacy, the requirements of this section may be satisfied by providing such person with access to a toll-free telephone service to facilitate communication between such person and the pharmacist at such pharmacy. The number of such toll-free telephone service shall be printed on a label affixed to each container of a prescription drug dispensed by a pharmacy to a patient

For the purposes of medical assistance and other third party reimbursements or payment programs, any of the above methods, or a combination thereof, shall constitute an acceptable offer to provide counseling.

If an offer to provide counseling is accepted, the pharmacist shall counsel the person presenting the prescription to the extent the pharmacist deems appropriate. Such counseling may include, but not be limited to, the following:

(1) the name and description of the medication;

(2) the dosage form, dosage, route of administration and duration of drug therapy;

(3) special instructions and precautions for preparation, administration and use by the patient;

(4) common adverse or severe side effects or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur;

(5) techniques for self-monitoring drug therapy;

(6) proper storage;

(7) prescription refill information; and

(8) action to be taken in the event of a missed dose.

Nothing in this section shall be construed to require a pharmacist to provide counseling if the person presenting the prescription declines to accept such offer for counseling.

The pharmacist or his designee shall make reasonable efforts to obtain, record and maintain the following patient information generated at an individual pharmacy:

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

(2) individual history where significant, including known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and

(3) any additional comments relevant to the patient's drug use, including any failure to accept the pharmacist's offer to counsel.

Such information may be recorded in the patient's manual or electronic profile or in the prescription signature log, or in any other system of records and may be considered by the pharmacist in the exercise of his professional judgement concerning both the offer to counsel and the content of counseling. The absence of any record of a failure to accept the pharmacist's offer to counsel shall create a presumption that such counseling was provided.

The provisions of this section shall not apply to any drug dispensed to an inpatient at a hospital or nursing home, except to the extent required by regulations promulgated by the Federal Health Care Financing Administration pursuant to the provisions of 42 USC 1396r–8.

247 CMR 9.17 Prospective Drug Utilization Review

(1) A pharmacist shall conduct a prospective drug utilization review ("DUR") before each new prescription or medication order is dispensed or delivered to a patient or a patient's agent. The DUR may include a review of computerized alerts, the patient record, and each new and renewed prescription or medication order for the purpose of promoting therapeutic appropriateness, by making a reasonable effort to identify the following:

(a) over-utilization or under-utilization;

(b) therapeutic duplication;

(c) drug-disease contraindication;

(d) drug-drug interaction;

(e) drug-food interaction;

(f) incorrect drug dosage or duration of drug treatment;

(g) drug-allergy interactions;

(h) abuse or misuse;

(i) any significant change in drug, dose, or directions; and

(j) any age related contraindications

(2) Upon identifying any of the above, a pharmacist shall take appropriate measures to ensure the proper care of the patient which may include consultation with the prescribing practitioner or direct consultation with the patient or patient's agent. A pharmacist shall document any measures taken in response to a drug utilization review.

(3) The DUR shall be based upon current standards which may include the following: (a) the American Hospital Formulary Service Drug Information; (b) the United States Pharmacopoeia Drug Information; (c) the American Medical Association Drug Evaluations; (d) Plumb's Veterinary Drug Handbook; and (e) other peer-reviewed medical literature.

247 CMR 9.18 Patient Counseling

(1) A pharmacist or pharmacist's designee shall offer the counseling services of the pharmacist to each person who receives a prescription medication.

(2) A pharmacist shall ensure his or her designee is appropriately trained to make the offer to counsel.

(3) Counseling shall be made by a pharmacist or a pharmacy intern. A pharmacy technician or other individual may not counsel any patient.

(4) A pharmacist or pharmacy intern shall provide counseling on each new drug therapy and each drug therapy that in the pharmacist's professional judgment is deemed to be significant for the health and safety of the patient.

(5) When counseling a patient, a pharmacist or pharmacy intern shall provide such information which, in the pharmacist's professional judgment, is necessary for the patient to understand the proper use of the patient's prescription which may include the following:

(a) name, description, and indication of the medication;

(b) dosage form, dosage, route of administration and duration of therapy;

(c) special directions and instructions for preparation, administration, and use by the patient;

(d) common side and adverse effects or interactions and therapeutic contraindications or precautions with legend and non-legend medications and other substances which the pharmacist deems relevant;

(e) techniques for self-monitoring drug therapy;

(f) proper storage and disposal;

(g) prescription refill information; and

(h) action to be taken in the event of a missed dose or adverse reaction.

(6) A pharmacy shall have a designated patient consultation area, with signage stating "Patient Consultation Area", designed to provide adequate privacy for confidential visual and auditory patient counseling. The private consultation area shall be accessible bya patient from the outside of the prescription dispensing area without having to traverse a stockroom or the prescription dispensing area.

(7) A pharmacy shall post a sign of not less than 11 inches in height by 14 inches in width in a conspicuous place, adjacent to each area where prescriptions are dispensed, for the purpose of informing customers of their right to counseling by a pharmacist. Said sign shall read, in letters not less than ½ inch in height: "Dear patients, you have the right to know about the proper use of your medication and its effects. If you need more information please ask the pharmacist."

(8) A pharmacy and pharmacist shall ensure counseling is available at all times when a pharmacy is open for business.

(9) A pharmacy and pharmacist shall dispense or recommend a proper measuring device with all liquid medications.

(10) The provisions of 247 CMR 9.18 do not apply to pharmacists while practicing in an inpatient setting, unless otherwise required by law or regulation.