Section 9.07 - Maintaining Patient Records, Conducting a Prospective Drug Utilization Review and Patient CounselingThe purpose of 247 CMR 9.07 is to enhance the public health and welfare by requiring that pharmacists offer consultation to patients regarding their prescriptions in order to promote optimum therapeutic outcomes, avoid patient injury and reduce medication errors.
(1)Patient Records. (a) A pharmacist or pharmacist's designee shall maintain a confidential record for all patients for whom prescriptions are dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the pharmacist to identify previously dispensed drugs at the time the prescription is presented for dispensing. The pharmacist or pharmacist's designee shall make a reasonable effort to obtain, record and maintain the following information: 1.name, address, telephone number, date of birth or age, and gender of the patient for whom the prescription is intended;2.individual history, including known drug allergies and drug reactions;3.a comprehensive list of medications and relevant devices dispensed by the pharmacy; and4.the pharmacist's comments relevant to the patient's drug therapy.(b) A pharmacist shall maintain the patient's record for a period of not less than 12 months from the date of the last entry in the profile record, except as otherwise required by state and federal law. This record may be computerized.(2)Prospective Drug Utilization Review. (a) A pharmacist shall conduct a prospective drug utilization review ("DUR") before each new prescription is dispensed or delivered to a patient or a person acting on behalf of the patient. This DUR may include a review of the patient record and each new prescription presented for dispensing, for the purpose of promoting therapeutic appropriateness, by making a reasonable effort to identify the following: 1.over-utilization or under-utilization;2.therapeutic duplication;3.drug-disease contraindication;5.incorrect drug dosage or duration of drug treatment;6.drug-allergy interactions;7.clinical abuse or misuse; and8.any significant change in drug, dose or directions.(b) Upon identifying any of the above, the pharmacist shall take appropriate measures to ensure the proper care of the patient which may include consultation with the prescribing practitioner and/or direct consultation with the patient.(c) The review shall be based upon current standards which may include the following: 1.The American Hospital Formulary Service Drug Information;2.the United States Pharmacopoeia Drug Information;3.the American Medication Association Drug Evaluations; and4.other peer-reviewed medical literature. (3)Patient Counseling. (a) The pharmacist or pharmacist's designee shall offer the services of the pharmacist to discuss, with all persons presenting new prescriptions, issues that in the pharmacist's professional judgment are deemed to be significant for the health and safety of the patient.(b) The pharmacist's designee shall be an individual appropriately trained to make the offer to counsel and under the direct supervision of the pharmacist.(c) A sign of not less than 11 inches in height by 14 inches in width shall be posted in a conspicuous place, adjacent to the area where prescriptions are dispensed, informing customers of their rights, pursuant to 247 CMR 9.07 and to M.G.L. c. 94C, § 21A, to counseling by a pharmacist where their prescription was filled. Said sign shall read, in letters not less than 1/2 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."(d) When the offer to counsel is accepted, the pharmacist 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: 1.Name and description of the medication;2.dosage form, dosage, route of administration and duration of therapy;3.special directions and instructions for preparation, administration and use by the patient;4.common severe side and adverse effects or interactions and therapeutic contraindications or precautions with legend and non-legend medications which the pharmacist deems relevant;5.techniques for self-monitoring drug therapy;7.prescription refill information; and8.action to be taken in the event of a missed dose or adverse reaction.(e) The offer to counsel shall be made to the patient, or the person acting on behalf of the patient when confidentiality can be maintained, either by face to face communication or telephone. If the patient does not pick up the prescription at a pharmacy or the offer is not made by telephone then the offer must be made in writing. This offer must provide a toll-free telephone service to facilitate communication between such person and the pharmacist and must state the following: "Dear patient, 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". Printed material containing information on the drug may accompany this written offer to counsel provided the patient is informed that said information is not comprehensive and that the patient should call for further information if needed.(f) Counseling must be made by a pharmacist, or a pharmacy intern under the direct supervision of the pharmacist if deemed appropriate by the pharmacist.(g) Counseling must be available at all times when a pharmacy is open for business.(h) The provisions of 247 CMR 9.07 shall apply to pharmacists who directly dispense medications to outpatients and patients being discharged from hospitals, institutions and
clinics.
(i) The provisions of 247 CMR 9.07 shall not apply to any drug dispensed to an inpatient at a hospital, nursing home or any other setting where medication is administered by an authorized individual, except to the extent required by the Federal Health Care Financing Administration pursuant to the provisions of 42 USC 1396r-8.Amended by Mass Register Issue 1265, eff. 7/18/2014.