Compliance Inspection Report (Page 9 of 11) in pdf

Item

Requirements

YES

N/A

Comment / Observation

No.

Standards for Prescription Labeling, Format & Containers

Every prescription written in the Commonwealth must be in a prescription format that conforms to the requirements as

set forth in 105 CMR 721.020. (247 CMR 9.01 (1)) (105 CMR 721.020).

The pharmacist filling a written or oral prescription for a controlled substance shall package the controlled substance in a

container, affixing to the container a label displaying all required elements as set forth in 105 CMR 722.070. (247 CMR

9.01 (1)) (105 CMR 722.070)

When a less expensive generic drug product has been dispensed, the words "interchange" plus the generic name and

manufacturer of the product shall appear on the label.

When a less expensive brand name drug product has been dispensed, the words "interchange" plus either the generic

name and manufacturer of the product or the less expensive brand name dispensed shall appear on the label. (247

CMR 9.01 (1)) (105 CMR 722.070 (A) (B))

Any drug for human use that is in a dosage form intended for oral administration and that is required by Federal law to be

dispensed only on or upon an oral or written prescription of a practitioner licensed by law to administer such a drug shall

be packaged in accordance with the provisions of S 1700.15 (a), (b), and (c); unless exempted under the Poison

Prevention Packaging Act (PPPA) or; current documented patient request for non-safety closures (Best Practice).

(247 CMR 9.01 (1)) (16CFR Ch.II S 1700.14 (10))

Patient Records, Counseling, and Prospective Drug Utilization

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. (247

CMR 9.07 (1) (a) and (2) (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. (247 CMR 9.07 (3) (a))

Counseling must be made by a pharmacist, or a pharmacy intern under the direct supervision of the pharmacist if

deemed appropriate by the pharmacist. (247 CMR 9.07 (3) (f))

Continuous Quality Improvement

Each pharmacy shall maintain a written copy of its CQI Program description on the pharmacy premises.

(247 CMR 15.04 (1))

The CQI Program description shall be readily available to all pharmacy personnel. (247 CMR 15.04 (1))

The CQI program shall include provisions to designate an individual or individuals responsible for monitoring CQI

Program compliance with the requirements of 247 CMR 15.00. (247 CMR 15.02 (1) (a))

The CQI program shall include provisions to identify and document QREs. (247 CMR 15.02 (1) (b))

The CQI program shall include provisions to analyze data collected in response to QREs to assess causes and any

contributing factors. (247 CMR 15.02 (1) (d))

The CQI program shall include provisions to use the findings of the analysis to formulate an appropriate response and

develop pharmacy systems and workflow processes designed to prevent QREs. (247 CMR 15.02 (1) (e))

The CQI program shall include provisions to provide ongoing education at least annually in the area of CQI to pharmacy

personnel. (247 CMR 15.02 (1) (f))

Each pharmacy shall maintain a record of all QREs for a minimum period of two years from the date of the QRE report.

(247 CMR 15.04 (2))

Compliance Inspection Report Page 9

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