§ 20-635 — Prescription error reporting. Definitions. Informational signs and statements. Regulations. Nondisclosure of records.

Connecticut § 20-635

• Jurisdiction: Connecticut
• Title 20: Professional and Occupational Licensing, Certification, Title Protection and Registration. Examining Boards
• Ch. 400j: Pharmacy

Text

(a) As used in this section: (1) “Dispensing” means those acts of processing a drug for delivery or for administration for a patient pursuant to a prescription consisting of: (A) Comparing the directions on the label with the directions on the prescription to determine accuracy; (B) the selection of the drug from stock to fill the prescription; (C) the counting, measuring, compounding or preparation of the drug; (D) the placing of the drug in the proper container; (E) the affixing of the label to the container; and (F) the addition to a written prescription of any required notations; (2) “Drug” means (A) an article recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary, or any supplement to any of them, (B) an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans, (C) an article, other than food, intended to affect the structure or any function of the body of humans; (3) “Pharmacy” means a place of business where drugs may be sold at retail and for which a pharmacy license has been issued to an applicant under the provisions of section 20-594 . For the purposes of this section, “pharmacy” shall include any areas of an institutional pharmacy where prescription drugs are dispensed to outpatients, employees and retirees; (4) “Prescribing practitioner” means an individual licensed by the state of Connecticut, any other state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or any territory or insular possession subject to the jurisdiction of the United States who is authorized to issue a prescription within the scope of the individual's practice; (5) “Prescription” means a lawful order of a prescribing practitioner transmitted either orally, in writing or by electronic means for a drug for a specific patient; and (6) “Prescription error” means an act or omission of clinical significance relating to the dispensing of a drug that results in or may reasonably be expected to result in injury to or death of a patient. (b) Each pharmacy shall display a sign concerning the reporting of prescription errors in a conspicuous location visible to consumers of prescription drugs. The sign shall measure a minimum of eight inches in height and ten inches in length and the lettering shall be in a size and style that allows such sign to be read without difficulty by consumers standing at the pharmacy prescription department distribution counter. The sign shall bear the following statement: “If you have a concern that an error may have occurred in the dispensing of your prescription you may contact the Department of Consumer Protection, Drug Control Division, by calling (Department of Consumer Protection telephone number authorized pursuant to section 21a-2 of the general statutes)”. (c) Each pharmacy that dispenses a prescription to a consumer shall include the following printed statement on the receipt or in the bag or other similar packaging in which the prescription is contained: “If you have a concern that an error may have occurred in the dispensing of your prescription you may contact the Department of Consumer Protection, Drug Control Division, by calling (Department of Consumer Protection telephone number authorized pursuant to section 21a-2 of the general statutes)”. The statement shall be printed in a size and style that allows such statement to be read without difficulty by consumers. (d) The Commissioner of Consumer Protection shall adopt regulations, with the advice and assistance of the Commission of Pharmacy, in accordance with chapter 54, concerning the implementation of a quality assurance program designed to detect, identify and prevent prescription errors in pharmacies. Such regulations shall require that each pharmacy implement a quality assurance program that describes in writing policies and procedures to be maintained in such pharmacy. Such policies and procedures shall include directions for communicating the details of a prescription error to the prescribing practitioner and to the patient, the patient's caregiver or appropriate family member if the patient is deceased or is unable to fully comprehend the communication. Such communication shall describe methods of correcting the prescription error or reducing the negative impact of the error on the patient. Such regulations shall require that records of all reported prescription errors shall be maintained in a manner ready for inspection for a minimum period of three years and that such records shall be made available for inspection by the Commissioner of Consumer Protection within forty-eight hours in any case where the commissioner is investigating a report of a prescription error. (e) Records collected or maintained pursuant to this section shall not be required to be disclosed pursuant to subsection (a) of section 1-210 for a period of six months from the date such records were created pursuant to subsections (c) and (d) of this section and shall not be subject to subpoena or discovery or introduced into evidence in any judicial proceeding except as otherwise specifically provided by law.

Legislative History

(P.A. 02-48, S. 1; P.A. 03-164, S. 2; June 30 Sp. Sess. P.A. 03-6, S. 146(c), (d); P.A. 04-169, S. 17; 04-189, S. 1.) History: P.A. 03-164 added Subsec. (e) re disclosure of records; June 30 Sp. Sess. P.A. 03-6 and P.A. 04-169 replaced Commissioner and Department of Consumer Protection with Commissioner and Department of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004.