OLR Bill Analysis
AN ACT CONCERNING MANUFACTURER NAMES AND MEDWATCH REPORTING INFORMATION ON GENERIC DRUG CONTAINERS, THE ELECTRONIC PRESCRIPTION DRUG MONITORING PROGRAM AND PHARMACIST CHANGES TO PRESCRIPTION DRUGS DISPENSED TO CERTAIN PATIENTS.
This bill prohibits a pharmacist from changing a patient's prescribed drug without a medical basis for doing so and the prescribing practitioner's express written consent if the pharmacist knows the patient is medically stable and diagnosed with a complex, chronic, or rare medical condition. Current law allows pharmacists to (1) substitute therapeutically equivalent generic drugs for prescribed drugs under certain circumstances and (2) modify prescribed drugs under collaborative drug therapy management agreements (CGS §§ 20-619 and 20-631).
The bill bars the consumer protection (DCP) commissioner from issuing or renewing a license of a practitioner who distributes, administers, or dispenses controlled substances, or seeks to do so, if the practitioner (1) is not properly registered with the agency or (2) failed to register for access to the state's electronic prescription drug monitoring program as existing law requires (see BACKGROUND). These practitioners include certain medical professionals, scientific investigators, hospitals, and other people or institutions that dispense in the course of professional practice or research.
Lastly, the bill expands the information pharmacists must put on generic prescription drug labels to include the manufacturer's name and contact information for MedWatch, a federal drug safety and reporting program.
EFFECTIVE DATE: October 1, 2015, except the prescription label provision takes effect January 1, 2016.
A “medically stable” patient is one whose condition the prescribing practitioner determines is not worsening, based on the practitioner's experience and taking into account the patient's condition and response to treatment.
A “complex or chronic medical condition” is a diagnosed or in-treatment condition that (1) has no known cure, (2) is progressive, and (3) can be debilitating or fatal if untreated or undertreated. The condition can be physical, behavioral, or developmental. A “rare medical condition” is a diagnosed or in-treatment disease or condition that affects fewer than (1) 200,000 people in the United States or (2) one in 1,500 people or fewer worldwide.
GENERIC DRUG LABELS
The bill adds to the information pharmacists must include on labels of generic prescription drugs. The law already requires pharmacists to put, on all labels, (1) the quantity of the prescribed drug, (2) an expiration date, and (3) any other information required by law.
Under the bill, for drugs sold only by generic name, pharmacists must also include the (1) manufacturer's name and (2) website and toll-free telephone number for MedWatch, the U.S. Food and Drug Administration's safety information and voluntary adverse event reporting program.
By law, a “generic name” is the chemical name or formula or the established name given by the United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary (CGS § 20-14a).
Electronic Prescription Drug Monitoring Program
This program requires DCP to collect prescription information from pharmacies on certain controlled substances (drugs that are acceptable for medical use but may be abused). Pharmacists are required to electronically report certain information to DCP, including the date a drug was dispensed, dispenser identification and prescription number, and certain patient identification data. The information is made available to medical practitioners and others so that they can track their patients' history and prevent improper or illegal drug use.
General Law Committee
Joint Favorable Substitute