Connecticut State Regulatory Update April 2019
Sec. 4. Subsection (h) of section 21a-254 of the 2018 supplement to the general statutes is repealed and the following is substituted in lieu thereof (Effective January 1, 2019):
- A complete and accurate record of all stocks of controlled substances on hand shall, on and after July 1, 1981, be prepared annually within four days of the first day of May of the calendar year, except that a registrant may change this date provided the general physical inventory date of such registrant is not more than six months from the annual inventory date, and kept on file for three years; and shall be made available to the commissioner or his authorized agents.
Sec. 6. Subsection (c) of section 20-633b of the 2018 supplement to the general statutes is repealed and the following is substituted in lieu thereof (Effective January 1, 2019):
- A sterile compounding pharmacy shall comply with the most recent version of the United States Pharmacopeia, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time. A sterile compounding pharmacy shall also comply with all applicable federal and state statutes and regulations.
What does this mean for pharmacists practicing in the state of Connecticut?
- All pharmacy management must ensure that their policies include the new controlled substance inventory requirements.
- All pharmacy management must ensure that they understand and that their standard operating procedures follow the updated USP guidelines for sterile compounding, as well as all federal and state regulations. Ensure that all staff are properly trained in these guidelines.
Connecticut State Regulatory Summary- 2018
The below laws were enacted to effect pharmacy practice by the Connecticut legislature during the 2018 session:
SB 195 - An Act Concerning Changes to Pharmacy and Drug Control Statutes. Effective January 1, 2019.
Provides guidance for drug manufacturers on recordkeeping and reporting of suspicious drug order activity from pharmacies.
SB 197 - An Act Concerning Biological Products. Effective October 1, 2018.
Unless the purchaser or prescriber instructs otherwise, the pharmacist may substitute a biological product for a prescribed biological product.
The pharmacist shall inform the prescribing practitioner within 72 hours of dispensing.
Each pharmacy shall post a sign in block letter, not less than one inch in height, stating that, "THIS PHARMACY MAY BE ABLE TO SUBSTITUTE A LESS EXPENSIVE DRUG PRODUCT OR INTERCHANGEABLE BIOLOGICAL PRODUCT WHICH IS THERAPEUTICALLY EQUIVALENT TO THE ONE PRESCRIBED BY YOUR DOCTOR UNLESS YOU DO NOT APPROVE."
A pharmacist may substitute a drug product or interchangeable biological product only when there will be a savings in cost passed on to the purchaser.
The provisions here shall not apply a pharmacy operated by a hospital.
HB 5384 - An Act Concerning Prescription Drug Costs. Effective January 1, 2020.
Establishes rules for insurance carriers and manufacturers to provide detailed information to the consumer and the state regarding pricing, rebates, premiums, and formulary lists.
SB 246 -An Act Limiting Auto Refills of Prescription Drugs Covered Under the Medicaid Program. Effective June 1, 2018.
A pharmacy provider may be prohibited from automatically refilling certain prescription drugs for a medical assistance recipient.
SB 302 - An Act Concerning Telehealth Services. Effective July 1, 2018.
At the time of the telehealth provider's first interaction with a patient, they must inform the patient of treatment methods and limitations using a telehealth platform and obtain the patient's consent to provide telehealth services.
No telehealth provider shall prescribe any schedule I, II or III controlled substances using telehealth, unless the treatment condition is exempt by law.
What does this new regulation mean for pharmacists practicing within the state of Connecticut?
- Pharmacists can apply the above cost saving discussions to biologics and interchangeable drugs, again helping to promote medication adherence for their patients. Within 48 hours of dispensing the interchangeable product, the pharmacist must report that information to the prescribing physician, ensure that all staff are trained to do so, and that software systems are equipped to retain and report the required data per law. Required signage informing the consumer of interchangeable drug substitution practices must be present in the pharmacy.
- Controlled substance inventories have been amended to reflect an annual completion, from the previous biannual completion requirement. Also, manufacturers and distributors are required to report any suspicious ordering practices. Ensure that proper inventory policies are in place at your location.
- Ensure that all auto-refill software account for the recent changes to prescriptions billed to Medical Assistance patients, who may not be eligible for this service.
- Pharmacists can participate in telemedicine services.
For full regulatory language visit the Connecticut Division of Pharmacy Regulation.
