Dispensing Reporting Waiver Requirements

Can an authorized practitioner who dispenses prescription drugs and medical devices get a dispensing waiver?

Yes, but Connecticut does not require a formal written request and approval for accessing dispensing waivers. All dispensing practitioners requiring the use of reporting waivers should read the following PMP dispensing waiver reporting process requirements.

What is the difference between Dispensing vs. Prescribing?

Prescribing: Prescribe means to order or designate a remedy or any preparation for a patient under the care of a practitioner. Practitioners who prescribe controlled substances in the State of Connecticut must hold an active Controlled Substance Practitioner (CSP) registration with the State of Connecticut and an active DEA registration. For CSP information please read the DCP guide “Prescribing Controlled Substances in the State of Connecticut” at https://portal.ct.gov/-/media/DCP/drug_control/pdf/Prescribing-Controlled-Substances_WEB.pdf
Dispensing: Dispense means to process a drug or device for delivery or for administration to a patient pursuant to a prescription. Dispense does not include delivering a drug or device to a patient or administering the drug or device to a patient.

For example, pharmacists dispense medications to patients at a pharmacy after the patient is issued a prescription by their prescribing practitioner. Only a pharmacy can accept a prescription for dispensing in the State of Connecticut.
Prescribing Practitioners Dispensing: Prescribing practitioners may dispense drugs but shall do so personally and cannot delegate any part of the dispensing process.

For example: Comparing the directions on the label with the directions on the prescription to determine accuracy; the selection of the drug or device from stock to fill the prescription; the counting, measuring, compounding, or preparation of the drug or device; the placing of the drug or device in the proper container; the affixing of the label to the container; and the addition to a written prescription of any required notations; is dispensing.

Who is required to report prescription dispensations?

Pharmacies, nonresident pharmacies, outpatient pharmacies in a hospital or institution, and dispensers that are licensed by the State of Connecticut. Both in-state and non-resident pharmacies and all prescriber/dispenser’s such as veterinarians or other health practitioners with dispensing authority.

Any individual practitioner that wants to dispense controlled substances must hold a CSP. Without both a CSP and a CT DEA#, a practitioner in or out of state is not permitted to distribute, dispense, conduct research, administer, or procure controlled substances during their professional practice as permitted by the Department of Public Health or another governing agency.

NOTE: All practitioners in possession of a CSP issued by the State of Connecticut, Department of Consumer Protection, are also required to register as a user with the PMP Connecticut Prescription Monitoring and Reporting System (CPMRS) at https://connecticut.pmpaware.net

How is the reporting of prescription dispensations done?

To report, all practitioners who dispense controlled substances and other reportable drugs and medical devices must register with the PMP CLEARINGHOUSE to upload prescription dispensation data.

The PMP requires all practitioners that are authorized to dispense prescription drugs in Connecticut to register with the PMP CLEARINGHOUSE by following the steps at https://portal.ct.gov/DCP/Prescription-Monitoring-Program/Pharmacist-Information and create a CT PMP CLEARINGHOUSE data upload account. An account must be created regardless of the actual prescription drug(s) dispensed. The method for completing reporting compliance is accomplished by maintaining a scheduled upload reporting of dispensing activities using the active PMP CLEARINGHOUSE account.

What prescription dispensations are reported?

Practitioners who meet ALL or ANY of the reporting conditions are required to submit data to the PMP CLEARINGHOUSE.

Dispense Schedule II-V controlled substances;
Dispense insulin drugs, glucagon drugs, diabetes devices, diabetic ketoacidosis devices, gabapentin, and naloxone (effective 1/1/2021).
Any veterinarian, licensed under chapter 384, are exempt from the reporting requirement for the dispensation of insulin drugs, glucagon drugs, diabetes devices, and diabetic ketoacidosis devices for animal patients.
Prescription supply dispensed is for greater than a 48-hour supply.

How often are prescription dispensations reported?

Mandatory reporting of dispensed reportable drugs or medical devices must occur within the 24 hours or next business day, whichever comes later. Reporting is mandatory everyday- open or closed. If no controlled substances or reportable drugs or medical devices are dispensed within a 24-hour period, the dispenser is required to file a “Zero Report” for that day.

Veterinarians are allowed to report dispensations weekly at a minimum, on Mondays. It is important that “Zero Report” still be filed for any day that there are no controlled substances or other reportable drugs dispensed.

How does an authorized dispensing practitioner get a dispensing waiver?

By establishing an upload account in the PMP CLEARINGHOUSE that is used for the mandatory dispensation reporting, any dispenser may also exercise their waiver need(s) by means of “Zero Reporting” for any of the following:

The dispenser does not hold a registration with the Drug Enforcement Administration (a DEA#).
This dispenser does not dispense; Schedule II-V controlled substances, insulin drugs, glucagon drugs, diabetes devices, diabetic ketoacidosis devices, gabapentin, or naloxone; or Schedule II-V controlled substances, insulin drugs, glucagon drugs, diabetes devices, diabetic ketoacidosis devices, gabapentin, or naloxone for greater than 48 hours.
The dispenser is exempt from reporting according to Connecticut General Statute: Chapter 400j. State exemption(s) for the following:
Sec. 20-609. (Formerly Sec. 20-184). (b) Any person owning, managing or conducting any store, shop or place of business not being a pharmacy who exhibits within or upon the outside of such store, shop or place of business, or includes in any advertisement the words “drug store”, “pharmacy”, “apothecary”, “drug”, “drugs” or “medicine shop” or any combination of such terms or any other words, displays or symbols indicating that such store, shop or place of business is a pharmacy shall be guilty of a class D misdemeanor. The provisions of this subsection shall not apply to any person that provides pharmacy-related services directly to pharmacies or practitioners and does not offer such services and drugs or medical services directly to the public.
Other: The reason for a reporting deadline waiver must be particular to a unique problem, incident or other issue that prevents the dispenser from uploading dispensation data validation. These reporting issues could be a hardship created by a natural disaster or other emergency beyond the control of the dispenser.

IMPORTANT NOTE: Any applied use of a waiver should be recorded by the dispenser and include all available documentation of the specific circumstance(s) that prevented the dispenser from meeting the reporting deadline. These records should also be made available for PMP compliance review as requested.

What help is available for the upload reporting of dispensation activities to the PMP CLEARINGHOUSE?

All data submitters should consult the PMP “Data Submission Guide for Dispensers”. The most recent version of the guide can always be found in the active users PMP Clearinghouse account under; Account > Multi-state Approval > click CT

Data submitters can also find the guide on the PMP website at https://portal.ct.gov/-/media/DCP/drug_control/PMP/Educational-Materials/CT-Data-Submission-Dispenser-Guide_v-24_April-2022.pdf

Lastly, data submitters can find direct help desk support and other specific information from the PMP CLEARINGHOUSE at https://pmpclearinghouse.zendesk.com/hc/en-us/

Are there exceptions to Connecticut’s prescription dispensation reporting requirements?

YES, there are some exemptions to the reporting requirements that do not require direct reporting or use of a waiver:

Any reportable drug administered directly to a patient by a prescriber;
Any reportable drug dispensed by a licensed health care facility provided that the quantity dispensed is limited to an amount adequate to treat the patient for a maximum of forty-eight (48) hours;
Any reportable drug sample or reportable medical device sample;
Any facility that is registered by the United States Drug Enforcement Administration (DEA) as a narcotic treatment program and is subject to the record keeping provisions of 21 CFR 1304.24;
Any reportable drug or reportable medical device to inpatients in hospitals or nursing homes (this exemption does not apply to assisted living);
Any reportable drug or reportable medical device to inpatients in hospices (this exemption does not apply to home hospice or hospice in an assisted living facility).

IMPORTANT COMPLIANCE STATEMENT FOR DISPENSERS:

By exercising the use of a PMP waiver, the authorized dispensing practitioner certifies that all reporting information is true to the best of their knowledge, information, and belief; and acknowledge that failure to provide accurate and true information may result in disciplinary action or the imposition of civil penalties.