Prescription Drug Reporting System

 

What is the Prescription Drug Reporting System?

The Prescription Drug Reporting System (PDRS) is a web-based application that the Office of Health Strategy (OHS) has developed to assist prescription drug sponsors and manufacturers with reporting required notices, information, and data as required under Connecticut General Statute (C.G.S.) §19a-754b.  The Manual and Guidance document , provides detailed instructions on user registration, portal navigation, reportable information, and terms and definitions.

Sponsors and manufacturers of certain prescription drugs are required to adhere to this prescription drug reporting process in these three instances:

  1. Notices from Sponsors of New Pipeline Drug and Biosimilar Drug (C.G.S § 19a-754b(b))

    Effective January 1, 2020, each sponsor that has filed a new drug or biologics license application for a pipeline or a biosimilar drug with the federal Food and Drug Administration (FDA), shall submit to OHS a written notice within sixty (60) days of receiving an action date* from the FDA. The Manual and Guidance document provides details and definitions to facilitate this reporting.

  2. Filings from Pharmaceutical Manufacturers of Pipeline Drugs (C.G.S § 19a-754b(c)(2))

    The statute authorizes OHS to require further information from pharmaceutical manufacturers (PM) of new outpatient pipeline drugs upon determination of significant impact on state expenditures.  PMs will be notified via the PDRS portal of the requirement to file this information. Manual and Guidance document provides details and definitions to facilitate this reporting.

  3. Filings from Pharmaceutical Manufacturers of Drugs included on the OHS list of ten outpatient prescription drugs with significant impact to cost in the state (C.G.S §19a-754b(d)(1)) The statute allows OHS to prepare a list of not more than ten outpatient prescription drugs that in the executive director's discretion are (A) provided at substantial cost to the state, considering the net cost of such drugs, or (B) critical to public health. The list shall include outpatient prescription drugs from different therapeutic classes of outpatient prescription drugs and at least one generic outpatient prescription drug.

To submit information to the PDRS portal:

https://ohs-pdrsportal.ct.gov

To view OHS reports of publicly available information:

 

Statute required list of Ten Outpatient Rx Drugs

Additional Reports

 

 

*For purposes of these filings, Action Date means approval date to enter market by the Food and Drug Administration.