Risky sampling in the State of Ohio: What it means for you.
Enabling your field reps to maintain compliance while sampling in the State of Ohio can be a challenge. In 2017, Ohio Governor Kasich signed legislation that expanded the list of practices and individuals required to be licensed under the Terminal Distribution of Dangerous Drugs (TDDD) law. According to the State of Ohio Board of Pharmacy, which manages the TDDD licenses, “a TDDD is a person (individual, partnership, association, limited liability company, corporation, or government agency) who is engaged in the sale of dangerous drugs at retail, or any person, other than a wholesale distributor or a pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person’s own use and consumption.”
For pharma companies, this law requires customers to be properly licensed at the point of distribution to legally receive samples.
For a field rep, this can present some complexities. It’s no longer sufficient to ensure that an HCP is properly licensed; now field reps must determine whether the HCP is working at a TDDD licensed HCO before sampling.
Sampling is important for your product’s success and can help drive HCP fulfillment of patient requests for brand name treatments. It may also help reduce the overall cost of care. But now, the sampling process comes with greater risk. Companies that fail to comply with Ohio regulations risk fines, negative publicity, tarnished reputations, sanctions, and even the possibility of operating under a restrictive corporate integrity agreement (CIA) and the costly list of obligations associated with it.
Your internal CRM system can help you uphold your compliance standards for the sampling process when the solution delivers accurate and actionable data to field reps when and where they are sampling. By providing a nimble solution that easily integrates with existing workflows, you can help to ensure that your reps can confidently keep up with regulation requirements and drive business forward, compliantly.
Always expect change
In June 2018, the State of Ohio changed some fields within their TDDD database. This change in the TDDD process means the database information has been rearranged, resulting in a change to presentation of the actual data. For example, instead of numerical representation of a limited license category (ex: 13), limited licenses are now indicated by a text field that contains the word “limited.”
In August 2018, Ohio made additional changes to their file formats—changes that put your business at risk of falling out of compliance unless your data is properly formatted with these new changes. Without proper formatting of the data in your CRM system, you may not be able to provide your reps with an accurate representation of HCPs who can be compliantly provide samples.
IQVIA is constantly monitoring these changes to ensure our systems are working to help you uphold your compliance standards.
IQVIA’s OneKey customers will have these changes applied to their data automatically. If you are not a OneKey customer, you will need to proactively engage your data provider to ensure their information is aligned with these new standards. Your IQVIA team can help you perform the proper checks to verify the formatting of your data will help you to uphold TDDD compliance.
Several other states, including New Jersey, are looking at legislation that is similar to Ohio’s TDDD licensing. IQVIA is closely watching these trends while at the same time ensuring data from IQVIA OneKey is formatted to allow field reps to easily confirm their customers are properly licensed at the point of distribution. We will continue to partner with our customers, helping you to make the right decisions about your sampling processes.