Government regulations impact prescriber engagement in Ohio
What to know and how to get ahead
By Paul Shawah, senior VP of commercial strategy, Veeva Systems
The U.S. regulatory landscape will continue to evolve in 2018, potentially adding complexity and compliance challenges to the life sciences industry. Recent changes are being driven by nationwide concerns with prescription drug abuse, which is prompting many states to enforce new mandates and programs regarding drug practices.
Ohio, for example, added new provisions in 2017 to oversee the interactions between pharmaceutical companies and healthcare organizations (HCOs) in the distribution of prescription drugs. In January, the Ohio governor signed legislation requiring all HCOs to obtain Terminal Distributor of Dangerous Drugs (TDDD) licenses to distribute specific products prescribed by licensed providers.
TDDD licenses are specific to particular drug categories uniquely defined by Ohio, and require life sciences companies to ensure that a prescriber’s address matches the licensed medical practice, pharmacy, or healthcare facility. As such, life sciences field reps can no longer drop off products or samples to physicians without first verifying their licenses as well as the licenses or exemption status of the facilities where they practice.
Ohio TDDD is the latest example of evolving regulations taking effect, with other cities and states, including Chicago and New Jersey, considering similar changes to address prescription drug abuse. There will clearly be implications for pharma and biotech companies. What steps can the industry take now to ensure compliance and continue to get products and treatments to healthcare professionals and HCOs?
This article will explore the requirements of the Ohio TDDD law, its impact on manufacturers, and how life sciences companies can stay ahead of evolving regulatory challenges.
Ohio TDDD creates complexity for pharma and prescribers
Any life sciences company that wants to interact with physicians or organizations, provide prescription drug samples, or sell drugs and medical devices in the state of Ohio must verify licensed HCPs are working at licensed HCOs. The industry already has systems and processes in place to confirm that a physician is properly licensed, but determining whether or not an HCO has a TDDD license adds a new layer of complexity and a new challenge.
So, what’s at stake? Companies that do not comply with Ohio regulations risk fines, adverse publicity, tarnished reputation, sanctions, and even the possibility of operating under a restrictive corporate integrity agreement (CIA). CIAs are enforcement tools used by the Office of the Inspector General (OIG) within the Department of Health and Human Services to improve the quality of health care and promote compliance, but they come with an extensive, often costly, list of obligations. A CIA typically lasts five years and requires companies to do things like hire a compliance officer or team, implement a comprehensive employee training program, and provide various reports to the OIG on the status of compliance activities.
For example, a large pharmaceutical company entered into a CIA last year that requires – among other things – the company implement measures designed to ensure that interactions with third-party patient assistance programs are compliant with the law. In addition, the CIA requires reviews by an independent review organization, compliance-related certifications from company executives and Board members, and the implementation of a risk assessment and mitigation process.
Ohio TDDD requirements impact many different life sciences teams. Not only is compliance affected, but the IT department must also find new approaches to process license data for HCOs, which potentially changes application processes and file structures, and requires system revalidations. It could even warrant the selection, implementation, validation, and training of an entirely new technology solution.
Additionally, marketing and brand teams must decide how to communicate with Ohio customers compliantly, re-review all materials currently being disseminated in the state, and possibly develop new promotional and educational materials specific to Ohio. Sales operations feels the impact of the regulatory changes, too, and must determine how to best educate the field to work compliantly. Likewise, customer-facing field reps must learn and adhere to Ohio compliance regulations.
Ohio’s legislation also impacts prescribing healthcare providers by requiring all practices that obtain certain controlled substances to have a current TDDD license or risk penalties. However, some physicians remain unaware or confused. For instance, when asked to comment about the impact of the new regulation, some physicians at one of the largest health systems in Ohio that serves nearly 50 counties, were unfamiliar with the legislation.
Legislation hinders an industry selling strategy
Ohio TDDD presents new, unique challenges specifically related to sampling programs, which are an effective way to build awareness and allow patients to trial new medications. A Journal of the American Medical Association study found that 40% of doctors who received drug samples complied with patient requests for brand-name drugs instead of prescribing a generic versus only 31% of physicians that did not receive drug samples. Even in the face of restricted access, companies still utilize e-sampling and third parties to fulfill sample requests.
The TDDD legislation could put a temporary halt to this important practice in Ohio. If adopted by other states, these programs could cease across multiple regions. Most importantly, bringing critical treatment options to prescribers and their patients could be delayed.
When disseminating information regarding this new law, the State of Ohio Board of Pharmacy (Board) received several questions specifically about the distribution of drug samples, particularly relating to license verification. To address these inquiries, the board developed guidance documents to assist life sciences companies, and distributed them to all licensees plus posted on their website.
According to Cameron McNamee, the board’s director of policy and communications, “The board has worked diligently with a number of companies, including hosting a number of conference calls and emailing regulatory compliance staff, to ensure wholesalers and manufacturers are aware of the licensure verification requirements so as to not disrupt the distribution of samples to Ohio patients.”
The Ohio Board’s efforts have helped educate companies, given the intricacies of the new requirements. The law holds the prescriber and the facility accountable, both requiring a TDDD license to give product samples to patients. This adds a level of complexity for companies, which in turn, must validate the prescriber license as well as the HCO where he or she works.
What makes this even more difficult is that prescribers often work in more than one type of facility such as a nursing home, EMT, lab, hospital, and practice. Collecting and verifying current data as well as correlating it across multiple, affiliated facilities represent a significant challenge for biotech and pharmaceutical companies. Add on the requirement to verify that HCPs who distribute controlled substances have the requisite, additional Drug Enforcement Agency (DEA) license, and the complexity is compounded.
To address Ohio TDDD and ensure uninterrupted supply of samples to providers and patients, life sciences companies are looking for options. A recent poll of members of the Sharing Alliance found that many members have been forced to comply with the new legislation in one of three ways:
1) Discontinue all sampling in Ohio or at least controlled substances;
2) Replace the practice of reps hand-carrying samples with reps taking sample requests from physicians, which, are then, fulfilled by a third party;
3) Revert to paper-based sampling and, later, manually recording the TDDD license in the CRM system. A small number of Alliance members said they are working to re-configure their internal CRM systems to create custom fields that store the Ohio TDDD license or license exemption. This task can be risky and expensive.
All three options create some level of disruption in service to providers and can impact patient treatment by preventing or delaying access to potential breakthrough medications. In addition, they potentially incur costs and hinder the productivity of the sales and marketing teams. There is a better way.
Bringing together data and validation to remain compliant
Customer relationship management technology is core to any effective engagement strategy in life sciences. It plays a major role in ensuring compliant interactions with providers and navigating changing regulations. Data plays a critical role, as well. The key is to combine both – up-to-date data and validation.
Securing accurate and comprehensive data is the first step. A recent industry survey revealed that a majority of companies struggle with data quality issues. Incorrect physician addresses, not knowing which doctors to contact, and outdated information about specialty and license status create frustration among field teams while impacting efficiency. As a result, 78 percent of companies are working on initiatives to improve data quality within the next two years.
But, better data is just part of the answer. To make data actionable, it must be accessible at the point of interaction – in this case, the sales call. Field teams need a single, integrated data/CRM solution that can validate that an HCP is at an HCO with an Ohio TDDD license before delivering a sample. This enables companies to automatically cross-reference and validate HCP, HCO, and affiliation data to swiftly confirm that organizations are properly licensed at the point of distribution. It allows companies to drive compliant interactions with HCPs in Ohio – and nationwide – without disrupting their important prescriber sampling programs and product access to patients.
Change is the only constant when it comes to the life sciences regulatory environment. The Ohio TDDD law is just one example, but demonstrates the impact of regulatory change as well as the importance of agility – in terms of both processes and technologies. Bringing complete, up-to-date data and validation together in the CRM is the way to efficiently address the challenges of the Ohio TDDD legislation, and other changing regulations still on the horizon.
