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White Paper
Pharmacy Compliance Report
Analysis of Potential Pharmacy Fines & Savings
May 10, 2018
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  • Pharmacy Compliance Report
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Federal efforts to curb prescription drug abuse and deaths have put pharmacies under tremendous pressure to verify prescriber credentials for hydrocodone combination products (HCPs), such as Vicodin, Lorcet and Lortab. Using data from OneKey Pharmacy Central Prescriber Validation, this report details the number of problematic DEA numbers, NPI numbers, OIG exclusions and inactive prescriber credentials that pharmacy customers saw from June to December 2016.

The reschedule of hydrocodone combination products (HCP) in 2014 has had critical logistical implications for U.S. pharmacies. Prior to the reschedule, many pharmacies were not in the regular practice of validating prescriber DEA credentials. In fact, a 2005 CASAColumbia study found that only 70 percent of pharmacists did so on a regular basis.

Under today’s environment of enforcement, however, pharmacies that fail to comply with regulatory requirements face serious consequences.

Changes in HCP prescription drug policies have been unfolding since 2004, when the U.S. Drug Enforcement Agency (DEA) first attempted to tighten restrictions. In 2013, recommendations by the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee (DSaRM) led to the 2014 reschedule. Since then, federal agencies and even Congress have given serious attention to the prevention of prescription opioid abuse and deaths, the latter of which reached historic numbers (more than 165,000) in 2014 .

Despite its decision in 2008 to keep HCPs classified as schedule III drugs, the U.S. Department of Health and Human Services (HHS) has now declared opioid prescription abuse and death a public health epidemic. Pharmacies are now being called on to be partners in the effort to combat opioid prescription drug abuse and deaths. To do so, pharmacies must ensure that their validation systems and processes are equipped to access the most up-to-date prescriber DEA data available.

With U.S. pharmacies filling more than 4 billion prescriptions every year, the ability to verify and validate prescriber credentials in a timely, efficient and accurate manner is not only vital for compliance but also for business.

As this pharmacy compliance report shows, pharmacies that fail to comply with the federal regulations governing Schedule II are subject to fines amounting to billions of dollars in just a six-month period. Additionally, failure to validate other data, including NPI numbers and OIG exclusions, can result in rejected reimbursements and withdrawals of payment.

The OneKey Central Prescriber Validation (CPV) solution provides modern pharmacies with a powerful, cost-effective and streamlined validation service to support current and future regulatory demands. The integration of OneKey CPV with QuintilesIMS, the largest healthcare data provider in the industry, has added a level of breadth that is unmatched in its capabilities and strength.


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