National Board of Pharmacy Matters
In September of 2012, the New England Compounding Center (“NECC”) meningitis outbreak that killed 64 and caused infections in 793 patients, ushered in a new era of enforcement by State Boards of Pharmacies (BOP) across the country. The former supervisory pharmacist of NECC was sentenced in 2019. Since that the NECC tragedy, BOPs have increased enforcement action against licensees exponentially, as have prosecutors. BOP enforcement actions are pursued against both the pharmacy license as well are individual pharmacists and technician licensees.
What Types of Matters does the Board of Pharmacy Investigate?
Matters investigated by BOPs range in complexity from simple paperwork errors to egregious conduct such as fraud and dispensing of adulterated medications. Other BOP enforcement and investigations include:
- Staffing ratios
- Inventory discrepancies
- Improper prescription receipt (e.g. filling prescriptions that were not e-prescribed)
- Change of ownership discrepancies
- Failure to notify BOP of discipline in other jurisdictions
- Improper employee licensure
- Hours of operation shortcomings
- Physical facility deficiencies
- HIPAA breaches
- Patient complaints
- Prescriber complaints
- Excluded providers
Expanded Scope of Enforcement by Boards of Pharmacy
Most recently BOPs have expanded the scope of enforcement by collaborating with state attorneys general offices to issue subpoenas focused on investigations into sources of prescriptions, marketing arrangements, telemedicine, management agreements, copay collections, and both drug manufacturer and HUB relationships.
How PBMs use Boards of Pharmacy
PBMs also use BOPs to do their bidding when PBMs turn over information to BOPs gleaned from pharmacy audits to instigate investigation by BOPs against independent pharmacies.
How Frier Levitt Can Help
Frier Levitt attorneys have handled BOP enforcement actions across the country. Applying a multi-disciplinary team of clinician lawyers, including Pharm. D., litigators, criminal defense attorneys and PBM specialists to defend pharmacies under investigation by BOPs. The goal of defending any BOP investigation is to mitigate the financial impact and avoid licensee discipline. Where reportable disciple occurs, we systematically and compliantly notify applicable BOPs and PBMs to avoid further issues for the pharmacy. Contact us today to learn more.