The first wave of enforcement in the quest by the State of Florida and the DEA to alleviate the problem of prescription drug abuse has focused largely on physicians. Now, although the physician “pill mill” problem still receives a lot of attention, the State and DEA (while not doing victory laps yet) have cut substantially into the problem. Either by stopping or scaring out of business a large number of rouge pain management practices.
Since eliminating physician dispensing of most controlled substances through legislation, the focus of enforcement efforts by the State and DEA is turning to pharmacies, in particular those associated with pain management clinics or the dispensing of what is perceived as large quantities of oxycodone. Although statistics show a large increase in the number of DEA license applications by pharmacies, the DEA is processing those applications very slowly, many say slowly enough to constructively deny the applications without having to go through the administrative process. It is expensive to operate a pharmacy, and without a DEA registration, almost impossible. So time is the regulators friend as businesses give up the process.
On the State level, pharmacies are finding their DOH inspections increasingly draconian and violations once noted on an inspection report are now causing licensing complaints. New legislation has made applicants for pharmacy licenses subject to much greater scrutiny (F.S. 465.018(3)); pharmacies and pharmacists responsible for reporting of doctor shopping (F.S.465.015(3); new disciplinary action for failure to properly review and validate prescriptions (F.S. 465.016(1)(t)) and has made due diligence by all drug suppliers mandatory. Although the DEA, through its own reporting mechanisms are aware of pharmacies ordering large quantities of controlled substances, the reporting of controlled substance prescribing and dispensing is now in effect and regulators will have a whole new well of information to analyze pharmacy practices.
By Bernard M. Cassidy