Health Law Blog

New York lawmakers and law enforcement agencies are intensifying their efforts to stem the rampant abuse of prescription drugs.  Currently, there are several major initiatives under consideration that are bound to make a dramatic impact on pharmacy operations.

The statistics on opioids and tranquilizers abuse is truly alarming.  According to CDC, in 2010, about 12 million Americans (age 12 or older) reported non-medical use of prescription painkillers in the past year.  Prescription painkiller overdoses killed nearly 15,000 people in the US in 2008. This is more than 3 times the 4,000 people killed by these drugs in 1999.  Nationwide, pharmacies received and ultimately dispensed the equivalent of 69 tons of pure oxycodone and 42 tons of pure hydrocodone in 2010, a dramatic rise over the previous decade, according to Drug Enforcement Administration data.  New York prescriptions for narcotics rose from 16.6 million in 2007 to nearly 22.5 million in 2010.  A large percentage of all emergency room visits involves non-medical uses of prescription opioids and tranquilizers.

In January 2012, the office of the New York Attorney General Eric Schneiderman issued a report on an epidemic in Americans' abuse of painkillers and introduced legislation to establish what he called the Internet System for Tracking Over-Prescribing, or I-STOP. That would require the state Department of Health to establish a computer reporting system where doctors and other care providers would have to review a patient's complete prescription drug history online before writing new scrips for painkillers. Pharmacists would have to check the same system to confirm all such prescriptions are legitimate before filling them.  Many states currently operate similar systems and report a significant decrease in doctor shopping and otherwise high levels of satisfaction with the program.  

Similar real-time systems have successfully operated in other states for many years.  New York regulations now require practitioners, including dentists, to report prescriptions they write monthly to the health department.  The new system would require real time reporting and tracking. 

Other measures include a recently passed senate bill, S5880, to reclassify hydrocodone, sold as Vicodin, Norco and Lortab, to Schedule II. That would require a new prescription each time, with no refills. The same bill reclassifies Tramadol as a Schedule III controlled substance.  The bill has passed the NY Senate and Assembly and is expected to be signed into law.

Another bill passed by the Senate would increase criminal penalties for physicians and pharmacists who illegally divert, prescribe or dispense prescription drugs. That would make the crime a felony with sentences up to 25 years.

While the new measures will add extra some steps that pharmacies will have to take when dispensing prescription controlled substances, the benefits will certainly outweigh it.  Aside from the obvious anticipated reduction in doctor shopping, the new monitoring system will likely put an end to civil lawsuits against doctors and pharmacies in which plaintiffs alleged that prescribers and pharmacies allowed addicted individuals to feed their addiction by uncontrolled dispensing and prescribing of addictive painkillers.  Reviewing the database and detecting patterns of abuse will prevent pharmacies from being the targets of the DEA civil and criminal enforcement actions.  Moreover, many pharmacies, out of fear of civil and criminal penalties and lawsuits, have stopped stocking Schedule II drugs, and are turning away legitimate patients.  Having access to real-time database will allow pharmacies to get a reliable perspective on whether the patients seek controlled substances for legitimate purposes.  This will make business sense.

The implementation of the database, however, will potentially raise some concerns.  To permit a pharmacy to dispense controlled drugs, the prescription will have to have been logged into the system.  For instance, we envision a situation when a dental patient, following an emergency procedure, turns to a nearby pharmacy for a painkiller just to learn that the dentist has not yet logged the prescription into the system to allow the pharmacy to dispense the medication.  Inevitable errors and discrepancies occasioned by data entry will also require further verification steps by pharmacies.

We believe however that the implementation of the database will be a positive development for pharmacies, physicians and legitimate patients.  We belive that even better results can be achieved by a more widespread use of e-prescribing (with real-time reporting to the I-STOP database) as well as by the implementation of a national drug monitoring database.