Rx & The Law

Impact of State Prescription Drug Monitoring Program

by Don R. McGuire, Jr., R.Ph., J.D.
General Counsel
and Allison Seiwert
PharmD Candidate 2010, JD Candidate 2012
Pharmacists Mutual Insurance Company

Overview of Programs

Prescription drug monitoring programs are helping states address prescription drug abuse, addiction and diversion.  As of July 2009, a total of forty states have laws allowing for a prescription drug monitoring program (PDMP) .  Thirty-three states have PDMPs in place and six more have legislation enacted but are not yet operational.  Washington’s program has been suspended due to lack of funding. PDMPs are not a new idea; Texas began collecting data in July 1982 for Schedule II prescriptions and recently expanded the program to also cover Schedules III, IV and V.  Pennsylvania passed legislation in 1972, but the program was not operational until 2002 .  PDMPs gather information that may include: patient name, date of birth, address; drug name, strength, and quantity; doctor name and DEA; and other prescription information, date written, refills, and day supply .

States vary in the information gathered as well as the drugs monitored.  Thirty-six states have the authority to monitor Schedule II, III and IV prescriptions.  Twenty states also monitor Schedule V substances1.  Nine states are allowed to monitor non-controlled substances (drugs of concern or have demonstrated a potential for abuse).  For example, Ohio, Washington and North Dakota have authority to monitor drugs containing tramadol or carisoprodol1. 

A major goal of PDMPs is to support legitimate use of prescriptions while minimizing illicit use.  The information obtained by the PDMP is accessible to prescribers and dispensers.  However, there is little guidance about what a practitioner should do with the information at hand.  It’s up to the individual practitioner to utilize the PDMP to ensure legitimate medical use of controlled substance prescriptions. 

Some state programs will notify prescribers and/or dispensers about patients receiving multiple prescriptions in the same class from multiple prescribers.  In sixteen states, the PDMP laws do not require the practitioners to utilize this information.  These states include: Alabama, Alaska, Arizona, Florida, Idaho, Illinois, Indiana, Iowa, Kansas, Minnesota, North Dakota, Ohio, Oklahoma, Oregon, South Carolina and Wyoming.  However, not all of the states protect practitioners from civil liability if they don’t use the information in the program.  Of the sixteen states, Alabama and Wyoming do not provide civil immunity.  Idaho and Illinois provide protection when information is accessed and used negligently but do not provide immunity for failing to access the program at all.  Indiana’s statute does not specifically include dispensers in the immunity provisions.  Prescribers are encouraged to use data provided by PDMP in order to optimize appropriate use.  Nevada mandates review by prescribers under certain circumstances to assess the medical necessity of a prescription . 

In summary, PDMP are in place in the majority of states across the US.  The programs vary based on type information gathered and how it’s used.  Overall, the goal is the same: reduce drug abuse by compiling data into a single source accessible to prescribers and dispensers.  The following case highlights how several pharmacies failed to use information provided by Nevada’s PDMP.  The district court dismissed the pharmacies from the case, but the plaintiff has appealed to the Nevada Supreme Court for further review. 

Nevada Case

The Nevada Supreme Court is expected to rule by the end of the year on whether seven chain pharmacy owners and one independent owner were rightfully dismissed from the civil case, Sanchez v. Wal-Mart Stores, et al .  The case arises from a June 2004 car accident caused by Patricia Copening.  While under the influence of prescription medications, she was driving along a busy Nevada highway.  The accident killed one man, Gregory Sanchez, Jr. and injured another, Robert Martinez. 

Prior to the accident, in June 2003, the Nevada controlled substance task force sent letters to 14 Las Vegas area pharmacies informing them that Copening may be abusing drugs.  It is not clear at this time what information was contained in the letter, but there is no documentation to show that it was considered prior to dispensing future prescriptions to the patient.  Yet she continued to receive multiple prescriptions for hydrocodone-acetaminophen and carisoprodol.  One year later, the accident occurred and she was found to have hydrocodone in her system.  She appeared confused and the police found prescription bottles and loose tablets in the vehicle.  She served nine months in jail after pleading guilty to reckless driving.  A civil case was filed by the Sanchez family, Mr. Martinez and his family against Copening, the doctors prescribing for her, and the pharmacies.  The district court dismissed the pharmacies as Nevada law does not specify the action to be taken by the pharmacies when notified of a potential drug abuser.  Therefore, the district court found the pharmacies did not have a legal obligation to refuse to fill Copening’s prescriptions.  This case of first impression may have an impact on how practitioners use information obtained from PDMPs.

The question of the case becomes: did the pharmacies have a duty to act upon information received from the task force warning of a patient’s potential drug abuse?  Time will tell.  An update will follow when the Nevada Supreme Court releases its opinion.

. Green, Sherry. Prescription Drug Monitoring Programs: A Brief Overview.  National Alliance for Model State Drug Laws (NAMSDL) August 2009. Available at: http://namsdl.org/documents/PDMPsBriefOverview7-31-09.pdf Accessed October 29, 2009.

. Questions and Answers: State Prescription Drug Monitoring Programs. November 2008. Available at: http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm#14.  Accessed October 29, 2009.

. State Statutory and Regulatory Prescription Monitoring Program Data Elements Required for Transmission to the Central Repository. January 2005. Available at: http://namsdl.org/resources/Chart%20of%20PMP%20Data%20Elements%20Jan05.pdf Accessed October 29, 2009.

. Kelsey, Sarah. Immunity for Failing to Access & Requirements to Access PMP Data. August 2009. Available at: http://namsdl.org/documents/August2009DoctorImmunityForFailuretoAccessData_000.pdf Accessed November 3, 2009.

. Merrick, Amy. “Case Spurs Pharmacies’ Fears of Lawsuits Over Drug Abuse.” The Wall Street Journal. 28 Oct. 2009.