by Kathryn E. Heagerty, BSN, JD
Professional Risk Management Services, Inc., Arlington, VA
Innov Clin Neurosci. 2013;10(11–12):28–30
This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS, Inc. (www.prms.com), a manager of medical professional liability insurance programs with services that include risk management consultation, education and onsite risk management audits, and other resources to healthcare providers to help improve patient outcomes and reduce professional liability risk. The answers published in this column represent those of only one risk management consulting company. Other risk management consulting companies or insurance carriers may provide different advice, and readers should take this into consideration. The information in this column does not constitute legal advice. For legal advice, contact your personal attorney. Note: The information and recommendations in this article are applicable to physicians and other healthcare professionals so “clinician” is used to indicate all treatment team members.
QUESTION
I’ve heard about prescription monitoring programs (PMPs), but haven’t registered to use the one in my state. What is the value of using PMP information in clinical practice?
ANSWER
To answer that question, let’s start with another. Have you ever suspected, but lacked proof, that a patient might be misusing the controlled substance you are prescribing or “doctor shopping” for multiple prescriptions? If so, perhaps you have counseled the patient on medication safety, prescribed, and crossed your fingers. Now you have an alternative to that uncertainty. Accessing data from a prescription monitoring program provides you with objective evidence of your patient’s prescription history that can be used to inform your clinical decisions. Use of such data can also enhance patient safety and minimize your professional liability risks. Further, you may be legally required to do so.
Prescription drug abuse epidemic. The Centers for Disease Control reported that 60% of overdose deaths in 2010 involved pharmaceutical drugs.[1] In 2011, 1.2 million emergency department (ED) visits involved nonmedical use of pharmaceuticals as did most of the 200,000 ED visits for drug-related suicide attempts.[2] The Obama Administration referred to prescription drug abuse as the “Nation’s fastest-growing drug problem.”[3] Naturally, there is an increased focus on prescribers as part of the problem and as an integral part of the solution – a solution that also includes prescription monitoring programs.
History. Prescription monitoring programs, also known as PMPs, are state-run electronic databases that collect, monitor, and analyze information on the prescribing and dispensing of controlled substances.[4] PMPs are authorized by state law and administered by a state agency, such as the health department, pharmacy board, or the attorney general’s office. Each state law sets forth the controlled substances for which dispensing data will be collected. Most PMPs collect data on Schedules II-IV drugs, but some states require reporting on other drugs of concern. Responsibility for reporting typically falls to pharmacies and other dispensers.
PMPs were created to assist clinicians and law enforcement in curbing misuse, abuse, and diversion of controlled substances.4 In 1991, Oklahoma became the first state with an electronic format for its PMP.[5] The number of states with operational PMPs began to climb in the 1990s.[6] For example, the Kentucky All Schedule Prescription Electronic Reporting Program (KASPER) began collecting data in 1999.[6] Florida, on the other hand, enacted PMP legislation in 2009 and only went operational in 2011 following mounting pressure to do so.[6] At present, PMPs are a component of the 2011 Prescription Drug Abuse Prevention Plan. This national strategy encourages action in four areas: education of clinicians and the public; development of proper medication disposal methods; provision of tools needed by law enforcement to stop improper prescribing and shut down pill mills; and implementation of PMPs in every state that are used by clinicians and that share information across state lines.[7] Thus, PMPs are likely to become a permanent part of the healthcare and law enforcement landscape.
Requirements for clinician access Most PMP laws explicitly set forth that clinicians were not required to access PMP data in an attempt to ensure that the laws were not overtly creating a new duty of care. Nevada and Delaware were the exceptions at that time in that clinicians were required to access PMP data under certain circumstances. Nevada law required clinicians to obtain a report prior to prescribing Schedule II, III, or IV substances for new patients and to patients whom the clinician had not prescribed controlled substances to for the preceding 12 months, if the practitioner had a reasonable belief that the patient might be seeking the drug for other than the treatment of an existing medical condition.[8] The Delaware statute had similar requirements.[9]
As expected though, the tides are changing and more states are requiring clinicians to access the PMP in certain circumstances. Some states that have gone in this direction are Kentucky,[10] Massachusetts,[11] Tennessee,[12] Ohio,[13] and New York.[14] Clinicians who practice in states that require PMP access should be familiar with and follow the law. For clinicians practicing in states without such a mandate, consider registering for and using the PMP data to inform your prescribing decisions and improve patient safety. Further, watch for changes in your state law as more states begin to require PMP use by clinicians.
Risk managment advice. Know state law requirements. Know what your state laws and regulations require of you. Professional licensing boards are a good resource for this information. Alternatively, a Google search using the name of your state and “prescription monitoring program” will typically take you to the program’s website.
Register and use. Consider registering for and using the PMP even if not required to do so. The information gained can help inform your treatment decisions, enhance patient safety, decrease diversion, and help identify those who may need substance abuse treatment. At the same time, incorporating the use of PMP data into your practice can minimize professional liability risks. Should you be sued, perhaps following a patient’s overdose, whether or not you accessed the PMP prior to prescribing controlled substances may be a factor in determining whether you met the standard of care.
Periodically check your own prescribing history for evidence of fraudulent use of your DEA registration. If you practice in a state that permits you to designate a staff member who can access PMP data using your registration number, educate the staff member on proper use of the PMP as you will may be held responsible for their actions.
Maintain confidentiality. PMP data is confidential and access is determined by state law. Most states penalize those who improperly access, disclose, or re-disclose PMP information. Penalties may include fines and/or criminal prosecution. As a general rule, only access PMP information on current patients for treatment purposes and know where your state stands on disclosure and re-disclosure.
Document. Finally, review and follow state statutes and regulations for documentation requirements pertaining to PMP review and the prescribing of controlled substances. Due to the restrictions on re-disclosure, at this time we do not recommend putting a copy of the PMP report in the patient’s chart unless specifically required by state law.
Conclusion. Change is difficult and incorporating that change into a busy practice day can be daunting. However, using the information available to you through the PMPs can provide you with peace of mind when prescribing controlled substances and minimize your professional liability risks. Most importantly though, patient health and safety will likely be enhanced.
References
1. Centers for Disease Control and Prevention [Internet]. Opioids drive continued increase in drug overdose deaths. Available from: http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html.
2. Substance Abuse and Mental Health Services Administration [Internet]. Rockville (MD): Drug Abuse Warning Network, 2011. National Estimates of Drug-Related Emergency Department Visits. Available from: http://www.samhsa.gov/data/2k13/DAWN2k11ED/DAWN2k11ED.htm.
3. Executive Office of the President of the United States [Internet]. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. Available from: http://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf.
4. Alliance of States with Prescription Monitoring Programs [Internet]. Prescription Monitoring Frequently Asked Questions (FAQ). Available from: http://www.pmpalliance.org/content/prescription-monitoring-frequently-asked-questions-faq.
5. Alliance of States with Prescription Monitoring Programs [Internet]. Prescription Monitoring Programs. Available from: http://www.pmpalliance.org/pdf/PPTs/LI2010/1-PMP-Overview-History.pdf.
6. Alliance of States with Prescription Monitoring Programs[Internet]. PMP Legislation and Operational Dates. Available from: http://www.pmpalliance.org/content/pmp-legislation-operational-dates?order=field_pmp_legis_enacted_value&sort=asc.
7. Office of National Drug Control Policy [Internet]. Prescription Drug Abuse Prevention Plan. Available from: http://www.whitehouse.gov/ondcp/prescription-drug-abuse.
8. Nev. Rev. Stat. § 639.23507 (2011).
9. Del. Code. Ann. tit. 16, s. 4798 (2012).
10. Kentucky Medical Association [Internet]. Summary of Controlled Substance Regulation. Available from: http://www.odcp.ky.gov/NR/rdonlyres/30C76281-477F-4001-8014-664C55F538AE/0/KMASummaryofControlledSubstanceRegulations.pdf.
11. MA Health and Human Services [Internet]. Guidance on MA Online PMP Automatic Enrollment and Requirements for Utilization. Available from: http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug-control/mcsr/pmp-automatic-enrollment.html.
12. Tennessee Board of Pharmacy [Internet]. Rules of the Tennessee Board of Pharmacy Chapter 1140-11 Controlled Substance Monitoring Database. Available from: http://www.state.tn.us/sos/rules/1140/1140-11.20130701.pdf.
13. Standards and procedures for review of Ohio Automated Rx Reporting System (OARRS). Available from: http://www.registerofohio.state.oh.us/pdfs/4731/0/11/4731-11-11_PH_FF_N_RU_20111110_1051.pdf.
14. New York State Bureau of Narcotic Enforcement [Internet]. Prescription Drug Reform Act Internet System for Tracking Over-Prescribing (I-STOP). Available from: http://www.health.ny.gov/professionals/narcotic/.
