It’s no secret that Pennsylvania is ground zero in the national opioid crisis, and in fact Allegheny County is seeing more overdoses than the rest of the state. The Drug Enforcement Agency reported 4,642 total fatal drug overdoses in Pennsylvania in 2016, a 37% increase from the prior year. 2016 represented the third consecutive year in which the number of fatal overdoses exceeded all prior years. Drugs contributing to the crisis include heroin as well as prescription pain medications such as morphine, codeine, methadone, oxycodone, hydrocodone, fentanyl, and hydromorphone. 

 There is plenty of blame to go around.  Although street drugs like heroin remain a factor, opioid manufacturers are under increased scrutiny for their marketing practices. The state of Massachusetts has sued OxyContin maker Purdue Pharma, alleging that the company misled physicians and patients about the risks of its pain medications, and additional litigation is likely. Further, PA Attorney General Josh Shapiro noted in a recent article that although pain levels reported by Pennsylvanians have remained stable since 1999, opioid prescriptions have quadrupled.  In January, Governor Tom Wolf signed a 90-day statewide disaster declaration to help combat the heroin and opioid overdose epidemic.   The Commonwealth continues to tweak the Prescription Drug Monitoring Program (PDMP) to track opioid use and help prevent prescription fraud and physician-shopping. 

 Among other actions adopted by the Commonwealth to address the crisis, Pennsylvania Act 124 of 2016, amending the “Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act,” requires all Prescribers or Dispensers (as defined in the Act) to complete mandatory continuing education in pain management, the identification of addiction or in the practices of prescribing or dispensing of opioids as a portion of the total continuing education required.   

 The Act defines “Prescriber”  as any person who is licensed, registered or otherwise lawfully authorized to distribute, dispense or administer a controlled substance, other drug or device in the course of professional practice or research in Pennsylvania, other than veterinarians. 

 A “Dispenser” is defined in the Act as any person lawfully authorized to dispense in this Commonwealth, including mail order and Internet sales of pharmaceuticals, but excluding licensed health care facilities that distributes the controlled substance for the purpose of administration within limitations; certain correctional facilities and their contractors; wholesale distributors; and hospice providers. 

 For first-time applicants for licensure, the CME must include at least two hours of education in pain management or identification of addiction and at least two hours of education in the practices of prescribing of opioids. This training can be part of the applicant’s professional degree educational program or continuing education program.  

 Physicians renewing their licenses must complete at least two hours of CME in pain management, identification of addiction, or the practices of prescribing of opioids during the 2017-2018 licensure period for 2019-2020 renewals, and for each licensure period thereafter.  The total of 100 hours required for continuing education is not increased, but two of these hours must include these topics.  

 The Pennsylvania Medical Society has received confirmation from the Pennsylvania Department of State that both the State Board of Medicine and the State Board of Osteopathic Medicine will accept continuing education courses in either Category 1 or Category 2 for the purpose of compliance with the requirements of Act 124 as long as the content meets the Board-required subject matter. 

 Pennsylvania Department of Health offers free online training at https://www.health.pa.gov/topics/programs/PDMP/Pages/Education.aspx.  Modules 3-7, Using the PDMP to Optimize Pain Management; Opioid Prescribing Guide; Referral to Treatment for Substance Use Disorder Related to Opioid Use; Approaches to Addressing Substance Use Disorder with Patients Identified by the PDMP; and Effective Opioid Tapering Practices, can be used to meet the Act 124 opioid education requirements. 

 Clinical training is essential for the safe and effective use of opioids, but physicians should also be aware of their obligations under applicable law. DEA regulations state:  “A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.”  Federal investigators have developed a profile to identify and prosecute “pill mill” doctors.  They will target physicians who:  

  • Write an unusually high amount of certain prescriptions.
  • Do not ask a lot of questions.
  • See patients for very short amounts of time (i.e. 30 seconds).
  • Accept cash in exchange for prescriptions.
  • Are willing to write multiple prescriptions at one visit.
  • Have patients lined up outside the practice each day.
  • Have groups of patients showing up in vans.
  • Provide a variety of seemingly unrelated services.

 

Meeting some of these factors (i.e. accepting only cash or having a busy waiting room) does not automatically indicate improper prescribing practices, but if you resemble the profile, you can expect heightened attention from enforcement authorities.