December 19, 2018
The Virginia Prescription Monitoring Program (“PMP”) is a statewide electronic database with information on dispensed controlled substances included in Schedule II, III and IV; those in Schedule V for which a prescription is required; naloxone; gabapentin; and soon cannabidiol/THC-A oil.[1] The primary purpose of the PMP is to serve as a helpful tool for healthcare providers by promoting safe prescribing and dispensing practices for covered substances. More recently, the PMP has become a source of data collection that can help in identifying unusual patterns of prescribing and dispensing of covered substances. Providers and dispensers should be aware of the recent laws involving the PMP that could lead to investigation of their prescribing and dispensing practices.
The prescription medications that are most commonly abused fall into four categories: pain relievers (i.e. opioids), stimulants (i.e. Adderall etc. for attention deficient disorders), tranquilizers (i.e. longer acting benzodiazepines and muscle relaxants), and sedatives (i.e. shorter acting benzos and barbiturates).[2]
Utilization of the PMP by prescribers, pharmacists, and their delegates has increased steadily over time.[3] Virginia PMP users now have access to a patient’s prescription history from thirty other states and D.C. thanks to developing electronic interoperability between systems. Vigilant utilization of the PMP can help prescribers and dispensers in monitoring their practice and identifying potential misuse of covered substances.
2017 PMP Amendment, Tool of Enforcement
In July 2017, the PMP received statutory authority permitting it to disclose PMP data indicative of unusual prescribing and dispensing of covered substances to the Department of Health Professions Enforcement Division. This was the first time the PMP was converted into an enforcement mechanism that could be used against prescribers and dispensers. Similarly, the Enforcement Division has historically been reactive to complaints, but now has a proactive approach to investigations. Since the 2017 Amendment, the Enforcement Division has conducted sixty-two reviews of prescribers and dispensers and initiated investigations as appropriate, which can lead to real consequences for prescribers and dispensers.[4]
2018 PMP Amendment, Updated Criteria for Investigation
In 2018, the Virginia General Assembly amended Code § 54.1-2523.1, which now reads, in pertinent part, that the PMP shall develop criteria for indicators of unusual patterns of prescribing or dispensing of covered substances by prescribers or dispensers and misuse of covered substances by recipients and a method for analysis of data collected by the Prescription Monitoring Program using the criteria for indicators of misuse to identify unusual patterns of prescribing or dispensing of covered substances by individual prescribers or dispensers or potential misuse of a covered substance by a recipient.[5]
Additionally, in cases where the data analysis indicates an unusual pattern of prescribing or dispensing of a covered substance or potential misuse of a covered substance by a recipient, the PMP may disclose this information to the Enforcement Division of the Department of Health Professions.[6]
In September 2018, the PMP convened and unanimously updated the criteria for indicators of unusual patterns of prescribing and dispensing of covered substances.[7] For the next year, the following will be used to guide PMP-initiated investigations:
Prescriber
- Top ten prescribers of opioids;
- Top ten prescribers of opioids with minimal PMP use;
- One or more patients prescribed 1,500 MME/day[8];
- Top ten prescribers of ER/LA[9] opioids to opioid naïve[10] patients;
- Top ten prescribers of buprenorphine for MAT dosing >24 mg/day[11].
Dispenser
- Top ten dispensers of opioids from out of state prescribers;
- Top ten dispensers based on ratio of Schedule II to all Schedule II-V prescriptions.
When evaluating PMP referrals for outlier prescribing, the Board of Medicine typically exempts review of prescribers with patients in hospice or palliative care as well as those with sickle cell anemia.[12] The PMP has advised that prescribers and dispensers are audited using the above criteria in alternating quarters of the calendar year. Additionally, a prescriber or dispenser who is identified in two or more quarters will be prioritized for referral to the Enforcement Division for a possible investigation on behalf of the Board of Medicine or Board of Pharmacy.
Practical Tips for Prescribers and Dispensers
Now that the PMP is being used to investigate prescribers and dispensers, keep in mind the following:
- Use the PMP often and when legally required according to Virginia statutes and regulations.
- The prescription data in the PMP is voluminous and includes not only what you describe or dispense, but how you do it. The PMP database also monitors when you or your delegates log on and for what patients. The PMP can produce data pursuant to specific queries, such as identifying the name and prescription profile for all patients with an MME over 100.
- Increase use of the PMP by integrating it into your electronic medical record or pharmacy software system. Grant funding is available.[13]
- Review your quarterly individualized Prescriber Report, which provides you with personal information regarding your current prescribing volumes, behaviors, PMP use, and a comparison to peers within the same specialty.
- Dispensers, if you are one of the top ten dispensers of opioids or Schedule II substances, be vigilant and look for the typical red flags. The Board of Pharmacy also appears to be reviewing the percentage of prescriptions paid with cash, pharmacy demographics, the distance that the patient lives from the pharmacy or from the prescriber, out of state prescribers, early refill requests and mistakes, and frequency of Naloxone prescriptions filled.
As a final cautionary note, unusual prescribing practices can garner the attention of the PMP and Virginia Board of Medicine, as well as federal enforcement officials. Federal prosecutors have begun proactively investigating doctors who are prescribing opioids in significantly greater numbers than their peers or who have prescribed them to a patient who later died from an overdose.[14] The U.S. Attorneys for Massachusetts and for the Northern District of Georgia have both begun sending warning letters to doctors to take stock of their prescribing practices and to make any necessary adjustments.[15]
If you have any questions, please contact: Jerry Canaan, Esq. jcanaan@hancockdaniel.com
The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.
[1] https://www.dhp.virginia.gov/dhp_programs/pmp/default.asp
[2] https://www.dhp.virginia.gov/dhp_programs/pmp/docs/2018AnnualReport.pdf
[3] Id.
[4] Id.
[5] https://law.lis.virginia.gov/vacode/title54.1/chapter25.2/section54.1-2523.1/
[6] Id.
[7] https://www.dhp.virginia.gov/dhp_programs/pmp/minutes/2018/PMPAdvisoryCte09272018_Draft.pdf and https://www.dhp.virginia.gov/dhp_programs/pmp/docs/2018AnnualReport.pdf
[8] Morphine milligram equivalent (“MME”) is a way to calculate the total amount of opioid and account for differences in opioid drug type and strength. The CDC specifies that dosages of 90 MME per day or greater should be avoided due to risk of fatal overdose. According to the PMP, as the MME increases, overdose risk increases.
[9] Extended release / long acting (“ER/LA”).
[10] Opioid naïve means an individual who has not taken an opioid in the last 45 days, according to the CDC.
[11] Medication-assisted treatment (“MAT”) is the use of medications, like buprenorphine, in combination with behavioral therapies to treat opioid use disorders. According to the PMP, when MAT dosing, buprenorphine without naloxone is more likely to be abused than buprenorphine bound to naloxone.
[12] https://www.dhp.virginia.gov/dhp_programs/pmp/minutes/2018/PMPAdvisoryPanel09272018_Draft.pdf
[13] https://www.dhp.virginia.gov/dhp_programs/pmp/default.asp
[14] https://www.law360.com/articles/1106334/mass-us-atty-sends-warnings-to-opioid-prescribing-docs
[15] https://www.usnews.com/news/best-states/massachusetts/articles/2018-11-29/us-attorney-warning-doctors-about-prescribing-opioids and https://www.ajc.com/news/crime–law/prosecutors-notify-doctors-about-excessive-opioid-prescriptions/fXSbsKBg8XiMc9y7wj3wPN/
