The opioid crisis is front of mind for healthcare providers, regulators, law enforcement, and the media. Communities across the country have been impacted by this crisis. Whether to prescribe these medications is a tough decision for providers who must balance the side-effects, risks of misuse, abuse, and overdose with the need to address patient pain. Most states have a prescription monitoring program, including Virginia and many of its neighbors – North Carolina, Maryland, West Virginia, and Tennessee. The Center for Disease Control sees these programs as essential tools to address the opioid epidemic with a focus on access and addiction. In Virginia, the PMP programs can be accessed by prescribers, law enforcement, certain regulatory agencies, including the Boards of Medicine and Pharmacy and other similar entities. Big money is being invested in using these programs across the nation to help identify geographic areas of concern, abuse, misuse and over-prescribing.
The purpose of the Virginia Prescription Monitoring Program (PMP) is to promote the appropriate use of controlled substances for legitimate medical purposes while deterring misuse, addiction, abuse, and diversion of controlled substances. Historically, the PMP collected prescription data for Schedule II-IV drugs into a central database that can, and often must, be accessed by prescribers and pharmacists before prescribing or dispensing. The 2018 General Assembly added Schedule V meds, including Naloxone to the list of medications that must now be reported to the PMP. The data collected by the PMP from dispensers is used by prescribers to learn what other medications patients have been prescribed, and by the Department of Health Professions to inform public health initiatives by tracking trends and identifying areas of possible abuse or misuse.
Dispensers, such as pharmacists, and prescribers have certain obligations under the PMP regulations to assist with gathering the data and using the data to prevent misuse and abuse, detect and deter addiction and diversion, and provide safer medical treatment.
Dispensers, which are defined by the PMP as a person or entity authorized to dispense a covered substance or maintain a stock of covered substances for the purpose of dispensing and dispenses the covered substance to a citizen of the Commonwealth regardless of the location of the dispenser or recipient. A dispenser could also be a prescriber under the definitions of the PMP depending on the circumstance. For example, a prescriber who is giving out samples of a covered substance to non-indigent clients is dispensing a covered substance and must report it to the PMP.
Covered substances include all controlled substances in Schedules II -IV and controlled substances included in Schedule V for which a prescription is required such as Naloxone, Cannabidiol oil, THC-A oil, as well as all “drugs of concern.” Drugs of concern are substances the Board of Pharmacy has identified as having been abused or that have the potential for abuse. Tramadol and Gabapentin are examples of “drugs of concern.”
Under the Prescription Monitoring Program, what Do dispensers have to report and when?
Upon dispensing a covered substance, a dispenser must report the following information to the PMP within 24 hours of dispensing, or the next business day (whichever is later):
- Recipient name, address, DOB (if for a pet – the owner’s information is reported)
- Name of covered substance, quantity, dose
- Prescriber ID number
- Dispenser ID number
- Method of payment
There are a few exceptions to reporting which can be found here.
Prescribers are then able to access this information before making certain treatment decisions for their patients.
What is a prescriber and what responsibilities does she have under the Prescription Monitoring Program?
A prescriber is a practitioner licensed by the Commonwealth or another state to issue a prescription for a covered substance. Prescribers include physicians, nurse practitioners, dentists, and osteopaths.
The PMP requires prescribers to query the PMP and pull a report on their patient before starting a new course of treatment to include prescription of opioids to last more than seven consecutive days to determine what other covered substances are currently prescribed to the patient. As of July 1, 2018, this includes prescribers prescribing opioids as part of post-operative or post-invasive procedure treatment. Prescribers must also query the PMP before prescribing Cannabidiol oil or THC-A oils. Of note, Fentanyl in all forms is now a Schedule I drug in Virginia. This means it has no legitimate medical purpose in the Commonwealth.
Though not a statutory requirement, it is a good idea for a provider to query the PMP before prescribing any covered substance. Doing so may reveal multiple prescriptions for the same substance from other providers or may reveal prescriptions for medications the patient forgot to include on their medication list but that would make a proposed opioid prescription contraindicated or higher risk for complication.
The rationale behind this requirement is the prescriber will obtain presumably complete information about the other covered substances prescribed to the patient and thus will be able to make a more informed treatment decision with regard to prescribing opioids, including deciding not to prescribe them.
The PMP allows prescribers to delegate their responsibility to pull the PMP report on a patient to a proper delegate as defined in the PMP regulations.
In certain circumstances, a prescriber does not have to query the PMP. These exceptions revolve around technical unavailability of the PMP due to a power outage, technical issue, or natural disaster. In such instances, the prescriber should document the reason she did not pull the PMP report for a patient before prescribing the opioid.
Other than treatment decisions, what can a prescriber do with the information from the Prescription Monitoring Program report?
A prescriber may discuss the findings of the PMP report with the patient and her other providers. However, the prescriber must NOT provide the patient with a copy of her PMP report. If a patient desires a copy of her PMP report, she can request it from the Department of Health Professions.
The applicable privacy laws pertaining to protected health information at the state and federal level apply to the PMP. The provider may, if she desires, place a copy of the PMP report in the patient’s chart; however, this is not required and not advisable from our perspective as the report could then be obtained by subpoena during litigation matters including custody, divorce, malpractice, or employment disputes and could be used out of context against the patient; thus placing the prescriber in an untenable position and possibly damaging the prescriber/patient relationship.
Prescribers are not expected to become ad hoc law enforcement agents or to investigate a patient with multiple prescriptions for covered substances from multiple providers (or perhaps too many from one provider). The provider’s own discretion and ethical obligations should guide whether and to what extent she feels she must take further action related to a concerning PMP query other than declining to prescribe a particular medication.
All dispensers and prescribers should be familiar with the state and federal guidelines pertaining to opioid prescription as well as any internal practice requirements.
The Prescription Monitoring Program is a useful tool for prescribers and should be used as such. Linden Legal Strategies PLLC can help your practice develop policies and procedures and training modules around the PMP and Opioid prescribing practices. For more information contact us: email@example.com
This article is for informational purposes only and does not constitute legal advice nor does it create an attorney-client relationship. Always consult appropriate legal counsel for specific questions related to your business. Some states may consider this attorney advertising.