Chapter 32 - State Prescription Drug Monitoring Programs

3-32.1  INTRODUCTION

1. Purpose.

   The purpose of this chapter is to establish and define participation of the Indian Health Service (IHS) with State-based Prescription Drug Monitoring Programs.

2. Authority.

   25 U.S.C. § 1680q

3. Background.

   The Prescription Drug Monitoring Programs are a tool for prescribers and pharmacists to monitor and deter prescription medication misuse, abuse, addiction, and diversion to ensure appropriate clinical care. Prescription Drug Monitoring Programs are State-based, electronic databases that collect data on controlled medications dispensed by registered pharmacies operating within the state. States often require providers to report to the State’s Prescription Drug Monitoring Program under State law. The IHS is not generally subject to State law, and accordingly, is not required by law to report to State-based Prescription Drug Monitoring Programs. However, the IHS has chosen to participate in State Prescription Drug Monitoring Programs, as outlined in this policy, under the authority set forth in 25 U.S.C. § 1680q.

   To facilitate reporting to State based Prescription Drug Monitoring Programs, the IHS uses a Memoranda of Understanding (MOU) with States to identify the authorities that allow disclosure to Prescription Drug Monitoring Programs in the absence of a signed patient release of information. For example, under regulations implementing the Health Insurance Portability and Accountability Act (HIPAA), the IHS may disclose data without patient authorization to Prescription Drug Monitoring Programs that perform public health activities or health oversight functions. Not all State Prescription Drug Monitoring Programs have been established as public health authorities. Some States have established Prescription Drug Monitoring Programs with law enforcement, rather than public health, as their primary mandate.

   The Prescription Drug Monitoring Programs established to perform public health activities and/or health oversight functions have a variety of purposes and goals that relate to the IHS mission, including:

   1. Supporting medication safety and legitimate medical access to controlled substances;
   2. Identifying individuals who may be misusing, abusing, or diverting controlled substance medications; and
   3. Helping identify individuals with potential substance use disorder and coordinating appropriate care.
      
      While the goals of Prescription Drug Monitoring Programs are similar, vast variations exist within State legislation, logistics, and program administration.
4. Scope.

   This policy encompasses Prescription Drug Monitoring Program querying and reporting requirements for all non-substance use disorder programs or providers at IHS facilities. Prescriptions issued by IHS prescribers, or dispensed by IHS providers, for medications that would identify a patient as having received or receiving Substance Use Disorder treatment may be subject to the additional requirements of 42 C.F.R. Part 2. Information that is subject to the requirements of 42 C.F.R. Part 2 is outside the scope of this policy.

5. Definitions.
   1. Delegates.  Those health care professionals who have been recognized by State legislation with authorization to receive Prescription Drug Monitoring Program access or request patient queries.
   2. Dispensers.  The entities that must submit data to the Prescription Drug Monitoring Programs for controlled drugs they have dispensed and administered. This includes pharmacies (both in and out of State), hospitals, and any prescriber-based dispensing.
   3. Prescribers.  Those clinicians who have the authority to prescribe controlled substances under State law.
   4. Memorandum of Understanding (MOU).  ). A written agreement between the IHS Area and a State-based Prescription Drug Monitoring Program that establishes the requirements for data disclosure to the State Prescription Drug Monitoring Program. Examples of Prescription Drug Monitoring Program MOUs may be obtained by contacting the IHS Principal Pharmacy Consultant.
   5. Solicited Reporting (Also known as Reactive Reporting).  ). A request from the prescriber or delegate for patient profile information from the Prescription Drug Monitoring Program.
   6. Unsolicited Reporting (Also known as Proactive Reporting).  A report generated and provided by the Prescription Drug Monitoring Program to the prescriber or dispenser of a particular patient that has exceeded dispensing thresholds established by the Prescription Drug Monitoring Program.

3-32.2  RESPONSIBILITIES

1. Area Director.  Ensures the Prescription Drug Monitoring Program MOU is current, signed, and archived as required in the terms of the MOU and as allowable by applicable authorities.
2. Clinical Director.  All Prescription Drug Monitoring Program reporting and prescriber utilization shall be a function of the medical staff under the direct oversight of the Clinical Director.
3. Pharmacy Director.  All Federal IHS pharmacy sites with an approved MOU between the IHS Area and the State in which the facility is located shall ensure that Schedule CII-CV dispensing data is reported daily, using the automated reporting functionality to ensure a complete and accurate patient record.
4. Prescriber.  The prescriber of a controlled substance prescription has the legal and ethical responsibility to ensure that all controlled substance prescriptions are issued in accordance with Federal law. Valid prescribing is for a legitimate medical purpose that includes patient assessment, a documented treatment plan, and appropriate monitoring. A Prescription Drug Monitoring Programs query is one tool to assist practitioners with assessing safe patient prescription medication use, misuse, addiction, or diversion. Prescribers must:
   1. Register with State Prescription Drug Monitoring Program;
   2. Request a solicited Prescription Drug Monitoring Program report as a normal process of accepting a new chronic pain patient. This information allows the prescriber to determine any possible drug-drug interactions with potential prescribed therapy and to assist with appropriate patient monitoring;
   3. Access Prescription Drug Monitoring Program patient data prior to patient appointments to facilitate meaningful interactions. Providers will review Prescription Drug Monitoring Program data when opioid prescriptions for acute pain exceed seven days, when progressing from acute to chronic opioid pain therapy, and periodically every three months during opioid therapy for chronic pain. Data can help prescribers to:
      1. Check for drug interactions or other harm;
      2. Check for addiction or undertreated pain;
      3. Check for misuse or multiple prescribers; and
      4. Use Prescription Drug Monitoring Program reports to verify compliance with medication safety/pain agreements;
   4. Evaluate and respond appropriately to unsolicited Prescription Drug Monitoring Program reports;
   5. Use delegate accounts where authorized. Delegates can help prescribers reduce time conducting queries. Check with the state to determine if delegates are allowed. It is recommended that a maximum of two delegate accounts per prescriber, as the prescriber is ultimately responsible for reports requested by the delegates; and
   6. Perform Prescription Drug Monitoring Program self-audits at least quarterly if functionality available through the State’s Prescription Drug Monitoring Program.
5. Pharmacist.
   1. The pharmacist shall review the patient Prescription Drug Monitoring Program report and discuss any concerns with prescribers during the following activities:
      1. Prior to processing an outside prescription for a controlled substance; and
      2. Every three months, prior to reissuing or refilling a chronic controlled substance prescription for Schedule CII-CV medications.
   2. Pharmacists may:
      1. Assist with conducting Prescription Drug Monitoring Program queries upon prescriber request; and
      2. Assist with provider interpretation of report findings as requested.