Beginning July 1, 2018 Maryland’s PDMP use mandate will take effect.  It requires prescribers to request and assess PDMP data:

•Before beginning a new course of treatment with an opioid or benzodiazepine

•When a course of treatment with an opioid or benzodiazepine extends beyond 90 days.  In this case, prescribers must query again at least every 90 days thereafter before prescribing or dispensing the opioid or benzodiazepine.

Prescribers must view at least the last 4 months of data (This will always be available within a PDMP data view.)

A prescriber delegate may pull the PDMP data, but the prescriber remains responsible for assessing the data prior to making a prescribing decision.

• Pharmacists licensed to practice and/or to dispense in Maryland
• Prescribers who have CDS prescriptive authority in Maryland (physicians, physician assistants, dentists, podiatrists, nurse practitioners, and advanced practice nurse midwives)
• Prescribing and dispensing in Maryland, regardless of where the patient resides

If a Maryland-licensed provider is practicing within another state, the laws and regulations of that state should be obeyed.

1. I practice in Maryland, but my patient lives in another state:  Yes, subject to mandate.
2. I have a Maryland license and a Maryland CDS license, but I practice in another state:  Yes, subject to mandate. 
3. I do not have a Maryland license and I practice in another state, but I have Maryland patients:  No, not subject to mandate.  Subject to laws and regulations in the state in which you practice.
4. I practice in Maryland at a federal facility only, but I am not licensed in Maryland:  No, not subject to the mandate, but can gain access to the PDMP.

Yes, there are exceptions.  A prescriber is NOT REQUIRED to request PDMP data if the opioid or benzodiazepine is prescribed or dispensed to an individual:

• For a period of 3 days or less (≤3 days)
• For cancer treatment or cancer-related pain
• For a patient who is

         o Receiving treatment in an inpatient unit of a hospital

         o Part of a general hospice program*

         o Diagnosed with a terminal illness*

         o Residing in a nursing home, long-term care, developmental disability, or assisted living facility

• To treat or prevent acute pain for a period of 14 days or less (<14 days) following:

          o Surgical procedure*

          o Bone Fracture

          o Significant trauma*

          o Childbirth

* See specific FAQs for definitions of these terms

There is no requirement to document in the patient chart that the PDMP data were not accessed and assessed in the clinical situations described above.

If one of the following situations applies, the provider must use reasonable medical judgment in determining whether to prescribe or dispense an opioid or benzodiazepine, and must document in the patient’s health record the reason PDMP data was not accessed.

The following scenarios would also be considered exempt from the PDMP Use Mandate:

• When accessing PDMP data would result in a delay of treatment that would negatively impact the medical condition of the patient
• When electronic access is not operational, as determined by the Department of Health
• In the event of temporary electrical or technological failure

Correctional facilities are not facilities explicitly exempted from the use mandate; therefore, the following applies to them:  There is no explicit exemption for types of in-patient units other than hospitals or exemptions for facilities that are not one of the following: nursing home, long-term care, developmental disability, or assisted living facility. If the intended supply is less than or equal to 3 days, the query mandate is not in effect. Also, many prescriptions for direct administration within various other facility settings would be exempt. If a patient leaves any facility with prescriptions, the use mandate may apply before discharge which would be a clinically important time to re-assess PDMP data prior to releasing a patient with new prescriptions.

Patients with sickle cell anemia are not excluded from the PDMP Use Mandate, unless the prescribing situation otherwise falls under one of the exemptions.  There are times when there will be exemptions to other State Program components that are different from PDMP.   

As defined in Maryland law (Health-General Article §19-901(d)):

“General hospice care program” means a coordinated, interdisciplinary program of hospice care services for meeting the special physical, psychological, spiritual, and social needs of dying individuals and their families, by providing palliative and supportive medical, nursing, and other health services through home or inpatient care during the illness and bereavement:

(1) To individuals who have no reasonable prospect of cure as estimated by a physician; and

(2) To the families of those individuals.

As defined in Maryland law (Health-General Article §21–2A–01(p)):

“Terminal illness” means a medical condition that, within reasonable medical judgment, involves a prognosis for a patient that likely will result in the patient’s death within 6 months.

A definition of Surgical Procedure has been proposed for promulgation in regulations. The intended definition reads:

Surgical Procedure means structurally altering the human body by incision or destruction of tissues, including the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transportation of live human tissue.

A definition of Significant Trauma has been proposed for promulgation in regulations. The intended definition reads:

Significant trauma means an injury that results from exposure to either a mechanical force or another extrinsic agent, including an extrinsic agent that is thermal, electrical, chemical, or radioactive, and is immediately life-threatening, or may result in death, hospitalization, disability or permanent damage, congenital anomaly or birth defect.

The original use mandate bill that was passed (HB437/Chapter 437, 2016) exempted prescribing of opioids or benzodiazepines for a surgical procedure in which general anesthesia was used. However, this year a bill passed (HB517/Chapter772, 2018) that amended this exemption and beginning July 1, 2018 the exemption will be for any surgical procedure, regardless of anesthesia use.

 

To comply with the requirements of the use mandate, in instances where query is mandated, prescribers need to document in the patient’s health record that the PDMP data was requested and assessed prior to prescribing the opioid or benzodiazepine.  If you have not received instruction from your place of employment that specific data integration in your EHR satisfies the documentation requirement, you should complete this documentation yourself.  While you may print a copy of the PDMP report for your files, there is no duty to do so as part of the PDMP use mandate.  Putting a PDF copy of the PDMP record queried does not, in and of itself, meet the requirement under the law to document that PDMP data was assessed prior to writing a prescription for an opioid or benzodiazepine.

There is no specific language expected of providers to meet the documentation requirement in the use mandate. This requirement to document that PDMP data was accessed and assessed may be accomplished through a number of mechanisms, including but not limited to check boxes or drop downs inserted in the EHR, or a provider-generated statement in the EHR or paper record.

An example of a written statement:  I have accessed and assessed PDMP data for this patient on [INSERT DATE] prior to writing the prescription for [INSERT MEDICATION].

There are some cases where prescribers must also document why PDMP data was not accessed and assessed prior to making a prescribing decision. These scenarios are:

• When accessing PDMP data would result in a delay of treatment that would negatively impact the medical condition of the patient
• When electronic access is not operational, as determined by the Department of Health
• In the event of temporary electrical or technological failure

Pharmacists are required to query the PDMP when dispensing any CDS (Schedule II – V) prescription under the following conditions:

• If a pharmacist or their delegate has a reasonable belief that a patient may be seeking to fill a prescription for a controlled dangerous substance (CDS) for any purpose other than the treatment of an existing medical condition.  In this case, the pharmacist should query the PDMP to determine if the patient has received other prescriptions that indicate misuse, abuse, or diversion of controlled dangerous substances.
• Pharmacists shall have corresponding responsibility as described in 21 CFR § 1306.04 in dispensing prescriptions for controlled dangerous substances.
• A pharmacist delegate may pull the PDMP data but the pharmacist remains the responsible party for assessing the data prior to making a dispensing decision. 

Please note that verifying an order is not considered dispensing.

There is no explicit requirement for pharmacists to document accessing and assessing the PDMP data prior to making a dispensing decision; however, pharmacists should comply with all State and federal laws and regulations, and policies governing pharmacy practice, including any documentation requirements.

Under the use mandate, a prescriber or pharmacist has a duty to access and assess the PDMP in certain prescribing and dispensing situations.  A delegate may be used to facilitate a prescriber or pharmacist’s access to the data by pulling the PDMP data. However, the prescriber or pharmacist is responsible for both reviewing the PDMP data before making a prescribing or dispensing decision and making the ultimate prescribing or dispensing decision.

          Delegator Fact Sheet and the CRISP Delegator Dashboard User Guide

          Delegate Fact Sheet and the ULP PDMP Search Guide for Delegates

Delegates can be a helpful resource to streamline a prescriber or pharmacist’s access to the PDMP data in the clinical practice workflow. A prescriber or pharmacist is responsible for the following:

• Taking reasonable steps to ensure that the delegate is competent in use of the Program
• Ensuring that access to the PDMP data by a delegate is limited to the act of pulling data on behalf of a delegating prescriber or pharmacist
• Protecting the confidentiality of PDMP data accessed by the delegate
• Any breach of confidentiality by the delegate

When using a delegate, a prescriber or pharmacist is required to:

• Make every reasonable effort to ensure the authorized licensed health care practitioner is requesting, redisclosing, or otherwise accessing PDMP data in clear compliance with the PDMP law and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records. Appropriate use of PDMP data is covered in the online PDMP training, also available for reference here: https://www.youtube.com/watch?time_continue=4&v=H8no_5Ow9VQ
• Immediately notify the PDMP at mdh.pdmp@maryland.gov or 410-402-8686 if the prescriber or dispenser believes that the delegate has compromised the confidentiality of PDMP data or security of the PDMP system. The prescriber or pharmacist must also inform the relevant health licensing board that regulates the practice of that delegate, if one exists.
• Immediately notify the PDMP through its IT partner, CRISP at support@crisphealth.org or 877-952-7477, of changes in that delegate’s employment status or need for access to PDMP data.

Yes, an authorized user may query the PDMP the day before a patient’s scheduled appointment to facilitate integration of this data review into the clinician’s workflow. It is advised that practices put in place procedures to obtain the most up-to-date PDMP data for a patient as is reasonable feasible.

See specific FAQs for details about who can serve as a delegate and the responsibilities of a delegator.

Prescribing of any opioid or benzodiazepine, regardless of the clinical indication, is subject to the conditions of the use mandate. There are separate requirements to report data to the PDMP if you dispense Schedule II-V prescriptions. In addition, some dispensing situations are exempt from the reporting requirement. If someone is dispensing methadone or buprenorphine for substance use disorder (SUD) treatment, that act of dispensing is covered by 42 CFR Part 2, the federal regulation that protects the confidentiality of drug treatment records. This type of dispensing is exempted from the REPORTING requirement (if a prescriber writes a prescription for buprenorphine and the patient takes it to a pharmacy to be filled, that prescription is no longer 42 CFR Part 2 covered, and thus is reported to the PDMP).

The requirement to ACCESS the PDMP as a clinician making the decision to prescribe an opioid or benzodiazepine is separate and distinct from any requirement to report data as a dispenser. This provider would be subject to the mandate (assuming he doesn't meet any of the exemptions) to use the PDMP like all other prescribers.

Maryland law (Health-General Article §21–2A–03(b)(3)) states that the MDH Secretary may identify and publish a list of monitored prescription drugs that have a low potential for abuse by individuals. A prescriber would not be required to query the PDMP prior to prescribing or dispensing a medication on this list.

The MDH Secretary has not identified or published such a list, and there are no plans to do so at this time. If a list is published, it will be made available on the PDMP website and notice will be made to providers.

Prescribers and pharmacists have slightly different use mandates.

For prescribers, any medication that is in the class of opioid or benzodiazepine, regardless of what Schedule it has been placed in, is subject to the use mandate.  Common medications within these affected drug classes are

• Opioids – narcotics like hydrocodone, oxycodone, and morphine
• Benzodiazepines – tranquilizers like alprazolam, diazepam, and lorazepam

You can look up the therapeutic class for any medication on the DEA’s website (https://www.dea.gov/druginfo/ds.shtml​) or utilize available medication software, like Micromedex, to check if medications you prescribe are opioids or benzodiazepines.   Scheduled drugs in other therapeutic classes, such as stimulants, are not subject to the mandate for prescribers.

For pharmacists, any Schedule II – V controlled dangerous substances (CDS) may qualify for the requirements of the use mandate.

Health profession licensing Boards that regulate a CDS prescriber or pharmacist’s practice have the authority to enforce the PDMP use mandate. Investigations into non-compliance with the use mandate will occur in the same manner as any other investigation conducted by one of these Boards. If a complaint is lodged with a Board, there is a duty to investigate said complaint. As part of the investigation, the Board may request a provider's PDMP data access records (audit log of queries made by that provider). Any action against a provider resulting from the investigation would be at the discretion of the investigating Board.

Contact the colleague to coordinate medical care, mentioning your findings in the PDMP.  If the issue persists, you can contact the health profession licensing board that regulates the colleague to begin an investigation.

No, prescribers must access Maryland’s PDMP, even if the prescriber has access to Maryland PDMP data through interstate sharing.  Maryland health profession licensing Boards have the authority to enforce the PDMP use mandate and they have the authority to subpoena Maryland’s PDMP to review prescription and audit trail records.