prescriber, under what circumstances am I required to request, assess and
document receipt of a patient’s PDMP prescription history?
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
must view at least the last 4 months of data (This will always be available
within a PDMP data view.)
prescriber delegate may pull the PDMP data, but the prescriber remains
responsible for assessing the data prior to making a prescribing decision.
Are there any
exceptions to the mandate for prescribers?
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
Receiving treatment in an inpatient unit of a
Part of a general hospice program*
Diagnosed with a terminal illness*
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:
* See specific FAQs for definitions of these terms
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
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
When electronic access is not operational, as
determined by the Department of Health
In the event of temporary electrical or
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.
‘terminal illness’ defined?
As defined in Maryland law (Health-General
“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.
‘surgical procedure’ defined?
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
‘significant trauma’ defined?
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
I thought the
exception was for ‘a surgical procedure in which general anesthesia was
used,’ but now the exception just says ‘surgical procedure.’ Which is
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.
What are the
prescriber documentation requirements for the PDMP Use Mandate?
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.
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.
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].
are some cases where prescribers must also document why PDMP data was not
accessed and assessed prior to making a prescribing decision. These scenarios
What are the
Use Mandate requirements for 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.
note that verifying an order is not considered dispensing.
10) Are there any documentation requirements for
pharmacists under the use mandate?
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
11) Can a prescriber or pharmacist use a delegate to
meet the use mandate requirement?
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.
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:
reasonable steps to ensure that the delegate is competent in the use of the
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
the confidentiality of PDMP data accessed by the delegate
breach of confidentiality by the delegate
12) What are the general responsibilities of a
prescriber or pharmacist who utilizes a delegate to access data on their
using a delegate, a prescriber or pharmacist is required to:
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:
notify the PDMP at firstname.lastname@example.org 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.
notify the PDMP through its IT partner, CRISP at email@example.com or 877-952-7477, of changes in that
delegate’s employment status or need for access to PDMP data.
13) Can a prescriber, pharmacist, or delegate run a
report on a patient the day before that patient’s scheduled appointment?
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.
specific FAQs for details about who can serve as a delegate and the
responsibilities of a delegator.
14) If a prescriber writes prescriptions for
buprenorphine or methadone as part of a MAT program are they exempt from the
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
42CRF 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 write 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).
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.
15) The MDH Secretary is allowed to publish a list of
drugs at low potential for abuse that may be exempted from the use mandate.
Has that happened?
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.
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.
16) What types of drugs are included in the Use Mandate
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
– narcotics like hydrocodone, oxycodone, and morphine
– 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.
17) How will the Use Mandate be enforced by the State
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.
201 W. Preston Street, Baltimore, MD 21201-2399
(410) 767-6500 or 1-877-463-3464