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Opiate Addiction - MA PMP FAQ - Includes Information on the 2014 Regulations

Massachusetts Department of Public Health, Bureau of Health Care Safety and Quality Prescription Monitoring and Drug Control Program

PMP Frequently Asked Questions December 2014 Page 1 of 5

MA PMP FAQ - Includes Information on the 2014 Regulations

What is the Massachusetts Online Prescription Monitoring Program?

The Massachusetts Online Prescription Monitoring Program (PMP) is a website, hosted by the state of Massachusetts’s Virtual Gateway. The Virtual Gateway is the secure Web portal of the Executive Office of Health and Human Services (EOHHS).

The PMP is a repository for a patient's prescription history for Schedule II – V prescriptions. The PMP shows a patient’s prescription history for the prior 12 months. Data is reported into the PMP by all MA pharmacies and by out-of-state pharmacies delivering to people in MA.

The PMP prescription history data informs clinical decision-making to help prevent or stop harm from duplicate drug therapy, prescription drug, misuse or abuse and diversion.

What do I need to do to enroll in the MA Online PMP?

Physicians, dentists and podiatrists have been automatically enrolled in the PMP since January 1, 2013. The Massachusetts Department of Public Health’s (the Department), Drug Control Program (DCP) automatically enrolls these providers when they obtain a new Massachusetts Controlled Substance Registration (MCSR) or have their existing MCSR recalled (renewed).

If you are a physician, dentist or podiatrist and you have either received a new MCSR or have recalled your existing MCSR since January 1, 2013, you have been automatically enrolled in the PMP. If you are due to have a new MCSR or recall your existing MCSR in 2015, you have not been automatically enrolled in the PMP.

If you are a physician, dentist or podiatrist and you volunteered to enroll in the PMP, then you are already enrolled.

Beginning on January 1, 2015, the DCP will begin automatically enrolling advanced practice nurses and physician assistants as participants in the PMP. This will be done when they obtain a new MCSR or renew their MCSR.

What does it mean to be "automatically enrolled" in the PMP?

? Currently, the MCSR recall (renewal) forms that are sent to physicians, dentists and podiatrists include instructions for the PMP automatic enrollment process. Starting on January 1, 2015, MCSR renewal forms that are sent to advance practice nurses and physician assistants will include instructions for the PMP automatic enrollment process.

Physicians, dentists and podiatrists applying for a new MCSR must use the revised application form located on the DCP Website at:

Massachusetts Department of Public Health, Bureau of Health Care Safety and Quality Prescription Monitoring and Drug Control Program

PMP Frequently Asked Questions December 2014 Page

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http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug-control/ma-online-prescription-monitoring-program/.

Old versions of the blank application forms can no longer be processed and will be returned to the applicant. Please discard any old versions of the application forms. A revised MCSR application form for new advanced practice nurses and physician assistants is being developed.

? All MCSR applicants (new and recalled or renewed) must complete the application form and sign that the information submitted is correct and that they will abide by the

Terms and Conditions for Prescriber and Dispenser use of the Massachusetts Online Prescription Monitoring Program.

? After the MCSR certificate is issued, and as the PMP application is processed, the DCP begins the process for prescribers to obtain login credentials for the EOHHS Virtual Gateway. Typically, within 2-3 weeks of issuing the MCSR certificate, prescribers are sent an email message with their password and with instructions for using the MA Online PMP.

What if my MCSR registration is not due to be recalled or renewed now?

Any prescriber who does not have access to the PMP can download and submit a PMP Enrollment form. MCSR registrants may enroll at any time regardless of when their MCSR is due to be recalled or renewed. This does not affect the date of the MCSR recall or renewal. There is no fee charged for enrolling in the PMP.

What do pharmacists need to know about enrollment in the MA Online PMP?

Although pharmacist enrollment remains voluntary, the new legislation requires pharmacists to obtain continuing education on use of the PMP. More information concerning continuing education resources for pharmacists will be available after January 31, 2013.

Are veterinarians automatically enrolled in the MA Online PMP?

No. Veterinarians are excluded from PMP enrollment. Veterinarians applying for a new MCSR need to download the separate MCSR application form for a veterinarian which does not provide instructions for PMP enrollment.

What do prescribers and dispensers need to know about requirements for using the MA Online PMP?

On November 12, 2014, the Massachusetts Public Health Council (PHC) approved amendments to regulations at 105 CMR 700.000. These regulations regard the utilization of the PMP. The regulations will be posted on the DCP website when they have been published by the Secretary of State.

Massachusetts Department of Public Health, Bureau of Health Care Safety and Quality Prescription Monitoring and Drug Control Program

PMP Frequently Asked Questions December 2014 Page

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What if I do not prescribe any Schedule II-V controlled substances?

Optometrists and other prescribers who elect to limit their prescribing to Schedule VI prescription drug products will be automatically enrolled in the MA Online PMP.

What happens if I do not want to be automatically enrolled in the MA Online PMP? Can I opt out of participating?

No, enrollment and utilization of the PMP is mandated in statute. There are no provisions for prescribers in MA to opt out of the automatic enrollment in the PMP.

What happens if I cannot log in to the MA Online PMP?

? The PMP is controlled by the EOHHS Virtual Gateway (VG). This gateway provides the general public, medical providers, community-based organizations and EOHHS staff with a single resource for technology applications.

? For assistance with logging in to the EOHHS Virtual Gateway, please visit

www.mass.gov/vg/loginassistance.

? Virtual Gateway customer service is available M

Monday - Friday from 8:30 AM to 5:00 PM. The EOHHS Virtual gateway phone number is 800-421-0983 (Voice) and 617-0847-6578 (TTY for the deaf and hard of hearing).

Where do I call for technical assistance with the PMP?

If you need PMP technical assistance, you can contact the DCP at 617-983-6700.

Is there anything that explains the prescription data?

Yes. You can refer to the

Prescriber Guide to Interpreting Prescription Monitoring Program Data, which can be found at: www.mass.gov/dph/dcp/onlinepmp.

Are they any "how-to" instructions for using the MA Online PMP?

The DCP is in the process of making short "how-to" videos. These will be uploaded to the MA Online PMP webpage as soon as they become available. Additional "quick reference" guides will also be available for download from the DCP website.

Massachusetts Department of Public Health, Bureau of Health Care Safety and Quality Prescription Monitoring and Drug Control Program

PMP Frequently Asked Questions December 2014 Page

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Under what authority does the DCP allow the use of delegates?

According to M.G.L. Chapter 94C §24A (a)(2)(c): "regulations may also specify the circumstances under which support staff may use the prescription monitoring program on behalf of a registered participant."

Who is a PMP "participant"? Who is a "delegate"

? A participant is a person who is duly authorized to prescribe or dispense a controlled substance. They are authorized by the appropriate Massachusetts Board of Registration or are authorized by the Department to utilize the PMP.

?

Participants include pharmacists and physicians, dentists, podiatrists, advance practice nurses, physician assistants and other prescribers who are enrolled to utilize the PMP.

? Participants who allow a delegate to use the PMP on their behalf are "primary account holders".   For residents and interns, policies and procedures for a delegate classification will be established. Residents and interns may issue prescriptions for controlled substance drug products according to state and federal regulations but are not registered by a Massachusetts Board of Registration.

How will delegates be enrolled in the MA Online PMP?

DPH is required by law to maintain policies and procedures to ensure the privacy and confidentiality of patient data. This includes patient information that is collected, recorded, transmitted and maintained by the PMP. This ensures the privacy and confidentiality of over 50 million prescription records.

Comprehensive policies and procedures for credentialing PMP participants and delegates are essential. The policies and procedures for delegates, including the delegate application form and the Terms and Conditions for delegates and primary account holders are currently being drafted.

The Department is not considering limiting the number of delegates per participant as is done in many states. Nor is the Department considering restricting a delegate to one primary account holder. The DCP will post the delegate and primary account holder policies, procedures and applications to the DCP website after December 15, 2014.

When do I have to utilize the MA PMP?

A registered individual practitioner who possesses a current and valid MCSR must utilize the PMP prior to prescribing, to a patent for the first time, a narcotic prescription drug in Schedule II or III or a prescription drug containing a benzodiazepine.

Massachusetts Department of Public Health, Bureau of Health Care Safety and Quality Prescription Monitoring and Drug Control Program

PMP Frequently Asked Questions December 2014 Page

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What is meant by "to a patient for the first time?"

This describes the patient-and-provider encounter when (a) the patient has not received a narcotic prescription drug in Schedule II or III or a prescription drug containing a benzodiazepine from the registered individual practitioner or (b) when the patient has not received a narcotic prescription drug in Schedule II or III or a prescription drug containing a benzodiazepine from another authorized prescriber who belongs to the same group practice (i.e. multiple provider practice, hospital or clinic) within the previous 12 months.

Are there exceptions to the required utilization requirement?

Yes there are exceptions to required use of the MA PMP prior to prescribing. The exceptions are listed in regulations at 105 CMR 700.012(H)(3).

What about the drugs that are determined by the Department to be commonly misused or abused?

The Department will create an advisory group in the coming months. This advisory group will help determine what other drugs in Schedules II or III merit additional safeguards. These safeguards can include that the Department should require prescribers to utilize the MA Online PMP each time they prescribe these prescription drugs. Any prescription drug so identified will go through the standard process for promulgating and publishing regulations. This process will ensure that registrants have notification of what drugs require additional utilization of the MA Online PMP.

For additional questions, please contact the MA DPH Prescription Monitoring and Drug Control Program at:

99 Chauncy Street Boston, MA 02111 phone: 617-983-6700 email:
dcp.dph@state.ma.us website: www.mass.gov/dph/dcp
 
                                              PART 2
 

Commonwealth of Massachusetts, Department of Public Health

Drug Control Program

Prescription Monitoring Program

99 Chauncy Street, Boston, MA 02111                  Telephone 617 983-6700

Prescriber Guide to Interpreting Prescription Monitoring Program Data

This guide is designed to assist prescribers in understanding the scope and limitations of the patient prescription history reports and electronic alerts of the Massachusetts Online Prescription Monitoring Program (MA Online PMP). Developed in consultation with pain and addiction specialists, it provides guidance in treating all patients including those for whom prescribers may have concern. It is important to note that, whether in the context of an electronic alert or a routine patient prescription history lookup, this guide does not mandate any particular action on the part of the prescriber.

About the MA Online PMP

The MA Online PMP is a secure website that can be utilized by authorized providers to retrieve the most recent twelve months’ of Schedule II - V dispensed prescription histories on their patients. It is a tool that supports safe prescribing and dispensing and assists in addressing prescription drug misuse and abuse. Use of MA PMP by prescribers can enable the early identification of behaviors suggestive of drug misuse, abuse or diversion and trigger early intervention. By viewing a patient’s prescription history, a provider can avoid duplication of drug therapy or possible drug interactions, and coordinate care by communicating with other providers to improve clinical outcomes and overall patient health.

Unsolicited Report Alerts

Email alerts are sent to MA Online PMP enrolled prescribers when any patients with prescriptions records associated with their Drug Enforcement Administration (DEA) registration number are identified as exceeding specified thresholds for prescriptions from multiple prescribers and dispensers. Unsolicited reports are designed to help prescribers assess whether a patient’s prescription history indicates possible drug misuse, abuse or diversion.

An alert message contains a computer generated case ID number that the prescriber enters into a specified field in the MA Online PMP. Entering the case ID enables the prescriber to retrieve the patient’s prescription records – referred to as the Unsolicited Report - that triggered the alert. The case ID retrieves the prescription profile as it appeared when the alert was generated. To get an accurate prescription history for the same patient at a later point in time (when additional prescriptions may have been loaded into the PMP), the prescriber should search for the patient using the first name, last name, and date of birth that appeared on the unsolicited report. MDPH does not require a provider to take any action that he or she believes to be contrary to a patient’s best interests.

It is important to understand that the MA PMP does not send any confidential information in the alert email message. And the MA PMP likewise instructs alert recipients to not send email correspondence containing confidential information. Since the case ID included in the email alert is a non-confidential computer generated number, that number can be sent to the PMP to expedite correspondence.

Prescriber Guide – Rev. 20130710-01

Limitations of PMP data

PMP reports contain data reported by pharmacies and may have limitations (e.g., spelling or keying errors, missing information) or inconsistent information (e.g., use of nicknames).

Therefore, it may be necessary to verify the accuracy of the information in the prescription history with other prescribers and/or dispensers listed before taking clinical action. The MA Online PMP database includes Schedule II-V prescription records for the most recent 12 months. In general, it takes up to two to three weeks between dispensing of a prescription and its inclusion in the Online PMP. Please refer to the MA Online PMP splash page for any current advisories regarding PMP data.

Assessment

The PMP report should be interpreted in the context of a complete patient assessment, not in isolation. As a first step, review reports and records: ?

Review and verify PMP prescription history for possible inaccuracies.

Review prior medical record if available.

Other elements of a complete patient assessment may focus on pain, sleep disorders, anxiety, and/or depression:
 
Evaluation of pain in addition to general history (including location, character, severity, effect on work, sleep daily activities).  
 
Physical examination and documentation (including painful area and nervous
system with focus on sensory function).

Psychosocial Evaluation (including how pain is impacting relationships and family, signs of depression, anxiety, suicidal thoughts). Validate and document justifications for chronic opioid therapy (benefits are outweighing risks; patient is compliant).

Informed consent including benefits and risks and reasons for discontinuing

opioid therapy. History of risk factors for prescription drug abuse, such as history of substance abuse or mental health issues in patient or family.

Patient Provider Agreement including patient responsibilities to avoid improper

use, policies on lost medication, refills, use of urine drug screens, education about safe storage and disposal and provider responsibility to treat patient with respect, answer questions and provide means to reach him or her in case of emergency.

Individualized written treatment plan including functional goals. 

Consultation with specialists when indicated.

Review of outside medical records or contacting other providers.

Interviews with “significant others” (spouses, family, employers, etc.).

Periodic review of treatment goals.

Prescriber Guide – Rev. 20130710-01

Addressing concerns about prescription activity

Listed below are some options for action in response to possible concerns about the patient’s prescription activity.

Discuss with patient: The first clinical step in response to potential concerns raised by a PMP report is generally to discuss them with the patient. This can include
 
Attempts to determine the causes of the observed behavior, for example:
 
administrative (changed doctor, etc.)

under-treatment of symptoms, e.g., pain, anxiety

misunderstanding of the rules of treatment

prescription drug abuse

criminal behavior (e.g. theft of doses by family member or guest, prescription drug rings, forgery, dealing, etc.)
?
Administration of a Brief Intervention, a 1-2 minute talk with the patient to:
express concern over the pattern of behavior; discuss how drug abuse begins and emphasize its negative consequences (on health, employment, finances, friends and family, etc.); and clarify expectations (e.g., receiving controlled medications from only one prescriber, using one pharmacy). See http://www.samhsa.gov/prevention/sbirt/ for resources on interventions

Physical examination for drug abuse (e.g. track marks, skin lesions, nasal septal damage). Increase the intensity of patient monitoring (e.g., urine toxicology, pill counts and early refills) and establish limits on refills or lost medications. For example, a Patient Provider Agreement (e.g., narcotic contract) noted previously under Assessment is widely believed to support patient-clinician communication, see

http://www.ncbi.nlm.nih.gov/books/NBK92049/#ch5.s8 for further information.

For persistent non-compliance, options include one or more of the following:

Tapering drug therapy over several weeks to avoid withdrawal; consider incorporating non-opioid pain treatments.
Referring to specialists, e.g., pain specialist, for evaluation of continued controlled substance prescribing.
Referring to addiction management (see Resources below).

Additional Considerations

It is desirable for patients with addictive disorders and/or complex chronic pain problems to maintain a relationship with a primary care provider, even if the management of the pain and/or addiction will be conducted primarily by specialists.

Discontinuation of the patient relationship may be required when (1) patients are excessively disruptive or unable to comply with office policies; (2) frank criminal behavior precludes a working relationship. However, it is important to attempt to maintain continuity of care or management for patients upon discontinuation. Referral to other providers with appropriate experience and capabilities is strongly encouraged.

Prescriber Guide – Rev. 20130710-01

There is no requirement for the provider to take action that he or she believes to be contrary to the patient’s best interests. Abrupt cessation of drug use may precipitate serious withdrawal syndromes (e.g., seizures in the case of benzodiazepines).
If the provider believes that a crime has been committed, such as misrepresenting oneself to obtain controlled substance prescriptions, it is the right of the provider or staff to contact law enforcement and/or other providers. In criminal matters HIPAA restrictions generally do not apply. Legal input in difficult cases may be helpful.

Additional Resources

MA Online Prescription Monitoring Program: www.mass.gov/dph/dcp/onlinepmp

Directory of treatment programs: http://db.state.ma.us/dph/bsas/search.asp.

Responsible Opioid Prescribing – A Clinician’s Guide, Second Edition, by Scott M.

Fishman, MD, CME accredited by Federation of State Medical Boards, Waterford Life

Sciences, 2012. URL:

http://www.fsmb.org/book/ (link to Federation of State Medical

Boards recommendation)

MA Board of Registration in Medicine (BORIM) regulations regarding termination
of patient relationship:

http://www.mass.gov/eohhs/gov/departments/borim/.:

BORIM Phone: 781-876-8200

Mass State Police, Narcotic Section Phone: 781-659-9842.
 
                                      Part 3
 
from   http://jada.ada.org     August 2013
 

Combining ibuprofen and acetaminophen

for acute pain management after

third-molar extractions

Translating clinical research to dental practice
 
ABBREVIATION KEY.
APAP: Acetaminophen, or N-acetyl-p-aminophenol. COX: Cyclooxygenase. FDA:
Food and Drug Administration. NNT: Number needed to treat. NSAID: Nonsteroidal
anti-inflammatory drug. OTC: Over the counter. prn: As needed. q: Every. RCT:
Randomized controlled trial.

 
Paul A. Moore, DMD, PhD, MPH; Elliot V. Hersh, DMD, MS, PhD
The strategy of combining two analgesic agents having distinct mechanisms or sites
of action, such as combining a peripherally acting analgesic with a centrally acting analgesic, has
been advocated for many years. 1-4 A common example is the analgesic formulation containing acetaminophen,or N-acetyl-p-aminophenol (APAP), combined with the opioid hydrocodone (for example, Vicodin [Abbott Laboratories, Abbott Park, Ill.] or Lorcet [UCB, Atlanta]). This
combination is the most frequently prescribed drug in the United States. 5 Analgesic formulations containing an opioid and a peripherally acting analgesic consistently provide greater pain relief than
do the component agents when administered alone. 3,4,6-9 In a Cochrane systematic
review of 20 high-quality clinical trials, investigators also confirmed the additive pain relief that occurs
when combining the opioid oxycodone with APAP. 10 Including an opioid as part of an analgesic combination formulation, however, increases the risk of patients’ experiencing adverse effects
such as nausea, vomiting and psychomotor impairment; restricts the use of central nervous system
depressants; and carries significant risk of experiencing drug misuse and abuse. 2,3,11,12 Alternative combination analgesics that do not contain opioids have been
advocated as a means for avoiding the potential adverse reactions associated with opioids.
Combinations of diclofenac or ketoprofen and APAP have been evaluated, and investigators
have advocated their use for many years. 13,14 An example of a fixed-dose analgesic combination
that does not contain an opioid is the formulation of ibuprofen with APAP (Maxigesic) that
has been marketed within the past five years in New Zealand by AFT Pharmaceuticals (Auckland,
New Zealand). 15


 
 

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