A. When the Legislature enacted the law requiring the Board to implement the program it stated that the collected data could be used for the identification of:

(1) individuals receiving prescriptions for controlled substances from prescribers who subsequently obtain controlled substances from dispensers in quantities or with a frequency inconsistent with generally recognized standards of use for those controlled substances, including standards accepted by national and international pain management associations; and

(2) individuals presenting forged or otherwise false or altered prescriptions for controlled substances to dispensers.

So, the purpose of the PMP is to identify individuals engaged in “doctor-shopping”. The Board encourages pharmacists and prescribers who identify such patients to help them get the help that they need to deal with either chronic, under-treated pain or chemical dependency.

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Reporting/Frequency of Reporting

Q. Which controlled substance prescriptions must be reported to the PMP?

A. Pharmacies licensed and located in Minnesota must report to the MN PMP all schedule II, III and IV controlled substance prescriptions that they dispense. This includes prescriptions for those drugs in federal schedule V that are schedule III in Minnesota. (Click here for a list of such drugs.) All such prescriptions must be reported, including those dispensed for non-Minnesota residents or mailed/shipped out of state.

Out of state pharmacies must report to the MN PMP all schedule II, III, and IV controlled substance prescriptions that they deliver, ship or mail into the state of Minnesota. This includes prescriptions for those drugs in federal schedule V that are schedule III in Minnesota. (Click here for a list of such drugs.) However, when a MN resident actually goes to another state and physically picks up the prescription(s) in that state, that prescription technically is not dispensed in MN and is not to be reported to the MN PMP.

Q. Are there any types of patients for whom reporting of controlled substance prescriptions is not required?

A. Yes. The law states that a dispenser is not required to submit data for those controlled substance prescriptions dispensed for:

(1) individuals residing in licensed skilled nursing or intermediate care facilities;

(2) individuals receiving assisted living services under chapter 144G or through a medical assistance home and community-based waiver;

(3) individuals receiving medication intravenously;

(4) individuals receiving hospice and other palliative or end-of-life care; and

(5) individuals receiving services from a home care provider regulated under chapter 144A.

Pharmacies that only dispense controlled substances for these types of patients can notify the Board and ask to be entirely exempted from the reporting requirement. Pharmacies that serve these types of patients but that also dispense controlled substance prescriptions to “regular”, ambulatory outpatients must report to the PMP, but may exclude the prescriptions dispensed to patients that are in one of the above-mentioned categories.

Q. Are Methadone clinics required to submit data to the PMP?

A. Federal Regulations 42 CFR Part 2 concerns the confidentiality of alcohol and drug abuse treatment records and 42 CFR 2.1 states:

"Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section.”

Since 42 CFR 2.1 subsection (b) does not mention that disclosure to prescription monitoring programs is authorized, the Minnesota Board of Pharmacy has determined that if methadone is dispensed for the treatment of addiction, the OTP can not disclose it to the MN PMP. However, if the methadone is dispensed for the treatment of pain, it is to be reported to the PMP.

In addition, nothing in 42 CFR Part 2 would prevent a physician or pharmacist working for an OTP from registering for access to the PMP and nothing would prevent a physician or pharmacist working for an OTP from requesting patient profiles from the PMP.

Q. Does a practitioner who administers a drug to a patient in a clinic, emergency room or other outpatient facility have to report the administration of a drug to the PMP? (For example, the IM injection of meperidine for a patient treated for pain in an emergency room).

A. No. The administration of a drug does not have to be reported to the PMP. The law states that “dispensing does not include the direct administering of a controlled substance to a patient by a licensed health care professional”. Only those drugs dispensed to the patient (i.e. given to the patient to take home for later use) must be reported to the PMP.

Q. How frequently must data be submitted to the program?

A. Daily. However, the Board may grant permission for dispensers to report less frequently if they only occasionally dispense controlled substance prescriptions or if they have some other valid reason.

Q. We only dispense outpatient prescriptions from our ER in an emergency situation and rarely dispense controlled meds. How do I obtain a waiver in order to not have to upload prescription information daily?

A. The “Request for Weekly Reporting” form is provided for you on the PMP web site at: http://www.pmp.pharmacy.state.mn.us

Q. Where can I get exemption forms (weekly, manual, exemption from reporting)?

A. These forms are available on the PMP website at: http://www.pmp.pharmacy.state.mn.us

Q. I have a pharmacy or am a dispensing practitioner but I never dispense controlled substances or do so only rarely. Do I still need to report?

A. A pharmacy or dispensing practitioner that never dispenses controlled substances can request permission from the Board to be entirely exempt from the reporting requirement. Those that dispense controlled substances only occasionally do need to report. However, they can submit “zero-claim” reports for periods during which they have not dispensed any controlled substance prescriptions.

Q. What options are available for the reporting of data?

A. Secure FTP over SSH, PGP encrypted files sent via simple FTP, upload via SSL Web site, and physical media (tape, diskette, CD, DVD). All of these methods must adhere to the American Society for Automation in Pharmacy (ASAP) 2007 standard. If an automated recordkeeping system capable of producing an electronic report in the ASAP format is not available, dispensers may submit prescription information via paper submission using a specially provided form.

Q. It would appear the only patients we would need to report data for are the occasional discharge prescriptions we might do on a weekend or holiday for post surgical patients. Our ER fills prescriptions through InstyMeds when local retail pharmacies are closed. Our hospital only deals with our attached LTC, inpatient and hospice patients. Are we exempt from reporting?

A. You do not need to report the controlled substance prescriptions that you dispense for patients in Long Term Care (LTC) facilities, inpatients or hospice patients. While the law does not explicitly exempt discharge prescriptions from the reporting requirement, the Board will not require hospitals to report discharge controlled substance prescriptions (i.e. prescriptions dispensed to patients upon their discharge after an inpatient hospitalization).

As for InstyMeds and any similar device, nothing in the law exempts controlled substance prescriptions that are dispensed from emergency rooms (or urgent care facilities) from being reported – no matter how they are dispensed. To the contrary, a provision which would have exempted prescriptions that contained less than a 48 hour supply of a controlled substance (and which were written with ER dispensing in mind) was removed from the law. The legislators were made aware of data indicating that "doctor shoppers" get a good portion of their drugs from visiting multiple ERs.

So someone is going to have to report the controlled substances dispensed from Emergency Rooms (and Urgent Care facilities) - whether they are dispensed from InstyMeds machines, or as "pre-packs" or "starter packs" or in some other way dispensed. The Board has always considered dispensing from InstyMeds machines (or any similar device) to be a type of prescriber dispensing. For InstyMeds machines (or any similar device), the prescriber who writes each prescription is also the dispenser - not the company that sells the machines. The Board would have no problem with ER staff (or other hospital staff) doing the reporting on behalf of the prescribers. The company that sells the machines could also report the dispensing - but only as an agent of the prescriber. It is never appropriate for the company that sells the machines to indicate, for any purpose, that it is the dispenser of the drugs vended from the machines. For the purposes of reporting to the PMP only the facility in which the machine is located should be listed in the prescriber field.

Q. Our facility is a small, critical-access hospital. Most outpatient controlled substance dispensing is for patients seen in our emergency room. The controlled substances are supplied as "pre-packs" or "starter packs" that are given to patients by the prescriber. Does such dispensing have to be reported?

A. Yes. Nothing in the law exempts controlled substance prescriptions that are dispensed from emergency rooms from being reported. To the contrary, a provision which would have exempted prescriptions that contained less than a 48 hour supply of a controlled substance (and which were written with ER dispensing in mind) was removed from the law. The legislators were made aware of data indicating that "doctor shoppers" get a good portion of their drugs from visiting multiple ERs.

So someone is going to have to report the controlled substances dispensed from Emergency Rooms - even when they are dispensed as "pre-packs" or "starter packs". In this scenario, the prescriber is actually also the dispenser - since this is a form of prescriber dispensing. For the purposes of reporting to the PMP only, the facility should be listed in the prescriber field.

Q. I am assuming that the reporting requirement means prescriptions that are dispensed on an outpatient basis; I hope this does not mean CII –IV meds given to inpatients in the hospital?

A. That is correct - only prescriptions dispensed on an outpatient basis need to be reported. Dispensing for hospital inpatients is specifically exempted from the law's reporting requirement.

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Accessing The PMP for Reporting

Q. How do I get a User name and Password for reporting to the PMP?

A. To log into the web site for reporting dispensed prescriptions, you will need a User name and a password. (Please note: The Board of Pharmacy does not send out your User name and password.) You will create your User name and password when you go through the steps for “Creating Your Account” as outlined in the Dispenser’s Implementation Guide. Note: if you do not have a Dispenser’s Implementation Guide, please download it from the “Forms and Documents” section of the PMP web site at http://www.pmp.pharmacy.state.mn.us.

For lost passwords, password changes or other technical questions, please contact the Health Information Designs (HID) Help desk at 1-866-792-3149.

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Dispensing for Animals

Q. Can you provide clarification regarding the reporting of controlled substances that are dispensed for pets or other animals?

A. The guidance contained in the dispenser’s Implementation Guide (v2.4) has been updated to state that when the recipient of the controlled substance is an animal, the following information is to be reported:

a. First name - animal's name

b. Last name - owner's last name

c. DOB - animal's DOB, if known. (Provide best estimate of DOB if exact DOB is not known)

d. Gender - animal's gender

e. Address - owner's address

Therefore, the prescription will indicate that the controlled substance has been dispensed to the animal, not to the owner of the animal.

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Inappropriate Prescribing

Q. Will the data maintained in the PMP database be used to identify “inappropriate” prescribing by practitioners?

A. No. The law contains the following two clauses:

(1) No permissible user identified under subdivision 6 may access the database for the sole purpose of identifying prescribers of controlled substances for unusual or excessive prescribing patterns without a valid search warrant or court order.

(2) No personnel of a state or federal occupational licensing board or agency may access the database for the purpose of obtaining information to be used to initiate or substantiate a disciplinary action against a prescriber.

In addition, the law also contains this language (emphasis added):

(1) Treatment of intractable pain. This section is not intended to limit or interfere with the legitimate prescribing of controlled substances for pain. No prescriber shall be subject to disciplinary action by a health-related licensing board for prescribing a controlled substance according to the provisions of section 152.125.

Finally, the Board is prohibited from releasing the name of a prescriber without the written consent of the prescriber or a valid search warrant or court order. Consequently, the boards that license prescribers will not have access to the program’s database.

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Legal Implications/Requirements

Q. Are pharmacists and prescribers required to use the database before issuing or dispensing prescriptions for controlled substances?

A. No. The law states that nothing “in this section shall require a pharmacist, prescriber, or other dispenser to obtain information about a patient from the program”.

Q. Are there any legal protections for dispensers who report data to the PMP and users who request patient profiles?

A. Yes. The law states that a “pharmacist, prescriber, or other dispenser making a report to the program in good faith under this section is immune from any civil, criminal, or administrative liability, which might otherwise be incurred or imposed as a result of the report, or on the basis that the pharmacist or prescriber did or did not seek or obtain or use information from the program”. It further states that “the pharmacist, prescriber, or other dispenser, if acting in good faith, is immune from any civil, criminal, or administrative liability that might otherwise be incurred or imposed for requesting, receiving, or using information from the program”.

Pharmacists and prescribers should note that they can request profiles only for those patients that they are currently treating and only if they are considering the prescribing or dispensing of a controlled substance. Pharmacists and prescribers must not look up the profiles of anyone that they are not currently treating.

Q. How long is prescription data maintained in the database?

A. By law, prescription data may be kept in the active database for no longer than 12 months.

Q. Do I have to notify customers that their prescription information is being reported to the PMP?

A. Yes. Minnesota Statutes Section 152.126 required pharmacies to begin reporting controlled substance (CII – CIV and the other C5 controlled substances classified as CIII under MN law) prescriptions to the Minnesota Prescription Monitoring Program (PMP) by January 4, 2010 and to post a "conspicuous notice” of reporting to the PMP database. The law doesn't specifically address how the notice must be given or provide specific wording to be included in the notice. It would seem that a conspicuously placed sign(s) in the patient area(s) would be the easiest way for a pharmacy (or other dispenser) to provide this required notice.

Example Signage - "Conspicuous Notice"

Other options for the pharmacy or dispensing agency could include the following:

(1) Print a "conspicuous" notice on the receipt for the controlled substance prescription

(2) Verbally tell patients about the reporting when they pick up prescriptions

(3) Put a sticker with a "conspicuous" notice on the prescription bottle/package

(4) Include a separate piece of paper with a "conspicuous" notice with the prescription when it is mailed out

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Display of Prescriber’s name in the PMP database

Q. I’m a prescriber completing the request form for access to the Prescription Monitoring Program (PMP). Should I check the box to allow my name to be displayed in the patient profile reports?

A. The law that created the PMP contains a provision that “The board shall not release the name of a prescriber without the written consent of the prescriber or a valid search warrant or court order.” Therefore, unless the PMP office receives permission from the prescriber for his/her name to be displayed, the controlled substance patient profile reports that prescribers and pharmacists can access through the PMP can’t include the name of a prescriber. Consequently, a prescriber or pharmacist who accesses a controlled substance patient profile may not know who prescribed each of the prescriptions listed on the profile, making it more difficult to make an assessment about whether or not the patient might be engaging in inappropriate drug-seeking behavior. Also, without knowing the name of the prescriber, it will be more difficult for prescribers and pharmacists to communicate with one another when drug-seeking behavior is suspected. Other states with PMPs display the names of the prescribers for the reasons provided above.

Q. I (a pharmacist) recently queried two patients that are exhibiting narcotic drug seeking behavior. I can't contact the prescriber (the PMP patient profile report says “permission has not been received to display prescriber's name”), so what do you suggest I do with the information?

A. The enabling legislation (M.S. 152.126) for the Prescription Monitoring Program (PMP) does not allow the PMP patient profile reports to display the prescriber's name unless permission has been received from the prescriber to do so. The PMP has already received more than 1000 applications for access from prescribers; however, since we are still in the very early stages of the PMP, that 1000 prescribers still represents a small percentage of all prescribers. Therefore, the names of most prescribers cannot be displayed at this time. (Please note that the vast majority of prescribers signing up for the PMP are indicating that we can display their names on the PMP patient profile reports.)

If you are filling a prescription for a patient, you would know the prescriber’s name. Our understanding of the HIPAA regulations is that since you are part of the medical team providing care to this patient, you could certainly call the prescriber to discuss concerns about the patient.

If the patient is receiving controlled substances at another pharmacy, you would not know the prescriber’s name; however, you would know the name of the pharmacy and could call that pharmacy to let them know that there are concerns regarding this patient. Then, that pharmacy could call the prescriber to let him or her know about the concerns about the patient’s history of receiving controlled substances.

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Access to the information in the PMP database

Q. I would like to be able to access the information about my prescriptions that have been reported to the Prescription Monitoring Program (PMP). How do I request this information?

A. Individuals may request information from the MN Prescription Monitoring Program (PMP) relating to their personal controlled substance prescription history. Forms and instructions for making such a request are found on the PMP website at: http://www.pmp.pharmacy.state.mn.us. Click on “Other Forms and Documents” and then also click on “Individual Request for Controlled Substance Prescription History Report”. Please note, access to the information in this database needs to be strictly safeguarded. Therefore, at this time, the PMP Office is requiring that individuals requesting this information must appear in person and provide appropriate identification.

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What information is requested on the RxSentry PMP Access Request Form?

Q. Why are you asking for the date of birth on the RxSentry Access Request form?

We appreciate your concerns about data privacy and share those same concerns. As a result, we have worked hard to develop forms and processes that provide for adequate assurance against identity theft and protection of the Prescription Monitoring Program (PMP) database while still providing qualified individuals with access to this information.

We ask for your first name, last name, date of birth, license number, notarization by a notary public (and DEA number if you are a prescriber) as a means of verifying that someone else is not applying for access to the PMP under your identity. (Please note that we do not ask for your social security number.) When we receive applications for access to the RxSentry PMP database, we verify that the name, date of birth and license number provided on the form match the information maintained by the respective licensing board and that the applicant is licensed and in good standing with their licensing board.

If the information does not match, we send the form back to the applicant and ask for the corrected information.

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PMP Query Tips

Q. I am attempting to pull up a profile on a patient whose last name begins with St. I know that this patient has received prescriptions for controlled substances, but no results show up in my query. Could you help?

A. Pharmacies use different formats for reporting patient addresses (e.g. 401egrantst vs. 401 E. Grant St.), patients change their addresses, patient names may have been entered incorrectly and pharmacies are not always consistent in how they report abbreviations.

Therefore, when submitting a query to the RxSentry PMP database, you are encouraged to follow these tips:

1. Enter the last name (Note: if the last name is a two part name e.g. “St. Peter”, submit the query once as “St. Peter” (including the period) and submit the query again as “St Peter” (without the period). If you think that the person may have used an alternate spelling of their last name, run the query a second time with the alternate spelling of the last name or use the “Begins with” or “Sounds like” option shown on the screen.

2. Enter part of the first name (e.g. if you enter only the “T”, the computer will search for T. Jones, Tom Jones, and Thomas Jones.)

3. Enter the “Target DOB” (birth date), but also click on the down arrow next to the “Within” box to indicate that you want to search on a two year time period before or after the target date of birth.

4. Do not enter a street address unless you are positive that you know the patient’s address. (If you enter a street address and the patient has moved, your query results will only include the prescriptions for the listed address and will not include the prescriptions for any other addresses for the patient.)

For more detailed instructions on completing a patient profile query, please see the “RxSentry Query and Reports Tutorial” link on the main menu.

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Last Updated 7/22/2010-JK

MN Prescription Monitoring Program | 2829 University Ave SE, Suite 530 | Minneapolis, MN 55414 Voice: 651/201-2836 | Fax: 651/201-2837