14-118 C.M.R. ch. 11, § 5 - Prescription Monitoring Program Requirements

A. Requirement to Register as PMP Data Requesters

1. Prescribers

All prescribers are required to register as data requesters with the Maine Prescription Monitoring Program.

2. Dispensers

All dispensers are required to register as data requesters with the Maine Prescription Monitoring Program.

3. Veterinarians

All veterinarians are required to register as data requesters with the Maine Prescription Monitoring Program.

B. Electronic Prescribing and Processing Requirements

1. Requirements for Prescribers

Prescribers must comply with the requirements regarding electronic prescription of opioids and waivers as set forth in:

32 MRSA §2210(3)

32 MRSA §2600-C(3)

32 MRSA §3300-F(3)

32 MRSA §4878(2)

32 MRSA §18308(3)

32 MRSA §3657(3).

2. Requirements for Dispensers

Dispensers must follow the requirements regarding processing of electronic prescriptions for opioids as described in 32 MRSA §13756.

C. Requirement that Dispensers Report Information to the PMP by Electronic Means and Waiver of Requirement

1. No later than the close of business on the next business day after dispensing a controlled substance, dispensers must, via approved electronic submission, provide the following information to the Prescription Monitoring Program unless subsection 2 applies:

a. The dispenser identification number;

b. The dates the prescription was filled and delivered (issued);

c. The prescription number;

d. Whether the prescription is new or is a refill;

e. The National Drug Code (NDC) for the drug dispensed;

f. The quantity dispensed;

g. The dosage;

h. The patient identification number;

i. The patient name;

j. The patient address;

k. The patient date of birth;

l. The prescriber identification number; and

m. The date the prescription was issued by the prescriber.

n. The exemption code and ICD-10 code (for Palliative Care exemptions) if the aggregate daily limit exceeds 100 MME. The implementation date of this requirement is July 1, 2018, and thereafter, the Department may grant a waiver to a dispenser, for good cause.

o. If the prescription is for an animal, a notation indicating such.

2. If a controlled substance is dispensed by a hospital emergency department to a person receiving care in the emergency department for use by that person during a period of 48 hours or less after the controlled substance is dispensed, the dispenser is not required to comply with subsection 1.

3. Dispensers must correct their own records and submit corrected copies of these records to the Program whenever they become aware of errors or omissions.

4. The Office may grant a waiver of the electronic submission requirement to a dispenser for good cause and according to the terms described in:

32 MRSA §2210(3)

32 MRSA §2600-C(3)

32 MRSA §3300-F(3)

32 MRSA §4878(2)

32 MRSA §18308(3)

32 MRSA §3657(3).

D. Requirement to Check the Prescription Monitoring Program system

1. Prescriber Requirements

a. Prescribers must check the Prescription Monitoring Program system for records related to the person for whom the medication is being prescribed in accordance with the terms described in 22 MRSA §7253(1).

b. In order to fulfill the requirement to check the Prescription Monitoring Program system, the prescriber must review the following information:

i. Aggregate Morphine Milligram Equivalent for the person or whom the medication is being prescribed. The aggregate Morphine Milligram Equivalent is the total daily Morphine Milligram Equivalent for the individual, to include the anticipated new prescription.

ii. The number of prescribers currently prescribing controlled substances to the individual; and

iii. The number of pharmacies currently filling prescriptions for controlled substances for the individual.

2. Exceptions

Prescribers are not required to check the Prescription Monitoring Program system when the conditions described in 22 MRSA §7253(3) have been met.

3. Dispenser Requirements

a. Dispensers must check the Prescription Monitoring Program system for records related to the person for whom the medication is being prescribed in accordance with the terms described in 22 MRSA §7253(2). In order to fulfill the requirement to check the Prescription Monitoring Program system, the dispenser must review the following information:

1. Aggregate MME for the person for whom the medication is being prescribed. The aggregate MME is the total MME for the individual, to include the anticipated new prescription.

2. The number of prescribers currently prescribing controlled substances to the individual; and

3. The number of pharmacies currently filling prescriptions for controlled substances for the individual.

4. A dispenser shall decline to fill a prescription until the dispenser is able to contact the prescriber of that prescription if the dispenser has reason to believe that the prescription is fraudulent or duplicative. Reasons to believe that the prescription is fraudulent or duplicative include, but are not limited to, lack of prior approval from the prescriber regarding any of the following:

i. Filling the new prescription would result in exceeding the limitations set forth in 32 MRSA §2210(1), 32 MRSA§2600-C(1)32 MRSA §3300-F(1), 32 MRSA §4878(1), 32 MRSA §18308(1)32 or MRSA §3657(1).

ii. Another prescriber is contemporaneously prescribing the same controlled substance to the individual.

iii. Another pharmacy/dispenser is contemporaneously filling a prescription for the same controlled substance for the individual.

b. Exceptions

Dispensers are not required to check the Prescription Monitoring Program system when the conditions described in 22 MRSA §7253(3) have been met.

4. Veterinarian Requirements

a.Veterinarians must check the Prescription Monitoring Program system in accordance with the terms described in 22 MRSA §7253(1). The following records must be checked:

i. Records related to the individual seeking care for the animal;

ii. If deemed appropriate by the prescriber, the records related to the owner of the animal, in the event the owner is not the individual seeking care for the animal.

b. In order to fulfill the requirement to check the Prescription Monitoring Program system, the veterinarian must review the following information:

i. Aggregate Morphine Milligram Equivalent (MME) for the individual seeking care for the animal, or, if appropriate, the owner of the animal.

ii. The number of prescribers currently prescribing controlled substances to the individual; and

iii. The number of pharmacies currently filling prescriptions for controlled substances for the individual.

c. In the event the prescribing veterinarian identifies concerns related to any of the following regarding the information found in the prescription monitoring program system, the veterinarian must contact the PMP coordinator.

i. Aggregate Morphine Milligram Equivalent for the individual seeking care for the animal, or, if appropriate, the owner of the animal.

ii. The number of prescribers currently prescribing controlled substances to the individual; and

iii. The number of pharmacies currently filling prescriptions for controlled substances for the individual.

5. Exceptions Veterinarians have twenty-four (24) hours after prescribing an opioid or benzodiazepine to check the Prescription Monitoring Program. When a veterinarian directly orders or administers a benzodiazepine or opioid medication to an animal in an emergency setting, the requirement to check the prescription monitoring information system does not apply. Veterinarians writing prescriptions to be filled upon discharge from an emergency setting must check the prescription monitoring information system.

Notes

14-118 C.M.R. ch. 11, § 5