Pharm Law: Prescribing/Dispensing - Massachusetts Prescription Law and Regulations
Massachusetts Prescription Regulations and Standards
Standards for Prescription Format and Security
Reference: 105 \text{ CMR } 721
Electronic Prescriptions (e-Rx) Mandate:
Every prescription generated in Massachusetts must be an electronic prescription and include an electronic signature.
Exceptions: Prescriptions issued in accordance with the exceptions list found in 105 \text{ CMR } 721.070 (e.g., veterinarians, technology failure, emergencies, out-of-state prescriptions, compounded preparations, Schedule VI, DME, EPT for chlamydia).
Required Prescription Elements
No Substitution / Interchange Mandate:
Prescriptions must enable the practitioner to instruct the pharmacist to dispense a brand-name drug by indicating "no substitution." This indication must not be by default.
Interchange is mandated unless the practitioner indicates "no substitution" in accordance with the law.
The indication of "no substitution" is a unique element of the prescription. It cannot be satisfied by any other element, including a signature (e.g., a check-off box or a dual signature line is not sufficient in Mass; it must be handwritten or explicitly selected).
Example: For Motrin (brand), the doctor must explicitly write "no substitution." Writing "no subs" or "DAW1" is insufficient in Massachusetts (DAW1 is a billing code, not a legal mandate in Mass).
If "no substitution" is not indicated for a generic-substitutable drug, dispense the generic (e.g., Ibuprofen for Motrin). The label would read "IC" (Interchange) followed by the generic drug name and manufacturer.
Prescriber Information:
Name and address of the practitioner must be clearly indicated.
For hospital or clinic prescriptions, the name and address of the hospital or clinic are required.
Registration Number of the Practitioner:
For Schedule VI substances (e.g., Motrin/Ibuprofen), a Massachusetts Controlled Substance Registration (MCSCR) number (a usually six-digit number for physicians) is required.
For Schedule II-V substances, a DEA registration number is required (which is typically letters followed by numbers).
Note: The National Provider Identifier (NPI) is for billing and is not a controlled substance registration number in Massachusetts.
Date of Issuance:
The prescription must be dated on the day it was issued.
No predating or postdating is allowed.
Drug Details:
Name, dosage, and strength per dosage unit (e.g., Motrin 800\text{ mg}).
Quantity (e.g., Number 90).
Patient Information:
Name and address of the patient (except for a veterinarian patient).
Directions for Use.
Number of Refills.
Opioid Schedule II Specific Requirement:
Must include a notation that the patient may fill, upon request, a prescription amount less than the recommended full quantity indicated. This is often referred to as "partial fill language" (MGL 94\text{C Section } 22\text{C} and 105 \text{ CMR } 721).
Note: If this language is missing for an opioid Schedule II drug, a pharmacist can add it.
Special Prescribers and Supervising Professionals
Certified Nurse Practitioners (CNP), Psychiatric Nurse Mental Health Specialists, Certified Registered Nurse Anesthetists (CRNA):
Prescriptions issued by these professionals must include the name of their supervising health care professional.
Exception: This is not required if the nurse is authorized for independent practice.
Physician Assistants (PA):
The supervising physician's name is not required on a PA's prescription in Massachusetts.
Written Prescriptions (When Permitted)
Facsimile (Fax) Transmission: Written prescriptions can be transmitted via facsimile.
An electronically transmitted prescription that fails (a "fallover") is considered an oral prescription.
Tamper-Resistant Forms (Federal Requirements for Medicaid):
Required for Medicaid prescriptions to prevent alteration.
Three Key Features:
Blue or Green Background: To visibly show erasure attempts.
"VOID" or "DUPLICATE" Appearance: When photocopied.
Serial Number.
Other potential features: heat-sensitive material (e.g., color change).
Note: These forms are costly, which limits their use for all non-Medicaid written prescriptions.
Fallover Prescriptions
Definition: An electronically transmitted prescription that fails to be transmitted electronically and becomes a fax or written prescription.
Treatment: Considered an oral prescription.
Requirements:
Must contain all information required under MGL 94\text{C Section } 20 (except for the signature).
Must be immediately entered into electronic pharmacy systems or reduced to writing.
If the prescriber is not known, the dispensing pharmacist must make a reasonable good faith effort to verify the fallover was issued by a legitimate practitioner.
Crucial Limitation: The drug cannot be an "additional drug" (e.g., gabapentin in Massachusetts).
Conflict with Federal Law: While state law considers it an oral prescription, federal law prohibits oral Schedule II prescriptions. Oral Schedule III-V prescriptions require a hard copy follow-up under federal law. Thus, for Schedule II-V, a hard copy should still be sought.
Mass General Law (MGL) 94\text{C Section } 22
This section details requirements for practitioners who dispense controlled substances, but also reinforces prescription content.
Content for Prescriptions: If a practitioner issues a written or electronic prescription for a controlled substance, it must state:
Name, address, and registration number of the practitioner.
Date of delivery/issuance.
Name, dosage form, and strength of the controlled substance.
Name and address of the patient (unless veterinarian).
Directions for use and cautionary statements.
Number of refills.
Labeling by Practitioner (for dispensed drugs, not prescriptions): If a practitioner dispenses a controlled substance for immediate delivery, it must bear a label with:
Practitioner's name and address.
Date of dispensing.
Name of the patient.
Name and dosage form of the drug.
Directions for use and cautionary statements.
Opioid Schedule II Partial Fill Notation: Reiterates the requirement for the partial fill language on opioid Schedule II prescriptions (MGL 94\text{C Section } 22\text{C}).
Quantity Limits and Partial Fills
Multiple Drug Products per Prescription Blank:
Massachusetts Rule: For retail prescriptions, only one drug product per prescription blank is allowed.
Exception: Medication orders in hospitals can contain multiple items.
Note: State laws vary (e.g., Maine might allow more).
Partial Filling Schedule II Controlled Substances:
Conditions: A pharmacist may partially fill a Schedule II controlled substance if requested by the patient (not if the pharmacy is out of stock - that's a 72-hour rule).
Process: The prescribed quantity can be dispensed in a lesser amount.
Subsequent Fills: The remaining portion of the prescription may be filled upon patient request, but only by the same pharmacy that originally dispensed the lesser amount.
Timeframe: The remaining portion must be filled no later than 30 days after the prescription issue date.
Record Keeping: Upon dispensing a partial fill, the pharmacist (or designee) must make a notation in the patient's record (accessible to the prescriber) indicating the partial fill and the quantity dispensed.
Impact on Policy: While company policy may dictate otherwise, Massachusetts law permits patient-requested partial fills for Schedule II drugs within these parameters.
Emergency Oral Prescriptions for Schedule II Controlled Substances
Waiver of e-Prescribing: Electronic prescribing requirements may be waived in an emergency situation (105 \text{ CMR } 721.060).
Definition of Emergency: The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (e.g., potentially up to 4 days if it's over a long weekend, but depends on clinical judgment).
Required Elements: The oral prescription must contain all required elements except for the signature.
Good Faith Effort: If the prescriber is unknown, the pharmacist must make a good faith effort to verify their identity and authorization.
Hard Copy Follow-up Requirement:
The prescribing practitioner must deliver a hard copy follow-up with "Authorization for Emergency Dispensing" written on its face.
Written Hard Copy: Must be delivered within 7 business days (105 \text{ CMR } 721.060).
Electronic Hard Copy: Must be delivered within 2 days (MGL 94\text{C Section } 20).
The hard copy is then stapled to the oral prescription record and filed.
e-Prescribing Exceptions (Detailed List)
Prescriptions do not need to be electronic in the following circumstances:
Issued by veterinarians.
Issued or dispensed where electronic prescribing is unavailable due to technology or electrical failure.
Issued by practitioners who have received a waiver.
Issued or dispensed in emergency situations (as discussed above).
Cannot be issued electronically under federal or state law.
Issued outside of Massachusetts (assuming the originating state does not require e-prescribing).
For Expedited Partner Therapy (EPT) treatment for chlamydia.
Note: For EPT, the patient's name typically reads "EPT" or "Expedited Partner Therapy" instead of an individual's name. This allows treatment of a partner without a direct prescriber-patient relationship for privacy and public health reasons.
For compounded preparations.
For Schedule VI drugs.
For Durable Medical Equipment (DME).
Other exceptions listed in the regulations.
Oral Prescriptions (General)
**MGL 94\text{C Section } 20 Requirements (when taking an oral prescription):
The pharmacist must immediately reduce the prescription to writing.
Record:
Prescriber's name, address, and registration number.
Name of the expressly authorized representative who called in the prescription.
Date of the prescription.
Name, dosage, strength per unit dose of the controlled substance.
Serial number assigned by the dispensing pharmacist.
Name of the pharmacy.
Name and address of the patient.
Directions for use and refills.
Inconsistencies: 105 \text{ CMR } 721 does not explicitly include the "expressly authorized representative," but the MGL does.
**Hard Copy Follow-up for Oral Prescriptions (Recap):
Electronic hard copy: Within 2 days (MGL 94\text{C}).
Written hard copy: Within 7 days (MGL 94\text{C} vs. 7 business days in 105 \text{ CMR } 721).
Note on "Days" vs. "Business Days": The MPJE may distinguish, so be aware. MGL generally refers to calendar days unless specified.
Schedule VI Drugs: No hard copy follow-up is needed for oral Schedule VI prescriptions.
Who Can Issue Prescriptions
A prescription for a controlled substance may be issued only by a practitioner who is:
Authorized to prescribe controlled substances.
Registered with the appropriate federal and/or state authority.
Authorized Disciplines in Massachusetts (Examples):
Physicians (MD, DO)
Dentists (DDS, DMD)
Optometrists
Podiatrists
Mid-level practitioners (Advanced Practice Registered Nurses - APRNs, Physician Assistants - PAs).
Pharmacists: Can write prescriptions in Massachusetts if they have a Collaborative Drug Therapy Management (CDTM) agreement.
Registration Requirements:
DEA: For Schedule II-V controlled substances.
Massachusetts Controlled Substance Registration (MCSCR): For Schedule VI controlled substances.
Authorized Agents: Prescribers' authorized agents can call in oral prescriptions if they are officially authorized by the prescriber.
Who Can Take Oral Prescriptions
Pharmacist
Intern
Certified Pharmacy Technician (under specific rules)
Massachusetts Compliant Prescription Label Requirements
A label affixed to the container must show:
Date of filling.
Pharmacy name and address.
Filling pharmacist's initials.
Serial number (prescription number).
Name of the patient (unless a veterinary prescription).
Name of the prescribing practitioner.
Name of the controlled substance.
Directions for use and cautionary statements.
Number of tablets or capsules.