104 CMR, § 28.06

Current through Register 1536, December 6, 2024

Section 28.06 - Medication

(1) The following terms as used in 104 CMR 28.06 shall be defined as follows:

Certified Staff Unlicensed staff members who are certified to administer medications pursuant to the Medication Administration Program. Certified Staff are authorized to administer medications at MAP registered service sites. These individuals have successfully completed the training and examination requirements established in 105 CMR 700.003(F) and 104 CMR 28.06(13) to be certified.

MAP Registered Service Site. The service site has been issued a MAP Massachusetts Controlled Substance Registration by the Department of Public Health to administer medications pursuant 105 CMR 700.003: Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C, § 7(g) at the site.

Medication Administration Program (MAP). A program administered by the Department of Public Health (DPH) in conjunction with the Department, the Department of Developmental Disabilities and the Department of Children and Families pursuant to 105 CMR 700.003(F).

Non-self-administering. Personally taking, consuming or applying medication in the manner directed by the Prescribing Practitioner with more than minimal assistance or direction by provider staff in accordance with the procedures and criteria approved by the Department of Public Health.

Prescribing Practitioner. A licensed physician, or a Qualified APRN, a licensed dentist, or licensed physician assistant, acting within the scope of applicable practice.

Self-administering or Self-administration of Medication. Personally taking, consuming or applying medication in the manner directed by the Prescribing Practitioner, with no more than minimal assistance, or direction by provider staff in accordance with the procedures and criteria approved by the Department of Public Health.

(2) For prescription medication to be administered by a provider, the medication shall be prescribed by the Prescribing Practitioner.

(3) Each person receiving medication shall be encouraged to see his or her Prescribing Practitioner at clinically appropriate intervals, as determined by the Prescribing Practitioner. The prescription shall be documented in the person's record together with the following information, if provided by the Prescribing Practitioner:

(a) The current dosage;

(b) A reconciliation of all medications being taken by the person;

(c) Any signs or complaints of neurologic side effects including tardive dyskinesia, metabolic syndrome, or other side effects;

(d) The reason for the use of the medication; and

(e) The effectiveness of the medication.

(4) Each person administered medication by a provider shall be encouraged and offered assistance, if needed, to receive a yearly physical examination and to authorize the sharing of the results with the practitioner prescribing psychotropic medication.

(5) A provider administering medication must have information relating to common risks and side effects of the medications used by the persons it served, the procedures to be taken to minimize such risks, and a description of any clinical indications that might require suspension or termination of a medication shall be available to persons and staff at every service site. Such information shall also be available to a persons' legally authorized representative, if applicable.

(6) Medication shall not be arbitrarily withheld, or used as punishment, or administered in quantities that are excessive in relation to the amount necessary to attain the person's best possible functioning.

(7) Medication shall not be used for the convenience of staff or as a substitute for programming.

(8)Administration. Prescription medication shall be administered in accordance with the written prescription of a Prescribing Practitioner and the provisions of M.G.L. c. 94C: The Controlled Substances Act,105 CMR 700.003: Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C, § 7(g) and 104 CMR 28.06.

(a) Medications administered to a person who is non-self-administering must be done by a practitioner, including a registered nurse or a practical nurse, currently licensed in Massachusetts and who is legally authorized to administer a controlled substance in accordance applicable licensing requirement, or if the person is at a MAP registered site, by Certified Staff in accordance with applicable procedures and criteria approved by the Department of Public Health.

(b) Prescribed medications shall only be administered to or taken by the person for whom the prescription has been written.

(c) The provider shall have a policy which specifies the administrative procedures to be followed in the event of a medical emergency. This shall include: the staff persons to be notified, the person(s) responsible for decision making and the physician, clinic, emergency room or comparable medical back up to be contacted. Such policy shall include provisions for ensuring the list of names and telephone numbers of staff persons and medical personnel to be contacted in an emergency is current. This information must be readily available to staff and must clearly indicate who is to be contacted on a 24-hour per day, seven days per week basis. The medical personnel to be contacted shall include the Prescribing Practitioner or, if unavailable, another licensed practitioner or appropriate emergency room personnel.

(d) Certified staff may only administer prescription medications which are oral, topical, ophthalmic, optic, intranasal, or products which are administered by inhalation.

(e) Parenteral drugs generally intended for self-administration or drugs administered by gastrostomy and jejunostomy tube may be administered by Certified Staff who have successfully completed a specialized training program in such technique taught by a physician, physician assistant, pharmacist, registered nurse, or nurse practitioner and approved by the Department and the Department of Public Health. Such technique shall be used only with the written authorization, and in accordance with the written instructions, of the Prescribing Practitioner.

(f) Whenever possible, a prescription for medication shall be limited to a 37-day supply and one refill.

(g) Administration of an over-the-counter drug by Certified Staff to a non-self-administering person requires the prior approval of a Prescribing Clinician and must be done in accordance with the procedures and criteria approved by the Department of Public Health. (h) Providers shall permit and encourage self-administration of medication by persons capable of self-administering, provided that:

1. the risks of misuse or abuse to the person and other persons within the service site are minimal;

2. the provider provides the person with adequate training assistance and supervision; and

3. the Prescribing Practitioner's directions are consistent with self-administration for the person.

(i) All persons who are non-self-administering shall be offered training to obtain or enhance self-administration consistent with the person's preferences, capacity, and assessed goals.

(j) Medication may not be administered PRN for restraint purposes; but may be administered PRN for treatment purposes. For persons who are prescribed medication PRN for treatment, the provider shall obtain from the Prescribing Practitioner a statement of specific target signs, symptoms and instructions for determining when administration of PRN medication is indicated.

(9)Storage. In accordance with 105 CMR 700.005: Security Requirements, drug security and storage requirements of federal and state laws shall be enforced at all storage sites where medications are stored. The following requirements shall also be followed:

(a) Medications shall be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation and security.

(b) Medications for all persons who are not self-administering shall be labeled and stored in a locked container or area, in which nothing except such medications are stored. Medications required to be refrigerated must be stored in a locked container within the refrigerator. The provider shall have a written policy describing the persons and the conditions under which persons may have access to such container or area and restrictions for access to the locked container.

(c) Prescription Medications for persons who are self-administering shall be stored in such a way as to make them inaccessible to all other persons. Such medications shall be stored in a locked container or area in which nothing except such medications are stored, unless the Director makes a determination that unlocked storage of the medication poses no threat to the health or safety of the person taking the medication or other persons; provided however, that all controlled substances set forth in the Department of Public Health's Controlled Substances Schedules II-V shall be secured in a locked container or area.

(d) Outdated medications, medications which have not been administered due to a change in the prescription or a stop order, and medications with worn, illegible or missing labels shall be disposed of and the disposal shall be documented in accordance with policies established by the provider, provided that prescription medications are disposed of in accordance with the procedures and criteria approved by the Department of Public Health.

(e) Medications or ointments used externally shall be stored separately from medications taken internally.

(10)Packaging and Labeling. All medications shall be properly packaged and labeled in accordance with M.G.L. c. 94C, § 21 and the following requirements:

(a) Provider staff shall not repack or relabel prescription medications which are taken or applied at any service site regularly or frequently attended by the person. All such medications shall be packed and labeled by a pharmacist or, in the case of medication dispensed for immediate treatment, by the dispensing practitioner.

(b) Where medication is taken or applied by a person at two or more locations on a regular or frequent basis, the medication shall be stored in a separate, properly labeled and appropriately secured medication container at each location. In circumstances where this is not practical or feasible, the Department shall establish an alternative procedure approved by the Department of Public Health.

(c) The provider shall have policies for obtaining a properly labeled container where there is a change in prescription or where the person frequently or regularly receives medication at two or more locations.

(11)Documentation and Communication. All prescriptions for, and administration of, medication shall be documented in accordance with 105 CMR 700.003: Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C, § 7(g) and the following requirements:

(a) All prescriptions for medication shall be documented in the person's record. The documentation shall specify for each person the name and dosage of medication, the condition for which the medication is prescribed, when and how the medication is to be administered, instructions for self-administration, if applicable, any contraindications or possible allergic reactions, common risks and side effects and appropriate staff responses and special instructions, including steps to be taken if a dose is missed.

(b) The provider shall establish appropriate policies and procedures to address how provider staff may obtain relevant prescription information as set forth in 104 CMR 28.06(3) and (5). In addition, such policies and procedures shall ensure that telephone medication orders and/or medication changes are received from licensed practitioners and properly documented in the person's record.

(c) The provider shall ensure that staff have ready access to the information specified in 104 CMR 28.06(5) by maintaining at each site where medications are administered a copy of a medication specific drug information sheet which states in plain language generally why the drug is used, when it is to be administered, how it should be administered, any special instructions or precautions, proper storage conditions, possible side effects and what is to be done if a dose is missed.

(d) To ensure proper communication among all providers serving the same person, a provider that is responsible for a non-self-administering person's medication shall, with necessary authorization, ensure that the other providers are appropriately informed of any prescription or non-prescription medications which the person is taking on a regular basis, and the information set forth in 104 CMR 28.06(11)(a) for each prescription medication which the person receives.

(e) The provider shall ensure that the appropriate consent or court order for medication is obtained in accordance with 104 CMR 28.03(1)(j) and is documented in the person's record.

(f) The administration of medication for non-self-administering persons, including Prescribing Practitioner ordered over the counter drugs, shall be documented in the person's record as follows:

1. The time that the medication is administered to the person;

2. Any off-site administration of medication which would normally be administered at the service site;

3. Any inconsistencies from the Prescribing Practitioner's prescription regardless of whether such inconsistencies resulted in harm or a risk of harm.

Persons who are self-administering shall not be required to document their own self-administration of medication.

(g) Any change in medications or dosage levels of a medication shall be treated as a new medication order for the purposes of documentation.

(h) The provider shall establish procedures to document the date that a person's prescription is filled and the quantity of medication dispensed by the pharmacy.

(i) Except for persons who are self-administering, the provider shall maintain a documented accounting of the quantities of controlled substances set forth in the Department of Public Health's Controlled Substances Schedules II-V stored at each service site, which shall be reconciled at the end of each shift, or as otherwise approved by the Department of Public Health.

(j) Whenever a non-self-administering person is taking an over the counter medication administered by a Certified Staff, the approval of the appropriate Prescribing Practitioner, as required under 104 CMR 28.06(8)(g), shall be documented in the person's record.

(12)Compliance. A provider shall:

(a) ensure that each service it provides establishes, maintains, and operates pursuant to, policies that ensure that prescription medication is administered only by a Massachusetts licensed nurse or properly trained and Certified Staff and is in compliance with the requirements of 104 CMR 28.06;

(b) maintain a current listing of all licensed nurses and Certified Staff and who are authorized by the service to administer prescription medications;

(c) permit the Department, and where applicable the Department of Public Health, to inspect provider and persons' records pertaining to the use and administration of medication and to make announced or unannounced on site visits or inspections of common areas and such other inspections as deemed necessary by the Department to monitor the provider's compliance with 104 CMR 28.06;

(d) promptly notify the Department and, where applicable, the Department of Public Health, of any suspected shortages or diversion of prescription medications;

(e) promptly report to the Department and, where applicable, the Department of Public Health, any suspected misuse of prescription medication arising from the administration of medication in a manner inconsistent with the practitioner's prescription or in violation of 104 CMR 28.00 which the provider has reason to believe created a risk of harm to the person;

(f) for registered sites, provide or arrange for technical assistance and advice to be provided as needed by a registered nurse, registered pharmacist or other licensed practitioner when questions arise regarding appropriate medication administration practices or the effects of medications. The provider shall establish policies and procedures which ensure reasonable access to such assistance and advice.

(13)Requirements Applicable to MAP Certification; Training, Duration, Suspension, Revocation and Denial.

(a)MAP Certification. Certification will be awarded to individuals who complete the training program and pass the examination requirements as established by the Department of Public Health in concert with the Department, the Department of Developmental Services, and the Department of Children and Families (collectively, "the Departments").

1. The training program for certification shall be taught by a registered nurse, nurse practitioner, physician assistant, pharmacist, or physician who meets applicable requirements for a trainer jointly approved by the Department of Public Health, and the Departments. The Department of Public Health and, as appropriate, the Departments shall have the authority to monitor the training program for compliance with established standards.

2. Certification will be valid for two years and may be renewed upon the person meeting the standards for retraining and/or retesting approved established by the Department of Public Health and the Departments.

(b)Suspension, Revocation and Denial of MAP Certification. Certification may be suspended, revoked or denied if the Department finds that there is reasonable cause to believe the holder of, or the applicant for, the certification:

1. has been charged with or convicted of a crime involving controlled substances

2. has furnished or made any misleading or false statement in the application for, or renewal of, certification;

3. poses a risk to the health, safety, and welfare of persons; or

4. is unfit to perform the duties for which the certification was granted.

No suspension, revocation or denial of certification will be made by the Department until it has given the holder or applicant notice of its intent to suspend, revoke or deny certification and the opportunity for an informal hearing before the Department to consider whether reasonable cause exists, and a hearing has been held, if timely requested. The hearing shall not be an adjudicatory proceeding within the meaning of M.G.L. c. 30A. The decision of the Department to suspend, revoke or deny a certification shall be final. Notwithstanding the foregoing, the Department may in its sole discretion immediately suspend an individual's certification pending delivery of notice and results of the hearing, if one has been requested.

(c)Notification. The Department shall notify the training program registry and all other Departments of any suspensions, revocations or denials of certification.

(d)Reinstatement. An individual whose certification has been suspended, revoked or denied may apply for recertification upon a showing that the conditions that led to such suspension, revocation or denial have been remediated. If the Department determines that such conditions have been remediated, the Department may approve such individual's application under terms of retraining and supervision as the Department may impose.

104 CMR, § 28.06

Amended by Mass Register Issue 1345, eff. 8/11/2017.

Amended by Mass Register Issue 1359, eff. 2/23/2018.

Amended by Mass Register Issue 1479, eff. 9/30/2022.