Current through Register 1531, September 27, 2024
(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.
