Section 5.15 - Medication(1) The use of medications by programs subject to 115 CMR 5.00 is prohibited except as provided in 115 CMR 5.15.(2) Medication shall not be used by programs subject to 115 CMR 5.00 as punishment, or in quantities that interfere with the individual's habilitation.(3) Medication shall not be used by programs subject to 115 CMR 5.00 for the convenience of staff or as a substitute for programming.(4) Medication used to manage or treat challenging behavior shall be administered subject to the requirements of 115 CMR 5.15. (a) Medication used to manage or treat challenging behavior shall be administered in accordance with the recommendations of the prescribing health care provider and contained in a medication treatment plan referencing the individual's PBSP, if appropriate. The presence of a medication treatment plan should be noted at the next annual individual support planning meeting.(b) The medication treatment plan shall contain at least the following information identified by the prescribing health care provider:1. a description of the challenging behavior described in objective terms, to be managed or treated;2. information concerning the common risks and side effects of the medication, procedures to minimize such risks, and description of clinical indications that might require suspension or termination of the drug therapy;3. data tracking necessary for ongoing monitoring such that the individual's clinical course may be evaluated; and4. in the case of antipsychotic medications only where there is a court order specifying the treatment, unless the individual is capable of giving informed consent for such treatment and has given consent or a medical emergency exists. A medical emergency is a situation in which the individual's mental condition requires medical attention or treatment to prevent immediate, substantial and irreversible deterioration of a serious mental illness.(5)Medication Incidental to Treatment.(a) Administration of medication incidental to the treatment requires the consent of the individual or guardian, except in a medical emergency.(b) It is expected that efforts to desensitize the individual to the treatment would be instituted in order to reduce or eliminate the need for medication incidental to treatment.(c) Medication incidental to treatment is not a restraint.(d) Medication may not be prescribed PRN for restraint purposes.(e) Medication may be prescribed PRN for treatment purposes. For non-self-administering individuals who are prescribed medication PRN for treatment, the program shall obtain from the prescribing health care provider: a statement of specific criteria, in the form of observable symptoms, for determining when the medication is to be administered.(6) Medication shall be administered in accordance with the written prescription of a practitioner and the provisions of 105 CMR 700.003: Registration of Persons for Specific Activity or Activities in Accordance with M.G.L. c. 94C, § 7(g). For non-self-medicating individuals, prescription medication shall be administered by licensed professional staff; provided, however, that for non-self-medicating individuals receiving services in the community, prescription medication may be administered by community program staff who have successfully completed the Department approved Medication Administration Program (MAP) Training and have been certified by the Department in accordance with 105 CMR 700.003(F)(2): Training.(7) Certified program staff of community programs may administer prescription medications to non-self-medicating individuals, provided that the community program is registered with the Department of Public Health in accordance with 105 CMR 700.004: Registration Requirements and staff meet the requirements set forth in 105 CMR 700.003(F) and 115 CMR 5.15(7). (a) Medication shall only be administered by unlicensed program staff that possess current Department MAP certification in accordance with 105 CMR 700.003(F)(2): Training, 115 CMR 5.15(5), and the MAP Policy Manual. 1. MAP certification issued by the Department will be valid for two years.2. The Department may recertify unlicensed program staff to administer medication upon the person meeting the standards for retraining and/or retesting established by the Department of Public Health and the Department.3. For purposes of 115 CMR 5.15(7)(a), the Department shall accept current MAP certification issued by the Department of Mental Health.4. Certification to administer medication may be withdrawn or rejected if the Department finds, after an informal hearing, that the holder of the certification: a. has been convicted of a crime involving controlled substances;b. has furnished or made any misleading or false statement in the application for, or renewal of, certification;c. has failed to exercise proper regard for the health, safety and welfare of community program residents; ord. is unfit to perform the duties for which the certification was granted. The informal hearing is not an adjudicatory proceeding within the meaning of M.G.L. c. 30A and the decision of the Department is final.
(b) The program shall establish, maintain, and operate in accordance with policies that ensure that prescription medication is administered only by certified personnel.(c) The program shall maintain a current written list of those staff who have1. successfully completed a training program meeting the requirements of 105 CMR 700.003(F)(2): Training;2. are authorized by the program to administer prescription medications; and3. are currently certified by the Department to administer medication.(d) The Department of Public Health and the Department shall be permitted by the program to inspect program and individuals' records pertaining to the use and administration of prescription medication and are permitted announced or unannounced on-site visits or inspections of common areas and such other inspections as the Department of Public Health is authorized to make in order to monitor the program's compliance 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 115 CMR 5.15;(e) The program shall promptly notify the Department of Public Health and the Department of:1. any suspected shortages or diversion of prescription medications;2. any other suspected misuse of prescription medication in accordance with guidelines established by the Department and the Department of Public Health; and3. any violations of Department or Department of Public Health regulations or inconsistencies from the physician's prescription that staff believe created a risk of harm to the individual.(f) The program shall 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 administration practices or the effects of medications. The program shall establish policies and procedures which insure reasonable access to such assistance and advice.(g) Individuals whose ISP teams have determined they may be capable of benefitting from training to obtain or enhance self medication skills, shall receive such training.(8)Storage. 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 115 CMR 5.15(7), medication security and storage requirements of federal and state laws shall be enforced at all storage locations and shall, in addition, meet the following requirements: (a) Prescription medications for all individuals who are non-self-medicating shall be labeled and stored in a locked container or area, in which nothing except such medications are stored. Prescription medications required to be refrigerated must be stored in a locked container within the refrigerator. The program 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.(b) Prescription medications for individuals who are self-medicating shall be stored in such a way as to make them inaccessible to all other individuals. Such medications shall be stored in a locked container or area, in which nothing except such medications are stored, unless the head of the provider makes a determination that unlocked storage of the medication poses no threat to the health or safety of the individuals taking the medication or other individuals; provided however, that all controlled substances in Schedules II through V shall be stored in a locked container or area. If a locked container or area is deemed necessary, and the medications are also required to be refrigerated, they must be stored in a locked container within the refrigerator.(c) 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 105 CMR 700.003(F)(3)(c).(d) Medications for external use shall be stored separately from medications taken internally.(9)Labeling. All medications shall be properly labeled in accordance with M.G.L. c. 94C, § 21, and 105 CMR 700.003(F)(4): Labeling, and the MAP Policy Manual.(10)Administration. All prescription medications shall be administered in accordance with M.G.L. c. 94C, applicable Department of Public Health regulations, and the following requirements: (a) MAP certified staff of community programs registered with the Department of Public Health are permitted to administer medications which are oral, topical, ophthalmic, otic, suppository, intranasal or products which are administered by inhalation. Such staff shall not administer any medication by injection. MAP certified staff who have successfully completed a specialized training program taught by a physician, physician assistant, nurse practitioner, pharmacist, or registered nurse, approved by the Department or the Department of Public Health, may administer certain parenteral medications generally intended for self-administration and medications by gastrostomy or jejunostomy tube. Such specialized training shall include on site competency evaluation. The specially certified staff shall perform these activities in accordance with written instructions and only with the written authorization of a prescribing practitioner. (e) The community program shall not store on-site more than a 30-day supply of any medication prescribed for an individual.(f) For any consumer who is non-self-medicating, and who receives prescription medication at a location other than the program site where staff are certified to administer prescription medication (off-site), the program shall, whenever possible, identify an individual responsible for administering the medication and make available to that person instructions as to how the medication is to be administered.(g) For non-self-medicating individuals who are currently receiving prescription or non prescription (over-the-counter) medication, the approval of the appropriate practitioner (a physician, dentist, pharmacist, physician assistant, nurse practitioner orregistered nurse) must be obtained and noted in the individual's record prior to administration to the individual of an additional over the counter medication. Compliance with 115 CMR 5.15(9)(g) shall constitute compliance with 105 CMR 700.003(F)(5)(h).(11)Documentation. All prescriptions for, and administration of, medication shall be documented in accordance with 105 CMR 700.003(F)(6): Documentation, 115 CMR 5.15(9), and the MAP Policy Manual, and the following requirements: (a) All prescriptions for medication shall be noted in the individual's record on a medication and treatment form(s) approved jointly by the Department and the Department of Public Health. Such form(s) shall specify for each individual, the type and dosage of medication, the reason for which the medication is prescribed, when and how the medication is to be administered, instructions for self-medication, if applicable, any contraindications or possible allergic reactions, and special instructions. The program shall establish appropriate policy and procedures to address how program staff shall obtain relevant information in accordance with the requirements of 115 CMR 5.15(10). In addition, such policy and procedures shall ensure that telephone orders for medication and/or changes in medication are received from licensed practitioners and properly documented according to the MAP Policy Manual. The program shall establish appropriate policies and procedures to insure that staff receive assistance as needed from registered nurses, registered pharmacists, or licensed practitioners to obtain the information required in 115 CMR 5.15(9)(a). In addition, such policies and procedures shall include specific instructions for staff which insure that written or telephoned medication orders or changes to such orders, received from licensed practitioners, are properly documented in the individual's medication record.
(b) To ensure proper communication among all programs providing services to the same individual, an individual's residential program shall notify the individual's day program of any prescription or nonprescription medications which the individual is taking on a regular basis, including medication scheduled to be taken solely at the day program, and shall provide the day program with a copy of a pharmacological reference approved by the Department of Public Health that covers each prescription medication that the individual receives.(c) The administration of medication, including practitioner ordered over-the-counter drugs, shall be documented in the individual's record as follows:1. The time that the medication is administered to the individual;2. Any off-site administration of medication which would normally be administered at the program site; and3. Any inconsistencies from the physician's prescription regardless of whether such inconsistencies resulted in harm or a risk of harm. Individuals who are self-medicating shall not be required to document their own self-administration of medication;
(d) Any change in prescription medications or dosage levels of a medication shall be treated as a new medication prescription order for the purposes of documentation.(e) The program shall establish procedures to document the date that an individual's prescription is filled and the quantity of medication dispensed by the pharmacy.(f) Except for persons who are self-medicating, the program shall maintain a documented accounting of the quantities of Schedule II controlled substances stored by the program which shall be reconciled at the beginning and the end of every shift or at such other frequency otherwise approved by the Department of Public Health.(g) Whenever a non self medicating individual is taking an over-the-counter medication in addition to a prescription medication or another over-the-counter medication, the consultation with the appropriate practitioner required under 115 CMR 5.15(8)(g) shall be documented in the individual's record.(12) Programs shall permit and encourage self-medication by individuals capable of self-medicating, provided that: (a) the risks of misuse or abuse to the individual and other persons within the program are minimal; and,(b) the program provides the individual with adequate training and assistance.(13) Notwithstanding any of the foregoing provisions of 115 CMR 5.15, individuals served by programs subject to 115 CMR 5.00 shall have the right to control the provision of personal medical treatment by such programs in accordance with the requirements of 115 CMR 5.15(12).(a) If a program subject to 115 CMR 5.15 arranges for but does not provide medical care, then such services shall be arranged only upon consultation with the individual or guardian to the fullest extent possible.(b) If a program subject to 115 CMR 5.15 provides routine or preventive medical care, including standard medical examinations, clinical tests, standard immunizations, and treatment for minor illnesses and injuries, then such services shall be provided only in accordance with: 1. a specific or general written authorization, to be renewed annually, for routine or preventive care given freely and knowingly at the time of entry to the program by: a. the individual, if not under guardianship and competent in fact to give informed consent concerning such routine and preventive care; orb. the individual's guardian, if any.2. a written authorization by the head of the provider, upon recommendation of the treating physician that such care is necessary and appropriate, where the individual is not under guardianship and is not competent in fact, as determined in an individual's ISP, to give informed consent concerning such routine or preventive medical care; or3. an authorization by a probate court or other court of competent jurisdiction. The provision of first and shall not be considered routine or preventative medical care.
(c) If a program subject to 115 CMR 5.15 provides any nonroutine or preventative medical care, other than that provided in emergency situations, such care shall be provided in accordance with a specific written authorization for care given freely and knowingly by: 1. the individual, if not under guardianship and competent in fact to give informed consent for such care;2. the individual's guardian, if any; or3. a probate court or other court of competent jurisdiction.(d) Nothing in 115 CMR 5.15(12) shall be interpreted to:1. restrict the right of physicians, nurses, and emergency medical technicians to render emergency care or treatment in accordance with M.G.L. c. 112, § 12B;2. restrict the right of physicians to provide medical care involving drug dependency to consenting minors, in accordance with the provisions of M.G.L. c. 112, § 12E;3. restrict the right of physicians, dentists, or hospitals to provide emergency medical care without the consent of the parent, guardian, or other person having custody of a minor, or the spouse of an individual, when delay in treatment will endanger the life of an individual; or4. restrict the right of a minor to give consent for medical or dental care at the time such care is given in certain circumstances, in accordance with M.G.L. c. 112, § 12F.Amended by Mass Register Issue 1411, eff. 2/21/2020.