Medication Management Services

(A) A Program shall: (1) in consultation with a registered nurse, physician, and pharmacist, develop and implement written policies and procedures governing medications, including the receipt, storage, and administration of all drugs and biologicals; or (2) adopt model written policies and procedures governing medications, including the receipt, storage, and administration of all drugs and biologicals, provided that such model policies and procedures are developed in consultation with a registered nurse, physician, and pharmacist. (B) A Program shall designate a registered nurse as supervisor of medication management services. (C) Medication policies and procedures shall address: (1) Receipt of medications; (2) Documentation of the administration of all medications; (3) Response to medication emergencies; (4) Storage of medications; (5) Wasting and disposal of unused medications; (6) Inventorying and auditing controlled substances in accordance with state and federal laws and regulations; (7) Reporting and documentation of medication errors; (8) Reporting theft or loss of medications including controlled substances; and (9) Procedures for resolving concerns raised by the Program or the participant or legally authorized representative regarding administration of medications. Such procedures shall provide for and encourage the participation of the participant or legally authorized representative. (D) A Program shall provide a copy of its written medication policies and procedures to each participant or his or her legally authorized representative upon enrollment. (E) Medication Orders. (1) The licensed nurse shall ensure that there is a complete and current medication order from a licensed prescriber in the participant's health record for each medication that has been prescribed and dispensed to the participant. (2) An order for any change in prescription medication that has already been dispensed to the participant, may only be received by the nurse. Any verbal order must be followed by a signed written order within seven business days. The medication order shall be obtained and documented and the medication administration plan updated. (3) A Program may not administer a non-prescription medication, or a prescription medication that has been prescribed and dispensed to the participant, without a medication order from a licensed prescriber that contains the following information: (a) Participant's name; (b) Name and signature of the licensed prescriber; (c) Name, route, and dosage of medication; (d) Frequency and duration of medication administration; (e) Date of the prescription; and (f) Any specific directions for administration. (F) Any research or investigational drug studies conducted at a Program must be in compliance with state and federal laws and regulations. Medication research projects governed by M.G.L. c. 94C, § 8 shall be conducted in accordance with 105 CMR 700.009: Research Involving Controlled Substances. (G) Only Program personnel who are legally authorized in accordance with current state and federal laws and regulations may administer medications. (H) Medications prescribed for a specific participant may not be administered to any other participant. (I) Administration of Medications. (1) The legally authorized individual administering medications shall: (a) Positively identify the participant who receives the medication; (b) Document assessments of the participant and communicate significant information relating to prescription medication effectiveness, adverse reactions, or other harmful effects to the participant or legally authorized representative and licensed prescriber; (c) Respond to medication emergencies; and (d) Have a current pharmaceutical reference available for his or her use. (2) Medication Errors. (a) Medication errors shall be documented by the nurse on an incident report form. Medication error incident report forms shall be retained by the Program and shall be made available to the Department upon request. (b) The participant or legally authorized representative shall be notified of all medication errors. (c) The primary care provider and prescriber shall be notified immediately of all medication errors with the potential for adverse participant consequences. (3) A Program may not add any medication to any food or beverage without the participant's or his or her legally authorized representative's knowledge or consent. (J) Participants may self-administer medications provided that the following requirements are met: (1) The nurse evaluated the participant's health status and abilities and deemed self- administration safe and appropriate; (2) The primary care provider's order or prescription indicates that self-administration is appropriate; (3) A nurse and the participant or legally authorized representative, where appropriate, entered into a written agreement which specifies the conditions under which prescription medication may be self-administered; (4) Self-administration is included in the plan of care; (5) The self-administered medications are stored in the medication cabinet; and (6) A nurse monitors the participant's self-administration. (K) A Program shall report all suspected drug diversion and drug tampering to the Division of Health Care Facilities Licensure and Certification and all appropriate local, state, and federal authorities. (L) Medication Administration Record. (1) A Program shall maintain a monthly medication administration record for each participant who receives medications at the Program. (2) All medications shall be accurately recorded and accounted for at all times. (3) Each dose of prescription and over-the-counter medication administered shall be recorded in the medication administration record. (4) A medication administration record shall include the following information: (a) The participant's name; (b) The current month and year; (c) The primary care provider's name; (d) Known allergies; (e) Medication prescriptions; (f) Contraindications; (g) Documentation of side effects, adverse reactions, and effectiveness of PRN medications; (h) The dose or amount of medication administered; (i) The name of the medication and the date and time of administration or omission of administration, including the reason for omission; and (j) The full signature of the nurse administering the medication. If the medication is given more than once by the same person, he or she may initial the record, subsequent to signing a full signature. (5) All documentation regarding medication administration shall be recorded in a permanent format that is not able to be altered. (M) Handling and Storage of Medications. (1) A participant, legally authorized representative, or delegated responsible adult shall deliver all medications to be administered by Program personnel or to be taken by self- administering participants to the nurse. Medications shall be delivered as follows: (a) Prescription medication must be in a pharmacy labeled container. (b) Over the counter medications must be in a manufacturer labeled container. (c) The nurse receiving the medication shall document the name, strength, and quantity of the medication delivered, and the date of delivery, in the participant's Medication Administration Record. (d) In extenuating circumstances, as determined by the nurse, the medication may be delivered by other persons; provided, however, that the nurse is notified in advance by the participant or legally authorized representative of the arrangement and the quantity of medication being delivered to the Program. (2) All medications shall be maintained and stored in original pharmacy or manufacturer labeled containers and in such manner as to maintain the integrity of the medications. Transfer to other containers is forbidden. (3) Security. (a) All medications shall be kept in a securely locked cabinet or closet used exclusively for medications. The medication cabinet(s) or closet(s) shall be locked except when opened to obtain medications. If a cabinet is used to store medications, it shall be substantially constructed and anchored securely to a solid surface. (b) Medications requiring refrigeration shall be stored in a permanently affixed locked box in a refrigerator or in a locked refrigerator used exclusively for medications. The refrigerator shall be maintained at temperatures of 38EF to 42EF. (c) The medication cabinet or closet shall be located in or near the nursing office and in a location that is not frequented by participants or visitors. (d) The medication cabinet or closet shall be well-lighted, locked at all times with a suitable lock, and maintained in a clean and sanitary manner. It shall be sufficient in size to permit storage without crowding. (e) The medication cabinet or closet shall be located near a sink for handwashing. (f) There shall be a separately locked, securely fastened compartment within the locked medicine cabinet or closet for the proper storage of prescribed controlled substances. (g) Medications for "external use only" shall be kept in a locked cabinet or compartment that is separate and apart from internal use medications. (4) Access to medications shall be limited to staff authorized to administer medications at the Program. (5) Participants or legally authorized representatives may retrieve medications from the Program at any time. (6) No more than a 30 day supply of any prescription medication may be stored at the Program. (7) All unused, discontinued, or outdated medications and medications with defaced labels shall be returned to the participants or legally authorized representatives and the return documented in the Medication Administration Record. (8) If unable to comply with 105 CMR 158.039(M)(7), unused, discontinued, or outdated prescription medications may be destroyed by two staff members, one of which must be a nurse, in accordance with guidelines of the Department.