105 CMR, § 150.008

Current through Register 1536, December 6, 2024
Section 150.008 - Pharmaceutical Services and Medications
(A) All facilities shall maintain current written policies and procedures regarding the procurement, storage, dispensing, administration and recording of drugs and medications.
(1) Policies and procedures shall be developed with the advice of a committee of professional personnel including a primary care provider, a pharmacist and a nurse.
(2) Provision shall be made for the prompt and convenient acquisition of prescribed drugs from licensed community, institutional or hospital pharmacies. Facilities shall make no exclusive arrangements for the supply or purchase of drugs. Residents or their guardian may arrange for the purchase of prescribed medications from pharmacies of their own choice provided medications are dispensed and labeled as specified in 105 CMR 150.008.
(3) No drug or medication removed from the market by the Food and Drug Administration shall be stocked or administered in any facility.
(4) Facilities shall comply with all federal and state laws and regulations relating to the procurement, storage, dispensing, administration, recording and disposal of drugs.
(B) There shall be a current written order by an authorized prescriber for all medication or drugs administered to residents.
(1) Verbal or telephone orders shall be given only to a licensed nurse (or responsible person in facilities that provide only Level IV care), immediately recorded in writing and signed by the same nurse or responsible person. All verbal or telephone orders shall be countersigned by an authorized prescriber within 30 days.
(2) A licensed nurse and the primary care provider together shall review each resident's medications at least every 30 days in a Level I or II facility; every 90 days in a Level III facility; and every six months in a Level IV facility. Any concerns regarding medication side effects or needs for adjustment shall be discussed by the prescribing primary care provider and the facility nurse to develop and implement an appropriate adjustment in the resident's plan of care.

If the resident also has an identified psychiatrist and the medication change involves psychiatric medication, the resident's psychiatrist should be consulted. If the resident is a Community Support Resident, any change in psychiatric medication and the rationale for that change must be communicated to the social worker so an appropriate adjustment in the Mental Health Treatment Plan may be made.

(3) Orders for medications and treatments shall be in effect for the specific number of days indicated by the prescribing primary care provider.
(a) Orders shall not exceed the facility's stop order policies where applicable.
(b) Orders shall not exceed the limits of 72 hours for narcotics and 14 days for stimulants, depressants, antibiotics and anticoagulants unless specified in writing by the prescribing primary care provider.
(c) Medications not specifically limited to time or number of doses by the prescribing primary care provider shall automatically be stopped in accordance with the facility's stop order policies or, in the absence of such policies, at the end of 30 days. The facility shall contact the prescribing primary care provider for renewal of orders or other instructions.
(4) Medication may be released to residents or their guardian on discharge. If the medication is abandoned by the resident or guardian, the facility shall dispose of the medication in accordance with Department guidelines.
(C)Supervision and Administration of Medication.
(1) Every medication administered in a facility shall be administered by a primary care provider, registered nurse, or licensed practical nurse, except as provided in 105 CMR 150.008(C)(2).
(2) In a Level IV facility or unit and a CSF, medications as specified in guidelines of the Department, may be administered by a responsible person who has documented evidence of having satisfactorily completed a training course approved by the Department on the topic of dispensing medications, or may be self-administered if so authorized by a physician or psychiatrist's order.
(3) A facility shall not permit self-administration by any resident, where this practice would endanger the resident, another resident or other residents.
(a) All medication to be self-administered shall be kept in the resident's room in a locked cabinet or in a locked drawer.
(b) In the case of a resident with a history of mental illness, a self-administration order must be supported by a written finding by the primary care provider that the resident has the ability to manage the medication on this basis.
(c) Every self-administration order shall be reconsidered as part of the periodic review of medications under 105 CMR 150.0008(B)(2).
(4) All medications shall be accurately recorded and accounted for at all times, and each dose of medication administered shall be properly recorded in the clinical record with a signature of the administering nurse or responsible person.
(5) Medications prescribed for a specified resident shall not be administered to any other resident.
(6) Medication errors and drug reactions shall be reported to the resident's primary care provider and recorded in the clinical record.
(7) A current medication reference book or electronic access to reference information shall be provided in the facility at each nurse's or attendant's station.
(D)Labeling, Storage and Supervision of Medications.
(1) All facilities shall provide a locked medicine cabinet or closet of sufficient size to permit storage without crowding within the nurses' or attendants' station for the proper storage of all residents' drugs except those approved for self-administration. Such cabinets or closets shall be used exclusively for the storage of medications and equipment required for the administration of medications.
(2) There shall be a separately locked, securely fastened compartment within the locked medicine cabinet or closet for the proper storage of prescribed controlled substances under the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
(3) Medications requiring refrigeration shall be properly refrigerated and kept in a separate, locked box within a refrigerator at or near the nurses' or attendants' station.
(4) Poisons and medications for "external use only," including rubbing alcohol, shall be kept in a locked cabinet or compartment separate and apart from internal medications.
(5) Medications shall not be stored in resident's rooms except drugs approved for self-administration.
(6) The custody of all keys to the medicine cabinets or closets shall at all times be assigned to a licensed nurse (or a responsible person in facilities that provide only Level IV care).
(7) The label affixed to each individual medication container shall clearly indicate the resident's full name, primary care provider's name, prescription number, name and strength of drug, quantity, dose, frequency and method of administration, date of issue, expiration date of all time-dated drugs, and name, address and telephone number of pharmacy issuing the drug.
(8) Prescription labels shall not be defaced, and medication containers with soiled, damaged, incomplete, illegible, or make shift labels shall be returned to the issuing pharmacy for relabeling or disposal. Containers without labels shall be destroyed as directed by the Department.
(9) Medications for each resident shall be kept and stored in the containers in which they were originally received; transfer to other containers is forbidden.
(10) Medications having a specific expiration date shall be removed from usage and destroyed at expiration. All medications no longer in use shall be disposed of or destroyed at as directed by the Department.
(11) Following a resident's death, transfer or discharge, all drugs prescribed for that individual, if not transferred with him or her, shall be disposed of as directed by the Department.
(12) An automated dispensing machine is permitted, provided its design and capabilities comply with all provisions of 105 CMR 150.008(D) for labeling, storage and supervision.
(E) An emergency medication kit shall be provided in all facilities.
(1) The contents of the kit shall be approved by the Department. In a SNCFC, a pediatric emergency kit and emergency resuscitation equipment and medication shall be provided. In addition, a chart listing pediatric doses for emergency drugs shall be included with emergency equipment.
(2) The emergency medication kit shall be kept in a separate, sealed container, which shall be stored in a suitable place when not in use. Drugs requiring refrigeration shall be kept in a separate sealed container under proper refrigeration.
(3) Each emergency medication kit shall be prepared, packaged and sealed by a pharmacist and shall contain a list of contents on the outside cover and within the box.
(4) The medications contained in the emergency medication kit shall be used only upon the orders of a primary care provider.
(5) After a kit has been opened, it shall be inspected, re-stocked and resealed by the pharmacist within 48 hours prior to further use.
(F) Facilities shall be permitted to stock those drugs and medical supplies approved as stock items or medicine chest items by the Department.
(G)Records.
(1) When drugs are transferred with a resident, an accurate record shall be made at the time of discharge including the following: date, name and new address of resident; name of drug, strength, quantity, pharmacy and prescriber's name.
(2) An individual narcotic and sedative record shall be maintained for each narcotic, sedative, amphetamine, barbiturate prescribed for each resident. This record shall include:
(a) Resident's name.
(b) Name of prescriber.
(c) Name of medication, quantity prescribed, strength or dosage prescribed, the amount of medication received and the balance on hand.
(d) Date received, prescription number and name of pharmacy that dispensed medication.
(e) Date, time, dosage and method of administration and signature of nurse who administered the medication.
(3) A recorded, dated count of controlled substances under the federal Comprehensive Drug Abuse Prevention and Control Act of 1970 shall be checked by a nurse or responsible person going off duty on each shift in the presence of a nurse or responsible person reporting on duty and both shall sign the count.
(4) All facilities shall have a method to document and track medication readily accessible upon inspection.

105 CMR, § 150.008

Amended by Mass Register Issue 1361, eff. 3/23/2018.