10- 144 C.M.R. ch. 113, § 7

Current through 2024-51, December 18, 2024

Section 144-113-7 - Medications and Treatments

7.1 Use of safe and acceptable procedures. The administrator shall ensure that all persons administering medications and treatments (except consumers who self-administer) use safe and acceptable methods and procedures for ordering, receiving, storing, administering, documentation, packaging, discontinuing, returning for credit and/or destroying of medications and biologicals. All employees must practice proper hand washing and aseptic techniques. A hand-washing sink shall be available for staff administering medications. [Classes I/II/III]

7.1.1 Consumers shall receive only the medications ordered by his/her duly authorized licensed practitioner in the correct dose, at the correct time, and by the correct route of administration consistent with pharmaceutical standards. [Classes I/II/III]

7.1.2 No injectable medications may be administered by an unlicensed person, with the exception of bee sting kits and insulin.

7.1.3 Before using a bee sting kit, unlicensed persons must be trained by a registered professional nurse in regard to safe and proper use. Documentation of training shall be included in the employee record.

7.1.4 Unlicensed assistive personnel must be trained by a registered professional nurse in regard to the management of persons with diabetes. The registered professional nurse must provide in-service training and documentation to include: [Class III].

7.1.4.1 Dietary requirements;

7.1.4.2 Anti-Diabetic Oral Medications - inclusive of adverse reactions and interventions, hyper and hypo glycemic reactions;

7.1.4.3 Insulin mixing including insulin action;

7.1.4.4 Insulin storage;

7.1.4.5 Injection techniques and site rotation including signs/symptoms;

7.1.4.6 Treatment and prevention of insulin reaction;

7.1.4.7 Foot care;

7.1.4.8 Lab testing, urine testing and blood glucose monitoring; and

7.1.4.9 Standard Precautions.

Documentation of training shall be included in the employee record

7.1.5 Urine testing shall not be done around medication or areas where food is stored or prepared. Proper Standard Precautions relative to body fluids shall be implemented. Toilets shall be used for the disposal of urine and test sample waste. Toxic urine testing chemicals (tablets, solutions) shall be stored in a locked area totally apart from oral medications.

7.1.6 For those residents for whom the facility is responsible for assistance with medication administration, no medications, including those brought into the assisted living program by the consumer, family or friends, shall be administered or discontinued without a written order signed by a duly authorized licensed practitioner or other person licensed to prescribe medications. [Class III]

7.1.7 Orders for medications and associated treatments shall be in writing, signed and dated by a duly authorized licensed practitioner and shall be in effect for the time specified by the duly authorized licensed practitioner, but in no case to exceed twelve (12) months, unless there is a written reorder. Orders for psychotropic medications shall be reissued every three (3) months, unless otherwise indicated by the duly authorized licensed practitioner. Standing orders for individual consumers are acceptable when signed and dated by the duly authorized licensed practitioner.

7.1.7.1 Upon admission to another facility, all existing orders are no longer in effect. Upon return to the facility, all orders must be reviewed and approved by the resident's duly authorized licensed practitioner within 72 hours. During that timeframe, orders that are signed and dated by the discharging duly authorized licensed practitioner are the current acceptable orders. Prior to admission to another facility all medications must be removed from service and placed in a locked area in accordance with Section 7.7.

7.2 Administration of medications.

7.2.1 Self-administration. Upon admission, each individual's ability to self-administer medications will be determined by an assessment of his/her ability or need for assistance, unless the consumer/legal representative elects (in writing) to have the assisted living program administer his/her medications. A final decision will be reached between the consumer, his/her legal representative, his/her duly authorized licensed practitioner, and a facility representative.

7.2.2 Medications administered by assisted living program. For those medications for which the assisted living program is responsible, the following apply:

7.2.2.1 Telephone orders shall be accepted only by a registered or licensed nurse or pharmacist. Written dated orders for telephone orders must be signed by the duly authorized licensed practitioner within five (5) working days. [Class III]

7.2.2.2 Facsimile orders are acceptable legal orders as long as they are in compliance with the Commission on Pharmacy regulations.

7.2.3 Unlicensed assistive personnel. Unlicensed assistive personnel administering medications and/or treatments must successfully complete training approved by the Department. There shall be evidence available in the assisted living program that such training has been successfully completed. Whenever the standards or guidelines of the medication administration course are substantially revised, unlicensed personnel must be re-certified within one (1) year of the revision, by a method approved by the Department. An additional exception will be made on a case-by-case basis for persons who only administer dietary supplements and/or minor medicated treatments, shampoos, lotions and creams that could be obtained over the counter without a physician's order.

A person qualified to administer medications must be on site at the assisted living program whenever a resident(s) have medications prescribed "as needed" (PRN) if this medication is not self-administered.

All unlicensed assistive personnel administering medications and/or treatments must complete a Department-approved eight (8) hour refresher course biennially for re-certification within two (2) years of the original certification. [Class III]

7.2.4 PRN Medications

7.2.4.1 PRN Psychotropic medications. Psychotropic medications ordered "as needed" by the duly authorized licensed practitioner, shall not be administered unless the duly authorized licensed practitioner has provided detailed behavior-specific written instructions, including symptoms that might require use of medication, exact dosage, exact time frames between dosages and the maximum dosage to be given in a twenty-four (24) hour period. Assisted living program staff shall notify the duly authorized licensed practitioner within twenty-four (24) hours when such a medication has been administered, unless otherwise instructed in writing by the duly authorized licensed practitioner.

7.2.4.2 A person qualified to administer medications must be on site at the assisted living program whenever a resident(s) have medications prescribed "as needed" (PRN) if this medication is not self-administered.

In no event, however, shall antipsychotic-type psychotropic medications be prescribed on a PRN basis only, having no routinely scheduled and administered doses.

7.3 Medication storage.

7.3.1 Consumers who self-administer medications and who handle their own medical regime may keep medications in their own apartment. [Class III]

7.3.2 Medications administered by the assisted living program shall be kept in their original containers in a locked storage cabinet. The cabinet shall be equipped with separate cubicles, plainly labeled, or with other physical separation for the storage of each consumer's medications. It shall be locked when not in use and the key carried by the person on duty in charge of medication administration. [Class III]

7.3.3 Medications/treatments administered by the assisted living program for external use only shall be kept separate from any medications to be taken internally. [Class III]

7.3.4 Medications administered by the assisted living program which require refrigeration shall be kept safely stored and separate from food by placement in a special tray or container, except vaccines, which must be stored in a separate refrigeration unit that is not used to store food. Refrigeration shall not exceed forty-one (41) degrees Fahrenheit. A thermometer shall be used to ensure proper refrigeration. [Class III]

7.4 Temporary absences. When a temporary absence from the assisted living program is expected to be greater than seventy-two (72) hours, medications leaving the assisted living program (except those by consumers who self-administer) must be in a form packaged and labeled by a pharmacist. For medications leaving the assisted living program for seventy-two (72) hours or less, the medication shall be packaged in such a way as to facilitate self-administration or administration by a responsible party of the correct medication at the appropriate time. Properly certified or licensed staff will use acceptable methods and procedures for preparing medications for leaving the assisted living program. Staff will follow the same policies used in the assisted living program for administering medications. The name of the consumer and the name and strength of each drug, as well as the directions from the original prescription package, should be conveyed to the consumer or their responsible party along with all cautionary information in writing, either directly on an envelope containing the appropriate dose or on a separate instruction sheet. If the medication is sent in original containers, pills must be counted and documented upon leaving and returning to the assisted living program. [Class III]

7.5 Medication labeling. For medications administered by the assisted living program, each prescription dispensed by a pharmacy shall be clearly labeled in compliance with requirements of the Commission on Pharmacy and shall include at least the following:

7.5.1 Prescription number;

7.5.2 Consumer's full name;

7.5.3 Name, strength and dosage of the drug;

7.5.4 Directions for use;

7.5.5 Name of prescribing duly authorized licensed practitioner;

7.5.6 Name and address of issuing pharmacy;

7.5.7 Date of issue of latest refill;

7.5.8 Expiration date; and

7.5.9 Appropriate accessory and cautionary instructions.

7.6 Improperly labeled medications. For medications administered by the assisted living program, all pharmaceutical containers having soiled, damaged, incomplete, incorrect, illegible or makeshift labels shall be returned to the original dispensing pharmacy for re-labeling within two (2) working days or shall be disposed of in accordance with the requirements contained in Section 7.9. [Class III]

7.7 Expired and discontinued medications. For medications administered by the assisted living program, medications shall be removed from use and properly destroyed after the expiration date and when discontinued according to procedures contained in Section 7.9. They shall be taken out of service and locked separately from other medications until reordered or destroyed. [III]

7.8 Medication owned by consumers. Prescribed medicines are the property of the consumer and shall not be given to or taken by other consumers or any other person.

7.9 Destroying medications. For medications administered by the assisted living program, all discontinued medications, expired medications or medications prescribed for a deceased consumer, except controlled substances and individual doses, shall be destroyed by the administrator or the administrator's designee and witnessed by one (1) competent person who is not a consumer. The destruction shall be conducted so that no person can use, administer, sell or give away the medication. Individual unit doses may be returned to the pharmacist and a credit or rebate made to the person(s) who originally paid for the medication. Amounts destroyed or returned shall be recorded on the consumer's record, with the signature of the administrator or the administrator's designee and witness(es). Destruction or return to the pharmacy shall take place within thirty (30) calendar days of expiration or discontinuation of a medication or following the death of the consumer.

7.10 Schedule II controlled substances. All Schedule II controlled substances administered by the assisted living program, listed in the Comprehensive Drug Abuse Act of 1970, Public Law 91-513, Section 202 and as amended pursuant to Section 202 are subject to the following standards. [Class II]

7.10.1 For all Schedule II controlled substances, there shall be an individual record in which shall be recorded the name of the consumer, prescription number, the date, drug name, dosage, frequency and method of administration, the signature of the person administering it and verification of the balance on hand. [Class II]

7.10.2 There shall be a recorded and signed count of all Schedule II controlled substances at least once a day, if such substances have been used in the assisted living program that day. [Class II]

7.10.3 All Schedule II controlled substances on hand shall be counted at least weekly and records kept of the inventory in a bound book with numbered pages, from which no pages shall be removed. [Class II]

7.10.4 All Schedule II controlled substances shall be stored under double lock in a separate locked box or cabinet within the medication cabinet or in an approved double-locked cabinet attached to the wall. [Class II]

7.10.5 All excess and undesired Schedule II controlled substances in the possession of a licensed assisted living program that are no longer required for a consumer, shall be disposed of in the following manner. The Administrator or a licensed or registered nurse shall list all such unused substances and keep the same in a securely locked area apart from all other drugs. Disposal shall be in the form of incineration or flushing into the sewage system only in the presence of an authorized representative of the Department, a licensed pharmacist, a member of the Commission on Pharmacy or an authorized representative of the Drug Enforcement Agency. At least one (1) of the persons must be a person who did not dispense the drug or who was the last person to inventory the drug. Documentation of such destruction shall be made on the consumer's record and in the inventory record required in Section 7.10.3, signed by the individual authorized to dispose of the drug. [Class II]

7.11 Bulk supplies. Assisted Living Programs may, but are not required to, stock in bulk supply those items regularly available without prescription at a pharmacy.

7.12 Medication/treatment administration records for medications administered by the assisted living program,

7.12.1 Individual medication/treatment administration records shall be maintained for each consumer and shall include all treatments and medications ordered by the duly authorized licensed practitioner. The name of the medication, dosage, route and time to be given shall be recorded in the medication/treatment administration record. Documentation of treatments ordered and time to be done shall be maintained in the same manner. These rules apply only to treatments ordered by licensed health care professionals. [Class III]

7.12.2 Whenever a medication or treatment is started, given, refused or discontinued, including those ordered to be administered as needed (PRN), the medication or treatment shall be documented on the medication/treatment administration record. It shall be initialed by the administering individual, with the full signature of the individual written somewhere on such record. A medication or treatment shall not be discontinued without evidence of a stop order signed and dated by the duly authorized licensed practitioner. [Class III]

7.12.3 Medication errors and reactions shall be recorded in an incident report in the consumer's record. Medication errors include errors of omission, as well as errors of commission. Errors in documentation or charting are errors of omission. [Class II]

7.12.4 Administration of medications ordered as needed (PRN) shall be documented and shall include date, time given, medication and dosage, route, reason given, results or response and initials or signature of administering individual. Treatments ordered PRN shall be documented in the same manner.

7.13 Medication containers. Graduated medicine containers, for the accurate measurement of liquid medications, shall be used. If not disposable, medicine containers shall be returned to the dishwashing unit for sanitization after each use. Only sterile disposable syringes and needles shall be used for insulin injection. Disposable medicine containers shall not be reused. [Class III]]

7.14 Breathing apparatus. When the assisted living program assists a consumer with a hand-held bronchodilator, metered dose nebulizers, intermittent positive pressure breathing machine or oxygen machine, there shall be documentation of the following:

7.14.1 The names of staff who are qualified or trained to use the equipment and/or to mix medications, the nature of their training, the date and who provided it;

7.14.2 The name of the distributing agency and the frequency and specific directions for cleaning the equipment; and

7.14.3 The consumer's record shall contain a copy of the duly authorized licensed practitioner's order, possible side effects to be monitored, specific instructions as to when the duly authorized licensed practitioner must be notified regarding side effects and instructions to the consumer on the use of the breathing apparatus.

7.15 Whenever a Registered Nurse teaches or provides in-service training to unlicensed personnel on medical issues, treatments and/or use of medical equipment not specifically outlined in these regulations there must be documentation for the employee file.

10- 144 C.M.R. ch. 113, § 7