CMS SOM App. PP, Tag F755

The facility must provide routine and emergency drugs and biologicals to its

residents, or obtain them under an agreement described in §483.70(f). The facility

may permit unlicensed personnel to administer drugs if State law permits, but only

under the general supervision of a licensed nurse.

§483.45(a) Procedures. A facility must provide pharmaceutical services (including

procedures that assure the accurate acquiring, receiving, dispensing, and

administering of all drugs and biologicals) to meet the needs of each resident.

§483.45(b) Service Consultation. The facility must employ or obtain the services of

a licensed pharmacist who--

§483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy

services in the facility;

§483.45(b)(2) Establishes a system of records of receipt and disposition of all

controlled drugs in sufficient detail to enable an accurate reconciliation; and

§483.45(b)(3) Determines that drug records are in order and that an account of all

controlled drugs is maintained and periodically reconciled.

INTENT §483.45(a) and (b)(1), (2), and (3)

The intent of this requirement is that:

• In order to meet the needs of each resident, the facility accurately and safely

provides or obtains pharmaceutical services, including the provision of routine

and emergency medications and biologicals, and the services of a licensed

pharmacist;

• The facility utilizes only persons authorized by state or local, regulation, or other

guidance to administer medications during the course of employment by a

facility;

• The licensed pharmacist collaborates with facility leadership and staff to

coordinate pharmaceutical services within the facility, guide development and

evaluation of pharmaceutical services procedures, and help the facility identify,

evaluate, and resolve pharmaceutical concerns which affect resident care, medical

care or quality of life such as the:

o Provision of consultative services by a licensed pharmacist as necessary; and

o Coordination of the pharmaceutical services if multiple pharmaceutical

service providers are utilized (e.g., pharmacy, infusion, hospice, prescription

drug plans [PDP]).

• The facility, in coordination with the licensed pharmacist, provides for:

o A system of medication records that enables periodic accurate reconciliation

and accounting for all controlled medications;

o Prompt identification of loss or potential diversion of controlled medications;

and

o Determination of the extent of loss or potential diversion of controlled

medications.

NOTE: Although the regulatory language refers to “drugs,” the guidance in this

document generally will refer to “medications,” except in those situations where the term

“drug” has become part of an established pharmaceutical term (e.g., adverse drug event,

adverse drug reaction or consequence).

For purposes of this guidance, references to “the pharmacist” mean the licensed

pharmacist, whether employed directly by the facility or through arrangement.

DEFINITIONS §483.45

Definitions are provided to clarify terminology related to pharmaceutical services and the

management of each resident’s medication regimen for effectiveness and safety.

“Acquiring medication” is the process by which a facility requests and obtains a

medication.

“Biologicals” are made from a variety of natural sources––human, animal, or

microorganisms. Biologicals are used to treat, prevent, or diagnose diseases and medical

conditions. They may include a wide range of products such as vaccines, blood and

blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant

therapeutic proteins.

“Controlled Medications” are substances that have an accepted medical use

(medications which fall under US Drug Enforcement Agency (DEA) Schedules II—V),

have a potential for abuse, ranging from low to high, and may also lead to physical or

psychological dependence.

“Dispensing” is a process that includes the interpretation of a prescription; selection,

measurement, and packaging or repackaging of the product (as necessary); and labeling

of the medication or device pursuant to a prescription/order.

“Disposition” is the process of returning and/or destroying unused medications.

“Diversion of medications” is the transfer of a controlled substance or other medication

from a lawful to an unlawful channel of distribution or use, as adapted from the Uniform

Controlled Substances Act.

“Pharmaceutical Services” refers to:

• The process (including documentation, as applicable) of receiving and

interpreting prescriber’s orders; acquiring, receiving, storing, controlling,

reconciling, compounding (e.g., intravenous antibiotics), dispensing, packaging,

labeling, distributing, administering, monitoring responses to, using and/or

disposing of all medications, biologicals, chemicals (e.g., povidone iodine,

hydrogen peroxide);

• The provision of medication-related information to health care professionals and

residents;

• The process of identifying, evaluating and addressing medication-related issues

including the prevention and reporting of medication errors; and

• The provision, monitoring and/or the use of medication-related devices.

“Pharmacy assistant or technician” refers to the ancillary personnel who work under

the supervision and delegation of the pharmacist, consistent with state requirements.

“Receiving medication”—for the purpose of this guidance—is the process that a facility

uses to ensure that medications, accepted from the facility’s pharmacy or an outside

source (e.g., vending pharmacy delivery agent, Veterans Administration, family

member), are accurate (e.g., doses, amount).

“Reconciliation”—for the purpose of this guidance—refers to a system of recordkeeping

that ensures an accurate inventory of medications by accounting for controlled

medications that have been received, dispensed, administered, and/or, including the

process of disposition.

Guidance §483.45

The provision of pharmaceutical services is an integral part of the care provided to

nursing home residents. The management of complex medication regimens is

challenging and requires diverse pharmaceutical services and formal mechanisms to

safely handle and control medications, to maintain accurate and timely medication

records, and to minimize medication-related adverse consequences or events. The overall

goal of the pharmaceutical services system within a facility is to ensure the safe and

effective use of medications.

Preventable medication-related adverse consequences and events are a serious concern in

nursing homes. The U.S. Department of Health and Human Services (HHS) Office of the

Inspector General issued a report in February 2014, Adverse Events in Skilled Nursing

Facilities: National Incidence among Medicare Beneficiaries (OEI-06-11-00370). The

OIG found that one in three SNF residents experienced an adverse event or temporary

harm event. Thirty-seven percent of these adverse events were related to medications and

66% of all medication-related events were preventable. Medication-related adverse

events included excessive bleeding due to anticoagulant use without adequate monitoring

and acute hypoglycemia. Consequences of medication-related adverse events included a

prolonged SNF stay, hospitalization, life sustaining interventions, permanent harm, and

death.

Factors that increase the risk of adverse consequences associated with medication use in

the nursing home setting include complex medication regimens, numbers and types of

medication used, physiological changes accompanying the aging process, as well as

multiple comorbidities.

The consultative services of a pharmacist can promote safe and effective medication use.

A pharmacist, in collaboration with facility staff, establishes, evaluates and coordinates

all aspects of pharmaceutical services provided to all residents within a facility by all

providers (e.g., pharmacy, prescription drug plan, prescribers). A pharmacist can also

help in the development of medication-related documentation procedures, such as

identification of abbreviations approved for use in the facility and can help guide the

selection and use of medications in accordance with the authorized prescriber’s orders,

applicable state and federal requirements, manufacturers’ specifications, characteristics of

the resident population, and individual resident conditions.

Providing pharmaceutical consultation is an ongoing, interactive process with

prospective, concurrent, and retrospective components. To accomplish some of these

consultative responsibilities, pharmacists can use various methods and resources, such as

technology, additional personnel (e.g., dispensing pharmacists, pharmacy technicians),

and related policies and procedures.

Numerous recognized resources address different aspects of pharmaceutical services and

medication utilization, such as:

• US Department of Health and Human Services (DHHS), Food and Drug

Administration (FDA)

Find Information about a Drug, Information on FDA-approved drugs released for sale on the market;

• The American Society of Health System Pharmacists (ASHP)

http://www.ashp.org

;

• The National Institutes of Health U.S. National Library of Medicine Medline

Plus, https://medlineplus.gov/druginformation.html

.

• AMDA - The Society for Post-Acute and Long-Term Care Medicine (American

Medical Directors Association) https://paltc.org/;

• The National Coordinating Council for Medication Error Reporting and

Prevention (NCCMERP), https://www.nccmerp.org/

;

• American Society for Parenteral and Enteral Nutrition (ASPEN),

https://www.nutritioncare.org/

.

NOTE: References to non-CMS sources do not constitute or imply endorsement of these

organizations or their programs by CMS or the U.S. Department of Health and Human

Services and were current as of the date of this publication.

A. PROVISION OF ROUTINE AND/OR EMERGENCY MEDICATIONS

The regulation at 42 CFR 483.45 requires that the facility provide or obtain routine and

emergency medications and biologicals in order to meet the needs of each resident.

Facility procedures and applicable state laws may allow the facility to maintain a limited

supply of medications in the facility for use during emergency or after-hours situations.

Whether prescribed on a routine, emergency, or as needed basis, medications should be

administered in a timely manner. Delayed acquisition of a medication may impede

timely administration and adversely affect a resident’s condition. Factors that may help

determine timeliness and guide acquisition procedures include:

• Availability of medications to enable continuity of care for an anticipated

admission or transfer of a resident from acute care or other institutional settings;

• Condition of the resident including the severity or instability of his/her condition,

a significant change in condition, discomfort, risk factors, current signs and

symptoms, and the potential impact of any delay in acquiring the medications;

• Category of medication, such as antibiotics or analgesics;

• Availability of medications in emergency supply, if applicable; and

• Ordered start time/date for a medication.

Procedures should identify how staff, who are responsible for medication administration:

• Ensure each resident has a sufficient supply of his or her prescribed medications

(for example, a resident who is on pain management has an adequate supply of

medication available to meet his or her needs). At a minimum, the system is

expected to include a process for the timely ordering and reordering of a

medication;

• Monitor the delivery and receipt of medications when they are ordered; and

• Determine the appropriate action, e.g., contact the prescriber or pharmacist, when

a resident’s medication(s) is not available for administration.

NOTE: Facility staff may encounter situations in which a medication is not available in

the resident’s supply or the facility’s emergency medication supply and then decide to

“borrow” medications from another resident’s supply. This practice of borrowing

medications from other residents’ supplies is not consistent with professional standards

and contributes to medication errors. Concerns about whether the facility has a system in

place to ensure each resident has a sufficient supply of medications for timely

administration should be cited under this tag Pharmacy Services (F755). However, if

staff borrow any medication from another resident’s supply due to failure to order the

medication and/or not following the facility’s system for reordering medications, refer to

§483.21(b)(3), F658, Services Provided Meet Professional Standards. Instances of

“borrowing,” as described in this paragraph, would not be considered to be drug

diversion.

Foreign Acquired Medications

It has been reported that some residents and/or facilities may be obtaining medications

from foreign sources. Medications obtained from foreign sources may present safety

issues since they have been manufactured or held outside of the jurisdiction of the United

States (U.S.) regulatory system. These medications may not be safe and effective for their

intended uses. The Federal Food, Drug, and Cosmetic Act (FFDCA) strictly limits the

types of drugs that may be imported into the U.S. Medications imported into the U.S.

may violate the FFDCA if they are unapproved by the FDA, labeled incorrectly, or

dispensed without a valid prescription. The facility should, in collaboration with the

pharmacist, assure that medications are provided or obtained from approved sources and

do not violate the FFDCA.

If it is determined that the facility is providing/obtaining foreign medications that are not

FDA approved for use by the residents, the State Agency must make referrals to

appropriate agencies, such as the FDA; depending on the medication classification, the

Drug Enforcement Administration; State Board of Nursing; State Board of Pharmacy;

and the State Licensure Board for Nursing Home Administrators.

B. PHARMACEUTICAL SERVICES PROCEDURES

The pharmacist, in collaboration with the facility and medical director, helps develop and

evaluate the implementation of pharmaceutical services procedures that address the needs

of the residents, are consistent with state and federal requirements, and reflect current

standards of practice. These procedures address, but are not limited to, acquiring;

receiving; dispensing; administering; disposing; labeling and storage of medications; and

personnel authorized to access or administer medications.

Acquisition of Medications

Examples of procedures addressing acquisition of medications include:

• Availability of an emergency supply of medications, if allowed by state law,

including the types or categories of medications; amounts, dosages/strengths to be

provided; location of the supply; personnel authorized to access the supply; record

keeping; monitoring for expiration dates; and the steps for replacing the supply

when medications are used;

• When, how to, and who may contact the pharmacy regarding acquisition of

medications and the steps to follow for contacting the pharmacy for an original

routine medication order, emergency medication order, and refills;

• The availability of medications when needed, that is, the medication is either in

the facility (in the emergency supply) or obtained from a pharmacy that can be

reached 24 hours a day, seven days a week;

• The receipt, labeling, storage, and administration of medications dispensed by the

prescriber, if allowed by state requirements;

• Verification or clarification of an order to facilitate accurate acquisition of a

medication when necessary (e.g., clarification when the resident has allergies to,

or there are contraindications to the medication being prescribed);

• Procedure when delivery of a medication will be delayed or the medication is not

or will not be available; and

• Transportation of medications from the dispensing pharmacy or vendor to the

facility consistent with manufacturer’s specifications, state and federal

requirements, and standards of professional practice to prevent contamination,

degradation, and diversion of medications.

Receiving Medication(s)

Examples of procedures addressing receipt of medications include:

• How the receipt of medications from dispensing pharmacies (and family members

or others, where permitted by state requirements) will occur and how it will be

reconciled with the prescriber’s order and the requisition for the medication;

• How staff will be identified and authorized in accordance with applicable laws

and requirements to receive the medications and how access to the medications

will be controlled until the medications are delivered to the secured storage area;

and

• Which staff will be responsible for assuring that medications are incorporated into

the resident’s specific allocation/storage area.

Dispensing Medication(s)

Examples of procedures to assure compatible and safe medication delivery, to minimize

medication administration errors, and to address the facility’s expectations of the in-house pharmacy and/or outside dispensing pharmacies include:

• Delivery and receipt;

• Labeling; and

• The types of medication packaging (e.g., unit dose, multi-dose vial, blister cards).

Administering Medications

Examples of procedures addressing administration of medications include:

• Providing continuity of staff to ensure that medications are administered without

unnecessary interruptions;

• Reporting medication administration errors, including how and to whom to report;

• Authorizing personnel, consistent with state requirements, to administer the

medications, including medications needing intravenous administration (see

Authorized Personnel section within this document);

• Assuring that the correct medication is administered in the correct dose, in

accordance with manufacturer’s specifications and with standards of practice, to

the correct person via the correct route in the correct dosage form and at the

correct time;

• Defining the schedules for administering medications to:

o Maximize the effectiveness (optimal therapeutic effect) of the medication (for

example, antibiotics, antihypertensives, insulin, pain medications, proton

pump inhibitors, metered dose inhalers, and medications via enteral feeding

tubes);

o Prevent potential significant medication interactions such as medication-medication or medication-food interactions; and

o Honor resident choices and activities, as much as possible, consistent with the

person-centered comprehensive care plan;

• Defining general guidelines for specific monitoring related to medications, when

ordered or indicated, including specific item(s) to monitor (e.g., blood pressure,

pulse, blood sugar, weight), frequency (e.g., weekly, daily), timing (e.g., before or

after administering the medication), and parameters for notifying the prescriber;

• Defining pertinent techniques and precautions that meet current standards of

practice for administering medications through alternate routes such as eye, ear,

buccal, injection, intravenous, atomizer/aerosol/ inhalation therapy, or enteral

tubes. For example, for enteral feeding tubes, define procedures including but not

limited to:

o Types of medications that may be safely administered via enteral feeding

tube;

o Appropriate dosage forms;

o Techniques to monitor and verify that the feeding tube is in the right location

(e.g., stomach or small intestine, depending on the tube) before administering

medications; and

o Preparing drugs for enteral administration, administering drugs separately,

diluting drugs as appropriate, and flushing the feeding tube before, between,

and after drug administration, including the amount of water to be used for the

flushing and administration of medications (and obtaining

physician/practitioners order to address a resident with fluid restrictions).

NOTE: Enteral feeding tube practice recommendations may be found in ASPEN Safe

Practices for Enteral Nutrition Therapy,

https://aspenjournals.onlinelibrary.wiley.com/doi/full/10.1177/0148607116673053

.

References to non-CMS sources do not constitute or imply endorsement of these

organizations or their programs by CMS or the U.S. Department of Health and Human

Services and were current as of the date of this publication.

• Documenting the administration of medications, including:

o The administration of routine medication(s), and, if not administered, an

explanation of why not;

o The administration of “as-needed” (PRN) medications including the

justification and response;

o The route, if other than oral (intended route may be preprinted on Medication

Administration Record (MAR); and

o Location of administration sites such as transdermal patches and injections;

• Providing accessible current information about medications (e.g., medication

information references) and medication-related devices and equipment (e.g.,

user’s manual) for all staff involved with the medication administration process;

• Clarifying any order that is incomplete, illegible, or presents any other concerns,

prior to administering the medication; and

• Reconciling medication orders including telephone orders, monthly or other

periodic recapitulations, and MAR, including who may transcribe prescriber’s

orders and enter the orders onto the MAR.

Disposition of Medications

Examples of procedures addressing the disposition of medications include:

• Timely identification and removal (from current medication supply) of

medications for disposition;

• Identification of storage method for medications awaiting final disposition;

• Control and accountability of medications awaiting final disposition consistent

with standards of practice;

• Documentation of actual disposition of medications to include: resident name,

medication name, strength, prescription number (as applicable), quantity, date of

disposition, and involved facility staff, consultant(s) or other applicable

individuals; and

• Method of disposition (including controlled medications) should prevent

diversion and/or accidental exposure and is consistent with applicable state and

federal requirements, local ordinances, and standards of practice;

Authorized Personnel

The facility may permit unlicensed personnel to administer medications if state law

permits, but only under the general supervision of a licensed nurse.

The facility assures that all persons administering medications are authorized according

to state and federal requirements, oriented to the facility’s medication-related procedures,

and have access to current information regarding medications being used by the residents,

including side effects of medications, contraindications, doses, etc.

Examples of procedures addressing authorized personnel include:

• How the facility assures ongoing competency of all staff (including temporary,

agency, or on-call staff) authorized to administer medications and biologicals;

• Training regarding the operation, limitations, monitoring, and precautions

associated with medication administration devices or other equipment, if used,

such as:

o IV pumps or other IV delivery systems including calculating dosage, infusion

rates, and compatibility of medications to be added to the IV or enteral

feeding pump;

o Blood glucose meters, including calibration and cleaning between individual

residents; and

o Using, maintaining, cleaning, and disposing of the various types of devices for

administration including nebulizers, inhalers, syringes, medication cups,

spoons, and pill crushers;

• Identifying pharmacy personnel in addition to the pharmacist (e.g., pharmacy

technicians, pharmacist assistants) who are authorized under state and federal

requirements to access medications and biologicals.

C. SERVICES OF A LICENSED PHARMACIST

The facility is responsible for employing or contracting for the services of a pharmacist to

provide consultation on all aspects of pharmaceutical services. The facility may provide

for this service through any of several methods (in accordance with state requirements)

such as direct employment or contractual agreement with a pharmacist. Whatever the

arrangement or method employed, the facility and the pharmacist identify how they will

collaborate for effective consultation regarding pharmaceutical services. The pharmacist

reviews and evaluates the pharmaceutical services by helping the facility identify,

evaluate, and address medication issues that may affect resident care, medical care, and

quality of life.

The pharmacist is responsible for helping the facility obtain and maintain timely and

appropriate pharmaceutical services that support residents’ healthcare needs, goals, and

quality of life that are consistent with current standards of practice, and that meet state

and federal requirements. This should include, but is not limited to, collaborating with

the facility and medical director to:

• Develop, implement, evaluate, and revise (as necessary) the procedures for the

provision of all aspects of pharmaceutical services, including procedures to

support resident quality of life such as those that support safe, individualized

medication administration programs;

• Coordinate pharmaceutical services if and when multiple pharmaceutical service

providers are utilized (e.g., pharmacy, infusion, hospice, prescription drug plans

[PDP])

• Develop intravenous (IV) therapy procedures if used within the facility

(consistent with state requirements) which may include: determining competency

of staff and facility-based IV admixture procedures that address sterile

compounding, dosage calculations, IV pump use, and flushing procedures;

• Determine (in accordance with or as permitted by state law) the contents of the

emergency supply of medications and monitor the use, replacement, and

disposition of the supply;

• Develop mechanisms for communicating, addressing, and resolving issues related

to pharmaceutical services;

• Strive to assure that medications are requested, received, and administered in a

timely manner as ordered by the authorized prescriber (in accordance with state

requirements), including physicians, advanced practice nurses, pharmacists, and

physician assistants;

• Provide feedback about performance and practices related to medication

administration and medication errors.

In addition, the pharmacist may collaborate with the facility and medical director on other

aspects of pharmaceutical services including, but not limited to:

• Developing procedures and guidance regarding when to contact a prescriber about

a medication issue and/or adverse effects, including what information to gather

before contacting the prescriber;

• Developing the process for receiving, transcribing, and recapitulating medication

orders;

• Recommending the type(s) of medication delivery system(s) to standardize

packaging, such as bottles, bubble packs, tear strips, in an effort to minimize

medication errors;

• Developing and implementing procedures regarding automated medication

delivery devices or cabinets, if automated devices or cabinets are used, including:

the types or categories of medications, amounts stored, location of supply,

personnel authorized to access the supply, record keeping, monitoring for

expiration dates, method to ensure accurate removal of medications and the steps

for replacing the supply when dosages are used, and monitoring the availability of

medications within the system;

• Interacting with the quality assessment and assurance committee to develop

procedures and evaluate pharmaceutical services including delivery and storage

systems within the various locations of the facility in order to prevent, to the

degree possible, loss or tampering with the medication supplies, and to define and

monitor corrective actions for problems related to pharmaceutical services and

medications, including medication errors;

• Recommending current resources to help staff identify medications and

information on contraindications, side effects and/or adverse effects, dosage

levels, and other pertinent information; and

• Identifying facility educational and informational needs about medications and

providing information from sources such as nationally recognized organizations

to the facility staff, practitioners, residents, and families.

NOTE: This does not imply that the pharmacist must personally present educational

programs.

D. CONTROLLED MEDICATIONS

Regulations require that the facility have a system to account for controlled medications’

receipt and disposition in sufficient detail to enable an accurate reconciliation, and that

the facility conduct a periodic reconciliation. This system should include, but is not

limited to:

• Record of receipt of all controlled medications with sufficient detail to allow

reconciliation (e.g., specifying the name and strength of the medication, the

quantity and date received, and the resident’s name). However, in some delivery

systems (e.g., single unit package medication delivery system or automated

dispensing systems utilizing single-unit packages of medications that are not

dispensed pursuant to a specific order), the resident’s name may not be

applicable;

NOTE: If permitted by, and in accordance with, state requirements, the facility may store

some controlled medications in an emergency medication supply. The facility’s policies

and procedures must address the reconciliation of this supply, see 42 C.F.R. §

483.45(b)(2) and (3).

• Records of personnel access, usage, and disposition of all controlled medications

with sufficient detail to allow reconciliation (e.g., the MAR, proof-of-use sheets,

or declining inventory sheets), including destruction, wastage, return to the

pharmacy/manufacturer, or disposal in accordance with applicable State

requirements;

• Periodic reconciliation of records of receipt, disposition, usage, and inventory for

all controlled medications (as defined by facility procedures or when loss is

identified). The reconciliation identifies loss or potential diversion of controlled

medications so as to minimize the time between the actual loss or potential

diversion and the time of detection and follow-up to determine the extent of loss.

Because diversion can occur at any time, periodic reconciliation should

accommodate actual facility experience, such that if there is any evidence or even

suspicion that diversion may be occurring, then that may dictate conducting the

periodic reconciliation as frequently as daily. State or other federal requirements

may specify the frequency of reconciliation.

o If discrepancies are identified during the reconciliation, the pharmacist and the

facility develop and implement recommendations for resolving them, and

make referrals to law enforcement agencies as appropriate.

o Data from injectable, scheduled drug tracking should be regularly reviewed

and discrepancies or unusual access patterns are investigated including

whether residents should be screened for exposure to blood borne pathogens.

See §483.80 Infection Control, F880.

o Liquid controlled medications are often dispensed in multi-dose containers

which indicate approximate volume. The containers may also be opaque to

protect the medication from light. It should be noted that absolute accuracy in

tracking volume and use of liquid controlled medications may not be possible.

The actual volume in these containers may be slightly over or under the

manufacturer’s stated volume depending on the shape and material of the

container and the formulation of the medication such as thick liquid

suspensions. The opaque container, measurement markings, manufacturer fill

volume variation, and method for recording usage all make detection of

diversion for liquid controlled medications more difficult. The general

standard of practice for documenting usage of liquid controlled medications is

to record the starting volume from the label, record each dose administered,

subtract the dose administered from the previously recorded volume, and

record the remaining amount. Any observed discrepancy between the

recorded amount and what appears to be remaining in the container should be

reported according to facility policy. Manufacturer’s instructions may list the

estimated volume variance (e.g., 30 mL plus or minus 2.5 mL). For liquid

controlled medications, signs of diversion may include: an observable

discrepancy between the written balances of remaining medication compared

to the remaining amount in the bottle upon visual inspection; changes in the

viscosity or color of the medication; reports of spills; and, as with other

controlled medications, statements from a resident that the medication is not

working.

• Disposal methods for controlled medications must involve a secure and safe method

to prevent diversion and/or accidental exposure.

• Fentanyl transdermal patches present a unique situation given the multiple boxed

warnings, and the substantial amount of fentanyl remaining in the patch after

removal, creating a potential for abuse, misuse, diversion, or accidental exposure.

Due to the life threatening risks associated with exposure to or ingestion of the

patch, the Food and Drug Administration (FDA) and manufacturer instructions

recommend consumers dispose of used fentanyl patches by folding the patch in half

with the sticky sides together and flushing the patch down the sink or toilet,

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e15a7e9b-8025-

49dd-9a6d-bafcccf1959f&type=display. . The Environmental Protection Agency

bans flushing of pharmaceuticals if they are considered hazardous waste

pharmaceuticals; fentanyl patches are not in this category,

https://www.epa.gov/hw/defining-hazardous-waste-listed-characteristic-and-mixed-

radiological-wastes#PandU. However, this method of disposal may not always be

appropriate in nursing homes, particularly in areas where state or local laws restrict

flushing of pharmaceuticals. Therefore, nursing homes may use drug disposal

products or systems for fentanyl patches and other controlled medications as long as

the facility can show that the product or system minimizes accidental exposure or

diversion. Disposal in common areas or resident room trashcans or sharps

containers are methods that would not prevent accidental exposure or diversion.

Concerns related to fentanyl patch disposal which could lead to accidental exposure

should be investigated at F689.

NOTE: The pharmacist is not required by these regulations to perform the reconciliation

of medications, but rather to evaluate and determine that the facility maintains an

accurate account of all controlled medications and completes the reconciliation

according to its procedures, consistent with State and federal requirements.

PROCEDURES §483.45

Use the Medication Administration Observation and the Medication Storage and

Labelling Critical Element Pathway, as appropriate, along with the above interpretive

guidelines when determining if the facility meets the requirements for, or investigating

concerns related to, the provision of Pharmacy Services.

KEY ELEMENTS OF NONCOMPLIANCE

To cite deficient practice at F755, the surveyor’s investigation will generally show that

the facility failed to:

• Provide medications and/or biologicals, as ordered by the prescriber, to meet the

needs of each resident; or

• Ensure that only appropriate personnel administer medications, consistent with

applicable state law and regulations; or

• Provide pharmaceutical services to meet each resident’s needs which includes:

acquiring, receiving, dispensing, accurately administering, or disposing of

medications; or

• Provide or arrange for a licensed pharmacist who consults on all aspects of

pharmaceutical services; or

• Establish systems to accurately reconcile controlled medications using acceptable

standards of practice; or

• Have safeguards and systems in place to control, account for, and periodically

reconcile controlled medications in order to prevent loss, diversion, or accidental

exposure.

DEFICIENCY CATEGORIZATION

In addition to actual or potential physical harm, always consider whether psychosocial

harm has occurred when determining severity level. For additional guidance, see also the

Psychosocial Outcome Severity Guide at the CMS Nursing Homes Survey Resources

website that can be accessed by visiting https://www.cms.gov/files/zip/survey-resources-

10262022.zip.

Examples of noncompliance that demonstrate severity at Level 4 may include, but

are not limited to:

• The facility, in collaboration with the pharmacist, failed to establish effective

procedures to meet the needs of the residents, such as:

o Assuring that pain medications were available to meet the needs of the

resident-- The facility failed to obtain the routine regularly scheduled pain

medicine for a resident who was to receive it every six hours. The

investigation confirmed that the resident had been without pain medication for

2 days, the equivalent of 8 missed doses. This failure resulted in the resident

complaining of excruciating, unrelieved pain (e.g., a pain score of 9 on a 10-point scale). The pain was all-consuming and overwhelming, leading to sleep

loss, and a loss in interest and ability to perform activities of daily living.

o Assuring that devices used to administer medications (such as IV pumps)

were working properly, leading to an adverse consequence at the immediate

jeopardy level, in which a resident received an incorrect dose of IV

medication.

o Provisions to assure that staff were trained or competent to use new

medication-related devices (e.g., intravenous pump). This resulted in a

resident receiving an inappropriate dose of medication requiring subsequent

hospitalization.

Examples of Level 3, Actual harm (physical or psychosocial) that are not immediate

jeopardy, may include, but are not limited to:

• The facility and the pharmacist failed to assure that procedures were developed

and implemented so that all medication orders were processed consistently and

accurately through the stages of ordering, receiving, and administering

medications (including transfer orders, admission orders, telephone orders, order

renewals, and the MAR). For example, an ordering error led to an incorrect dose

of a medication being administered and the resident experienced spontaneous

bruising and frequent nosebleeds requiring medical intervention that was able to

be performed in the nursing home.

• The facility failed to implement a system to consistently and accurately reconcile

controlled medications. As a result, when staff attempted to administer pain

medication to a resident, staff found no available medications despite

documentation which showed the medications were available. The resident

experienced mild to moderate pain that prevented the resident from attending

physical therapy.

Examples of Level 2, No actual harm with a potential for more than minimal harm

that is not immediate jeopardy, may include, but are not limited to:

• As a result of failure of licensed staff to supervise medication administration by

authorized unlicensed personnel, two residents received their oral antibiotics late

on one day, however the residents did not experience any harm.

• The facility failed to obtain or provide the services of a pharmacist or to

collaborate with the pharmacist to assure that effective policies and procedures

were established and implemented including, for example:

o A resident did not receive medication for heartburn for two or more days and

had difficulty sleeping during that time due to nocturnal heartburn. The level

of discomfort did not interfere with the resident’s participating in activities or

performing activities of daily living.

o As a result of failure to identify medications that should not be crushed for

administration, a resident received a newly ordered medication that was

crushed, contrary to the manufacturer’s specifications. While the resident did

not experience any harm, the potential for harm to the resident was present.

Severity Level 1: No Actual Harm with Potential for Minimal Harm

Severity Level 1 does not apply for this regulatory requirement because the failure of the

facility to provide routine and emergency drugs and biologicals to its residents creates the

potential for more than minimal harm. This provision, along with pharmaceutical

procedures and services are essential aspects of both process and outcome requirements.

Potential Tags for Additional Investigation

Examples of some of the related requirements that should be considered when concerns

have been identified include the following:

• 42 CFR §483.12, F602, Right to be Free from Misappropriation/Exploitation

o Determine if the facility diverted a resident’s medication, including, but not

limited to, controlled substances for staff use or personal gain. If it is

determined that a resident’s medications were diverted, the State Agency must

make referrals to appropriate agencies, such as local law enforcement; Drug

Enforcement Administration; State Board of Nursing; State Board of

Pharmacy; the state Medicaid Fraud Control Unit, and possibly the State

licensure board for Nursing Home Administrators.

• 42 CFR §483.35, F725, Sufficient Staff and F726, Competent Staff

o Determine if the facility had competent staff in sufficient numbers available to

provide medications on a 24-hour basis to meet the needs of the residents,

based upon the comprehensive assessment and care plan.

• 42 CFR §483.45(g) and (h), F761, Labeling and Storage of Drugs and Biologicals

o Determine if the facility properly labeled and stored all drugs and biological in

accordance with currently accepted professional principles.

• 42 CFR §483.70(g), F841, Medical Director

o Determine whether the medical director, in collaboration with the facility and

the pharmacist, and based on current standards of practice, helped the facility

develop procedures for the safe and accurate provision of medications to meet

the needs of the residents.

• 42 CFR §483.70(h), F842, Medical Records

o Determine whether the facility has maintained clinical records, including

medication administration, in accordance with accepted professional standards

and practices that are complete, accurately documented, and readily

accessible.

• 42 CFR §483.75(g), F867, Quality Assessment and Assurance

o If concerns regarding pharmaceutical services have been identified,

determine whether the quality assessment and assurance committee has

identified and responded to those concerns, as appropriate, and has

developed, implemented, and monitored appropriate plans of action to

correct identified quality deficiencies.