1 2006 Pharmaceutical Services Guidance Training CFR § 483.60, 483.60(a)(b)(1) F425.

1 2006

Pharmaceutical Pharmaceutical ServicesServices

Guidance TrainingGuidance Training

CFR CFR §§ 483.60, 483.60(a)(b)(1) 483.60, 483.60(a)(b)(1) F425F425

2006 2

F425 Pharmaceutical ServicesF425 Pharmaceutical Services

Training ObjectivesTraining ObjectivesAfter today’s session, you should be able to: Describe the intent of the regulation Explain the regulatory components

incorporated into F425 Utilize the components of the investigative

protocol Identify compliance with the regulation Appropriately categorize the severity of

noncompliance

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Regulatory LanguageRegulatory Language(F425) 42 CFR 483.60(F425) 42 CFR 483.60

The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in Sec. 483.75(h) of this part. The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.

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Regulatory Language Regulatory Language ContinuedContinued(F425) 42 CFR 483.60(a)(b)(1)(F425) 42 CFR 483.60(a)(b)(1)

(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. (b) Service consultation. The facility must employ or obtain the services of a licensed pharmacist who—(1) Provides consultation on all aspects of the provision of pharmacy services in the facility.

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Pharmaceutical ServicesPharmaceutical Services

Interpretive GuidelinesInterpretive Guidelines

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Interpretive GuidelinesInterpretive GuidelinesComponentsComponents Intent Definitions Overview Provision of Routine and/or Emergency

Medications Services of a Licensed Pharmacist Pharmaceutical Services Procedures Investigative Protocol (Sub-Task 5E) Determination of Compliance Deficiency Categorization

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Interpretive GuidelinesInterpretive GuidelinesIntentIntent Facility provides pharmaceutical services to

meet the needs to residents Medications and biologicals Services of licensed pharmacist

Pharmaceutical services are coordinated within the facility

Procedures developed and implementation evaluated

Pharmaceutical concerns and issues affecting residents and care are identified and evaluated

Only persons authorized under state requirements administer medications

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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions Acquiring medication Administering medication Biologicals Current standards of practice Dispensing Disposition Pharmaceutical Services Pharmacy assistant or technician Receiving Medication

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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions

DispensingDispensing - 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.

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BiologicalsBiologicals - are products isolated from a variety of natural sources––human, animal, or microorganism––or produced by biotechnology methods and other cutting-edge technologies. They may include a wide range of products such as vaccine, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

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What is included in the concept What is included in the concept of Pharmaceutical Services? of Pharmaceutical Services?

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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitionsPharmaceutical ServicesPharmaceutical Services The process 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;

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.

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Interpretive GuidelinesInterpretive GuidelinesOverviewOverview Overall goal is to ensure safe and effective use

of medications for each resident Risk of adverse consequences increases with:

Complex medication regimens Numbers and types of medications used Physiological changes associated with aging Multiple comorbidities

Medication-related adverse consequences leading to death and serious events are too common and are often preventable

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Interpretive GuidelinesInterpretive GuidelinesProvision of Routine and/or Emergency Provision of Routine and/or Emergency MedicationsMedications

Facility must provide or obtain routine and emergency medications and biologicals to meet needs of each resident

Meeting needs includes timeliness

Factors affecting timeliness: Resident condition and risk factors Category of medication Ordered start time Availability of medications

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F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesServices of a Licensed Services of a Licensed PharmacistPharmacist Facility is responsible for employing or

contracting pharmacist

Pharmacist collaborates with staff to: Provide feedback about medication

administration practices and medical errors Develop, implement, evaluate and revise

procedures Coordinate pharmaceutical services Develop intravenous therapy procedures Determining contents of supply of medications

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F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesServices of a Licensed Services of a Licensed PharmacistPharmacist

Pharmacist collaborates to establish procedures for:

Conducting monthly MRR for each resident Addressing time frames Addressing irregularities Documenting and reporting results of

review

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F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures

Acquiring Receiving Dispensing Administering Disposition Labeling and storage of medications

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Acquisition of Medications - Examples Availability of supply (emergency or otherwise) When, how to and who may contact pharmacy Verification or clarification of orders Actions in response to delayed delivery or

unavailability of medication Transportation of medications to prevent

contamination, degradation, and diversion of medications

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Receiving Medications - Examples Receipt of medication and reconciliation with

order and requisition for medication

Staff identified and authorized to receive and deliver medication to secured area

Staff responsible for assuring that medications are incorporated into resident’s specific allocation/storage area

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Dispensing Medications - Examples Delivery and receipt

Labeling

Types of medication packing

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F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProceduresAdministering Medications – Examples Preventing unnecessary interruptions during the

medication pass Reporting of errors Using only authorized personnel to administer

medications Assuring correct medication and dose given to

correct person Defining schedules for administration Defining guidelines for specific monitoring related to

medications Defining techniques and precautions for

administration

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Disposition of Medications – Examples Removal of medications for disposition Storage method for medications awaiting

final disposition Control and accountability of medications

awaiting final disposition Method of disposition consistent with

applicable state and federal requirements, local ordinances, and standards of practice

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Labeling – Examples Requirements for labeling medications not

labeled by a pharmacy, such as bulk supplies or IV solutions prepared or hung by facility staff

Modifying labels due to changes in the medication orders or directions

Labeling multi-dose vials to assure product integrity (e.g., modified expiration dates upon opening the multi-dose vial)

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Storage of Medications – Examples Location, security (locking), and authorized

access to the medication rooms, carts and other storage areas

Temperatures and other environmental considerations of medication storage area(s)

Location, access, and security for discontinued medications awaiting disposal

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Controlled Medications – Examples Location, access, and security for controlled

medications

A system of records of receipt and disposition of all controlled medications that accounts for all controlled medications

Periodic reconciliation of controlled medications

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Authorized Personnel – Examples Assuring ongoing competency of staff

Training on operation, limitations, monitoring, and precautions associated with medication administration

Identifying 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.

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Investigative ProtocolInvestigative Protocol

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Pharmaceutical ServicesPharmaceutical ServicesInvestigative Protocol Investigative Protocol

Use Sub-Task 5E – Medication Pass and Pharmacy Services

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Use of Sub-Task 5E:Use of Sub-Task 5E: Medication Pass and Pharmacy Medication Pass and Pharmacy ServicesServices

Services of licensed pharmacist Provision of pharmaceutical services

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Determination of Determination of ComplianceCompliance

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Determination of ComplianceDetermination of Compliance

Synopsis of RegulationSynopsis of Regulation1. Facility must provide routine and or

emergency medications and biologicals or obtain them

2. Facility must have pharmaceutical procedures to meet the resident’s needs

3. Facility must have a licensed pharmacist who provides consultation and oversees service

4. Facility must follow laws about who may administer medications

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Determination of ComplianceDetermination of ComplianceCriteria for ComplianceCriteria for Compliance

The facility is in compliance if they provide: Medications and/or biologicals for each resident

as ordered by the prescriber

Development and implementation of procedures for the pharmaceutical services

A pharmacist who provides consultation regarding all aspects of pharmaceutical services

Personnel to administer medications, consistent with applicable state law and regulations

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Determination of ComplianceDetermination of ComplianceNoncompliance for F425Noncompliance for F425

Noncompliance may include the facility failure to:

Utilize the services of a pharmacist

Ensure that only appropriate personnel administer medications

Provide medications and/or biologicals to meet the needs of the resident

Develop or implement procedures for any of the following: acquiring, receiving, dispensing or accurately administering medications

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F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesDetermination of ComplianceDetermination of CompliancePotential Tags for Additional Potential Tags for Additional InvestigationInvestigation

F353 Sufficient StaffF501 Medical DirectorF520 Quality Assessment and AssuranceF514 Clinical Records

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Deficiency CategorizationDeficiency Categorization

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Deficiency CategorizationDeficiency CategorizationSeverity DeterminationSeverity Determination

The key elements for severity determination The key elements for severity determination are:are:

Presence of harm or potential for negative outcomes

Degree of harm or potential harm related to noncompliance

Immediacy of correction required

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Deficiency CategorizationDeficiency CategorizationSeverity Determination LevelsSeverity Determination Levels

Level 4Level 4: Immediate Jeopardy to resident health or safety

Level 3Level 3: Actual harm that is not immediate jeopardy

Level 2Level 2: No actual harm with potential for more than minimal harm that is not immediate jeopardy

Level 1Level 1: No actual harm with potential for minimal harm

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Deficiency CategorizationDeficiency CategorizationSeverity Level 4: Immediate Severity Level 4: Immediate JeopardyJeopardy

Level 4: Immediate Jeopardy to resident health or safety

Noncompliance with one or more requirements of participation: Has resulted in or is likely to cause serious

injury, harm, impairment, or death to a resident

Requires immediate correction

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Deficiency CategorizationDeficiency CategorizationSeverity Level 3: Actual HarmSeverity Level 3: Actual Harm

Level 3: Actual harm that is not immediate jeopardy

Noncompliance resulted in actual harm

May include clinical compromise, decline, or resident’s inability to maintain and/or reach his/her highest practicable level of well-being

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Deficiency CategorizationDeficiency CategorizationSeverity Level 2: Potential for HarmSeverity Level 2: Potential for Harm

Level 2Level 2: No actual harm with potential for more than minimal harm that is not immediate jeopardy

Noncompliance resulted in: No more than minimal discomfort to

resident; and/or Has potential to compromise resident’s

ability to maintain or reach his/her highest practicable level of well-being

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Deficiency CategorizationDeficiency CategorizationSeverity Level 1:Potential for Minimal Severity Level 1:Potential for Minimal HarmHarm

Level 1: No actual harm with potential for minimal harm

Verify that no resident harm or potential for more than minimal harm identified at other requirements was related to: Lack of pharmaceutical services Absence of or failure to implement

pharmaceutical procedures Absence of or oversight by pharmacist

1 2006 Pharmaceutical Services Guidance Training CFR § 483.60, 483.60(a)(b)(1) F425.

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Transcript of 1 2006 Pharmaceutical Services Guidance Training CFR § 483.60, 483.60(a)(b)(1) F425.