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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
2006 3
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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.
2006 4
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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.
5 2006
Pharmaceutical ServicesPharmaceutical Services
Interpretive GuidelinesInterpretive Guidelines
2006 6
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 8
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions Acquiring medication Administering medication Biologicals Current standards of practice Dispensing Disposition Pharmaceutical Services Pharmacy assistant or technician Receiving Medication
2006 9
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
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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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
What is included in the concept What is included in the concept of Pharmaceutical Services? of Pharmaceutical Services?
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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 14
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 15
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
2006 16
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
2006 17
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
Acquiring Receiving Dispensing Administering Disposition Labeling and storage of medications
2006 18
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
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
2006 19
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
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
2006 20
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
Dispensing Medications - Examples Delivery and receipt
Labeling
Types of medication packing
2006 21
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
2006 22
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
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
2006 23
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
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)
2006 24
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
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
2006 25
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
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
2006 26
F425 Pharmaceutical ServicesF425 Pharmaceutical ServicesInterpretive GuidelinesInterpretive GuidelinesPharmaceutical Services Pharmaceutical Services ProceduresProcedures
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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Pharmaceutical ServicesPharmaceutical Services
Investigative ProtocolInvestigative Protocol
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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
Pharmaceutical ServicesPharmaceutical ServicesInvestigative Protocol Investigative Protocol
Use Sub-Task 5E – Medication Pass and Pharmacy Services
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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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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Pharmaceutical ServicesPharmaceutical Services
Determination of Determination of ComplianceCompliance
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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 32
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 33
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 34
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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Pharmaceutical ServicesPharmaceutical Services
Deficiency CategorizationDeficiency Categorization
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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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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F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 38
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 39
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 40
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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
2006 41
F425 Pharmaceutical ServicesF425 Pharmaceutical Services
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