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

2. F425 Pharmaceutical Services 2006 2 Training Objectives After 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

3. F425 Pharmaceutical Services 2006 3 Regulatory Language (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.

4. F425 Pharmaceutical Services 2006 4 Regulatory Language Continued (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. 5 2006 Pharmaceutical Services Interpretive Guidelines

6. F425 Pharmaceutical Services 2006 6 Interpretive Guidelines Components 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

7. F425 Pharmaceutical Services 2006 7 Interpretive Guidelines Intent 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

8. F425 Pharmaceutical Services 2006 8 Interpretive Guidelines Definitions Acquiring medication Administering medication Biologicals Current standards of practice Dispensing Disposition Pharmaceutical Services Pharmacy assistant or technician Receiving Medication

9. F425 Pharmaceutical Services 2006 9 Interpretive Guidelines Definitions Dispensing Dispensing - 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.

10. F425 Pharmaceutical Services 2006 10 Interpretive Guidelines Definitions Biologicals Biologicals - 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.

11. F425 Pharmaceutical Services 2006 11 Interpretive Guidelines Definitions What is included in the concept of Pharmaceutical Services?

12. F425 Pharmaceutical Services 2006 12 Interpretive Guidelines Definitions Pharmaceutical 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.

13. F425 Pharmaceutical Services 2006 13 Interpretive Guidelines Overview 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

14. F425 Pharmaceutical Services 2006 14 Interpretive Guidelines Provision of Routine and/or Emergency Medications 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

15. F425 Pharmaceutical Services 2006 15 Interpretive Guidelines Services of a Licensed Pharmacist 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

16. F425 Pharmaceutical Services 2006 16 Interpretive Guidelines Services of a Licensed Pharmacist Pharmacist collaborates to establish procedures for: Conducting monthly MRR for each resident Addressing time frames Addressing irregularities Documenting and reporting results of review

17. F425 Pharmaceutical Services 2006 17 Interpretive Guidelines Pharmaceutical Services Procedures Acquiring Receiving Dispensing Administering Disposition Labeling and storage of medications

18. F425 Pharmaceutical Services 2006 18 Interpretive Guidelines Pharmaceutical Services Procedures 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

19. F425 Pharmaceutical Services 2006 19 Interpretive Guidelines Pharmaceutical Services Procedures 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

20. F425 Pharmaceutical Services 2006 20 Interpretive Guidelines Pharmaceutical Services Procedures Dispensing Medications - Examples Delivery and receipt Labeling Types of medication packing

21. F425 Pharmaceutical Services 2006 21 Interpretive Guidelines Pharmaceutical Services Procedures Administering 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

22. F425 Pharmaceutical Services 2006 22 Interpretive Guidelines Pharmaceutical Services Procedures 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

23. F425 Pharmaceutical Services 2006 23 Interpretive Guidelines Pharmaceutical Services Procedures 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)

24. F425 Pharmaceutical Services 2006 24 Interpretive Guidelines Pharmaceutical Services Procedures 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

25. F425 Pharmaceutical Services 2006 25 Interpretive Guidelines Pharmaceutical Services Procedures 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

26. F425 Pharmaceutical Services 2006 26 Interpretive Guidelines Pharmaceutical Services Procedures 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.

27. 27 2006 Pharmaceutical Services Investigative Protocol

28. F425 Pharmaceutical Services 2006 28 Pharmaceutical Services Investigative Protocol Use Sub-Task 5E – Medication Pass and Pharmacy Services

29. F425 Pharmaceutical Services 2006 29 Use of Sub-Task 5E: Medication Pass and Pharmacy Services Services of licensed pharmacist Provision of pharmaceutical services

30. 30 2006 Pharmaceutical Services Determination of Compliance

31. F425 Pharmaceutical Services 2006 31 Determination of Compliance Synopsis of Regulation 1. 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

32. F425 Pharmaceutical Services 2006 32 Determination of Compliance Criteria 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

33. F425 Pharmaceutical Services 2006 33 Determination of Compliance Noncompliance 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

34. F425 Pharmaceutical Services 2006 34 Determination of Compliance Potential Tags for Additional Investigation F353 Sufficient Staff F501 Medical Director F520 Quality Assessment and Assurance F514 Clinical Records

35. 35 2006 Pharmaceutical Services Deficiency Categorization

36. F425 Pharmaceutical Services 2006 36 Deficiency Categorization Severity Determination The key elements for severity determination are: Presence of harm or potential for negative outcomes Degree of harm or potential harm related to noncompliance Immediacy of correction required

37. F425 Pharmaceutical Services 2006 37 Deficiency Categorization Severity Determination Levels Level 4 Level 4: Immediate Jeopardy to resident health or safety Level 3 Level 3: Actual harm that is not immediate jeopardy Level 2 Level 2: No actual harm with potential for more than minimal harm that is not immediate jeopardy Level 1 Level 1: No actual harm with potential for minimal harm

38. F425 Pharmaceutical Services 2006 38 Deficiency Categorization Severity Level 4: Immediate Jeopardy 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

39. F425 Pharmaceutical Services 2006 39 Deficiency Categorization Severity 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

40. F425 Pharmaceutical Services 2006 40 Deficiency Categorization Severity Level 2: Potential for Harm Level 2 Level 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

41. F425 Pharmaceutical Services 2006 41 Deficiency Categorization Severity Level 1:Potential for Minimal Harm 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