Copyright 2006 American Society of Consultant Pharmacists

1. CMS Interpretive Guidelines: Pharmacy Services and Unnecessary DrugsCarla Saxton McSpadden, RPh, CGPAssistant Director of Policy and AdvocacyAmerican Society of Consultant Pharmacists Copyright 2006 American Society of Consultant Pharmacists

2. Timeline for Pharmacy Tags • Reminder: Appendix N Deleted - Effective June 2004 • Pharmacy Services and Unnecessary Medications • Released for 1st public comment period - October 2004 • 1st Comment period ended - January 2005 • Expert panels reconvened - April 2005 • Due to significant number of comments received during 1st comment period and subsequent revisions, a 2nd draft was released September 2005 • Expert panels reconvened again - December 2005/January 2006 • Final documents released - September 15, 2006 • Effective date/implementation scheduled for DECEMBER 18, 2006 c 2006 ASCP

3. Tags Combined • Unnecessary Medications • New Tag F329 = Old Tags F329, F330, F331 • Unnecessary Drugs • Pharmaceutical Services • New Tag F425 = Old Tags F425, F426, and F427 (b) (1) • Pharmaceutical Services, Procedures, Consultation • New Tag F428 = Old Tags F428, F429, F430 • DRR/MRR • New Tag F431 = Old Tags F427 (b) (2) and (3), F431, F432 • Control, Labeling, and Storage c 2006 ASCP

4. SOM Components • Appendix P: Survey Protocol for LTC • Task 5 – text added that describes the assessment of pharmaceutical services • Sub-Task 5A – text revised to state that each surveyor completing a medication pass observation will review drug storage on their assigned units • Sub-Task 5C – text added to guide the surveyor to use the investigative protocol for F329 for each Resident Review, DELETED adverse drug reactions section of 5C, part G3 • Sub-Task 5E – complete revision of text and renaming of 5E as Medication Pass and Pharmacy Services c 2006 ASCP

5. SOM Components • Appendix PP: Interpretive Guidelines for LTC • Regulations (Haven’t Changed) • Interpretive Guidelines, or Guidance to Surveyors • Investigative Protocol • New combined investigative protocol for Unnecessary Medications (F329) and Medication Regimen Review (F428) • Deficiency Categorization/Severity Guidance c 2006 ASCP

6. Training of surveyors • Representatives from each state survey agency will be attending 2-day train-the-trainer session in Baltimore this week (including association representatives); They will receive info/tools to bring back to their state for training of other surveyors • Satellite/webcast training sessions in December; registration/info available at: • http://cms.internetstreaming.com c 2006 ASCP

7. Key Points • Care Process - Looking at patient and medication regimen holistically • Importance of all aspects of medication management • When taking multiple meds, risks and benefits of any one must be viewed in relation to the entire regimen • Broadening focus beyond psychoactive medications • Additional guidance on: • Monitoring for effectiveness • Assessing possibility that med may paradoxically cause/exacerbate symptoms it was intended to treat/prevent c 2006 ASCP

8. F425 - Pharmaceutical ServicesRegulations • The facility must: • Provide routine and emergency medications and biologicals to its residents, or obtain them under an agreement • Provide pharmaceutical services including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all medications and biologicals to meet the needs of each resident • Employ or obtain the services of a licensed pharmacist who provides consultation on all aspects of the provision of pharmacy services in the facility • The facility may: • Permit unlicensed personnel to administer medications if state law permits, but only under the general supervision of a licensed nurse. c 2006 ASCP

9. Pharmacy Services - What does it say now? • Interpretive Guidelines • The facility is responsible for the timeliness of the services • A drug, whether prescribed on a routine, emergency, or as needed basis, must be provided in a timely manner; If failure to provide a prescribed drug in a timely manner causes the resident discomfort or endangers his or her health and safety, then this requirement is not met • Survey Procedures • During the surveyor’s observation of the drug pass, are all ordered medications available? c 2006 ASCP

10. New F425 - Overview • Provision of Medications • Timeliness/Availability to meets needs of each resident • Services of a Pharmacist • “The pharmacist is responsible for helping the facility obtain and maintain timely and appropriate pharmaceutical services that support residents’ healthcare needs, that are consistent with current standards of practice, and that meet state and federal requirements.” • Pharmaceutical Services Procedures • Acquiring - Administering • Receiving - Disposal • Dispensing - Labeling/Storage, incl. CSs • Authorized personnel c 2006 ASCP

11. F425 - Pharmaceutical ServicesProvision of Meds • Factors that may help determine timeliness and guide procedures for acquisition include: • Availability of meds to enable continuity of care for anticipated admission or transfer • Condition of resident (e.g., severity/instability of condition, current S+S, potential impact of a delay) • Category of medication (e.g., antibiotic, pain) • Availability of medications in emergency supply • Ordered start time c 2006 ASCP

12. Considerations Regarding Timeliness • Do you have a mechanism/process to identify and prioritize the communication of new medication orders and new admits? • Do facility staff know to tell and pharmacy staff know to ask whether a re-admit needs a supply of their medications re-sent? • Do you have a way to identify and ‘fast-track” antibiotics, pain medications, and other “acute condition” treatments (e.g., N/V)? c 2006 ASCP

13. Considerations Regarding Timeliness • Do you periodically look at E-Kit utilization and medications dispensed after-hours to evaluate whether medications need to be added to or deleted from the E-Kit? • Do nursing facility staff prompt or encourage MD/NPs to utilize medications in the E-Kit when they are prescribing medications after-hours? Do the MD/NPs servicing residents in your facility have copies of or off-site access to the list of E-Kit contents? c 2006 ASCP

14. Considerations Regarding Timeliness • Do your state rules/regulations and/or the facility’s policies and procedures and/or your pharmacy contract mention specific medication delivery/ administration timeframes? • Are your staff aware of any of the above rules/policies? Are they aware of the timeliness stipulation in the regulatory guidance? c 2006 ASCP

15. F425 - Pharmaceutical ServicesPharmacist Services • Services of a Pharmacist • “The pharmacist is responsible for helping the facility obtain and maintain timely and appropriate pharmaceutical services that support residents’ healthcare needs, that are consistent with current standards of practice, and that meet state and federal requirements.” • Consultant pharmacist’s responsibilities, in collaboration with the facility, MAY include: • Coordinating pharmaceutical services if and when multiple service providers are utilized, for example: • Multiple pharmacies • Infusion provider • Hospice • Prescription Drug Plan (PDP) c 2006 ASCP

16. F425 - Pharmaceutical ServicesProcedures • Pharmaceutical Services Procedures • Acquiring • Receiving • Dispensing • Administering • Labeling/Storage, including controlled substances • Disposal • Authorized personnel c 2006 ASCP

17. Policies and Procedures • First, you need them! • And, you need to educate and train staff about them - including PRN staff! Both PHARMACY and FACILITY STAFF! • And, you need to use them! • And, you need to revisit them occasionally! • If your contract is fairly specific, make sure policies and procedures are consistent with it • Look at F425 (+other tags) for examples of what to address in your policies and procedures, as it specifically outlines topics that can serve as a guideline for reviewing/writing your P+Ps c 2006 ASCP

18. Examples of P+Ps • E-Kits (from F425) • “Availability of an emergency supply of medications, if allowed by state law, including… • 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 • Steps for replacing the supply when medications are used” c 2006 ASCP

19. Examples of P+Ps • IVs (from F425) • “Intravenous (IV) therapy procedures if used within the facility (consistent with state requirements) may include… • Determining competency of staff • Facility-based IV admixture procedures that address… • Sterile compounding • Dosage calculations • IV pump use • Flushing procedures” c 2006 ASCP

20. Examples of P+Ps • IVs (from F431) • “Label contains… • Name and volume of the solution • Resident’s name • Infusion rate • Name and quantity of each additive • Date of preparation • Initials of compounder • Date and time of administration • Initials of person administering medication, if different than compounder • Ancillary precautions, as applicable • Date after which the mixture must not be used” c 2006 ASCP

21. Examples of P+Ps • Receipt of medications by facility (from F425) • “How the receipt of medications from dispensing pharmacies (and family members or others, where permitted by state requirements) will occur • 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 • 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” c 2006 ASCP

22. Examples of P+Ps • Disposal of medications (from F425) • “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/quantity • prescription number (as applicable) • date of disposition • involved facility staff, consultant(s) or other applicable individuals • Method of disposition consistent with applicable state and federal requirements, local ordinances, and standards of practice” c 2006 ASCP

23. F428 - MRRRegulations • The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist • The pharmacist must report any irregularities to the attending physician and the director of nursing • And,these reports must be acted upon c 2006 ASCP

24. Are once monthly drug regimen reviews performed by a pharmacist still required? • Yes - this is a regulatory requirement; therefore, it has not changed • As stated in both the new guidelines and the current guidelines, there is mention of more frequent reviews when necessary, depending on: • Resident’s condition • Risks for adverse consequences related to medications c 2006 ASCP

25. F428 - MRR • What is MRR? • Definition in glossary: “Thorough evaluation of the medication regimen of a resident, with the goal of promoting positive outcomes and minimizing adverse consequences associated with medications; The review includes preventing, identifying, reporting, and resolving medication-related problems (MRPs), medication errors, or other irregularities and collaborating with others members of the interdisciplinary team.” c 2006 ASCP

26. F428 - MRRWhere to Conduct the Review • Generally within facility because important info may be attainable only by talking to staff, reviewing “paper” chart, observing/speaking with resident • BUT new technology (electronic health records) may permit the PHARMACIST to conduct some components of the review outside of the facility c 2006 ASCP

27. F428 - MRRMRR Considerations • MRR considers factors, such as: • Has MD/staff documented objective findings, diagnoses, symptoms to support indication? • Has MD/staff identified and acted upon, or should they be notified about, resident’s allergies, potential interactions/averse consequences? • Is dose, frequency, route, duration consistent with resident’s condition, manufacturer’s recommendations, and applicable standards of practice? c 2006 ASCP

28. F428 - MRRMRR Considerations • Has MD/staff documented progress towards or maintenance of the goal(s) for medications therapy? • Has MD/staff obtained and acted upon lab results, diagnostic studies, or other measurements? • Do med errors exist or do circumstances exist that make errors likely to occur? c 2006 ASCP

29. F428 - MRRMRR Considerations • Has MD/staff noted and acted upon possible medication-related causes of recent or persistent changes in the resident’s condition?…think “Geriatric Syndromes” • Anorexia and/or unplanned weight loss, or weight gain • Behavioral changes, unusual behavior patterns • Bowel function changes • Confusion, cognitive decline, worsening of dementia • Dehydration, fluid/electrolyte imbalance • Depression, mood disturbance • Dysphagia, swallowing difficulty • Excessive sedation, insomnia, or sleep disturbance c 2006 ASCP

30. F428 - MRRMRR Considerations • Falls, dizziness, impaired coordination • GI bleeding • Headaches, muscle pain, generalized aching/pain • Rash, pruritis • Seizure activity • Spontaneous or unexplained bleeding, bruising • Unexplained decline in functional status • Urinary retention or incontinence c 2006 ASCP

31. F428 - MRRNotification of Findings • Pharmacist is expected to document either that no irregularity was identified or the nature of the irregularity(ies), if any were identified • If none, pharmacist would include a signed and dated statement to that effect • Different iterations of this requirement throughout the various drafts, but final focus is on the use of the word “report” as a verb rather than a noun c 2006 ASCP

32. F428 - MRRNotification of Findings • Timeliness of notification depends on potential for or presence of serious adverse consequences • Examples include: • Bleeding resident on anticoagulants • Possible allergic reactions to antibiotic • Collaborate with facility to identify the most effective means of notification/documentation • Notification/documentation may be done electronically c 2006 ASCP

33. F428 - MRRNotification of Findings • Pharmacist’s findings are part of clinical record • If not maintained within active clinical record, it must still be maintained within facility and readily available • Find balance between: • Encouraging/facilitating other HC professionals to utilize • Allowing facilities flexibility in determining a consistent location that suits their needs c 2006 ASCP

34. F428 - MRRResponse to Findings • Physician either: • Accepts recommendation and acts, OR • Rejects the recommendation and provides a brief explanation, such as in a dated progress note • “It is not acceptable for a physician to document only that he/she disagrees with the report without providing some basis for disagreeing.” • For those direct care issues that do not require physician intervention, DON or designated nurse can address and document action taken c 2006 ASCP

35. F428 - MRR: Response to Findings Current (‘old’) Interpretive Guidelines • The director of nursing and the attending physician are not required to agree with the pharmacist’s report, • Nor are they required to provide a rationale for their acceptance or rejection of the report • They must, however, act upon the report • This may be accomplished by indicating acceptance or rejection of the report and signing their names • The facility is encouraged to provide the medical director with a copy of drug regimen review reports and to involve the medical director in reports that have not been acted upon c 2006 ASCP

36. F428 - MRRLack of Action or Rejection • What about when MD does not act upon or rejects MRR report/recommendations and there is the potential for serious harm? • Facility and CP should contact Medical Director, OR • When attending and MD are same, follow established facility procedure to resolve the situation • No specific timeframe provided for when a report that is not acted upon officially becomes delinquent or “not acted upon” c 2006 ASCP

37. F428 - MRRLack of Action or Rejection • What about continuing to document an issue that the physician has disregarded or rejected? • “Pharmacist does not need to document a continuing irregularity each month if it’s deemed to be clinically insignificant or there is evidence of valid clinical reason for rejection” • “In these situations, pharmacist need only reconsider annually whether to report again or make new recommendation.” c 2006 ASCP

38. F431- Storage, Labeling, Controlled MedsRegulations • The facility must employ or obtain the services of a licensed pharmacist who: • Establishes a system of records of receipt and disposition of all controlled medications in sufficient detail to enable an accurate reconciliation • Determines that medication records are in order and that an account of all controlled medications is maintained and periodically reconciled c 2006 ASCP

39. F431- Storage, Labeling, Controlled MedsRegulations • Labeling… • Medications and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions and expiration date when applicable • Storage… • In accordance with state and federal laws/requirements, the facility must store all medications and biologicals in locked compartments under proper temperature controls and permit only authorized personnel to have access (to the keys) c 2006 ASCP

40. F431- Storage, Labeling, Controlled MedsRegulations • Controlled Meds… • The facility must provide separately locked, permanently affixed compartments for storage of controlled medications listed in Schedule II…and other medications subject to abuse, except when the facility uses single unit package medication distribution systems in which the quantity stored is minimal and a missing dose can be readily detected c 2006 ASCP

41. F431 - LabelingNew Key Points • Facility ensures labeling in response to order changes is accurate and consistent with state requirements (I.e., nurse cannot re-label or alter label) • For meds designed for multiple administrations - “Multi-Dose” (e.g., inhalers, eye drops, etc), label is affixed in manner to promote administration to resident for whom it was prescribed • In other words, if there isn’t space for an entire label, still better have - at least - resident’s name on actual product container c 2006 ASCP

42. F431 - LabelingNew Key Points • For compounded IV preparations, label contains: • Name and volume of solution • Resident’s name • Infusion rate • Name and quantity of ach additive • Date of preparation • Initials of compounder • Date and time of administration • Initials of person administering medication if different than compounder • Ancillary precautions, as applicable • Date after which mixture must not be used (i.e., expiration date) c 2006 ASCP

43. F431 - LabelingNew Key Points • For OTCs in bulk containers (in states that permit), label contains: • Original manufacturer’s OR pharmacy-applied label indicating: • Medication name • Strength • Quantity • Accessory instructions • Lot number • Expiration date, when applicable • If resident-specific supply of OTC, label contains above plus resident’s name c 2006 ASCP

44. F431 - Access and StorageNew Key Points • Access can be controlled by keys, security codes or cards, or other technology (e.g., fingerprints) • Med pass… • During a med pass, medications must be under the direct observation (vs. control) of the person administering the medications or locked in the med storage area/cart • Self-administration… • Important that the facility have procedures for the control and safe storage of medications for those residents who can self-administer c 2006 ASCP

45. F431 - Access and StorageNew Key Points • Temperature, light, humidity… • Important that facility implement procedures that address and monitor the safe storage and handling of medications in accordance with manufacturer specifications, state requirements, and standards of practice (e.g., USP) c 2006 ASCP

46. F329 - Unnecessary Meds Regulations • Each resident’s medication regimen must be free from unnecessary medications. An unnecessary medication is any medication when used: • In excessive doses (including duplicate therapy); or • For excessive duration; or • Without adequate monitoring; or • Without adequate indications for its use; or • In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or • Any combinations of the reasons above c 2006 ASCP

47. F329 - Unnecessary Meds Regulations • Antipsychotics - Based on a comprehensive assessment of a resident, the facility must ensure that: • Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and • Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs c 2006 ASCP

48. F329 - Medication Management as part of the Care Process • Indications for use of the medication; • Monitoring for efficacy and adverse consequences; • Dose and duplicate therapy; • Duration; • Reevaluation and Tapering of a medication; • Prevention, identification, and response to adverse consequences. c 2006 ASCP

49. F329 - Unnecessary MedsGeneral • Diagnosis alone may not warrant treatment with medication • PRN meds - important to evaluate and document: • Indication(s) • Specific circumstances for use • Frequency of administration • Orders from multiple prescribers can increase resident’s chances of receiving unnecessary meds • Although the guidelines generally emphasize the older adult resident, adverse consequences can occur at any age; therefore, these requirements apply to residents of all ages c 2006 ASCP

50. F329 - Unnecessary MedsGeneral • Lab tests (i.e., serum medication concentrations) are only rough guide • Significant adverse consequences can occur even with lab results are within therapeutic range • Lab results alone warrant evaluation, but do not necessarily warrant dose adjustment c 2006 ASCP