Copyrighted - American Society of Consultant Pharmacists - September 29,

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Practical Tips to Prepare for and Implement the New Pharmacy Sections of the Nursing Home Survey Guidelines Carla Saxton McSpadden, RPh, CGP Assistant Director of Policy and Advocacy American Society of Consultant Pharmacists 1 POLL QUESTION #1 Did you participate in ASCP s first webcast on the SOM changes? 2 POLL QUESTION #2 How would you describe your primary responsibilities or job title? 3 29, 2006 1

F425 - Provision of Medications Key point: Timeliness/availability of medication acquisition and administration to meets the needs of each resident 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 4 Evaluation of Timeliness by CP Were meds available soon after admission/transfer? Is there evidence in chart that resident complained of signs/symptoms prior to med delivery/administration? Were emergency med orders administered ASAP, either via E-Kit or pharmacy STAT delivery? Were all antibiotics and pain medications available and administered ASAP? 5 Evaluation of Timeliness by CP If the medication ordered was in the E-Kit, was it taken out rather than waiting for delivery from pharmacy? Were any meds ordered with specific start times? If so, were they started by the specified time? Do the facility policies require that specific meds or med classes be started within a certain amount of time? If so, were those medications started within that timeframe? 6 29, 2006 2

Considerations for Pharmacy Regarding Timeliness Do you have a mechanism/process in your pharmacy to identify and prioritize the completion of new medication orders and new admits versus all orders (reorders and new) mixed together? 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)? 7 Considerations for Pharmacy 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? Does 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(ies) have copies of or off-site access to the E-Kit contents? 8 Considerations for Pharmacy Regarding Timeliness Does your state rules/regulations and/or the facility s policies and procedures and/or your contract with the facility mention specific medication delivery/ administration timeframes? Is your pharmacy staff (pharmacists, technicians, etc) aware of any of the above rules/policies? Are they aware of the timeliness stipulation in the regulatory guidance? 9 29, 2006 3

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 and can serve as a guideline for reviewing/writing your P+Ps And, look to see if any forms you use include this info 10 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 11 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 12 29, 2006 4

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 13 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 14 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 15 29, 2006 5

Examples of ways in which to Based on these. F425: 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 F329: An evaluation of the resident helps to identify his/her needs, comorbid conditions, and prognosis to determine factors (including medications and new or worsening medical conditions) that are affecting signs, symptoms, and test results. This evaluation process is important when making initial medication/intervention selections and when deciding whether to modify or discontinue a current medication intervention 16 Examples of ways in which to You might want to help them develop a process/form that prompts them to ask certain medication-related questions to the MD/NP when notifying them about a new problem, medicationrelated problem, or when obtaining a new medication order When a problem is being reported to MD/NP among the general assessment info they collect and pass along, you might suggest obtaining and communicating the following info: Non-pharmacological interventions tried Previously attempted medications to treat same or similar problem and response Current medications and diagnoses/conditions Allergies/Sensitivities What was the reaction? 17 Examples of ways in which to Resident goals/preferences, for example - are they in a hospice program, near end-of-life, or does their Advance Directive state anything about medications? See Minimum Data Set (MDS), Section J (Health Conditions), Question 5 - If checked, they have endstage disease with 6 or fewer months to live See MDS, Section P (Special Treatments and Procedures) - if (O) is checked under Question 1a, they are in a hospice program See MDS, Section A, Question 10 - if (G) is checked, they have medication restrictions mentioned in their Advance Directive 18 29, 2006 6

Examples of ways in which to You may suggest they use a standard form/process for taking a new medication order, including: Medication? Strength? Dosage form? Dose? Frequency? Specific times? With or without food? Routine/Scheduled or PRN? Indication? Should a new diagnosis be added to resident s record? If PRN, what are the specific circumstances for use? Are there any exceptions to administration (e.g., BP or pulse less than X)? 19 Examples of ways in which to Duration? Monitoring We ll know it s working if. Something might be wrong if. What to monitor? When to monitor? How/By Whom should monitoring occur? When to follow-up with or contact MD/NP? This will help to: Prompt the MD/NP to address Unnecessary Med issues upfront Provide more documentation/evidence about the clinical rationale and expectations associated with the medication - protects the facility if a surveyor were to walk in Reduce the need for future clarification by the pharmacy 20 POLL QUESTION #3 Do you feel like your facility(ies) already collect this level of detailed info when reporting a new problem to the MD/NP or when taking a new medication order? 21 29, 2006 7

Examples of ways in which to EDUCATION!! Examples of educational opportunities/in-services that might be of benefit to the facility Policies and procedures regarding pharmacy services, including: Where to find the P+P manual What s in the manual Other pharmacy-related How-To s that aren t mentioned in the manual - such as:» How to request a reorder» To whom to ask billing questions» How to contact pharmacy after-hours Maybe also include an overview of what the consultant pharmacist does within the facility 22 Examples of ways in which to Examples of educational opportunities/in-services that might be of benefit to the facility Medications and Falls Falls are mentioned 15 times in F329, 14 of those incidences are regarding specific medications or classes with the potential to cause or contribute to falls Plus, falls are mentioned in F428 as a geriatric syndrome that should be evaluated for its potential connection to medication use And, falls are documented on MDS and trigger Quality Indicators (QIs) 23 Examples of ways in which to Examples of educational opportunities/in-services that might be of benefit to the facility IV Medications, as mentioned before Disposal of medications, as mentioned before Labeling Labeling preparations compounded or prepared in facility Labeling OTC bulk/stock items Properly dealing with label changes when medication order changes Indicating Date Opened on multi-dose products 24 29, 2006 8

Examples of ways in which to Examples of education opportunities/in-services that might be of benefit to the facility Medication error reporting Mentioned 5 times in F425 guidelines Included in definition of pharmaceutical services and medication regimen review (MRR) Mentioned in 3 examples of F425 deficiencies Manifestations of geriatric syndromes and how they can actually be medication-related problems Run a utilization report for the most frequently used medications in that facility or unit, then train ALL staff (especially front-line staff) on the top 3 (or #X) medications, what they re used for, what to monitor, the most common side effects, etc. 25 Examples of ways in which to In addition to the standard psychotropic medication classes, can you now provide utilization reports for all psychopharmacological medications, as defined in the new guidelines? Can your software system identify medications based on how they re used rather than in which class they fall (e.g, Can diagnosis be matched to medication to facilitate running of reports?) Labeling..of course you should comply with state/federal requirements, but also address specific items mentioned in new guidelines, such as: Multi-dose product labeling Adding a Date Opened auxiliary label to top of container, reminding staff of such documentation Affixing partial or additional label on product container, in addition to label on outer container 26 Examples of ways in which to Provide or recommend drug information references/resources F425: Recommending current resources to help staff identify medications and information on contraindications, side effects and/or adverse effects, dosage levels, and other pertinent information F329: The facility s pharmacist is a valuable source of information about medications. Listings or descriptions of most significant risks, recommended doses, medication interactions, cautions, etc. can be found in widely available, standard references, and computer software and systems that provide up-to-date information Don t forget to consider How the facility will learn about new FDA warnings/alerts as they are released How often the reference/resource will be updated or replaced and whose responsibility it will be to do this 27 29, 2006 9

Examples of ways in which to F425: A pharmacist can also help in the development of medication-related documentation procedures, such as identification of abbreviations approved for use in the facility It s also a JCAHO Requirement Resources: http://www.jointcommission.org/patientsafety/nationalpa tientsafetygoals/abbr_tips.htm http://www.ismp.org/tools/errorproneabbreviations.pdf http://www.medpass.com/shopping/shopexd.asp?id=3065&marketid=12 00000&CategoryID=1211900 28 Considerations for Medication Regimen Review (MRR) Procedures for conducting MRR for each resident Expected time frames for conducting and reporting Addressing irregularities Documenting and reporting results Addressing MRRs for residents: anticipated to stay less than 30 days who experience an acute change in condition as identified by facility staff» How and when the need for a consultation will be communicated» How the medication review will be handled if the pharmacist is off-site» How the results or report of their findings will be communicated to the physician» Expectations for the physician s response and followup» How and where this information will be documented 29 Considerations for Medication Regimen Review (MRR) Ways to help identify those short-stay residents and/or residents with acute changes in condition (This also provides useful info, in general, and helps identify specific residents on which to focus when conducting MRR). CHANGE IN CONDITION Ask facility for a list of residents for which a Change in Condition MDS was completed - Section AA and/or A of MDS, Question 8 (a) will be answered with a 3 if the resident has experienced a significant change in status. Ask for or look up which residents have triggered Section J, Question 1 of MDS, as this indicates new problems present in the last 7 days 30 29, 2006 10

Considerations for Medication Regimen Review (MRR) Ask for or look up which residents have triggered Section P, Questions 5, 6, 7, 8, or 9 (5) - Hospital Stays in last 90 days (6) - ER Visits in last 90 days (7) - MD Visits in last 14 days (8) - MD Orders in last 14 days (9) - Abnormal Lab Values in last 90 days SHORT STAY RESIDENTS See Section Q of MDS, Question 1 (c): Stay projected to be of a short duration - discharge projected within 90 days (do not expected discharge due to death): 0. No 1. Within 30 days 2. Within 31-90 days 3. Discharge status unknown 31 POLL QUESTION #4 Did you know the information described in this program could be found on the MDS? (Be honest.) 32 Considerations for Medication Regimen Review (MRR) How can Quality Indicators (QIs), Quality Measures (QMs), and Resident Assessment Protocols (RAPs) help me during MRR? Many of the QIs, QMs, and RAPs correlate with the list of Geriatric Syndromes and other manifestations of medication-related problems mentioned in F428 and F329 Ask the facility for QI reports and RAPs You can find QM info on the Nursing Home Compare website: http://www.medicare.giv/nhcompare 33 29, 2006 11

POLL QUESTION #5 When you re consulting, do you request and utilize the QIs, QMs, and/or RAPs? 34 Considerations for Medication Regimen Review (MRR) When should I implement the new gradual dose reduction/tapering guidelines? Probably not wise to initiate dose reduction attempts on every psychopharmacological medication for every resident in December, just to comply with guidelines Might be more prudent, on an individual basis, to evaluate past gradual dose reduction/tapering attempts when considering future attempts don t necessarily want the burden of managing dose reductions on a multitude of residents at one time 35 Considerations for Medication Regimen Review (MRR) Consider proactive MRR by dispensing pharmacist F425: 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 F428: Transitions in care such as a move from home or hospital to the nursing home, or vice versa, increases the risk of medication-related issues. It is important, therefore, to review the medications. Currently, safeguards to help identify medication issues include The pharmacist reviewing the prescriptions prior to dispensing 36 29, 2006 12

Considerations for Medication Regimen Review (MRR) Chances are dispensing pharmacists are most likely already providing proactive MRR, but it may not be identified or labeled as such Do you have a mechanism in place to document these MRR interventions in your pharmacy s software system or through some other means, which can then be communicated to the CP for incorporation into their report or communicated to the facility? What if we had electronic health records?? 37 Reminder of SOM Components Appendix P: Survey Protocol for LTC Task 5E Revised - Now evaluates not only the Medication Pass, but ALSO Pharmacy Services (F425), including Storage/Labeling/Controlled Medications (F431) 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) Severity Guidance 38 Investigative Protocols Be aware there is an increased likelihood that you may be interviewed by the surveyor during a survey For example, combined Investigative Protocol for F329 and F428 states: If problems are identified with the MRR, interview the pharmacist, as indicated, to determine: How he/she conducts the MRR, including the frequency and extent of the medication review and under what circumstances a review might be conducted more often than monthly; How the facility communicates with him/her regarding medication-related issues in specific residents; and How he/she approaches the MRR process for short stay residents 39 29, 2006 13

Investigative Protocols Here are the suggested steps for observation and record review for surveyors in the F329/F428 Investigative Protocol - it outlines a mini-mrr process: Determine if the resident has been transferred to acute care since the last survey and/or has recently (e.g., the previous 3 months) experienced a change in condition or currently has signs and symptoms, such as those previously listed as Geriatric Syndromes If observations or record review indicate symptoms or changes in condition that may be related to medications (refer to Tables I and II, supplemented with current medication references), determine whether the facility considered medications as a potential cause of the change or symptom Cont 40 Investigative Protocols Review the record (including the care plan, comprehensive assessment, and other parts of the record as appropriate) to determine whether it reflects the following elements related to medication management for the resident indication, non-pharmacological interventions, dose, duration, GDR/tapering, monitoring, adverse consequences 41 COORDINATION & COMMUNICATION! Now is the time to begin talking to one another share ideas for implementation, develop a plan for transitioning to the new guidelines, collaboratively write/review/update policies and procedures Have you considered keeping a notebook in the facility so that they can write down pharmacy questions or issues as they arise, then CP can review during his/her visit? 42 29, 2006 14

COORDINATION & COMMUNICATION! Examples of where this is mentioned in new guidelines F425: Develop mechanisms for communicating, addressing, and resolving issues related to pharmaceutical services F425: Interacting with the quality assessment and assurance committee to develop procedures and evaluate pharmaceutical services 43 COORDINATION & COMMUNICATION! Examples of where this is mentioned in new guidelines F329: It is important that the facility clearly identify who is responsible for prescribing and identifying the indications for use of medication(s), for providing and administering the medication(s), and for monitoring the resident for the effects and potential adverse consequence of the medication regimen; This is also important when care is delivered or ordered by diverse sources such as consultants, providers, or suppliers (e.g., hospice or dialysis programs) F425: Coordinate pharmaceutical services if and when multiple pharmaceutical service providers are utilized (e.g., pharmacy, infusion, hospice, prescription drug plans [PDP]) 44 POLL QUESTION #6 Will you be attending the ASCP Annual Meeting coming up in a few weeks in Phoenix? 45 29, 2006 15

POLL QUESTION #7 How many people are attending this webcast at your site? 46 Final Points Walk through your current process for conducting MRRs (if you don t have one, now is the time to get one) while reading through or thinking about new guidelines and figure out how your workflow and thought process will need to change Help your facility(ies) prepare they will be looking to you for guidance 47 Final Points Don t fret every single detail just take good care of the resident, document everything you possibly can, and be knowledgeable about the new guidelines - that s all you can really do! Get to know your Medical Director (if you don t already) they should be your friend, if possible :) 48 29, 2006 16

Final Points Take advantage of this opportunity provide good service at this critical moment and you ll end up with loyal clients/customers and potential increase in business market your knowledge and strengths It s going to be time to re-address your contracts! 49 Thanks everyone!! Questions? Email: csaxton@ascp.com Information available at: www.ascp.com/som 50 29, 2006 17