New FTag 309: Guidance on

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• New F-Tag 309 Guidance on
• Pain Management for
• Nursing Facilities
• Carla McSpadden, RPh, CGP
• Assistant Director, Professional Affairs
• American Society of Consultant Pharmacists

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Disclosures

• I have no financial disclosures.

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Learning Objectives

• 1. Highlight the main points of the new
  Interpretive Guidelines for F-Tag 309 published
  in the CMS State Operations Manual.
• 2. Describe how the consultant pharmacist might
  interact with the surveyor during the facility's
  survey to answer questions about the
  pharmacological treatment of pain.

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Learning Objectives

• 3. Summarize the pertinent clinical practice
  guidelines applicable to pain management in older
  adults that are mentioned in the CMS Interpretive
  Guidelines.
• 4. Discuss how the Minimum Data Set (MDS) and
  Quality Measure reports can be utilized by
  consultant pharmacists when evaluating pain
  management.
•  

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Learning Objectives

• 5. Discuss the regulatory implications for
  long-term care pharmacies in regards to timely
  delivery of pain medications.
•  

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F-309 Quality of Care

• Each resident must receive and the facility
  must provide the necessary care and services to
  attain or maintain the highest practicable
  physical, mental, and psychosocial well-being, in
  accordance with the comprehensive assessment and
  plan of care.

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Re Pain, which residents will surveyors review?

• Any resident
• Who states he/she has pain or discomfort
• Who displays possible indicators of pain that
  cannot be readily attributed to another cause
• Who has a disease or condition or who receives
  treatments that cause or can reasonably be
  anticipated to cause pain

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Re Pain, which residents will surveyors review?

• Any resident
• Whose assessment indicates that he/she
  experiences pain
• Who receives or has orders for treatment for
  pain
• Who has elected a hospice benefit for pain
  management

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Mention of Consultant Pharmacist

• Because complimentary/alternative medicine can
  include herbal supplements, some of which
  potentially can interact with prescribed
  medications, it is important that any such agents
  are recorded in the residents chart for
  evaluation by the physician and consultant
  pharmacist.

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Mention of Consultant Pharmacist

• The interdisciplinary team (nurses,
  practitioner, pharmacists, etc.) is responsible
  for developing a pain management regimen that is
  specific to each resident who has pain or who has
  the potential for pain, such as during a
  treatment.

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Mention of Consultant Pharmacist

• If the interventions or care provided do not
  appear to be consistent with current standards of
  practice and/or the residents pain appears to
  persist or recur, interview one or more health
  care professionals as necessary (e.g., attending
  physician, medical director, consultant
  pharmacist, director of nursing or hospice nurse)
  who, by virtue of training and knowledge of the
  resident, should be able to provide information
  about the evaluation and management of the
  residents pain/symptoms.

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Surveyor Questions, potentially to CP

• How were chosen interventions determined to be
  appropriate?
• How do you guide and oversee the selection of
  pain management interventions?

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Surveyor Questions, potentially to CP

• What is the rationale for not intervening, if
  pain was identified and no intervention was
  selected and implemented?
• What changes in pain characteristics may warrant
  review or revision of interventions?

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Surveyor Questions, potentially to CP

• When and with whom do you discuss the
  effectiveness, ineffectiveness and possible
  adverse consequences of pain management
  interventions?

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Clinical Practice Guidelines

• American Geriatrics Society (AGS) The
  Pharmacological Management of Persistent Pain in
  Older Persons JUST UPDATED!
• www.americangeriatrics.org/education/cp_index.shtm
  l
• American Medical Directors Association (AMDA) -
  Pain Management in the Long-Term Care Setting,
• www.amda.com/tools/guidelines.cfm

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AGS CPG APAP

• APAP as initial and ongoing Tx for persistent
  pain, particularly musculoskeletal
• Do NOT use in Hepatic Impairment, Alcohol
  Dependency
• Not to exceed 4gms / 24hrs

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AGS CPG NSAIDs, COX-2

• NSAIDs and COX-2 to be used only RARELY, with
  EXTREME CAUTION
• Do NOT use in PUD (LOW), Renal Disease, Heart
  Failure
• Also use CAUTION in HTN, H. Pylori, Hx of PUD,
  and concomitant use of steroids or SSRIs
• Plus, routinely assess for these conditions (LOW)

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AGS CPG NSAIDs, COX-2

• NSAID and COX-2/ASA users should receive PPI or
  misoprostol for GI protection
• No more than ONE NSAID/COX-2 at a time (LOW)
• No concomitant use of ASA and Ibuprofen

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AGS CPG Opioids

• Opioids should be considered for all pts with
  (LOW)
• Moderate-severe pain,
• Pain-related functional impairment, or
• Diminished quality of life due to pain
• Around-the-clock dosing for those with
  frequent/continuous pain (LOW)
• Anticipate breakthrough pain and treat with
  short-acting, IR opioids

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AGS CPG Opioids

• Anticipate, assess for, identify adverse effects
• Keep in mind APAP content in opioid combination
  products
• Use methadone cautiously
• Monitor for therapeutic goals, adverse effects,
  etc.

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AGS CPG Adjuvants

• Consider adjuvant analgesics for pts. with
• Neuropathic pain
• Fibromyalgia
• Other types of refractory persistent pain (e.g.,
  back pain, headache, diffuse bone pain, etc.)
  (LOW)
• Tertiary tricyclic antidepressants should be
  AVOIDED

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AGS CPG Adjuvants

• May be used alone, but often more effective in
  combo with other analgesics
• Start low, go slow, but some adjuvants have
  delayed onset of action (e.g., gabapentin 2-3
  wks)
• Adequate trial before discontinuation (LOW)

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AGS CPG Others

• Corticosteroids reserved for pain-associated
  inflammatory disorders or metastatic bone pain
  (not osteoarthritis)
• Consider topical lidocaine for
• All pts. with localized neuropathic pain
• Pts. with localized, NON-neuropathic pain (LOW)

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AGS CPG Others

• Consider topical NSAIDs for all pts. with
  NON-neuropathic pain
• Other topicals (capsaicin, menthol) may be
  considered for regional pain syndromes
• Other agents may require caution and warrant
  further research (e.g., glucosamine etc.) (LOW)

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Things to think about or consider

• Are there any meds that can CAUSE pain??

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Things to think about or consider

• Are there meds that SECONDARILY provide
  analgesia?
• Good to remember if youre looking for a
  dual-purpose med
• Important to know if that med gets decreased or
  discontinued Pain should be evaluated shortly
  thereafter

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Things to think about or consider

• Trial of APAP prior to initiation of
  psychotropic secondary to distressed behaviors?
• Routinely review PRN analgesic utilization If
  frequent, recommend scheduled analgesic

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Things to think about or consider

• Evidence or risk/benefit analysis for off-label
  use of meds as adjuvant analgesics
• Resident may accept partial pain relief in order
  to experience fewer side effects

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Things to think about or consider

• Identify who is to be involved in managing the
  pain and implementing the care or supplying the
  services (e.g., facility staff, attending
  physician, hospice, therapist, pharmacist)

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Things to think about or consider

• Predict pain when possible, and treat
  accordingly
• Pressure ulcers
• Diabetes with neuropathic pain
• Immobility
• Amputation
• Post-CVA
• Venous and arterial ulcers
• Multiple sclerosis
• Oral health conditions
• Infections
• Moving a resident
• Physical or occupational therapies
• Changing a wound dressing

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Minimum Data Set (MDS)

• Completion of the pain questions on MDS does not
  remove facility's responsibility to document a
  more detailed pain assessment

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Minimum Data Set (MDS)

• MDS 2.0 Section J
• Frequency
• Intensity
• Pain sites
• DRAFT MDS 3.0 Section J
• On scheduled pain medication regimen?
• Received PRN pain medications?
• Received non-medication intervention for pain?

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Minimum Data Set (MDS)

• DRAFT MDS 3.0 Section J
• Pain presence in last 7 days? Y/N
• How much of time in pain in last 7 days?
• Pain made it hard to sleep?
• Pain limited daily activities?
• Rate worst pain over last 7 days, numeric and
  verbal descriptor
• Indicators of pain (verbal and non-verbal)
• Adequacy of treatment regimen to control pain

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Minimum Data Set (MDS)

• Other MDS sections as potential indicators of
  pain
• Sleep cycle
• Change in mood
• Decline in function
• Instability of condition
• Weight loss
• Skin conditions

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Quality Measure Pain

• Long-term QM
• Percent of residents who have moderate-severe
  pain
• Short-stay QM
• Percent of short-stay residents (facility stay
  less than 30 days) who had moderate-severe pain

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Quality Measure Pain

• Proper coding of MDS is essential to ensure
  accurate QM reports
• Residents who are receiving pain management, but
  who have experienced no pain, should be coded as
  No Pain on the MDS

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Other Quality Measures/ Indicators

• Additional QIs QMs to take a look at
• Incidence of new fractures
• Prevalence of falls
• Prevalence of pressure ulcers
• Ask for list of residents experiencing a fall,
  accident, fracture, new pressure ulcer in the
  past month
• Help prevent a Sentinel Event through
  prophylactic laxative use in residents taking
  opioids

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Analgesics with Warnings

• Analgesics with Black Box Warnings
• Propoxyphene, opioids, fentanyl
• Analgesics on the Beers list
• Propoxyphene, meperidine, indomethacin,
  amitriptyline,
• NSAIDs, ASA gt 325mg, etc.
• Analgesics in Table 1 of F-Tag 329
• Acetaminophen gt4gms, NSAIDs and celecoxib,
• propoxyphene, opioids, pentazocine

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FDA Actions
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FDA Adv. Panels Recommendations re APAP

• Do you recommend that the maximum total daily
  dose (4 grams/day) of acetaminophen in
  nonprescription single ingredient and combination
  products be lowered? YES
• Do you recommend that the maximum nonprescription
  single adult dose be limited to 650 mg? YES

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FDA Ad Panels Recommendations re APAP

• If the current doses of nonprescription products
  are lowered, do you recommend that the current
  maximum dosage of acetaminophen (i.e., 2 x 500
  mg) be switched to prescription status? YES
• Do you recommend that pack size limits be
  implemented for nonprescription acetaminophen
  products? NO
• Do you recommend eliminating nonprescription
  acetaminophen combination products? NO

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FDA Ad Panels Recommendations re APAP

• Do you recommend that only one concentration of
  nonprescription acetaminophen liquid be
  available? YES
• Do you recommend eliminating the prescription
  acetaminophen combination products? YES
• If prescription acetaminophen combination
  products continue to be marketed, do you
  recommend that unit-of-use packages be
  required? YES
• Do you recommend that FDA require a boxed warning
  for prescription acetaminophen combination
  products? YES

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FDA Propoxyphene

• July 7 FDA requires propoxyphene mfrs to
  strengthen label (Black Box Warning, Med Guide)
• Requiring new safety study to evaluate effects of
  higher doses on heart
• Partnering with CMS and VA to calculate
  propoxyphene usage among older adults and to
  evaluate safety profile compared to other
  analgesics
• Future regulatory action possible

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Timely Dispensing Administration

• Surveyors directed to Determine if the
  medications required to manage a residents pain
  were available and administered as indicated and
  ordered at admission and throughout the stay.
• If not, F-Tag 425 (Pharmacy Services) can also
  potentially be cited

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Operational Issues

• Range orders
• Q4H prn moderate-severe pain
• 1-2 tabs Q4H
• Stat or Now orderswhen are they
  administered in your facilities?

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DEA Controlled Orders

• Need full Rxs for all controlled substances for
  nowsignature, quantity, etc.
• CIII-Vs (CIIs in emergency) can be phoned in by
  MD or MDs employee, but probably not LTC nurse
  Also must verify person calling in
• CIIstake advantage of partial fill up to 60 days
• Proactively seek new Rxs for CIIs maintain
  tracking/reminder system
• Do not use emergency allowance for every CII
  order

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Questions?
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Assessment Questions

• 1. The regulations at F-Tag 309 pertain to
  quality of care, which encompasses pain as well
  as other clinical/care issues.
• True
• False

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Assessment Questions

• 2. Which of the following conditions or
  activities may cause or contribute to pain and
  should be addressed proactively?
• a) Denture re-fit
• b) Neuropathic pain secondary to diabetes
• c) Wound debridement
• d) All of the above

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Assessment Questions

• 3. Which of the following is the most
  appropriate/clear order for a PRN analgesic?
• a) Hydrocodone 5/500mg 1-2 tabs PO Q4H PRN
  breakthrough pain (1 tabpain scale 3-5 2 tabs
  pain scale 6-8)
• b) Hydrocodone 5/500mg 1 tab PO Q4-6H PRN
  pain
• c) Hydrocodone 5/500mg 1-2 tabs PO Q4H PRN
  moderate-severe pain

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Assessment Questions

• 4. Residents who are receiving pain management,
  but who have experienced no pain, should be coded
  as having pain on the MDS 2.0.
• a) True
• b) False

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Assessment Questions

• 5. Complimentary/alternative medicine options,
  such as herbal supplements, are not approved by
  the FDA therefore, consultant pharmacists are
  not required to review them as part of their
  medication regimen review.
• a) True
• b) False