InformRx CLINICAL & REGULATORY NEWS BY PHARMERICA JULY/AUG 2018 continued on page 2 Pain Management and Opioid Use in the Elderly By Jim Mooney, RPh Pain is common in older adults and is associated with the increased prevalence of conditions such as osteoarthritis and diabetic neuropathy as people age. Pain may be unrecognized by the practitioner and left untreated for a variety of reasons, including the reluctance of the patient to report pain, the patient’s own perception of tolerable pain and fear of potential loss of independence. But when it is treated, prescription pain medications can be abused. On average, there were 731.2 prescriptions for opioids written for every 1,000 persons nationwide. In the past year, 11.8 million people in the US misused prescription drugs or heroin; of those, 2.3 million were first-time users. Statistically, opioid related deaths are listed as the leading cause of accidental death. While federal and state legislatures, agencies and associations are beginning to tackle this crisis, facilities have a role to play as well: stewards. Stewardship defines the appropriate use of resources to preserve them and protect the patient. It is a continuous process that begins with accepting responsibility and continues with accountability for the judicious use of medications, not only for antibiotics but pain medications as well. To help curb inappropriate opioid usage, consider these strategies: • Non-Pharmacologic Interventions: Pain management in older adults should be multifactorial and include non-pharmacologic approaches such as exercise, physical therapy and cognitive behavior therapy to improve
Transcript
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CLINICAL &
REGULATORY
NEWS BY
PHARMERICA
JULY/AUG 2018
continued on page 2
Pain Management and Opioid Use in the ElderlyBy Jim Mooney, RPh
Pain is common in older adults and is associated with the increased prevalence of conditions such as osteoarthritis and diabetic neuropathy as people age. Pain may be unrecognized by the practitioner and left untreated for a variety of reasons, including the reluctance of the patient to report pain, the patient’s own perception of tolerable pain and fear of potential loss of independence. But when it is treated, prescription pain medications can be abused.
On average, there were 731.2 prescriptions for opioids written for every 1,000 persons nationwide. In the past year, 11.8 million people in the US misused prescription drugs or heroin; of those, 2.3 million were first-time users. Statistically, opioid related deaths are listed as the leading cause of accidental death. While federal and state legislatures, agencies and associations are
beginning to tackle this crisis, facilities have a role to play as well: stewards.
Stewardship defines the appropriate use of resources to preserve them and protect the patient. It is a continuous process that begins with accepting responsibility and continues with accountability for the judicious use of medications, not only for antibiotics but pain medications as well. To help curb inappropriate opioid usage, consider these strategies:
• Non-Pharmacologic Interventions:Pain management in older adultsshould be multifactorial and includenon-pharmacologic approaches suchas exercise, physical therapy andcognitive behavior therapy to improve
InformRx PHARMACY NEWS
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function and independence in daily living activities. Simple interventions such as hot or cold packs can often also provide relief. In addition, transcutaneous electronic nerve stimulating (TENS) devices have been shown useful in pain arising from neurologic sources. Once these options have been attempted and no longer provide adequate relief, pharmacologic interventions could be considered in addition to these treatments.
• Opioid Alternatives: Thereare pharmacologic alternativesto the use of opioids, includingacetaminophen, non-steroidalanti-inflammatory agents, topicalanesthetic products for neuralgia,topical counter irritants andmuscle relaxants, all of which canbe attempted prior to the use of an opioid. As with all drug therapy,discontinuation of ineffectivemodalities is recommended priorto adding other medications.
• Safe Opioid Therapy: Startinga pain management regimenwith long-acting opioids shouldbe avoided in older individuals,although low-dose, short-actingagents may be useful in hipor knee osteoarthritis. Beforeinitiating therapy with an opioid,conduct a complete and thoroughevaluation of the patient’smedical history, document andverify current medications,perform a comprehensivephysical examination and includedocumentation of psychiatrics tatus and substance use
Pain Management, cont.
For more information on Pain Management and Opioid Use in the Elderly, contact your PharMerica Consultant Pharmacist.
history. When starting therapy, begin at 25% to 50% of the usual adult dose and slowly up taper. Doses in excess of 60mg morphine equivalent daily dose (MEDD) should be avoided and if the daily dosing requirement exceeds 90mg MEDD, a referral to a pain specialist may be indicated. Remember that high doses of these medications are not associated with improved efficacy but with impaired cognitive function, increased risk of aberrant drug-related behaviors and the potential for opioid induced hyperalgesia.
• Risk Avoidance: Addiction topain medications is always aconcern, and continuing these
medications when there are no indications that they are effective may only exacerbate the risk. Combining these medications with benzodiazepines must be done cautiously and is recommended only for short-term use. Another concern is the risk of diversion of these medications, particularly when dealing with cognitively impaired residents. Access to the medications must be controlled, and strict accountability is imperative. Adhere to the current accountability process in place in your facility, take it seriously and scrupulously follow the procedures put in place to protect the patient and the caregiver from unwarranted suspicion.
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Checklists for Compliance: Prepare for the Survey WindowBy Lynn Johnson, RPh
InformRx F-TAG FOCUS
On September 28, 2016, CMS revised the SNF and NF Requirements of Participation, which have a three-part implementation phase-in. We made it through Phase 1, Phase 2 is now in full swing, and Phase 3 will go into effect November 28, 2019. So when can you expect the new survey team?
Surveys are unannounced. But every long-term care facility is required to have at least an annual survey that takes place in the “survey window” range from three months before and after last year’s annual survey date. Six-month surveys for focus facilities and complaint surveys may occur between the annual surveys.
Arrival of the CMS survey team at your door is not the time to start getting ready. Following are some of the new Final Rule pharmacy highlights, corresponding PharMerica Policy and Procedure Manual references, and facility compliance checklists to help you navigate the “Phase maze “ and prepare for survey success.
Final Rule Phase 1 became effective on November 28, 2016, and required:
1. Review and modify documents andpolicies referencing the definition“psychotropic drugs” (PharMerica P&PManual (PPPM) Section 8.4)
2. Develop/modify policies and proceduresfor the monthly drug regimen review(PPPM Sections 1.3 and 8.1)
3. Response inclusion on medical record(PPPM Section 8.1)
SURVEY WINDOW COMPLIANCE CHECKLIST: PHASE 1
q Pharmacy Policy and Procedure Manual updated
q Physician response to pharmacist recommendations filed in resident’s chart
q Permission for use of psychoactive medications obtained when required by state law
q Director of Nursing summary report is utilized to track action/response to nursing and physician recommendations made by the Consultant Pharmacist
q Physician and nursing responded in 30 days from date of Consultant Pharmacist recommendations
q Copy of pharmacist recommendations is given to the Medical Director
Final Rule Phase 2 became effective on November 28, 2017, and required:
1. Medical chart review (PPPM Section 8.1)
2. PRN orders for psychotropic drugs limited to use only whennecessary to treat a diagnosis-specific condition documentedin clinical record and added a 14-day limitation on psychoactivewith option for extension if prescriber documents rationale inmedical records and a duration of PRN order (PPPM Section8.4)
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InformRx F-TAG FOCUS
Checklists for Compliance, cont.
3. PRN orders for anti-psychotic drugs limited to 14days for PRN order and cannot be renewed unlessthe attending physician evaluates the resident andwrites a new prescription if medication deemedappropriate (PPPM Section 8.4)
4. Antibiotic Stewardship: antibiotic use protocol andsystem to monitor use (PPPM Section 8.4)
5. New F-Tag numbering and updated interpretiveguidelines
6. New survey process
SURVEY WINDOW COMPLIANCE CHECKLIST: PHASE 2
q Pharmacist reviewed all resident’s medical charts during each monthly drug regimen review and plan in place for:- New admissions- Readmissions- Short-stay residents
q Physician’s diagnosis in place for PRN psychoactive medications
q Facility plan for 14-day limitation on psychoactive medications
q Facility plan for 14-day limitation for antipsychotic medications (physician must directly re-evaluate and new prescription written to obtain another 14-day limitation period)
q All psychotropic medication dose reductions conducted
q Antibiotic Stewardship - Antibiotic Stewardship team defined- Antibiotic timeout procedure in place- Plan for communicating facility antibiotic use to
Consultant Pharmacist
**Note: While CMS has provided the following list of F-Tags included in the 18-month moratorium, please check your current facility policy. The facility must follow its current policy in the list below. Noncompliance with these tags can still be cited by surveyors.
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• F655 (Baseline Care Plan); §483.21(a)(1)-(a)(3)• F740 (Behavioral Health Services); §483.40F741
(Sufficient/Competent Direct Care/Access Staff-BehavioralHealth); §483.40(a)(1)-(a)(2)
• F758 (Psychotropic Medications) related to PRN limitations §483.45(e)(3)-(e)(5)
• F838 (Facility Assessment); §483.70(e)• F881 (Antibiotic Stewardship Program); §483.80(a)(3)• F865 (QAPI Program and Plan) related to the development
of the QAPI Plan;• §483.75(a)(2) and,• F926 (Smoking Policies). §483.90(i)(5)
A Longer Look into the Window of Pharmacy Services
Under the Final Rule, a facility must provide pharmaceutical services that ensure accurate acquiring, receiving, dispensing, and administering of all drugs to meet the needs of the residents. The facility must:
1. Employ or obtain services of a licensed pharmacist
2. Provide consultation on all aspects of pharmacyservices
3. Establish a system of records that tracks receipt anddisposition of all controlled drugs in sufficient detail toenable accurate reconciliation
4. Have a licensed pharmacist review monthly allresidents’ drug regimens
5. Establish a communication system betweenpharmacist, physician, and director of nursingthrough which to report irregularities
6. Label all drugs and biologicals according toprofessional principles
7. Store all drugs and biologicals in locked compartments under proper temperature and
8. Permit only authorized personnel to have access tothe keys
9. Have a separate locked compartment for controlleddrugs listed in Schedule II of the ComprehensiveDrug Abuse Prevention and Control Act 1976
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InformRx F-TAG FOCUS
Checklists for Compliance, cont.
One goal of every Administrator, Director of Nursing and facility should be to be survey ready every day. A mock survey can be a valuable tool to make certain your residents, resident families, and permanent and pool staff are well-versed in the new survey process. And when the survey team arrives? Be proactive and contact your PharMerica Consultant Pharmacist, pharmacy and Medical Director. Briefly answer the surveyors’ question without adding unnecessary information and, if you do not know the answer, find someone who does. Always remember that mutual respect and cooperation between surveyors and staff is the best way to accomplish quality care for the residents.
q Contract in place with Consultant Pharmacist/pharmacy services and copy of their license
q Does your consultant pharmacist have access to all resident charts (paper and electronic)?
q Emergency kit in compliance with state law - who checks it for expiration?
q Procedures in place to order new medications, refills, and emergency medications
q ALL pharmacies utilized can be reached 24 hours a day, seven days a week
q Procedure in place to document receipt of medications and reconcile with orders
q If medication held, is there a documented explanation on MAR?
q If PRN medication is given, is there justification for use and response documented on MAR?
q Did the nurse assess resident before a medication aide gave a PRN medication in accordance with state law?
q All medications properly labeled and dated when opened
q Medications reviewed for expiration and procedure in place to prevent diversion of all medications waiting for disposition
q Drug disposal record lists resident name, medication name, strength, Rx number, quantity, date of disposition and individual signatures as required by state/federal law
q No drugs are disposed of in the sharps containers
q Signature documentation of controlled medications and reconciliation at shift change (including Ekit, fridge, hospice and patches on residents)
q Medication pass review and staff competencies
q Only the nursing staff have keys/access to medication room and carts
q All medications, including controlled medications, are properly locked per state and federal regulations
q Are medications left at bedside or at meal table without an order for medication self-administration and routine assessments for self-administration?
q Do medications administered crushed have a physician order to do so? And are they crushable, per manufacturer’s recommendation?
q Are medications crushed together or given one at a time per facility policy?
q Medication administration: compliance with 6 Rs (right resident, right route, right medication, right dose, right time, right documentation)
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InformRx CLINICAL CORNER
Kidneys are Nothing to Kid About! By Karen D. Shorter, MBA, PharmD, B.C.G.P.
The kidneys are powerful organs that perform many vital functions, such as removing waste products from the body, balancing bodily fluids, releasing hormones that regulate blood pressure and controlling the production of red blood cells. When the organs stop working properly, individuals may not notice any symptoms. However, they can be at risk for renal disease.
Chronic kidney disease (CKD) is a permanent loss of kidney function that begins as a diminished renal reserve and progresses to chronic renal insufficiency. CKD decreases the kidneys’ ability to perform necessary functions and may eventually lead to kidney failure, requiring dialysis or a transplant to maintain life.
The National Kidney Foundation estimates that one in three people may develop kidney disease. Since there is evidence that earlier stages of CKD can be detected and treated, long-term care nurses should be familiar with the standards of care for all stages of CKD.
CKD Detection
One of the most common causes of CKD is diabetes. Current recommendations call for annual urine testing of all individuals with diabetes. To determine residents at
risk for CKD who may already be in the early stages of the disease, a simple, cost-effective diagnostic tool, the urine albumin test, can be ordered. This test detects microalbuminuria and is the most sensitive test for detecting early-stage CKD.
• Stopping smoking
• Exercising regularly
• Decreasing salt consumption
• Decreasing use of cola-basedand alcoholic beverages
Since patients with CKD are at an increased risk of mortality through cardiovascular disease, kidney failure, and other comorbidities, earlier diagnosis and treatment is critical to slowing or stopping the progression of CKD.
For more information on Chronic Kidney Disease (CKD) contact your PharMerica Consultant Pharmacist.
Additionally, testing for proteinuria with the dipstick method is a quick and easy option.
CKD can also be clinically diagnosed by the glomerular filtration rate (GFR), which measures the level of kidney function and determines the stage of kidney disease. Normal GFR in both kidneys in adults is 120 to 125ml/min. Lower GFR results indicate decreased kidney function.
Disease Management
Residents in early stages of decline may decrease the risk of further kidney disease by:
• Controlling blood pressure
• Controlling blood sugar
• Controlling weight
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reduce the risk of lipodystrophy (skin thickening or pits at the injection site).
ADMELOG was approved as a Follow-On Biologic, not as a generic medication. ADMELOG requires a new prescription and cannot be directly interchanged with other insulin lispro products. When switching between insulin lispro products (e.g. ADMELOG and Humalog), continue with the same insulin dose.
ADMELOG should be used exactly as prescribed. Upon discharge, residents should be reminded how much, how often, and when to administer ADMELOG and all insulin products.
ADMELOG and all meal-time insulins should be used in conjunction with other diabetic medications and should not be used as the sole treatment for high blood sugar due to the increased risk of hypoglycemia in older adults. Clinical trials of
InformRx MEDICATION SPOTLIGHT
Transmembrane receptors called insulin receptors (IR) are activated by insulin, or insulin analogues, in order to regulate glucose homeostasis and lower blood glucose levels. When either insulin fails to properly interact with IRs or lower levels are secreted in the body, or a combination of both, diabetes results.
ADMELOG is an insulin lispro subcutaneous injection that shares an identical amino acid sequence to Humalog®. It is used for glycemic control in diabetic patients with hyperglycemia. Hyperglycemia is the state of abnormally high levels of glucose in the blood (>130mg/dl) with the most common symptoms being increased thirst and frequency to urinate. Hyperglycemia is a trademark sign of both Type 1 and Type 2 diabetes, as well as prediabetes, and can lead to ketoacidosis, also known as a diabetic coma.
ADMELOG is indicated to improve glycemic control in adults with Type 1 and Type 2 diabetes mellitus, and may be used off-label for the treatment of mild-to-moderate diabetic ketoacidosis. ADMELOG is currently supplied in a 100unit/ml 10ml vial and a 3ml SoloStar® pen. It should be injected subcutaneously within 15 minutes before or right after a meal in the upper arms, stomach, buttocks, or thighs. Rotation of the injection site within the area can
For more information, ask your PharMerica Consultant Pharmacist or visit www.admelogpro.com.
Medication Spotlight: ADMELOG (insulin lispro)By Brian Garcia, PharmD
insulin lispro show rates of severe hypoglycemia in 2% to 14% of participants.
ADMELOG was approved by the FDA in December 2017 and may be a more cost effective alternative to Humalog.
