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Page | 1 www.accuscriptspharmacy.com August 2017

We at AccuScripts Pharmacy strive to collect and publish the most meaningful, worthwhile and current information

in our quarterly newsletters to benefit direct and indirect caregivers, and urge that these newsletters be widely

distributed so that all can read and benefit from this publication. We further encourage the distribution of these

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clinical updates and other important long-term care related topics.

A NEW NAME FOR CORRECTING POLYPHARMACY Attention is sorely needed to integrate deprescribing into routine clinical practice in order to address the growing problem of polypharmacy in the elderly. Nursing facility residents are at increased risk of adverse drug reactions, falls, hospitalizations, drug-induced morbidity and mortality due to polypharmacy. It can be a challenge, though, to know when, how and which medications to reduce the dosage of or discontinue altogether. The following is discussed from a June 2016 publication by Annals of Long-Term Care, ‘Clinical Care and Aging’: In the United States, up to 50% of nursing facility residents are on 9 or more medications, and the rate of adverse drug reactions / outcomes is twice as high as those on less than 9 medications. There is a significant need for effective intervention to better manage pharmacotherapy in our long-term care facilities. Deprescribing – the process of dose lowering, tapering, stopping or withdrawing medications that are unnecessary or inappropriate – is an effective way to minimize polypharmacy and improve health outcomes. However, as stated before, it can be somewhat daunting to decipher and filter out medications that can be successfully withdrawn in order to reduce the relatively high number of drugs being administered and yield a neutral to positive outcome in the process. Scott and colleagues put together an algorithm that will be included here (attached separately) which may prove helpful as a guide for lessening the medication burden for those exposed to polypharmacy. Additionally, the American Geriatric Society’s (AGS) ‘Beers Criteria for Potentially Inappropriate Medication Use in Older Adults’ has been discussed in several previous newsletters which may serve as a meaningful guide for clinicians to refer to for reducing the dosage of, taper and discontinue certain medications that have a history of causing significant, negative outcomes in much of our elderly population.

ALSO IN THIS ISSUE:

Proton Pump Inhibitors: Long-term Use 3

Sudden Hospital Readmissions & Ramifications 4

Antibiotic Stewardship 6

New FDA Drug Approvals & Expanded Indications 7

CMS CASPER Data Update 9

See also accompanying Tip Sheets for Deprescribing


The following table provides some examples of medications that may be safely tapered and discontinued under specific circumstances:

Statins Consider discontinuing in residents with limited life expectancy (<5yrs). Check lipid panels. Often elderly residents continue statins when no longer needed. May be able to discontinue in residents with no known cardiac disease.

Antihypertensives Use the least number of agents possible and lower the dose. Possibly taper off altogether to maintain BP < 150/90 for residents over 60 years.

Biphosphonates No current evidence of effectiveness after 5 years of continuous use. NSAIDs Intended for short-term use only unless no other alternative. PPI/H2 Antagonists

Often able to be discontinued after hospital discharge or peptic ulcer healed/ other gastropathies resolved.

Ferrous Sulfate, Folic Acid, B12

Periodic check of CBC w/iron, folic acid, B12 levels to determine ongoing need. Many forms of anemia may be temporary and resolvable. Some forms of chronic anemia will never respond favorably to hematinic pharmacotherapy.

Laxatives Review diet, fluid intake, exercise and meds contributing to constipation. If resident on a laxative which works by causing water to be absorbed into the stool (Miralax, lactulose, sorbitol) and is also on a stool softener (docusate sod, docusate calcium), the stool softener can probably be discontinued.

Cholinesterase Inhibitors & Memantine

Discontinue in advanced dementia, weight loss, syncope, falls, bradycardia, GI issues.

Vitamins May no longer be indicated if consuming well-balanced diet Antipsychotics Scheduled GDR attempts and consideration for discontinuation if behaviors

or signs of distress have abated. Sulfonylurea Hypoglycemics

Replace with less potent, shorter acting agents.

Antiemetics Rarely needed long-term

A major contributor to polypharmacy can be that which is known as the ‘prescribing cascade.’ In most, if not all cases, this phenomenon should be able to be prevented; a few examples are:

a cholinesterase inhibitor is prescribed (donepezil, rivastigmine) with subsequent urinary incontinence developing. Prescriber then issues an antimuscarinic agent (oxybutynin)

a medication with the propensity to cause dizziness (Ca channel blockers, B-blockers, alpha blockers, opioids, anxiolytics) is prescribed and the prescriber then orders meclizine

an NSAID is prescribed which results in increased blood pressure; prescriber then orders an antihypertensive

digoxin or an opioid or an NSAID or an oral corticosteroid is prescribed with resultant nausea; prescriber then orders prochlorperazine or a proton pump inhibitor or ondansetron.


In these examples, discontinuation of the offending agent (which induces an adverse outcome / side effect) and replacing it with an agent that is much better tolerated would certainly be more prudent. A final note that needs to be brought to the fore involves the protocol to be followed if and when a medication / medications may be considered for discontinuation; one and only one medication should be considered for discontinuation at a time. The majority of pharmacological classes of drugs, when being discontinued, may need to be done so in a manner consistent with a slow taper. For instance, the following table describes potential outcomes if the med is tapered too dramatically (or may not be able to be tapered / discontinued at all if attempted):

Alpha Blockers Rebound hypertension; agitation if stopped at once; headache Antimuscarinic Agents Rebound of urinary frequency, urgency ACE Inhibitors Rebound heart failure/ hypertension Benzodiazepines Anxiety, agitation, confusion, delirium, insomnia, nausea, seizures Diuretics for Heart Failure Re-emergence of heart failure B-Blockers Rebound tachycardia Proton Pump Inhibitors Rebound hyperacidity Antidepressants Dysphoria, agitation, headache Antipsychotics Agitation, insomnia, dyskinesia, rebound psychotic symptoms

(delusions, hallucinations)

In conclusion, safe and appropriate discontinuation of medications requires a solid commitment from clinicians, nursing staff, medical director and consultant pharmacist. Success of this endeavor depends on understanding and embracing the principles of prescribing for the geriatric population in a holistic and individualized manner. Clinicians should always integrate deprescribing into routine clinical practice in order to improve the health of the patient as well as to minimize potential harm and costs associated with inappropriate or unnecessary medication use. Deprescribing can be rewarding. The potential benefits of reducing polypharmacy are indisputable in terms of better health outcomes, fewer hospitalizations, financial savings and reduced time-burden associated with heavy medication passes.

Since the late 1980’s six PPI’s have been approved for treating various gastropathies in the United States (omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole and rabeprazole). PPIs have proven to be effective and safe in managing GERD, healing peptic ulcers, reducing the incidence of GI mucosal inflammation precipitated by NSAID usage and generally suppressing gastric acid secretion within the proton pump located in the parietal cells (which may be indicated for various other gastropathies). Their superb efficacy and low toxicity have resulted in FDA approval for over-the-counter sales in the U.S. This panacea-like evolution regrettably has resulted often times in their overuse, misuse, and in some cases, forever-use. Health care providers are often prescribing these agents for


prolonged – even lifetime—use, and many patients are taking the same, OTC products beyond the recommended course of therapy without any supervision. Over the years there has been growing concern from increasing documentation of PPI (long-term) pharmacotherapy precipitating hypergastrinemia, pneumonia, increased fracture risk, hypocalcemia, hypomagnesemia, C-Diff associated diarrhea, B12 deficiency, acute interstitial nephritis. These are all relatively rare, but can evolve into very serious, even life-threatening situations. In fact, with few exceptions (where short-term therapy has been completed as in stress ulcer prophylaxis, H Pylori eradication and peptic ulcer therapy), the taper and eventual discontinuation of a PPI needs to be completed via a gradual dose reduction (up to total discontinuation) when moderate to long-term pharmacotherapy has been undertaken. The stress ulcer prophylaxis – H Pylori eradication and peptic ulcer treatment w/cure (which may last from several days to 4 weeks, and in some cases, 8 weeks duration) may be considered for immediate discontinuation of the PPI where only several days’ therapy was given. Any longer duration of pharmacotherapy than this necessitates consideration for a gradual taper down to total discontinuation, otherwise, hypergastrinemia (rebound gastric acid hypersecretion [i.e., severe acid reflux]) is most likely to occur when abrupt discontinuation is undertaken. In conclusion, PPI’s have found favor (and in some cases, too much favor) with clinicians that need to manage their patients’ g.i. issues in which gastric acid secretion reduction is indicated. The historic and ongoing problem remains that perpetual use of these agents without thought (on the part of the prescriber or patient) of lowering the dose or undergoing a gradual dose reduction to total discontinuation lingers on. Dr. Barbara Farrell, a clinical scientist at the Bruyere Research Institute and C.T. Lamont Primary Health Care Research Centre and assistant professor at the Department of Family Medicine, University of Ottawa told Medscape that even chronic reflux (for which an extremely high number of PPI prescription orders have been written with directions for daily use, indefinitely, with forever refills) can be managed by the patient himself via self-administering the prescribed PPI on demand only – that is – when gastroesophageal reflux symptoms occur. The concept that ongoing, daily PPI administration needs to be continued indefinitely because of occasionally reoccurring reflux symptoms is an erroneous one. On demand, self-administration at the onset of symptoms with discontinuation of the PPI upon cessation of symptoms is a reasonable and prudent manner of managing chronic g.e.r.d. contends Dr Farrell. Even if symptoms persist daily in an ongoing fashion, it is not unreasonable to attempt every other day dosing of a PPI in order to ‘deprescribe’ from daily use.

As part of the very comprehensive Affordable Care Act, a legislative mandate was crafted and included to save Medicare a great deal of money (that technically was unnecessary and wasteful spending). According to a recent Annals of Long-Term Care special edition publication, resident readmissions to hospitals (from where they were recently discharged) are costly to the facility and payer. Recent data shows that almost 20% of readmissions (to hospitals) that occur consist of patients discharged from that same hospital within the past 30 days and approximately ¾ of these may be preventable.


More than 50% of readmitted patients received no care or follow up in the 30 day period post-hospital-discharge. Unplanned readmissions cost Medicare more than $17 billion annually. The most common reasons for (sudden) readmissions are:

poor discharge instructions poor transfer of information to ambulatory or long-term care providers lack of timely post-discharge physician visits Poor medication reconciliation yielding omission, duplication, erroneous

medication transcribing and dosing or drug-drug interactions. The Hospital Readmissions Reduction Program (HRRP) was established as an add-on provision in the Affordable Care Act requiring Medicare to reduce payments to hospitals that have a high 30-day readmission rate for specific health conditions. These conditions include: post-myocardial infarction, heart failure, cerebral vascular accident/stroke, pneumonia, COPD, total hip AND knee arthroplasty. Starting a while back, acute care facilities with too high a (within 30 day) readmission rate for one of these conditions started to see their Medicare payment reduced by 3%. This has had a huge monetary impact on hospitals (and, at some time in the near future, rehab or subacute care facilities [which may be a wing within a nursing facility] may see penalties if there are unresolved or uncorrected errors perpetrated on the subacute care side). Of the four most common reasons for (sudden) readmissions, the forth one listed (poor medication reconciliation) is the one that probably is most preventable from the perspective of the receiving (rehab / long-term care) facility. Each facility has its own protocol for transcribing all discharge orders into its own (i.e., the resident’s) clinical record. An absolute minimum of two (2) staff personnel must be involved in this transcribing process. A double and triple and quadruple check of all transcribed orders will insure greater accuracy in the continuity of care during and after transfer. The consultant pharmacist will serve as an additional monitor in the reconciliation process to make absolutely certain the medication regimen at discharge matches the regimen documented in the receiving facility’s (patient’s) clinical record. The only [and rare] exception to this would be if the attending physician or nurse practitioner were physically present upon arrival of the resident or has arrived at the facility in very short order after the patient’s admission and went ahead to perform an admissions physical and assessment which then might include a change or alteration in the medication regimen. Additional responsibilities for the admissions nurse and consultant pharmacist would be to scrutinize the medication regimen to ascertain that certain types of medications would be documented/prescribed in the physician’s orders that are to be included as part of the medical standard of practice for the admitting diagnosis / diagnoses the patient has (e.g. a low molecular weight parenteral anticoagulant or a p.o. NOAC to prophylax against a thrombo-embolism if the patient has been admitted post knee replacement surgery). Additionally, lab monitoring and reviewing/assessing results in response to the admitted patient’s diagnoses and/or med regimen would also be incumbent upon the consultant pharmacist.


Current data on antibiotic use in long-term care facilities is somewhat limited as only a few small studies have been, to-date, conducted. Over the course of a year, approximately 4 million individuals receive care and services in a nursing facility. Antibiotics are some of the most commonly prescribed medications in nursing homes with 50 to 70 percent of all residents receiving (at least) one course of antibiotic pharmacotherapy over the course of a year. The CDC estimates that close to 75% of these antibiotics prescribed are ordered incorrectly! The most common prescribing problems found in the long-term care setting are:

prescribing an antibiotic when not needed choosing the incorrect antibiotic choosing the correct antibiotic but prescribing the wrong dose or duration

These maladies of antibiotic prescribing can lead to harm including side effects, allergic reactions, C. difficile infection and antibiotic-resistant infections. This is especially problematic as nursing home residents are already at high risk for contracting a C. difficile infection. From a recent small study conducted by the CDC, nine U.S. nursing facilities in four states had their medical records examined to determine antibiotic usage. Researchers found that 11% of nursing home residents (on average) were on antibiotics on any single day. About one in three antibiotic prescriptions were ordered to treat a UTI. Sadly, reports the CDC, about half of these orders were for either the wrong drug, dose or duration. Additionally, a little over a third of all antibiotic prescriptions lacked documentation of one or more prescribing elements (strength, duration of therapy, how to be given w/regard to food, specifying site of infection with identification of the offending organism if known etc.). The CDC is launching a much larger study with larger numbers of nursing homes and pursuing partnerships with nursing home networks, pharmacies and other companies to identify where action is needed most. Over the past two plus years the long-term care industry has been urged (and now mandated) by federal guidance to have in place an in-house antibiotic stewardship program. Back in the 1st quarter of 2016, we printed in that newsletter the onset of overtures expressed by CMS and the CDC which maintained that heightened awareness and stricter enforcement of antibiotic stewardship in extended-care facilities would be forthcoming. Now this is the law of the land. Due to an unacceptably high incidence of antibiotic prescribing within U.S. long-term care facilities which is unnecessary or inappropriate, CMS is reminding all facilities about a portion of F-tag 329: F329 Medication Issues of Particular Relevance: All Antibiotics Indications -Use of antibiotics need to be limited to confirmed or highly suspected bacterial infection


Adverse Consequences -Any antibiotic may cause diarrhea, nausea, vomiting, anorexia, hypersensitivity/allergic reactions -Antibiotics are partially non-selective and may result in the eradication of beneficial microorganisms and the emergence of undesired ones, causing secondary infections such as oral thrush, colitis and vaginitis. In addition to this reminder, the CDC has published a press release advising all nursing homes to implement certain core elements which should be found within any antibiotic stewardship program that will lead to improved antibiotic use:

leadership commitment accountability drug expertise action tracking

Furthermore, all health care facilities need to direct their health care providers to improve antibiotic prescribing by strictly adhering to the following algorithm:

start the right antibiotic promptly at the right dose for the right duration reassess the prescribed antibiotic within 48 hours after starting therapy based on

tests or patient exam recheck the initial prescribing documentation re: dosage, duration and indication Over time, assess any emerging in-facility antibiotic resistance patterns and oversee

that the facility has put into place an Infection Prevention and Control Officer. Combined effort including this officer, the medical director, the director of nursing and the infection control committee needs to be undertaken if such resistance patterns develop, with an action plan to then be put into place to reverse the resistance trend.

If all the aforementioned guidance is followed, the extended-care facility should be able to eliminate the pattern of excessive and unnecessary antibiotic usage which will, in turn, allow for overall better health care and a significant reduction in health care spending.

Two (2) new agents that belong to a brand new pharmacological class of drugs were approved in the early spring of 2017 which have enormous ramifications in treating a specialized movement disorder that to-date has had no good treatment options. This new pharmacological class of agents which show great promise is known as vesicular monoamine transporter 2 inhibitors. Vesicular monoamine transporter-2 (VMAT-2) is responsible for the storage and release of dopamine from synaptic vesicles in the brain. A


blocker or inhibitor of this integral membrane protein (which transports monoamines), will enable the regulation of monoamine uptake from the cytoplasm to the synaptic vesicles for storage and release. Though the complete mechanism and role that VMAT-2 blockade plays is not fully understood, the outcome by exerting at least a partial antagonism of VMAT-2 membrane proteins appears to be a significant reduction in dyskinetic movements, possibly regardless of the underlying cause. This phenomenon, now, is a huge breakthrough regarding the likely success in treating various forms of dyskinesias. The drug, deutetrabenzine (Austedo – Teva Pharm) is a VMAT-2 inhibitor recently approved by the FDA to manage Huntington’s Chorea and Huntington’s Disease. Huntington’s Disease (HD) affects more than 35,000 people in the United States. About 90% of these people will develop chorea (involuntary, random and sudden twisting and/or writhing movements) at some point in the course of their illness. The administration of Austedo should significantly reduce these dykinesias and substantially improve the quality of life for HD patients. Currently, the FDA is evaluating Austedo for managing tardive dyskinesia (TD). In April the FDA approved another VMAT-2 inhibitor, valbenazine (Ingrezza – Neurocrine Biosciences) for managing TD. Until now, tardive dyskinesias that emerged secondary to dopamine receptor antagonist therapy (i.e., administration of 1st or 2nd generation antipsychotics) proved, in many cases, to be troublesome, though the underlying psychotic disorder may have been moderately to well managed. And until now, there has been a significant unmet need for a treatment option that does not disrupt primary treatment regimens prescribed to manage psychiatric illnesses. As VMAT-2 inhibitors continue to be discovered and refined, very significant progress will ensue to manage movement disorders that are a part of a medical condition or that develop secondary to specific drug therapies. In June of 2017 the FDA approved betrixaban (Bevyxxa – Portola Pharmaceuticals) for prophylaxing relatively immobile patients against venous thromboembolism (VTE) who are hospitalized or institutionalized with moderate to severe mobility restriction, and have other risk factors for VTE. Betrixaban is a novel anticoagulant agent that is a member of the factor Xa inhibitors. Other factor Xa inhibitors that have met FDA approvals and are enjoying increasing usage for VTE prevention/prophylaxis are rivaroxaban (Xarelto), apixaban (Eliquis) and edoxaban (Savaysa). The dosing regimen for Bevyxxa is 160mg p.o. on day 1 followed by 80mg q.d. starting on day 2 X 35-42 days. The medication should be taken w/food at the same time each day. Dosing needs to be halved if creat cl is < the 30ml’s/min and halved if patient is on a P-glycoprotein inhibitor drug (amiodarone, azithromycin, clarithromycin, ketoconazole, verapamil). In cases of severe renal impairment (<15ml/min creat cl) Bevyxxa should be avoided. In June of 2017, Melinta Therapeutics receive the green light from the FDA to market and distribute delafloxacin (Baxdela) indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. This antibiotic is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens including MRSA and is available in both intravenous and oral formulations. Dosing can be given orally with or without food - 450mg q 12 h or IV – 300mg q 12 h for 5 –


14 days. The same precautions and warnings and notifications for discontinuing Baxdela are the same as for any other FDA approved fluoroquinolone (signs/symptoms of tendinitis/tendon rupture, peripheral neuropathy, CNS effects/symptoms). Melinta Therapeutics launched R and D for this product chiefly due to increasing antibiotic resistance. Janssen Biotech Inc (Janssen) has just announced that the U.S. FDA has approved guselkumab (Tremfya) for the treatment of moderate to severe plaque psoriasis. Tremfya is to-date the only biologic / monoclonal antibody that selectively blocks interleukin-23 (which may or may not be responsible for an unusually large improvement rate vs other agents designated to treat the same indication and has been found to play a key role in attenuating plaque psoriasis). Patients with moderate to severe plaque psoriasis symptoms are eligible for this treatment if also they would be candidates for systemic or phototherapy. Tremfya is administered subcu – 100mg q 8 weeks following two starter doses at weeks 0 and 4. Superior clearing of plaques was demonstrated by Tremfya when compared to psoriasis resolution being treated with Humira (adalimumab) at weeks 16, 24 and 48. And finally, an antiepileptic medication, perampanel (Fycompa – Eisai Inc) has just received FDA approval as monotherapy to treat partial-onset seizures with or without secondary generalized seizures in patients 12 years of age and older. This approval makes available a drug entity that may be prescribed as a single agent in treating partial-onset seizures which, to-date, is rather uncommon, as most approved anti-epileptic drugs developed for managing partial-onset seizures are approved in the capacity as being adjunctive medications only. Additionally, this medication has a (desired) dosing regimen of 2mg p.o. once daily @ h.s. – increase regimen by 2mg daily at 1 week intervals, but at 2 week intervals for the elderly and do not give if creat cl is less than 30ml/min. May be administered without regard to food. Fycompa was initially approved for adjunctive use (only) in managing partial-onset seizures and has been approved in 55 countries worldwide. An oral suspension is also available that was approved just last year.

Periodically, our newsletter staff relays information, as it become available, to our customers and readers, which reveals psychoactive medication usage; the following page is a comparative table in which many individual states’ classes of psychotropic drugs that are prescribed and administered (in all their extended-care facilities) are listed and compared to one-another, and compared to the national average. At the bottom of the comparative table are comments regarding Ohio’s past and current status….


Feels like the pharmacy “right around the corner.”

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promises and produces the service:

Denis Holmes, President

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Craig Baughman, VP Operations

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