As influenza seasons go, 2015-16 has so far been mild. A few states are now showing up with activity, but the overall activity has not been as significant as previous years. Still, we could be in for a late flu season. Some researchers believe that we have had a good match between vaccine antigens and the current strains, which is particularly good news for patients who have received the high-dose vaccine because recent trials show that when there is a good match year, the effectiveness at preventing cases and complications improves.
In First Monday December 2014, I mentioned the new CDC recommendations for pneumococcal vaccination. Essentially, when a patient comes into our LivingCenter, the admitting nursing staff must find out whether he or she has had the pneumococcal vaccine, when it was given, and whether it was the 23–valent polysaccharide vaccine (PSV23, pneumovax(R)), or the newer conjugate vaccine (PCV13 vaccine, Prevnar 13(R)).
For patients 65 and over or with chronic lung disease or immunicompromise, patients need to have both vaccines.
The original recommendations from November 2014 were a bit confusing, because a gap of six months was needed if the PCV was given first and 12 months if the PPSV was given first. In order to avoid confusion, this has been changed so that regardless of which vaccine was given initially, the other vaccine should be given after 12 months.
There is no physical side effect from giving a vaccine inside of these intervals, but a patient theoretically may get less of a long-lasting antibody response if they are closer together. A patient who has had both vaccines still may require a final PPSV23 if they had their PPSV23 before age 65. This last immunization would come at least one year after the PCV 13 and at least five years since the PPSV23.
Please work with your DNS and attending staff as needed to make sure that your LivingCenter is paying attention to the details and following this CDC recommended process. If you have any questions, feel free to contact me.
Intervals Between PCV13 and PPSV23 Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Weekly, September 4, 2015/64(34); 944-947.
AMDA, the Society for Post-Acute and Long-Term Care Medicine will hold its annual national conference March 17-20 in Orlando, Florida. I encourage you to attend. Each year the conference provides a unique blend of clinical education combined with regulatory and administrative guidance. Attendance of the designated sessions are also an integral part of the process of obtaining AMDA certification in medical direction, the CMD. For more information go to: http://www.paltcmedicine.org/
Golden Living will hold an evening gala for our medical directors, which will be held on Friday night onsite. Golden Living Chief Executive Officer Dr. Neil Kurtz will be at the gala, along with Golden LivingCenters President, Julianne Williams and your Regional Medical Directors. We will award our annual Medical Directors of the Year at that time, and we will have an interactive discussion about the evidence-based choices in medicine. The exact location will be announced when available.
Because Orlando is such an attraction in March, hotels are filling up quickly. If you are thinking of attending, please make arrangements as soon as you can. Please contact Golden Living Head of Medical Director Services, Reene Dux at Maureen.firstname.lastname@example.org or (972)372-6311 if you have any questions.
I look forward to seeing you there!
In 2015 Golden Living took a very proactive step by making high-dose flu vaccine available for patients 65 and over. Large studies have supported this practice in the SNF setting and demonstrated superiority in elders over standard dose vaccine. At the time of this newsletter (January 2016) influenza is not yet widespread in the US. This means that there is still time to encourage anyone who has not yet had their flu shot and has no contraindications to get vaccinated. If you don’t know how successful your LivingCenter has been this fall in vaccination, check with your DNS. It takes about two weeks for antibody levels to rise.
Is it the flu? Do you have an outbreak?
When a suspected influenza case arises in your Living Center, you will want to confirm that this is indeed influenza through testing. Rapid testing is available. It is important to confirm your index cases because decisions regarding influenza outbreak management have significant implications regarding how patients are cared for in your LivingCenter. Also, antiviral treatment and prophylactic medication has associated risk of side effects. Once you have determined that your facility is in the midst of a flu outbreak, it will no longer be necessary to test all suspected cases. In fact, the local department of health may advise against it in order to avoid exhausting diagnostic testing resources. I think it would be wise to say that pending positive test results to treat ILI as actual flu as that is what we advise them to do. I get a lot of reports that say they have five or six people with symptoms but all tested negative. If it looks like the flu they should act accordingly.
The CDC threshold for calling an outbreak is having one confirmed case (by testing) of influenza which occurred in the LivingCenter, in combination with at least one other patient with flu-like illness.
Once an outbreak is determined to have happened, you must assume that influenza-like illness is the flu and address it as such. False negatives may occur, so you should believe a positive influenza test, but you should not be fooled by a negative test in a patient who appears to have the flu. Again, this is the reason why once you have determined that an outbreak is occurring in your Living Center, that widespread testing for influenza is not particularly helpful.
What else should I do in an outbreak?
Work together with your ED, DNS and LivingCenter infection control nurse. There are guidelines on what to do in both the Policy Center and in the Flu Information Site link on the Facilities main page. Some but not all of the listed steps include the need to:
- Notify the local health department, families, and patients
- Postnotices in the Living Center (examples can be found in the Flu Information site)
- Treatsymptomatic patients
- Prophylax –The CDC recommends prophylaxing all residents and staff in an outbreak, but you may decide to modify your decision based upon medication availability, DOH recommendations, and facility layout. If you choose to do this, prophylaxis should continue until a week after the end of the outbreak. If you are considering facility prophylaxis, please feel free to contact our GLC Pharmacy Directors Steve Hord (email@example.com 404-904-7741) or Eric Stratford (firstname.lastname@example.org 919-895-8488) who can assist with obtaining antiviral medication.
- Monitorcases with a “line listing.” Your DNS will report cases to their Field Service Clinical Directors who then report to Melissa Purvis in Plano. During flu season, a weekly outbreak report is circulated based upon these reports. This may serve to warn living centers when outbreaks are nearby.
- Take Infection Control measures
- Isolate – Decide whether to segregate a unit, floor or entire LivingCenter and adjust according to circumstances. Workers in units or hallways with multiple cases should wear masks at all times and be meticulous with hand hygiene.
- Effective isolation is vital in order to avoid a prolonged outbreak. Patientswith active influenza or influenza-like illness should be confined to their rooms when possible. They should be on droplet precautions. If cohorting is possible and practical, then that should be considered as well. Curtains should be drawn between patients with influenza and their roommates. Healthcare workers with the flu or influenza-like illness should stay at home. They should receive antiviral medications if possible and be encouraged to consult with their physician. Because some of our workers in the LivingCenters have limited healthcare resources and may take quite a bit of time to get to their own physicians or the emergency room, the CDC recommends prophylaxis of all workers without contraindications. When the Medical Director provides prescriptions for antiviral treatment, it greatly increases the chance that staff will receive prophylaxis and start it in a timely fashion.
- Ramp up cleaning efforts
- Begin wearing masks
- Consider adding additional hand-sanitizer stations
Patients with the flu should be treated if possible. It is advisable to begin treatment with antiviral medication upon suspicion, rather than waiting for confirmation before initiating treatment. Studies have estimated that neuramidase inhibitors such as oseltamivir (Tamiflu®) can be as effective as 70-90 percent. Patients treated tend to have less severe symptoms, a shorter duration and less chance of complications such as pneumonia and death. Because most treatment is supportive aside from antiviral medications, you should be able to care for the vast majority of patients with the flu in the LivingCenter. As always, the decision to transfer a patient to the hospital is up to the clinical judgment of the attending physician and must be individualized.
The CDC recommends antiviral treatment as soon as possible for residents of nursing homes and ideally patients should be started within 48 hours of onset of symptoms. Treatment initiated after this period of time is up to the discretion of the physician. There is still evidence of effectiveness when treatment is initiated up to four or five days following onset. Usual treatment duration is five days. Longer periods of treatment could be considered for critically ill or immunocompromised patients.
Oseltamivir (Tamiflu®) – Flu treatment options remain the same as last year. Due to amantidine resistance and its side effects in the elderly, the mainstay of antiviral treatment are the neuramidase inhibitors, and the one most appropriate for SNF use is oseltamivir (TamifluÒ). Oseltamivir is an oral agent, which also may be administered via enteral tube. Treatment and prophylaxis dosing is outlined in the table below. Keep in mind that mental status changes are one potential side-effect of this class of medication.
Zanamivir (RelenzaÒ)is an inhaled powder but is contraindicated in persons with underlying lung disease such as COPD or asthma. Zanamivir is also not recommended in patients with severe influenza.If you are considering zamamivir treatment, please discuss with your consultant pharmacist.
Oseltamivir dosing guidelines
|Oseltamivir (TamifluÒ) dosing:||Cr Clest|
|>60 mL/min||60-30 mL/min||<30 to 10 mL/min||< 10 mL/min
on hemodialysis (HD)
on peritoneal dialysis (PD)
|75 mg BID||30 mg BID||30 mg Daily||30 mg following each HD tx||30 mg immediately following exchange|
(2 weeks and up to 1 wk following end of outbreak)
|75 mg Daily||30 mg Daily||30 mg every other day||30 mg after every other HD Tx||30 mg weekly, immediately following exchange|
Oseltamivir is not recommended for patients in End-stage renal disease (ESRD) who are not on any form of dialysis.
Helpful Resources You may also contact me or your regional medical director if you have any questions.
CDC Surveillance site
CDC LTC Toolkit
Specific LTC guidance for health professionals
- Antiviral Drugs for Seasonal Influenza, Med Lett Drugs Ther. 2015 Dec 21;57(1484):169-71
- CDC, Interim Guidance for Influenza Outbreak Management in Long-Term Care Facilities
Mark your calendars! AMDA – The Society for Post Acute and Long-Term Care Medicine, is holding its annual conference in Orlando, Florida from March 17-20, 2016. As we have done for years, a stipend is available to Medical Directors who attend this conference and our Golden Living Physician Gala which will be held on site on Friday Night. The conference is unique in its blend of clinical and administrative content, providing the best available resource on how to excel as a Medical Director. The keynote speaker is Dr. John Abramson, lecturer in Health Care Policy at Harvard Medical School. He will be speaking on the subject of how much we can trust evidence that underpins our evidence-based medicine.
At the Golden Living Gala, you’ll get a chance to meet with your fellow Medical Directors, see the awards presentation of the Golden Living Medical Director of the Year for each Region and hear from our corporate leaders.
The conference site will be the Gaylord Palms Resort & Convention Center. Early registration helps to save on costs and assure lodging. Please join me in March!
History of Beers Criteria
In 1991, the late geriatrician Dr. Mark Beers published a landmark article in the field of geriatrics. In it, he and a group of experts listed medications which could be considered potentially inappropriate medications in the frail elderly population. There actually were two lists, one which outlined potentially inappropriate medications (PIMs) and one in which medications were potentially inappropriate in patients with common chronic diseases. This article helped to alert doctors caring for the elderly that there were certain medications which were particularly harmful in older patients or in which had a very poor benefit to risk ratio.
Over the years, the “Beers List” as it came to be known, became accepted broadly as a guide to physicians. The list was updated several times, and its aim expanded to include all patients 65 and over. In 2011 the American Geriatrics Society (AGS) assumed the responsibility for updating and maintaining the Beers Criteria. Updates by the AGAS have been was published in 2012 and 2015.
Not surprisingly, organizations and agencies, such as the National Committee for Quality Assurance (NCQA ) and CMS have relied on the Beers criteria to help them develop quality measures addressing medication related quality measures. CMS also incorporates Beers criteria into Medicaid Part D policy.
Now in November 2015, the latest update has been published. The methods used to choose the medications for the list are extensive and careful. A comprehensive literature review was performed by a multidisciplinary committee of 13 experts, who graded evidence and reached a consensus on each decision.
Some notable changes in the 2015 update include:
- Identification of select medications which should have dosage adjustments in patients with renal insufficiency
- Recommendation to avoid use of scheduled Proton Pump Inhibitors (PPIs) beyond a maximum of eight weeks
- Clarification of what is meant by “avoid sliding-scale insulin”
- Recommendation against use of newer non-benzodiazepine sleep medications
- Opioids added to avoid list in patients with history of falls/injuries
- Meclizine added to the avoid list regardless of indication
- Addition of select drug-drug interactions
Medication list for which dosage adjustments or avoidance is recommended in renal impairment
There are over 20 medications on this list, and creatinine clearance thresholds at which action is required are listed. Among the medications listed are certain novel anticoagulants (NOACs), potassium sparing diuretics, and H2 blockers.
Patients with prolonged PPI use
Evidence continues to mount regarding the harms of the relatively common practice of prolonged scheduled Proton Pump Inhibitor usage. Resultant changes in gastric pH make patients more prone to infections such as C. Difficile. Bone loss and fractures also have been associated with prolonged PPI usage.
Clarification regarding Sliding-Scale Insulin
The AGS authors clarified that their recommendation to avoid sliding-scale insulin refers to usage as sole insulin coverage in the absence of basal or long acting insulin. It does not refer to “correctional insulin” (i.e. titration of basal insulin or use of additional short- or rapid-acting insulin in conjunction with scheduled insulin).
Nonbenzodiazepine, benzodiazepine receptor agonist hypnotics
Continued evidence shows that drugs in the non-benzodiazepine sleep medications (eszopiclone, zaleplon, and zolpidem) have side effect profiles similar to the benzodiazepines and share a similarly unfavorable efficacy to risk ratio. In 2012, the Beers list recommendation was to avoid usage over 90 days. Now they strongly recommend to avoid them without regard to duration of use, just like they recommend against use of benzodiazepines.
Opioids have been added to the list of medications which affect the CNS and should be avoided in patients with a history of falls or fractures. Keep in mind that NSAIDs remain on the list of drugs to avoid when possible, especially indomethacin due to its negative side effect profile.
This medication, frequently prescribed for patients with vertigo, was already on the warning list of medications with strong anticholinergic properties. In 2015, the medication is now on the list for meds to avoid regardless of diagnosis.
In addition to the previous recommendation against usage in behavioral problems of dementia, antipsychotics were recommended against as first line treatment of delirium, due to conflicting evidence of efficacy and risk of adverse effects (appropriate usage exceptions: schizophrenia; bipolar disorder; short term anti-emetic usage during chemotherapy).
AGS identified a few selected drug-drug interactions
Most were straightforward such as recommending against utilizing multiple medications which together would increase the anticholinergic burden. Others were less obvious, such as the warfarin -amiodarone combination which may cause an increased risk of bleeding.
What does this mean for the rounding SNF physician?
The Beers list is not intended to replace clinical judgment. Each patient has his or own unique set of medical issues and personal values, and this must always be taken into account by the physician. The Beers list should not dictate what medicines are prescribed for each individual patient.
It is important to know that because of the specific needs and different therapeutic goals for patients who are under palliative care or hospice care, the AGS Expert panel specifically excluded them from their analysis of these medications.
I recommend that you review the article carefully and see which medications you more frequently use or are frequently prescribed to patients who come under your care. Our patients are increasingly complex with multiple diagnoses, and often we “inherit” patients from the hospital who have some of these medications on the list.
In general, it is a good idea to consider an alternative medication if a patient is admitted with one or more of these PIMs as part of their regimen. Your consultant pharmacist also can assist you in finding an appropriate alternative medication, corresponding dosage and give advice on the safest way to wean a patient of a medication if necessary.
If you decide to use a medication on this list, then it makes sense to clearly document why this decision was made, and to discuss it with the patient and family if appropriate. This will help protect you and your LivingCenter from a liability and regulatory standpoint and will assure that the patient is empowered to take part in the decision.
As Medical Director, you may be approached by your DNS or consultant pharmacist about an attending physician on your staff who may be using more potentially inappropriate medications than advisable. It will be up to you to discuss the cases clinically and figure out the best way to communicate any concerns to your physicians.
As we increase the number of younger, subacute patients, there will be more who have “Beers list” medications as part of their regimen upon admission. While these patients may be younger and have better renal function, they still may have complex medical issues and opportunities for drug-drug or drug-disease interactions.
You can get the Beers list update for free at:
American Geriatrics Society 2015 Beers Criteria Update Expert Panel, American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults J Am Geriatric Soc 63:11 November 2015, pp. 2227-2246.
Background on Clozapine
As you may recall, clozapine was one of the first atypical antipsychotic medications. It provided an alternative to phenothiazines, one that had much lower incidence of extrapyramidal side effects, and it was another option for patients who hadn’t responded to the traditional medications. Unfortunately, it soon was realized that clozapine had its own significant side effect, that of neutropenia. This led to periodic monitoring of white blood cell counts which has for years been mandatory. In order for a pharmacy to be permitted to dispense clozapine – now available as Clozaril(R) , FazaCloz(R) and Versacloz(R), a patient has had to be registered in one of the several clozapine registries and have proof of a recent ANC (absolute neutrophil count, requiring a CBC with differential cell count). The protocol is that if the ANC is acceptable, only enough medication is allowed to be dispensed to get the patient to their next scheduled ANC. This could be only enough for a week, two weeks or a month. Until the registry gets proof of the ANC, the drug may not be dispensed.
What has changed?
All patients on clozapine are therefore in some registry and this was the system until October. Together with the FDA, the makers of clozapine consolidated the registries into one. Patients and doctors in the registries are supposed to be automatically “migrated” from their previous registries into the new Clozapine REMS (Risk Evaluation and Management Strategy) registry.
Up to this point, pharmacies had been given significant latitude in order to help the physician with the prescribing and monitoring of clozapine. As of Nov. 2, 2015 (today) in addition to prescribing or ordering the medication, physicians are required to register the patient and enter the labs into the registry. Once registered, physicians may allow another party, such as a pharmacist or office employee, to be a designee.
Physicians who currently are registered as prescribers of Clozapine should have received notification by mail, e-mail or fax from both the registries and from your pharmacy provider. Nevertheless, this information is provided in case you missed it.
What this means for you
Since it is now Nov. 2, you must do the following ASAP today:
Physicians who have patients on Clozapine (even prescribers who have been using a previous registry), must become certified through the new Clozapine REMS registry. Fortunately, this process is quick and painless. There is a minimal information input followed by a brief education program concerning neutropenia and clozapine management. There are a few post-test questions. This takes about 20 minutes, at most. You can get to this at: www.clozapinerems.com
if you are interested in naming a designee to retrieve and enter information into the registry for you, there is a process to do this on the website. The potential designee must also register, once that is processed, you may select them for a patient as a designee.
Because this applies to all attending physicians, please communicate this information to your medical staff. Talk to your DNS and Consultant pharmacy to see if there are patients in your Living Center who are receiving clozapine. Feel free to give your fellow providers in the LivingCenter a copy of this issue of First Monday.
GLC and Our Pharmacies Can Help
We are working with our pharmacy partners and staff to make sure that you will be advised as a prescriber of the status of patients with regard to the timing of ANCs. Please feel free to contact your pharmacy provider or consultant pharmacist for assistance in getting registered.
What you need to know about Clozapine REMS, may be found at: https://www.clozapinerems.com/CpmgClozapineUI/rems/pdf/resources/Clozapine_REMS_Guide_Patients_Caregivers.pdf
Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers:
Several copies of Doctor to Doctor, Second Edition, revised this year, will be distributed this week to all Golden LivingCenters. Medical Directors also will receive an electronic copy via email. This guidebook is full of information which can help Golden Living Medical Directors with how to be a success at the position. If you are new to medical directing, have been doing it for a while or are even an “old hand” at it, you’ll want to check this out.
There are there practical tips on everything from what to do during survey time to your role in QAPI to how to document in a way that minimizes your risk. The medical director’s contractual obligation section is revised to focus on what is absolutely required of you, and how to work with your ED and DNS on identifying your objectives for the year. There’s even a copy of the monthly timesheet you need to fill out for your Executive Director conveniently located in the back of the book.
Because doctors are busy, and medical directors are no exception to this, the guidebook is concise enough that you could probably read it in one sitting over a cup of coffee.
For Medical Directors to request an electronic copy, please contact Maureen.Dux@goldenliving.com.
-Al Barber PharmD, CGP AlixaRx Clinical Services
On August 28, the U.S. FDA warned that a commonly used class of medications for Type-2 diabetes (DPP-4) inhibitors may cause joint pain that can be severe and disabling. (1)
Commonly used DPP-4 inhibitors include:
- Sitagliptin (Januvia®)
- Saxaglipitin (Onglyza®)
- Linagliptin (Tradjenta®)
- Alogliptin (Nesina®)
DPP-4 inhibitors lower blood glucose levels in Type-2 diabetics by slowing incretin metabolism. Incretins, (including GLP-1) are gut hormones that are secreted from enteroendocrine cells into the blood within minutes after eating. One of their many physiological roles is to regulate the amount of insulin that is secreted after eating.
Since 2005, two new classes of drugs based on incretin action have been approved for lowering blood glucose levels in T2DM: incretin mimetics (i.e. exenatide, which is a potent long-acting agonist of the GLP-1 receptor) and incretin enhancers (i.e. sitagliptin, which is a DPP4 inhibitor). Exenatide is injected subcutaneously twice daily and its use leads to lower blood glucose and higher insulin levels, especially in the fed state.
There is glucose-dependency to its insulin secretory capacity, making it unlikely to cause low blood sugars (hypoglycemia). DPP4 inhibitors are orally active and increase endogenous blood levels of active incretins leading to prolonged incretin action. The elevated levels of GLP-1 are thought to be the mechanism underlying their blood glucose-lowering effects. (2)
Information for Health Care Professionals
- Severe and disabling joint pain has been reported with the use of DPP-4 inhibitors. The time to onset of symptoms following initiation of symptoms varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. Some patients had a recurrence of severe join pain when restarted on either the original or a different DPP-4 inhibitor.
- Consider DPP-4 inhibitors as a possible cause for any patient who presents with severe and persistent join pain, and consider discontinuation of therapy with this class of drugs.
- The FDA identified 33 cases of severe arthralgia reported with the use of DPP-4 inhibitors from 2006 to 2013. All patients experienced arthralgia that resulted in a substantial reduction in their prior level of activity, including 10 patients who were hospitalized due to disabling join pain. In 22 cases, symptoms appeared within one month of therapy initiation. In 23 of 33 cases, symptoms resolved less than one month after discontinuation of the drug.
- Ten of the 33 cases reported fever and chills, rash, and swelling, which are suggestive of an immunological reaction. However, the majority of these patients had negative or normal test results and the positive results were not specific for a particular autoimmune condition that can cause severe joint pain.
The bottom line:
While the DPP-4 inhibitors are an important class of medications, if you have a patient on one of these who has developed severe unexplained joint pain, even years after beginning treatment, consider a trial off of the medication. –mjy
- FDA Drug Safety Communication 8-28-15: FDA Warns that DPP-4 inhibitors for type 2 diabetics may cause severe joint pain http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf
- Wook K, Egan J The Role of Incretins in Glucose Homeostasis and Diabetes Treatment Pharmacol Rev. 2008 Dec; 60(4): 470–512. Published online 2008 Dec 12 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2696340/
At the end of August, Dr. Evans gave a well-received talk on decreasing inappropriate use of antipsychotic medications. Very practical information was shared about how to evaluate your patients and your LivingCenter for off-label use of antipsychotic medications in patients with dementia. Tips on gradual dosage reduction were discussed, and the need for a multidisciplinary approach was stressed. A copy of her presentation slides in PDF format was sent to the doctors on the First Monday distribution list. If you did not receive this and would like a copy, please click here or contact Reene Dux at Maureen.email@example.com.