The Daily Dose™

February 9, 2015

OTCs: It’s Not Just What, It’s When. Timing is Everything.

Levothyroxine (Synthroid, Levoxyl and generics) is the most commonly prescribed drug in the US. Osteoporosis is a common co-morbid condition with hypothyroidism among older females, who also often exhibit iron-deficiency anemia as well.  So what happens in the real world when patients are also medicating with calcium and iron supplements?

A 2015 Clinical Endocrinology study looks to shed some light on this subject.  Authors studied over 10,000 Tayside, Scotland residents (82% female) who were prescribed levothyroxine for hypothyroidism, and found that both calcium and iron supplements were associated with greater TSH levels (indicating less effective treatment). Unfortunately the researchers were not able to capture when levothyroxine and other agents were taken.

Patients taking levothyroxine are typically advised to take a calcium supplement to counter the effects of a low TSH on bone resorption. The American Thyroid Association (www.thyroid.org) and levothyroxine prescribing information have long advised that levothyroxine be taken on an empty stomach and separated from calcium, iron and other mineral supplements (including antacids) by 4 hours.

So what are patients actually doing? Our prior research found that the majority of patients (80%) reported taking calcium within 4 hours, 67% within 1 hour. This practice can reduce levothyroxine absorption by nearly a third.

Trying to educate patients to correctly separate their levothyroxine from potentially risky OTC medications can be a challenge in itself. First of all you have to know exactly WHEN patients are taking each of their medications to see if there is indeed a problem.  Secondly, Individuals who have consistently timed their levothyroxine and calcium supplement may have had their levothyroxine doses increased to maintain therapeutic levels. However, sporadic or inconsistent timing of calcium administration could result in variations in TSH and T4 levels and concomitant symptoms of hypothyroidism. And lastly, patients who have had their levothyroxine dose increased as a result of taking calcium within 4 hours of their levothyroxine could experience an over-suppressed TSH – and even symptoms of hyperthyroidism – if they revise their self-medication regimen upon learning that they should separate their calcium and levothyroxine by 4 hours.

So we really need to know…What, then When, and then What to Do.  Our ActualMeds structured patient interview queries when each medication or supplement is taken and our proprietary rules algorithm tailors alerts around timing. ActualMeds provides a visual heuristic of the self-medication regime – and avoids the over-alerting (“alert fatigue”) seen with other solutions (e.g. a levothyroxine and calcium supplement drug interaction alert regardless of timing). There is no point in firing an alert if the patient is taking levothyroxine and calcium 4 hours apart! If there is a timing issue, ActualMeds prompts clinicians to intervene, patients are educated around proper administration and follow up TSH levels would certainly be recommended. Let’s start asking “When?” after we ask “What?”! It’s all about the timing!

Irving SA, Vadiveloo T, Leese GP. Drugs that interact with levothyroxine. An observational study from the thyroid epidemiology, audit and research study. Clin Endocrinol. 2015;82(1):136-141 http://www.medscape.com/viewarticle/837370?nlid=75075_764&src=wnl_edit_medp_imed&spon=18

Michel R, Neafsey P, Dzurec LC. Self-medication practices among patients taking levothyroxine. Internet J Adv Nurs Pract. 2003;6(2) https://ispub.com/IJANP/6/2/11898

Neafsey P J. Levothyroxine and calcium interaction. Timing is everything. Home Healthcare Nurse. 2004;22(5):338-339.

 

Patricia J Neafsey, PhD (pharmacology): Co-founder and Principal Scientist, ActualMeds Corporation.  Professor Emeritus, University of Connecticut School of Nursing. @PharmacoQueen

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February 4, 2015

ANTICHOLINERGIC MEDICATIONS AND DEMENTIA: ENOUGH ALREADY. IT’S TIME WE DRAW THE LINE! 

A new study recently published online in JAMA Internal Medicine “Cumulative Use of Strong Anticholinergics and Incident Dementia-A Prospective Cohort Study” has raised the bar on confirming the link between anticholinergic medication use by older adults and all-cause dementia.  In an accompanying editorial, Noll L. Campbell PharmD of Purdue University College of Pharmacy called the study “the strongest evidence to date that anticholinergic drugs cause dementia”.

A team lead by Shelly L Gray PharmD, University of Washington, Seattle prospectively followed over 3400 participants over the age of 65 (mean age of 73) for 10 years, and assessed their use of strong anticholinergic medications and the incidence of all-cause dementia. (Strong anticholinergics are those that scored a “2 or 3” on an anticholinergic scale of 1-3.) They found about 20% of the participants were using one of the list of strong anticholinergic medications.  They developed a process to characterize the medication use according to dosage, frequency and cumulative time on drug.  The results showed that about 23% of the participants developed all-cause dementia, and of these, the vast majority was Alzheimer’s disease (80%).

Several things impressed us about the study.  Some previous studies on the topic have low participant numbers, did not ascertain actual dose or duration of medications and/or had short follow-up periods.  The study by Gray et al. seems to address these issues with a robust cohort size; specific criteria for determining dose/duration of medications, and a 10 year follow up study period.  Essentially the findings collaborate what many clinicians believe…the more you use, the higher the dose, the longer the period of use…the higher the risk of dementia.  We think the paper is an important read.  You can use the following link to access the abstract, and obtain a full copy. http://archinte.jamanetwork.com/article.aspx?articleid=2091745

The study also brings us to strike once again some familiar chords.  While Gray et al. focused on a strict method for characterizing anticholinergic medication use, the ‘list’ of offending medications were all ‘moderately strong’ and ‘strong’ anticholinergic medications.  We know that many medications, prescription and OTC alike, have mild to moderate anticholinergic activity…and similarly when you stack all of those up into one medication regimen, particularly over time, you can get the same amount of cumulative harm as incurred by use of any one of the ‘strong’ ones.  Even as marked a result as this study showed, the authors only focused on prescription claims data to identify anticholinergic medications use.  Imagine if OTC medications had been included (loratadine (Claritin) anyone?), alone or in combination with prescribed medications as assessed via claims data.

So how do we reduce the utilization of anticholinergics in circumstances where dementia risk is a concern?  Well, just scroll back a bit to a couple of our other blog postings “Is it Really Dementia?  Or is it an Adverse Drug Event??” (10-29-2014) or “Taking a Closer Look at Benzodiazepine Use and Risk of Alzheimer’s disease in Older Adults” (9-14-2014).  Like we said, ‘familiar chords’.

Claims are a good start for risk analysis, but let’s not just limit our risk analysis to strong prescribed anticholinergics.  We need to go beyond claims or even medication orders and perform a comprehensive medication review that includes a structured patient interview which captures OTC and CAMs.  We need to have a way to figure out the cumulative anticholinergic burden across ALL possible medications – Rx and OTC, and address the highest burden patients first.  And lastly, we need a robust and agile way to communicate these findings to the rest of the health care team…not just keeping our findings in one silo, but letting all team members benefit from the knowledge of risk identified by one team member.

Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation.  Past President, American Society of Consultant Pharmacists. @jgactualmeds

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January 26, 2015

Warfarin Interactions. We Should Be Worrying More About OTCs Than Spinach.

Newer oral anticoagulant medications that do not have troublesome drug-drug and drug-food interactions may offer alternatives for some patients with certain conditions; however they are pricey, leaving warfarin to continue as the most commonly prescribed anticoagulant. Patients initiated on warfarin are typically warned about two things: 1) use acetaminophen for pain or fever – don’t self-medicate with aspirin or NSAIDs such as ibuprofen or naproxen and 2) avoid dark green leafy vegetables (such as spinach). While well intentioned, both of these points miss the mark.

While acetaminophen used infrequently is much less likely than aspirin, ibuprofen or naproxen to raise INR and result in bleeding in individuals on warfarin, acetaminophen used often (more than 8g/week or more than 2g/day) increases INR in a dose-dependent manner. Acetaminophen is ubiquitous in OTC preparations, many taken for symptoms other than pain and fever. Individuals may just not realize how much they are actually taking. Of course, being able to decipher OTC labels is a challenge for many older adults.  All of these factors contribute to patient risk, and provider challenges in ascertaining that risk.

The conundrum of OTCs and older adults was the topic of a recent national summit. ActualMeds cofounders Pat Meisner and PJ Neafsey were invited participants.  (http://www.chpa.org/2013medbehaviorolderadults.aspx ) Improved OTCs labels, usable technology to track specific OTC ingredient/dose/frequency of use, and improved communication among professionals, patients and family caregivers were hot topics at the summit. (See the full paper http://www.medscape.com/viewarticle/836537?nlid=73646_429&src=wnl_edit_medp_fmed&uac=36806BZ&spon=34  Medscape subscriptions are free.)  To the last point, a recent Medscape article reviewed the evidence around the acetaminophen dose-response interaction with warfarin. (http://www.medscape.com/viewarticle/838026_2).  As of this writing, only 48% of readers selected acetaminophen as the OTC agent taken on a daily basis that could increase INR. (The other choices were calcium carbonate, ranitidine, docusate). That adds up to a lot of unidentified risk that could be driving adverse events. How can we do better?

Calcium carbonate does not interact with warfarin, but certain “osteoporosis” or “women’s” formulations do because they have vitamin K added. It is now well known that vitamin K has an important role is maintaining bone density. The vitamin K added to calcium supplements (and many multivitamins) is 80% bioavailable (i.e. 80% gets into the blood). Someone following the label instructions could expect to absorb 96 mcg of vitamin K in a day. In contrast, the bioavailability of vitamin K in spinach is only 3%. Eating spinach with oil (as in a salad) increases vitamin K bioavailability, but to only 9%.  Three servings a day of dark green leafy vegetables would result in only 30 mcg absorbed, total. Maintaining a consistent dark green leafy intake makes sense – warfarin can be titrated to this consistent intake – and dark green leafy vegetables have a host of heart healthy attributes: potassium, antioxidants and nitrates.

Current drug-interaction software does send out an alert if warfarin and acetaminophen are reported – but with any dose of acetaminophen. This contributes to the “over alerting” phenomenon whereby identified risks are ignored or worse, the risk alerts are turned off. We can do a better job of “threading the risk needle” with better tools.  Using the ActualMeds structured interview tools, ActualMeds captures the often-missed risk factors and the context of how and when they are being consumed. The risk rules track and sum weekly dosages of individual OTC ingredients (e.g. acetaminophen and vitamin K as well as other OTC ingredients that interact with warfarin such as vitamin E and CoQ10). The resulting tailored risk messaging is actionable by providers, family caregivers and patients alike. This takes the worry out of adverse self-medication behaviors and lets everyone get on with enjoying that daily spinach salad.

Patricia J Neafsey, PhD (pharmacology): Co-founder and Principal Scientist, ActualMeds Corporation.  Professor Emeritus, University of Connecticut School of Nursing. @PharmacoQueen

 

Neafsey, P.J. (2004). Of blood bones and broccoli: Warfarin-vitamin K interactions. Home Healthcare  Nurse, 22(3), 178-184. (CE Article)

Neafsey, P.J. (2004). Self-medication practices that alter the efficacy of selected cardiac medications.  Home Healthcare Nurse, 22(2), 88-100. (CE Article)

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January 14, 2015

Treating Older Persons with Diabetes and Complex Conditions…Are We Overshooting the Mark?

As we know, it takes a long time for the health care community to understand and embrace guidelines and new treatment paradigms.  Once we finally get the snowball rolling down the hill it can be hard to change course or realize when a nuanced approach is needed. The ‘seven and under HbA1C’ guideline (as the threshold for demonstrating controlled diabetes) snowball has gathered momentum; all of the publicity around the diabetes epidemic in our young people, and its massive costs to the healthcare system have added to that momentum.  But for our older patients with diabetes and complex co-morbidities, have we swung the pendulum too far?

In 2012, the ADA and AGS published a consensus statement endorsing higher HbA1C targets for some older patients as well as use of metformin as initial therapy for appropriate patients.. AGS had also updated the Beers Criteria to include an oral diabetes medication and certain strategies for insulin dosing as ‘potentially inappropriate’ for older adults.  CMS has followed suit in their quality measures designating certain medications as ‘high risk’.  But is anyone paying attention?

In a recent Journal of the American Medical Association Internal Medicine on-line publication (http://archinte.jamanetwork.com/article.aspx?articleid=2089233) researchers take on the task of advocating for individualized treatment plans for older adults with complex conditions and multiple co-morbidities.  The lead author also shares personal thoughts on changing the approach to her own patients in a New York Times Op-Ed ( http://www.nytimes.com/2015/01/12/opinion/when-diabetes-treatment-goes-too-far.html?smid=nytcore-iphone-share&smprod=nytcore-iphone&_r=0).

The study “Potential Overtreatment of Diabetes Mellitus in Older Adults with Tight Glycemic Control” showed that roughly 60% of older adults with very complex to intermediate complex conditions had an A1C level of 7% or less, and that these patients were being treated with sulfonylureas or insulin. Despite this aggressive treatment, the health status of these patients did not markedly improve.  The researchers concluded that “intensive glycemic control strategies markedly increase the risk of hypoglycemia, the results of which ( dizziness, fainting, etc) can have far more serious consequences in an older adult.   Therefore, intensive strategies to lower glucose levels may result in more harm than benefit, particularly among older, sicker patients”.

Is it the tight control that is the issue, or is it the type of medications used to treat this specific cohort of patients and the consequent risks?  In a response to the study, Dr. Alan Garber of the Baylor College of Medicine in Houston is quoted as saying that while “the traditional goals are perhaps too low…you have to try them on medications with a low risk of hypoglycemia”.

So, for our complex frail older patients with diabetes, it seems like we need to address both goals and treatment strategies when determining treatment plans.  Let’s make sure we have reasonable HbA1C goals, and let’s also make sure we avoid hypoglycemic medications and dosage regimens that are known to predispose to hypoglycemia. We  should actively interview our patients to make sure that how they are using their medications is not contributing to adverse medication events, and that they are not using ‘hidden’ medications or herbals/supplements that might also be causing harm. And finally, let’s assess risk on an individual basis, based on what we learn from the patient.

As lead author Dr. Kasia Lipska says in her New York Times piece, “The goal is not to get a perfect score on a report card, but to weigh these risks to make a good decision”.

Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation.  Past President, American Society of Consultant Pharmacists. @jgactualmeds

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October 29, 2014  Is It Really Dementia? Or is it an Adverse Drug Event??

In her recent New York Times blog (@TheNewOldAge) author Paula Span asks the question: “Is It Really Dementia?”  Or is it really something else.  We ask:“Is It Really Your Medication?”

The blog raises the point that while there are other reasons for memory and cognitive impairment symptoms, most often for a 75 year old person with longer-onset symptoms, the diagnosis is usually dementia and usually Alzheimer ’s disease.

While this is generally true, the discussion continues around other causes of memory and cognitive decline, especially when symptoms appear abruptly.  We concur, and posit that a large contributor to the development of ‘delirium’ symptoms (as opposed to a dementia presentation time-line) is medication use, specifically Adverse Drug Events (ADEs).

Ms. Span quotes Dr.P Murali Doraiswamy, a noted researcher at Duke: “There’s a long list, several hundred drugs, both prescription and over the counter, that can impair memory.”

Indeed, in 2012 The American Geriatrics Society (AGS) published a revision of the Beers’ Criteria- an exhaustive list of medications known to cause memory and cognitive decline in older adults as well as many other types of ADEs.  CMS has continued that thread with their STAR RATINGS quality measures for Medicare Part D Health Plans, warning of potential ADEs as a result of a set of ‘High Risk Medications’.

Two articles recently published in the pharmacy literature point out the connection between older adults, medication use and ADEs.  Older adults just use more medications.  A study in The Consultant Pharmacist (ConsultPharm 2014;29:689-97) showed a study group of older adults used an average of 7.2 medications AND an additional 6 over-the-counter medications on top of that (OTCs are available today that were once prescription-only, and at the same Rx strength).  The authors found that ADE risk doubled when patients were in the 5-7 Rx range and quadrupled when patients were taking 8 Rxs or more.

Synder et al, in a study published this month in Pharmacotherapy (Pharmacotherapy 2014;34(10):1022-32) supports that the number of medications used by older adults is predictive of ADEs.  Both authors state that the current CMS requirement of Medicare Plans to provide Medicare Therapy Management Programs may be inadequate to predict and intervene specifically on patients with increased risk of ADEs.

Dr. Doraiswamy also states that older adults suffer from conditions that also impair memory and cognition, such as depression, anxiety and insomnia.  We observe that in addition, medications used to TREAT those conditions can also worsen memory and cognition in their own right (see previous blogs by us on this topic)

So, follow the convergence.  Older adults are most at risk from dementia, who have conditions which cause dementia-like symptoms, are treated for those conditions with medications which cause dementia-like symptoms, who take the most medications, who are also mostly at risk for ADEs, which is a predictor of future ADEs which can cause memory and cognitive decline symptoms in a population already at risk for dementia. It sounds like Catch-22.

Okay, how do we break  this cascade of convergence, and what do we do?  As Span says, many times it’s dementia, but as we observe above, sometimes it’s not.  We need to make sure we do a thorough medication reconciliation when we start the medication management process, starting by really validating “known” quantities from claims or orders, but also making sure to include a structured patient interview which captures over-the-counter (OTCs) and complementary-alternative medications (CAMs).  We need to have a clear and complete picture of the patient’s actual medication use, and combining all best possible sources of data gives the clinician a clear starting point for assessment, and streamlines the process of assessing a complex situation. We also need to make sure we have the resources to understand how those medications are interacting to the detriment of the patient’s memory and cognition, and have a good process to communicate our finding to the rest of the health care team. Better yet, let’s use our analytics and talents to design predictive programs that reach out, identify patients who are at risk for ADEs, and do our best to resolve and prevent them. Understanding risk isn’t enough if we haven’t established an efficient, scalable process for making those risks actionable across the care team.

Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation.  Past President, American Society of Consultant Pharmacists. @jgactualmeds

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October 12, 2014    Rethinking the Social History in the Oct. 2 issue of the New England Journal of Medicine 

Several months ago, I accompanied an older friend to her first visit with a “diabetologist.” We waited along with at least a dozen other new patients. Each patient was given the typical clipboard with pages of questions to be answered. Maybe it was the soothing sound of the bubbling fish tank or the small intimate nature of the waiting room, but the patients started to chat with each other and ask why these questions were not available to be answered from their home computers, tablets or phones. One man in his 50s exclaimed “This is the third time this month I’ve answered the same sort of questions! First my regular doctor, then my cardiologist and now here! I thought we had electronic health records!” Other patients chimed in with similar comments, and one deaf woman in her 40s (who read lips, but whose speech could not be understood by the medical assistant) gesticulated with her smart phone and clipboard, clearly agreeing that she would prefer to answer the questions electronically.

Behforouz, Drain and Rhatigan’s recent Rethinking the Social History in the Oct. 2 issue of the New England Journal of Medicine ( http://www.nejm.org/doi/full/10.1056/NEJMp1404846 ) aims to motivate physicians to expand their social history interview to include “new” items such as diet and exercise, financial, English literacy, health literacy, self-perceived health, barriers to medication adherence and more. Missing from the list are other crucial topics such as sleep habits, self-medication behaviors (prescribed and over-the-counter medications and supplements, and alcohol – including when each agent is taken), allergies/food intolerances and symptoms, including a pain scale. One of my colleagues likes to cite her mantra “It’s the workflow, stupid!” every time one of us comes up with another great idea to improve patient outcomes. How can a complete history be obtained in the workflow of the average practice that has small, crowded waiting rooms, full exam rooms and 14 minute visits and who is going to pay for the additional time and effort to conduct the expanded social history interview?

Medical sociologists, public health nurses and registered dietitians (RDs) as well as nurse practitioners (NPs) have long obtained social histories in their scope of practice and pharmacists are now querying patients about their social history as they conduct Medication Therapy Management (MTM). While adding RDs, NPs and pharmacists to group primary care practices improves patient outcomes, using these health professionals to conduct patient social histories prior to the primary care visit is not using skills at the top of their licenses – and does not solve the associated workflow issues and costs.

Why not enable patients to report their social histories electronically? Intuitive user interfaces are being designed to enable medical assistants to conduct both social and medication use histories as they sit beside the patient. (We say beside because the interviewer should communicate with the patient, not the device in order to avoid the problem of the “third person” in the room dominating the interviewer’s attention). Medical assistants can conduct these interviews with patients in the office or home – or speak with patients by phone or video. Medical assistants are cost efficient – but they need private office space and practices need enough of them to maintain adequate patient flow.

Many patients (or their family members or other caregivers) could complete these histories at home before their office visit – using secure HIPPA compliant servers. Interfaces for patients are being designed with universal usability, i.e. consideration of lower health literacy (simple language, use of illustrative icons and animations) and various psychomotor skills (large targets and scroll bars that can be used with a finger or stylus, voice activated, etc.).  Behforouz, Drain and Rhatigan conclude: “To be able to treat the patient, a physician must ask the right questions and know how to act on the answers”.

The workflow problem of collecting social histories can be solved. Acting on the answers includes considering the patient’s health behaviors as an essential data channel and integrating those data into all of our electronic systems, algorithms, and support tools.  We need to make sure our process for asking the right questions is not only patient friendly and efficient, but is done in a way that maximizes the efficiency of the health care team ( it’s “the workflow, stupid”), and is truly incorporated into our actions and decisions on behalf of the patient.

Patricia J Neafsey, PhD (pharmacology): Co-founder and Principal Scientist, ActualMeds Corporation.  Professor Emeritus, University of Connecticut School of Nursing. @PharmacoQueen

Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation.  Past President, American Society of Consultant Pharmacists. @jgactualmeds

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Taking a Closer Look at Benzodiazepine Use and Risk of Alzheimer’s disease in Older Adults, September 14, 2014

A Study published on-line  September 9th in the British Medical Journal is getting a lot of response from healthcare blogs, print media, and other sources such as Medscape.  The Canadian case-controlled study set out to investigate the relationship between the risk of Alzheimer’s disease (AD) in older adults and exposure to benzodiazepines (BZNs) five years prior to first diagnosis of AD. Researchers used a retrospective administrative claims database (prescription drug events).

Using a formula to normalize the benzodiazepine exposure in the participants’ claims data, the authors reported that those who took an equivalent of daily doses for three to six months over a five year period were about 32% more likely to develop Alzheimer’s than those case controlled patients who took no study medications.  Those patients who took daily doses for more than six months were 84% more likely to develop Alzheimer’s disease.

The potential for adverse medication events (falls, cognitive impairment and decline, impaired activities of daily living) as a result of use of BNZs by older adults is well documented, and addressed previously in this blog (http://www.adheretx.com/blog-2/).  While the authors stated an objective to study relationships or possible causality with Alzheimer’s disease, the lead author herself has stated “The nature of the link (causal or not) is still not definitive, but these conclusions reinforce the suspicion of a possible direct link.”  The authors also note that a study limitation exists due to the nature of the “use of claims databases without direct access to patients.”  Dr. Gisele Wolf-Kline, who is director of geriatric education for the North Shore-LIJ Health System in New Hyde Park, N.Y., stated in review of the study “The study was only able to find an association between the drugs and Alzheimer’s risk.  One reason is that the findings are based on prescription records [only].  We know the drugs were prescribed, but we don’t know how often people took them, or if they took them at all.”

Our thought is,  causal or not, the association between benzodiazepine use and risk of Alzheimer’s disease seems to be dose related and progressive based on time of exposure.  We also note that the authors show NO increased risk for older adults who had less than one month exposure for insomnia use, and three months exposure for anxiety.  In any event, to accurately determine a patient’s risk, it is imperative that a patient interview be completed to determine a patient’s actual exposure to BZNs, and not rely on formulas and/or prescriptions claims data.  Such algorithms can assist us in knowing where to look, but the patient’s own actual medication use must be characterized and is a critical part of risk assessment.

Joseph Gruber RPh, CGP, FASCP Chief Clinical Officer, ActualMeds Corporation. @jgactualmeds

http://www.medscape.com/viewarticle/831403?nlid=65244_2981&src=wnl_edit_dail&uac=25947DX#2

http://www.bmj.com/content/349/bmj.g5205

http://www.latimes.com/science/la-sci-sn-anxiety-drug-alzheimers-20140909-story.html

http://consumer.healthday.com/cognitive-health-information-26/alzheimer-s-news-20/anxiety-medications-tied-to-alzheimer-s-risk-691577.html

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Are We  Going Backwards In Our Approach to Pain Management in Older Adults? August 25, 2014

Recently the DEA, despite pleas from the national pharmacists professional societies (http://www.pharmacist.com/sites/default/files/files/Joint_Rescheduling_Letter_to_HHS_10_2013.pdf) rescheduled hydrocodone combination products into schedule II: imposing significant restrictions and barriers to access to these products, particularly affecting older adult Americans (http://www.ofr.gov/OFRUpload/OFRData/2014-19922_PI.pdf) .While the prescription abuse epidemic indeed is a critical problem, the ‘addict’ label does not apply for the vast majority of our nation’s frail elderly. Use of medications for pain carries the same benefits and risk considerations of all medication use.  Appropriate use and identifying and resolving mis-use is always a part of a care plan which includes medication therapy.  We are throwing the baby out with the bathwater, and the DEA action is another example.

Pain used to be the sixth vital sign.   Drastically reducing older Americans’ access to needed pain therapies takes us back decades.  Untreated pain is a huge burden for patients, their families, and complicates all other conditions we are trying to treat.  We will now have to work twice as hard to address our patients’ needs.

Joseph Gruber RPh, CGP, FASCP Chief Clinical Officer, ActualMeds Corporation. @jgactualmeds

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One-in-Four Americans Purposefully Misuse Prescription Drugs.

Author Michael Johnsen reports in Drug Store News that a new national survey by FindLaw.com reports that as many as 24% of survey respondents report that they have either taken a medication prescribed for someone else, or have given their own prescription to someone else.  When we read a statistic like that we most often think of intentional prescription drug abuse.  While the epidemic of prescription drug abuse is important, it is equally important to note that the survey indicated that 95% of the time, patients’ misuse of prescription medications was to ‘self-medicate a medical condition’.

As health care professionals, we go to great lengths to obtain as much prescription information as we can from pharmacies, hospitals, insurance companies, electronic medical records, health information exchanges and the like so that when we determine what medications a patient is actually taking we have as complete a picture as possible.  Of course, those sources only provide information on medications that were actually prescribed for the patient.  This study reminds us that a quarter of the time there are unknown prescription medications that must be identified, and incorporating the results of the patient medication interview into the medication reconciliation and medication management process is a critical step.  The full article in Drug Store News can be accessed at:  http://www.drugstorenews.com/article/one-four-americans-purposefully-misuse-prescription-drugs

Joseph Gruber, RPh, CGP, FASCP , Chief Clinical Officer   ActualMeds Corp

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More on Sleeping Pills and Older Adults, The New Old Age Blog

Author Paula Span has recently posted a series of articles to the New York Times.com blog commenting on the use of sleeping pills by American older adults.  The most recent posting occurred July 30th.  The ActualMeds clinical team posted an edited response on July 31st.  Following is the complete version.

As Paula Span recently comments, many have been fretting for years about sedative-hypnotic use, especially in older adults.  These medications have also been the target of geriatric-specialist pharmacists for many years in the nursing home setting and most recently since medication therapy management services have been required by Medicare for eligible patients covered by the Medicare Part D Prescription Drug Benefit.

We agree that for several reasons, the Z-drugs emerged as the ‘go to’ alternative to the benzodiazepines, but are they really the way to go?  Ms. Span mentioned that in February 2013 the American Geriatric Society (AGS) put sedative hypnotics on their “Five Things Physicians and Patients Should Question,” and the FDA has required labelling changes to the Ambien dosage recommendations.   The AGS had also included Ambien specifically in their 2012 American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults (J Am Geriatr Soc. 2012;60:616–631.).

The AGS Beers update also notes many other medications with similar side-effects for older adults that can make the effects of the sedative-hypnotics like Ambien even worse.

 

In February 2014, the AGS expanded their watch list to ‘Ten Things Physicians and Patients Should Question’.  We note that #9 is “Don’t prescribe a medication without conducting a drug regimen review.” Drug Regimen Review (DRR) starts with determination of the patient’s current medication regimen (medication reconciliation), and works to identify high-risk medications and potentially inappropriate use of medications (like the sedative-hypnotics). In addition, capturing potentially harmful over-the-counter medications and supplements is an important part of the process.  DRR has a host of other components and benefits (Gruber et al: The Consultant Pharmacist Nov 2010 VOL. 25. No. 11).  In fact, an annual comprehensive medication review for older adults is a quality indicator set by CMS (the Centers for Medicare and Medicaid Services).

In reality, medication reconciliation and medication review have the most critical importance whenever the patient has a change in the setting of care.  These ‘transitions of care’ are most often the time when medications can ‘fall through the cracks’.  If we can better characterize an older adult’s medication use at home, at the doctor’s office and when they change care settings, we may be able to put a dent in those ‘one in five E.R. visits’ mentioned by Ms. Span.  http://newoldage.blogs.nytimes.com/2014/07/30/more-on-sleeping-pills-and-the-elderly/?ref=health

Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation.  Past President, American Society of Consultant Pharmacists. @jgactualmeds

PJ Neafsey, PhD (pharmacology): Co-founder and Principal Scientist, ActualMeds Corporation.  Professor Emeritus, University of Connecticut School of Nursing. @PharmacoQueen