According to a recent Kaiser Health News report, 20% of Medicare patients hospitalized with one of five conditions (heart failure, heart attack, pneumonia, chronic lung problems or elective hip or knee replacements) return to the hospital within a month of discharge.1 Medicare penalizes hospitals if they have higher 30-day readmission rates than predicted by a Medicare formula based on the hospital’s mix of patients with any of the five conditions listed above and on the overall nation-wide readmission rates during the period July 2011 – June 2014. More than half of the nation’s hospitals were penalized by Medicare in October because they exceeded their predicted hospital readmission rates. Some hospitals do better than others and some states do better than others. Eleven states have unacceptable readmission rates in more than three quarters of their hospitals. Sens. Manchin (D-W.Va) and Wicker (R-Miss) argue that socioeconomic factors should be considered in assessing Medicare penalties; they’ve introduced a bill in the Senate to this effect. There must be additional reasons, however, because other states with underserved populations have lower hospital readmission rates and fewer penalized hospitals (e.g. Maine at 31%, Alaska at 33%). What do Connecticut and New Jersey have in common that results in 90% and 97 % of their hospitals, respectively, penalized for their high readmission rates? Both CT and NJ are among the top three highest per capita income states; the others are DC and MD. Could “more” care result in higher readmission rates in these high income states?
A recent study by Picker and colleagues published in BMC Health Services Research provides a clue.2 The researchers used a retrospective cohort study design to assess predictors of readmissions among 5,507 patients, of whom 21% were readmitted within thirty days. They found that the number of discharge medications was significantly associated with the risk of hospital readmission within thirty days. For example, 18% of patients with 4 to 6 discharge medications and 34% of patients with more than 12 discharge medications were readmitted within 30 days. A predictive model and corresponding risk score for 30 day readmission was developed and included: a) more than 6 discharge medications (1 point), b) more than one emergency department (ED) visit in the prior six months before hospitalization (2 points), c) low hemoglobin value (< 9 gm/dl) (1.5 points), and d) diagnosis of heart failure (1.5 points), peripheral vascular disease (1 point) and, or, metastatic disease (1 point). They found that a quarter of patients with a risk score between 1 and 5 and 35% of patients with a risk score > 5 were readmitted within 30 days. The authors concluded that their predictive model reflects the medical complexity of the patient – and it is medical complexity which ultimately drives hospital readmission.
Heart failure is a good example of this medical complexity. Applying Piker’s risk score, an individual with heart failure (1.5 points) who had one ED visit in the prior six months before hospitalization (2 points) and is discharged on more than 6 medications (1 point) would have a risk score of 4.5. But what does that ‘more than 6 medications’ look like in a real life clinical situation interviewing patients? To find out, Knecht3 used the ActualMeds Medication Management System to interview 41 Connecticut patients with heart failure who were recently discharged from homecare following a hospital admission. The patients reported taking an average of 12.6 medications (all took at least 5), many with multiple dosing times. Self-medication with OTCs accounted for 29% of medications. Most patients (71%) were taking medications on the Beers list of potentially harmful drugs in older adults and 48% had related symptoms. Nearly all (95%) were taking medications with anticholinergic side effects and more than half had a high anticholinergic burden score4 thus increasing their risk of cognitive impairment and falls. These results add a lot of granularity to the Picker data: “more than 6” may really be average of twelve medications for patients with heart failure, and it’s not just the number of medications being taken, but medications which pre-dispose patients to adverse drug events (ADEs) coming full circle in causing unplanned (and unpaid for) readmissions. To prevent those re-admissions and even the original admissions in the first place, we need to look seriously at ALL of the medications that a patient is taking, and focus our energy on identification and stratification of patients who are at risk for ADEs.
ActualMeds offers a proprietary suite of evidence-based tools to stratify patients at greatest risk for adverse drug events (ADEs) and resulting emergency visits, hospitalization and readmission. Separate data channels show risks as assessed in the EHR, medication claims, and patient interview. ActualMeds tracks prescriptions by prescriber and also tracks patient self-medication with OTCs, herbal preparations and supplements. The ActualMeds dashboard provides visual heuristics that reveal at a glance those patients taking the most medications and the most complicated regimens. Risks are exposed relative to important drug-drug interactions and quality and patient safety measures such as the Beers’ Criteria medications and CMS STARS alerts. An intuitive workflow enables the system to be used by all levels of licensure; making ActualMeds powerful analytics actionable for the patient’s entire health care team.
Patricia J Neafsey, PhD (pharmacology): Co-founder and Chief Scientific Officer, ActualMeds Corporation. Professor Emeritus, University of Connecticut School of Nursing. @PharmacoQueen
]]>ActualMeds CEO Patricia Meisner discusses how reducing complexity and risk of medication regimens in older adults is a fundamentally different approach to improving adherence. In order to do this care teams must be aware of a patient’s medication history to guide therapy and interventions at the point of care. Listen to the entire podcast at: http://www.relentlesshealthvalue.com/48
]]>We wholeheartedly endorse the Triple Tree Blog posting April 7th 2015 which describes that “an effective [Medication Therapy Management] MTM program can dramatically improve adherence…”.1 While pharmacists have long been personally delivering patient care services in a variety of settings, it is true as the blog states that market drivers such as the 2003 Medicare Modernization Act (MMA) which established the requirement for Medicare Plans to provide MTM services and the Centers for Medicare and Medicaid Services (CMS) Star Rating System which offers bonus payments for meeting quality metrics have taken the complexity and the outcomes of MTM programs and services to the next level.
MTM begins with a focus on improving the various dimensions of non-adherence , but it also addresses the full range of medication related problems including unnecessary and inappropriate medication use, medication over- and under-use, inappropriate dosing, drug interactions, and adverse drug events. 2,3 The two MTM case studies in the Triple Tree blog represent this nicely, showing that MTM intervention identified unnecessary duplicate therapy, revealed overuse of an acute medication and underuse of one that actually addressed the condition itself, rather than symptoms. The process also identified gaps in use of medications recommended by evidence-based guidelines and of course adherence issues.
We note that the two case studies were 37 and 54 year old patients, demonstrating that MTM can add value beyond the geriatric patient population. But, imagine the clinical impact and ROI of MTM services applied to all of our nation’s seniors over 65 years of age who use an average of 7 daily Rx medications AND an additional 6 over-the-counter preparations and herbal/supplement products. Such patients are at great risk of adverse drug events: a patient taking 7 medications has twice the risk, and patients taking eight or more medications have a quadruple risk of suffering adverse events which can lead directly to emergency department visits, hospitalizations and re-admissions.5
Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation. Past President, American Society of Consultant Pharmacists. @jgactualmeds
Triple Tree points to examples of market activity validating the MTM model. We need to build on these examples around some key concepts:
We embrace these principles and have made them part of the ActualMeds formula for meeting the ultimate goal of MTM: helping all patients to successfully engage with their care team to manage their medications, and particularly for our older adults to age in place with dignity and quality of life. Our technology enables a team-based approach and promotes pro-active, longitudinal personal engagement with patients and providers. Our managed services offer an on demand consulting pharmacist if needed. Care teams are informed first with what medications patients are actually taking, second that all medications are necessary and not harmful, and third that the regimen is designed to be as simple as possible. Armed with this information at point of care the care team has the best opportunity to engage the patient and tailor the intervention that will have the greatest impact for improving outcomes.
1 Medication Non-Adherence: A $290 Billion Unnecessary Expenditure;Triple Tree Blog April 7, 2015
2 Hepler CD, Strand L. Am J Hosp Pharm 1990;47:533-43 and Strand L. Pharm J 1997;258:899-904.
3 Medication Therapy Management in Chronically Ill Populations: Final Report. Acumen, LLC, Burlingame, CA Agusut 2013
5 ConsultPharm 2014;29:689-97
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More than a decade ago, World Health Organization (WHO) identified medication non-adherence a problem of great importance. In a 2003 white paper, WHO states that the medication non-adherence rate for patients with chronic diseases in developed countries is a full 50%.1 George, et al. performed a systematic review in 2008 and determined complex medication regimens as a key root cause for medication non-adherence.2 Our previous posts in this blog speak to the many causes of adherence, and we have always posited “To get to the root causes we need to talk to our patients.”
Well, that’s exactly what a group of pharmacists from the Massachusetts College of Pharmacy and Health Sciences (MCPHS University) did, and are reporting in the March 2015 issue of The Consultant Pharmacist, the peer-reviewed journal of the American Society of Consultant Pharmacists.3 The authors noted that previous work has shown that older adults often had increasing difficulty in scheduling their medications as the number reaches seven or more, that only 18% of independent-living seniors reported that any health care provider worked with them to simplify their medication regimen, and that 40% of the time seniors did not even realize there was an option to work with their care team in streamlining medication use.4,5
The authors reported on the effects of a face-to-face Comprehensive Medication Review (CMR) between a pharmacist and a group of 75 independent-living older adults as part of an outreach program at a New England community senior center. While the CMR was comprehensive in nature, the patient encounter focused on two areas: 1) simplifying complex medication regimens and thereby improving adherence, and 2) educating older adults that medications can be an important risk factor for falls.
The study participants were presented with a Personal Medication List (PML) and a Medication Action Plan (MAP) that outlined opportunities for simplification of their medication use and were urged to contact their prescribers to discuss the pharmacist’s recommendations. Upon follow up, it was noted that there was a statistically signification reduction in the number of medications per patient and patients had reduced multiple daily dosing periods from more than six, to three or fewer. In addition, at follow up, study participants’ awareness of medications that could contribute to fall risk increased from 28% pre-survey to 56% post-survey.
These results are encouraging; we have often written about the value that pharmacists can bring to care teams, particularly for independent-living seniors and those seniors in assisted-living communities. Like most medication review, this was a” one and done” CMR encounter with patients who were only given an Action Plan and urged to contact their prescribers. How much more of a difference could we all make for our patients by introducing routine engagement by pharmacists with the rest of the care team to simplify complex regimens and identify and resolve medication related problems which pre-dispose older adults to falls and fractures?
We believe ActualMeds has a “secret sauce” for helping older adults in ambulatory settings who so desperately want to age in place with dignity and quality of life. The ingredients are professionals and technology which foster a team-based approach and a pro-active longitudinal personal engagement with patients and providers. This assures first, that we know what medications patients are actually taking, second that all medications are necessary and not harmful, and third that the regimen is designed to be as simple as possible. The ActualMeds solution can facilitate all of these critical elements by bringing the care team together with the right information at the right time.
Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation. Past President, American Society of Consultant Pharmacists. @jgactualmeds
1Sabate E, ed. Adherence To Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization 2003
2Geroge,J, et al: A systemic review of interventions to improve medication taking in elder patients prescribed multiple medications. Drug Aging 2008;25:307-24
3Bartlet, D. et al: Pharmacist Consultations: Simplifying Daily Drug Regimens and Providing Education on Fall Risk for Older Adults. Consult Pharm 2015;29:141-52
4Wolf, M.S. et al: Helping patients simplify and safely use complex prescription regimens. Arch Intern Med 2011;171:300-5
5Lakey, S.L. et al: Assessment of older adults’ knowledge of and preferences for medication management tools and support systems. Ann Pharmacother 2009;43:1011-9
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March 9, 2015. The literature is replete with warnings of medication related problems, adverse drug events, and all-cause mortality related to use of antipsychotic medications for patients with dementia.1 As a large portion of the nursing home population have a dementia diagnosis and have historically had a high prevalence of antipsychotic medication use, the US Health and Human Services (HHS) agency has aimed to effect reductions in antipsychotic use for these patients. How are we doing, and what if anything is being done to assess and impact antipsychotic use by patients with dementia who do NOT reside in nursing homes? Those questions were put by Congress to the Government Accounting Office (GAO) who recently published results of their studies in a GAO report entitled “Antipsychotic Drug Use.”2
The report outlines modest progress in the reduction of antipsychotic use for patients with dementia who reside in the nation’s nursing home facilities. At the beginning of 2012, the HHS Centers for Medicare and Medicaid Services (CMS) launched the National Partnership to Improve Dementia Care in Nursing Homes. The Partnership began with a goal of reducing antipsychotic use by 15% by the end of 2012 (from a baseline of 23.8 percent Q42011). The report observes that the goal was not met by 2012, but with continued efforts a 15.1% reduction in antipsychotic use among nursing home patients was noted by the end of 2013. Building on these gains, in September 2014, CMS established a new set of national goals to reduce antipsychotic prescribing an additional 10% by 2015 years end and another 5 % by the end of 2016. If met, this would reflect a 30% reduction in antipsychotic use over four years.
How is this to be done? The National Partnership has incorporated reduction in antipsychotic use as a quality measure for the CMS Star Ratings System which measures quality in nursing home practice. In addition, the Partnership holds regular conference calls with stakeholders and experts in the field to share best practices. CMS has stepped up required training of nursing home surveyors to include antipsychotic reduction strategies, has contracted with state Quality Improvement Organizations (QIOs) to provide training directly to nursing homes, has funded pilots to effect changes in prescribing habits and has published individual nursing homes successes or failures on their Nursing Home Compare site.
In addition to all of the resources being put forth for nursing home patients as described above, CMS requires quarterly care plan meetings, mandated regular trials to reduce antipsychotic use, stiff fines and penalties for inappropriate prescribing, and requires MONTHLY the services of a consultant pharmacist to provide an extensive Comprehensive Medication Review (CMR) to address all issues surrounding medication use for nursing home patients. It would be interesting to learn if all of this focus of resources has resulted in the reduction of the highest costs of healthcare: long term care. Could this same approach have more impact on improving outcomes and reducing costs by focusing on the older adult population who have not yet entered long term care? In the words of the GAO: “HHS has done little to address antipsychotic drug use among older adults with dementia living in settings outside of the nursing home.” The report shows that almost 14% of these patients are receiving routine antipsychotic medications.
For those lucky few Medicare Part D beneficiaries that meet requirements to be placed in the Medication Therapy Management Programs (MTMPs) CMS requires an annual CMR be completed, usually by a pharmacist, to identify, resolve and prevent medication related problems including inappropriate antipsychotic use. At present, only about 10-15% of beneficiaries are targeted by CMS and their health plans, and of those, less than 25% wind up actually receiving the service. What can we do to balance the scales for ambulatory patients with dementia regarding inappropriate antipsychotic use?
The GAO report suggests extension of many of the initiatives listed above to the ambulatory care setting on behalf of patients. GAO says that the National Partnership should extend their interventions to ambulatory settings, and provide education to health care providers in the community relative to appropriate treatment of dementia and use of antipsychotic medications. Specifically, training for care givers at home and in assisted living settings on non-pharmacologic interventions and ways to avoid and reduce patients’ behavioral outbursts could go a long way in stopping the knee-jerk reaction to prescribe an antipsychotic agent.
Other governmental initiatives could increase the availability of medication management for ambulatory patients, such as requiring that more patients be offered Medicare CMR services, that pharmacists’ patient care services be reimbursed under Medicare billing regulations, and a continued push for paying for quality of care rather than quantity of services rendered. We also think that a closer integration among the care team regarding a patient’s medication use is key to properly managing medications. Particularly in the ambulatory setting, patients’ medication use is not as structured as it is in institutional settings – certain prescription medications, over-the-counter preparations and supplements may cause delirium in the older adult, interpreted as worsening dementia and prompts the antipsychotic prescription in the first place.
In addition, the technical and workflow challenges for medication management are much greater in the ambulatory setting. They include the need to aggregate and validate medication information from multiple disparate sources, including the patient; the need to identify, interpret and make risk actionable; and the need to share it among all the members of a patient’s care team. Most care teams do not have access to the expertise of a consulting pharmacist to fill these gaps or offer the support needed. ActualMeds is committed to building the suite of technical solutions and managed services that can provide longitudinal medication and risk information that is integrated with a patient’s care management.
By focusing medication management resources on ambulatory older adults can we slow down the progression to, and shorten the time needed for long term care? We think all stakeholders can benefit from this approach. Rigorous patient-centered medication management can help to avoid ED visits and hospitalizations and the need for long term care for payers, resulting in fewer and more successful transitions of care for providers, and most importantly, improved quality of life for seniors.
GAO-15-211 (http://gao.gov/assets/670/668221.pdf)
Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation. Past President, American Society of Consultant Pharmacists. @jgactualmeds
]]>February 24, 2015
A recent on-line article in Pharmacy Times1 has reported that the Rx to OTC movement is generating increasing momentum. The author states that in 2010 alone over 240 million Americans spent approximately $23 billion on OTC medications. With a reported 6:1 return on investment (ROI) in avoided health care system costs, this is an estimated $102 billion value for the US health system, and a $13 billion value for consumers. Primary care physicians estimate that 10% of office visits could be avoided if OTCs were used appropriately and 92% of them agree that they are effective and appropriate for initial treatment of minor illnesses.2
Initial classes of medications moving from prescription to OTC status have included antihistamines, decongestants, NSAIDS, acid reducers (H2s and PPIs), and most recently transdermal anticholinergics for bladder control and nasal steroids.
In 2012, the FDA established the Nonprescription Safe Use Regulatory Expansion (NSURE) task force charged with evaluating new strategies and future Rx to OTC targets. Possible candidates for OTC status include medications for erectile dysfunction, migraine, hypercholesterolemia, overactive bladder and benign prostatic hypertrophy (BPH).3
While there is certainly something to be said for savings billions of dollars and demonstrating impressive ROIs, let’s take a different slant on what is happening here. Let us repeat the Rx to OTC list in a different way: first generation sedating/confusing antihistamines, blood pressure elevating decongestants, GI-bleeding implicated NSAIDS, first generation sedating/confusing H2s, and drug-drug interacting and osteoporosis implicated PPIs; and coming soon: drug-drug interacting erectile dysfunction and migraine medications, muscle and liver antagonizing statins, anticholinergic bladder medications and blood pressure crashing BPH alpha-blockers. So remember the last time you looked at the labeling on an OTC container? Imagine also the patient insert for these future OTC targets being reduced to consumer labels. Bad enough for most of us, but consider the risk for our older adult population.
ActualMeds Principle Scientist and co-founder Patricia J. Neafsey, PhD has made patient self-medication behavior her life’s work. Participating in the recent Gerontological Society of America (GSA)/Consumer Healthcare Products Association (CHPA) OTC Summit, Neafsey and her colleagues advise: “Ensuring that consumers safely and effectively use OTC products is critical in order to minimize potential drug–drug interactions and unintentional misuse. Yet we know surprisingly little about the ways older adults select OTC medications and decide when to start or stop use, how older people actually take these medications, or how involved clinicians and family members are in older adult OTC behavior”.4
The NSURE task force advocates the need for increased awareness for consumers on the benefits and risks of OTC use. The rapid increase in information via healthcare technology can help. But older adults may not be “plugged in” to the on-line information highway, and may have physical and cognitive impairments that prevent them from getting the information they need from packaging, labels or patient educational materials. The GSA/CHPA Summit participants outlined a five stage process necessary for effective self-medication decision-making, and warn that older adults may be more vulnerable to failures in any one of the components that other consumers. Older adults need to be exposed to the information, they must perceive that the information is a warning, they must encode the fact that the warning applies to them, they must comprehend the call to action of the warnings, and they must take the necessary action i.e. recognize that the OTC medication is inappropriate for them to use.
Ok so how do we capitalize on the good OTCs can offer, while avoiding the medication adverse events that a poor choice might bring? We can do it through technology and teamwork.
There are many web-based medication management systems, drug interaction decision support tools, medication reconciliation applications and population-based medication analysis services available. All rely on accessing prescription medication claims data and/or EHR medication orders to begin to paint the picture of a patient’s medication use and the co-incident risks. Only the most unique technology and service solutions will be able to add OTC medications to the picture. These tools and services must have a robust patient interview capability to be able to completely capture and characterize OTC use, and thus present clinicians with the total picture of medication risk for their patients. The more that potent Rx medications are transitioned to “hidden” OTC status, the more important engaging the patient to capture OTC use will be. In addition medication “alert” algorithms need to be able to digest multiple-ingredient OTC formulations and easily integrate them into the medication risk assessment to make sure that our patients’ self-medication behaviors are helping and not hurting their overall quality of life.
Once we have brought the patient into the picture, and have made sure that our technology and practices are “OTC friendly,” we need to make sure that the rest of the care team is engaged. Neafsey’s research shows that point of care counseling on self-medication use can improve patients’ choices and improve their overall health.4,5 All medication management systems need to make the results of patient encounters actionable, and accessible to the patient’s entire health care team. Each team member needs to act at their highest and most efficient level of practice on behalf of the patient, making sure the patient’s self-medication choices are identified, shared with and acted upon by all team members as appropriate to their discipline.
1Rx-to-OTC Switches: Trends to Watch http://www.pharmacytimes.com/publications/issue/2015/february2015/rx-to-otc-switches-trends-to-watch/P-2
2Consumer Healthcare Products Association. The value of OTC medicine to the United States. www.yourhealthathand.org/images/uploads/The_Value_of_OTC_Medicine_to_the_United_States_BoozCo.pdf. Published January 2012. February 2015
3Engelberg Center for Health Care Reform at Brookings. Exploring implications of the Nonprescription Drug Safe Use Regulatory Expansion (NSURE) Initiative on Reimbursement and Access. www.brookings.edu/~/media/events/2013/11/04%20nsure%20engelberg/discussion%20guide_nsure%20114.pdf. Accessed February 2015
4Albert, M.A., Bix, L., Bridgeman, M.M., Carstensen, L.L., Dyer-Chamberlain, M., Neafsey, P.J., Wolf, M.S. (2014). Promoting Safe and Effective use of OTC Medications:CHPA-GSA National Summit. The Geontologist, 54, No.6, 952-963
5Neafsey, P. J., M’Lan, C. E., Ge, M., Walsh, S. J., Lin, C. A., & Anderson, E. (2011). Reducing adverse self-medication behav-iors in older adults with hypertension: Results of an e-health clinical efficacy trial. Ageing International, 36, 159–191.
Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation. Past President, American Society of Consultant Pharmacists. @jgactualmeds
]]>February 19, 2015
As a brand new Consultant Pharmacist many years ago, I welcomed the newly-published CMS regulations for nursing home practice that began to restrict the usage of harmful medications for frail elderly nursing home patients. The medication classes most keenly focused on were anticholinergics, anti-psychotics, and benzodiazepines. While the use of these medications in that setting has been greatly reduced since the early 90s, there is still work to be done. So, surely that medication management trend has carried over to the ambulatory setting correct? Well not so much!
Through the last several months here in The Daily Dose™ we have commented on the links between continued use and potential adverse events from anticholinergics (Feb 2015), anticholinergics and sedative-hypnotics (Oct 2014), benzodiazepines (Sept 2014) and ‘Z-drugs’ for insomnia (July 2014). Throughout we have referred to a succession of evidence based studies and guidelines regarding use of these medications including the original CMS 1987 guidelines for nursing home patients, the initial Beers’ List of inappropriate medications for older adults, with an American Geriatrics Society update in 2012, and another expected in 2015, and the more recent implementation of quality measures regarding the use of high risk medications in older adults by CMS, HEDIS, NQF and others.
Yet, in a study published this week in JAMA Psychiatry, Olfson1 et al. described a retrospective claims data analysis which showed that greater than 5% of the US population of adults 18 to 80 years filled one or more prescriptions for a benzodiazepine annually. More importantly, the OLDER the patient cohort, the HIGHER the prevalence of benzodiazepine use, with 8.7% of adults between 65 and 80 years filling one or more prescriptions, a whopping one third of whom reported ‘long term use’ (greater than 120 days in the year). Benzodiazepine adverse events of dementia, cognitive impairment, falls, impaired activities of daily living, etc. are well documented. The authors conclude “Despite cautions concerning risks associated with long-term benzodiazepine use, especially in older adults…use remains common in this age group. More vigorous clinical interventions supporting judicious benzodiazepine use may be needed.” As a health care professional community, what part of ‘NO’ do we not understand?
In her New York Times blog The New Old Age (http://nyti.ms/1CoF3RS) Paula Span outlines challenges we face in reducing the use and potential adverse events from benzodiazepine medications:
First of all they work really well, and fast. Boom, you were not sleeping well and the first dose first night, you did. More benign treatments such as implementing a sleep hygiene program, eliminating ‘stimulating’ self-medication behaviors and food choices (i.e. caffeine), and antidepressants/behavioral therapy for anxiety all take some time to work.
Secondly, even recognizing the need for short-term therapy, discontinuing therapy may often cause a return of insomnia/anxiety symptoms for which the medications were used in the first place. Patients may be very resistant to returning to the ‘bad old days’ prior to benzo treatment.
Lastly, our health care delivery system is really not aligned to encourage providers to spend the time on general medication management, much less the weeks of routine patient encounters that might be required to taper and discontinue from long term benzodiazepine use. And it’s hard to say “no” when all the patient wants is an Rx refill.
So what can we do? We could push for a repeat of the propoxyphene scenario…just get the FDA to take harmful benzodiazepines off the market. OK, not happening. What about giving the primary care providers a hand…mobilizing the members of the care team with an all hands on deck call to get the numbers going in the opposite direction…reducing benzo use as patients get older. Some evidence (see links below) show that interventions with patients at transitions of care can work.
We need to follow the HEDIS recommendation for full medication reconciliation with each primary care visit. By using the ActualMeds Comprehensive Medication Management System we can make sure we capture all of the patient’s medications and characterize exactly when and how patients are using them. We need to go beyond the ‘one and done’ Medicare Part D MTM Comprehensive Medication Review, and follow patients longitudinally through all transitions of care to make sure that benzodiazepine use is identified and assessed. Most importantly, we need to put the patient at the center of the team, with a clear plan to taper and remove/replace inappropriate medications for our older adult patients, and we need to be able to keep the team up to date on the patient’s progress.
1Olfson, M et al: Benzodiazepine Use in the United States. JAMA Psychiatry 2015;72(2):136-142
http://archinte.jamanetwork.com/article.aspx?articleid=1860498&resultClick=3
http://www.benzo.org.uk/manual/
Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation. Past President, American Society of Consultant Pharmacists. @jgactualmeds
]]>February 15, 2015
A recent study published by Hutchins et al. in the journal Circulation: Cardiovascular Quality and Outcomes is causing a buzz on news sites and blogs. Paraphrasing some of the headlines we have seen: “Many prefer an early death to pill taking” and “Some patients willing to pay almost $1500 to avoid taking daily medication”. These headlines may grab attention, but it’s important to understand the research behind them, the reasons adherence is such a big issue, and what is at stake.
Depending on who you talk to, the issue of medication non-adherence is a $100-300 Billion hit to our total spending for health care in America. With all the attention on new payment models for health care delivery, which focus on paying for quality outcomes rather than the quantity of services performed, we are not going to make any progress on improving outcomes or bending the cost curve if patients do not take their medications and take them appropriately.
From our glass half-full prespective, we see a cohort of patients answering Hutchins et al.’s hypothetical questionnaire on the value of taking preventative (not treatment) medications which would prolong their lifespan. Headlines notwithstanding, ~70% of patients were NOT willing to trade any amount of their lifetime to avoid taking daily preventive medications, and only ~40% say they would be unwilling to pay ANY amount of money as well (respondants were willing to pay $1445 on average to avoid daily preventive medication use).
This of course does not lessen the fact that 30% of patients had a strong aversion to adherence to a daily preventive medication regimen, and that patients would be willing to spend some real money to simplify their medication use and improve the quality of their daily living.
The lead author himself states “Most physicians I know are very well aware of that, however, so it reiterates that we should be having discussions with patients about what their priorities are…”
So let’s take a step back and approach adherence from the perspective of understanding root causes and context. Adherence is a complex issue with many facets and many dimensions, much bigger than just considering a hypothetical pill a day to get an extra year of life. It should include assessing medication use for treatment of conditions that are causing poor quality of life right NOW. Ask an asthma or COPD patient if they will trade their medications for more life time to struggle with their conditions. . Certainly as this study shows, patient beliefs and preferences about medication use and value are important to understand. But root causes for non-adherence may go beyond patient beliefs and preferences to the complexity of medication regimens, poly-pharmacy and unnecessary medications (including OTCs); and utilization (cost) control policies that foster multiple times a day dosing rather than single daily dosing or restrict more costly combination products in favor of less costly multiple individual medications. Adherence may be impacted by access to a pharmacy or affordability of medications, or perceived or real side effects. (Remember the folks in the study were willing to put down some real money to improve their “medication quality of life”).
To get to those root causes we need to talk to our patients. Analytics show us refill frequencies, and help us to predict the “non-adherent” patient type. We can send a text to a mobile device or implement any number of reminder or administration solutions, but in the end we must talk to the patient to understand what is working, and what isn’t. Tools and analytics help point us to a potential problem, but a full regimen analysis provides all-important context. Any adherence intervention that does not involve hands-on patient interview to address root causes is a glass half-empty approach, and ultimately likely to be unsuccessful. In the ActualMeds solution for medication reconciliation and risk assessment, integration of patient-self reported information and a structured interview process helps uncover these root causes and enable more specific assessment of risk – critical to understanding the context of a patient’s regimen, and assuring that any adherence interventions applied are likely to succeed.
Joseph Gruber, RPh, CGP, FASCP: Chief Clinical Officer, ActualMeds Corporation. Past President, American Society of Consultant Pharmacists. @jgactualmeds
]]>February 9, 2015
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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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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