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Medication Adherence TECHNOLOGY Brief update 2016

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Medication Adherence TECHNOLOGY Brief update 2016

  1. 1. Medication Adherence Enabling Technologies January 18, 2016 (revised from May 7, 2009 version) Michelle Y. Williams, RN, MSN, PhD candidate TECHNOLOGY BRIEF
  2. 2. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 2 OF 11 Executive Summary The inability to achieve medication adherence, also known as medication compliance and concordance, is a multifaceted problem that imperils the health of individuals and populations, and hamstrings the efficiency of the health care system at large. Its reach extends to care in the home, clinic, hospital, networked health care system, and beyond. According to the American Heart Association (AHA), the #1 problem in treating illness today is the failure of patients to take their prescribed medications correctly.1 Ernst and Grizzle (2001) found that prescription medication nonadherence contributes to more than 125,000 deaths each year in the U.S., costing the health care system over $177B annually. The Joint Commission (JC) has found that prescribing and medication administration errors typically occur when a patient is admitted to, transferred within, or discharged from a health care facility.2 Moreover, errors originating within the hospital can follow patients when they are discharged, prolonging the harmful impact to the patient. The medical device industry continues to churn out new, innovative medication adherence solutions that range from very basic manual and battery-operated devices to high tech systems that can handle more complex patient care needs. A scan of the industry found 21 different medication adherence technologies that can be used to store, organize, and dispense medications, including some that can be programmed to deliver medication reminders via phone, text, and email. Our recommendation is that interested groups consider pilot studies to test and measure outcomes from different medication adherence technologies. This will help determine whether they add additional benefits above and beyond the medication lists provided to patients at discharge from the hospital. 1 See Appendix B: Medicine Safety – A Toolkit for Families. 2 http://www.jointcommission.org/sentinelevents/sentineleventalert/sea_35.htm.
  3. 3. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 3 OF 11 The Challenge Medication errors harm an estimated 1.5M people and kill several thousand each year in the U.S., costing the nation more than $3.5B annually.4 According to the Joint Commission, accurate and complete medication reconciliation can prevent prescribing and administration errors. Techniques like medication reconciliation helps prevent omissions, duplications, dosing errors, or drug interactions, and should be done at every transition of care, when new medications are ordered, or when existing orders are rewritten.5 However, the most problematic cause of medication error is patient behavior, something not within the direct control of the health care provider. Patient Noncompliance Fifty percent of patients are noncompliant with their medications.6 In a meta-analysis looking at patient adherence to medical treatment, researchers found a 76% discrepancy rate between the medicines patients were prescribed, and those they actually took. Of those discrepancies, 51% were due to patients taking unrecorded medicines; 29% were from patients not taking a prescribed medicine; and 29% were from incorrect dosages.7 Additionally, 32M Americans take at least three medications daily; 29% stop taking their medicine without their physician’s consent; and 22% take less medication than is prescribed to them.8 Not surprisingly, medication nonadherence has been called “America’s other drug problem,” leading to needless disease succession and even fatality.9,10 Furthermore, 10% of all hospital and 23% of all nursing home admissions occur because patients fail to take their prescription medications correctly.11 4 http://www.iom.edu/Object.File/Master/4/117/ToErr-8pager.pdf. 5 http://www.jointcommission.org/sentinelevents/sentineleventalert/sea_35.htm. 6 National Council on Patient Information and Education(NCPIE). 7 Bedell, S., et. al. 2000. Discrepancies in the Use of Medications. Archives of Internal Medicine (July 24, 2000) Vol. 160. 8 http://www.americanheart.org/presenter.jhtml?identifier=107. 9 DiMatteo, M.R., et al. 2002. Patient Adherence and Medical Treatment Outcomes: A Meta-Analysis. Med Care (September 1, 2002) 40: 794-811. 10 Ernst, F.R., and A.J. Grizzle. 2001. Drug-Related Morbidity and Mortality: Updating the Cost-of-Illness Model. J American Pharmaceutical Association (March-April 2001). 11 http://www.americanheart.org/presenter.jhtml?identifier=785.
  4. 4. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 4 OF 11 What can we do to improve medication adherence? Vendors of technology-based medication adherence solutions claim their solutions can help address the noncompliance problem in the home, where there is no nurse or pharmacist to reconcile medications. Some studies have confirmed this, showing that such solutions may have a place in a multi- pronged approach.12,13,14 The Solutions Medication adherence vendors offer in-home devices and software packages for medication self-management featuring storage, dispensing and organizing units, and reminder systems using email, phone, and text messaging. The devices range from low tech manual and battery- operated products to high tech systems that can be integrated into a health care organization’s electronic medical record (EMR). How Do They Work? There are many different technology approaches to medication adherence. Which one is best? Medication adherence is a problem that affects many different populations such as pediatric and adult patients. Thus the technology must be tailored to the target patient population. The table below lists 21 different products, their key features, photos, and website URLs where available. They represent the spectrum of products available today. Typical device categories are pill boxes, reminder systems, and sensors that measure post-ingestion and physiologic drug uptake. One of the most striking things about this assorted batch of med adherence gadgets is the broad range of features they offer. 12 Schoenthaler, A. 2008. Patients’ Perceptions of Electronic Monitoring Devices Affect Medication Adherence in Hypertensive African Americans. The Annals of Pharmacotherapy (April 8, 2008) 42(5): 647-652. http://www.theannals.com/cgi/content/abstract/42/5/647. 13 Walker, E.A., et al. 2007. Adherence to Preventive Medications: Predictors and outcomes in the Diabetes Prevention Program. Diabetes Care (September 2006) 29(9): 1997-2002. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1762037. 14 Riekert, K.A., and C.S. Rand. 2004. Electronic Monitoring of Medication Adherence: When is High-Tech Best? J Clinical Psychology in Medical Settings (March 2002) 9(1): 25-34. http://www.springerlink.com/content/w76f76595kun74h6/.
  5. 5. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 5 OF 11 TABLE 1. Medication Adherence Solutions. Product Name and Vendor Product Availability Product Features Product View 1. CADEX Medication Reminder Watch (12-Alarm Wristwatch) by ePill Commercially Available Medication reminder system with 12 daily alarm capacity, alpha reminder messaging, and beeping sound with medical snooze. 2. CareCalls by Freedom Telecare Commercially Available Secure web-based application with 24/7 access to live care call service plus the ability to automatically check on clients, send reminders, and capture caregiver visit results. 3. Compliance for Life TM by iReminder Commercially Available Secure web-based customizable audio/voice reminder system, including phone, email, and textmessaging. 4. CompuMed Medication Dispenser by ePill Commercially Available Secure tamper-proof automated medication box and reminder system that organizes and dispenses pills. 5. DialogMeds™ by Medica- Safe Clinical Trials Secure web-based medication reminder and pill bottle system controls and tracks pill dispensing, provides reports, and handles medication packaging and refills. 6. Didit™ by The Gentle Reminder TM Commercially Available Manual plastic device that can be attached to the pill bottle to display day and dose reminders. 7. Dispense-a-Pill by HealthOneMed Clinical Trials Access-controlled automated medication box with reminder system and dispenser. 8. EMMA TM System by InRange Systems® Commercially Available Web-based medication management system that documents drug compliance and enables the caregiver to remotely manage medications. http://seniorjournal.com/NEWS/Health/2007/7-06-21- EMMA.htm. 9. Ingestible Medicine Pills by Proteus Biomedical® Clinical Trials Raisin™ microchip-enabled ingestible pills to track medication adherence. http://www.thestandard.com/news/2009/01/16/briefly- proteus-biomedicals-creates-ingestible-technology. 10. Implantable Electronics by Proteus Biomedical® Clinical Trials ChipSkin™ technology protects implanted electronic devices used to track physiologic parameters or deliver medications from deteriorating.
  6. 6. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 6 OF 11 TABLE 1. Medication Adherence Solutions(continued). 11. Med-eMonitor by InforMedix Clinical Trials Automated medication box, reminder system, and dispenser with detachable portable pill box. http://boston.bizjournals.com/washington/stories/2008/03/ 03/story9.html 12. Medication On Demand (MOD)® by Avancen Commercially Available Automated bedside medication-on-demand system with RFID wristband for patient identification. 13. MedSignals by MedSignals Corp. Commercially Available Automated medication box, reminder system, and dispenser with four separate web- or device- programmable drug compartments. 14. Medtime XL by ePill Commercially Available Automated medication box and reminder system that organizes and dispenses pills. 15. Monitored Automatic Pill Dispenser MD2 by ePill Commercially Available Automatic medication box and dispenser with a phone reminder system. 16. OnTimeRx® by AmeliaPlex Commercially Available Two-way mobile application featuring email, text messages, phone, and pager reminders for daily pill doses, doctor appointments, prescription refills, etc. 17. Pill Phone by Vocel Commercially Available The Pill Phone is a mobile handset application that sends permission-based personalized reminders to patients to take their medications or refill their prescriptions. 18. SMART by SIMpill Commercially Available Secure web-based medication adherence monitoring system that detects nonadherence and sends alerts. 19. Seven-Day Organizer and Reminder by ePill Commercially Available Automated 7-day pill organizer, medication box, reminder system, and dispenser. 20. Timex Daily Medication Manager® by MEDport Commercially Available Battery-operated pill box with audio, beeping, and visual reminders. 21. The Talking Rx TM by Dynamic Living Commercially Available Battery-operated pill bottle with integrated audio recording device that can be programmed to verbalize the drug information and prescription.
  7. 7. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 7 OF 11 The Larger Picture Medication adherence is a complex problem with many contributing factors. Beyond devices, there are other complementary approaches depending on which aspect of the problem one is addressing.15 Contributing Factors: 1. Socioeconomic factors include limited English language proficiency, low health care literacy, lack of family or social support, and high medication cost. 2. Provider-patient and health care system factors include poor provider communication skills, inability of the system to educate patients and provide follow-up, patient information materials written at too high a literacy level, and lack of continuity of care. 3. Cognitive factors include patient misperception of illness severity, rejection of diagnosis or treatment, lack of motivation for treatment, and functional limitations due to other conditions (e.g., mental retardation, psychotic disorders, depression, and chronic conditions). 4. Therapy-related factors include complexity of medication regimen, frequent changes in medication regimen, medications with social stigma, and unpleasant side effects. 5. Other patient factors include physical and psychological issues, such as visual and hearing impairment, self-perceived risk or susceptibility to disease, general motivation, psychosocial stress, anxiety, and alcohol or substance abuse. Patient-related factors are just one determinant of adherence behavior. Adherence is a complex behavioral process strongly influenced by the environments in which people live and the characteristics of their health care providers. Whether people take medications as directed depends on knowledge and beliefs about their illness, motivation to manage it, confidence in their ability to engage in illness-management behaviors, and expectations regarding the outcome of treatment and the consequences of poor adherence (World Health Organization, 2003). 15 http://www.who.int/medicinedocs/en/d/Js4883e/7.2.2.html.
  8. 8. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 8 OF 11 Alternative Solutions Of the many interventions used to improve medication adherence, the following were most often cited in the literature:  Education to increase patient knowledge  Using adherence aids such as medication refill reminders  Prescribing fewer drugs or fewer doses Simplifying a medication dosage regimen alone, however, is unlikely to have an effect on a person who, for instance, does not believe that medications will improve their health condition. Rather, getting to the root cause of the nonadherence is the key to a successful intervention. According to medication adherence experts, the ideal time to initiate adherence interventions is when therapy first begins. The Industry Many different groups make up the medication adherence ecosystem and industry16,17,18 – from individuals and their families and social networks to big business, including pharmaceutical companies, health care organizations, health care and patient safety consumer interest groups, policy and lawmakers, technology companies, politicians and lobbyists, and health care regulators and licensing and accrediting agencies. No estimate of market size has been published, but if the $177B cost of nonadherence is any indicator, the market is sizable. President Obama signed a government stimulus package that allocates $19B for health information technology (HIT), comparative effectiveness research (CER), and medical research.19 Although the details are not clear, there is hope throughout the country that at the very least, dollars will be directed towards remote and home-based telehealth20 and telemedicine21 solutions that may help improve medication adherence. 16 http://www.who.int/medicinedocs/en/d/Js4883e/6.1.3.html. 17 http://www.jointcommission.org/sentinelevents/sentineleventalert/sea_35.htm. 18 http://www.google.com/search?hl=en&q=medication+adherence+industry&start= 10&sa=N. 19 http://www.hrsonline.org/Policy/LegislationTakeAction/stimulus_signed_feb09.cf m. 20 Delivery of health care services at a distance via communications technology. 21 The practice of medicine at a distance; in particular,teleconsultation.
  9. 9. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 9 OF 11 The Companies The device companies in this report range from new startups focused on a single product and solution, like Gentle Reminder’s Didit, to research organizations creating disruptive preclinical-stage products, like Proteus Biomedical’s Ingestible Pill and Implantable Electronics. In a changing U.S. economy, many technology giants like Intel, Google, and Microsoft are also looking for new opportunities in health care. It would not be surprising to see Microsoft and Google, who have already created online personal health portals, enter the medication adherence market. Key Issues There are several issues medication adherence devices raise for healthcare organizations. 1. Technical integration. In some cases, vendors will need to integrate with an organization’s infrastructure and connect with legacy systems. 2. Cost. Medication adherence products are not currently covered as a health plan benefit. Sorting out who should bear the cost for these adherence aids will be an important decision that must factor in longer term benefits such as reduced hospital utilization and chronic care costs. 3. Security and HIPAA. Some of the technologies use third- party vendors to host patient clinical data. Although all data is stored in an encrypted format and transmitted between all parties using a VPN and standard encryption, external hosting does raise HIPAA and security management issues. Additional transport layer security is required on SSL/TLS to provide end-to-end security. 4. Patient acceptance and capability to use these systems. Inherent to medication adherence is individual cooperation. Current research has linked treatment resistance to poor acceptance of enabling technologies. In fact, nonadherence at the start of one study was the strongest predictor of nonadherence two years later. Other studies found high acceptance and capacity to use enabling technologies by patients regardless of age, previous computer experience, or socioeconomic background. Key success elements included frequent delivery of educational content and sessions with providers for self- testing and feedback.
  10. 10. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 10 OF 11 5. Outcomes measurement. While patient acceptance of and capability to use medication adherence technologies are key outcome metrics to monitor, improvement in operational efficiency and quality of care are equally as important. Additionally, baseline metrics on disease- specific quality of life, including general satisfaction, self-efficacy, and specific satisfaction with treatment processes should be obtained and compared regularly. Recommendations Medication adherence is a complex problem with many causative factors, and a host of possible solutions depending on which piece of the puzzle one is tackling. We recommend a holistic approach – a personalized medication adherence strategy31 – that focuses on the case-specific barriers to adherence. Such an approach is more likely to be successful because it leverages educational and behavioral interventions, incentives, and technology only where they are suitable to the case at hand. The strategy should be developed in concert with the patient and applied consistently by all the patient’s caregivers and providers. There should be ongoing measurement of adherence as well as comparative effectiveness of interventions, thus metrics need to be built into the strategy. How to best deliver those metrics is a question every medication adherence pilot team should address so that the organization can start to build a body of expertise and experience. One area where medication adherence strategies will play an important role is telehealth. With telehealth programs currently underway in many settings, I recommend that telehealth investigators measure the outcomes of medication adherence interventions as an essential part of study protocol. 31 Haynes, R.B., et al. 2009. Interventions for enhancing medication adherence (Review). The Cochrane Library (2009) Issue 1. Hoboken, NJ: John Wiley & Sons Ltd. http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD000011/pdf_fs.ht ml. Almost all of the interventions that were effective in the long term were complex, including combinations of information, reminders, self-monitoring, reinforcement, counseling, family therapy, psychological therapy, crisis intervention, manual telephone follow-up, and supportive care.
  11. 11. TECHNOLOGY WHITE PAPER MEDICATION ADHERENCE TECHNOLOGIES PAGE 11 OF 11 References Agency References Agency for Healthcare Research and Quality (AHRQ). 301.427.1364. Website: www.ahrq.gov. American Association of Poison Control Centers (AAPCC). 800.222.1222. Website: www.aapcc.org. American Society of Health-System Pharmacists. Website: www.safemedication.com. Email: Safemedication@ashp.org. Centers for Disease Control and Prevention (CDC). 800.311.3435. Website: www.cdc.gov. National Center for Complementary and Alternative Medicine (NCCAM). 888.644.6226. Website: www.nccam.nih.gov/timetotalk. U.S. Food and Drug Administration (FDA). 888.463.6332. Website: www.fda.gov. Articles Borrelli, B., et al. 2007. Brief motivational interviewing as a clinical strategy to promote asthma medication adherence. J Allergy Clinical Immunology (November 2007) 120(5): 1023-1030. Dankert, M.E., et al. 2008. Attitudes of patients and family members towards implantable psychiatric medication. J Schizophrenia Research (October 2008) 105(1): 279-286. Haynes, R.B., et al. 2009. Interventions for enhancing medication adherence (Review). The Cochrane Library (2009) Issue 1. Hoboken, NJ: John Wiley & Sons Ltd. Levin, A. 2008. Several strategies can increase medication adherence. J American Psychiatric Association (June 6, 2008) 43(11): 35. Osterberg, L. and T. Blaschke. 2005. Adherence to Medication. New England J Medicine (August 4, 2005) 353: 487-97. The Nation (Bangkok). 2007. Phoned pill reminders make inroads against TB. Retrieved February 27, 2009 from http://www.globalproblems- globalsolutions- files.org/unf_website/assets/publications/technology/mhealth/mHe alth_impact_needs.pdf World Health Organization. 2003. Adherence to Long-Term Therapies: Evidence for Action. http://www.who.int/chp/knowledge/publications/adherence_report/ en/index.html.