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A mining engineer “does not assay a mountain of ore by testing one rock.”

This was an argument Jeff Holter used in support of his ambulatory cardiac monitor [1,2]. The device provided an extended view of a patient’s condition with data from outside of their clinic or inpatient visit. The benefits of this wearable device (granted US Patent 3,215,136 in November of 1965) were clear to many practitioners of the time [3]. Wearable medical technology can come in many forms, but they serve two primary roles (diagnostic and interventional). While eyeglasses qualify as the earliest wearable technology being invented in Pisa, Italy in 1285 [4], the earliest modern wearables besides the Holter Monitor include the pacemaker (late 1950’s) and insulin pumps (1970s) [6,7].

Within the past five or so years, technological advancements in battery life and wireless connections have made wearable devices (most notably watches) very popular with the general public. Primarily focused on health conscious consumers, fitbits and Apple watches have been able track heart rate and daily activity. The benefits of these basic health tracking tools to improve patient outcomes is not clear. A recent meta-analysis concluded that there is not enough evidence to prove that wearable technology has significant impact on patient outcomes. It was noted, however, that certain groups (COPD, Parkinson’s disease, hypertension, and lower back pain) may benefit from the intervention and wearable technology with personalized coaching was an effective way to improve individual health [8].

So, how does this apply to pharmacy? What are the current wearable technologies influencing medication delivery?

• In 2017, the FDA approved a patch that tracks medication compliance. The Abilify MyCite system consists of a tablet with a sensor that transmits to a wearable patch. The patch, in turn, sends the information to a phone application and electronic dashboard [9]. The benefits to such a system are to be able to remotely track medication compliance. This allows the ability to direct interventions to patients that need assistance and conserve resources.  
• Diabetic patients now have the option of continuous glucose monitoring devices. These monitors provide both current and longitudinal information on the patient’s glycemic control, although it is noted that the accuracy of hypoglycemia is not reliable for some products (40% of readings under 60 mg/dL were actually between 81-160 mg/dL) [10].

The ability for these and other similar items to provide a bounty of real world data has not escaped the attention of the FDA. In December of 2018, the FDA released a framework document for wearables and other devices that give real world data and evidence to apply to drug review programs. The guide is designed to help support products under review for revisions, labeling, effectiveness, and safety. [11]  

As such, the pipeline for wearables has numerous new and innovative products. A search for “wearable” in clinicaltrials.org revealed 362 active studies [12]. Similar to the Ability MyCite system, a sensor to monitor the ingestion of antiretroviral medications is under investigation [13]. Another type of monitor is being studied to detect hypoventilation (respiratory depression) due to opioid overdose with the goal of preventing opioid-related deaths [14]. In addition to the active clinical trials, there are numerous rumors of wearable technological advancements with the potential to change healthcare. In particular, reports of noninvasive glucose monitoring from companies like Apple, Google and others highlight the interest in companies and the public for innovation in healthcare [15].

There are some additional safety considerations that apply to wearable technology. This especially true for those that are Wifi or bluetooth enabled. In March of 2019, the FDA released a safety communication regarding cybersecurity concerns with a wireless implantable defibrillator. [16] No instances of patient harm have been reported as part of this statement. However, this does serve as a reminder of the risks when healthcare devices are exposed wirelessly.  

While a mining engineer may not assay a mountain by testing one rock, there may be a limit to the amount of real world data that a physician can consume. There are some opinions that the deluge of information that wearable technology is able to provide may be too much to decipher [17]. The key to successful wearable technology in healthcare will be to walk the line of useful information and extra noise.

Authors:

Published on behalf of the Clinical Application Workgroup for the Clinical Application SAG:

Alec Huang, Pharm.D. Epic Business Intelligence Developer. Thomas Jefferson University Hospital. Philadelphia, PA.

Ben Iredell, Pharm.D. MBA, BCPS, Pharmacy Informatics Manager, Cedars-Sinai Medical Center. Los Angeles, CA.

Chad S. Stashek, Pharm.D., M.S., Clinical Informatics Pharmacist, Affiliated Faculty. Oregon Health & Science University. Portland, OR.

Hesham Mourad, Pharm.D., BCPS, BCCCP, CPHIMS, Medication Management Informaticist, Assistant Professor of Pharmacy. Mayo Clinic. Jacksonville, FL

John Siejak, Pharm.D., CPHIMS, Pharmacy Informaticist, Kaleida Health. Buffalo, NY

Lisa Starost, PharmD. Manager – Pharmacy Informatics and Program Director, PGY2 Informatics Residency. Indiana University Health. Indianapolis, IN

Raymond Chan, Pharm.D. Pharmacy IS Specialist. Sentara Healthcare. Virginia Beach, VA

Tanya O. Ezekiel, Pharm.D., BCPS. Clinical Informatics Pharmacist. Prisma Health–Midlands. Columbia, SC

References:

1. At the Heart of the Invention: The development of the Holter Monitor. Retrieved from: https://americanhistory.si.edu/blog/2011/11/at-the-heart-of-the-invention-the-development-of-the-holter-monitor-1.html. Accessed 4/14/19
2. Roberts W, Silver MA. Norman Jefferis Holter and ambulatory ECG monitoring. Am J Cardiol 1983;52:903-906.
3. Ioannou K, Ignaszewski M, MacDonald IA. Ambulatory electrocardiography: The contribution of Norman Jefferis Holter. Retrieved from: https://www.bcmj.org/articles/ambulatory-electrocardiography-contribution-norman-jefferis-holter. Accessed 4/14/19
4. Letocha CE, Dreyfus J. Early Prints Depicting Eyeglasses. Arch Ophthalmol. 2002;120(11):1577-1580. doi:10.1001/archopht.120.11.1577 https://jamanetwork.com/journals/jamaophthalmology/article-abstract/272834
5. Rapid Growth: The Past, Present and Future of Wearable Technology. https://online.grace.edu/news/business/the-past-present-future-of-wearable-technology/.  Accessed 4/14/19
6. Aquilina O. A brief history of cardiac pacing. Images Paediatr Cardiol. 2006;8(2):17–81.
7. Sherr J, Tamborlane WV. Past, present, and future of insulin pump therapy: better shot at diabetes control. Mt Sinai J Med. 2008;75(4):352–361. doi:10.1002/msj.20055
8. Ely K. Wearable Biosensors Have No Significant Impact on Clinical Outcomes- https://www.ajmc.com/newsroom/wearable-biosensors-have-no-significant-impact-on-clinical-outcomes. Accessed 4/18/19
9. ABILIFY MYCITE. 2019 Otsuka America Pharmaceutical, Inc., Rockville, MD. https://www.abilifymycite.com/ Accessed 4/14/19
10. Freestyle. 2018 Abbott Laboratories. https://provider.myfreestyle.com/ Accessed 4/14/19
11. Framework for FDA’s Real-World Evidence Program. December 2018. https://www.fda.gov/media/120060/download Accessed 4/18/19
12. US National Library of Medicine. ClinicalTrails.gov. https://clinicaltrials.gov/ct2/results?term=Wearable&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&age_v=&gndr=&type=&rslt= Accessed 4/14/19
13. Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Initial ARV Therapy. ClinicalTrials.gov Identifier: NCT02800655. https://clinicaltrials.gov/ct2/show/NCT02800655?term=Wearable&recrs=abdf&draw=12&rank=103 Accessed 4/12/19
14. Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose. ClinicalTrials.gov Identifier: NCT03845699.  https://clinicaltrials.gov/ct2/show/NCT03845699?term=Wearable&recrs=abdf&draw=15&rank=140 Accessed 4/14/19
15. Farr C. Apple has a secret team working on the holy grail for treating diabetes. https://www.cnbc.com/2017/04/12/apple-working-on-glucose-sensors-diabetes-treatment.html) Accessed 4/14/19
16. Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication. Date Issued: March 21, 2019. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm633960.htm Accessed 4/18/19
17. Pearl R. 7 Healthcare Predictions Based On Data From 5 Million Forbes Readers. Forbes.  https://www.forbes.com/sites/robertpearl/2019/02/11/healthcare-predictions/#6d6756fb414b Accessed 4/16/19