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TECH: First Digital Pill Track When Patients Take The Drug
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First Digital Pill Track When Patients Take The Drug
By Fanny Bates
BT 201808 Tech 03日本药企大冢(Otsuka)与合作伙伴美国数字医药公司Proteus Digital Health于去年联合宣布,美国食品和药物管理局(FDA)已批准全球首个数字化药物Abilify Mycite(含传感器的阿立哌唑片)。Abilify MyCite是美国FDA批准的首款内置数字追踪的医药产品,该产品可能对治疗依从困难的某些患者有用。FDA支持开发和使用新技术用于处方药,同时致力于与企业共同合作,了解这些新技术如何使患者及临床医生受益。这是一款药物+设备组合产品,由内嵌了一款摄入性事件标记(IEM)传感器的口服阿立哌唑片组成。这颗IEM传感器只有一粒沙子大小,并且由可食用成分制成,当药物被摄入进入胃部后接触到胃液时被激活,并向贴在患者身上的可穿戴传感器Mycite Patch发送信息。最终,这款IEM传感器会被消化并排出体外。Mycite Patch传感器用于监测和记录药片摄入的日期和时间,以及特定的生理数据(如活动水平),并将这些数据发送至可兼容的移动设备Mycite App,该APP用于显示患者的药物摄入情况、日常活动水平,以及心情及休息情况。患者也可邀请其他人查看这些数据。

此次数字药丸的批准为医生客观评估患者是否按时服药提供了可能。不过需要注意的是,目前还没有证据显示该药物提高了患者的服药依从性。服药依从性差是疾病防治实际工作中普遍且长期存在的一个‘顽疾’,严重程度因疾病性质、药物特点、治疗方式等的不同而不同。很多患者会忘记服药、无法按时服药或忘记是否服用过药物,因此治疗效果也产生了很大影响。采取这种科技手段监控服药情况,帮助那些“管不住自己”的患者或是记不住吃药的患者提高服药依从性,有它积极的意义。

BT 201808 Tech 01The idea of a digital pill is based on the principle first outlined two centuries ago when Alessandro Volta invented a battery comprising of two dissimilar metals (zinc and copper). Last year, the FDA (Food and Drug Administration) announced its first-ever approval of a medical digital pill, ushering the US into a new era of smart medications and medical surveillance.
 

The Abilify MyCite – First Digital Pill

The pill called the Abilify MyCite is prescribed and worn by patients who suffer from mental disorders such as schizophrenia, bipolar disorder, anxiety and depression. It is fitted with a tiny ingestible sensor being only 1 millimeter wide and 0.3 millimeters thick. The sensor becomes activated when it comes in contact with stomach acid, and the signal is transmitted to the wearable, adhesive sensor or patch worn by the patient on the left rib cage. This patch is connected to a smartphone application that tracks the exact time when the pill was taken. Its primary role is to monitor the patient’s usage of prescribed medication since medical non-adherence represents one of the major problems with patients who suffer from different kinds of mental illnesses. With this digital pill, there is a digital record of the time when the medication is consumed.

BT 201808 Tech 02This digital pill, the size of a grain of sand, is made of silicon copper, and magnesium. It operates through electrical signals which are sending the information only 3 minutes after the pill is ingested. The information of time and dosage of the pill is received via Bluetooth, and it can also check if the person took the pill was lying down or standing. "It works in a similar way as an EKG," or electrocardiogram said the chief medical officer, Dr. George Savage. These machines pick up on changes in electrical current in the body to monitor heartbeats. The wearable sensor does the same thing, though the current is smaller, he also stated. People who can access the patient’s information are the doctor and family members who have this permission. Dr. Savage also stated that the information is being encrypted, so the signal cannot be influenced or accessed without permission.
 

The digital pill came after years of joint research between the Japanese pharmaceutical company Otsuka and digital medicine service Proteus Digital Health, the manufacturer who made the sensor. The approval also opens the door for other information being gathered from a digital pill and conditions which go beyond mental health.

BT 201808 Tech 04Coping With Medical Non-adherence

Remembering to take medications has become more and more challenging for many Americans. A study published in Jama in 2015 found that an estimated 15% adults need to take 5 or more prescription medications. At the same time, doctors are stating that around half of the patients fail to take medications in the prescribed time and dosage. It has become a public health problem since many patients such as TB patients are putting people who come in contact with them at risk. Doctors and medical staff have been trying many different interventions to improve medical adherence such as telephone reminders, apps, timers, and counseling.
 

Advantages of these pills could be numerous; however, manufacturers still need to deal with data security. There are broader privacy concerns when it comes to sensors and people who have permission to access the information. "We've seen time and time again that stuff that's being transmitted ends up in the hands of people it shouldn't," says Dr. Walid Gellad, co-director of the center. The potential cost factor could also be one of the things which need to be solved in future. Even though it doesn’t have a price yet, the smallest vial of the long-acting injectable introduced in 2013 has a list price of $1,478, according to The Wall Street Journal.
 

Dr. Gellad also points out that there are some other possible solutions to address the non-adherence problem. Those are high-tech pill bottles that track whether they have been opened or not. If a patient misses a dose, the bottle emits first the light, then a sound, and if that does not work, the patient or a family member receives a phone call or message as a reminder.

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