A Review on digital medicine and its implications in drug development process

 

Amber Vyas1, Tanu Bhargava2, Surendra Saraf3, Vishal Jain1, Darshan Dubey2*

1University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (CG)

2Institute of Pharmacy, Vikram University, Ujjain (MP)

3Columbia College of Pharmacy, Tekari, Raipur (CG)

*Corresponding Author E-mail: darshandubey@gmail.com

 

ABSTRACT:

A field known as "digital medicine" is focused with using technology as aid for assessment and involvement in the interest of better public health. Digital medical solutions are built on top-notch technology and software that supports the practice of medicine broadly, including treatment, rehabilitation, illness prevention, and health promotion for individuals and across groups. Digital medical products can be used independently or in conjunction with pharmaceuticals, biologics, devices, and other products to enhance patient care and health outcomes. With the use of smart, easily accessible tools, digital medicine equips patients and healthcare professionals to treat a variety of illnesses with high-quality, safe, and efficient measures and data-driven therapies. The discipline of digital medicine includes both considerable professional knowledge and responsibilities linked to the usage of these digital tools. The application of these technologies in digital medicine is supported by the development of evidence. Technology is causing changes in medicine. Wearable and sensors are becoming more compact and affordable, and algorithms are becoming strong enough to forecast medical outcomes. Nevertheless, despite quick advancements, the healthcare sector lags behind other sectors in effectively utilizing new technology. The cross-disciplinary approach necessary to develop such tools, needing knowledge from many experts across many professions, is a significant barrier to entry. The participation in digital medicine programs is optional, complies with all legal requirements and standards, and protects patient data in line with relevant state and federal privacy legislation, just like other data created and maintained in electronic medical records. Aside from helping doctors more correctly titrate dosages and assess how well a treatment works, experts say digital medicine programs hold promise as a solution to the problem of medication adherence.

 

KEYWORDS: Smart Pills, Digital Tools, Artificial Intelligence, Global Score, Clinical.

 

 

 

 

INTRODUCTION:

Products for digital medicine have a lot of potential to advance medical measurement, diagnosis, and therapy. While many other industries have welcomed digital disruption, the healthcare sector has not seen the advantages in outcomes, accessibility, and cost-effectiveness long promised by the digital revolution. The regulatory environment, which often prevents progress while health officials strive to lessen adverse consequences, is one of the reasons the healthcare industry lags behind other industries.1.

 

Definition

Digital medicine refers to a subset of pharmaceuticals in the field of digital health that "combine a prescription medication with an ingestible sensor component." Digital drugs can notify them when a patient has taken a specific dose of medication through the use of web-based and/or mobile applications. Product in this category needs clinical validation and regulatory control because of the ingestible sensor component and link to prescription medications. Digital medicine(s) seek to increase patient adherence in order to enhance pharmaceutical therapy.2

 

Fig 1–fields of digital medicine

 

Did you know that video games can also be used as digital medicine? Take the FDA-approved MusicGloveTM and the game for stroke rehabilitation developed by Jintronix, for instance. Software-based treatments for illnesses including addiction, depression, ADHD, and autism are being developed by organizations like Akili Interactive Labs, Click Therapeutics, and Pear Therapeutics.3 It has been demonstrated that giving patients more therapy time will help them recover their motor function after a stroke. However, in the present one-on-one therapy models, it is frequently impossible to provide more therapeutic time. Stroke survivors may be given access to rehabilitation-based virtual reality exercise gaming systems like Jintronix as a supplement to conventional therapy. The primary goal of this review is to assess the initial clinical efficacy of employing an exergame system to provide supplemental therapy while investigating its feasibility and safety.4

 

Figure 2- Therapeutic video games

 

DIGITAL MEDICINE SYSTEM:

The "digital medicine" industry focuses on using technology to improve people’s life style and health through examination and action. Digital medical solutions are built on top-notch software and techniques that facilitate the general practice of medical, including safeguarding from illness, recovery, intervention, and group and individual health enhancement. To patient concern and health benefit, digital medical items can be used alone or in combination with medications, biologics, devices, and other goods. With the use of smart, easily accessible tools, digital medicine equips patients and healthcare professionals to treat a variety of illnesses with superior quality, secure, and efficient measures and data-oriented therapies.5

 

The area of digital medication includes responsibilities associated with the use of these digital tools as well as substantial professional knowledge. The use of these tools is supported by evidence, which is the focus of digital medicine. An novel method for objectively reporting real medication adherence is provided by a recently created digital medical system (DMS). This technology combines a wearable sensor, a cloud-based computer system, and a sensor built inside an ingestible tablet. Basically, an ingestible sensor that, when engaged, interacts with a sensor that is worn is connected to a Medical Device Data System (MDDS) on a smart phone is how a DMS for psychiatric use is developed.6,7

The MDDS imparts the data to one more application on a similar gadget known as the Patient Part Application (Application). The Application interfaces, in both directions, via a server in the cloud, which examinations information on understanding prescription             compliance. 8, 9

 

Through a web portal, the data from the DMS is then presented graphically, making it simple for healthcare professionals, family members, and caregivers to retrieve and compile the person's drug compliance trends 10.

 

In both commercial and clinical contexts, digital medications are utilized to treat a range of illnesses. In the fields of congestive heart failure (CHF), , diabetes, hepatitis C, hypertension, hypercholesterolemia, mental well-being, HIV, Tuberculosis, and organ transplantation, ingestible sensor-enabled medications are being administered.11,12,13

 

For digital health technologies to be useful and qualitative, they need to undergo comprehensive validation. More significantly, though, is that they must be adaptable enough to users' behavioural and cognitive requirements. For instance, it's common knowledge that software with poor usability can lead to increased annoyance and user error. To determine the impact of a digital medicine offering (DMO) that tracks medication compliance using wearable sensor patches, mobile device apps, and digital medicines (medication taken with ingestible sensors) on lab-measured blood pressure (BP) and glycated haemoglobin (HbA1c). In patients who are not responding to oral treatment for hypertension and diabetes, this DMO, which provides dose-by-dose feedback on medication adherence, can lower blood pressure, haemoglobin A1c, and cholesterol. It can also promote patient participation and provider decision-making.14

 

Research and Development of DMS:

The goal of digital medicine is to improve human health by utilising technology as tools for assessment and intervention. Top-notch hardware and software enable digital medical solutions that support all aspects of general medical practise, including diagnosis, treatment, and education. Digital health interventions are when linked devices and technology are used to enhance healthcare delivery and outcomes. This covers telemedicine, electronic medical records, wearable technology, mobile health programmers, and other applications of digital health technology. In order to achieve this, a number of research and development initiatives across numerous sectors are gaining momentum. For instance, a variety of quickly designed and implemented smart biomedical materials and medical equipment are being digitally enabled.15, 16

 

OTSUKA Pharmaceutical recently established an umbrella-master study to supervise a number of studies aimed at evaluating the performance, safety, and tolerability of its DMS. The research and development of this DMS are described in two recently published publications, which demonstrate its accuracy, efficacy, and user-friendliness.17

 

Regulatory agencies have approved the use of aripiprazole in the treatment of bipolar I disorder and schizophrenia. In addition to having a strong binding affinity for the serotonin 5HT2A receptor, it is a partial agonist for dopamine. Aripiprazole's effectiveness and tolerability have been demonstrated in numerous double-blind, randomised clinical trials using dosages of 10–30 mg daily for schizophrenia and 15–30 mg daily for bipolar I disorder-related manic or mixed episodes. When introducing or withdrawing from another antipsychotic, lower starting doses become more important. In order to increase tolerability, individualising therapy may also benefit from appropriate dose. The metabolic profile of aripiprazole seems to be favourable, and it doesn't seem to have any tendency to make people gain weight or cause hyperprolactinemia.18,19

 

 

 

Figure 3 - Contents of data communication

 

 

Benefits of Digital Medicine20

Recovery, performance, and therapy selection: Utilizing wearable sensors that are -enabled more frequently while recovering for orthopedic surgery patients.

 

Digital metrics like step count and range of motion enable for remote patient progress monitoring. More sophisticated metrics can determine whether a patient is completing their rehabilitation exercises in real time.

 

Digital fall detection systems enable for real-time safety monitoring of elderly and vulnerable populations. In this kind of monitoring, wearable sensors, cameras, motion sensors, microphones, and/or floor sensors are commonly employed.

 

Treatment adherence: One of the most challenging clinical care issues can now be assessed in certain situations with the use of an ingestible sensor integrated into a medication. This sensor detects when the patient takes their medication as prescribed by reacting with stomach acid and sending a signal to a patch sensor placed over their abdomen.

 

The only medication approved for use in the US that has a digital ingestion tracking device is Abilify MyCite. The prescription packaging of some other developments, such as "smart packs," has sensors that track when a medicine is taken and automatically remind patients to take their prescriptions.

 

Multimodal data integration incorporates data acquired remotely into electronic medical records (EMRs), personal health records, patient portals, and clinical data repositories with the goal of improving clinical decision-making and supporting data-driven medicine.

 

Digital Technology Development

1. Basic research: Higher investments in digital medicine research, development, and implementation are required because most costly medical equipment and digital medical systems are imported from western nations. This will allow us to identify our special advantages and traits.21

 

2. Digital hospital construction: Countries like Australia have been researching the creation of digital hospitals since the 1990s, and a few of them have already begun to take shape. While some hospitals in China have studied and used clinical medical information systems, such as digital surgery, expert diagnosis systems, intensive care, electronic patient records, long-distance diagnosis systems, and Japan and South Korea have assumed the top positions among Asian countries in this field. These techniques improve the precision of choosing transplant objects by enabling surgeons to directly arrange surgeries from digital X-ray pictures.22

 

3. The application and development of “Internet and Med” model: A brand-new medical paradigm made feasible by cross-pollination into traditional medical practises and integrated innovation, " "Internet and Med" is reliant on the internet and uses big data, cloud computing, and the Internet of things to sustain itself.

 

4. Big data application: Big data, also known as mass data, is a collection of different data types that are information assets with great volume and speed. Big data's scientific predictability in fast and consistently through data analysis and extraction processes, obtaining the information and inner worth of the data using math and software technology is its fundamental component.

 

5. Precision medicine relationship: Similar to how many well-known multinational corporations like GE and Siemens have invested substantially in research on digital medicine products, many institutions have translated the outcomes of fundamental study on digital medicine into precise and creative solutions aimed at the market.

 

6. Applications of 3D printing and robot technologies: Individualised treatment is now possible thanks to the 3D printing industry's rapid development. The use of surgical robots has transformed conventional surgical techniques with improved surgical precision, making indirect rather than direct incisions the norm. 23, 24, 25, 26

 

Patient Involvement

Service users were invited to take part in a patient focus group by the patient and public participation lead from two research sites. The goal of the focus groups was to get opinions on the app technology and gauge how well certain app functions were carried out. The groups determined whether more explanation was necessary, for example, to make sure the app could send messages to patients, issues that may have delayed the performance of important duties. Additionally, opinions about language and colour in general were                  gathered.26, 27,28,29,30,31.

 

Examples of Digital Medication

Founded in 2001 in Silicon Valley, Proteus Digital Health has grown into a mature business with $422 million in loan and equity from reputable investors like Novartis, Oracle Corporation, and The Carlyle Group. Their creation is predicated on the concept of "medication adherence," which refers to the fact that most adult individuals do not take their prescription drugs as prescribed. How important is this problem? "Uncontrolled health conditions, excess hospitalisations, ER visits, and office visits" cost the US economy more than $290 billion annually, according to Proteus..32,33,34,35

The CEO of Proteus reportedly stated in the summer of last year, according to the San Francisco Chronicle, "we're the only company in the world that can do this". Given the recent disastrous failure of one possible rival to increase medicine adherence, this assertion is even more likely to be true. Based on their most recent bankruptcy filing, Medmetrics is one company Proteus won't have to worry about. Medmetrics' idea was to provide patients a pill that would distribute doses gradually and consciously. The product brochure describes the IntelliCap® as a swallowable, single-use capsule with a microprocessor-controlled drug delivery system. This allows for the creation of almost any delivery profile. Although it would have helped patients follow their medication regimes, this device doesn't seem to be very well-liked. Presently, it seems that the Intellicap is owned by a German company called Evonik, though it's possible that they are too busy managing one of the biggest speciality chemical companies in the world for them to be involved. 36,37,38

This innovative company exists to serve as a reminder that although digital medicines aren't precisely in pill form, taking medication "in pill form" isn't always the best way to take them.

 

This company, which we first wrote about in 2014, was known as MicroCHIPS until rebranding to "Microchips Biotech," which seems to be significantly more accurate of the direction they're moving. With $57.8 million in funding from investors like Novartis and Medtronic, they set out to create a "self-contained hermetically-sealed drug delivery device that is easy to implant and remove in a physician's office setting, that can store hundreds of therapeutic doses over months and years, and release each dose at precise times."39,40,41

 

Smart Pills For Capsule Endoscopies

We'll give you some background information before moving on to the next section, which may be useful if you're under 40. You may be wondering how a colonoscopy differs from an endoscopy if you've ever heard of one. Whether you've heard of either word before or not, we'll help you get straightened out. In contrast to an endoscopy, which involves the doctor inserting a tube down your throat to view ISHT, a colonoscopy involves the doctor inserting a tube into a different part of your body where he is likely to observe significantly more ISHT. If you want to view everything at once, why not just swallow a camera instead of having tubes put into you? Individuals in the   medical world call this device capsule endoscopies”.42,43,44

 

Big companies sometimes have the financial luxury of holding onto innovations for a while, which is one reason to consider investing in large dividend growth equities. Condensed version: Our next company was previously an Israeli startup called Given Imaging. Covidien eventually acquired it, and Medtronic (NYSE:MDT), a $116 billion medical equipment maker, then bought it. What Medtronic ultimately purchased was the PillCam COLON Capsule, which can be used in lieu of "invasive colon exams."Since then, Medtronic has worked to increase the capsule's applications in a way that is compliant with the FDA's extended approvals, such as this one. For long-term investors, MDT has shown to be a wise investment as the company has successfully raised its dividend for 40 years running.45,46,47

 

Founded in 2005, CapsoVISION is a California corporation with its main office located in Saratoga. Over the years, it has collected about $33 million to develop its capsule colonoscopy technology, which is focused around the CapsoCam Plus, a smart pill that offers a full 360o panoramic lateral image of wherever it is going in high resolution. When you take into account the "logistical challenges" of such a camera, the necessity of owning one should become abundantly clear.According to CapsoVision, they are "currently operating in more than 70 countries through strong distribution partners." 48, 49,50

 

It appears that they are selling using a "platform as a service" business model because they state that "no capital expenditures" have been made. CapsoCam Plus is currently only certified for adult use in the United States, but it received CE certification for children aged 2 and up late last year.51,52,53,54,55

 

The Medtronic PillCam is the "most widely used worldwide," according to the article "Emerging Issues and Future Developments in Capsule Endoscopy."

 

CONCLUSION:

People is moving towards modern medication, where more excellent information is available than at any other time in recent memory and some of it has the potential to affect ongoing negotiations and high-stakes estimations. This is the perfect time to reshape the local health care industry. To ensure that digital medicine will enhance the healthcare system, we must adopt a number of ontologies, frameworks, and decisions. The field will advance more quickly, collaboratively, and with greater trust if language is explained and a standard dictionary is set up. This preliminary is a beginning step, and over time, we anticipate and have faith that a usual structure and understanding will emerge.

 

It is crucial to keep in mind that all frameworks are first developed by people who plan the motivating forces when our people group is faced with difficult moral decisions, particularly those involving observation, accommodation, personalization, and security. Instead of letting things develop naturally, let's design the future we want to live in. We want to make sure that when we adopt new medical service innovations, it is because they actually merit our trust.

 

Ethicist dealing with biological preparation has expressed concerns regarding technology which records and provides data and patterns of taking medicines. From the standpoint of both individual and group patient freedoms, these worries are legitimate. Whatever the case, supporters point out that participation in computerized pharmaceutical programs is thoughtful, adhere to all relevant laws and regulations, and safeguard patient data as needed by the relevant state and federal governments. The same is true for additional data that is produced and kept in electronic clinical records. Advanced pharmaceutical programmes, according to experts, give confidence as a solution for prescription adherence in addition to assisting doctors in more correctly titrating measurements and evaluating how well the treatment performed.

 

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Received on 10.08.2023         Modified on 06.09.2023

Accepted on 19.10.2023   ©Asian Pharma Press All Right Reserved

Asian J. Pharm. Tech. 2023; 13(4):263-269.

DOI: 10.52711/2231-5713.2023.00047