5 Challenges - Mylan Hackathon Bangalore on October 13th and 14th 2018 Hackathon
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse/side effects with pharmaceutical products. However the side effects of drugs very rarely get reported once the drug enters in to the market. There is no easy mechanism for the patient to report these effects he/she encounters after intake of the drug. The pack insert usually contains an email id which the patient can email the details to. But the leaflet contains a lot of information and is thrown away in a majority of cases. Doctor also need a fill a form with the details and most of todays’ HCPs in India don’t have time to fill in all the details. Knowing the side effects of the drug is of vital importance to HCPs, drug manufacturers and regulatory bodies.

Apart from reporting adverse events, it would also be good for the patients to have a basic understanding of the condition they have and drug that has been prescribed when they purchase a drug. Enabling this capability on the product will be useful, but when the drugs come in strips, most of the written content on the strip fades over time and very minimal details of the drug are available. Could something be worked on which would enable patients in both rural and urban areas to seek more information.
Only 12.5% of cancer patients get treatment in early stages. In other words, late detection of cancer is the cause of 70%  deaths  in  India.  According  to  WHO, At  least   8.8 million  people  die of cancer annually due to late diagnosis.
Some early signs of cancer include lumps, sores that fail to heal, abnormal bleeding, persistent indigestion, and chronic hoarseness. Early diagnosis is particularly relevant for cancers of the breast, cervix, mouth, larynx, colon and rectum, and skin. Also in the developing markets Doctor to population ration and qualified hospital staff to population ratio is very imbalanced. This leads to a high volume of specimens and reports to be analyzed by qualified staff like radiologist, pathologist. The in availability of these qualified personnel in all care centers leads to long diagnosis time as the specimens and reports have to be mailed to other locations and then brought back.

With the advent of technology , looking for solutions that can be used to detect early cancer symptoms and help tackle the resource scarcity problem by automating preliminary analysis of specimens and reports

A drug molecule is sold to the general public for a particular disease/indication following extensive clinical studies on patients and healthy volunteers.

As the molecules are tested in a clinical setting (there are often numerous inclusion/exclusion criteria), is there a way to use technology to map the following post drug launch  (list not exhaustive)

    • Patient experience with the drug in the real world post launch
    • Subgroups of patients who experience maximum benefit
    • Building a repository of treatment cases/paradigms for healthcare providers
    • Identification of patients for patient assistance programs etc

How can technology/AI be used more extensively to ensure the right patient benefits from the treatment

    • Using technology to identify the right patient- in many countries, especially in the developing world, limited data and statistics are available through public sources on the number of patients suffering from a disease, number of patients likely to contract a disease due to other conditions etc

Tuberculosis is one of the top 10 causes of death globally and resulted in 1.8 million deaths in 2016 alone. 95% of TB deaths occur in low-and middle-income countries like India, African countries, china etc. Tuberculosis is a serious form of infection that affects lungs and at times other parts of the body like bones, joints and kidneys. It is caused by bacteria Mycobacterium tuberculosis. A previous study showed that TB killed 60,000 children below 15 in India, the highest in the world, in 2015. It is estimated that about 40% of the Indian population is infected with TB bacteria which is roughly 50 crores of population, the vast majority of whom have latent TB rather than TB disease (data source). Tuberculosis is an infectious disease. The classic symptoms of active TB are, chronic cough with blood containing sputum, fever, night sweats, and weight loss. TB spreads through sputum from one infected person to normal individual while coughing, singing, speaking. Apparently, there are 3 different stages of TB based on drug resistance called Rif-DR TB, MDR, XDR. 

Initiatives Taken so far: Indian govt. has taken several initiatives starting from 14000 DOTs centers creation, launching aspirational project END-TB campaign by 2025, engaging different stakeholders like HCPs, Pvt. Doctors, NGOs in different TB projects etc. But still TB needs much more attention as far as patient awareness, patient adherence is concerned. 

Major Challenges: India is a hub of TB and different factors play pivotal role for a person become TB patient or a primary TB patient become DR-TB patient, starting from - lack of awareness, lack of knowledge at doctors as well as at patient level, poor economic conditions etc. But among all most prominent reason for a primary TB patient become drug resistant TB patient is “Poor patient adherence to therapy”. TB treatment is min. 6 months to maximum 24 months long, based on type of TB. But in many cases after 2-3 months when patients are in recovery phase, patient stops taking the medicines, assuming he/she got cured already. Because of this, after few months or year patient develop resistance to primary drug and become DR-TB patient. 

Need of the hour: Transition from primary TB patients to DR-TB patient must be controlled and monitored, and for that we need to improve ‘patient adherence’ through continuous monitoring of patients. A solution is needed by which Patients can be tracked on their daily doses, pill habits, missing dosages, therapy duration etc.

The modern pharmaceutical supply chain is complex. Medicines are made from ingredients sourced from different countries. Final formulations are then exported. Packaging, repackaging, and sale can happen in many other countries. Drugs change hands many times between the manufacturer and patient; every transaction is an opportunity for falsified or substandard products to infiltrate the market. Changes to the drug distribution system by introducing effective end to end tracking could improve drug quality around the world.

Also, tracing each product unit to the end consumer helps in understanding the number of patients on treatment, consuming Mylan product, especially in areas where such detailed data is not available and is impossible to obtain. There is currently no mechanism to track the stock till the consumer. Currently, the information is available only till the stocks reach the distributor, and have no visibility to track beyond that, hence have very limited information on actual patient volume in a country, or areas where there the product is shipped to heavily. Therefore, there is a need to track and trace the product units from the time it leaves Mylan via all distributions channels - govt- clinics- pharmacies till it reaches consumers.