Blockchain, the distributed ledger technology, is impacting industries across the board. The pharmaceutical industry has already started to take an interest. Drug companies and healthcare organizations are developing blockchain-based solutions to help with drug supply-chain management. The technology also has the potential to help organizations implement pharmacovigilance programs to improve drug safety.
What is Pharmacovigilance?
Pharmacovigilance encompasses processes for monitoring and evaluating adverse drug reactions (ADRs). It helps drug companies with drug safety and efficacy. The term has broad implications in the pharma industry. Pharmacovigilance can help with operations, surveillance, regulations and more. It plays key roles in the following areas:
Blockchain for Pharmacovigilance
A blockchain is a form of distributed database. Instead of maintaining the data through a central authority, blockchain allows users to process data through nodes on the network. The benefit of this process is that users of blockchain can transact with each other without a third-party intervention. Two users can have a ‘trustless’ transaction using blockchain without knowing each other.
For example, if party A and party B are transacting with each other over the network, there needs to be a party C to verify the identities of A and B. Party C can be a bank, a government or a healthcare regulatory body. But in a blockchain environment, there isn’t any need for party C. This opens up new possibilities for transactions.
Here are some of the ways blockchain technology can help with pharmacovigilance tasks.
Tracking and Timestamping Clinical Trials
In pharmacovigilance, the traceability and historicity of the data are important in clinical trials. If drug companies can falsify or beautify data to suit their own needs, then it will lead to safety and trust issues. In blockchains, records are immutable. So the blockchain technology provides a reliable and transparent way to track and timestamp clinical trial data. Blockchain data entries are mathematically tied together. So drug companies can’t manipulate data post-trial to show desired outcomes. Naturally, the storage of clinical trial documents in blockchain has become a key area of research for the pharmacovigilance industry.
Smart Contracts for Clinical Phase Controls
Smart contracts provide ways to automatically execute certain tasks on the blockchain. For example, if a drug company is collecting data about their products in the field, any report of adverse drug reactions can trigger a code that can report the case directly to the drug regulatory boards. Implementing this kind of solutions can improve drug safety. At the same time, consumers will have more information directly collected on blockchains to verify the side effects of any drugs. It can increase the efficacy of drugs currently on the market.
Reliable Data Sharing for Post-marketing Safety Monitoring
Blockchain’s ‘trustless’ data sharing allows drug companies, regulatory boards, and consumers to create an ecosystem where data flows reliably. Consumers are able to make more informed decisions about any available drugs. They can directly check the ADR data for the drug they want to use. Today when consumers receive information about a drug, they have to take it with a grain of salt because the information gets sieved through the drug companies. But blockchain-based data sharing solutions mean consumers can better trust the pharmacovigilance data.
Aligning International Drug Regulatory Requirements
International standards for clinical trials and drug monitoring have been difficult to maintain. Central databases can become huge bottlenecks in this kind of endeavors. Blockchain’s distributed nature helps drug companies across the globe maintain their clinical trials and drug monitoring data in a more systematic way. It can also help spread drug safety procedures to countries where there are no monitoring systems in place. It will lead to better drug standards across the globe.
Pharmacovigilance deals with life and death situations. So it needs highly reliable and effective solutions for sharing information and establishing trust. The blockchain technology can play a crucial role in helping the pharmacovigilance industry meet the challenges of ensuring the safety of current and future drugs.