Blockchain for Drug Recall Handling

Drug recalls are a turning into a potential threat for the pharma industry. Drug recalls issued by manufacturers is increasing at an alarming rate. It was in Q1-2018, Pharma recalls rose 52%, compared to the same quarter in 2013, accounting for the highest in number of recalls.

An estimate by Tufts Center for the Study of Drug Development have stated that ,it takes a whopping $2.558 billion average for  developing and gaining approval of a new drug.

Also, pharma companies spend 10-17 Years for releasing a drug into market, considering this huge timeline, and cost involved in drug development, even a single drug recall to a company is colossal.

Recalls along with damaging the financial prospects of the company, can also keep the company’s reputation at stake.

Deploying blockchain in drug supply chain can address all the major drug recall problems, blockchain in pharma supply chain can mitigate the number of inefficient and faulty drugs reaching the market. This can help in making the drug making process more trustworthy and error-free, thus reducing the drug recall numbers.

A drug recall is usually initiated by a pharmaceutical manufacturer or distributor for removing their drug from the market. Most of the time it is companies, after discovering potential problems that are in violation of the law initiate a voluntary recall from their end.

In USA the Food and Drug Administration (FDA) also involves in identifying the problems in drugs and raise requests to the company for recall. FDA may pursue regulatory action; in case the companies fail to comply with these types of requests.

Recalls can also occur at 3 levels namely consumer, retail or wholesale level.

  • Consumer level Recall: covers individual patients, physicians and hospitals (may require action on the part of the consumer).
  • Retail-level Recalls: These are directed at retailers and providers.
  • Wholesale-level Recalls: Recalls involve distribution between the manufacturer and retailer.

FDA Classification of Drug Recalls:

FDA has classified drug recalls in US into 3 types

  • Class I:A dangerous or defective product that could cause serious health problems or death.
  • Class II:A product that might cause a temporary health problem, or pose slight threat of a serious nature.
  • Class III:A products that is unlikely to cause any adverse health reaction, but that violates FDA labelling or manufacturing laws.

How Blockchain can be the Game Changer?

Employing blockchain in pharma supply chain can act as preventive measure for drug recalls, blockchain can also facilitate targeted recalls in case of inevitable recalls. Here is how Blockchain can address the major issues that are accounting for drug recall.

1.Mislabelling:
There may be few cases where the instructions on a medication label are unclear or misleading, resulting in overdose, under-dose or other adverse effects. According to FDA Mislabelling is the cause of 14% of all the pharmaceutical recalls.

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Labelling is a critical procedure for maintaining compliance, however traditional labelling solutions relies on offline data sources like data entry or spreadsheets.

How Blockchain Can Help?
Blockchain can help in dealing with local labelling inefficiencies, with the help of a permissioned ledger that can store critical drug information. Only authenticated parties will have access to this ledger.

This distributed ledger can provide access to all manufacturing sites, about the critical drug information required for labelling, thus avoiding to extract the data from traditional database system. All of the Information is made available in real-time, in a consistent and recurring format.

This can help in maintaining the consistency of labelling data across all the manufacturing sites anywhere in the world.  On the other hand, distributed ledger’s data will be verified by a trusted authority at every stage of drug development process, ensuring authenticity. Blockchain thus can help in avoiding drug labelling with false or misleading information. Blockchain can also provide the access to FDA for monitoring the labelling process.

2.Failed Specifications:

Inadequate quality-control processes during manufacturing results in poor-quality drugs to hit the market.

How Blockchain Can Help?

Blockchain can address the quality control issue by providing visibility at all points in the pharma supply chain. This can be achieved by tagging drugs with unique bar codes. By scanning these bar codes, the drugs records are kept on a blockchain in secure digital blocks.

These records are updated in real-time as drugs travels from one entity to the other in the supply chain. This mechanism of tagging the drugs to trace and track them is known as serialization, provides access to the authorized parties for checking the records any time.

Each and every input and output in the drug development cycle will be monitored. A progress can be made to the next cycle of drug development, only when the drug meets the required standards of drug efficacy, efficiency, product specification, substance specification, and other expected results.

Multi-party computation enables all the stakeholders of the drug supply chain to validate the clinical trial results, thus ensuring the correctness of drug specifications. It can also ensure that CGMP (Current Good Manufacturing Practice) regulations are met.

Blockchain technology by detecting the faulty drugs at the initial stages of manufacturing, can safeguard the manufacturers from hitting losses. By detecting discrepancies in any stage of drug development, the process can be improvised to meet the industry standards.

3.Targeted recalls & Serialization:
There exist some special cases of recalls where even blockchain can’t handle, these include

  • Risks due to the usage of medicines becomes evident, only after widespread use.
  • Drugs which are contaminated on their way from the manufacturer to the retailer.
  • Cold Chain Inefficacy- a situation that leads to comprise of chemical composition of drug, due to storage at inappropriate temperatures.
  • Drug Recalls due to revisions/amendments in FDA Regulations.

Serialization enables manufacturers to issue targeted recalls of individual drug packages (contaminated). Manufacturer can directly issue recall for the affected drugs, based on its visibility status, and serial number of drug units. This can save a lot of manufacturer effort, as they can target on specific units of products, instead of broad range. By leveraging Blockchain, supply chain partners can more effectively and securely share data across the supply chain and, eventually, with the end patient.

Drug recall is hitting the pharma industry for losses,along with the deaths related to medicine failures.Blockchain can help to reduce the drug recalls that arises due to mislabeling and failed specifications. On the other hand Blockchain can also helo in issuing targeted recalls,saving significant amount of time for Drug Manufacturers.

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