Medical devices and drugs can be intentionally falsified, diverted, stolen, fraud object, or unfit for distribution. The sooner these products are recalled and quarantined, the smaller the losses for the interested parties.
Manufacturers of medical devices and medicines, product distributors and pharmacies implement product tracking systems to ensure proper quality and adherence to official federal regulations including CFR and GDP. However, such monitoring systems have some significant drawbacks that can cause potential financial and reputational losses. The product tracking systems, utilized by manufacturers, distributors, and point of sales, commonly report product non-conformities per email-notification. This approach is outdated and inefficient, since both warehouse workers and administrators are involved in multiple internal processes.
The process of tracking and regulation of devices and drugs is way more established at the production stage. This is, the company doesn’t bear significant losses in connection with recall and quarantining of products. When talking about distribution and sales, the process of notification, and therefore the process of regulation, is slower and way less efficient. This means that companies must bear greater losses.
Medical devices and medicines, which are potentially falsified or substandard in any other way, should be immediately recalled and quarantined. Immediate regulation is essential for every involved participant of the supply chain, which are manufacturer, distributor, and pharmacy.
Market regulation and its main shortcomings
Pharmaceutical requirements or regulations are measures, which companies are obliged to take to ensure safety, efficacy, and quality of the distributed products, as well as relevance of information about products. Governmental regulations are taken to safeguard both participants of the supply chain and the end consumer.
As already mentioned above, all participants of the supply chain are using tracking systems as recommended. However, these don’t allow to recall and quarantine substandard products right away. It takes up to 24 hours to respond to notifications about non-conformities. This process doesn’t provide for a timely reaction.
Regulating practices applied by responsible authorities often cause large losses and even reputational damage. This is why found substandard products have to be separated right away.
But what could provide the solution to this common problem? Well, let’s dive deeper.
Alarm system for the immediate notification of all involved parties
Implementing immediate alarming systems might provide numerous benefits to each interested member. Appropriate reaction to found substandard products is key to ensure both productivity of business and safety of the end consumer.
Manufacturers of medical devices and drugs are often the only involved party getting recall notification letters. Other participants of the supply chain are responsible for manually monitoring information on official governmental websites.
The concept we describe is an alarming system for smartphones and tablets, which notifies interested parties right after substandard devices or drugs are detected in the supply chain and marked for recall and withdrawal. Such a smart solution could improve regulating practices and increase business profitability.
The solution should be primarily designed for smartphones and tablets in order to reduce response time. Warehouse workers and administrators could receive immediate notifications without having to regularly update information published on governmental resources.
Here is the concept explained briefly:
- Competent authorities provide access to official federal databases
- The algorithm regularly gathers any updates about recall or other relevant information
- The system immediately notifies every participant of the supply chain as soon substandard products are found
- Involved parties immediately react and withdraw any products, which must be segregated
Implementing an alarming system might provide numerous benefits:
- The tool might reduce reaction time and decrease financial and reputational risks
- The system might provide better safety to the end consumer by not letting products, which are not fit, to point of sales
The risks of an unfit product entering the pharmaceutical market
Improved cooperation between authorities and all involved parties of the supply chain can change the game. Without everyone taking action, manufacturers, distributors, pharmacies, laboratories, and the end consumer might face unpleasant consequences.
The most probable consequences of a substandard product entering the pharmaceutical market:
- Financial losses
- Reputational losses and significant brand damage
- Undermined innovation
- Court proceedings
- Disease progression, drug resistance, and even fatal outcome
- Disease increase among people and communities in developing, low-income countries
Advanced technology to improve regulation practices
Advanced technology — artificial intelligence, machine learning, natural language processing, etc. — is changing the world and the way people go about daily routines like studying, work tasks, and even household matters. Cutting-edge solutions are revolutionizing every industry by notably simplifying processes and increasing business productivity.
Blockchain technology is one of those scientific achievements relentlessly transforming business operations. The distributed ledger technology is utilized to improve employee performance, identify and eliminate risks, enhance security and transparency.
If speaking about the pharmaceutical industry, the technology:
- Automates processes
- Improves track and trace of products
- Provides reliable, real-time data
- Enhances discovery and trials
- Improves procurement of materials
- Improves transportation
Utilizing modern, cutting-edge solutions can be game changing when regulating counterfeit devices and drugs. For example, blockchain technology can be used to facilitate track and trace of products being quarantined.
Despite the strict regulation of the pharmaceutical industry at all trading levels, it is still impossible to eliminate the problem of unfit, substandard products entering distribution and sales supply stages after manufacturing. Delayed response is one of the main reasons for such non-conformant products not being timely recalled.
The introduction of an immediate recall notification solution can change the game and help involved parties quickly respond to emerging risk factors at each trading stage, whether it’s production, distribution, or sales. Receiving up-to-date product information, warehouse workers and administrators can recall and quarantine non-conformant products without browsing federal websites and save valuable resources.