Drug shortages can prevent effective care, increase hospitalizations, and even enhance mortality in patients. Not only have geopolitical crises and pandemics impacted them hard, but also the rising pharma globalization and supply chain challenges caused a steady worsening of the situation for the past 15 years. Only in the USA, the percentage of people of all ages who delayed or did not receive needed medical care due to delivery disruptions and delays increased by nearly 30% between 2021 and 2022. In this article, we show how PharmaTrace helps pharma companies to build efficient partner networks, maintain adequate medication stock levels, implement effective inventory management systems, and address key barriers that may impede patient access to medical treatment.
Drug shortages are situations where there is a limited supply or insufficient availability of specific medications in the market. They can impact both brand-name and generic medicines and have significant consequences for patients, healthcare providers, and the healthcare system as a whole.
Here are some key implications of drug shortages for patients:
Delayed or interrupted treatment: When a medication is not available or in short supply, patients may experience delays in starting their treatment or may have to switch to alternative medications that may not be as effective for their condition. This can lead to prolonged illness, worsening of symptoms, or disease progression.
Compromised medication adherence: Patients may struggle to adhere to their prescribed treatment regimens due to medication shortages. They may be unable to obtain their medications consistently or may be given partial doses. Inconsistent medication use can reduce the effectiveness of the treatment and potentially lead to treatment failure or recurrence of symptoms.
Suboptimal treatment alternatives: During medication shortages, healthcare providers may need to substitute the prescribed medication with an alternative drug. These alternative medications may not be as suitable or effective for the patient's condition. It can result in suboptimal treatment outcomes, increased risk of adverse effects, or inadequate symptom control.
Increased healthcare costs: Medication shortages can lead to increased healthcare costs for patients. When alternative medications are used, they may be more expensive or not covered by insurance plans, placing a financial burden on patients. Additionally, the shortage itself can drive up the prices of available medications due to increased demand and limited supply.
Adverse events and complications: In some cases, medication shortages can lead to serious adverse events or complications. For example, if a critical medication is unavailable for patients with life-threatening conditions, it can result in avoidable harm or even fatalities. Furthermore, if healthcare providers are forced to use alternative medications or different dosages, there is a risk of medication errors or adverse drug reactions.
Psychological and emotional impact: Medication shortages can cause significant stress, anxiety, and frustration for patients who rely on these medications for their health and well-being. The uncertainty and fear associated with not being able to access necessary medications can have a negative impact on a patient's mental health, leading to decreased quality of life and emotional distress.
Drug shortages can result from various factors such as manufacturing issues, regulatory challenges, supply and demand imbalances, as it was during the Covid-19 pandemic, raw material deficacy, or quality control problems. As already mentioned they can significantly impact patient access to necessary medications and can lead to the delays and supply disruptions.
To mitigate the impacts of drug shortages, healthcare providers and policymakers often work together to implement optimal strategies, however, most of them are still not as effective as the market requires.
At PharmaTrace, we are developing blockchain-based SaaS solutions for secure and easy networking across the pharmaceutical supply chain. The tailor-made, modular approach allows our clients to quickly add their partners and in such a way build scalable networks in a plug-and-play mode.
By enhancing visibility, blockchain and AI used in our solutions enable better inventory management, demand forecasting, and supply planning. This can help identify potential shortages in advance and enable proactive measures to address them.
What is more, our customers can effectively collaborate within our PharmaTrace ecosystem. The implementation of a token gives the possibility for its owners to exchange data, and insights not only within their own networks but across the whole platform. Partnerships between manufacturers, distributors, regulators, and healthcare providers, are tremendously beneficial in addressing inventory issues. On our platform it is also possible to conclude B2B trade deals, as it can help anticipate and address supply chain disruptions promptly and without hassle.
Below we will show in mode detail how PharmaTrace helps pharmaceutical companies, especially SMEs, to address different factors causing medicine shortages.
The pharmaceutical supply chain is intricate, involving numerous logistics processes, and multiple stakeholders, such as manufacturers, distributors, wholesalers, pharmacies, and healthcare providers. Each step, from drug manufacturing to distribution, presents various challenges including ensuring proper storage and transportation conditions, maintaining product integrity, and complying with regulations. Moreover, different partners can use different tools for management. Some of them are still using paper tables or Excel files. All these can increase the risk of errors, inefficiencies, and, as a consequence, delays in supply. As proof, the World Health Organization (WHO) estimates that roughly 50 percent of product recalls are a result of mislabeling and artwork errors.
Implementing blockchain in the pharma supply chain allows us to offer easier networking with your partners in a plug-and-play mode, additional automation, and full visibility. A decentralized and transparent digital ledger enables secure and efficient recording, verification, and tracking of transactions. It helps to eliminate the need for manual paperwork, redundant data entry, and reconciliation processes. Smart contracts also automate several supply chain operations, such as inventory management, and order tracking, leading to improved operational efficiency, faster delivery, and reduced costs.
Effective inventory management is crucial to ensure an adequate supply of medications while avoiding excess or expired stock. And vice versa, lack of it can result in stockouts, overstocking, or wastage. Forecasting demand accurately, optimizing storage and distribution, and coordinating inventory levels among different stakeholders are key challenges in maintaining an efficient pharmaceutical supply chain.
By having access to real-time inventory data on the blockchain, our clients can coordinate their activities more effectively, optimize supply and demand planning, and make informed decisions regarding inventory levels.
Smart contracts can also automate various inventory-related processes, such as order placement, verification, and payment settlement. This helps to reduce manual intervention, enhance accuracy, and improve the speed of inventory management operations.
What is more, by recording supplier information, certifications, and performance data on the blockchain, pharmaceutical companies that are subscribed to our services can make more informed decisions when selecting business partners.
The pharmaceutical supply chain is vulnerable to the infiltration of counterfeit or substandard drugs. They can enter the supply chain through unauthorized channels or due to weak quality control measures. Quite often fraudulants are able to take advantage of the drug shortages. Counterfeit medicines pose significant risks to patient safety, as they may contain incorrect ingredients, incorrect dosages, or no active ingredients at all. Substandard drugs may not meet quality standards and can lead to ineffective treatments or adverse effects. When the counterfeit is uncovered, it may take time to supply proper medications to all the dispensing points.
Our blockchain-based solution enables end-to-end visibility of the entire supply chain. Each transaction and movement of pharmaceutical products can be recorded on the blockchain, allowing for real-time tracking and traceability of every step involved. Once data is recorded on the blockchain, it becomes nearly impossible to alter or manipulate, ensuring the integrity and security of the data. It enables stakeholders to verify the authenticity and integrity of the pharmaceutical products at any point in the supply chain.
What is more, the decentralized nature of blockchain eliminates the need for intermediaries, reducing the chances of fraud and counterfeiting.
And if any fraudulent actions are suspected, our system sends a notification to all the stakeholders. As blockchain can trace both the location and the time of each tracked product, it will not take too much time to figure out where and how an incident happened, as well as to take appropriate measures.
More information on how counterfeits can harm your pharmaceutical business and patients as well as how our solutions can help to deal with the problem see here.
Compliance with regulations and regulatory changes adds complexity to the pharmaceutical supply chain. Each country has its own regulatory requirements for drug manufacturing, labeling, distribution, and import/export. For example, the Falsified Medicines Directive in the European Union requires pharmaceutical companies to use serialization codes on every applicable medication (with few exceptions) and have a track and trace tool in place. WHO is also becoming stricter on end-to-end batch traceability, so it’s an obligatory measure in the pharmaceutical supply chain.
However, meeting these regulations can be challenging, especially for multinational companies that operate in multiple jurisdictions. Often big pharmaceutical companies need to consider the local, federal, and individual country’s regulatory requirements. Regulatory delays or non-compliance can disrupt the supply chain and affect patient access to medications.
Blockchain can help pharmaceutical companies comply with regulatory requirements by providing an immutable record of all transactions and movements of pharmaceutical products across the supply chain and different locations. The use of smart contracts simplifies the audit process and ensures adherence to local regulations such as serialization, track and trace, and data privacy.
Our modular solution allows adding all the obligatory pharma compliance steps from serialization to track and trace. Besides this, it is also possible to configure regulatory requirements and automate sending reports to governmental authorities. This will help to ensure that all the papers are errorless and sent on time.
Recalls are taken by the pharmaceutical industry players to address potential issues with pharmaceutical products and aim to ensure patient safety, maintain product quality, and comply with regulatory requirements. However, they involve a number of actions (identification, investigation, classification, notification, retrieval, corrective actions such as process improvements, equipment calibration, staff training, or changes in quality control procedures) that might take a lot of time and lead to the temporary removal of certain products from the market. All these cause a strain on the supply and contribute to shortages.
In the event of a product recall, our blockchain and AI-based solution enables quick identification of the affected batch or product. The immutability and transparency of the recorded data make it easier to pinpoint the origin of the problem, isolate the affected products, and minimize the impact on public health. It is also possible to configure the notifications so that the supplier had more time to restock necessary products to dispensaries.
Addressing drug shortages includes improving communication and information sharing, implementing robust quality control measures, investing in technology and data analytics for inventory management, promoting transparency, and exploring strategies for strengthening the supply chain to mitigate risks and ensure the availability of essential medications.
At PharmaTrace we are building blockchain and AI-backed solutions that can cope with all these requirements by providing real-time visibility, reducing discrepancies, facilitating coordination with partners, enabling automation through smart contracts, streamlining recalls, and enhancing collaboration.