Emptying trays with vital drugs make doctors all over the world make tough decisions about how to treat their patients, including rationing doses and looking for alternative options that may cause serious side effects in patients. No doubt, tackling deficiencies in medicines requires collaboration among various stakeholders — pharmaceutical companies, regulatory agencies, healthcare providers, and policymakers. But while the authorities use the war in Ukraine and the energy crisis to cover up the real causes instead of addressing the problem, we tell about the actions drug manufacturers and their partners can take by themselves to protect end consumers and keep good relations with healthcare providers and pharmacies.
Over the past 20 years, shortages of prescription medicines have raised dramatically in Europe. They increased 20-fold between 2000 and 2018, and the situation is getting worse from year to year.
All European countries have faced the issue. Italy reported the most severe shortages from 2018 to 2023 amounting to 10,843 for human medicines. Czechia (2,699) and Germany (2,355) took the second and third places respectively.
In France, as of January 23, nearly 320 medicines of major therapeutic interest were in high demand according to the Agence Nationale de Sécurité du Médicament et des Produits de Santé (National Agency for the Safety of Medicines and Health Products; ANSM).
The average duration of deficiencies constituted 94 days with Greece having the longest median duration (130 days).
The most affected medicines are those related to the neural system (19.0% of the total), cardiovascular drugs (14.5%), and antibiotics (12.5%).
In the meanwhile, new drug shortages in the US increased by nearly 30% between 2021 and 2022, according to the Senate’s report. At the end of 2022, 295 products reached a five-year record deficiency. And current drug shortages 2023 list includes 377 names. They include common antibiotics, anesthetics, and sterile fluids for intravenous drug tube cleaning.
Also, because of the worsening of chemotherapy drug shortages that forces doctors to delay treatment or use alternatives, the American Medical Association is backing legislation to create an advance warning system for impending shortages.
In the US, each affected medicine is lacking for about 1.5 years on average. However, more than 15 critical drug products have been in shortage for over a decade.
Medicine deficiencies can have several reasons, which can vary depending on the region and specific circumstances.
While most people all over the world became aware of national drug shortages during the Covid-19 pandemic, the issue is more common for patients with life-threatening diseases. However, increased demand is only one, but far from being the main cause of emptying shelves with vital medicines.
Economic analysis of the causes of drug shortages shows that manufacturing issues, raw material problems, globalization, low profitability, economic instability, and price pressures on the generic manufacturers, are among the most common problems, however, there are several underestimated factors that in fact have a far more meaningful impact on the situation.
Here they are:
Regulatory challenges: Complex approval processes and newly adopted stringent serialization and track and trace regulations can slow down the processes of obtaining necessary approvals, rearranging the supply chains, and taking additional measures to integrate all the partners in one seamless network, as well as ensuring appropriate reporting to the governmental bodies. Obviously, all these factors together can cause delays, resulting in long-term medicine shortages.
Global distribution: In the search for cheaper production costs, pharma companies can choose to have manufacturing sites overseas, in the countries where they source raw materials or where the labor is cheaper. As a result, products go a long way before they reach the patients. Disruptions in the global supply chain can also affect the availability of medicines. Factors such as natural disasters, transportation problems, or geopolitical issues can lead to delays or interruptions in the delivery of drugs to their intended destinations. In addition, there is a rising problem of ensuring regulatory compliance and reporting, especially when the product passes several countries or even continents on its way to the end consumer.
Supply chain vulnerabilities: Drug supply chains are often complex and involve multiple intermediaries. If the systems in place are lacking data security, integrity, and visibility, a lot of issues can happen during the product journey: from counterfeiting to inventory loss and regulatory fines. And, of course, any disruption or failure at any stage of the supply chain can lead to delays or shortages.
The gap in information: It is essential for doctors to have timely and up-to-date information about drug shortages to effectively manage patient care. However, the communication between regulatory agencies, pharmaceutical companies, wholesalers, and healthcare providers may not always be seamless. What is more critical, neither governments, nor companies themself have proper tools to forecast the biggest demands or shortages for the most common causes, and, thus prevent undesired situations.
Despite authorities and pharma companies being the main decision-makers in terms of preventing drug shortage issues, it’s always the doctors who have to make tough decisions when the problem occurs and people’s lives are at risk. Thus, drug shortages can have significant effects on healthcare providers and their ability to provide optimal care to their patients. Here are only some of them:
Treatment limitations: If a particular medication is unavailable or in short supply, doctors may need to consider alternative treatments, which may be less effective, have more side effects, or be unfamiliar to them. This can make it challenging to provide the best possible care for their patients.
Compromised patient outcomes: The unavailability of essential medications makes doctors make difficult decisions about prioritizing patients or allocating limited supplies of drugs, potentially impacting the effectiveness of treatment and patient recovery.
Increased workload and stress: Dealing with drug shortages can create additional workload and stress for doctors. They may spend more time searching for alternative medications, adjusting treatment plans, and communicating with patients about the shortage and its implications. This can add to the already demanding workload of healthcare professionals and impact their overall well-being.
Ethical dilemmas: In some cases, doctors may face ethical dilemmas due to drug shortages. They may need to make decisions about allocating scarce resources, potentially prioritizing some patients over others based on clinical need and available supplies. These decisions can be emotionally challenging and may conflict with the doctor's commitment to providing equitable care.
To avoid the above-mentioned effects, the majority of doctors and hospitals prefer to contract with manufacturers, wholesalers, or non-hospital pharmacies to ensure a stable supply of necessary products, but the problem is that those parties are lacking control over the inventory themselves, as we have learned in the previous section.
At PharmaTrace we are committed to ensuring better healthcare for everyone by covering all the issues that may harm the patient’s ability to have timely access to high-quality medicines. Naturally, the drug shortage management module is one of the many useful tools we offer to the subscribers of our wholesome SaaS pharma ecosystem.
We use Blockchain and AI/ML technologies to help the pharmaceutical industry players benefit from improved prediction capabilities and proactive management of any product insufficiencies. This approach enables our customers to take timely actions, optimize supply chain operations, and minimize the impact on patient care. Here are some features the module incorporates:
What is more, using Blockchain to record all the transactions as well as AI/ML technologies and a network of platform participants allows us to predict critical drug shortages for our clients based on their needs and business models, and visualize on an interactive map.
However, as already mentioned, addressing drug shortages is a complex issue requiring a comprehensive approach from the companies. And other features of our solution can help our customers to develop and incorporate wholesome medicine management policies.
Here are some other PharmaTrace app possibilities that can contribute to the prevention and mitigation of drug shortages that will help pharma companies to ensure a more stable and reliable supply of essential medications for patients, as well as improve relations with the dispensaries and other stakeholders:
Robust supply chain integration: We offer an easy plug-and-play connection to seamlessly integrate all your partners, even if they are not subscribed users of the PharmaTrace platform. This will help to share all the information (including those related to the medicine deficiencies) within the established supply chain network quickly and securely without additional effort.
Collaboration with healthcare providers and patients: Building collaborative partnerships with healthcare providers and end consumers can facilitate effective communication and understanding of supply needs. We can develop tools for your company to work closely with healthcare providers to align supply and demand, identify critical medications, and develop strategies to ensure availability during shortages, as well as apps to notify affected patients about possible drug supply issues so that they can stockpile necessary products.
Pharmaceutical Compliance: We provide all the services to satisfy serialization and traceability regulatory requirements. Those include the generation of serial numbers according to the applicable rules, data transfer secured by Blockchain, track and trace, product verification, as well as reporting to the selected authorities. This will help not only to avoid drug supply delays caused by legal issues but also to prevent counterfeiting and other logistics disruptions.
Risk assessment and contingency planning: Blockchain integrated into the supply chain makes it possible to conduct thorough risk assessments to identify vulnerabilities within the supply chain. Using our solutions, our clients can develop robust contingency plans to mitigate risks and ensure alternative supply sources or manufacturing options are available in case of disruptions.
B2B interactions: We are committed to building a collaborative community within our ecosystem, where all the industry insiders can interact effectively to help each other tackle burning issues. We have introduced a utility token to facilitate all kinds of possible collaborations: from insights and other data exchange to B2B sales on our upcoming sales platform. This will help companies to share information and forecasts on drug shortages as well as to provide medicine alternatives to each other.
Collaboration with stakeholders, proactive planning, and continuous improvement are crucial in addressing the complexities associated with drug shortages. And our solutions can help pharma companies, big and small, to implement effective strategies to prevent and mitigate medicine deficiencies, ensuring a more stable and reliable supply of essential medications for patients and better relations with their client healthcare providers and independent practitioners.