The Key to Avoiding Drug Supply Interruptions Rests with Oversight from Start to Finish
Medication shortages are a nightmare, but they are avoidable through better, more comprehensive process management. Image Source: Flickr User: Andres Rueda
Drug shortages negatively affect all stakeholders. From researcher to consumer, these interruptions are frustrating and costly. Recently, a major hospital in Zimbabwe chose to suspend all elective surgeries amid a sedative drug shortage that has hit their country.1 Hopefully, the pharmaceutical companies supplying these drugs can find an efficient way to catch up that doesn’t lead to a shortage elsewhere or a suspension of other essential surgeries.
The causes of drug shortages appear to be consistent, stemming from the quality of the product. Be it finished product or raw materials, there are ways to navigate the complex world of compliance and quality. By using innovative computer software, it is possible to better support the process from discovery through to manufacturing, ensuring quality and keeping drug shortages at a minimum.
Major Causes of Shortages
Quality is a major contributing factor to shortages. According to statistics delivered by the FDA, three of the prominent contributing factors to drug shortages are:
- Product manufacturing issues
- Facility remediation efforts
- Raw materials shortage.2
All these issues are entirely manageable, a primary roadblock being the dire need for modern software that functions as a regulatory platform. Such a platform would allow stakeholders, from R&D to export, to be better informed about what is going on and what needs to be done in a manufacturing facility. This will cut back on both product manufacturing and facility remediation issues.
For example, quality, regulatory and compliance concerns can be fairly consuming when manufacturing is done in-house, but can be further complicated when commercial manufacturing organizations are introduced into the mix. If paper communication is the predominant way that a pharmaceutical or biologics company communicates with its manufacturer, there are items that will slip through the cracks. Some information will be mistranslated and other information will be lost altogether. This can have costly repercussions and further exacerbate shortages. What manufacturers and pharmaceutical companies need is a modern lab software that has a common platform for communication and tracking.
Adopting More Efficient Strategies
There are three main strategies that pharmaceutical companies can take to deal with ensuring enhanced quality and reduced shortages:
- Create more sustainable manufacturing operations: This will look different for every company depending on their portfolio, but one common thread is the need to avoid bottlenecks. By using computer software rather than paper-based methods to track and manage the workflows, it will be easier to see and prevent bottlenecks before they occur.
- Minimizing quality risks: By using innovative computer software to track items through from start to finish, manufacturers will have an easier time tracking where deficiencies are occurring. Proactive steps can then be taken to ensure that flawed products do not accumulate and lead to a shortage.
- Ensure consistency between lab and outsourced manufacturer: Researchers and producers can better communicate, utilizing real-time updates and easy-to-track process modifications offered by high end lab software.
BIOVIA Made to Cure supports companies from discovery through to manufacturing. This innovative suite of biologics capabilities allows for pharmaceutical companies to plan and manage their production to avoid drug shortages. There are ways to track the quality of raw goods, the potential for bottlenecking points along the production process and implement changes with fewer disruptions. This comprehensive software allows firms to better implement processes across the board ensuring compliance with current regulations. All-in-all, it is a time and cost saving measure that will help pharmaceutical companies and all of their stakeholders. Please contact us today to learn more about how our software options can support the efforts of your lab.
- ”Zimbabwe: major hospital suspends surgeries amid drug shortage,” October 15, 2016, http://www.africanews.com/2016/10/15/drug-shortage-hits-zimbabwe-hospitals-suspends-some-surgical-operations/ ↩
- “Strategic Plan for Preventing and Mitigating Drug Shortages,” October 2013, http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf ↩