Monitoring and automation can reduce supply inefficiencies, safeguarding accessibility to pharmaceuticals
The United States is the world’s richest nation and principal developer of pharmaceuticals and yet, it keeps running out of medicine.
This is one of the great dilemmas of our age.
How did a country awash in resources and drug manufacturing also become a hotbed of shortages so wide and deep that the FDA has to keep a running tally?
And what can be done about it?
These shortages are widespread, occurring across the entire health system and affecting access to many types of drugs.
Patients visiting the emergency room in a hospital are being impacted as are seniors on fixed incomes relying on a predictable regimen of drugs from their local pharmacy.
In 2020, as Covid-19 began spreading, the country already suffered from an insufficient supply of medication required by people relying on ventilators. The Washington Post reported:
Hospitals in regions experiencing a surge of coronavirus patients are struggling to maintain supplies of antibiotics, antivirals and sedatives required for patients on ventilators, and other drugs produced in countries where the pandemic has halted or curbed manufacturing.
Regardless of the drug, the factors leading to shortages are consistent – issues with raw material supplies or problems during manufacturing.
Studies have linked medicine shortages directly to patient deaths. Until you or a loved one is impacted, this can feel like a distant problem with a dizzying number of stressors to remedy.
Even when patients don’t succumb, lacking essential medication can hamper their recovery, expose them to complications, and increase the time needed for them to recuperate.
According to experts, boosting supply chain resilience could be the solution.
In various industries, manufacturers and supply chain stakeholders are already turning to process automation and advanced monitoring systems such as those offered by Sonicu to minimize supply chain inefficiencies.
A temperature and environmental monitoring system like Sonicu will help drug manufacturers as well as distributors by alerting them of an excursion that could impact the drug's efficacy or viability.
Sonicu is already trusted in dozens of hospitals and private pharmacies as well as county health departments managing vaccine administration programs.
Source: https://asia.nikkei.com/static/vdata/infographics/chinavaccine-3/
Medicine manufacturing and supply is a complicated process
Making prescription drugs is complicated, to say the least.
Manufacturers need to source ingredients that could originate from different parts of the world. These ingredients are then blended through technically advanced processes.
Factories must be fitted with sophisticated equipment, while the entire process needs to remain feasible from an economic perspective.
Problems often emanate right from the manufacturing stage, from equipment breakdowns to scarcity of ingredients or contamination. There is currently significant focus from the government to onshore the raw ingredients that over the past decade were sourced from China.
Source: https://asia.nikkei.com/static/vdata/infographics/chinavaccine-3/
Even India, another pharmaceutical giant regarded as an alternative to China, relies on Chinese supplies. According to the European Commission, India accounts for about 20 percent of global generic drug demand by volume, but it imports about 70 percent of the active ingredients from China, according to Nikkei.
At the moment, the FDA doesn’t require manufacturers to attribute the cause of a shortage.
However, this could change.
The FDA is continuously assessing guidelines as illustrated by the Drug Supply Chain Security Act.
Moreover, manufacturing conditions could prompt a shutdown by the FDA like what prompted the baby formula shortage that struck the United States recently. T
he CDC cited both supply chain challenges and product recalls as the primary reason for the baby formula shortage.
This incident raise the public’s awareness about the threats related to supply chain and ingredient sourcing for critical needs, but the issue has not relented as other supply chain issues have become less acute.
This chart below from McKinsey demonstrates the number of threats facing the pharmaceutical industry organized by likelihood and estimated economic impact. While many of these threats are rare, we have seen most of them occur in the past several decades and can expect more of the same in the future.
Source: https://www.mckinsey.com/industries/life-sciences/our-insights/four-ways-pharma-companies-can-make-their-supply-chains-more-resilient
A concerning aspect of this problem is that the most widely-used medicines are generic products that have a low number of suppliers. If one supplier runs into challenges, half or more of the supply gets wiped out leaving the healthcare system vulnerable.
Supply disruptions are hard to resolve quickly as companies typically use just-in-time production meaning there’s no emergency supply in stock.
Additionally, since these generic drugs are largely low cost, manufacturers lack a financial incentive to scale up production in such cases.
Unless policy changes address this, the economics of drug production are bound to continue affecting supply in this way. A concentration of suppliers, overseas supply chain challenges and incentives against building a resilient stock of supply are significant challenges on their own merit.
Collectively, they represent a serious challenge to the healthcare system. Some healthcare professionals are taking proactive action to protect their medicines from the sort of threats detailed in the McKinsey report as well as simple human mistakes or forgetfulness.
Tim Livesay, Pharmacy Director, at Hancock Regional Hospital, said he relies on Sonicu temperature monitoring to protect against the threat of drug shortages that threaten his ability to provide exemplary patient care.
“The supply issues were bad before COVID but have become even worse since,” Livesay explained. “So we’re even more sensitive now to taking every precaution and installing every preventative measure to ensure we protect our supply since we know it won’t be as easy to replace it if there is an issue.”
Issues can also arise during distribution such as transport workers striking or sudden surges in demand.
The DSCSA attempts to address some of these challenges presented in distribution but does not account for challenges like labor shortages, resurgent COVID-19 outbreaks and inflationary pressure on operations challenges across many industries.
How can drug shortages be prevented moving forward?
Upon the request of The Department of Health and Human Services, the National Academies of Sciences, Engineering, and Medicine established a committee to evaluate the resilience of the country’s medical supply chains.
The committee authored a report outlining several recommended action points that the government could implement to address medicine shortages.
These include trade agreements that aim to make medicine imports more seamless as well as overhauling the National Strategic Stockpile which has reserves of essential drugs in store for use when there are supply constraints.
Another proposed solution is the creation of a national database containing information on medicine supply chains.
This would be publicly accessible and involve multi-agency cooperation.
While these are steps in the right direction, they would take considerable time to achieve their desired intent.
Under the current system, there’s a limit to what the government can do to combat let alone prevent shortages.
This shifts focus to manufacturers and other stakeholders.
One proposal that would be easier to adopt and enforce is the call for greater public transparency on the part of manufacturers.
We’ve already seen how this can be realized through policy changes mandating transparency for food manufacturers and handlers across the chain through the Food Safety Modernization Act or FSMA.
This recommendation would require drug manufacturers to publicly disclose details on manufacturing such as location(s), active ingredients, sources of raw materials, as well as the volumes of drugs and medical equipment.
In addition, this could mean the FDA making public assessments conducted on the safety of medicine manufacturing plants.
Greater transparency would make it easier for government officials to identify potential vulnerabilities in the supply chain. This could improve our capacity to anticipate oncoming shortages in the event there are supply constraints of essential materials or quality issues at factories.
Eventually, this could result in a publicly accessible rating system that helps healthcare providers as well as patients to make better-informed choices on medicine purchases.
In short, more transparency across the supply chain and manufacturing process.
Higher-quality medication is bound to cost more, however.
For many healthcare facilities, the cost is perhaps the greatest factor affecting purchasing decisions. The government could, therefore, offer incentives such as tax credits on purchasing medicine from highly rated manufacturers.
If a regulation enforcing greater public transparency was to come into effect, manufacturers and distributors of pharmaceutical goods would need to improve their processes and deploy systems that capture data on their operations in order to have it available on the public database.
Furthermore, they would need to demonstrate compliance.
Sonic's wireless temperature monitoring platform meets this need, ensuring all relevant information is captured and can be shared with the relevant parties.
Sonicu today already serves dozens of pharmacies as well as many pharmaceutical distributors who rely on our trusted temperature and environmental monitoring solution to comply with their regulatory requirements and deliver safer products to their patients and customers.
“Large food and drug distributors appreciate the value of our solution since it is wireless and can be installed rapidly and configured simply,” said Bryan Mitchell, Vice President, Marketing & Business Development, Sonicu.
“And when you add our ability to integrate with a building management or automation system so that temperature and environmental data is shared widely and simply across an organization, it’s easy to see how much value the platform can provide to a diverse set of stakeholders.”
When coupled with Sonicu’s SNAP Calibration Program, virtually any organization focused on compliance can simply and affordably ensure they are always NIST compliant.
For medicine manufacturers, Sonicu’s solutions contribute to safety, precision, and quality control.
To meet the advanced needs that come with pharmaceutical manufacturing, Sonicu offers an end-to-end set of systems including:
- Temperature monitoring
- Air pressure and humidity monitoring
- Third-party sensor monitoring via 420 mA adapter
Almost any local sensor can relay data through the Sonicu Duo communicating meter.
Data is transmitted online via a secure cloud for constant and consistent monitoring.
Any activity outside the set normal range is flagged automatically and reported, making it easier to respond to any arising issues faster.
Most importantly, all real-time data collected from manufacturing systems gets synced to guarantee data integrity.
With the cloud-based architecture, monitoring can be done anywhere, even on mobile devices.
Medicine distributors can also use the temperature and humidity monitoring solution to ensure these sensitive goods remain under ideal conditions while in transit and that they arrive without defects.
There are many capabilities to explore with Sonicu.
To learn more about our solutions and see them in action, request a demo.
Additional reading:
https://nap.nationalacademies.org/resource/26420/Supply_Chain_Recommendations.pdf
https://ncpa.org/sites/default/files/2020-10/dscsa-essential-steps-slides.pdf
