Labeling Mismatches are Bad News in Healthcare

Getting the label right is important in most industries, but in pharma it can literally be a life-or-death scenario. If your package is labeled with one kind of medication and shipped with another, patients’ health and safety may be at serious risk. If your package is labeled with incorrect dosage information, patients health and safety are at serious risk.

With this in mind, a number of recent recalls have shown that as far as labeling is concerned, the pharma industry still has a number of issues to sort out:

  • In late August, Pfizer issued a recall for a specific lot of Children’s Advil Suspension in bubblegum flavor. In this case, the dosage information was wrong. While the dosage on the label was measured in milliliters, the dosage cup was labeled in teaspoons. The product was distributed nationwide.
  • Around the same time, Accord Healthcare called for a nationwide recall of a drug known as hydrochlorothiazide after containers of the drug were found to contain spironolactone instead. While both drugs treat high blood pressure, patients accustomed to hydrochlorothiazide can experience life-threatening consequences if they accidently substitute spironolactone.
  • Lastly, Camber Pharmaceuticals recently announced a voluntary recall of its asthma drug, Montelukast, when bottles labeled with the drug were found to contain losartan potassium tablets instead. Losartan is commonly used to treat high blood pressure and mitigate stroke risk. When taken by accident, it can cause renal dysfunction, and in pregnant women the drug even has the potential to induce miscarriage.

As you can see, drug recalls – especially those centered around mislabeled packaging – are beginning to cluster.  This clustering has diverse causes and requires diverse remedies. What can the pharma industry do about drug recalls?

What’s the Reason Behind Increased Recalls?

One main factor behind drug recalls is new overseas supply chains. Over the last few years, pricing pressure has driven US-based manufacturers to discontinue their lineups of generic drugs. In 2017, Indian companies manufactured 40% of generic drugs purchased in US markets.

The increase in overseas manufacturing has correlated with an increase in generic drug recalls. Multiple drug manufacturers in India, China, South Korea, and Japan have been cited by the FDA for failing to resolve issues such as data integrity errors, manufacturing errors, and insufficient testing protocols. A few have even been added to the FDA’s “Red List,” an import ban targeting manufacturers who refuse to admit FDA inspectors.

These issues have culminated in an extremely visible ongoing recall related to a generic blood pressure medication known as Valsartan. Valsartan is commonly made from cheap bulk ingredients sourced in China and then compounded by manufacturers in India. In June, three bulk producers announced that their Valsartan was contaminated with NDMA, a cancer-causing chemical. This led 50 firms, including Novartis, to initiate an ongoing global recall of over 10 billion pills.

Not only are these recalls terrible from a patient health perspective, they’re also bad from a reputation and revenue perspective. When a company recalls their drugs, it’s an expensive process – the average drug recall now costs $8 million USD. If a patient gets sick from taking a recalled drug, expect lawsuits, negative publicity, and more costs as customers reject your brand. How can manufacturers cut down on drug recalls?

Rescued by Regulations?

The Drug Supply Chain Security Act (DSCSA) was passed in 2013 as a gesture towards removing counterfeit medicine from the U.S. supply chain. The FDA will start enforcing part of the regulation in November 2018. These regulations will force drug suppliers to use a uniform system – in both human- and machine-readable formats – that identifies drugs by serial number, lot number, expiration date, and National Drug Code (NDC).

While the DSCSA does apply to overseas drug manufacturers, certain caveats apply. The first is that for this regulation to take effect, pharmacies and manufacturers must actually comply with it – and quickly. The new labeling requirements were supposed to go into effect during November of last year, but pharmaceutical manufacturers, distributors, and pharmacies were not judged to be ready at that time. The FDA was forced to extent their enforcement deadline in order to ensure that manufacturers were still able to sell into the US and that drug shortages did not occur.

Will drug manufacturers be ready to meet this November’s new enforcement deadline? Time will tell. What’s for certain is that overseas and domestic drug manufacturers need to rapidly update both their serialization capabilities – to expedite drug recalls under DSCSA – and  prevent the labeling mishaps that lead to recalls in the first place.

Avoid Product Recalls with Enterprise Labeling Solutions from Loftware

In pharma, long supply chains produce process errors. Imagine that you’re a US-based organization working with distributors or subsidiaries overseas. Your subsidiaries are the ones who manufacture and label drugs for sale in the United States.

Even if there isn’t a language barrier, cultural differences might get in the way of labeling best practices --- especially if you’re selling the same drug in both the US and other countries. For example, there’s the difference between metric and imperial measuring units. Drugs sold in Europe should have dosages measured in milliliters, and drugs for US markets should be labeled in teaspoons. How can you prevent this from turning the other way around? If an incident occurs, how quickly and effectively can you implement a recall and identify the root issue?

As companies expand their supply chain to include new partners and new regions, they need better visibility to ensure quality and react faster to events—from fake or falsified goods to accidental incidents that impact customer safety. There are many consequences and risks associated with limited traceability. They include health and safety issues, lengthy costly recalls, fines and penalties, supply chain disruptions and damaged brand/reputation. That’s where Enterprise Labeling and traceability come into play to offer the risk management solution that’s needed. 

The right Enterprise Labeling solution lets companies throughout the pharmaceutical supply chain turn labeling into a high-value, strategic element of the overall manufacturing and distribution process. By tightly integrating pharmaceutical labeling with business processes you already use, you can:

  • Automate and centralize labeling to improve accuracy and eliminate complex, error-prone data replication
  • Respect and leverage “validated sources of record” to comply with regulatory, customer and CMO requirements
  • Easily build and securely share templates that comply with DSCSA, 21 CFR Part 11 ERES, EU FMD and other regulations  
  • Reduce label template maintenance with an integrated and automated solution
  • Quickly configure and update labels to meet evolving needs, expand into new markets
  • Save time and reduce cost of implementing a validated enterprise labeling solution
  • Extend labeling to distributors, suppliers, 3PLs to eliminate relabeling—save millions in inventory costs
  • Leverage standardized enterprise-wide labeling and GS1 standards to improve tracking of drugs, help prevent counterfeiting

No wonder many of the leading pharmaceutical companies rely on Loftware Enterprise Labeling Solutions. By driving labeling straight from ERP, MES, Compliance and other enterprise systems, those “sources of record,” the label is always accurate. You can comply with customer and regulatory demands to keep product moving—even across international boundaries.

The enforcement deadline for DSCSA is just around the corner and recalls show no sign of slacking off. Make sure you’re ready – and that patients are safe – by creating a well-integrated, well-supported Enterprise Labeling Solution that ensures accurate and consistent data, so you avoid recalls. Request a consultation today!

 

Laura Johnson

Posted By Laura Johnson

Laura brings over twenty years of expertise working with both Pharmaceutical and Medical Device manufacturers to improve processes and meet regulatory requirements such as Serialization, UDI and Secure Supply Chain. Laura’s career has also focused on the application of technology to drive efficiencies in manufacturing, warehousing and distribution environments. Her expertise includes leveraging core functionality within major ERP systems like SAP and Oracle and implement automatic data capture technologies such as vision inspection, printing, shop floor devices, barcode and RFID data collection.

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