Drug contamination is a constant threat to the pharmaceutical industry. While such events are rare, they have dire implications, from endangering patient lives to killing business reputations. Most manufacturers go the extra mile to ensure compliance with the rules and regulations set by the US Food and Drug Administration. Yet drug contamination remains a concern in the country.
Recently, the Centers for Disease Control and Prevention (CDC) have raised concern over EzriCare, an eye medication linked with the risk of blindness and death. In another incident, a cancer-causing chemical was discovered in Merck’s diabetes drug. While the company says it can fix the issue, the risk persists.
The increasing number of drug recalls in the US shows that the threat looms large. Going by statistics, there have been more than 14,000 drug recalls in the past decade. More events of drug contamination may surface in the future. They can put patients at risk of complications and cost manufacturers millions of dollars to pharmaceutical companies.
Identifying the source of contamination is the best way to deal with the risk and manufacture safe and high-quality products. Patient awareness is equally critical. We will explain the potential sources and impact of drug contamination.
Types of Drug Contamination
FDA ensures drug quality by monitoring manufacturers’ compliance with the Current Good Manufacturing Practice guidelines. But contaminants may still find their way into the process and affect the quality and integrity of medicines. Here are the common ones found in pharmaceutical products:
Physical contaminants include particles, chips, and fiber materials that may reach manufacturing or packaging processes. The worst thing about these materials is that they can contaminate the entire batch of products.
Moisture, vapor, gasses, or molecules can affect sterile pharmaceutical products, leading to major safety and quality issues.
Biological Components and Pyrogenic Substances
Biological components include bacteria, viruses, or fungi that may lead to diseases. Likewise, pyrogenic microorganisms result in fever once they reach the user’s bloodstream.
TorHoerman Law notes that EzriCare contamination is a case of biological contamination, with bacteria resulting in drug-resistant Pseudomonas aeruginosa (CRPA) for users. While the CDC is probing into the manufacturing process, the FDA has warned consumers to discontinue the product.
The sad truth is that 81 cases of Pseudomonas aeruginosa and four deaths have been reported in the US as of March 2023. A victim can file an EzriCare lawsuit against the manufacturer to claim compensation for these outcomes. But no amount of money is enough to make up for vision loss or the death of a loved one.
Potential Sources of Contamination
Drug manufacturers should prioritize the identification of the sources of contaminants to prevent contamination and ensure the highest levels of safety for products and processes. The potential sources of drug contamination are:
People working or supervising the drug manufacturing and packaging processes may be responsible for the contamination. Lack of training, direct contact with the materials, not following hygiene standards, and malpractices such as eating in the manufacturing or storage areas may compromise the safety of products.
Factors such as the quality, handling, and storage of raw materials may lead to drug contamination. Besides degradation due to environmental conditions, poor labeling, sampling, and testing are a few red flags.
In many cases, the facility or the building is the source of contaminants in drugs. For example, inadequate space or poor design can lead to mix-ups and cross-contamination. The absence of things such as good lighting and ventilation, pest control, waste management measures, and sanitization practices may cause contamination.
The production process may have some loopholes contributing to the chances of contamination. For example, lack of zoning and absence of compliant hygiene and cleanliness standards are something manufacturers should worry about. Outdated equipment may also introduce contaminants into the product.
Besides complying with manufacturing guidelines and industry standards, manufacturers must have contamination prevention measures in place. Here are a few steps that can help:
Manage Personnel Contamination
Having trained and qualified personnel for the production and handling process should be a priority. They can be trusted to maintain hygiene and cleanliness. Additionally, they should have access to protective clothing and equipment to avoid direct contact with materials and products. Strict discipline and hygiene standards are essential.
Improved Facility Design
A compliant facility design ensures adherence to the optimal humidity, temperature, and air filtration requirements for the drug manufacturing process. Using restricted access barrier systems, UV air-locks, and laminar flow in manufacturing and packing areas can help eliminate contaminants from the facility.
Regular Cleaning and Disinfection
Regular cleaning and disinfection are vital for preventing pharmaceutical contamination. Besides cleaning the facility, the hygiene of workwear is equally crucial. The use of distilled water minimizes the risk of water-borne contamination.
The Bottom Line
Pharmaceutical companies must do their bit to prevent drug contamination because it can tarnish their reputation for good. It can even lead to lawsuits as patients suffering due to contamination can legally claim compensation for their suffering.
Fortunately, the threat can be addressed with relevant controls and safety measures. Manufacturers must commit to implementing best practices to manufacture quality products and maintain their reputation.
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