Tamper-Evident Packaging in Pharmaceuticals

Packaging is a critical aspect of manufacturing and selling drugs. Without a good packaging material, the pharmaceutical product will be exposed to environmental factors and will be vulnerable to tampering. In the past few years, there has been a substantial rise in counterfeit medications and an even higher number of ways to tamper with products. Hence, the pharmaceutical industry has turned towards tamper-evident packaging to ensure product safety.

Tamper-evident packaging in pharmaceuticals ensures no unauthorized access to the compromised products, reducing safety risks. Tamper-evident packaging ensures a brand’s reputation as it helps the company comply with regulatory standards and ensure consumer safety. A pharma company can use antitampering technologies to assure its consumers of the efficacy and safety of its products once they are in transit.

Considering the importance of packaging in the pharmaceutical industry—this article highlights why tamper-evident packaging technologies have become so crucial in today’s pharmaceutical space.

What’s Making Tamper-Evident Packaging So Important?

Tamper-evident packaging technologies play several crucial roles in the industry:

Safety

Tamper-evident packaging is crucial in increasing consumers’ trust by ensuring that the pharmaceutical product they have received is safe. The seals on tamper-evident packaging protect the product against contamination and counterfeiting, ensuring its quality, efficacy, and safety for the patient. Consequently, consumers trust the pharmaceutical company and its products.

Regulatory Compliance

Many authorities mandate the use of tamper-evident features for pharmaceutical products. Such guidelines are most commonly implemented for over-the-counter medication and prescription drugs. Hence, the use of tamper-evident packaging in pharmaceuticals is critical to ensure regulatory compliance with local and international authorities.

The position of the company is favoured within the market if it adheres to regulations regarding tamper-evident packaging. Tamper-evident packaging can help companies avoid fines, product recalls, and other issues related to non-compliance.

Counterfeit Deterrence

Specialized tamper-evident features ensure the product is not tampered with once it is out of the manufacturing unit and before reaching the consumer. By acting as a deterrent, tamper-evident packaging technologies ensure the patients receive the recommended dose and not a falsified product.

While these are the three main advantages of tamper-evident packaging, an added benefit is that unique tamper-evident features can also serve as branding opportunities. For example, by creating unique designs and patterns with multiple layers and using them as packaging materials, pharma companies can create anti-tamper packaging while creating a unique/fun statement with which consumers can associate their brand.

Product Integrity

Tamper-evident packaging also protects the products against environmental hazards and potential contamination, extending the product's shelf life. It ensures the final product received by the patient retains the quality and efficacy designed and intended by the manufacturer.

Consumer Trust

By integrating visible tamper-evident features, consumers can check whether the product they purchase has been contaminated or harmed in some form. Hence, by providing visual assurance before purchase, consumers will be more likely to trust the brand and the product for its safety and efficacy. This will lead to repeat purchases and brand loyalty.

Fraud Prevention

Unauthorized product access and alteration can be prevented by tamper-evident packaging, reducing the risk of fraudulent medicines ending up in the hands of consumers. By avoiding infiltrating counterfeit medications, the pharma company can ensure they don’t face litigation.

Traceability

Tamper-evident packaging technologies like QR codes and RFID tags can help companies trace their product across the supply chain. Hence, if the product is identified as being tampered with at the end of the supply chain, the companies know who can be held responsible.

These benefits of tamper-evident packaging are enough to promote their implementation in the industry. However, realistically, the implementation is limited by several key challenges.

Types of Tamper-Evident Packaging Technologies

Here are some common types of tamper-evident packaging technologies used in the pharma industry:

1. Breakable seals: Breakable seals have components that are molded onto the cap or opening of the package. This component must be “torn-off” or “snapped off” to access the product. This packaging type is also found on ketchup bottles.
2. Shrink wraps and bands: In this packaging, a plastic or foil is heat-sealed on the neck of the container and must be broken to access the contents. This packaging is generally found on pharmaceutical bottles.
3. Blister packs: Blister packs have individual compartments for tablets, pills, and capsules that are sealed with an aluminum foil and plastic. Blister packs are the most common packaging used for tablets and capsules. 
4. Tamper-evident labels: Tamper-evident labels are generally made of adhesive tapes with printed messages or branding. The tape needs to be removed to access the product. Hence, tampering is evident because the message/branding is disrupted when opened.
5. Stretch films: Stretch films are generally used to secure bulk product quantities on pallets during large-scale shipment. In this packaging, a thin film is wrapped all around the pallet to secure it. Any access attempt is easily identified because the film is torn.
6. Vacuum seals: The product can also be placed in a plastic bag and vacuum-sealed. This method is generally opted for environment-sensitive products. Tampering attempts are evident because vacuum seals are difficult to replace without proper equipment.
7. Flexible pouches: While relatively less popular, flexible pouches can be used as tamper-evident packaging for pharmaceutical products. Generally, flexible pouches have one sealed opening (see image below). Tampering attempts are easily understood because the seal is broken.

Challenges for Implementing Tamper-Evident Packaging Technologies

Cost

The development and usage of advanced tamper-evident technologies in the packaging of pharmaceutical products is costly for pharmaceutical manufacturers, especially small-sized pharma companies. Hence, innovative packaging technologies that balance the cost and security requirements must be developed.

Technological Advancements

In reality, new counterfeit methods are being developed every day. Counterfeit specialists are finding new and innovative methods to bypass current tamper-evident packaging methods. Hence, companies must constantly innovate new packaging technologies to provide better security and stay ahead of evolving threats.

Regulatory Changes

The regulatory guidelines on tamper-evident packaging technologies are stringent. Hence, even if companies can develop and implement new technologies, they still have to ensure they comply with regulatory standards—which adds another layer of challenge.

However, tamper-evident technologies have shown exceptional advantages in preventing counterfeiting and ensuring safety. Many types of tamper-evident packaging technologies are currently used in the industry.

Conclusion

Tamper-evident packaging is indispensable for ensuring pharmaceutical products' efficacy, safety, and integrity. Using tamper-evident packaging in pharmaceuticals offers several advantages, including improved consumer trust, higher brand loyalty, regulatory compliance, and guaranteed fraud detection. However, in the current scenario, implementing such technologies is costly and challenging, especially for small-sized pharma companies. Hence, new anti-tamper packaging solutions need to be identified and developed in the near future.

Frequently Asked Questions

• What is tamper-evident packaging in pharmaceuticals?

A packaging that shows visible signs of a tempered or opened package before the purchase is known as tamper-evident packaging. It ensures the integrity of the product and assures the consumer of its security.

• Why are tamper-evident packaging technologies gaining attention?

Tamper-evident packaging protects consumers from purchasing counterfeit products and ensures the products reach consumers in the quality they are manufactured.

• What are some common types of tamper-evident features?

Common features associated with tamper-evident packaging in pharmaceuticals are breakable seals, shrink bands, induction seals, tear strips, and holographic labels, all of which indicate the products have been accessed previously.