The role of labels in patient safety

Fig. 1. Peel-off labels allow healthcare providers to better document drug administration. Credit: Schreiner

Among the many challenges the pharmaceutical industry is facing today, patient safety remains key. Within a complex regulatory landscape, as well as diversified markets and medications, it is even more important to ensure safe drug administration for healthcare providers and consumers alike. Sophisticated label solutions can play an important role in supporting product and patient safety.

Initially, the label serves to clearly and reliably mark the pharmaceutical product by providing information on the product, its administration, batch number, expiry date, etc. However, dosage forms and drug delivery methods can vary widely, so the label design has to be optimally tailored to meet the specific requirements of the medication. Ideally, the label provides additional functionalities that add value to the product by enhancing user friendliness and product safety.

Helping avoid medication errors: labels with detachable parts

According to the World Alliance for Patient Safety 2010, annual medication errors cost between $5.8 billion and $27.3 billion worldwide. In the United States alone, an estimated 7,000 people die every year due to inappropriately dispensed drugs. A report published by the Institute of Medicine (IOM) in July 2006 concludes that labeling and packaging issues are the cause of 33% of all medication errors and 30% of fatalities from medication errors.* The report also pointed out that “product naming, labeling and packaging should be designed for the end user—the provider in the clinical environment and/or the consumer.”

* Aspden P, Wolcott JA, Bootman JL, Cronenwett LR, eds. Preventing Medication Errors. Institute of Medicine, The National Academies Press: Washington DC. 2006.

In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was signed into law as part of the Food and Drug Administration Amendments Act (FDAAA). In this context, FDA committed to certain goals to reduce medication errors related to, among other issues, error-prone labeling and packaging designs. In June 2010, FDA held a public workshop to receive comments on the topic of medication error reduction. This resulted in a Draft Guidance “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors,” published in April 2013.

One of the recommendations included in the FDA’s draft guidance refers to “transferrable or peel-off labels for injectable medications,” emphasizing the fact that refilling injection solutions from, e.g., a vial or ampoule into an unlabeled disposable syringe harbors a particularly high risk of medication errors, since this might lead to administration of the wrong drug or wrong strength. By equipping the primary container with a label, including an integrated peel-off part, such instances could be avoided. The peel-off part is instantly available at the point of product preparation and can be easily and reliably attached to the unmarked syringe. Besides, it cannot be accidentally discarded as in the case of auxiliary labels provided with the carton.

A cost-effective, yet intelligent solution to meet the above recommendations could be a single layered peel-off label, which due to its special design, is particularly suited for labeling small containers for single-dose applications, such as ampoules and vials. The label can be easily wrapped around the container and provides sufficient space for all critical information, as well as for the inscription of variable data and printing of barcodes. The detachable part contains the product name, the barcode, an area for post-printing of variable data, as well as space for manual inscription of dose, date and administrator’s signature. Thus, it is ensured that all crucial information is directly available at the disposable syringe after reconstitution. The detachable part can be applied to the syringe like a flag without covering the graduation lines. The product information is easy to read and scanning of the code is simple. For greater ease of use when wearing gloves, the detachable part slightly lifts, so it can be easily peeled off when the label is opened.

More sophisticated solutions of peel-off labels feature multiple layers to accommodate several detachable parts and are mainly suited for multi-dose containers. They can be adapted to all kinds of primary containers and specific customer applications and demand extensive know-how in material and advanced printing technologies.

High-efficiency multi-functional labels

Efficient and safe drug administration plays an important role in daily healthcare practice. Intelligent, multi-functional label solutions can help optimize processes in healthcare environments and thus contribute to patient safety. Only to mention one example: A hanger label for infusion bottles, which provides extended space for text information and additional detachable parts.

Due to the multi-layered design, the label offers enough space for detailed product descriptions; while the integrated hanger allows the administering caregiver to quickly and easily hang the infusion bottle on a bedside rack. With the help of additionally integrated detachable label parts, the infusion can be documented in the patient’s medical records as well as the hospital files, thus ensuring reliable documentation and traceability of the medication. An alternative, even more sophisticated approach would be the addition of a paper booklet with many pages for texts in different languages.

Fig. 2. The Needle-Trap combines labeling with stick prevention

Label-integrated needle protection

A growing number of injectables are administered in prefilled syringes, which are ready to use and easy to handle. However, needlestick injuries harbor a high risk for healthcare personnel to be infected by contaminated blood after the injection. Roughly 3.5 million work-related needlestick injuries occur globally every year. Regulatory requirements by the US FDA and NIOSH demand that sharps instruments have to be equipped with safety devices. Also, in the European Union, member states had to implement directive 2010/32/EU on the prevention of sharps injuries into national legislation in May 2013.

By integrating the safety mechanism into the syringe label, regulatory demands can be met in a smart and user-friendly manner. The compact design of the needle trap label allows the blood-contaminated needle to be simply and safely secured after the injection, and can be easily operated by healthcare personnel in a controlled, single-handed fashion. After the needle is locked into the plastic trap, it is irreversibly protected.

Additional features to cover patient safety aspects may be integrated into the label, like peel-off parts for documentation of the administered injection, graduation lines for delivery of the right dose or anti-counterfeiting features for product security and brand protection.

Ensuring product integrity

Packaging and labeling are critical to product authentication and should provide a reliable hurdle against counterfeiting and tampering. Due to international regulations, serialization and tracking of a product through the complete supply chain becomes a growing issue. Following the recently signed Drug Quality and Security Act (DQSA), FDA has started work on a US-wide track and trace system. Also, in Europe, directive 2011/62/EU will have an impact on packaging and labeling. The ultimate goal is to find solutions to clearly authenticate and secure drugs through the supply chain. Labels including, for instance, 2D matrix codes or alphanumeric codes for online authentication ensure traceability and authentication on the unit level.

In general, integrated security concepts should ideally combine several security technologies in a multi-layered approach including overt and covert features. Thus, a customized solution could for instance include overt technologies like holograms, color-shifting inks, guilloche, micro-text printing or thermochromic inks. Covert technologies, like voiding effects, special pigments that can only be seen by a special reader, or luminescent digital watermarks, etc., would only be visible for informed experts. Ultimately, the objective should be to work closely with the pharmaceutical manufacturer in a consultative approach in order to find the ideal solution that suits his specific security requirements, while integrating easily into the usual brand appearance.

Fig. 3. This p

This peel-off label allows reliable identification of unmarked syringes after refilling injection solutions

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Reliable self-medication and user comfort

User safety and comfort is the primary concern in the development of pens and autoinjectors for self-injection. Multi-functional label solutions can be individually customized to further enhance reliability and ease of use of these injection devices. The range of functionalities that can be realized includes a temperature indicator producing a reversible color shift that shows when a defined room or cooling temperature has been reached. A special varnish coating improves grip and feel of the surface and helps patients to safely use the pen. In addition, integrated tactile elements make it easier to tell apart similar systems containing different active ingredients through touch.

If the pen has a transparent window to check the medication, the contents can be protected against UV rays by a double-layered label which can be easily opened and closed again. Alternatively, the transparent window included in the label can be equipped with UV protection.

Integrated peel-off parts serve to remind the patient to regularly check the contents. First-opening indication as well as anti-counterfeiting features can be integrated as well.

Ensuring patient compliance

Sophisticated label solutions can also support patient safety by the integration of printed electronics as well as RFID and NFC technologies (radio-frequency identification, RFID, and near-field communications, NFC). Noncompliance to prescribed drugs can harbor severe risks for patients, particularly in case of chronic diseases. With the help of a label that features printed electronics and is attached to a tablet blister, it is possible to document patience compliance. When an individual cavity is opened to remove a pill, the printed conductor path is destroyed, which diverts the flow of current provided by the battery. This results in a higher resistance level that is read and electronically stored. Labels including RFID or NFC chips can also add interactive functionalities which benefit the end user, for instance authentication features, product information, medication warnings or general customer communication.

Addressing the healthcare environment

The usual complaint against high-performance labels is that they cost more, on a unit basis, than conventional labels. While this might be true in many instances, a true economic evaluation would include the value to healthcare providers in safer operations during drug administration, the enhanced supply-chain security, and, above all, the higher level of consumer satisfaction. A higher level of patient adherence to medication regimen can have clear economic value. In an era where patient outcomes are becoming a more direct measurement of both drug efficacy and healthcare operational performance—“value-based healthcare”—these issues will only become more important going forward.

Sophisticated label solutions can offer much more than just product marking. They integrate multiple functions in the label that are optimally tailored to the specific product and its application. Thus, they help to optimize processes in healthcare practice, enhance user comfort and ensure patient safety as well as product security. Also the label should not only support brand appearance of the pharmaceutical product, but also add value to it by clearly differentiating it from the competition. Last but not least, it has to be easily and efficiently integrated into the production processes at the pharmaceutical manufacturer.

ABOUT THE AUTHOR

Peter Seidl is director technical support at Schreiner MediPharm, a Germany-based provider of specialty pharmaceutical labeling solutions with global activities, including a US manufacturing facility in Blauvelt, NY. Mr. Seidl has been with Schreiner for 35 years and has extensive experience in developing multi-functional labeling solutions with value-added benefits tailored to the specific requirements of the pharmaceutical industry.