Supply Chain Integrity and Patient Safety
Schreiner MediPharm Provides Labeling Solutions that can Prevent Fraudulent or Incorrect Use of Medicines
Investigation into future trends in the medical and pharmaceutical sector shows that digitalization is changing supply chains in the healthcare industry. Such diverse issues like counterfeit drugs, aging population or self-medication have one thing in common: packaging and labeling solutions can prevent fraudulent or incorrect use of medicines and increase supply chain security and integrity. Partners of the pharmaceutical industry such as Munich-based Schreiner MediPharm provide customized solutions that are highly functional and offer value-added benefits. Many solutions of the German family owned high-tech company have set standards in the pharmaceutical industry. Digitalization will be a trailblazer for future technologies such as smart labels. Dr. Michael Reubold discussed opportunities for innovation with Ann L. Merchant, President of Schreiner MediPharm.
CHEManager: Ms. Merchant, Schreiner MediPharm is a long-standing partner of the pharmaceutical industry. What is your track record as a solutions provider?
A. Merchant: Our customer base includes the majority of the top 20 pharma companies. With our special pharma expertise, we position ourselves as the innovation leader in providing high-quality solutions in the functional labeling space. By utilizing our innovative strength, we proactively assist our customers to find the ideal solution for their specific applications and provide support from the initial idea to commercial production. Our role is to be the enabler, while the pharmaceutical company has to decide what type of features or information they want to include in their individual solution. Ultimately, we always strive for a holistic and highly customized approach.
When you ask about our track record, we invented the hanger label and the label with detachable parts, as well as the Needle-Trap system for needle stick prevention, just to name a few. The most important aspect on the technology side is to truly understand the major trends in the pharmaceutical industry and for us to determine how we can support our customers in meeting current and future requirements.
What do you see as the major trends in the pharmaceutical industry, and based on these trends, what are your focus areas?
A. Merchant: The mega trends are the aging population, the increase of wealth in emerging markets, and the informed patient. So, we have more elderly people who have chronic diseases. The increase of wealth in emerging markets enhances the demand for better products. And the industry is looking into how they can better connect to the increasingly well informed patient. All three of those trends actually have a direct impact on us. We are focusing on end-to-end supply chain integrity, patient centricity, connectivity and patient safety.
Regarding the supply chain, which features are you offering?
A. Merchant: If we think about supply chain security, it is a fact that there are counterfeit drugs in the market place and we want to make sure that those are tracked and found, and not used. Or, if we think about some of the new regulations, like the EU Falsified Medicines Directive, it is very clear that you need to make sure that your outer package is sealed. So to support the implementation, we have some concrete solutions.
We help a pharmaceutical company to ensure that the patient receives a genuine product. For instance, we offer first-opening indication and tamper evidence, multi-level counterfeiting protection, as well as tracing solutions. And we try to understand what is the customer’s objective, how valuable is their product, and to what extent does it need to be protected?
And this ties very well again to the Falsified Medicines Directive (FMD). The directive is going in the right direction but there are different pillars that you have to look at. The FMD requires serialization and first-opening indication, but it does not consider authentication. However, only the combination with additional counterfeit-proof authenticity features can offer a comprehensive approach against fraud, misuse and tampering. Customized security concepts, including analog as well as digital features using an integrated Near Field Communication (NFC) chip ensure that all stakeholders, if an informed expert or the end user, can be involved in the authentication process.
Do you think the pharmaceutical industry is well prepared for putting this directive into action?
A. Merchant: I would say it’s a mixed bag. Some are well prepared and recognize that the improved visibility into their supply chain can offer advantages to the company as a whole. Others are in earlier stages of adoption and implementation. I think that the challenge will be with some smaller pharmaceutical companies, because it is a really large effort and it costs a lot of time and money to implement.
Supply chain agility is another area you are focusing on.
A. Merchant: Yes, the ‘agile supply chain’ refers to a growing market segmentation and the demand to react to different needs in different market places. Our solutions in this field include late stage customization of functional labels and additional supply chain services. Emerging markets typically have very small lot sizes from a manufacturing perspective. They have their own regulatory authorities, which means they have specific labeling requirements. So we have come up with a method where we can apply all of the features that they would like to have, while the turnaround time is only a number of days versus weeks. This is achieved by pre-manufacturing the labels conventionally with all functional features, storing them in our warehouse and customizing them at short notice via digital print. Theoretically, you could print one label and you’re done, but you still have the value-added benefits of functional labels. Thus, we are able to support the supply chain in a very agile manner.
Turning to the patient, where is your focus in terms of patient centricity?
A. Merchant: In order to ensure reliable self-medication in a growing homecare market, we developed customized label solutions for pens and autoinjectors, supporting convenient and safe handling of injection devices. Functional features include for instance grip, anti-slip varnishes and tactile elements, a temperature indicator or UV protection. Smart labels with integrated RFID/NFC inlay for interactive applications support the patient by providing access to additional product information, user videos, reminder functions or digital authentication.
Our solutions for patient compliance monitoring feature integrated printed electronics for digital monitoring of medication intake and adherence tracking which can be adapted for diverse packaging concepts. Via NFC or Bluetooth technology information can be transmitted to a smartphone for interaction between patient and physician. Digital patient compliance monitoring is also interesting for clinical trial settings with their strictly regulated environment, where non-compliance is causing longer study time cycles, higher costs and postponed drug approval processes prior to commercialization.
Another important area is patient safety.
A. Merchant: Yes, and it is actually the ultimate goal with regard to all medications and of utmost importance in drug dispensing. We offer solutions for the avoidance of medication errors and for needlestick prevention. For instance, there is a sophisticated label with self-lifting detachable parts for multi-dose vials to clearly identify disposable syringes after the refilling process.
I would also like to highlight our Needle-Trap system, which is a unique, label-integrated safety device for prefilled syringes to secure the needle after the injection with a plastic catcher – with the aim of improving patient and healthcare giver safety.
What is your vision when it comes to progress in medicine?
A. Merchant: Looking into the future, I think that advances in technology will allow medicines to be produced to specifically target cancer and diseases of the aging like Parkinson’s or Dementia, and also that they will be more personalized, so that you get the medicine that works for you.
When it comes to digitalization and connectivity, as a participant in the healthcare system, I personally would like to see a better use of the data that is being generated to link findings from one doctor to another, to always understand interactions between medicines and to know which ones will work best for me.