TRACK AND TRACE IN PHARMACEUTICALS

Serialization regulations apply to every pharmaceutical supply chain companies around the world.

There is a continuously growing threat of counterfeit drugs, so governments, manufacturers and dispensers need to work together to meet the growing regulatory requirements and to implement successful track and trace strategies to reduce or eliminate these risks. Regulations vary from country to country. The European Union formulated the Falsified Medicines Directive (2011/62/EU) in order to confine counterfeiting, control authenticity and to identify packaging.

“Manufacturers serving the EU are preparing to meet serialization requirements at the package level which are expected to start in early 2018, requirements that include supporting both global and national identifiers and following strict uniqueness regulations.” (Source: http://www.tracelink.com/solutions/global-serialization)

The current regulation focuses on the legal supply chain, from production to the end customer. Beyond the established provisions, it has given authorization for an additional detailed legalization that will be issued in mid 2016 about the safety elements to be placed on the pharmaceutical products. As of the 1st quarter of 2018 the manufacturers should provide every prescription and some over-the-counter medicine with a tamper evident closure and a safety application (2D Data Matrix Code)  that is printed onto each product. A centralized repository will be established for track and trace purposes. This means that every box “logs in” during production and “logs out” at the final delivery/dispense.

The Data Matrix Code can include identification code, lot number and expiration date. It is one of the most reliable codes to be found in the industry. It supports thermal transfer and inkjet printing and uses information redundancy which means that the codes can still be read even if they become damaged.  

An example of  step by step process of track and trace system according to Bosch Packaging

1. "A combination of selectable GS1 applications are printed onto each product. These could include the combination of a unique serial number, an expiration date, a batch number or a global trade item number.
2. The data is encoded into a machine-readable 2D data matrix code.
3. The 2D matrix code and human readable text are printed on the package.
4. The camera reads both the 2D data matrix code and human readable text before the software compares the content and checks the printing for accuracy and quality.
5. All information can be stored in a centralized database, which enables the tracing of individual products throughout the supply chain." (Source: http://www.boschpackaging.com/en/pa/services/after-sales-services/modernization/track-and-trace/track-and-trace-4.html)

There are of course other track and trace solutions that can be applied like barcode technology or RFID tags but they are either too costly or less secure because they can be easily replicated.

Finding and applying the right serialization strategy can be very beneficial for manufacturers. It helps protect consumer safety as well as brand reputation by making it more difficult for counterfeiters to replicate valid codes. Manufacturers can gain the necessary information throughout the supply chain which also has numerous benefits like cost control or increased shipping accuracy just to mention a few. A proactive approach to serialization will give companies who took the proper steps an advantage in the future against those who didn't take action in time.

Tamper-evident technologies in focus

Tamper-evident packaging has long been a major requirement for pharmaceutical, food, beverage and beauty products. It is designed to indicate to a customer, wheter the product which have bought might have been opened.
In pharma packaging FDA (Food and Drug Administration) requires that pharma manufacturers use tamper-evident packaging on over-the-counter (OTC) products for retail sale to ensure customer safety. Accordig to FDA a tamper evident packaging "is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." In addition, the indicator or barrier must be "distinctive by design,"

There is a wide range of solutions and below you can find some examples of clever tamper-evident devices.

Constantia Teos is a tamper-evindet foil cover developed by Constantia Flexibles. It was originally designed for syringes housing tumor necrosis factor inhibitors, also called TNF Blockers. The biggest advantage is peelable cover foil that is functionally destroyed during initial opening. As such, the cover foil provides reliable protection against the package’s illegal reuse. It hides several possibilities like holograms, customized security foil, special security pigments and inks, and unique-to-product security printing, such as microtext, hidden graphics, and built-in pattern deviations.


source: www.packworld.com

Pressure-sensitive tape
ShurSeal®, is a carton sealing system offered by Shurtape Technologies. It  combines Shurtape HP Series packaging tape with a PrimeLoc™ tape applicator. The tape and applicator add consistentand highly secure seals and when needed, offer visual evidence via fiber tear that the tape has been removed or tampered with.


source: www.healthcarepackaging.com

Security seals
A brand protection program was developed by Leica Geosystems and Schreiner ProSecure’s security seals are  playing an important role in this product protection strategy. These seals are used worldwide to identify the originality of Leica products, but it can be used for other target groups as it combines several security features:



 

• Color-shifting security ink,
• Holographic strips.
•  KeySecure in human-readable format (each label has an unique number and the customer can confirm the authenticity  of the product on a website)
• KeySecure as QR code for smart phones
• Tamper protection.The seal has die cuts that make it more difficult to detach without destroying it.

source: www.healthcarepackaging.com 




Last but not least, Igb last year presented a tamper-evidnet folding box. It’s a mechanical solution which provides both the authenticity of the contents and the technical security of the box. All with the least economical impact on the pharmaceutical industry and the habits of the final user.

source: www.pharmapackeurope.com

CREATIVE DESIGNS: DO THEY WORTH IT?

I think today I found an interesting and divisive topic: Does the creative pharma packaging worth the investment?

Nowadays packaging has several functions. It protects the product, helps with the identification, provides convenience, and maybe the most important for business: promotion. Producers spend millions to influence customer purchase decision. A unique and quality design is essential for good branding and marketing, so the appearance of the product has to be eye-catching and creative.

If I want to summarize the packaging trends of this year I would say growing green movement, recycled, biobased materials, clear packaging with natural colors, using of raw elements and simplicity are among the hottest design trends,

But the question arises: Is it the same with the pharmaceutical products? Do they really have to have a unique and creative design?

Below you can see some medicines with a remarkable design:

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Although these are stunning designs, some pharma experts have the opinion of pharma does not need creativity in packaging.
They think it is a waste of time and money cause the main expectation from a drug is to work and the design is just not an important angle. Customers won't buy the medicine because it looks 'cool', they purchase it because the doctor recommended it.

Another disadvantage that a funny and colorful packaging destroys child-resistance. It doesn't matter how secure the packaging itself, but it raises the child's attention and puts them at higher risk.

So the answer to the question 'Does the creative pharma packaging worth the investment?' I would say, in some contexts yes.

• OTC medications like non-prescription meds, vitamins, antacids can be designed creatively, with eye-catching packaging to convince the customer and to stand out the row and win the competition.
• The other field is the samples given to doctors and clinics for distribution. Elaborate design can persuade the doctor to prescribe this meds over another.

So it seems that pharma packaging is a field where looks don't really matter, or at least just in certain cases. What pharma packaging really needs is to combine creative design and pharma knowledge to innovate medicinal packaging. To create an easy to use, senior and child-friendly, safety packaging.

Source: Creativebloq.com, pharmaphorum.com

LATEST TRENDS AND INNOVATIONS OF PHARMA PACKAGING

Earlier pharmaceutical packaging used to make mainly for preservation and the presentation of the product itself. Nowadays big significant changes are undergoing and the basic functions are things of the past. Pharma packaging has become one of the most complex industry and it is broadened with many aspects like communication, promotion, and motivating customers. Furthermore, packaging faces bigger challenges like fighting against counterfeiting, being child-resistant, tamper-evident, cost-effective and also eco-friendly, meeting with the regulatory requirements etc...

In this article, we examine the key trends and innovations which are currently shaping the pharma 

packaging.

Pharma packaging market is predicted to reach 80$ billion by 2020

According to a recent report of MarketsandMarkets, the market for Pharmaceutical Packaging, in terms of value, is projected to reach more than $80 Billion by 2020, witnessing a CAGR  (Compounded Annual Growth Rate) around 6.50% between 2015 and 2020.

Smart Blister Pack

Can you imagine a blister pack which plays a recorded message about the exact dosage and details of the patient when it is pressed? Moreover, it would have a timer that alerts the patient to take the tablets. Or even more, by pressing the pack it shows us the product information or speaks it out for those who are not able to read it.

These smart blister packs are not distant dreams anymore.

The Med-ic® called as the most accurate smart blister in the world. It monitors the condition of products and track their progress via Radio Frequency Identification Device (RFID) tags. It has many advantages for example, with the RFID the temperature of multipacks can be recorded and monitored, moreover, it makes easier to locate items during shipping.

Although there is an undeniable potential in this technology, electronic blister packs with RFID devices are rarely used in primary packaging of pharmaceuticals as they are quite expensive. But further developments can find a way to make this technology cost-effective.

Senior-friendly and Child-resistant Packaging

The significant share of elderly in the world population is increasing, it is crucial for pharma packaging industries to focus on senior-friendly packaging. MedLock EZ is a child-resistant, senior-friendly and sustainable unit dose alternative to amber prescription vials. It uses a locking mechanism (patent pending) that is difficult for children to open and easy for adults. Besides SF packaging, Child resistant packaging solutions are also important. ln 2014, Locked4kids was introduced by Romaco and Ecobliss Holding BV and it won several awards  in the Packaging category. It is a re-closable and child-resistant carton for blister packs.

"The carton has openings at two sides in which the tray automatically locks when fully inserted. The tray has hooks at two sides which have to be pushed simultaneously to unlock. While keeping the hooks pressed the tray should be pulled out of the carton.

The push points are placed diagonally across each other at a distance that adults can physically cover. This distance however is too much for young children."

Anti-Counterfeiting strategies

Maybe the biggest challenge for drug regulators and producers is the counterfeit medicine. The big multinational pharmaceutical companies invest huge amount of money for new drug formulations and also packaging but they have to deal with a serious problem. Counterfeiters create fake medicines in the market and they are just copying the appearance of the product so just the packaging. So it is essential to innovate the packaging technologies in order anti-counterfeiting.

For example, the producers can place covered features like hidden text, UV printing, magnetic inks etc.. on the packages. It is difficult to copy and these kind of hidden features are becoming very popuar in the pharma sector.

Beside these, the innovation of the printing of packages is a effective way to fight against counterfeiters. Hologram, vignette technology, laser printing, coin reactive printing, sandwich printing, both sides printing registration etc. are becoming popular.

Although several techniques have been developed, unfortunately it is not sufficient.

They have to be made more consumer friendly in order to make it easier to recognise the counterfeited drugs, so an average man can detect the 'fake' drugs just by looking at the packaging of it. 

Source: Articles from: informationmediary.com, pharmtech.com,linkedin.com thesmartcube.com, chiefpackagingofficer.com, 

SUSTAINABILITY AND GREEN PHARMA PACKAGING

“The pollution of environment (water, soil and air) with pharmaceutical residuals is an environmental concern. Consumption of human medicines is between 50 to 150 g per person per year in the EU. Veterinary drugs are used in smaller quantities, but pets are a growing segment of the veterinary products market. In the majority of EU Member States, of unused human medicinal products (3 to 8% of the total amounts sold), about 50% is not collected.”

(Source from: www.greenfacts.org)

Within recent years the growing green movement and sustainability have come into focus and also reached the pharmaceutical packaging, one of the industry's most complex sector. There is an increase in using veterinary and human pharmaceuticals and it endangers not just the wildlife but also the humans by drinking tap water. The most existing wastewater treatment systems can't remove medicals like hormones and antidepressants from the wastewater. So if we flush down the drain these unwanted chemicals they can end up in our drinking water.

Day by day several articles pop up about how the humanity pollutes the environment and how the pharma chemicals devastated wildlife populations. For example, one of the most harmful is the death of millions of vultures in Asia caused by vet drug and not to mention the widespread feminisation of male fish caused to hormonal cocktails which got into their territory. So it is essential for the big producers accept the responsibility for their drugs from the time of production till its use.

Brands and companies should consider the following key points in order to establish environmental sustainability:

1. Develop a Sustainability Plan: It is including the examination of resource management and waste management to find solutions to limit the environmentally harmful effect. Innovate, find new technologies and resources.
2. Use eco-friendly, recyclable or biodegradable materials: The most common materials which are used for this packaging are recycled paper, cardboard, corn starch, cellulose and chitin. Just using fewer ink colors, thinner and unbleached paper can have a postivie impact. Moreover adopting this type of packaging adds a brand value to a product with eco-labels. 
3. Reduce the quantity of packaging: It is the most effective way to decrease the harmful impact of pharma packaging.
4. Innovation: Create new manufacturing procedures and new technologies also support the eco-friendly pharma packiging. For example, in 2014 Schott launched the concept of a ready-to-use-pharmaceutical vial called adaptiQ and they received a really positive feedback from the market. Now the company is ready for the commercial launch. The adaptiQ enables a new era of cutting edge manufacturing. The main advantage of this product is that the companies can fill the vials immediately and steps like washing,drying, sterilizaton, freeze-dying, weighing and closing are not necessary anymore.

"With adaptiQ, up to 100 sterile and prefillable vials can be securely fixed inside a single nest. Each vial is securely held in place at the neck by three clips. The vials thus survive the manufacturing process on the filling line without coming into contact with one another. This prevents scratches and breakage and consequently lowers the reject rate, a crucial aspect for pharmaceutical companies."(Source from: www.manufacturingchemist.com)

As you can see the pharma companies have to realize the growing necessity of the sustainability and eco-friendly packiging. The packaging material has to be recyclable or biodegradable. It is a difficult task to create a green pharma packaging, but also preserve and not to compromise on a package's safety or accessibility. It requires innovation, further investments in resources and also in time, but if you understand the trends, you can adapt to them and the result could be easily seen in the increase of customer loyalty and sales numbers.  

Sources: Articles from: Canadianpacking.com, World Applied Sciences Journal 

and reports from: Chemtrust.com, algonquin-eco-watch.com

ANTI-COUNTERFEITING IN PHARMACEUTICAL INDUSTRY

The counterfeit pharmaceutical industry is worth around $200 billion annually, which is slightly less than the $246 billion illicit drug trade. Nanotech Security, a Sophic Capital client, has a solution successfully used in the banknote industry which is easily adaptable  to prescription pills. The technology is called KolourOptik, and it is a low cost, end-user engaging, near impossible to duplicate anti-counterfeiting technology that can be applied on almost any surface including pharmaceutical pills.

Fake pharmaceutical drugs are the largest, global counterfeit market. Fake pharmaceutical drug margins are high this attracts criminal organizations who have little to fear from the lack of anti-counterfeiting laws. Fake pills are often made exploiting children and migrants, in unsanitary conditions using toxic materials, even reducing dosages to minimize costs and evading taxes.

Sadly, people will die from counterfeit drugs. Interpol estimates that  up to 1 million people will die annually from counterfeit pharmaceuticals taking into consideration that 10 to 30% of all pharmaceutical drugs in circulation in the world are counterfeit. Counterfeiting IS NOT a victimless crime – especially in the fake pharmaceutical drug industry.

Let´s have a look to some numbers in different countries. In the United States, the number of new pharmaceutical drugs approved surprisingly few. From 1827 till the end of 2013, only 1,453 drugs were approved. In Nigeria, counterfeit drugs infested the market this last years. A survey found out that almost 20% of Nigerians believe they are victims of the counterfeit pharmaceutical industry. France commandeer 8.8 million counterfeit articles in 2014 (up 15.4% over 2013). Last but not least, the problem of counterfeit pharmaceuticals is especially alarming in Afghanistan. One government ministry estimates that that at least 50% of Afghanistan’s $700 to $880 million pharmaceutical import market is counterfeit.

Authoritied have limited resources to combat fake drugs. Enforcement agencies don’t have the budgets, the time, or the laws needed to combat not only fake drugs but also the counterfeit industry as a whole. Criminal organizations know this and are exploiting these deficiencies. Success is particularly easy in the developing world. Take Colombia and Venezuela, for example. “Contraband drugs is a multi-million (dollar) business that affects thousands of lives and seems to have no end in sight.”

In a more positive note, it seems that technology can stem the rise of counterfeit drugs. There are two types of technologies targeting counterfeit drugs: tracking and authentication. Tracking involves the movement of drugs through the supply chain and typically involves barcodes or radio frequency identification (RFID) for validation. Authentication is for the end user. These consist of packaging holograms, optically variable devices (like holograms but without 3D effects), and colour shifting inks and micro-taggants on packaging or film-coated tablets. Authentication technologies experiences a major weakness. There is no amount or advanced technology of anti-counterfeiting that will protect consumers. Not unless they are educated about the product’s and their anti-counterfeiting measures. Allister McCullum, a former counterfeit expert at the European Central Bank, stated that counterfeiters “aren’t interested in producing near-perfect notes that will get past bank checking machines… They just aim for something that’s good enough to fool the general public.”

Nanotech Security (NTS:TSXV), a Sophic Capital client, has the technology that pharmaceutical companies can use to engaging doctors, pharmacists, and patients at the same time. This technology, KolourOptik, is a nanotechnology solution based upon the optical properties of the blue morpho butterfly. KolourOptik creates a grid of nano-sized holes that imitate the interaction light has with this butterfly’s wings. The outcome is the creation of vibrantly-coloured images comparable to LEDs when illuminated. At the moment, they are focused on the banknote industry, but KolourOptik can be applied to a wide range of surfaces including pills and any type of packaging. There is no additional need for dyes or pigments. Pharmaceutical companies can even embed data in the design thereby allowing all points in the supply chain to track and authenticate the drugs. KolourOptik’s is nearly impossible to duplicate. Unlike holograms, which can be peeled off, KolourOptik images are embedded into the packaging.

We can conclude from this that even with all those obstacles around the anti-counterfeiting, not enough laws, criminal organizations, uneducated consumers, etc. technology is reaching a solution and making big steps towards a less dangerous world.