White Papers | Pharma Packaging Solutions

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The Impact of Patient Compliance on Pharma Manufacturers

By Cindy Dubin

The Burden of Medication Non-Compliance

Research shows that half of all patients in the United States and the European Union do not take their medicines as prescribed. Poor patient compliance, or medication adherence can lead to worsening of disease, serious and avoidable health risks, increased hospitalization, and even death. In fact, patient non-compliance is the fourth leading cause of death in the United States, and the annual cost of non-compliance in the U.S. is estimated to be $317 billion and $125 billion in the EU, according to research group MarketWatch.

Ensuring patient compliance is a burden placed on drug manufacturer’s shoulders. First, the pharmaceutical company must ensure that the end-user, the patient, knows exactly how to self-administer the drug product to achieve the most successful treatment outcome. This can be achieved by communicating drug dosage requirements directly to the patient via the medication’s package. This packaging should also promote ease of use to ensure a patient takes the prescribed medication as directed.

Second, manufacturers must use packaging that promotes compliance, which can be costly. So finding a way to contain and/or reduce the cost of bringing a drug product to the market in a compliance package can be an added burden.

Finally, competition among pharmaceutical companies can be a burden on drug makers, so they are always looking for ways to boost product sales and gain a competitive edge over competitors’ products and packaging.
The Rise of Compliance Packaging

Packaging is growing in importance as patients are increasingly self-administering medications, and thus there is an increased demand for personalized, smaller sized, and simpler packaging. Packaging affects how the customer uses the product at home, and how a hospital, nursing home, or retailer handles a product.

The method in which medication is administered has changed to improve dosage control. Patient compliance packaging solutions can contribute significantly to assuring successful treatment. Research has shown that simple, easy-to-use medication packaging helps patients become, and stay, adherent with their prescriptions, especially complex long-term, chronic illnesses requiring multiple medicines over time. When the sequence of medications and the intervals are clearly laid out, and the patient can visibly see the progression of pill administration, patient compliance and overall health are improved.

Collaborating With a Contract Packager

Some contract packagers in the industry will collaborate with drug manufacturers to develop a drug adherence package that communicates dosage information through print and graphics. Consider choosing a contract packager that can design the package and guide how dosage information can be communicated to the patient via design and packaging. For example, extended content labels can be adhered directly to pill bottles, while blister packages provide additional space for printing that information on the inside or back side of the package.

Last April, the Food and Drug Administration (FDA) issued a Draft Guidance: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. Specifics about where to place labels on packaging, label color, and print size and font are outlined in the guidance. So, it is important to work with a contract packager that understands any and all requirements regarding adherence packaging.

Also, seek out a contract packager that can design the package, test it, and scale it up from clinical trial volumes to commercial blockbuster volumes. Working with a vertically integrated contract packager facilitates a one-stop approach that promotes all of these activities under one roof – package design, carton production, primary and secondary packaging, and one point of shipping and receiving – rather than having a provider to handle each of these tasks. This will reduce overhead costs and save time.

Finally, drug makers can get a leg up on their competitors by working with a contract packager that can create customized packaging which captures market attention while maintaining a patient compliance design.

A Patented Compliance Package

One type of adherence packaging that the FDA went on record supporting in 2010 is unit-dose, or blister, packaging.¹ Globally, blister packaging, along with plastic bottles, made up 56% of the primary pharmaceutical packaging sector in 2012.²Blister packs are attracting interest as a patient-compliance tool because the patient can easily view the contents, acting as a visual prompt to take the medicine.

Despite the benefits of blister packaging, 90% of U.S. solid-dose drug prescriptions are still filled in bottles, compared to 80% in the U.K. While it may sound trite to state that the U.S. uses bottles because it always has, that is exactly why bottles are more prominent in the U.S. And, the bottles are widely accepted by patients. The pervading mindset has been: where there isn’t a problem, there is no need for a fix.

There is also an economic factor. Pharma manufacturers can place more tablets in bottles more efficiently and cost effectively. In contrast, when creating a blister pack, there is a need for complex custom-made tooling, as well as costs associated with film and foil.

But there are some contract packagers trying to buck the trend and develop blister packs. In fact, Pharmaceutical Packaging Solutions (PPS) developed and patented the CRx Pack™ wallet card to assist with dosage compliance. For drug manufacturers who have found that a drug historically delivered in a bottle is not fostering patient compliance, a blister pack like the CRx Pack™ wallet card can help ensure confidence that the drug is being consumed in the appropriate quantities. An example can be seen here.

PPS created the CRx Pack™ for pharmaceutical customers in need of compliance packaging, up to and including the F=1 designation, the industry’s most protective packaging type. Its format and packaging dimensions are available in flexible configurations to accommodate monthly regimens. Smaller formatting sizes are also available for holding one or several tablets. In fact, the wallet card’s structure can hold just one tablet or monthly quantities, and far fewer tooling costs are associated with filling the card, making it unique in the market as other blister packs require significant upfront tooling.

The wallet card can hold multiple dosing regimens within one package. So, for example, dosage A might be in blue tablets, while dosage B would be in yellow tablets. Each would be trapped in the same framework to reduce the cost of needing two different packages. And, from a compliance standpoint, it is much more convenient for the consumer to have just one package instead of two.

As part of the package’s customized design, CRx Pack™ offers ample billboarding for marketing messages. The package offers multiple panels, versatile sizes, economical SBS paperboard construction, and extensive space for graphics and product information.

All CRx Pack™ primary and secondary packaging is created and completed in one facility to ensure that customers benefit from accelerated speed to market, as well as reduced setup costs.

Adherence Packaging Is Bridging A Drug Delivery Gap

The CRx Pack™ wallet card platform is bridging an important gap in adherence packaging as it can accommodate different drug delivery systems, not just to solid-dose pills, but also prefilled syringes and vials for more personalized drug dosing.

According to a report published in November 2013, the global prefilled syringe market was valued at $2.09 billion in 2012 and is expected to more than double to $4.98 billion in 2019. Prefilled syringes are advanced drug delivery devices filled with single-measured dose of injectable drugs.³ These syringes are gradually becoming the preferred delivery devices for various categories of injectable drugs, mainly due to the advantages offered to drug manufacturers, healthcare providers and patients over conventional vial and ampoule packaging systems. To drug manufacturers, they are important because they reduce overfill to 4%-5% from 20% in vials, and thus, are preferred for dispensing therapeutic classes (mainly biologics), which are expensive. With respect to healthcare providers and patients, prefilled syringes help with factors such as ease of operation, low risk of contamination, and more accurate dosing for patient compliance.

No matter the delivery system, patient compliance begins with packaging: the patient either succeeds or fails because of packaging. Drug makers can ensure compliance with adherence packages like blister packs such as the CRx Pack™ wallet cards. This packaging eases burdens on some pharmaceutical companies regarding costs to market, patient communication, and the competitive pharmaceutical landscape.

References

Pharmaceutical Packaging Designed to Reduce Medication Error: Calendarized blister packaging can safely improve adherence to once‐daily, long‐term medication for chronic conditions. By: Barbara Zedler, M.D., Venebio, Chief Medical Officer, FDA Public Workshop: Packaging Practices to Minimize Medication Errors, June 24, 2010. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM219171.pdf.
Pharmaceutical Packaging Market by Packaging Type (Plastic bottles, Blister packs, Caps & Closures, Ampoules, Vials and Others) Raw Material (Plastics, Paper & Paperboard, Glass, Aluminum foils), and Drug Delivery Type – Global Trends & Forecast to 2018. http://www.marketsandmarkets.com/Market-Reports/pharmaceutical-packaging-market-890.html
Prefilled Syringes Market (Glass and Plastic) – Global Industry Analysis, Size, Volume, Share, Growth, Trends and Forecast, 2013 – 2019, published by Transparency Market Research, http://www.transparencymarketresearch.com/prefilled-syringes-market.html

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Key Elements for Selecting a Pharma Packaging Partner

By Sidney Randall

Choosing the right packager for your products can be a daunting task and one that should not be taken lightly. There are numerous companies that claim to be expert packagers. However, when entrusting an outsource party to serve your supply chain, it is imperative to choose a partner that has a similar culture and shares a similar vision. Additionally, one that employs values and integrity instilling these traits within their associates is invaluable. The following eight elements are a guide to selecting a qualified outsource partner.

Capabilities

Each packaging project is unique, whether the need is for primary and or secondary packaging. Choosing a partner that has the ability to provide these services in a professional manner based on the customer’s specific needs is important. Does the packager maintain the agility necessary to deliver turn-key value; like bottling and labeling, blistering, fold-over card heat sealing, basic tear-down and re-work, as well as, general product packaging? The right partner must be able to satisfy your minimal packaging requirements while meeting production requirements in a timely manner. One that can exceed your minimal packaging requirements will provide long-term sustainability.

Resources

13_Pill_Machine_300_225 When considering a potential packager; people, equipment, and facilities are the key to a successful partnership. The selected outsource team needs to maintain the appropriate talented personnel, at all levels within the organization. Associates need to have experience, be customer focused, and participate in continuous training.

Equipment and tooling should be well maintained with documented preventive maintenance schedules. Should a piece of equipment fail or a tool break, does your outsource partner ensure back-ups are available? Downtime is costly for all parties involved. As a result, your outsource partner should possess the mindset of forward thinking for serving their customers.

The packager’s facility should be certified and employ cGMP standards. Designated areas such as quarantine, finished goods, and incoming inspection should be clearly defined and labeled appropriately.

Certifications

Depending on your specific packaging needs, certifications from the following agencies should be held and maintained by your partner of choice:

Food and Drug Administration (FDA)
Drug Enforcement Agency (DEA)
Medicines and Healthcare products Regulatory Agency (MHRA)
State Board of Pharmacy

Quality Systems

Quality Assurance is one of the most important elements when packaging pharmaceuticals. Having world-class systems in place to ensure compliant, validated, and repeatable processes is vital to both the customer and packager. Any packager that does not have documented Standard Operating Procedures with strict cGMP practice adherence should be questioned as a potential partner.

Customer Service

41_225_300 (1) Customer Service can determine the success of the partnership. Knowledgeable, customer focused representatives are a vital part any outsource relationship. Ensuring external and internal customer needs are understood and met on-time and on budget, provides long term success for all stakeholders.

Turn-key Solutions

Choosing a partner that offers a complete solution can be a win-win scenario. Value added services such as component sourcing, inventory management, and project management that allow a packager to manage all aspects of the packaging process, are more advantageous than those who merely provide labor for product packaging.

Flexibility/Innovation

In a competitive market the ability to serve compressed lead times has become an expectation. Customers at all levels want instant response. The packaging partner selected must be able to react to these demands and offer customized solutions for non-standard packaging campaign requests.

Packagers that offer packaging design and in-house component production can assist in the speed to market challenge. Shelf space is a premium and once gained, the presence on the shelf can determine a product’s success. Offering innovative concepts in both graphical and structural design is one way to help clients gain a competitive edge.

Cost

When developing product costs, experience has shown that many view packaging as an afterthought. As a result, the packaging system becomes an easy target for reducing costs. After all, it is just packaging, but in reality, studies have proven that packaging sells. Developing the correct balance between packaging systems that are compliant, right sized, convey the intended consumer communication, and maintain cost effectiveness, can be accomplished by choosing a qualified outsource partner.

Conclusion

In today’s economy having a competitive edge is imperative for long-term sustained growth and success. Many companies are becoming lean by performing internal assessments to concentrate on core competencies and eliminate functions that are best served by outsource partners. For many manufacturers of ethical and over-the-counter (OTC) drugs choosing to have their products packaged by an outside partner is one result of the aforementioned assessment practice. The key elements outlined can serve as guide to choosing the best qualified partner for your packaging needs.

About the author

Sid Randall is the Technical Services Manager for Pharma Packaging Solutions, a pharmaceutical packaging company that delivers original, turn-key contract and compliant packaging solutions to global pharmaceutical and nutraceutical companies. Sid’s experience includes 25 years of domestic and international manufacturing of Pharma, industrial, and consumer products; focusing on quality assurance, continuous improvement, and maximizing profits and synergies. Specialization includes the areas of product and brand management, packaging development, lean manufacturing, engineering management, program management, procurement, marketing, and supply chain management. He has a BS from Old Dominion University and an MBA from Liberty University.

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Why Foil Packaging?

Mederma_P1070483_250_166_250_166 Foil packaging, plain and simple, is the most effective means of immediate shelf differentiation and lift in sales. A high-end looking foil package conveys several things to the consumer: New, Better, Advanced Formula, Superior Product, High Quality, Classy. It also suggests that the other products on the shelf are inferior in some way, of a lesser quality, value or class. “Bling” remains King… When given the choice between two products that otherwise seem the same, consumers overwhelmingly chose the better looking and more visible package. In virtually every market, we see our customers gain a lift in sales when foil packaging is used. In many cases we have seen customers’ foil-packaged product sales outpace the sales of their base or main line product. Here at Pharma Packaging Solutions, we make a lot of foil packaging and we watch our customers continuously reorder foil well beyond their planned limited launch of a product.

Who, What, When and Where?

Who? Virtually every maker of consumer goods can effectively market using foil packaging. At Pharma Packaging Solutions we see foil packing in markets across the board:

Pharmaceutical products
Nutritional products
Cosmetic products
Personal care products
Beverage products

What? Use of foil comes in many forms. We offer:

Foil Board: laminated board converted into foil packaging
Cold Foil: laminated spot foil in-line into foil packaging
Foil Stamping: hot stamping of foil in spot locations on packaging

When? Foil packaging can be employed most anytime and anywhere. At Pharma Packaging Solutions we see the benefit of foil packaging for:

New product launches
Re-introduction or re-branding of products
New or improved products
Promotional or limited offers
Security and counterfeit prevention (foil holographs)
Seasonally, at holiday time
Shelf differentiation, to convey better, superior, higher quality, higher class

Where? Our customers employ foil packaging in virtually all retail locations and display areas. A large portion of point-of-purchase items are in some type of foil package to attract the impulse buy (almost all chewing gum packaging is foil). In any shelf space, however, the “bling” will stand out. At Pharma Packaging Solutions we can advise and make foil packaging for any retail location and need.

Cost? Use of foil packaging will cost more but, with any marketing decision, you have to weigh the lift in sales potential to the cost. The materials’ cost increase can range from 30% more for spot foil applications (cold foil or hot foil stamping) to as much as double the price of the package for full foil laminate material. If your carton supplier has the right converting tools, the converting cost is nominally more than the cost of non-foil packaging. At Pharma Packaging Solutions, we have the right tools for the most cost-effective foil packaging in the industry.

Don’t be Foiled!!!

Alternatives to foil packaging: there are plenty of alternatives, all with the intentions of being less costly. Common alternatives include: Mirror foil (highly shiny metallic ink), metallic inks with high-gloss coatings, and a process called “cast and cure” (an inline, printed version of extrusion). While these process are viable alternatives, often the cost difference is not that significant and, more importantly, the effect is something less than foil packaging. Our numerous years of experience at Pharma Packaging Solutions, combined with our cost-effective processes have proven to show the best customer satisfaction comes with traditional foil packaging applications: Foil Board, Cold Foil Laminate and Hot Foil Stamping.

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How to make forecast vs reality work in pharmaceutical contract packaging.

Let’s face it, not all pharmaceutical drug launches are blockbusters. Even after carefully modeling the market to forecast potential sales, the underlying data used may prove to have some challenges. Many sales forecasts are based on the idea that the market can be represented as a continuous variable, but this may not be the case for a generic product whose fate may be determined by a single decision on the part of a drug wholesale company.

In the case of a branded product, was a patient-based or prescription-based model used? Were epidemiology and access to healthcare filters correctly applied? For therapeutic applications where drugs may not be reimbursed, did patients pick the non-pharmaceutical alternative or a shorter course of therapy due to high drug costs, thus forestalling sales?

The challenge is compounded by the long and expensive drug development cycle—potentially as long as a decade—and the threat of counterfeits and me-toos. Add in new therapeutic regimens from generics and biosimilars and the pressure builds at the end of the development cycle to get a drug to market as fast as possible.

If any variable wobbles and it is almost guaranteed that one will, headlines may result that read “Company X slashes Drug Y Forecast as Sales Disappoint.”

A memorable example was GSK and its drug Agenerase, used to treat HIV, forecasted to reach $1.5 billion by 2002, but only generated $70 million by that time. A more recent example is Biogen’s Multiple Sclerosis drug,

Tecfidera, which caused the company to slash its forecast. Citi Research reports that more than two-thirds of novel drug launches fail to meet first-year launch estimates. From the under-achieving sales of Viagra tothe opposite example, mega blockbusters like Lipitor, we can conclude that pharmaceutical forecasts can be fragile.

What happens when you’re not batting 1000?

It may be that a pharmaceutical company’s best strategy is not necessarily to hope for a successful batting average, but rather to learn how to respond more flexibly and ably to the market no matter which way the pitch rolls. After all, even if product sales fail to meet forecast, they may still be perfectly viable as long as their owner can manage their costs.

One strategy used by pharmaceutical companies is to build in cost savings on the packaging end. Repatriating the part of the supply chain that is not a core focus may ultimately add value to a supply chain. Most pharmaceutical companies consider their core focuses to be in research and development, drug formulation, and marketing.

The minutiae world of drug packaging, which now includes the complexities of serialization, may not be the wisest investment of time or resources. Most companies outsource projects in order to reduce costs and to gain outside expertise. A survey by The Conference Board indicated the following “Top-10″ outsourcing objectives:

Reduce costs (40%)
Access to expertise (38%)
Improve internal service (37%)
Focus on core business (34%)
Maximize resources (27%)
Internal flexibility (25%)
Improve external service (24%)
Changing customer needs (20%)
World-class standards (15%)
Continuous improvement (15%)

Rather than investing in packaging equipment, tooling, project setup costs, specialized labor, packaging components, serialization technology and more, pharmaceutical companies increasingly find themselves practicing cost avoidance.

Using a packaging supplier’s infrastructure helps avoid capital outlays and it is much easier to manage fluctuations in demand at the critical pharmaceutical lifecycle points. In addition, due to serving more diverse markets, the greater packaging complexity (54% more SKU’s from 2006 to 2011 according to one McKinsey study) is better managed by companies who have experience with brite stock labeling and Rest-of-World (RoW) packaging.

Without the heavy in-house investment, these pharmaceutical companies are able to change a fixed cost into a variable cost – paying based on the number of units actually being sold rather than the number of units forecasted.

Picking up the pitch Contract Packaging Organizations (CPO’s) have variable floorspace, equipment, processes, and a trained workforce that can handle multiple packaging requirements in addition to process flow design plans that adapt to incoming projects. Their flexible and multi-faceted equipment can deliver short or long runs. GDUFA (Generic Drug User Fee Amendments) compliance, cGMP manufacturing expertise, serialization readiness—all these are pluses. By gaining access to these specialized services, most pharmaceutical companies see gains in newer, better methods of packaging as well as improving their manufacturing quality and efficiency. Evaluating a company’s compliance record, industry experience and technological expertise are starting points for establishing a new relationship, but there are more points to consider.

Successful technology transfers and ongoing cooperation are not to be taken for granted. How quickly a company communicates bad news is one measure of a healthy communication plan. The tighter the project management team values, the more productive the team. The most successful relationships are those built on culture, service, knowledge, cost, and quality.

Knowing that contract packaging companies are designed for flexibility isn’t enough to justify an outsourcing decision. Alignment by right-fitting to the correct capacity and technical services is a start, but more importantly, meshing project management team’s focus and values may yield many more cost advantages and add significant value to the entire project outcome.

Treating that contract packager as a vital vendor partner provides pharmaceutical companies with an end-to-end operating model.

Whether it is a product launch with many unknown variables or a dedicated forecast based on a complete sales history, contract packagers working as a supply partners can still identify major opportunities for supply chain optimization.

SOURCE: http://www.healthcarepackaging.com/contract-packaging/strategy/building-cost-savings-packaging-end

Links:

http://www.healthcarepackaging.com/sites/default/files/styles/lightbox/public/field/image/PPS_Products.jpg?itok=M1e1sw0b
https://www.pharmapackagingsolutions.com

For more information:

Scott Garverick
Vice President of Business Development
Pharma Packaging Solutions
SGarverick@pharmapacksol.com
800.533.7744
614-361-3036
341 JD Yarnell Industrial Parkway
Clinton, TN 37716
https://www.pharmapackagingsolutions.com

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Solutions to Global Pharmaceutical Supply Chain Challenges

Find out how a contract packaging company can deliver the expertise and flexibility needed to ship pharmaceuticals internationally.

The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and improved speed to market – while ensuring compliance with myriad regulatory requirements in countries – forming a challenging landscape for the global pharma industry.

One of the drivers of this change is the merger and acquisition (M&A) activity in the industry. According to PricewaterhouseCoopers, M&A activity in the pharmaceutical sector surged in the second quarter of this year with 62 deals announced representing almost $170 billion of total value. Merging supply chains is a complex process, and anyone who questions the impacts should consider what happens when supply chains break down: Drugs are delayed to market, customers experience poor service, security and compliance risks heighten, and a host of missed opportunities occur.

Also impacting pharma supply chains are complexities around logistics and regulatory requirements. Logistics encompass the time from when the product is produced to when it is packaged and labeled to when it is distributed and includes special care regarding product shelf life, temperature control, storage, and shipping location. And from a regulatory standpoint, different government agencies have different opinions about approving drugs – some are approved in countries and some are not.

Finally, and probably the most critical issue driving change in pharmaceutical supply chains is the area of serialization, also known as track and trace, because drug counterfeiting has become a multi-billion dollar industry. In fact, earlier this year, INTERPOL seized 9.4 million doses of fake medicines.

Compliance with US DSCSA (Drug Supply Chain Security Act), China, Brazil,Korea, Argentina, EU and other track and trace regulations will cover more than 75 percent of global medicines by 2018. The serialization, product tracing, product verification, and government reporting requirements are complex and the risk is high.

Use a Contract Packager

In response, the pharmaceutical industry is turning to contract packaging companies, as is evident from a technical market research report, Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging. According to the report, the global market for pharmaceutical and biopharmaceutical contract manufacturing, research, and packaging was valued at $219.9 billion in 2012 and is expected to reach nearly $374.8 billion by 2018.

Outsourcing packaging has become a viable and a beneficial business strategy that is enabling pharma to transfer non-core activities to external partners in order to restructure their distribution networks, leverage resources, and intensify focus on research and development. For many, this strategy has resulted in improved supply chain management and can yield a 25 to 50 percent reduction in total supply chain costs.

Contract Packager Capabilities

There are some specific capabilities that a contract packaging company should offer to a global pharmaceutical company. For instance, as the issue of serialization has become front and center in ensuring the quality and safety of drugs as they move through the supply chain, a contract packager should be well versed in this area. Second is the issue of bright stock labeling, which can help streamline drug distribution in countries other than where the drug was manufactured.

And finally, a contract packager should have flexible packaging lines to handle a variety of products and batch sizes.

Preparedness for serialization e-pedigree

Whenever drugs are being shipped internationally, the government agencies involved all have to feel confident that what is being purported to be the drug is the drug. In November 2013, the Drug Quality and Security Act became law in the U.S. FDA is tasked with developing a means of tracking drug products throughout the supply chain to minimize the risk of contamination and counterfeiting. All pharmaceutical companies are required to add serial numbers to all packages in the next four years. The labels must be upgraded to electronic codes within the next ten years.

Any pharma company using a CP should ensure that the CP has a complete serialization program is in place to track the history of a given product’s chain of custody from the manufacturer to the point of dispensing. Additionally, an epedigree (electronic history) should provide data on the history of a particular batch of a drug. Contract packagers can affix a unique and traceable serialized number to every package, bundle, case and pallet. This serial number is read many times as the product moves from manufacturer to consumer and, each time, an entry is made in a database to document the official chain of custody.

These standards are used mainly to reduce counterfeiting and a contract packager should be familiar with the subtle differences in requirements defined for each country.

Bright stock labeling

Products are manufactured in large, cost-efficient batches and stored in unlabeled primary containers with expiration dates and tracking information.

These containers are then labeled with the compliant labeling in the correct language just prior to shipment. Beneficial for the Rx and OTC markets, bright stock labeling allow a pharma company to deliver “Just In Time” or “Made to Order” inventory using a contract packaging partner.

For example, a U.S.-based contract packager will receive capped bottles from Europe, and then label and shrink wrap the product with inserts adapted for the domestic market where the drug will be consumed. Labeling and packaging the product closer to the shipment time allows for a more accurate inventory forecast. This can eliminate the costs involved in labeling and packaging the product at the time of manufacture, which results in overforecasted items languishing at the retail level as their expiration dates quickly approach. A contract packager serving the U.S. market, for example, can accept a bright stocked label from a drug manufactured in Europe. The U.S. packager will be more familiar with the market, language, and regulations in the U.S. Bright stock labeling also supports the goal of delivering drugs to the patients most in need in North America through logistical simplicity.

Rest of World labeling

If a pharma company’s aim is to create a worldwide development program for their new drugs not just on humanitarian grounds, but also for economic gain in emerging markets, then compliance with global regulatory agencies must be met. Rest of World (RoW) packaging is similar to bright stock labeling in that inventories specific to the country in which the product will be consumed will be labeled with compliant information in the correct language, but it specifically relates to packaged product which will be sold in developing global markets outside of the US, Europe, and Japan.

Flexible primary and secondary packaging lines

How flexible is the contract packager’s production? Do they have several lines to run your product or just one? Equipment should handle large and small batch sizes and can change over easily to be more adaptable to a variety ofdrug delivery systems.

Choosing a Contract Packager

When selecting a contract packager to handle your international drug shipments, there are several factors to consider:

Project Management

Ask the contract packager to describe their project management system in terms of who is handling your project, expected turn6 around time, if there will be a dedicated line just for your product’s run–and for as long as it’s needed. Look for a structured plan to define and execute the requirements of each new project. Project management promotes “team” planning and communications through weekly or bi-weekly meetings.

Packager profile and history

Look at the experience of the management group and the team’s knowledge. The employees need to deliver confidence and trust in their communication and documentation. Find out how long the packager has been in business and that turnkey solutions are provided under one roof for tighter supply chain control.

Regulatory capabilities/track record

Ask about FDA audits and how the contract packager performed. Find out when the last audit occurred, if the site is cGMP compliant, and if any 483s have ever been issued. Caution: if the company does mostly nutraceuticals, check into their regulatory status to ensure they are FDA-audited and DEA-registered so that they can handle your pharmaceutical needs.

Dedicated resource availability

Depending on how many lots you anticipate running, the packager should be able to tell you whether or not they have the right equipment and tools needed to produce and manage your project.

Summary

Pharmaceutical companies want to make drugs and want to sell them, sell them quickly, and get the right drug in the right patient’s hands; this is their core competency. As industry has become a global supply chain, meeting those goals has become more challenging. A contract packager can eliminate those complexities and ensures that pharma’s objectives are achieved.

For more information:

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