Improving quality, while reducing costs in healthcare packaging

Can packaging and labeling innovation play a role in healthcare reform? Despite economic struggles in the United States, President Barack Obama is pushing for healthcare reform. His appointees to the Health and Human Services (HHS) and FDA are pushing, too. Their approaches include prevention, improving healthcare quality, and reducing costs and waste, among other initiatives. Given the critical roles packaging and labeling play in maintaining the safe and effective use of pharmaceuticals and medical devices, you may be able to help them.

For instance, in July, The House Committees on Education and Labor, Ways and Means, and Energy and Commerce introduced “The America’s Affordable Health Choices Act.” The committees report that the act “is consistent with President Obama’s overall goals of building on what works within the current health care system by strengthening employer-provided care, while fixing what is broken.”

While packaging and labeling are not mentioned in the legislation, two of the key principles could be achieved with packaging and labeling: “Improving quality of care for every American and protecting consumers and reducing waste, fraud, and abuse.”

HHS Secretary Kathleen Sebelius has also emphasized the need for improving quality and ensuring patient safety. In May, when releasing two new HHS reports published by the Agency for Healthcare Research and Quality, the annual 2008 National Healthcare Quality Report and 2008 National Healthcare Disparities Report, Sebelius reported that $50 million from the America Recovery and Reinvestment Act are available “to fight health care associated infections and improve patient safety.”

And while speaking in June at the Annual Conference of the Endocrine Society, FDA Commissioner Margaret Hamburg spoke of prevention and the agency’s role in achieving it: “The agency should also be open to the concept of effective preventive therapy and interventions for people at very high risk of developing diabetes, working with researchers to define how to study and demonstrate the safety and efficacy of such approaches.”

Packaging professionals for years have been developing technologies that improve patient and practitioner safety, encourage drug regimen compliance, minimize medical errors, and enhance product protection. “Depending on the drug product, the packaging contributes to, among other things, security and authentication, therapy or regimen comprehension and ease-of-use, therapy or regimen adherence, and product integrity protection,” explains Daryl Madeira, director of marketing, contract packaging, Alcan Global Pharmaceutical Packaging. “By allowing creative packaging design and deployment to be an integral part of the drug product and process development and eventual manufacturing, pharmaceutical and medical device companies improve the likelihood that the medication therapy is completed as required and the medical outcome is achieved.”

Many packaging innovations, however, have not been employed widely. Changes to traditional packaging operations move slowly, given the pharmaceutical and medical device industries’ aversion to risk and to any new process that may raise regulator attention. The industries have also been streamlining packaging operations and cutting costs over the past decade. Given the recent economic challenges facing the country as well as the push to contain or even lower healthcare costs, what are the chances that packaging innovation will take off? Or instead, could an appreciation for the role that packaging could play in improving patient outcomes, easing healthcare procedures, and improving product tracking, among other benefits, increase demand for such innovation?

Improving patient outcomes

Discussions of fixing the U.S. healthcare system, thankfully, involve improving care. While much of the improvements may focus on the practice of medicine and the availability of and access to care, the role of technology is a critical component.

The Healthcare Compliance Packaging Council (HCPC) argues that packaging can be used to improve healthcare while reducing costs. In June, executive director Peter Mayberry wrote to Sebelius, Hamburg, and Nancy Ann Min Deparle, a White House counselor, urging them to include packaging in healthcare reform discussions. “Nonadherence to pharmaceutical regimens is a well-documented, national problem that . . . drains more than $180 billion from our national economy every year in the form of lost productivity, unnecessary emergency room visits and hospital stays, nursing home admissions, and the like. Research commissioned by HHS and conducted by Ohio State University, however, documents that use of unit-dose packaging with compliance-prompting features instead of cap-and-vial pharmacy vials results in significantly higher levels of on-time refill and significantly better healthcare outcomes.”

Mayberry points out that the Institute of Medicine (IoM) has recommended greater use of unit-dose formats as a means of reducing dispensing errors and improving the pharmaceutical distribution chain. (To read more from the HCPC, please see the July 2009 issue of Unit Dose Alert.)

In July, HCPC met with White House staff and healthcare reformers in the Senate. Walter Berghahn (AmerisourceBergen Packaging Group), chairman of the HCPC Board of Directors, as well as HCPC Board members Sandra Luciano (Alcan Packaging) and William Sharpless (Winpak) were accompanied by Mayberry and HCPC associate director Kathleen Hemming. HCPC shared data and detailed its arguments about unit-dose packaging with compliance-prompting features.

Others, too, find nonadherence with drug regimens a problem. Steven Anderson, as president and CEO of the National Association of Chain Drug Stores (NACDS), defines adherence as the “correct utilization of medications . . . essential for improving patient health and reducing long-term healthcare costs.” Anderson spoke at the Florida Pharmacy Association Annual Meeting in July. There he noted that poor adherence has been estimated to impose $177 billion annually in direct and indirect costs, from preventable emergency room visits, treatment of chronic conditions to lost productivity. (He argues that pharmacists can help improve adherence.)

Carol Kelly, senior vice president of government affairs and public policy at NACDS, addressed Congress in July. According to a press release, she urged “propatient, propharmacy policy” in healthcare reform, including “the need to expand access to medication therapy management (MTM).” Some packaging experts have suggested that compliance-enhancing packaging could play a role in MTM, given its potential to help patients adhere to therapies.

Packaging technology providers for years have been touting the adherence benefits of unit-dose packaging. “Wallet-style blister packages are predominantly used to enhance patient compliance via written instruction and physical display formatting,” explains Simone Steiner, strategic marketing and communication for Körber Medipak. “The standard blister in a box is the simplest form of compliance packaging. But if someone is looking to elevate compliance, to better balance child resistance and senior friendliness, and to have more billboard space, the best thing is to consider a wallet package.” Regardless of their form, wallets usually feature other elements that offer literature, calendars, or other dosing reminders. Many styles feature unique child-resistant and senior-friendly features.

Innovation could be applied to medical device packaging, too, to ease product use, which could also improve outcomes. “Healthcare providers are very aware of the cost and patient care benefits that can be achieved by improving efficiency and reducing waste,” explains Dhuanne Dodrill, president of Rollprint Packaging Products. “Focusing on areas such as reducing the time for surgery room turnaround, positive verification of product, and packaging waste generation are all part of those efforts.”

During a doctors and nurses panel discussion Rollprint had conducted, operating room nurses reported that package designs that provided multiple points of access and that consistently assured aseptic delivery allowed them to more quickly prepare operating rooms for surgery or deliver a device into a doctor’s waiting hands, Dodrill reports. To meet such needs, Rollprint designed the Duet pouch, which also provided cost savings compared with conventional packaging.

Such input was also seen in an Institute of Packaging Professionals survey of nurses through the Association of periOperative Registered Nurses (AORN). “Ease of sterile presentation” was a key respondent concern, reported Jennifer Blocher, a Clemson University Master’s Candidate who helped coordinate this year’s survey working under Dr. Kay Cooksey. Blocher assisted Jennifer Neid, CPP. The two spoke at HealthPack 2009.

Interestingly, procedures and hospital stays are getting shorter these days, so packaging and labeling that support safe, expedited procedures are in demand. “The new wave in medical we are seeing is the high-tech, minimally invasive device,” explains Lauren Foos, national accounts manager, medical, for Placon Corp. (Madison, WI). “For endovascular procedures, for instance, the devices are long and elaborate. The thermoformed trays must be designed to support and protect these long products, which often have heavy handles used to guide and deploy the device, while focusing on ergonomic needs to ease nursing presentation. Our designs are incorporating internal seal islands and retainers to protect the high-priced, high-value products.”

Patient safety

Improving healthcare also involves reducing medical errors. The Consumers Union, which is advocating its “Safe Patient Project,” also wrote to President Obama, urging him to include in healthcare reform those mandates that aim to reduce medical harm. The group points out that little progess has been made since the publication of the IoM report, To Err Is Human. “The report called for increased public accountability, better training in patient safety for doctors and nurses, and aggressive action to prevent medication errors,” reads the letter. “But attempts to measure progress, if any, in error reduction have been frustrated because basic information is not collected and publicly reported.”

This IoM report did make recommendations for packaging and labeling: “Drugs may be prone to error in use due to sound-alike or look-alike names, unclear labeling, or poorly designed packaging. FDA standards for packaging and labeling of drugs should consider the safety of the products in actual use.”

In its additional 2007 report, Preventing Medication Errors: Quality Chasm Series, IoM writes that “enhancing the safety and quality of the medication-use process and reducing errors requires improved methods for labeling drug products and communicating medication information to providers and consumers.”

IoM argues that FDA should develop guidance documents for industry on labeling and packaging. “FDA and industry should collaborate to develop . . . methods of applying failure modes and effects analysis to labeling and packaging.” In addition, it suggests that FDA, the pharmaceutical industry, and other stakeholders should collaborate to develop a strategy for expanding unit-of-use packaging for consumers to new therapeutic areas. Studies should be undertaken to evaluate different unit-of-use packaging.”

Technology is available. “Pharmaceutical manufacturers can benefit from functional labeling to enhance patient safety and improve drug administration,” explains Gene Dul, president of Schreiner MediPharm L.P. The company manufactures functional labeling solutions, such as those with detachable label segments. “Processes can be optimized, since the label can add useful features beside pure identification. It can be used for recordkeeping by applying a detachable part, including all crucial data to the patient’s record. Such use could avoid incorrect or incomplete transfer of medication information. It can be used for clear labeling of drugs during preparation and administration at the hospital.”

Dul explains that medication is typically transferred after reconstitution from the original primary packaging into a different device, such as a syringe or bag. “Sophisticated labels ensure that no information gets lost between the preparation of a drug and its administration at the patient’s bedside. By applying a detachable label part with product details and possible warning messages to the syringe or bag, all crucial information is easily available at the moment of use, thus helping to avoid possible medication errors.”

Packaging and labeling can also assist patients administering their own therapies. “As is the case for improving patient adherence through packaging, issues related to patient safety and medication errors are commonly a result of the patient’s understanding and following the medication therapy as intended. Packaging plays a significant role in facilitating this comprehension and behavior,” says Madeira of Alcan.

To fight dispensing errors, companies are looking to simplify labeling by printing in two colors, reports Brian McCarthy of Catalent Printed Components. There is also a growing interest in printing the tablet image on prescription drug labeling, he says. “FDA is interested. It could significantly change labeling for prescription products altogether, and it could potentially migrate to patient inserts and medication guides,” he says.

Economic struggles

Respondents to this year’s salary survey spoke of spending and salary freezes and nearly unprecedented cost cutting. So how can drug and medical device companies make the investments needed to introduce packaging innovations, especially if capital equipment is needed?

To help companies develop packaging that can encourage safe product use and therapy adherence, technology providers such as Alcan Packaging “design packaging for fit and function to meet the requirements of customers in the area of handling, product stability, and regulatory compliance,” explains Garry Hager, director of product and process development, plastics, and contract packaging. “The methods used include design and process FMEAs and FMEAs to identify the best manufacturing approach using the latest manufacturing technology in the areas of overall manufacturing costs and efficiencies. The goal is to ensure the best approach to sustaining the packaging. Alcan has designed and developed several new packaging solutions for compliance packaging that have involved many of our business units working together toward a multimaterial solution that provides the best approach to meet customer needs.”

When it comes to changing materials to cut costs, Foos of Placon doesn’t see much migration from the traditionally used PETG for rigid trays. To save on tooling costs, however, customers are looking at large, interchangeable mold cavities that allow use of one tool for multiple medical devices in one product line, she reports.

While downgauging is almost a norm in the medical device industry, reducing material for sustainability’s sake has not been a key issue for Placon’s customers, whose products need “serious protection,” she says. In fact, Foos says that many devices measuring 20 to 25 in. are in trays with a 40- to 50-ml material start gauge. Instead, companies are looking at sterilizing faster, which often relies on high pressures to expedite degassing, “so the packages need to withstand the rigorous processes and provide adequate venting and air flow around product.”

Lean is in, however. “Pharmaceutical companies have been running leaner these days,” says McCarthy. “And things have run their course with auctions and e-bids. Companies are looking for new ways to take costs out, such as in supply chain and inventory management.”

While make-and-ship ordering has been the standard for many organizations, many pharmaceutical companies are now receptive to locking in demand for a certain period of, say 90 days, if there are savings to be realized,” McCarthy says.

Customers are also more receptive to change, as long as quality and control can be maintained. “Things such as combination or gang printing and process colors, which have typically been viewed as taboo by most of the pharmaceutical industry, are now being considered for their cost savings potential. They just want assurance that the right controls are in place, such bar code verification.”

In the case of equipment purchasing decisions, purchase price often influences buyers, notes Brian Raehsler of Aspect Automation. (Raehsler has written an article scheduled for publication in the October 2009 issue of IVD Technology.) “This type of buyer considers the equipment something of a commodity, similar to buying pens and paper. The expectation is that results will be largely the same regardless of whom they choose to supply their system,” he writes.

“Beyond the cost of the equipment itself, buyers must look at output performance and after-sale expenses such as installation, operation, maintenance, and disposition,” Raehsler explains. Metrics for evaluating system performance have included Mean Time Between Failure, Total Cost of Ownership, and Overall Equipment Effectiveness (OEE). OEE represents the measurement of efficiency and effectiveness. The three components utilized to measure OEE are availability, performance, and quality.

With some capital budgets frozen, drug and device manufacturers may put off installations of new equipment. But the equipment itself could lead to longer-term savings. “Additional up-front costs may seem daunting or even prohibitive, but can create a more robust and durable revenue stream for many years,” Raehsler writes. “The better your system runs, and the longer it stays running, the more profitable it will ultimately become.”

Some packaging innovations may be more expensive than traditionally used ones, but cost savings may be possible through improved patient outcomes and reduced errors and waste. For instance, Dul of Schreiner MediPharm argues that while “a functional labeling solution might be a bit more costly at first sight, compared with simple solutions that do not offer these features and are not as easy to handle, the cost factor becomes relative. The option to increase product safety and to help avoid medication errors should outweigh this by far.”

Capital-strapped manufacturers interested in packaging innovations should share their needs with technology suppliers. Schreiner MediPharm, like other companies serving these industries, can look for ways improve production efficiencies, points out Dul.

For instance, improving quality and reducing cost is at the forefront of Alcan Packaging Medical Flexibles model, explains the company. It continuously partners with customers on projects to create added value, through package redesigns, material alterations, and providing innovative alternatives to their current package. One recent innovation is DesiShield desiccant embedded packaging, eliminating the need to use a separate desiccant product. This can provide cost savings and improve manufacturing efficiency.

Rollprint, too, has introduced its offerings with an eye on reducing costs while maintaining quality. “Rollprint’s Allegro T was designed to seal to uncoated Tyvek and uncoated paper but provide the consistent seal strength and premium appearance of a seal to a heat-seal coated product,” explains Dodrill. “With its very wide operating window, validations are simplified and packaging confidence increased without incurring the costs of a coated product.”

Catalent can help with resource rationalization, McCarthy says. “Our commercial packaging business utilizes similar equipment to what our customers use, so we can assist them with any in-house packaging challenges.”

Catalent continues to invest in expansions, partnerships, and inventory management solutions, such as e-magineering. “In pharma, a lot of stuff is up in the air, waiting to drop. We have to prepare ourselves to be ready for anything. As a printed components provider, we see a mix of initiatives, such as product security and track and trace,” McCarthy says.

As packaging professionals look for innovative materials to help them take costs out while maintaining quality, they should also be focusing on continuous improvement of their own operations. Technology suppliers are being called upon to help with such analysis and implementation of best practices. Explains Serge Caron, vice president, operational excellence and continuous improvement for Alcan Global Pharmaceutical Packaging: “We continue with joint continuous improvement projects (between Alcan Packaging and customers) and the deployment of lean management principles such as Kanban systems, zero complaints, and vendor managed inventory programs.”

Dodrill, too, calls attention to the opportunity for improvement. “Rather than worrying about the economy as a whole, companies should look inward and focus on what they can control: operational excellence,” she explains. “Lean and Six Sigma practices can benefit a company improving quality and processing while lowering costs. A recession does not last forever. Take the time now to align your businesses to flourish as we emerge into a stronger global economy.”

One pharmaceutical company turning to such quality practices for its packaging design is Merck. The company is reaching out to patients for input on packaging design and utilizing Six Sigma–based decision-making tools, among others, to enhance product quality through package innovation.

Other drivers?

Packaging innovations may serve pharmaceutical and medical device manufacturers in other, surprising ways. With controversy surrounding marketing and promotion, manufacturers and brand marketers may find themselves with shrinking venues for their branding messages. Packaging, however, could be the perfect vehicle. If manufacturers provided patient-friendly branded packages in unit-of-dispense formats with complete product information, patients may begin to trust and perhaps favor certain brands.

But FDA is keeping a watchful eye over all promotional labeling, including packaging. FDA’s May 2009 guidance, “Presenting Risk Information in Prescription Drug and Medical Device Promotion,” addresses promotional labeling, which includes advertising materials as well as promotional statements made in packaging and labeling outside of the FDA-required product labeling statements. “The guidance is FDA’s mission for truth in advertising,” says Narendra Srivatsa, business development manager for Cortegra (Fairfield, NJ). “The agency wants to ensure that products approved for certain diseases are not promoted for anything else. It doesn’t matter to FDA where promotional claims are made.” The sample package, for instance, is often a promotional vehicle, Srivatsa adds.

As long as products carry FDA-required and -approved labeling and include required risk statements, firms should be OK to include product claims that are specific and factual, advises Srivatsa.

In fact, The Consumers Union believes that drug safety depends on providing consumers with “full information about prescription drugs.”

At press time, the debate over healthcare reform continued. Critics continued to question the plans proposed so far.

Regardless of whether healthcare is actually reformed, packaging and labeling improvements can still be made. Increasing patient safety and improving patient outcomes will change care on their own.