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What Can Packagers Do to Fight Online Fakes?

June 17, 2010 – 3:43 pm

Can patients really still be falling for rogue pharmacies? And if so, what should you be doing to prevent drug sales from such sites from putting patients at risk?

FDA today warned consumers about a “generic Tamiflu” sold over the Internet. Not only is there no such FDA-approved generic Tamiflu, but the product doesn’t even contain Tamiflu’s active ingredient, oseltamivir. Instead, it contained cloxacillin, an ingredient in the same class of antibiotics as penicillin, FDA reported on its Web site in a press release. This could be life-threatening to patients who are allergic to or may have experienced adverse reactions to penicillin. (Like my mother and husband!)

To date, the FDA is not aware of any reports of adverse reactions, the agency says in the press release.  The agency explained that it bought the fraudulent product without a prescription from a Web site claiming to be an online drugstore. The site is no longer working, but FDA warns that “the fraudulent version is likely to be found for sale on other Web sites, however.” According to the release, “the product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder. The foil backing is printed, and labeled in part, “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.”

For more details from FDA, click here.

Last week the National Association of Boards of Pharmacy (NABP) saluted Yahoo! for changing its policies for Internet pharmacy advertising, NABP wrote on its Web site. Yahoo! joined Google and Microsoft’s Bing.com in requiring online pharmacy advertisers to be accredited through the VIPPS (Verified Internet Pharmacy Practice Sites) program.

“On behalf of the state boards of pharmacy, NABP is pleased to see Yahoo! taking steps to protect the public health against rogue Internet drug outlets,” wrote NABP President William T. Winsley, MS, RPh, on NABP’s Web site. “We congratulate Yahoo! on its conscientious decision to hold pharmacy advertisers accountable to the laws established in the US to protect patient health.”

Will this be enough to fight online drug pirates? Or should you be joining the fight with a few weapons of your own?

Daphne Allen

Packaging Should Be Used to Improve Health Literacy

June 16, 2010 – 6:26 pm

How important is health literacy to patient outcomes? I found an interesting blog post on this topic on Twitter courtesy of @JNJComm, aka Marc Monseau. The blog was written by Scott C. Ratzan, MD, MPA, Vice President, Global Health, Government Affairs & Policy, Johnson & Johnson. “The way people interact with the health system has great impact on whether they can improve their health,” he wrote. “And improving people’s understanding of health information is an important first step.”

Ratzan wrote that he was pleased that the U.S. Department of Health and Human Services has developed a National Action Plan to Improve Health Literacy, and I am, too. I hope, though, that the impact that packaging and labeling technology could have on health literacy will also be considered.

“Basic health literacy is fundamental to the success of each interaction between health care professionals and patients—every prescription, every treatment, every recovery,” wrote Howard Koh, M.D., M.P.H., assistant secretary of health in the plan’s foreword. Much of the plan discusses “health literacy” in general terms, such as improving “patient-provider communication” such as “written materials, videos, or other targeted approaches to patient education.”

While I didn’t find any direct references to packaging or labeling, the plan does say that “studies have shown that picture-based instructions promote better understanding of how to take medication and decrease medication errors among patients.”

I firmly believe that packaging is an important, yet underused technology that can do so much to support patient education. Beyond its primary function of protecting product efficacy, packaging can also communicate use instructions and even clarify complicated regimens, if designed properly. And unlike doctor handouts or pharmacy-generated materials, which could end up in the file cabinet or worse yet, the waste bin, packaging can stay with the product, keeping those instructions literally at hand.

So look for ways to add those “picture-based instructions” to packaging and labeling. The HHS plan advises that researchers, evaluators, and funders “explore technology-based interventions to improve health literacy.”  I would like to volunteer packaging technology for that job.

Daphne Allen

Are You Ready for the 100% Cargo Screening Mandate?

June 3, 2010 – 6:45 pm

I listened to an informative roundtable  courtesy of American Airlines Cargo on the upcoming 100% Air Cargo Screening Mandate, which becomes law on August 1, 2010. All cargo to be shipped on passenger airplanes will need to be screened before it is loaded. The law is to “ensure the safety of those passengers above that cargo,” explained Doug Brittin, general manager, air cargo, Transportation Security Administration (TSA).

We covered this issue last September 2009 in “Pharma Firms Set Up Cargo Screening,” in which senior editor David Vaczek reported on Pfizer’s efforts to get pharma working with the TSA to develop screening procedures. We’ll follow up on that effort.

But judging from the roundtable, pharmaceutical companies have been active in TSA’s Certified Cargo Screening Program (CCSP). According to TSA, “the program enables freight forwarders and shippers to pre-screen cargo, avoiding any potential bottlenecks at the airport.”

The good news is that many in “the pharmaceutical industry realized early and went in early to become CCSP facilities,” explained Dave Brooks, president of American Airlines Cargo, during the roundtable. But gaps do remain.

For instance, after August 1, what could happen with shipments that are not pre-screened through a CCSP-certified facility? “We’ll have to screen them,” explained Brooks. Typical methods of screening include x-ray systems, use of explosive trace detection, and physical inspection. But x-ray cannot be used with all pharma shipping containers, like drums, and some radioactive healthcare materials could yield positive explosive trace detection tests, noted roundtable speakers. And physical inspection requires screeners to open packages, which could compromise sensitive pharmaceuticals and break custody chains.

The law also requires piece-level inspection. “If pieces are put on a skid and wrapped and we can see multiple pieces, we are obligated to separate and inspect each piece,” Brittin of TSA says. That means that pallet loads with multiple individual shippers shrink-wrapped onto a skid that are not prescreened will have to be opened and inspected using these methods.

“There are improved screening technologies available, but they require extra steps,” explained Brooks. “That means more time, more equipment, more space, and therefore more cost.”

Unscreened shipments risk departure delays, because airlines will not delay passenger flights waiting for late cargo, Brooks said. “If the freight is not screened and that plane is ready to go, that freight won’t fly,” he explained. And as such shipments wait for screening and perhaps later flights, they risk exposing products to conditions outside specified parameters.

All roundtable speakers agreed that the best option to comply with the law is to pre-screen their products under CCSP certification. “Inspection can happen as the commodity is being packed,” explains Brooks.

Brandon Fried, executive director of the Airforwarders Association, agreed. “It is better is the shipper does the screening. It doesn’t mean that we are not ready to do the screening ourselves, but that it is better for shippers to screen as they pack,” he said.

Brooks said that approximately half of the world’s cargo capacity is provided by passenger airplanes, and he does not want to see that business shift to other modes of transportation. “We are hugely motivated to make sure that the dock process goes as smoothly as possible. We are spending a lot of money to be compliant ourselves. Shippers and forwarders that can do this work themselves and present shipments to us as prescreened will have a better experience at the dock.”

Daphne Allen

Health Reform Invites Innovation

May 24, 2010 – 5:56 pm

The healthcare reform act simultaneously expands insurance coverage to millions of Americans and drives additional drug spending through discounts to others, while seeking to lower healthcare costs.

New programs for evaluating cost control and improving quality of care are central features of the healthcare act signed into law by President Obama.

As new patient care models and payment strategies are tested, they will create new incentives for pharma industry innovation, says Dr. John Michael O’Brien, executive director of the Responsible Health Institute, and clinical adjunct professor, the Ernest Mario School of Pharmacy at Rutgers University.

“The healthcare reform bill provides an important opportunity to evaluate and implement new ideas to improve medication adherence–a problem that seriously undermines quality of life and quality of care, patient outcomes, and the value of our healthcare dollars,” O’Brien says.

The reform includes a national strategy to improve healthcare outcomes. Medicare, for example, will focus on linking payment for services to quality outcomes, O’Brien said at the Healthcare Compliance Packaging Council‘s annual symposium.

The legislation clears the way for testing a spectrum of approaches for care delivery and payment models. The new Medicare Innovation Center will investigate, for example, pay and practice reform in primary care, including patient-centered medical homes. Tele-health models for coordinating care among the home-bound chronically ill will be evaluated.

The Innovation Center can expand compliance solutions throughout Medicare and Medicaid programs if they are shown to reduce cost and improve quality, O’Brien says.

Grants will support evaluation of pharmacist-provided medication therapy management services, which Part D plan sponsors will be required to expand.

As the provisions of healthcare reform drive more drug use and drug spending, the government will seek to change the way it pays for drugs.

“If the government focuses solely on costs, they may seek to implement price controls or implement aggressive formulary practices. There is significant variability in the generic dispensing rate among plans in Part D.”  CMS could require more multisource drugs in a Part D plan’s formulary, or require prior authorization or step therapy, O’Brien says.

“A better approach would be to include drugs in pay-for-performance, value-based formulary designs, or other approaches that recognize the value of medicine, improve quality, and reduce overall healthcare costs,” O’Brien says.

A 15-member Independent Payment Advisory Board (IPAB) will offer recommendations to reduce the per capita rate of growth in Medicare spending if spending exceeds a target growth rate. The board must submit recommendations every other year for slowing the expenditure growth, without compromising quality of care.

“Improved clinical outcomes as a result of improved adherence could be important when the (IPAB) evaluates future drug spending. Hospitals may also want to include compliance packaging as a component of their discharge strategy. These costs would be offset by the improved payment rates provided to hospitals that prevent readmissions,” O’Brien says.

Expanding healthcare coverage, while reducing costs and improving quality, is a tall order. While studies to date have demonstrated the impact of adherence on overall health costs, the reform bill should yield new insights, given its emphasis on pay and practice innovation.

Dave Vaczek

How Vigilant Are You?

May 24, 2010 – 4:24 pm

Rx-360.org sent out an alert over the weekend about another pharmaceutical cargo theft, this time in Memphis. The grassroots group got a lead from FreightWatch International, and I am researching the story now.

In the meantime, I went back and reviewed FDA’s advice on warehouse and cargo thefts. The agency is hoping that you will help it identify best practices in preventing cargo and warehouse theft, and this is an incredible opportunity for you to work closely with the agency ahead of formal guidance, standards, or even rules.

“The best intervention is prevention,” said Ilisa Bernstein, director of pharmacy affairs in FDA’s Office of the Commissioner, Office of Policy, in an April 28 conference call with industry stakeholders. The call was held the same day that FDA issued a letter on cargo theft to industry trade associations to share with their members. “Firms that provide medical products and infant formula to the public have a fundamental responsibility to continuously review . . . their security practices and procedures for transporting products to make sure that measures are in place to minimize the risk of warehouse and cargo theft. Awareness, vigilance, and diligence can prevent theft.”

While FDA has only recently been “engaged in finding out about these threats,” the agency senses that such incidents are on the rise because “the numbers have gone up in terms of what we are aware of,” Bernstein said. The agency has issued “20 public alerts since April 2009,” she added. These alerts pertain only to domestic incidents.

FDA has set up a Cargo Theft Response Team that includes agency members from the Office of Criminal Investigation as well as from the Offices of Compliance for all relevant agency centers. Agency members focusing on international affairs and regulatory affairs are involved, too.

FDA expects stakeholders to respond to thefts immediately and to be able to provide risk assessment plans and action plans. (Interestingly, the FBI was on the call, too, urging stakeholders to notify them as well about such thefts.) For a good idea of what information you’ll need to be able to provide, see the appendix at the end of FDA’s letter.

But how can you predict whether you’ll be prepared—and in compliance—should your cargo fall victim? It may pay to start working with FDA now to help the agency craft those best practices that compliance officers may one day hold you to.

FDA is already working on standards to secure the supply chain against counterfeit drugs, so I asked the agency whether future standards or regulations could be issued pertaining to stolen products. It seems to me that FDA may be looking for one family of standards to address all such crime. As two FDA spokespeople told me, stolen products are “another threat to the supply chain, and as we think about further securing the supply chain, we need to keep stolen product in mind.”

Could use of the serialized National Drug Code (sNDC; FDA’s suggested Standardized Numerical Identification) identify stolen products better than lot numbers? I asked.

“Use of a serialized NDC will be very helpful in better identifying stolen products that make their way back into the supply chain,” they told me.

How ready are you? If you are not using the sNDC and your shipments fall victim, what will the Office of Compliance think? Will FDA question whether you could have been more vigilant?

Daphne Allen

Are There Gaps in Labeling Security and Sampling Programs?

May 19, 2010 – 12:56 pm
McNeil Consumer Healthcare’s recent recall of certain children’s products appears to be related to quality issues. And now FDA is widening its investigation. However, I read FDA’s inspection report a few days ago and learned there were some packaging-related observations included, too. It is unclear whether any of these would have been reason enough for a recall. But making note of these observations may serve to educate others in the industry.
For instance, FDA inspectors noted that “strict control is not exercised over labeling issued for use in drug product labeling operations.” Specifically, “labeling was not stored in a locked cage with limited access,” read the report.
The labeling observation intrigues me because strict accounting of label supplies should be part of a company’s error-prevention program as well as a brand security program. But how is this commonly achieved throughout the industry? Are there gaps that need to be addressed? By whom?
Also from the inspection report: “There is no written testing program designed to assess the stability characteristics of drug products.” Specifically, “stability samples collected off of the packaging line for lots . . . were pulled from the beginning of the packaging run. . . . Stability samples are not representative samples from the beginning, middle, and end of the fill run specifically for the three batches with super potent end sample fills.”
I have heard many questions from the industry about sampling, and this observation should serve to address some. Packagers wonder how to develop a statistically sound sampling method. FDA very clearly seems to state that sampling should involve the beginning, middle, and end of a run. Is this enough feedback from FDA–or is a more-specific plan required?

Daphne Allen

Could Patient-Centered Labels Spread beyond the Pharmacy?

May 13, 2010 – 12:41 pm

Today is the final day for comments on California’s new prescription drug labeling requirements aimed to boost patient safety. Don’t worry–they appear to target pharmacy-generated labels, not manufacturer-generated labeling–but I wonder how they ultimately could influence your labeling.

The new rule drives a number of changes that would result in what is called “a patient-centered label.” What intrigues me most (today) is the debate over font size. Early language lists the minimum font size at 12 points, but the California State Board of Pharmacy changed the proposed minimum to 10 points and then added a clause that 12 points are to be used if the consumer requests it.

The State Board of Pharmacy had received several letters from senior citizens, their advocates, and others objecting to the 10-point minimum. Another comment period was announced, concluding today. (For details, visit the board’s regulation page.)

To read some of the past comments, visit the board’s April meeting page and read all the attachments under “1707.5 Patient-Centered Prescription Labels.” There’s a lot of passion in these letters. For instance, Gary Taylor wrote: “Confusing or hard-to-read prescription labels pose a major threat to the safety of patients, especially seniors and others with limited eyesight. We need safer, clearer labels to help prevent deadly errors.” In conclusion, he wrote: “Requiring a 12-point font on the most important parts of medication labels is a small step that will save lives. I urge the Board to return to its initial recommendation and vote for stronger prescription label standards for Californians.”

Steven Wallace, PhD, Professor and Vice-Chair, Dept. Community Health Sciences, UCLA School of Public Health, is optimistic that technology can deliver the 12-point font. “While some bottles and packaging may be small, there are a number of innovative ways to attach labels that are large enough to support 12 point type with key information.”

How does this affect you, a packaging professional at a pharmaceutical or medical device manufacturer? In terms of current regulations, very little, I imagine. But if labeling font size truly influences patient comprehension, as these letter writers stressed, you may want to look at your own labeling, especially if you are intending some of it for patients.

Yes, 12-point font size is large, especially when you compare it with FDA’s minimum font size of 6 points for Drug Facts labeling text for over-the-counter drugs.

But I wonder what FDA may think now. Interestingly, in its “Strategic Plan for Risk Communication,” FDA writes: “Clear and easily understood information on prescription drug labels and instructions for use, as well as extra efforts to target specific identified problems and populations, can help ensure appropriate and safe use. For example, if particular drugs are more likely to be used by elderly people, considering carefully that group’s cognitive limitations could lead to instructions for use that are more likely to be followed.”

Could California’s influence over pharmaceutical labeling soon be felt even more?

Daphne Allen

Larger the Package, Larger the Liability?

May 6, 2010 – 2:08 pm

A jury has found Teva Parenteral Medicine and Baxter Healthcare Services partially liable in a lawsuit filed by Henry and Lorraine Chanin, reports the Las Vegas Review-Journal. We shared the case yesterday in our daily newsletter, and our sister publication Pharmalive.com shared the jury’s decision today.

The case claimed that Henry Chanin’s hepatitis C infection was the result of too-large propofol vials that “enticed” nurses to use the vials for more than one patient, the journal reported.

While it is unclear to me how the large vials were marked in terms of dosing instructions, the Las Vegas Review-Journal‘s story quotes a Teva spokesperson’s reference to “product misuse.”

Patients have been exposed to blood-borne diseases through product sharing before. Last year FDA issued an alert reminding healthcare providers to not use insulin pens and insulin cartridges for more than one patient after reports that such pens may have been shared among patients at hospitals in 2007 to 2009. According to FDA, “Some of the potentially exposed patients have reportedly tested positive for hepatitis C; however it is not known if the hepatitis infection occurred through insulin pen sharing, or if those who tested positive had previously undiagnosed hepatitis C.”

While the jury accepted the Chanins’ claims, the doctors and nurses reportedly settled their cases a while ago, so it would be unfair to say that the drug companies were found entirely liable. And yet I wonder: Could the Chanin case and other potential instances of infection drive pharmaceutical manufacturers to switch drugs currently packaged in large or multiple-dose vials and other containers to smaller, unit-dose formats?

Daphne Allen

Mount an Aggressive Attack on Fraud with Supply-Chain Visibility

April 27, 2010 – 12:48 pm

I left a message at the White House for Communications Director Dan Pfeiffer about his blog today on Health Reform. He wrote that the health reform law will strengthen Medicare “by taking aggressive new steps to fight waste, fraud, and abuse within the system.”

Fraud itself could amount to $60 billion EVERY YEAR, reported ABC News last month when it shared a Nightline investigation into Medicare fraud.

That’s a heck of a lot of tax dollars that could instead be spent on making healthcare reform work. Were these potential savings even considered by the economic experts at the Health and Human Services Department who analyzed the law and found that it “falls short of the president’s goal of controlling runaway costs”? (We shared news of that report last week in our daily e-newsletter.)

I wonder what President Obama’s “aggressive new steps” could be? More investigators, more muscle? Another report from ABC just yesterday paints a pretty rough picture of the criminal element behind such fraud.

But why not fight these criminals through increased supply-chain visibility? If unique product serial numbers that could be verified through an exchange system much like the financial industry uses were required for Medicare reimbursement, the government could at least stop reimbursing the phantom pharmacies that Senator Chuck Grassley describes in his letter to HHS Secretary Kathleen Sebelius.

I have also heard that electronic pedigrees could arm prosecutors with the evidence needed to convict criminals once captured. Paper trails are much hard to follow.

I am waiting for Mr. Pfeiffer’s call, so I will let you know what I hear. In the meantime, feel free to suggest your own ideas for fighting fraud. We have shared industry concerns that increased taxes levied against the industry would be tremendously burdensome and could stifle innovation by cutting R&D.

Instead, wouldn’t it be great news if fraud prevention could pay for healthcare reform?

Daphne Allen

Proposed Labeling Rules to Come?

April 26, 2010 – 5:44 pm

It’s a good thing I decided to search regulations.gov today for updates on some pending FDA regulation. The Department of Health and Human Services just posted its Unified Agenda. Among other tasks, FDA is working on two potential actions that could change the way you label drugs and medical devices.

Electronic Inserts
FDA has rescheduled its notice of proposed rule making several times for “Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products.” According to this agenda, FDA plans to release a proposed rule sometime in June 2010. “This rule would require electronic package inserts for human drug and biological prescription products, in lieu of paper, which is currently used,” reads the agenda. “This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.”

This issue is a complicated one, given the role pharmacies would need to play in equipping themselves to access electronic information. Real-time updates could be incredibly beneficial. But some worry that electronic package inserts could push industry toward electronic patient inserts; they fear that relying solely on pharmacies to distribute mandated product risk information to patients could introduce inconsistent or incomplete information. State boards of pharmacy would need to cooperate at some point, given the fact that FDA has no regulatory authority over pharmacies.

Unique Device Identification
Under the FDA Amendments Act of 2007, FDA was charged with promulgating “regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions,” reads the agenda. “The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number.”

The big debate here is whether to use a lot code or a serial number.  And I have heard this question asked over and over again: “So do we serialize every tongue depressor?”  Some in industry are inclined to base decisions on the level of risk presented by devices.

A notice of proposed rule making is scheduled for December 2010.

What do you think of these potential proposals?

Daphne Allen