Potentially Harmful Stolen Products Found in Pharmacies

It was probably only a matter of time. Pharmaceutical products reported stolen in August 2009 have surfaced in pharmacies.

Today FDA is warning patients “that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used,” the agency reported on its Web site. FDA called stolen medicine “harmful” because it could be stored in improper conditions or could be tampered with.

These inhalers are the first products from the stolen lots to be found in “commerce,” FDA reported. The products were taken in August 2009 from a GlaxoSmithKline warehouse near Richmond, VA.

According to FDA’s site, the lot numbers, doses, and quantities of the stolen Advair Diskus inhalers are:

• Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010 (14,400 inhalers)
• Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010 (11,200 inhalers)

In April FDA alerted stakeholders to warehouse and cargo threats, imploring industry to step forward to share best practices. Have you begun your own discussions with FDA? Judging from the number of thefts in the last few months alone, its seems as though pharmaceutical products are under increasing attack. Have you evaluated your own vulnerability?

It remains to be seen how these inhalers made their way into the legitimate supply chain. Wide use of FDA’s suggested standardized numerical identification (SNI)–the serialized NDC–could provide pharmacists and patients greater assurance of product custody and legitimacy.

But using the SNI is voluntary. Will it take supply chain demand to drive its use–or mandates?

Daphne Allen

Posted in Compliance Packaging, Diversion, FDA, Theft | 1 Comment »

CAPS Study Zeroes in on Patient Safety

In a decades-old debate, the United States Pharmacopeia (USP) is expected to take action that could prevent manufacturers from printing U.S. Food and Drug Administration-required and approved dosage and other identifying information on the caps of injectable drugs. This information serves as a final warning and safety checkpoint before a drug is dispensed and injected.

On April 15, 2010, the Consortium for the Advancement of Patient Safety (CAPS) submitted results of a three-part report, including a human factors engineering analysis, on the relationship between patient safety and printed messages on ferrule and cap overseals used to secure injectable drug vials. CAPS commissioned this study to provide independent, empirical data to the USP in response to USP’s proposed revision of USP General Chapter, Injections, Labeling on Ferrules and Cap Overseals. CAPS was formed to educate and promote awareness of the benefits of printing on drug packaging, specifically secondary closures, to mitigate medication errors and improve patient safety.

“USP appreciates that CAPS provided data in support of its comments on the proposed standard,” says Matthew Heyman, VP, external affairs and strategic integration, USP. “The study, along with other comments on the proposed standard, was presented to the Nomenclature Expert Committee for its consideration. That Committee’s decision and other relevant information will be posted shortly on www.usp.org.”

The USP proposal, expected to become effective May 2011, would limit printing and other types of messaging on the top of the drug vial, such as ferrules and cap overseals. The USP published its most recent revision in the Pharmacopeial Forum Vol. 36 (1), around February 2010. Because of the absence of data on this issue, a member of the Food and Drug Administration recommended that CAPS conduct a HFE study during a meeting CAPS had with the agency last year.

CAPS members believe that limiting information to warnings of imminent life-threatening situations ignores the potential impact of medication errors. Patient safety includes more than just imminent life-threatening events. The affect of other medication errors should be taken into consideration.

The proposed limitations may interfere with anti-counterfeiting strategies applied to ferrules and cap overseals. A plain cap is easier for counterfeiters to duplicate. Product identification efforts are often linked to anti-counterfeiting efforts, so even product names serve a purpose not related to advertising or marketing. Counterfeiting is a threat to public health and should be considered in any patient safety program.

“We are hoping that the independent comprehensive study, contracted by CAPS, will correct some of the misperceptions which seem to be the premise for the proposed restrictive language in USP General Chapter 1, Injections, section on Labeling on Ferrules and Cap Overseals,” says Fran DeGrazio, VP, marketing and strategic business development, West Pharmaceutical Services Inc. “The approach that CAPS has taken to utilize an independent scientific and fact-based study to understand this issue is logical. Our hope is that this information will be strongly considered by the USP in their decision concerning the revised wording of this section of Chapter 1. I believe we are all interested in ensuring that results from our decisions promote and support patient safety.”

Printing on caps can be changed easily to support evolving patient safety initiatives and does not impact the primary packaging. The CAPS organization believes that the drug company is the most appropriate to determine what information to present on ferrules and cap overseals.

“The CAPS empirical study was completed in March 2010,” says Frederick J. Balboni, Jr., executive director, CAPS. “For the first time, we are able to cite factual, unbiased data strongly supporting and validating our hypothesis that the revision has the potential to pose a serious threat to patient safety.”

In three parts, the data states that there was no finding of medication errors associated with this type of printing; that the majority of participants felt the messages were important and beneficial in preventing medication errors, and consequently were in favor of less restrictive language; and the evaluation associated with understanding how the presence or absence of information is noticed by health care providers indicated that “less is not necessarily more,” meaning that limiting the messages to less critical information does not make the critical information more visible.

On May 25, 2010, CAPS presented this data on this issue at a meeting of the USP’s Nomenclature Expert Committee. It is the organization’s hope the unbiased data garnered in this study will assist the Nomenclature Committee in developing a viable standard acceptable to both USP and industry with the primary objective of insuring patient safety.

Gina Monari

Posted in Labeling, Medical Errors | No Comments »

Save Steps

We received some valuable feedback on our Webcast, “Ensuring Sterile Barrier System Success.” I wanted to share it with you because it rightly associates “user friendliness” with “sustainability.”

Daphne,

This is a great presentation. It gave me a good idea of what the sponsors are doing to work with their customers to make packaging better. This makes me happy and hopeful that there are suppliers willing to put themselves into the position of advancing the field and reputation of Good Packaging.

On the other hand, I am totally concerned about the number of designers not including their suppliers, customers or end user considerations. (Editor’s note: We polled Webcast attendees and found that only 34.5% test package designs with nurses or doctors, while 48.9% invite packaging suppliers to be a part of package design reviews. These are final results; broadcasted results differed slightly.)

On a personal level, I have, at every chance, avoided the use of controversial materials and methods. My methods also include the process of considering the end-user as well as every person involved from manufacturing to disposal.  This takes me to the next and related issue of sustainability.

Along with the sustainable movement, I really do believe that there needs to be an equally emphasized movement regarding end-user safety and efficiency. Whoever ends up owning this program should direct it toward the product managers and marketing people as well.

I have found, by the school of hard knocks, that there are some product managers that do not know about, nor care about or want to deal with end-user concerns or sustainability.

Bottom line, sustainability issues would naturally improve if an “awareness” were to be made about doing “right or holistic design.”

A personal caveat, just for the sake of the issue: I am fairly hard on people that talk the story of being concerned about sustainability and then market their cost reductions as being sustainable. When in reality, they are doing something that should or would have been done anyway by those responsible for maintaining their corporate bottom line. In other words they are doing cost reductions and calling them green or sustainable changes.

In it’s basic form, “sustainability” means “doing no harm” and returning back to the environment what was taken from it so that life can go on.

I don’t mean to preach, but I just want to raise awareness of what reality should probably look like.

Again, good presentation!

Sincerely,

Warren Schirado
A Concerned Engineer

Mr. Schirado’s letter takes me back to some advice my great-grandmother gave me long ago: “Save steps,” she would always tell me. I wonder how much end-user trouble (and product waste) could be avoided if all medical device manufacturers would ask end-users what they need before products are designed?  And how much time could be saved (and great ideas utilized) if packaging engineers were brought to the R&D table to add their input? Finally, if packaging suppliers were also involved to offer new materials or new processes, qualifications could begin early enough to avoid product launch delays.

Saving excess packaging material could also result in process savings, too.

What do you think?

Daphne Allen

Posted in Uncategorized | No Comments »

They May Not Be Fakes But . . .

Perusing the California State Board of Pharmacy’s Web site, I came across a memo on pharmacies investigated for filling prescriptions for Web site operators. If these prescriptions are not backed up by an appropriate prescriber exam, these “pharmacies are facilitating the illegal distribution of prescription drugs from the Internet,” the memo explained.

Apparently the board has already issued millions of dollars in fines to these pharmacies. According to the memo, many of these pharmacies have reported that they had received offers via fax to fill these Internet orders for a fee.

How big of a threat is there? These patients may be self-medicating. Patient health is at risk when prescription drugs are used without professional advice. Patients may also be at risk for drug interactions or other complications when not fully aware of the products’ proper use. And sadly, a few days ago we shared the report that “abuse of painkillers and other medication is sending as many people to the hospital as the use of illegal drugs.”

Internet opportunists appear to be taking advantage of these patients and the legitimate supply chain. They are creatively persistent and will continue to look for gaps.

Wouldn’t it be wonderful if every prescription could be serialized so that its path through the supply chain–including prescribing history–could be precisely traced? That way, legitimate pharmacies looking to supplement their income won’t be drawn into the latest scams. And your products won’t be caught up in the mix.

Daphne Allen

Posted in Counterfeiting, Internet, Labeling, Medical Devices, Pharmacies, Safety, supply chain | 2 Comments »

Another Threat You Need to Track: Falsified APIs

While drug counterfeiting is considered by many to be a significant worldwide problem, there could be an even bigger one looming: falsified active pharmaceutical ingredients (APIs). Today Rx-360 Board Member and Hovione CEO Guy Villax called the threat of falsified APIs an “iceberg.” He spoke in the Webcast, “To What Extent Can Pharmaceutical Counterfeiting Ever Be Contained?” which is part of The Walpole Lectures.

What does this threat have to do with packaging? Directly, not much. But if product traceability is considered a potential weapon against counterfeit and diverted drugs, your emerging task of assigning unique numbers to the items you package could potentially involve referencing upstream API sources.

The threat comes from “hidden API manufacturers” that may exist and supply ingredients to traders that serve registered and approved API manufacturers. Villax spoke of traders obtaining APIs from these hidden sources, which could be using counterfeit chemicals or those made in rural locations that may not meet expected quality standards. Once these “falsified APIs” enter the legal supply chain through the registered API manufacturers, these manufacturers then supply dosage-form manufacturers, he said.

Falsified APIs could put a significant number of patients at risk. “One API batch could [reach] 10,000 to 200,000 patients,” Villax said.

Interestingly, when presented with the attendee question, “How can counterfeiting threats be measured?” Villax likened the solution to that of catching “speeders” on a highway. “You need number plates” and other tools so you can track those speeding.

Another event speaker, Marisa Matias, remarked that while there is a lot of uncertainty about the real numbers behind counterfeits or related threats, “even if just one patient is affected, we should tackle it.” Matias is MEP, Rapporteur - Counterfeit Medicines, European Parliament and Member of the European Parliament.

Villax lamented that while “we can all look at our shirts” and at our produce and know exactly where they came from, that cannot be done with medicines.

Daphne Allen

P.S. Mark Davison, Pharmaceutical Consultant & Writer, was session chair of this event. I found his insightful blog today and will stop by regularly. Other Webcast speakers included Janice M. Soreth, Deputy Director, U.S. FDA Europe Office; and Hans Bijl, Sr. Business Development Manager at Siemens’ Industrial Automation Competence Centre Life Science (Antwerp, Belgium.)

Incidentally, Soreth said during the event that addressing counterfeiting is “very high on the agenda for FDA” and that the agency is engaged internationally in “capacity building.”

Are you building up your own capacity to track these threats, too, in order to prevent them from putting your products at risk?

Posted in Compliance Packaging, Counterfeiting, Diversion, FDA, Medical Devices, security | No Comments »

DANGER: Patients Misinterpret Directions, Need Clear Labeling

What are some of the challenges you face when designing labels and cartons to reduce the risk of medication errors? FDA wants to know, and pretty soon. By the end of FY 2010, the agency is scheduled to publish draft guidance “describing practices for naming, labeling, and packaging drugs and biologics to reduce medication errors,” it wrote in the Federal Register on April 12.

This week FDA is holding a workshop to discuss such guidance. June 24 in particular will be an important day for you to attend, given its all-day focus on packaging and labeling. Representatives from FDA will be presenting and leading panel discussions on container label and carton design; the use of human factors analysis, failure mode and effects analysis (FMEA), usability studies, and other studies; and manufacturers’ packaging.

Just how critical is carton or label design to safe product use? Earlier this month the Institute of Safe Medication Practices (ISMP) published a report of a patient who failed to use a cleaning and disinfecting solution correctly for her contact lenses. Clearer warnings in packaging and labeling might have helped to prevent such misuse, ISMP suggests. (ISMP does an excellent job of providing error reports, end-user perspectives, and its own error analysis, which should be of interest to all packaging engineers and designers even if their product categories are not being discussed. I encourage you to read its newsletters regularly to learn what trips up end-users.)

I am not sure that FDA’s workshop will go into such product specifics. But discussing “usability studies” is a step in the right direction, since users provide essential design feedback.

If you cannot attend FDA’s workshop this week, you will have until July 23, 2010, to submit comments under the public docket [FDA-2010-N-0168-0001]. We will post the link to the transcript as soon as it is available and look forward to continuing the discussion of how to use packaging and labeling to prevent medication errors.

Daphne Allen

Posted in FDA, Labeling, Medical Errors | 1 Comment »

Smart Card Helps Track Outpatient Distress

A leader in extending hospital care into the home, Meridian Health is enhancing its home -based services with its agreement to use the Memori card from Stora Enso. The smart card will be used with Meridian’s electronic Health Journal for outpatient pain monitoring. 

Patients will use the diary format card in tandem with their solid dose packaging. Patients press buttons to indicate how they are taking the medication and their levels of distress while and after they take the drug. Doctors can then quickly scan up the information retained in the card at the patient’s next visit.

 Patients don’t have to rely on recall or incomplete notes for documenting their pain levels. “Meridian’s Health Journal including the Memori card is a tool for accurately measuring stress and pain, which enables the doctor to properly diagnose the patient’s condition,” says Ralph Mendoza, sales and marketing manager, Stora Enso.

 A format of Stora’s Pharma DDSi intelligent package, the Memori card was developed by Meridian Health as a quickly deployable solution. Meridian plans to move to a medication package that combines the diary with time-stamping of tablet egress at some point, Mendoza says.

 Designed with conductive traces by Stora, the packaging incorporates a third generation ASIC microchip from Cypak.

 ”We decided to work with Cypak because they are focused on development of standards-based technology.  The promise is the creation of a common platform for all packaging and devices used in the home, so they work together and create a seamless experience for the patient,” Mendoza says.

 A non-profit healthcare organization with four hospitals and in-home and community based services serving Monmouth and Ocean Counties in New Jersey, Meridian is also a Cypak partner. The companies announced they will jointly develop new technology products and services aimed at improving patient care and clinical outcomes, with an initial focus on medication and pain management, and various chronic conditions.

 And earlier this year, Meridian’s home care services–Meridian At Home– launched MediSuite SM for home-based medication management, with tools including an automated medication dispensing system, phone call reminders, and access to trained nurses.

Dave Vaczek

Posted in Compliance Packaging | 1 Comment »

What Can Packagers Do to Fight Online Fakes?

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

Posted in Counterfeiting, FDA, Pharmacies | 1 Comment »

Packaging Should Be Used to Improve Health Literacy

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

Posted in Labeling, Medical Errors, Uncategorized | 1 Comment »

Are You Ready for the 100% Cargo Screening Mandate?

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

Posted in Cold Chain, Safety, Transporation | 2 Comments »