Just in Case Thieves Are Working this Labor Day

FreightWatch sent out some good holiday advice that I thought I would pass along to you. Dan Burges, CPP, director, global intelligence of FreightWatch, issued the following alert today via e-mail (in italics below) and gave me permission to share it with you:

Event: Holiday Awareness
Date: Labor Day Weekend

Description: Shippers, manufacturers, and transportation companies must remain aware of the increased security risks during the upcoming Labor Day holiday.

Holidays can cause long delays for drivers attempting to deliver loads. These delays will increase the risk to drivers and loads in-transit by leaving them vulnerable for longer periods of time.

Holiday weekends are notorious for high volumes of cargo theft activity, especially at terminals and drop yards where loaded trailers are parked for long periods of time.  This amplifies the need for logistics professionals to ensure their security protocols are up to date and in line with industry best practices.

For warehousing operations, ensure your security alarm systems are functioning properly.  FreightWatch also recommends the following:

•    Treat all alarm trouble signals as an intrusion alarm.
•    Do not rely on a backup (cellular/radio) system.
•    If primary alarm fails assign security officer to patrol facility exterior.

For in transit operations, FreightWatch recommends drivers remain vigilant and maintain communication with their dispatch when stopped at high risk areas such as truck stops and rest areas.  Loads should not be dropped or left unattended for any reason.

Reading Burges’s advice made me recall two occurences I saw recently. While traveling in Illinois, I saw a major pharma distributor’s truck parked at a fast food restaurant. I had remarked on it to an industry member, who pointed out the fact that the distributor had a location just around the corner. He didn’t seem too alarmed. But I wondered–couldn’t a criminal just follow one of these trucks around, waiting for the driver to get hungry? If so, are there safeguards in place to prevent (or catch) theft?

I also saw a food distributor’s truck stopped in traffic this week after a minor fender-bender. Mindful of the cold chain, I wondered whether these delays (and they’ve got to be common, at least here in Los Angeles) ever put loads at risk.

Burges’s advice is valuable, given the amount of cargo theft activity FDA has reported here. Be sure to follow Freightwatch on Twitter for other updates.

Daphne Allen

Posted in Theft, Transporation, security | No Comments »

Don’t Shy away from a Brand-Protecting Label Change

While working on our next issue of Tracking & Tracing Pharmaceutical Products, we checked in with Huda Midani, business development manager, Schreiner ProSecure, Schreiner MediPharm L.P. about making a switch to a security label. I hear from many of you that changing packaging or labeling can often be challenging given potential regulatory hurdles, so we wanted to get their input.

In Schreiner’s experience, deploying a security label often has minimal regulatory impact, says Midani. “A Changes Being Effected (CBE) or annual report submission to FDA may suffice,” she says. “If the label modification is such that it impacts function, and other attributes that affect the caregiver/patient’s ability to use the product, then the label must go through a regulatory review of the agency.”

Schreiner “works directly with the brand owners and encourages a cross-functional, interdisciplinary working group, with members from quality and regulatory having input to any changes or modifications to the labels prior to any implementation. All labels produced for the pharmaceutical sector must be signed off and approved by the brand owner who evaluates their compliance with all CFR labeling requirements and their equivalents on international fronts,” says adds.

Effective teamwork will benefit companies not only throughout the label change process, but also in the fight against counterfeiting and diversion. Midani urges pharmaceutical companies to unite internally for a truly holistic approach. “It should include the efforts of legal, quality, marketing, and sales responsibilities to make technologies successful. Communication, training, and education programs to target audiences such as customs, wholesalers and/or doctors, pharmacists, and patients are fundamental to the program’s success.”

To help companies switch, from a standard label to a security label, Schreiner offers full systems integration consultative services to help minimize the impact of that switch in their production process. “As a company who subscribes to lean manufacturing, six sigma, and total quality management philosophies, Schreiner will ensure that the security label suggested has minimal impact on the equipment, while maximizing the value of its implementation so that there is a tangible return on investment. As a global leader in label technologies, we have relationships with raw material and component suppliers globally so that we may provide suitable materials at suitable prices,” Midani says.
Daphne Allen

Posted in Compliance Packaging, Counterfeiting, Diversion, FDA, Hospital, Labeling, Medical Devices, Safety, security, supply chain | No Comments »

Packaging=Education=Prevention, Just in Time!

I was excited to learn about the “Prevention Above All” conference hosted by Medline Industries Inc. this past week, which succeeded in bringing together doctors, nurses, hospital executives, and design experts to explore ways to improve patient safety. This is exactly the sort of collaboration that needs to occur to bring about meaningful results. I encourage you to watch the short videos of the speakers to get a sense of the effort behind prevention.

Packaging plays a key role in prevention, and this event emphasized that, among other interventions. Design expert Deborah Adler, who designed Medline’s Foley catheter management system, spoke about her work observing catheter use in the field and responding to nurse feedback with a package intended to reduce catheter-associated urinary tract infections. She found that product instructions included inside packages often get overlooked or practitioners simply don’t want to be seen reading them in front of patients. So she and Medline developed a label that is affixed to the outside top of the tray package that can be opened and read before the package is opened. And with the “sticker” on the package, the tray remains sterile, she points out. A stop-and-check list is also included at the bottom of the label. (For details on this tray, please see Gina Monari’s article in our March 2010.)

Similarly, Mikel Gray, editor-in-chief of the Journal of Wound, Ostomy, and Continence Nursing, spoke about one nurse’s study comparing the use of “just-in-time educational” packaging with traditional packaging for wound care dressings. Nurses receiving the “just-in-time educational” packaging appeared to be more confident in their ability to apply wound dressing than those given traditional packaging, he explained.

I have not heard a lot about “just-in-time” educational packaging before, but given today’s high-pressure environment in hospitals, it sounds like it could offer some much-needed support. Searching through Medline’s site I found that Medline’s Prevention Above All program “introduces six practical and targeted interventions to help improve outcomes,” one of which involves the use of “advanced wound care educational packaging.” The packaging serves as a “two-minute course on advanced wound care,” and it reduces confusion with clear, step-by-step information, eliminating the clutter and highlighting critical information.”

I am pleased to see packaging and labeling being tapped as a teacher. Interestingly, such an educational role was made possible only because designers like Adler and companies like Medline became students themselves, studying nurse behavior and learning from nurses. As Adler points out in her video on Medline’s site, “We all learn from each other.”

Daphne Allen

Posted in Medical Devices, Medical Errors, Safety | No Comments »

Close Call at My House

In terms of product recalls, it has been an interesting week in my house. Over the weekend we got a call from Ralphs alerting us to an egg recall, and we saw several news spots urging consumers to visit eggsafety.org to check their own supplies.

Then on Monday, my mother got a letter from her insurer alerting her to recalled Advair Diskus inhalers being found in some pharmacies.

In case you are wondering, we did not have the affected eggs or inhalers. (What a story that would have been!) But we were left with a bit of wonder as to how the egg industry and the grocery industry managed to inform consumers about the recall within days, whereas it seems to have taken the healthcare industry one year to inform my mother. (To be fair, GlaxoSmithKline and FDA did issue their own notice in August 2009. But how often does my mother visit those Web sites unless I point out something interesting?)

I also remember seeing something from my insurance company a while ago. And perhaps my mother did get an earlier alert but just forgot it. Patients can be forgetful.

So here’s how our conversation went:

Mom: What’s this about Advair being stolen?

Me: Yep. Last year. I blogged about it a while ago. Remember I told you?

Mom: Last year? They were stolen last year? Why am I just now hearing about it? Wait–you have a blog?

It seems like more people need to read our blog!

Daphne Allen

Posted in Diversion, FDA, Pharmacies, Theft | 1 Comment »

Supply Chain Safety in an Era of Globalization

We recently surveyed our readers in our annual salary survey, and many of them referred to the supply chain as a global one, like it or not. (Many, of course, are worried about losing jobs to other countries, but there may be some good news for them on that front.)

Fears aside, we must prepare our products and processes and ourselves for the global market. FDA is. FDA Commissioner Margaret Hamburg remarked on this fact in June as she spoke at the Woodrow Wilson International Center for Scholars. “The world in which the products we regulate are discovered, developed, and marketed is effectively getting smaller. When FDR first created the modern FDA back in 1938, imports were just a tiny part of the products used in our country. But in 2010, it’s a different story altogether. What we as Americans consider “our” products are, in reality, global commodities. Every day the percentage of imported products we consume continues to increase, and the distinction between domestic and foreign products becomes increasingly blurred. This is a challenge we share with many other countries . . . and it’s urgent that we address it.”

Hamburg reported that “some 80% of active pharmaceutical ingredients in drugs consumed in the U.S. come from outside our borders. . . In addition to the sheer volume of imports and foreign facilities, there has been an increase in the variety and complexity of imported products … and a large expansion in the number of countries involved in producing these products … including many with less sophisticated regulatory systems than our own.”

Globalization makes the tasks of maintaining product quality and security much more challenging. “This all adds up to an enormous task for the FDA — especially because we’ve already seen the warning signs. The recent problems with contaminated heparin, the melamine-tainted milk products, the international problems with diethylene glycol adulterated products, and the growing prevalence of counterfeit drugs make clear that we must bring our oversight in line with the reality of the global economy.”

FDA is expanding its purview by stepping up inspections at foreign facilities and opening offices in China and other locales. But “FDA simply does not have — and will never have — the resources to inspect every foreign manufacturer, or every shipment of products from overseas,” Hamburg said.” Yes, we need new approaches. But more importantly — we cannot accomplish this task alone.”

Some experts believe that tightening the supply chain can contribute to quality assurance. “Our customers put a great deal of emphasis on quality assurance. They want to provide consumers/patients with the confidence that they are getting genuine products,” notes reports Dirk Corsten, managing director of Uhlmann Packaging Systems LP.  “One way to achieve this is by using e-pedigree or track and trace, some of the anticounterfeit initiatives that are designed for the purpose of gaining quality assurance.”

What tools are you using? Do they have global reach?

Daphne Allen

Posted in Electronic Pedigrees, Imports, Safety, security, supply chain | No Comments »

Pharmacy Group Pushes One-Document Solution, But What Does FDA Think?

Almost a year ago, FDA held the workshop, “Providing Effective Information to Consumers about Prescription Drug Risks and Benefits,” to explore whether “one document” could be developed for dispensing consistent information with all prescription drugs. The workshop brought to light the scant information that patients are often provided as well as the number of the challenges pharmacies face.

The one-document approach has not yet materialized, but today the National Association of Chain Drug Stores (NACDS) wrote to the Los Angeles Times hopeful about its use. NACDS submitted its letter in response to an August 9 article in the newspaper critical of pharmacy-provided information.

The letter, submitted by NACDS President and Chief Executive Officer Steven C. Anderson, IOM, CAE, stated that “this ‘one-document solution’ could harmonize multiple documents that arise from different FDA-imposed legal requirements or information interpretations, and from different offices and constituencies within FDA. NACDS is working collaboratively with FDA to help advance the objective of this petition, and is hopeful that the result will enhance communications with patients about their medications.”

To read the entire letter from NACDS, please click here.

But the “one-document” solution may not be an easy one to implement consistently. I encourage you to read the FDA meeting transcript to learn more about the pharmacy environment and some of the challenges in printing information. As we pointed out last last year, Marcie Bough, Pharm. D., director, federal regulatory affairs, American Pharmacists Association, said that “One of the things we would have to consider is if we had a single document of standard format, we would need some guidelines or guidance that somehow portrays what you can do with that for retrofitting a document into the existing printing systems within pharmacies where there may be a one-print mechanism, so that the label is part of a different stock of paper than what is just a ream of paper we’re buying at the print store,” Bough said. And later she added: “If you think of the Med Guide systems, there’s some very strict standards and problems that have been somewhat overcome on how to print those, but I think we would need clear guidance of what could or could not be done to that information from a data perspective to retrofit it into the printing options.”

We also explained that other speakers described challenges in printing colors or high resolutions with “legacy printing systems” at pharmacies as well as the trouble maintaining the high print quality currently expected of the pharmaceutical industry. To read more of our story, click here.

Patients clearly still need improved information. Interestingly, efforts this year have turned to “patient-centered labeling.” Does the whole package and label system need an overall?

And what steps will FDA take in the next year?

Daphne Allen

Posted in FDA, Labeling, Medication Guides, Package Inserts, Pharmacies | 2 Comments »

Reimportation Issue Returns

Attempting to prevent drug reimportation, the National Association of Chain Drug Stores (NACDS) wrote a letter to Congress pointing out its safety concerns. Have you written your own letters?

“NACDS strongly supports policies to help make prescription drugs more affordable.  However, we do not believe consumer safety can be ensured in a system that allows for the personal reimportation of prescription drugs,” the letter stated.  “In addition to legitimate concerns about the safety and effectiveness of these products, individuals who obtain medications through personal importation schemes do not have a licensed pharmacist available to consult with them about using the medications safely and effectively.”

If you don’t buy NACDS’s argument and the need to take action, check out this story from The Partnerhship for Safe Medications. It is reporting that Health Canada “warned consumers about the potential dangers of purchasing prescription drugs” from a particular site because it is “not a licensed Canadian pharmacy.” It included this link for more details. (Thanks to Martin G. VanTrieste of http://www.rx-360.org for tweeting this story out.)

The site appears to be a safe one, as it displays “safe site” and “customer certified” seals and logos. If I were a penny-pinching consumer looking to save money on prescription drugs (wait, I am), I just might be convinced (probably not though since I have been writing about this for so long).

But other patients may not be aware of how Web sites can use the words “safety” to fool them as well as the larger issues of buying from unapproved Web sites. But I hope now that Congress is.

Daphne Allen

Posted in Pharmacies, Reimportation | No Comments »

Can YouTube and Social Media Drive Safer Medical Device Use Among All Patients?

We came across a remarkable study on the number of children injured by medical devices such as contact lenses and others and shared it in our daily newsletter today.  Reported to be the first study of its kind, the research put forth some scary numbers. It also reminded me of an earlier report from the Institute for Safe Medication Practices (ISMP) on a patient who failed to use a cleaning and disinfecting solution correctly for her contact lenses.

These stories made me wonder–how many of these errors occur because patients (including children) do not comprehend use instructions?

Interestingly, after we ran the story I found this video on YouTube posted by Bausch & Lomb, along with a number of other videos. (B & L had tweeted it on Twitter today–how serendipitous!  I am always being reminded by my colleagues at Med Ad News that social media can be a useful tool in promoting proper product use, and pointing these videos out on Twitter could very well be an example.)

Given YouTube’s popularity among children, perhaps pointing to such videos can help foster a better understanding of medical devices among younger patients? (Come to think of it, YouTube shouldn’t be wasted on the young–we are all on YouTube these days anyway.)

So when developing product packaging and labeling, you probably should be including some online references to direct patients to such sites for visual demonstrations.

Daphne Allen

Posted in Labeling, Medical Errors | 1 Comment »

Finding Lapses In the Last Mile

While drug manufacturers have refined their packaging and management of temperature-sensitive shipments, a physicians’ survey, and a recent first hand study of wholesaler and hospital practices, point to major quality lapses in the “last mile” of distribution.

Physicians perceive cold chain breaks as commonplace, according to a Harris Interactive survey announced by TempTime Corp. featured in the PMP News.com Daily newsletter.

A large majority of primary care physicians and practice specialists expressed concern over cumulative exposure leading to heat-damaged product, with more than seven in ten saying they’ve experienced cold chain breaks first hand. Less than one third reported being “very confident” that medicines are handled properly to prevent temperature damage.

“With advancements in science and medicine trending toward increased use of biologics, vaccines and other temperature-sensitive medicines, we need far more vigilance around the cold chain to protect our patients from associated risks stemming from undetected temperature abuse,” said Donald T. Allegra, MD, FACP, in reference to the survey.

In recent auditing of several major wholesalers, and through a case study with a Massachusetts hospital, Thermal Packaging Solutions (Ocean, NJ) identified a lack of audit controls for temperature susceptible product at the distribution centers and hospital. A prevailing “safety gap” left product exposed to damaging temperatures.

“We have known for years from first hand observations that the last leg of the distribution cycle, which transports refrigerated products from local distribution/ wholesaler centers to hospitals and pharmacies is freezing the drugs because of their method of packaging,” says TPS’s Sandy Cook.

Despite guidance and regulation on essential practices, wholesalers are providing substandard packaging and lack appropriate controls over storage and distribution, Cook says.

In examining palletized EPS totes received from wholesalers in the hospital study, TPS found unbuffered packouts of minus 20 degree C gel packs in direct contact with product requiring 2 to 8 degree storage temperatures. The packaging lacked temperature monitors.

“(These) packouts can be expected to deliver sub-zero assaults (and temperatures that will freeze the product) nearest the gels, and potentially throughout the package,” TPS investigators found.

TPS’s study will be featured in the September issue of Pharmaceutical & Medical Packaging News.

“We identified a high degree of potential deleterious distribution of refrigerated pharmaceutical products in thermal packaging which can be expected to reduce if not obliterate the efficacy (of some biologic products),” Cook says.

Ensuring the safety and efficacy of medications up to the time they are administered to patients is a cold chain-wide issue, addressed by guidance including USP’s <1079> and PDA’s Technical Report 39.

Though state boards of pharmacy and the Joint Commission (formerly JCAHO), the  accrediting agency for hospitals, exercise regulatory oversight, the auditing “does not appear to be directed toward temperature control of incoming prescription drugs or in their distribution within the hospital,” TPS’s study finds.

Auditing, training, and appropriate packaging is called for at all levels of storage and distribution–at the wholesaler, in the hospital pharmacy, and in the doctor’s office.

Hospitals, TPS suggests, can begin by performing due diligence when selecting a distributor. The pharmacies should develop an approved distributor program, that includes auditing of product storage, validated packaging, packout consistency following SOPS, training, and, where necessary, retraining.

Dave Vaczek

Posted in Cold Chain | No Comments »

Tackle Labeling Errors, One Product at a Time

FDA’s meeting last month on developing packaging, labeling, and naming guidance to reduce medication errors focused largely labeling, no doubt because many errors occur when users are identifying products and reading instructions. FDA pulled together a diverse group of healthcare professionals who provided valuable input on the challenges, so please spend some time reading the transcript. You may get some hints on how to make your own labels easier to read and comprehend.

I am happy to report that there have been some new product launches in the past few weeks intended to reduce error and confusion. In June, Baxter International Inc. launched Fentanyl Citrate Injection, USP CII (50 mcg/mL, 2 ml vial), with new labeling intended to help reduce medication selection errors. The label has 20% larger font size and a color combination highlighting the drug and concentration in a diagonal label, Baxter reported. In addition, a tear-off cautionary label extends above the main label and requires an additional step to open the drug vial, which could act as an additional safety check.

And in July, Sagent Pharmaceuticals Inc. reported FDA approval for its nine presentations of heparin sodium injection, USP.  The vials feature the firm’s proprietary PreventIV Measures packaging and labeling to help users distinguish between the nine presentations, using a unique color for each total strength, easy to read drug name, concentration and fill volume, and cartons printed on all sides, the company reported.

However, labeling and even packaging issues still do persist. The Institute for Safe Medication Practices sent out an alert today on a needlestick that had occurred after a nurse struggled with a Lovenox prefilled syringe label that was lifting away from the syringe. Similar problems were noticed on other, unused syringes still packaged in blisters.

Can FDA guidance put an end to such problems? It may certainly help offer a basic framework or checklist to follow for packaging and labeling evalutions, but ultimately you and your team of innovators are responsible for ensuring your products meet end-user requirements. Even if no one states it explicitly, one of those requirements is proper product identification and safe administration.

Daphne Allen

Posted in Uncategorized | No Comments »