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MR. TAYLOR: Okay. Well, I want to thank the members of Panel 2 very much for your thoughtful comments, and I'd like Panel 3 to please come to the table. The first speaker will be John Gans from the American Pharmacists Association.
MR. GANS: I don't know whether to say good morning or good afternoon. I knew I was going to do good afternoon, but we've changed the schedule a little bit.
Thank you for the opportunity to present the views of the American Pharmacists Association. Founded in 1852 as the American Pharmaceutical Association, we were the largest national professional society of pharmacists in the nation, representing more than 50,000 practicing pharmacists, pharmaceutical scientists, and student pharmacists. Also, our reason to be was really about the integrity of the drug supply back in 1852. It's interesting how we have now come almost full circle on that, but there are a lot more players and this responsibility falls really in the hands of the FDA and for our part the USP.
First, let me provide APhA's support of FDA's goal to combat counterfeiting through advance technologies and the coordination of efforts of all parties, including manufacturers, wholesalers, pharmacists, and patients. The protection of our medication supply is of vital interest to pharmacists, including efforts to prevent an introduction of counterfeit products into a system, and the quick identification and elimination of such products from the system if the medication supply is infiltrated.
Pharmacists rely on a safe, pure supply to help patients make the best use of their medications. My comments today will address three basic areas: the patient and provider education; two, packaging and distribution technologies; and, three, areas of public and private sector collaboration to this important agenda.
Pharmacists have a role in this agenda as educators, purchasers, and protectors of the medication supply which they work with. As the agency further develops this agenda, APhA encourages you to consider two things:
First, we must keep in mind the goal of all of our efforts should be to increase the integrity of our drug supply and never move off of that goal.
Second, we must consider the reality of every member in the pharmaceutical system, and that is the issue of limited resources.
While these things cost a lot of money, when they move through the system there are very limited margins in many of those areas. Therefore, in determining your directions, you must look at reasonableness, and reasonableness, we think, must consider cost.
The cost of this new system should not outweigh the benefits, and the cost/benefit analysis of any new activity should be considered. One approach to maximizing the use of our resources would be creating standard processes for identifying medications most likely to be counterfeited and to focus our resources on those drugs. Obviously, this review process would have to be updated frequently to ensure that it remains current.
One theme in the report and in today's hearing is that staying ahead of very sophisticated counterfeiters will require sophisticated countermeasures. Technology is an important part of that sophistication. APhA agrees with FDA's assertion that new covert and overt technologies must be implemented in combination to provide the strongest system possible. Additionally, technologies must be flexible to adapt to ever changing counterfeiting activities.
To improve the integration of these technologies in pharmacies, we recommend the agency use practicing pharmacists to evaluate anti-counterfeiting technologies and that they be used at the pharmacy level. But technologies are only a part of the solution. As medication experts on the health care team, pharmacists play a leadership role in identifying counterfeits and preventing their introduction into the system, the distribution system and educating consumers about counterfeits and how to address a suspected counterfeit product. We believe that pharmacists and consumers are critical.
Recognizing this reality, APhA supports efforts to increase the understanding by pharmacists of the role they play in preventing counterfeit medications from reaching patients to help improve pharmacists' baseline understanding of the regulation of our prescription drug supply. Most pharmacists today I don't even think understand all the licensing that's involved, so we are publishing a continuing education piece in the next few weeks that will address this issue.
APhA also supports the profession developing and pharmacists implementing best business practices for buying medications to help them identify legitimate buyers. These simple steps can move us closer to a better system, and it can be done very quickly.
Another essential role pharmacists play in protecting the medication supply is reporting routine problems with products. Pharmacists are the first health care provider notified by patients of suspect medications and have an important role in alerting the FDA and manufacturers about suspected and counterfeit medications. But to facilitate the reporting, pharmacists need timely, accurate, and pertinent information. Such notification should take place in a priority order, with an optimal situation for notifying the pharmacy community first, not the consumer press, and an immediate subsequent notification to the public and the rest of the health care system. By communicating first to the pharmacy community, both pharmacists and pharmacies, the agency will prepare the community most likely to receive communications, to receive products back.
When a counterfeit medication is suspected, pharmacists need the following information: product name; lot numbers, including the suspected scope of the problem; three, the source and distribution and route of administration of the product, how the product is suspected to be counterfeit; and information on the level of risk to the patient.
This information helps the pharmacist determine the relative risk of the drug supply which was infiltrated by the drug in question.
Consumers are essential to our efforts. Patients need to be educated about how medications differ from other goods, and other steps must be taken to protect themselves. I recently worked on an international paper that talked about medications as being special. At first, I didn't like the term, but as we moved into it, I began to realize that the public through direct-to-consumer advertising and some other steps, they may begin to look at medications differently than they've looked at them in the past. So we need to go back and educate them that they have a role here.
To fulfill their role in identifying counterfeit medications, patients must learn about the importance of reporting and where to report their concerns. They must understand how easily drugs can be counterfeited and how difficult it is to detect counterfeit drugs. Patients must understand that medications are different from other imported goods, and counterfeit drugs are not necessarily evident to the human eye. They need to know that they should tell their pharmacist when the drug looks, smells, feels, and tastes different than what they previously experienced.
All that being said, the consumer's best protection from counterfeit medication is using legitimate, trusted sources of supply--a licensed U.S. pharmacy.
Moving to the area of packaging and distribution, APhA agrees that pedigrees are an important tool to consider adding to the kit of anti-counterfeiting devices. In concept, pedigrees may be an appropriate tool to track the preparation of drugs from manufacturer to wholesaler to pharmacist. However, we have significant concern about cost, potential benefits, and the potential benefits of a paper-based system which may only provide a track record of product movement or simply provide a counterfeit record of product movement, a trail as fake as the product that it accompanies.
The value of the paper-based system is limited by the ease of counterfeiting paper pedigrees. If an entity is sophisticated enough to counterfeit a product, we believe that the entity has the same and equal capability of counterfeiting a paper pedigree. APhA recommends that the agency consider alternate formats, such as an electronic pedigree system. If such a system automatically created a pedigree, it could be implemented with minimal administrative burdens and would be less likely to be falsely produced by counterfeiters.
In addition to the pharmacist's direct role in reducing the risk of counterfeit products, there are other components of the draft paper that warrant comment, specifically unit-of-use technology. Although there are many questions that need to be addressed with this technology, APhA supports the use of unit-of-use packaging because of its potential to enhance patient safety, patient adherence, and drug distribution efficiencies. Efficient implementation of unit-of-use packaging requires state laws to authorize the pharmacist to modify prescribed quantities. Little issues like "Is a month 28 days, 29 days, 30, 31, or is it 35 days?" need to be standardized.
When considering collaboration with the role of the Boards of Pharmacy, it should always be considered in developing an anti-counterfeit agenda. Currently, many State Boards of Pharmacy are faced with a challenge of regulating store-front operations which facilitate personal importation of pharmaceuticals. APhA firmly believes that one of the greatest risks to patients receiving counterfeit drugs is through personal importation. These facilities are clearly participating in the delivery of medications to patients and practicing pharmacy. Unfortunately, some of these store-fronts operate in a gray area of the law.
APhA applauds FDA's work with the Boards of Pharmacy and NABP and individual state regulators to rein in these illegal and unscrupulous distributors. We support efforts to update NABP's rules, reviewing the 50 state practice acts, and moving forward.
Finally, APhA recommends the agency collaborate with private stakeholders in designing communications strategies among stakeholders. The private-public partnership could facilitate a standard anti-counterfeit communication which would be very helpful. The agency knows that "Dear Doctor" and "Dear Pharmacist" letters are not always read. APhA recommends using a website of resources for pharmacy professionals, pharmacists.com, to deliver FDA's message on counterfeiting. Pharmacy.com is a single-source site for professional resources that are vital to the continuous development of pharmacists' needs about professional development.
Pharmacist.com is a joint venture between the National Association of Boards of Pharmacy and APhA. And it assembles in one place resources that pharmacists need. We now know that each pharmacist in the country, over 200,000 unique visits have occurred to this site, and it is well used. The site also could be used to help pharmacists link directly to MedWatch to facilitate and ease the reporting of suspected counterfeits.
As medication experts and the most accessible health care provider for patients to go to with questions about medications, it's essential that pharmacists play this role and be, in fact, empowered to do it. APhA is pleased that the FDA is addressing this important issue. The review of current policies and systems is timely given the recent increases in counterfeit medications and importation by individual patients.
APhA looks forward to working with the FDA as we collaborate to provide patients with quality pharmaceuticals and the education to make the best use of this valuable technology.
Thank you.
[Applause.]
MR. SCHECKELHOFF: Good afternoon. My name is Douglas Scheckelhoff, and I am the Director of Pharmacy Practice Sections for the American Society of Health-System Pharmacists. ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, HMOs, long-term care facilities, home care agencies, and other components of health care systems. I am pleased to provide you with ASHP's views on the serious problem of counterfeit drugs entering the nation's drug supply chain.
In June of this year, ASHP adopted a policy that encourages the FDA to develop and implement regulations to restrict or prohibit licensed drug distributors from purchasing legend drugs from unlicensed entities and to accurately document the original source of drugs and chain of custody from the manufacturer to the pharmacy. My comments today and ASHP's written comments in response to the Federal Register notice will discuss how that policy relates to the work of the FDA Counterfeit Drug Task Force.
Over the next few minutes, I would like to comment on four areas that are addressed in the interim report. These include regulatory and legislative issues, industry and health care professional issues, technology issues, and public education.
First, regulatory and legislation issues. Most consumers have no idea of the scope and complexity of the drug distribution chain in its business components, particularly the buying and selling of products between wholesalers. ASHP remains extremely concerned about vulnerabilities in the pharmaceutical supply chain, particularly with respect to secondary distributors. While these entities may perform a role in providing needed medications in some situations, ASHP believes that stronger state and federal oversight may be needed.
Any changes to federal law and regulation should be patterned after recent legislation enacted in Florida. Florida's new law begins to address the lack of authenticating and documenting the chain of custody of a product from the originating manufacturer. This is particularly important with respect to the high-risk drugs identified by the state as being prone to counterfeiting.
Recent discussions by ASHP's policy recommending councils noted the need for uniformity in state regulation of a national standard in order to maintain the integrity of the drug supply. However, we should be sensitive to the unintended consequences of the creation of new barriers in distributing prescription drugs, particularly with respect to legitimate returns of unused product from pharmacies.
ASHP does not believe that paper pedigrees are an optimal solution to the counterfeiting problem. However, ASHP believes that the development of a limited uniform list of drugs considered to be at high risk for counterfeiting and determined by the FDA should be a priority. Products on the list should not be shifted around among wholesalers. This list should be maintained through a paper pedigree system in the interim, with the eventual goal of developing an electronic pedigree for these and other drugs.
In terms of augmenting state pharmacy practice acts, ASHP believes that attempting to rely on State Boards of Pharmacy to improve control over wholesalers will require 48 or 49 additional states to take actions similar to Florida and, therefore, be inconsistent and potentially delayed. In the meantime, counterfeiters will simply move to states with fewer restrictions and controls. Many Boards of Pharmacy and Health Departments do not have the resources needed to effect the needed changes at the state level, and effective anti-counterfeiting measures will be slow in coming. The FDA should become more involved in controlling wholesalers.
Now onto industry and health care professional issues. Electronic means and systems for alerting pharmacists to counterfeit products already exist through professional organizations. For example, ASHP maintains an e-mail list of over 23,000 members who receive news items from us on a weekly basis. The development of a new independent counterfeit drug alert network is not needed since other systems already exist, and the cost of populating and keeping a system such as this current would be prohibitive.
ASHP stands ready to provide rapid alerts to members and hospital pharmacy departments about counterfeit drug incidence, which is in keeping with our longstanding partnership to the FDA's MedWatch reporting system.
Pharmacists should be the focal point for patient contact, education and follow-up when a product is suspected of being counterfeit. Training materials should also be developed to educate pharmacy and product receiving staff with information on how to screen product packaging and what steps to take when they find a suspicious product.
Now, the technology issues. ASHP believes that applying technology for overt security methods will be of limited value to most pharmacists as a means of verifying authenticity. The reality is that most hospital pharmacies stock more than 1,500 distinct products from hundreds of vendors. It would be virtually impossible for pharmacy staff to be knowledgeable about the specific overt methods for each company and product. In addition, many experts agree that overt security methods should be changed at least annually to keep ahead of counterfeiters. All of these factors contribute to the complexity of the problem. Covert security methods may be of some value as a means of authenticating product but only when the product is suspect. Whatever technologies are adopted need to be practical and inexpensive for the use at the pharmacy level. Funds might be better spent on technology for a universal electronic pedigree for drug products facilitated through some sort of machine readable coding on drug packaging.
Finally, public education issues. Public education activity should focus on overall public awareness of the counterfeiting problem, but generally not focus on specific products. Messages should alert patients to be on the lookout for problems such as a different look, taste or packaging of a drug, and instruct consumers to bring these problems to the attention of their pharmacists. Perhaps public education programs focusing on product integrity could be the focus of next year's National Pharmacy Week public service campaign.
ASHP appreciates the opportunity to present its views at this meeting, and we applaud the FDA's efforts. Thank you.
[Applause.]
MR. MAYBERRY: Greetings. My name is Peter Mayberry, and I am here today on behalf of the Healthcare Compliance Packaging Council, a not-for-profit trade association established in 1990 to promote the many benefits of unit dose blister-in-strip packaging.
For anyone not familiar with unit dose packaging, it is widely used throughout most of the rest of the world as manufacturer's original packaging to dispense pharmaceutical drug products. In the United States, however, unit dose formats are primarily used for over-the-counter drugs and only one class of Rx drugs, oral contraceptives or birth control pills, is dispensed in unit dose formats as the manufacturer's original packaging. It is also used with some individual drug products, but by and large, most drugs in the United States are dispensed in bulk rather than in manufacturer's original packaging.
Now, while unit dose formats can take many forms, the distinguishing characteristic of these packages is that each dosage unit is housed in a separate compartment. For solid oral dosage drugs such as pills, capsules and tablets, unit dose packages typically take the form of a blister card which houses multiple single dosages in separate cavities, but unit dose packaging can also take the form of strips, ampules, pouches, or any other configuration in which each dosage unit is kept separate from all others. I should also point out that unit dose packaging is non-reclosable so it's only used one time.
Corporate members of the Healthcare Compliance Packaging Council include manufacturers of the film, foil and paperboard used to create unit dose packaging, as well as manufacturers and machinery use in the production of unit dose formats. HCPC corporate members also include contract packaging firms who are hired by pharmaceutical manufacturers to put drug products into specialty packaging, and repackaging firms who purchase drug product from pharmaceutical manufacturers, put that product into unit dose formats and resell it to hospitals, inpatient facilities and others.
My message today is to commend FDA for recognizing the role that unit-of-use packaging formats can play in deterring counterfeit drug products as noted in the recently released interim report from FDA's Counterfeit Drug Task Force. Unit dose formats are a subset of unit-of-use packaging, and as such, FDA should strongly consider action that would result in greater use of unit dose formats as manufacturers original packaging. The HCPC also supports FDA task force findings regarding the need for pedigree requirements for repackaged drug products, use of tamper-evident packaging, and the incorporation of covert and overt anti-counterfeiting technologies in pharmaceutical packaging and labeling.
Simply stated, the growing problem of drug counterfeiting in the United States could be deterred significantly if counterfeiters have to replicate drug products as well as the manufacturer's original packaging, or replicate the professionally repackaged pharmaceuticals in unit dose formats that bear the products pedigree. This is especially true with unit dose formats where counterfeiters would have to have access to expensive form, fill and seal machines used by pharmaceutical manufacturers, contract packagers and large-scale FDA-licensed repackaging operations. Moreover, unit dose formats can be designed with multiple features that deter counterfeiting. While it would be inappropriate in a public setting for me to outline exactly what sorts of anti-counterfeiting features are currently available, I can say that unit dose formats can include features that are incorporated into the packaging materials, printed on the packaging, adhered or embedded int packaging or otherwise used in such a manner that consumers and counterfeiters alike may never even know that the features are present.
On behalf of the entire HCPC I thank FDA for this opportunity to present our views. I also volunteer the expertise of our industry to meet with FDA officials and demonstrate some of the anti-counterfeiting features which are currently available.
Thank you.
[Applause.]
MR. TREALEAVEN: My name is Carl Trealeaven. I am the Vice Chairman of the Pharmaceutical Printed Literature Association. The Pharmaceutical Printed Literature Association, known as the PPLA, plays a key role in the supply chain for pharmaceuticals, linking product manufacturers with pharmacists, and upon occasion, patients. We're responsible for printing the majority of package inserts distributed in the United States today. Our close association with the pharmaceutical manufacturers qualifies us to comment on packaging and security technologies that can strengthen supply chain integrity. To that end, we offer the following recommendations.
First, the FDA should encourage the use of specific security technologies in product packaging. As has already been discussed today, these technologies can be characterized as both overt and covert. And overt security tools are the ones that are easily identified, and the covert ones are not and require a highly-trained eye or even sophisticated tools to detect them. We believe that both methods ought to be used. Examples of some of the overt technologies are holograms, radio frequency ID tags, paper watermarks and intentional print error on the package. And examples are some of the covert features are invisible markings or threads that are embedded into paperboard, micro print, micro tags in the paper stock or packaging adhesive and security inks.
Common manufacturing practices in printed packaging should be leveraged and expanded to better utilize the authentication and track-and-trace technologies. The pharmaceutical industry is served by a group of printed packaging suppliers that currently operate under the CGMPs. And although not audited by the FDA, suppliers that are held to the highest standards by the most demanding customers adhere to policies and procedures that can be expanded to utilize authentication and track-and-race technologies.
Second, the PPLA supports findings by FDA's Anti-Counterfeiting Task Force regarding the role that unit-of-use package formats can play in deterring counterfeiting. The most effective means of incorporating and preserving package security technologies throughout the distribution chain is through manufacturer provided unit-of-use packaging. Without such packaging the integrity of the supply chain between manufacturer and consumer is broken at the pharmacy stage and counterfeit product can more easily be inserted into the distribution chain.
Fourth, the PPLA reiterates our testimony before the FDA on July 31st that mandatory FDA-approved manufacturer produced printed information for consumers can help fight counterfeiting and empower consumers as the last line of defense in combating counterfeit drugs. Overt and covert security features can be incorporated into patient package inserts, package inserts and medication guides to maintain the security of the supply chain all the way to the end user. Patient-facing security enhancements also can be accomplished via manufacturers' self-adhesive labeling and folding cartons that require special equipment to produce and are therefore difficult to unlawfully duplicate.
The PPLA applauds the FDA in its efforts to aggressively address drug counterfeiting and stands ready to assist the Agency in employing security technologies and packaging to advance anti-counterfeiting strategies.
I thank you.
[Applause.]
MR. TAYLOR: Okay. Any questions from the task force members? It's Michael. Just state where you're from.
MR. ROGERS: I'm Michael Rogers. I'm in the Officer of Regulatory Affairs, and I'm the Director of the Division of Field Investigations.
I guess I have a general question for the panel, and that is whether or not you all see any opportunities to enhance the reporting requirements for those who receive suspected or counterfeit products?
MR. GANS: I think that your systems work fine. It's pharmacists knowing about those. I don't think it will ever get to the point where consumers would know about their access, et cetera, and I think you need to be constantly working with professional associations of pharmacists to advertise those links, how to make those reports. That needs to be constantly done to put it top of mind to a pharmacist.
MR. SCHECKELHOFF: I would agree that it's largely an awareness issue I think for pharmacists. The other part is really having a system where pharmacists can authenticate or validate whether it's a real problem product or not, so that there's not a lot of reporting of things that shouldn't actually be reported and ending up with a system that's flooded with false reports.
MR. MAYBERRY: My association doesn't have any expertise in this area, but my personal view is that consumers should be involved and should have knowledge of who to report counterfeits to.
MR. TAYLOR: Yes, Vicky?
MS. KAO: Hi. This is Victoria Kao, Officer of External Relations.
I have a question about pharmacists--excuse me--an awareness campaign for pharmacists. Again and again we've heard today it stressed that customized messages delivered correctly to targeted audiences is crucial to the success of any educational campaign, and I was just wondering, for the pharmacists, your presentations went very much in depth into the messages and the information that you need to hear from law enforcement officers, from regulators. I was wondering if you could touch a little bit on the mechanisms you think that would be successful in us delivering those messages to you?
And the second part of the question is, as was also stressed today, that it takes money to have a successful public education awareness campaign, that we at the FDA don't have that luxury, and I was wondering if there are mechanisms out there among your organizations that would step to the plate and help us in such a collaboration? How can we best hone the messages out there and to continue to hone and focus these messages successfully with your help?
MR. GANS: I think we need to take a step back and have a very consistent long-term approach, a certain access point, 800 number, website, et cetera. All pharmacies that I know of have administration distribution computer systems, and there has to be a way to effectively penetrate those systems through the FDA, state boards of pharmacy, through the large chains, through hospitals, et cetera, to be able to get that message and be able to immediately access that for a pharmacist, and I think that should become sort of a requirement that the FDA could get that information into the system.
As far as--and then we have our own websites which could easily be used, and they're getting tapped all the time. I mean we have one website for the Pharmaceutical Technician Certification Board that gets over a million web hits a month from technicians, so they're looking for information all the time. So what you've got to do is get it standardized and get it out there and just continue to repeat it and make it easily accessible, and accessible the same way in everybody's system. So that's how I would do it for pharmacists.
As far as the consumer is concerned, I don't know how you're going to communicate to consumers how they report information back. Most consumers are going to take the product back to the pharmacy that they got it from or to call that pharmacy, and since most counterfeiting does not occur in a hospital or a community pharmacy, they're going to get a positive result from that pharmacist talking them through it, and then going on some website somehow to pull down information if that product has been reported as a counterfeit. So that's how I think we're going to deal with it with consumers.
And the way to finance that is there's plenty of money out there to do direct consumer advertising, and one of the things that concerns me about our profession and industry is there's lots of great ads on anti-tobacco, there's lots of great ads on not driving and drinking. I think we've done a great job of penetrating people about driving when they've had too much to drink or had a drink. I think it's time that we took some of that money and began to tell the consumer about what they needed to know about counterfeit drugs and that they do exist and where to buy them. So those messages could become part of, it seems to me, the requirement among these advertising programs. A lot of people making money off of drug ads. It seems to me they could put a little space into doing consumer-oriented ads at your behest.
MR. SCHECKELHOFF: I would agree that having a consistent message that can be shared with pharmacists would be helpful and something that they can, you know, grab onto and remember. I think working with the professional associations will allow you to get to a very high percentage of practicing pharmacists, and by using things like state boards of pharmacy newsletters, you'll get to every pharmacist who's licensed in those states. So I think those type of communication tools will be able to get the message out, but it's an ongoing thing that will need to happen over and over.
MR. TAYLOR: Jeff?
MR. SHUREN: Jeff Shuren, Office of Policy.
This is a question to the panel. We've had a lot of discussion today about the potential value of using anti-counterfeiting technologies, and as you all know, if there's value to it, it requires not only adoption but actually use of those technologies by the various participants in the drug distribution system.
I want to get your sense of the role, if any, of the market, health care organizations, the states and the federal government in promoting or requiring the adoption of those technologies as well as the use of those technologies by various participants.
MR. MAYBERRY: Speaking from the packaging perspective, we're of the opinion that perhaps the greatest thing that could be done is a movement away from the current paradigm in the United States where drugs are dispensed in bulk from the manufacturer by and large. The bulk distribution, which is somewhat unique to the United States, operates all sorts of opportunities for introducing counterfeits into the system. Now, whether there ought to be regulatory requirements or whether industry ought to be encouraged to move away from bulk distribution and more into unit-of-use and unit dose distribution, I wouldn't want to speak to that subject with such a limited amount of time, but the bottom line is that the entire nation would benefit if we moved from bulk and more to manufacturers' original packaging.
MR. GANS: There is an enormous amount of money being spent by pharmacies to repackage drugs. They're buying machines that can do so many prescriptions an hour to replace a pharmacist, and to us, if we were into the unit-of-use type of system, that's money that doesn't need to be spent. Plus the packaging I think gives us all kinds of advantages. So we have investments into these machines, 50, 100, $150,000. They easily return on investment because you eliminate a pharmacist's salary if you have enough volume. Why are we even doing that? Why don't we have standardized packaging in this country? It seems to me that if you have standardized packaging, that gives you a whole lot of other material to put anti-counterfeiting devices into it. I mean you look at this new $20 bill, one of the big jokes when you travel internationally is that people love to travel with American money and Canadian passports, but most foreigners don't like our money because it looks all the same, and every now and then they whip out a $100 bill and they mean to whip out a 20, but they both look the same to them.
Well, I think our drug products and our mass and our bulk is something that we're moving away from, and there was a big debate in our House of Delegates this year, where one delegate took on 500 people and turned all of their minds from moving away from us requiring unit-of-use to requiring unit-of-use. That's our policy today. So we would strongly encourage moving in that direction, and then having different things embedded in there to help us determine whether or not something was counterfeited.
MR. MAYBERRY: Including barcodes.
MR. TREALEAVEN: We would also support, as I had said in my comments, the use of unit-of-use or possibly unit dose, but the idea is, is to have a package that goes directly from the manufacturer intact all the way to either the pharmacist or occasionally the end user. So there isn't, as the other gentleman said, any type of repackaging.
The other thing I would add in there would be--a possibility you could do is to mandate that there is at least one overt and one covert security feature in each package. Now, you wouldn't necessarily have to mandate the specific type that you put in. Perhaps you might offer a menu of choices to the manufacturer, a menu of overt features that you might put in, and a menu of covert. But simply to say that you have to have at least one of each on the package, and then provide a means of educating the users of the product what those different features are, and then how actually they might use them, but the important point is, is that you mandate that there must be something like this in there and you have to have at least one of each unit.
MR. SCHECKELHOFF: As I mentioned in my comments, I think that you have to take into consideration, when it comes to technology, especially covert, is that virtually every pharmacy out there is very busy and has a high volume of products. So when you look at the monetary system where you have maybe four or five different bills that are used commonly, it's the awareness that people need to have of what those overt methods are is very limited, but when you have hundreds and even thousands of different products it's just not going to be practical and it would be a shame to spend that money and not have it to use, and our belief is that spending money on an electronic pedigree system would be money better spent.
MR. TAYLOR: Any more questions from the panel, task force?
We realize that lunchtime has come and gone and that we're a little behind. We were going to break for lunch now. However, members of Panel 4 were originally scheduled to go on before lunch, so if there are any members of Panel 4 that would like to go on before lunch, I invite you to do. If not, what I propose is that we have a 45-minute lunch, and then we come back and start Panel 4.
Yes, sir?
MR. BLAIR: Can I make a suggestion? As far as community awareness is pharmacists are licensed practitioners and continuing education is required. A great way to get to those practitioners is through mandatory CE on counterfeit would be one option that would be funded by drug companies or whomever. It would be very low cost. The second one is the unit-of-use packaging is--I've seen that work in the UK--by the way, I'm Jerry Blair with Cerna [ph] Corporation. The unit-of-use packaging they use in the UK is very beneficial in the fact that not only does it give you the ability to do counterfeit, but it also improves patient safety significantly, so by getting that all the way to the patient.
MR. TAYLOR: Thank you.
It sounds like we're ready to go to lunch. People, please report back in 45 minutes, which is 1:30. There is obviously a restaurant upstairs. I'm not sure if they can service everyone, so there's some other restaurants in the area, next door to the hotel, Chatters and another place.
[Whereupon, at 12:45 p.m., there was a luncheon recess.]
Table of Contents | Introduction | Panel 1 | Panel 2 | Overview | Panel 3 | Panel 4 | Panel 5 | Panel 6 | Panel 7