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**COMMENTS TO THE FDA ON THE**

**"COUNTERFEIT DRUG TASK FORCE INTERIM REPORT"**

**Submitted by**

**HIGPA's Pharmacy Working Group**

[IV. Questions Related to the Potential Options for Improving
Prescription Drug Security]{.underline}

### A. Questions Concerning Technology

> [Question 1.]{.underline} *Discuss the advantages and disadvantages of
> unit of use packaging. Please provide any information on the economic
> impact of requiring unit of use packaging.*
>
> Unit of use packaging is older technology that filled a void in some
> countries because it fit into the practice of outpatient dispensing,
> which is different than in the US. (Unit of use in this section
> appears to describe packages typically used in outpatient dispensing.
> Care should be taken not to confuse unit of use and unit dose
> technologies.). Electronic technologies currently under development
> minimize the need for unit of use packaging and will avoid the
> significant barrier that would need to be overcome in order to change
> practice in the US.
>
> [Question 2]{.underline}*. Should the European Union requirements be
> used as a model for unit of use packaging?*
>
> See #1, to the extent that we consider adoption of practices already
> in place in other countries, then yes.
>
> [Question 3]{.underline}. *Discuss the advantages and disadvantages of
> using tamper evident packaging on drug products. Please provide any
> information on the economic impact of requiring tamper evident
> packaging features on these products*.
>
> Tamper evident packaging in the form of unique tapes, dyes, etc., that
> would require periodic changing to maintain security would not be
> practical. Too difficult to keep up with what is the latest color,
> etc.
>
> [Question 4]{.underline}. *What anti-counterfeiting technologies are
> currently being used? Are there any data on which technologies are
> successful?*
>
> There are very few, other than seals on the inside of caps, etc. Most
> are physical or overt, although some companies are working on covert
> measures.
>
> [Question 5]{.underline}*. What, if any, minimum number of
> anti-counterfeiting technologies should be utilized on packaging and
> labeling? Should technologies be utilized on all dosage forms (e.g.,
> APIs, finished dosage forms) and products or just dosage forms and
> products at high risk of being counterfeited?*
>
> If electronic, and feasible from a financial perspective, it should be
> on all products regardless of cost. The Tylenol example from several
> years ago is a good example of why differentiation should be made
> based upon cost. Systems need to protect against both tampering and
> counterfeiting. Ideally, a system can be developed such that only one
> type of device per package is necessary.
>
> [Question 6]{.underline}. *Should any specific anti-counterfeiting
> technologies be utilized? Should covert technologies always be
> utilized? Should overt technologies always be utilized?*
>
> Covert technologies only work if the person who needs to validate the
> integrity has access to the combination to determine the integrity.
> Ideally, new electronic measures under development will make this
> discussion a non-issue.
>
> [Question 7]{.underline}. *Should some anti-counterfeiting
> technologies only be identifiable by the manufacturer and/or the FDA?*
>
> Requiring practitioners to be a part of the validation system creates
> a significant number of issues. Ideally, validation would occur at the
> final point of the supply chain distribution just prior to sale to the
> end user. The end user then needs to make certain that they do
> business with companies that will certify the pedigree up to, and
> including, during transit to the final point of distribution.
>
> [Question 8]{.underline}. *On what dosage forms and products should
> taggants, other markers, or unique characteristics be utilized? All
> dosage forms and products? High-risk dosage forms and products? Are
> there unique characteristics of products that can be utilized in lieu
> of taggants or chemical markers for forensic analysis?*
>
> The safety of the drug delivery system for all products must be the
> primary concern. To differentiate based on cost would be difficult in
> lieu of Tylenol tampering vs. Procrit, Lipitor and Zyprexa.
> Determining high risk vs. cost may be difficult to quantify.
>
> [Question 9]{.underline}. *What role should the FDA play in reviewing
> the use of (i) anti-counterfeiting technologies incorporated into the
> packaging and labeling, (ii) taggants, markers, and other unique
> characteristics incorporated into the product itself, and (iii) track
> and trace technologies?*
>
> Either the FDA or some other agency should oversee the development of
> standards and validate associated technologies provided that there is
> sufficient opportunity for industry input.
>
> [Question 10]{.underline}. *How should "validation" of an
> anti-counterfeiting measure or track and trace technology be
> determined? Should only "validated" anti-counterfeiting measures be
> used? Who should do the validation?*
>
> There needs to be concern for both the use of non-validated measures,
> as well as how reliable the validation methodology would be? However,
> an effective system should employ only validated methods. FDA, or
> non-profit consumer organization (i.e. Underwriters Lab), may be
> involved.
>
> [Question 11]{.underline}. *Should a database, as described in
> Technology Option 5 be created? If so, who should develop the
> database? Where should it be housed? Who should have access to the
> data? Who should be responsible for updating and maintaining it?*
>
> Such a database would be the key to exchange of information concerning
> products and should be developed. This database should be developed by
> an organization charged with validation. Some thought should be given
> to a Web-based access, tied to provider of HIN number, or other
> universal provider identifying number, and perhaps a consumer based
> database for OTC products, with proper security and access
> restrictions.
>
> [Question 12]{.underline}. *Discuss the advantages and disadvantages
> and the role of track and trace technologies, in particular bar codes
> and RFID.*
>
> The advantages are that track and trace technologies enhance
> anti-counterfeiting validation measurements, are readily retrievable,
> and provide a source for secured information. The disadvantages are
> that the cost of development and implementation are not totally
> defined at this point, and the timeline of availability and
> implementation versus immediate need is unknown.
>
> [Question 13]{.underline}. *What are the costs and challenges involved
> with setting up an infrastructure for utilizing various track and
> trace technologies?*
>
> An agreement needs to be reached on the type of technology to be used,
> which in itself will be a big challenge. Agreement over bar codes has
> shown that a multitude of special interests seems to have moved ahead
> of patients' and the public's safety. Once a technology is chosen, are
> there enough variables within this technology to create the needed
> enhancements to be able to outwit the counterfeiters as they become
> more sophisticated in their ability to beat the technology.
>
> The cost within the supply chain needs to be clearly outlined. If the
> technology had multiple uses, perhaps some costs could offset expenses
> in other areas. For example, a reduction in personnel needed to
> maintain inventory or move product through the channel might allow
> companies to reduce staff needed in other areas. Also, a reduction in
> number of medication errors could produce huge savings.
>
> [Question 14]{.underline}. *Tracking and tracing drugs and biologics
> throughout the drug distribution chain may result in the creation of a
> large database that includes tracking data from each entity that
> "handles" the product. Who should create and maintain such data? Where
> and how should the data be housed? Who should have access to the data?
> How can appropriate confidentiality be assured?*
>
> If the data base is not maintained within the control of the federal
> government then all parties access this data will need an assurance
> that the data is accurate and has not been tampered with. The data
> should be viewed in a read only format with data tracking entered into
> a buffer table and entered into the master data base by controlled
> operators. A Quality Assurance and Quality Control process are very
> important.
>
> [Question 15]{.underline}*. Are there additional benefits beyond the
> ability to detect counterfeit product that anti-counterfeiting and
> track/trace technologies can provide for industry, (e.g., inventory
> control, facilitation of product recalls, and identification of theft
> and product diversion)? Give specific examples.*
>
> Yes, inventory control systems throughout the supply channel could
> benefit from one such system. Supply shortages could be noticed early
> on or possibly prevented by seeing where inventory product is at any
> point in time within the supply chain. This could be a big benefit for
> patient care. If products need to be recalled because of a
> manufacturing problem, the potential to limit the recall to specific
> products only, rather than an entire lot, could be possible. The
> technology could assist with getting the affected product out of the
> supply chain quicker thus reducing the potential harm to patients. The
> technology could also assist with the reduction in adverse drug
> errors.
>
> [Question 16]{.underline}. *Discuss the logistic, economic, and public
> health effects of direct shipment of product to retailers and other
> end users.*
>
> Most facilities have significantly decreased the inventory they hold
> because of the distribution options available to them. A majority of
> facilities have transitioned to a "just in time" inventory process.
> This transition could contribute to the frequency of shortages as each
> facility will have smaller inventories in their facility. Product
> waste could increase as inventory turns decrease, then products would
> expire and need to be discarded. Manufacturing cost will go up as they
> will now have to handle potentially thousands of shipments to all of
> their customer's verses only a number of large deliveries to the
> wholesaler distribution points. It would eliminate many of the
> efficiencies of the current drug distribution chain.
>
> [Question 17]{.underline}*. For products that are shipped directly
> from manufacturers to retailers, would the use of track and trace
> technology on those products provide any additional benefits?*
>
> Yes, there has been some questionable product which has possibly
> flowed from a care giver facility back into the distribution channel
> and the tracing nor storage of this product is exactly known. Patient
> confidence in the system would also be increased in knowing that the
> pharmaceutical they are receiving gave a documented flow from the
> point of manufacture right through to administration.

**B. Questions Concerning Regulatory Requirements and Secure Business
Practices**

> [Question 9]{.underline}*. Comment on the advantages and disadvantages
> of manufacturers sharing market data with the FDA for use in
> identifying counterfeit products.*
>
> I would be concerned that this would get mired in the bureaucracy.

**C. Questions Concerning Rapid Alert and Response Systems**

> As a general comment for this section, there needs to be a method to
> make sure that all of the various information sites are updated
> automatically. This will be a challenge.
>
> [Question 1]{.underline}. *What are the advantages and disadvantages
> of adapting the MedWatch system for use in disseminating information
> about counterfeit drugs?*
>
> The advantages of adapting the MedWatch system are that is would
> provide centralized collection system for information, and it uses an
> existing reporting system, so it would not require creation of another
> system
>
> The disadvantages are that it relies on voluntary reporting, and that
> voluntary reporting systems (e.g., medication errors, adverse drug
> reactions \[ADRs\], product problems, etc.) result in significant
> under-reporting. Additionally, since the focus of the MedWatch system
> is reporting ADRs, it would require alteration of the system to
> segregate counterfeit drug issues. Not all stakeholders receive
> MedWatch.
>
> [Question 4]{.underline}. *What capabilities should a communication
> network have in order to be part of a counterfeit alert system? For
> example: Should the system be accessible to all stakeholders (e.g.,
> pharmacies, wholesalers)? How fast should the system be able to
> disseminate information about suspect product? Should messaging be
> active? How should the system flag messages about suspect product as
> opposed to less urgent information? Should access be at no cost?
> Should all networks in the system have a uniform method of presenting
> and distributing information? How secure must the system be? Should
> access to information be selective? Should the system be capable of
> direct linkage to the FDA? Should the system be able to transmit
> educational information?*
>
> Capabilities of a counterfeit alert system:

-   Should be accessible to all stakeholders

-   Should have the ability to 'push' information to network. It would
    not be adequate to merely post on a website

-   Should alert within 24 hours of validation of counterfeit product in
    supply channels

-   It should flag suspect product notifications with visual alert

-   There should not be a cost for user access

-   An embedded link in message could take user to a central site like
    MedWatch, or perhaps an FDA website, to assure everyone receives the
    same message without interpretation

-   There should be a high level of security to prevent misinformation
    and unwarranted concern

-   Direct linkage to the FDA website is desirable

-   Transmittal of educational material is a bonus, but not necessary
    for initial system implementation

**D. Questions Concerning Education and Public Awareness**

> As a general comment, we do not need to create excessive fear
> regarding security of the supply chain.
>
> [Question 1]{.underline}. *How can FDA best assist in making sure the
> public knows what they need to know to help them avoid counterfeit
> drugs?*
>
> The FDA should sponsor public awareness efforts regarding the
> identification of the issue and simple steps to identify and report
> issues.
>
> [Question 2]{.underline}. *What role should the private sector,
> professional/trade associations and consumer representatives play in
> educating consumers and health professionals? Are there other groups
> that FDA should solicit for help?*
>
> Pharmaceutical manufacturers, distributors, etc., should help fund and
> support an educational campaign.
>
> [Question 4.]{.underline} *What education and communication tools are
> available? Which will be the most effective and efficient for this
> effort?*
>
> Educational tools to be used would be infomercials, web based sites,
> perhaps educating the public at the high school level in required
> "health courses."
>
> [Question 6]{.underline}. *How should these efforts be supported or
> funded? Is partnership with potentially affected parties appropriate?*
>
> A partnership with all stakeholders (FDA, pharmaceutical
> manufacturers, distributors, providers, etc.) is in order
>
> [Question 7]{.underline}. *Are there additional long term messages, in
> addition to those listed above, that the FDA should deliver to its
> targeted audiences? Similarly, are there additional messages that the
> FDA should deliver when a report of a counterfeit product is received
> by the agency?*
>
> Confirmed counterfeit information needs to be communicated to the
> public and health care providers based on type of product (OTC versus
> Rx, press release, websites, etc., would be appropriate.)

**E. Questions Concerning International Issues**

> [Question 2a]{.underline}. *What global standards are needed to
> address the problem of counterfeit drugs?*
>
> International legislation and regulations need to be established and
> adhered to by the entire legitimate pharmaceutical industry. Good
> manufacturing practices need to be universally accepted and regulated.
> A competent international drug regulatory authority needs to be
> established with adequate resources to police this industry through
> the entire supply chain.
>
> Because counterfeiting is an organized criminal activity, policing
> this activity is inherently dangerous. Full cooperation with national
> and international security/intelligence would be undertaken.
>
> Those individuals operating outside of these global standards would be
> subject to criminal prosecution under international law.
>
> [Question 2b]{.underline}. *Who should develop these standards?*
>
> The FDA and their global equivalents, would establish universally
> accepted GMP's. Existing security and intelligence organizations would
> need resources as appropriate.
>
> [Question 3]{.underline}. *What processes will be effective in setting
> global standards?*
>
> First, the global community needs to accept that counterfeit
> pharmaceuticals represent a threat to all mankind; second, there is no
> acceptable level of counterfeiting and; third, that counterfeiters
> will be punished to the full extent of the law.
>
> Once these tenets are accepted, the global community will be ready to
> establish global standards for eradicating pharmaceutical
> counterfeiting.
>
> \# \# \#

Members of HIGPA's Pharmacy Working Group:

Allen Dunehew, AmeriNet, Chair

John VanEeckhout and Jeff Primovic, Child Health Corporation of America

Tony Gulczynski, Premier

George Rudolph, Healthcare Services of New England

David Hardy, Health Resource Services

Ron Hartmann, MedAssets HSCA, Inc.

Terry Stein, Shared Services

Joel Nitti, Consorta

Larry McComber, Novation

Mike Cunningham, National Oncology Alliance

Gary Freeman, AllHealth

Paul Chilcutt, Resource Optimization & Innovation

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