Security Printing and Imaging : Pharma

Puzzling Advice From the FDA: Add Chemicals to your Drugs

StevenSimske — Thu, 16 Jul 2009 14:52:00 GMT

The FDA is advocating the addition of chemicals to pharmaceuticals to improve the identification of counterfeits.

http://www.in-pharmatechnologist.com/Industry-Drivers/FDA-advocates-food-pigments-and-flavours-to-combat-counterfeits/?c=JiBz%2FX6W897ybeGc6YCjow%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

This is puzzling advice in several ways. First off, the article states:

"IMS health recently estimated that the counterfeit drugs 'market' generates almost $800bn annually and is growing at almost 6 per cent a year." This is either hyperbole or simply poor reporting. $80bn annually is the correct current estimate.

Next, the summary of the advice is stated:

"The Food and Drug Administration’s (FDA) new document argues that incorporating PCIDs into drug formulations could be a cost effective way of differentiating genuine products from fakes. The agency went on to say that PCIDs used in drugs should be pharmacologically inactive and suggests that: 'food additives, colorants, or excipients with established safety profiles,' would be ideal candidates. While in common with other anti-fake labelling methods, PCIDs can be easily detected in the laboratory, their big advantage over traditional methods is that they can be readily identified by patients, healthcare practitioners and pharmacies."

There is certainly a trend to include less, rather than more, exogenous chemicals -- dyes, expedients, etc. -- in food and drugs. So, the FDA advice bucks that trend.

Also, adding PCIDs "with established safety profiles" by definition means that the list of PCIDs to add is public knowledge. This makes it easier for the would-be counterfeiter to obtain those PCIDs, doesn't it?

Regardless, the use of PCIDs would presumably follow one of two strategies:

(1) Controlled substance, in which case the PCIDs used should only be sold by authorized suppliers to authorized buyers. The type of fraud to prevent in that case, then, is the insidious insider who orders PCIDs and sells them for profit to his counterfeiting buddies.

(2) Security by obscurity, in which case the PCIDs should not be published. This is also susceptible to insidious insiders, however, and certainly makes authentication more difficult.

Using PCIDs, in addition, may complicate the authentication process--requiring the deployment of specialized analysis equipment and personnel. The FDA is certainly enamored with nanotechnology, and this may relate. However, track and trace and authentication through the appropriate combination of security printing (remember that tablets can be printed on and linked to the information on the package through the application of the appropriate inference model) and RFID seems, to me, easier, more cost-effective, more scalable, and more effective.

The full draft of the guidance is posted here:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171575.pdf

Some highlights salient to the discussion:

"There are various available means for presentation and detection of PCIDs (e.g., photolithography, holography, laser scanning devices, and excitation/fluorescence detection). Many identifying characteristics, such as pigments or flavors, could be easily observed by patients, healthcare practitioners, and pharmacies. Some could require the use of instrumental detection (e.g., a scanner or photometric detector)."

"To minimize toxicological risk, FDA recommends using permissible direct food additives, including those affirmed as generally recognized as safe (GRAS), or those ingredients listed in the FDA Inactive Ingredient Guide (IIG)."

What are your thoughts? Any comments? Please post below! Thanks,

Steve

FDA seeking 19% budget increase for supply chain security

StevenSimske — Sun, 31 May 2009 04:11:00 GMT

Apparently, this post was lost in the transition to the new blogging application (which took place May 15-22). The FDA earlier this month announced plans to increase field testing and other inspection of imported food and pharma goods in response to the recent salmonella and drug scares.

The FDA budget document states:

“In the complex and rapidly changing environment driven by globalisation, FDA cannot rely on traditional approaches – inspection and sampling at the US border – to protect Americans and ensure the safety of medical products. FDA will use traditional and innovative mechanisms that include FDA inspections and field exams, integrated federal-state oversight, and greater access to inspection data and results acquired from trusted foreign regulatory authorities.”

The plans include a more than 100% increase in the number of field tests of imported drugs, and a boost in the inspections of high-risk foreign and domestic facilities by nearly 20%.

See the overview article at:

http://www.in-pharmatechnologist.com/Industry-Drivers/FDA-requests-19-funding-boost-to-secure-supply-chain/?c=JiBz%2FX6W896enue4TQ%2BDEw%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

Cheers, Steve

Canadian Pharma Bar Coding Project

StevenSimske — Mon, 11 May 2009 03:20:00 GMT

The Institute for Safe Medication Practices (ISMP) Canada, in agreement with the Canadian Patient Safety Institute (CPSI), have "endorsed the adoption of the GS1 global standard for automated identification (e.g. bar coding) of pharmaceutical products in Canada".

According to the ISMP Canada Safety Bulletin, Volume 9, Number 4 (May 8, 2009),

"The use of bar coding (the most widely recognized machine-readable identifier) in a point-of-care scanning system, combined with a computerized database, allows healthcare professionals to verify that the right drug, in the right dose and by the right route of administration, is being given to the right patient at the right time."

See http://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2009-4-PharmaceuticalBarCodingMovingForwardinCanada.pdf, please, for the full article.

Why barcoding? Same as before--it ties a physical mark to a physical object, with low fuss and as part of the normal printing process. Moreover, hybridizing (tying the bar code to another security/process control mechanism) with RFID is readily accomplished. But, starting with the bar code means that the recommendation can be adopted with little (or no) assumptions about the "asset inertia" in the pharma workflow.

Cheers,

Steve

Simplified Labels do not Improve Compliance...by Themselves

StevenSimske — Wed, 01 Apr 2009 22:55:00 GMT

in-Pharma Technologist reports that Target's 4-year implementation of simplified labels may not increase patient compliance:

http://www.in-pharmatechnologist.com/Packaging/Target-s-packaging-failed-to-increase-compliance-study

The gist of the report is summarized here:

1. Patient compliance is problematic: greater than half of the "patients with chronic illnesses fail to adhere to their medications".

2. "Failure to properly follow a prescription can result in worse health outcomes and more frequent hospitalisations, which has been estimated to cost the US health care system $170bn (€129bn) annually."

3. Target introduced simplified packaging in 2005, "to increase readability and understanding of the product’s label".

4. "A study published in the Journal of General Internal Medicine that compared 23,745 Target users with one of nine chronic diseases and 162,368 matched non-Target pharmacy users found no significant difference in compliance between the groups."

This is not the last word. Other factors (increasing dependence on the internet, primary care provider, pharmacist, etc. for compliance information) may have helped create a situation in which the label is less important for compliance (thus evening the ground between the two pools of users).

However, it also suggests the creation of a hybrid label where the most salient (and dictated by law) information on compliance is printed on the packaging, and the packaging also contains a mark that leads either directly (e.g. barcode to URL such as the Open Mobile Alliance and GS1 efforts) or indirectly (e.g. listing of a URL to go to for more information) to the salient (and updated!) additional product compliance information.

This works well for both the brand owner and the consumer. The consumer has the key information on the product, but can get additional information as needed. The brand owner can update the URL to reflect real-time changes (recalls, new compliance regulations, new instructions, side effects, etc.). This is easier said than done--the regulators will have to carefully consider how to implement this. But it is possible.

Cheers,

Steve

Getting a feel for Label Requirements

StevenSimske — Thu, 19 Mar 2009 14:39:00 GMT

Label and packaging folks, especially, take note--

A Braille standard has been proposed by the IADD for pharma packaging. This was actually a key discussion point at the recent Graphics of the Americas "Brand Protection" conference. Sure, there is an easy joke here--"If I'm reading this, then it doesn't affect me". Think again.

The U.S., as with so many things these days (try mobile barcoding), is not the leader here:

"Since 2005 it has been mandatory in the European Union to include Braille wording on the pack of every newly approved medicine, including uncontracted forms of the drug name and its strength if more than one is made available. By October 30, 2010, the requirement will be applied to all products, regardless of when they were approved. The European Commission published revised guidance on Braille in January. "

The full article is at:

http://www.in-pharmatechnologist.com/Packaging/Braille-standard-drawn-up-for-US-pharma-packaging/?c=JiBz%2FX6W894S79s6QuBFwQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

In the absence of US legislation, "The International Association of Diecutting and Diemaking (IADD) has produced a Braille standard for pharma packaging in North America that it plans to publish at the 2009 IADDFSEA Odyssey show in May, according to a report in Packaging News."

Cheers,

Steve

No Re-Packaging Ban in EU

StevenSimske — Sat, 13 Dec 2008 01:26:00 GMT

Under pressure from repackagers, who have convinced the EU in this time of economic meltdown that banning repackaging would be a misstep, the EU has changed its decision.

http://www.forbes.com/afxnewslimited/feeds/afx/2008/12/05/afx5786503.html

"EU Industry Commissioner Guenter Verheugen faced heavy pressure from parallel traders who said such a ban would have wiped them out, as they have to repackage drugs so that explanatory leaflets to patients are in the right language."

However, the EU is going to provide a more US/New Zealand like model of advertising for the pharmaceutical providers, another contentious issue (generic pharma feels it is unfair): "Direct-to-consumer advertising of prescription drugs is permitted only in the United States and New Zealand and was heavily attacked by consumers in the wake of the 2004 withdrawal of Merck & Co's heavily promoted painkiller Vioxx."

The main thrust of the legislative reform is to increase customer safety, and to do so requires deft political maneuvering, since repackagers, generic manufacturers and brand manufacturers will all find elements of the legislation against their best wishes. There is to be a more powerful system of safety monitoring for patients, improved anti-counterfeiting legislation, and more direct-to-consumer (DTC) information on the products allowed.

The biggest safety concern is response time--getting all potentially dangerous products out of customer-facing locations as soon as possible. The Irish pork recall showed that the response system is indeed fast, and generally seems to provide patient welfare. But, it needs to be more cost-effective. Full provenance track and trace, then, is more or less inevitable.

Cheers,

Steve

The Unflat Earth Strikes Again--Inspection Unflatness

StevenSimske — Sat, 25 Oct 2008 05:17:00 GMT

For this interesting article on U.S. inspection of pharma manufacturing plants, I thank my friend Pipo Caban, a systems, supply chain, manufacturing and pretty much all-around expert at HP:

http://www.newsobserver.com/1573/story/1263668.html

The article states:

"13 years is...the time it would take U.S. inspectors to visit each of 3,249 foreign manufacturing plants that make medications for the American market, according to congressional investigators...The Food and Drug Administration is nowhere near to closing an oversight gap so foreign facilities get the same scrutiny as domestic plants. Pharmaceutical factories in the U.S. get a federal inspection every 2.7 years, on average. Although the FDA will soon be placing inspectors in China and India, 'given the growth in foreign drug manufacturing for the U.S. market, and the large gaps in FDA's foreign drug inspection program, significant challenges remain,' the Government Accountability Office said in its report."

In other words, the Unflat Earth, and not the Flat Earth, strikes again. Motivation to move your manufacturing overseas? How about you get inspected 1/5 as often?

I have posted about the Unflat earth in previous blogs; specifically, the July 5th and 6th blogs this year. I'll revisit these now in light of this information.

On July 5th, I noted:

"Evasion of the local laws. Sure, every large company claims they're simply 'staying competitive' with their competition as they try to squeeze the last penny out of their costs. The truth is, most of this cost is due to finding out how the Unflat Earth (the real one, which still has countries, with different laws and rules and requirements in them) works and using it to advantage. Can you find a country with no health care costs? Great, put your assembly line there. Can you find a country with relaxed environmental laws? Excellent place for any pollutant-producing manufacturing operations. Companies aren't necessarily choosing where to place their employees based on a Flat Earth--that's just spray-on gloss to hide the Unflatness they're actually exploiting."

Add inspection to this list.

On July 6th, I added:

"The earth is not flat...yet. If you want to have engaged partners around the world, you have to work to even the playing field. Eventually, healthcare, environmental, auditing, compliance and other factors involved in selecting a spot to design, manufacture and assemble products will be more uniform. The world will be, truly, more flat. However, until that date, respectful citizens of the planet will work to improve the working conditions and environmental impact of doing business everywhere. Even if only out of self-interest, this strategy makes sense."

I also noted that increased costs of fuel might make offshoring certain types of production, manufacturing and assembly less profitable. Of course, that also makes inspection more costly, so those two will continue to trade off (if I still save more money by being inspected far less, paying less employee benefits, and not having to perform as many environmental-safety tasks, I can absorb those increased fuel costs).

But, the article goes on, into even more disturbing areas:

"The report found that the FDA isn't even sure how many foreign facilities are producing for the American market. One government database suggests it's 6,760. Another, which government officials believe to be more accurate, says about 3,000."

and...

"When FDA inspectors find problems at an overseas plant, the manufacturers usually take steps to fix them. But the report found that it can take as long as four or five years for the FDA to conduct a follow-up inspection."

I'm feeling some serious unflatness here. No wonder so many industries have been coasting down the hill of offshoring. It brings an entirely new track and trace problem to the fore. Forget about track and trace of the individual items in your supply chain (mass serialization). Forget about track and trace of all the locations your supply chain goes through (ePedigree). When you aren't even sure within a factor of two how many foreign facilities are producing for your market, you need to start at the most elemental level--find out who your partners are and get engaged with them. A very good way to ensure quality is for there to be a vested interest by all parties in the supply chain.

As Pipo notes, "[There are] so many regulations and restrictions for the locals but we are letting others control our health." In other words, the unflat regulations drive production overseas, where concern over our health is almost certainly--if not inevitably--less than it would be for locals, whose families might be customers.

Again, I am not against offshoring. Differences in distribution of raw materials, talented humans, and needs argue for responsible offshoring in most industries. But this works best if those distant workers are engaged, empowered, and "bought in" to the company performing the offshoring. It's not just about long-term economic viability of the partnership--it's about security and health.

-Steve