'What's in the Bottle': Launch of New Series in Pharmacy Today

Pharmacy Today, the magazine published by the American Pharmacists Association (APA) in July started a new series of articles about "What's in the Bottle".

As the publisher L. Micheal Posey in the July edition so aptly writes in his Today's Perspective:

Pharmacists and the public recently have faced a rash of extensive and disheartening recalls of medications. It's difficult to know whether something is amiss in the world of quality control or if this is just another symptom of the general problems in today's world. We do, after all, seem to be living in an era where humanity's technologic and scientific prowess seems to be exceeding the ability to predict and handle problems (think oil spill) and where some companies appear to be viewing product-liability problems as remote possibilities or perhaps another line on their balance sheet (consider some of the settlements and fines paid by pharmaceutical companies in recent years, with amounts in the hundreds of millions or even billions of dollars).

As detailed in FDA inspection reports and other documents, some companies in the ethical pharmaceutical industry are engaging in practices once thought of as completely out of the question: use of contaminated raw materials, product of medications outside current Good Manufacturing Practices, and release of products that have failed quality control tests.

At the same time, the shift of contract pharmaceutical manufacturing to other countries is taxing the U.S.-based FDA's ability to oversee manufacturing processes of companies making prescription medications, nonprescription products, and dietary supplements. Counterfeit medications are found far too often in the medication-supply chain in the United States and elsewhere. Drug products are being stolen by the truckload from warehouses and during interstate transport and diverted to the largely illegal Internet-based market or to collaborating buyers in the health profession who are eager for the "savings". Pharmacies are being robbed and burglarized for the valuable medications they stock, with diversions going mostly to the illicit market bu perhaps some back int the pharmaceutical supply chain.

These situations have pharmacist wondering. "What's in the bottle?"

The July edition of Pharmacy Today has an excellent first piece in the series titled, Empty Shelves: Med Recalls Creating Questions which details to newest challenges faced by the pharmaceutical supply chain and industry giants Baxter and McNeil.

Secure Pharma Chain is excited that publications that cater to pharmacists are begining to weigh in on the critical issue of supply chain safety and the huge business that fraudulent, adulterated, diverted and counterfeit medications have become.

Ultimately Secure Pharma Chain believes that pharmacists as with other members of the pharmaceutical supply chain must take measures to authenticate and validate their inventories before they pass them onto the consumer.

Technologies exist today that enable the supply chain to efficently and economically authenticate pharmaceuticals within their sealed unit-of-sale container.

To read the Pharmacy Today series, visit: http://www.pharmacytoday.org/.

To learn more about pharmaceutical authentication solutions, visit: http://www.xstreamsystems.net/.

Baxter's Heparin Saga Continues

The Wall Street Journal writes about the preliminary legal wrangling by Baxter regarding their class action lawsuit over the 2008 contamination of heparin products which led to 81 deaths in the United States.

In the class action lawsuit, Baxter and its heparin supplier Scientific Protein Laboratories are cited as being negligent because they did not do enough to check the quality of the contaminated active pharmaceutical ingredient that ended up in heparin products distributed to patients.

According to the story in the Wall Street Journal, “Baxter and SPL are trying to block an attempt by Amphastar Pharmaceuticals to force disclosure of documents relating to the case which they claim contain proprietary and commercially-sensitive information.”

Amphastar claims that the documents could reveal important information about the origins of the tainted API.

Among the documents under dispute is the deposition of another company, Momenta Pharmaceuticals, which assisted the US Food and Drug Administration in its investigation of the scandal.

This story, like several other high profile issues regarding the quality and efficacy of pharmaceuticals, is a cautionary tale to all within the pharmaceutical supply chain to protect their products.

With an entire criminal industry that focuses on counterfeiting and what many call economically-motivated adulteration, in which ingredients are deliberately adulterated to fool lab testing and increase their value, the pharmaceutical industry, the value of their individual brand and the health and well being of the average consumer is in the cross hairs. Manufacturers, distributors and dispensers need to deploy and integrate technologies to verify and authenticate their raw materials, products, inventories and dispensed medications.

As it relates to Baxter, the FDA believes that the heparin was purposely laced with cheaper, toxic contaminants - oversulphated chondroitin sulphate – which ultimately lead to the deaths of 81 people.

To read The Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748704868604575433960537183170.html?mod=googlenews_wsj.

Chain of Custody Dilemma: Recovering Stolen Pharma Products

By: Alan Clock, Senior Vice President, XStream Systems

What happens to pharmaceutical products that are recovered intact, meaning in their original packaging or shipping containers, following a theft or high jacking?

According to most experts, the policy of Pharma companies is to destroy these recovered products because they have broken the chain of custody or transaction. The logic is that no one wants to assume the liability of the efficacy of the products because they are uncertain if the products were affected or somehow altered during their time spent outside of legitimate charge.

This is an obviously an expensive and wasteful expense especially if there is a technology available that would allow the supply chain to test these products, within their sealed, unit-of-sale container. A technology that will verify that the material inside is safe and has not been altered, tampered or somehow counterfeited without destroying or degrading the drug.

Recent statistics are showing a significant surge in criminal organizations targeting Pharma products within the pharmaceutical supply chain (manufacturer, distributor, dispenser and consumer). These groups are stealing large shipments; in transit to sell within gray or black markets for significant profits. Fortunately as the problem escalates, law enforcement and security often are recovering or interdicting these criminal acts quickly.

The following are some recent examples:

- Polish police have recovered eleven tons of human blood plasma that had been stolen at a truck rest stop in Germany while in transit to Austria. The owner of the plasma, BioLife Plasma Services, a subsidiary of Baxter International, valued the shipment at around $1.4m. All of the product had been recovered in its original boxes and packaging.

- Police recovered intact a shipment of Alcon Labs and Teva Pharmaceutical products, stolen on February 22. The value of the shipment has not been disclosed but included 70 pallets of assorted prescription, over-the-counter and personal healthcare products.

- A pharmaceutical shipment including products valued at over $500,000 belonging to Sanofi-Aventis was hijacked in Puerto Rico on January 29. A wide range of prescription medicines and vaccines was taken in the incident.

- AstraZeneca lost in transit, a FedEx shipment in late December/early January. The total value of the shipment, which included Casodex, Seroquel, Nexium, Toprol XL and Crestor and Zomig was in excess of $500,000.

As it stands today, even with the product recovered intact and within its original containers the product will be slated for destruction because of the lost chain of custody. However there is a readily available technology solution.

The most effective way to effectively know that the lost chain of custody has not impacted the quality, efficacy or somehow adulterated the stolen medications is to look inside the sealed container to screen, verify and authenticate the product inside the package.

An ideal solution, it allows packaged drugs to remain intact and is readily available to test products once they are retrieved. This technology provides a level of confidence that the temporary loss of chain of custody has not altered the product and that public safety is ensured.

XStream System’s technology solution is the ideal solution for the pharmaceutical industry's chain of custody challenge by using Energy Dispersive X-Ray Diffraction (EDXRD). This innovative technology allows the user to molecularly screen the product inside its original container without destroying or degrading the product.

This solution transforms the process from looking at the chain of custody and/or transaction to looking inside the packaging with Molecular Screening. Ultimately, this truly provides all of the members of the supply chain, from manufacturer to consumer, the confidence to know that the medications in their inventories or supply chain are safe and efficacious.

EDXRD solutions function by matching the diffraction pattern obtained by the instrument with a library of patterns previously obtained for comparison. The EDXRD diffracted spectral patterns of crystalline substances are markedly different, even to an untrained eye. Much like a human fingerprint, although there may be a few features that are common to both patterns, they are nonetheless very different. In current iterations of the technology, which is fitted with a computer-based detection device, the system relies on a sophisticated mathematical algorithm to extract a unique feature set from the pattern and use them to identify the material giving rise to that pattern.

In general, the EDXRD methods are highly material specific, since the diffraction patterns of crystalline materials are unique. As it relates to pharmaceuticals, the signature of diffracted aspirin is very different from ibuprofen, acetaminophen, codeine, etc. Equally important is the fact that the diffracted patterns of the excipients specific to the unique recipe of the formulation are unique and one can determine differences in manufacturer, packaging, dosage, etc. For example, acetaminophen, 325mg from one vendor, will differ from acetaminophen 325mg from another vendor unless they follow the exact same recipe, density, pill configuration and utilize the exact same packaging.

This material sensitivity of EDXRD has two important ramifications - high detection/verification rates and low false alarm rates. Under ideal conditions (i.e. - low absorption and high test mass), the detection rate is close to 100% and the false alarm rate is 0.1% or lower. In addition because it uses X-Ray, EDXRD technology can penetrate through nearly all plastics, cardboard, wood and metals in order to screen the material.

XStream Systems has succeeded in establishing EDXRD as a robust Molecular Screening tool that can be used within the supply chain. XStream has conceptualized and architected the world’s first countertop EDXRD machine, the XT250 Material Identification System.

The XT250 has turned a complex technology into an easy to operate solution for the average end user. The XT250 system is now fully deployed in drug wholesalers, pharmaceutical manufacturers and pharmaceutical reverse logistics companies. The system is designed to be used either in a standalone or integrated capacity anywhere along the supply chain; the deployment can be in a warehouse setting and operated by a non-technical warehouse worker.

With the XT250, there no longer needs to be the very expensive and wasteful dilemma of product destruction because the product has lost its chain of custody. Because the XT250 can authenticate products non-destructively, will no longer be incumbent on the supply chain to absorb multi-million dollar losses as the threat of cargo theft proliferates.

To learn more about XStream Systems, material identification solutions, visit: http://www.xstreamsystems.net/.

Medical High Jacking: Polish Police Recover 11 Tons of Stolen Plasma

Polish police announced that they have recovered 11 tons of human blood plasma that had been stolen from the U.S. Company BioLife Plasma Services, a collection facility owned by Baxter International. The plasma was on its way to Austria, officials said Thursday.

The stolen Blood Plasma was worth more than euro1 million ($1.4 million), and was taken while the driver made a rest stop in Germany.

The plasma was recovered in its original boxes originating from Harrisonburg, Virginia, where BioLife Plasma Services, has operations.

BioLife spokeswoman Laura Jacobs said the plasma had come from other facilities as well, but did not elaborate.

Jacobs said the company was working with local authorities to determine how the theft occurred. "Importantly, the plasma has been recovered and is currently in Baxter's Vienna facility," she said.

Plasma is a critical component used in the treatment of a wide range of medical procedures. Given that the product was stolen and has lost its official chain of custody it remains to be seen if all of the Blood Plasma would need to be destroyed due to potential issues of contamination and adulteration.

This particular incident, based on stolen but critical medical supplies, energizes the need for routine material screening of products within the supply chain, from manufacturing to dispensing, to properly protect consumers from fraud, adulteration, contamination and counterfeiting.

To learn more about supply chain material testing solutions, visit: http://www.xstreamsystems.net/.

FDA Investigating Deaths of Heparin Patients

Two patients have died from adverse reactions to heparin at Beebe Medical Center in Delaware. Another patient hospitalized at Beebe is also experiencing the same adverse reaction. The deaths are being investigated by the Food and Drug Administrations (FDA) and Baxter Healthcare, who supplied the blood thinner to facility. It is uncertain what caused the reaction. Unlike last year’s recall in which patients developed low blood pressure, these patients developed intracranial bleeding.

Baxter stated that the active ingredient in the product was obtained from Pfizer and not bulk suppliers in China. Pfizer commented that while they do source heparin raw materials from China, they believe that the lot number in question was purchased domestically.

This reaction seems to be an isolated case and has not been reported as any other facilities.

The Delaware hospital where both patients died emphasized that it's not sure heparin caused the deaths. "We are not pointing fingers at Baxter," a Beebe Medical Center spokesman stated. "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves."

FDA says drug stores sold expired medications

The Medicine Shoppe, a subsidiary of Cardinal Health (one of the “Big Three Distributors”), sold expired or presumed fake prescriptions to their customers. Granted this was just two of their stores located in Baltimore, but it does make one wonder – How did this happen?

Especially troubling is that this may just be the beginning. In Europe, officials are seeing an upward trend of expired product simply being relabeled to appear good. It is estimated that 10% of medicines sold there are counterfeited or adulterated.

The Medicine Shoppe's suspect medications and the conditions they treat include:

• Lisinopril (20 milligrams) _ hypertension
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg) _ cough
• Gabapentin (100 mg, 300 mg and 400 mg) _ epilepsy
• Metoprolol (50 mg) _ hypertension
• Nifedipine (30 mg) _ hypertension
• Diclofenac Sodium (30 mg) _ anti-inflammatory
• Glucophage (500 mg Extended Release) _ diabetes
• Glucovance (125 mg and 500 mg) _ diabetes
• Glipizide/Metformin (2.50 mg/250 mg) _ diabetes
• Furosemide (20 mg) _ diuretic
• Tamoxifen Citrate (10 mg) _ breast cancer
• Metformin HCl ER (500 mg) _ diabetes
• Calcitrol (0.25 micrograms) _ osteoporosis

It has long been assumed that if product was purchased straight from the manufacturer and/or one of the major distributors, that naturally, the medicine was pristine. However, these days that assumption, sadly, is no longer valid. This year alone, we have witnessed recalls from Baxter for adulterated heparin, Ranbaxy for counterfeit HIV medications, and NOW a major drug store chain for fake or expired prescriptions.

To view the full article from Associated Press, click here.


Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Baxter CEO Says Heparin Purposely Tainted

Yesterday on Capitol Hill, a house subcommittee heard testimony on the recent issue of contaminated Heparin. Robert Parkinson, CEO of Baxter testified that the company believes the heparin was deliberately tainted.

Most heart wrenching, was when the family’s victims told their stories on how the tainted Heparin has destroyed their lives.

Leroy Hubely, was in tears as he explained how his wife Bonney died in December 2007 and then a month later his son, Randy died under the same circumstances. Only after the recall of Heparin, did he learn from his local dialysis center that tainted heparin, and not some cruel twist of fate, led to both of their deaths.

His daughter-in-law Collen Hubely, a dialysis nurse, testified: “As a nurse, I thought that I would be there to save my husband from any errors, but I guess I was naive. I never thought the life saving medication we were relying on might be contaminated. If citizens are truly going to ever to feel safe in this country going to the hospital, a doctor, taking your daily medication; we have a responsibility to be make sure that everything that is given is free from contamination.”

Families demanded more stringent policies and testing to protect consumers from dangerous materials hidden in our medications.

Heparin Contaminant found in 11 Countries!

China is continuing to deny their part in the contamination of the Heparin supply and the related deaths. They have even gone so far as to imply that the contamination could have occurred in a US plant. There is no denying on their part now, as the countries affected have climbed to 11 including: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

With this latest revelation, China has at least accepted responsibility for the contaminant (oversulfated condroitin sulfate, or OSCS), but denies this resulted in the over 800 adverse reactions and the 81 deaths the FDA has attributed to it in the U.S. alone. FDA has conducted testing which has linked the OSCS to the adverse reactions observed. Additionally, The FDA has traced the lots in question to 12 Chinese companies involved in the heparin’s manufacturing.

Worldwide, the heparin recalls have expanded to include recalls from numerous companies that use heparin in a variety of medicinal products: Baxter (heparin); B.Braun (heparin solutions); Covidien (pre-filled syringes); American Health Packaging (heparin sodium vials); Hospira (heparin syringes, vials, and bags); AstraZeneca (heparinized saline); Sanofi-Aventis (Clexane drug); Rotexmedica (heparin products); Opocrin (heparin API); Sierra Pre-Filled Inc.(heparin lock and normal saline flushes); G. Bichsel AG (heparin products); and Arseus NV -Fagron (heparin).

The FDA has updated their testing to include two screening tests and is currently working with US Pharmacopeia, a non-profit organization dedicated to safety in the pharmaceutical industry on further testing.

Clearly, the magnitude of these recalls echo the need for more encompassing and rapid screening tests in the pharmaceutical arena. As the saga continues, manufacturers and suppliers should ask the question – Am I doing everything possible to ensure my supply is secure?

As the number of deaths stemming from the Heparin tragedy increases, so must our vigilance to make sure this does not happen again.