Drug Companies Need to Improve Their Screening for Quality and Counterfeits

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

Recent massive recalls on generic drugs imported from overseas contract manufacturers are making significant reverberations within the pharmaceutical industry and making the case for more stringent screening of drugs both in finished form and in raw materials.

Manufacturers in the past have seemingly been immune to this level of public scrutiny because it has often been perceived that their products are at their most pristine at the point of manufacture however with the continued proliferation of contract manufacture of product and raw material sourcing from companies located in lesser developed countries the need for more robust screening from point of manufacture through the supply chain seems obvious.

These global recalls are not just happening to the smaller generic companies that contract their manufacturing overseas but also the generic divisions of big Pharma companies are feeling the sting of substandard product within their brand.

Although the liability to the stakeholders of these impacted companies is great, the impact and consequence to the consumers of these inferior medications should remain paramount. For those in the know within the pharmaceutical supply chain, the message and actions seem clear.

XStream Systems supports the concept of screening products throughout the pharmaceutical supply chain from raw materials, to the point of manufacture, packaging, throughout the supply chain and finally at the point of dispensing to the patient.

The level of screening required is important as well, realize that all of the poor quality recently recalled product in question were passed or would have been passed on to the consumer through the process of pedigree, serialization, bar codes and RFID tags.

End-to-end screening does not have to be costly, overly time consuming or onerous to the various members of the supply chain. Current technologies exist to rapidly screen raw materials at the point of production while XStream’s XT250 has a robust solution of analytical testing of products within the sealed container in the supply chain. At the point of dispense there are a variety of technologies available currently which test for product quality and medication errors before they reach the consumer. We at XStream believe that the most effective way of protecting the product is to employ a variety of solutions at each link of the supply chain.

As the world continues to move to a global economy and the pieces of the pharmaceutical supply chain scatter beyond borders a watchful eye towards quality and security are in the interest to all of those who either make a business of or consume pharmaceuticals.

FDA Links 100 Deaths to Heparin Since 2007

Late yesterday, the FDA announced publicly that over 100 patients within the United States have died while taking the blood thinning medication Heparin since January 2007.

The FDA found that over 62 of the deaths are the result of allergic reactions to contaminated batches of Heparin, which is significantly higher than their previous estimate of 19 deaths. Many of these deaths were not reported when they occurred, but are only now being reported to the FDA.

Allergic reactions to heparin are rare with only 3 deaths reported in 2006. However these increased in 2007, jumping dramatically to 8 in November, 12 in December, 16 in January, and 11 in February. FDA has posted the month to month mortality statistics on their website.

The presumed cause of the increased reactions is the adulterated compound the FDA discovered in the recalled products, whose ingredients were imported from China (See: Chemically Altered Chondroitin-Sulfate Found in Recalled Heparin).

China is a major supplier of raw heparin, which is derived from pig intestines. Recent decreases in swine population, due to blue ear disease, have caused Chinese plants to turn to smaller wholesalers for their own supply. Chondroitin-Sulfate is less expensive than its genuine heparin counterpart, which may explain why it was incorporated in the raw heparin.

In answer to this major threat, recalls have expanded to seven countries: U.S., Germany, Japan, Denmark, France, Italy, and Australia. Furthermore, the FDA has upgraded the pharmaceutical testing of imported Heparin.

Outsourcing: The Whole is Only as Good as the Sum of Its Parts!

One of the little known facts about the pharmaceutical industry is how much of its manufacturing is outsourced. Over 80% of the pharmaceutical ingredients used in the manufacture of US drugs are outsourced to foreign countries, with a majority of these ingredients coming from China and India.

Understandably, with the current news on the contamination of heparin in the US supply and the role the Chinese supplier played in this case being questioned, quality control has become a major concern. Since the whole is only as good as the sum of the individual pieces, should we not be questioning the quality and safety of all outsourced materials?

Timely testing of these ingredients should greatly reduce quality issues, adverse reactions and recalls. After all, diligence in safety of what goes in to our bodies cannot be overstated!

Remedy for a Plagued Drug Supply Chain

One of the current issues on everyone’s mind today is the quality and authentication of prescription drugs. With the rising cost of prescriptions, individuals are ordering online, senators are proposing drug importation, and manufacturers are outsourcing their raw materials. All of this has compromised our drug supply.

Counterfeits have plagued the medical community for longer than most people realize. Did you know that the first regulatory action against counterfeit medicines in the U.S. was the Pure Food and Drugs Act of 1906?

It was titled “An Act of preventing the manufacture, sale or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for relating traffic therein, and for other purposes.”

Since then, great strides have been made both by those developing new drugs to save us and by those profiteering pirates who contrive to make copies good enough to visually fool even the most learned man. But now science is causing a glitch in the illicit trade program. A new “scientist-in-a-box” technology which can look at a drug’s molecular level right on the front line has been unveiled!

Think of what this means: bringing real-time analysis to manufacturers, wholesalers, and repackagers. Forewarned is forearmed - and the sooner you can detect a counterfeiter the soon you can put your company and the public out of harm’s way!