Physical Security For The Pharma Supply Chain

By Louis Garguilo, Chief Editor, Outsourced Pharma

Charles “Chuck” Forsaith quietly enters his office as the light of day lands on Stamford, Connecticut. For a little over an hour he pours over intelligence briefings on illicit drug activity around the globe.

Sound like the start of a Tom Clancy novel? Rather, it’s the reality of a security professional charged with assessing supply-chain risk for the receipt and delivery of pharmaceutical goods.

Forsaith is director of supply chain security at Purdue Pharma Technologies, and also chairman of the Pharma Cargo Security Coalition (PCSC). He and his peers at pharmaceutical companies around the world receive intelligence analysis each day to help assure their products are shipped and arrive when and where intended, and are ultimately consumed by patients in the products’ specified condition. 

Securing Purdue First

Forsaith concentrates most morning briefings on source areas of opiate raw materials, and logistics centers where that type of product (both raw and finished dosage) is most likely to pass through the pharmaceutical supply chain.

In pursuing his mission, he’s not permanently holed-up in a high-tech intelligence room monitoring screens and communications. He dedicates as much as sixty percent of his time to travel, including visiting destinations to conduct his own personal assessments – lending both leadership and expertise. As we might expect from someone who describes much of his work as “physical security,” he says, “Face-to-face interactions are always preferred.”

For nearly 20 years Forsaith was a member of state law enforcement, as a member of the New Hampshire State Police. Among other duties, he helped keep illicit drugs off the streets. For the past 15 years or so he’s focused on keeping un-prescribed stolen and counterfeit drugs off streets in countries around the world. Both these activities – theft and counterfeiting – risk the health of legitimate patients in need of proper medications. Purdue hired Forsaith in 2001, as it was distributing the highly effective, opiate-based pain medication OxyContin. The drug was a “scheduled” narcotic, and as such added potential for both theft and abuse.

Few people – even within the biotech and pharma industries – have a realistic appreciation for risk levels associated with complicated pharmaceutical supply chains. Burglaries, robberies, truck, air and seaport thefts, subtle diversions, as well as the introduction of counterfeit materials and products, are what keep professionals like Forsaith on their toes. “What is the current location of that shipment headed to the hospital’s distribution center in Guatemala … or in Gaithersburg?” is the type of question asked of a supply-chain security expert on any day.

An Industry-Wide Bodyguard

Since joining Purdue, Forsaith has been devoted to protecting those patients who utilize his company’s drugs – the success of which he takes pride in and shares with many others. But Purdue Pharma, very much to its credit, has also allowed Forsaith to share his knowledge and intelligence sources with other industry players and supporting organizations.

Forsaith helped establish and remains the acting chairman of the Pharma Cargo Security Coalition (PCSC). The group’s membership reads like a veritable list of who’s who in the drug manufacturing, wholesaling and retailing disciplines. To name a few: Amgen, Boehringer Ingelheim, Catalent, Genentech, Gilead, Johnson & Johnson, and Novo Nordisk. PCSC also includes law enforcement and government entities, cargo insurers, carriers and risk management advocates … all dedicated to preventing theft of pharmaceutical products in both transit and storage.

“PCSC ensures that our members have the most accurate and up-to-date pharmaceutical cargo theft intelligence and security information,” he says. Forsaith issues his own theft alerts and intelligence, and offers avenues of training to coalition members. Purdue Pharma helped out be establishing and funding an information clearinghouse for data related to pharmacy robberies, burglaries and cargo thefts that involve the loss of controlled substances. RxPATROL® (Pattern Analysis Tracking Robberies and Other Losses) is an initiative designed to collect, collate, analyze and disseminate pharmacy theft intelligence to law enforcement throughout the U.S.

The Food & Drug Administration lists the PCSC as a resource. Its FDA Cargo Theft website is  “committed to protecting consumers from the threat of stolen, counterfeit, and diverted FDA-regulated products such as prescription or over-the-counter medicines, medical devices, or infant formula.” It provides notices to the public about cargo thefts involving FDA-regulated products that have been stolen either from warehouses or tractor-trailers.

Other industry groups include the Pharmaceutical Security Institute (PSI), the National Biopharmaceutical Security Council (NBSC), and the American Society of Industrial Security’s (ASIS) “Pharmaceutical Security Council.” According to Forsaith, these entities regularly share expertise, exchange information on ideas for enhancing security in the industry, and discuss best practices.

Collaborative efforts to combat large-scale theft of pharmaceutical shipments, from both transportation entities and warehouses, are proving highly effective. For example, statistics maintained by the PCSC show that in 2009 there were approximately 47 large-scale illicit incidents of theft, with an average loss in each incidence of $4.2 million; by 2013 that had dropped to just 23 with an average value of $228,000.

Forsaith says this year the PCSC has concentrated on the safety and security of ‘the last mile portion of the pharma supply chain.” This covers the final deliveries to retailers such as CVS, Walgreens, and Rite Aid. It also includes “a somewhat forgotten portion of the supply chain – that of reverse distribution,” says Forsaith.

Reverse distributors provide a service to pharmacies by processing unused drug inventory – either for return to the manufacturer for credit, or for safe disposal – while also helping to protect public health by maintaining compliance with federal/state laws and regulations. The federal regulatory bodies that oversee the reverse distribution process are the same that govern pharmaceutical waste management: Drug Enforcement Administration (DEA), the Environmental Protection Agency (EPA), Department of Transportation, and Occupational Safety and Health Administration (OSHA). According to Forsaith, reverse distribution security presents unique challenges for professionals in his field, and as with the other parts of the distribution supply chain, can be vulnerable to diversions. 

Epilogue

Years ago, while working in economic development for a state governor, I had the opportunity to interact with a number of state troopers. To a man and woman, they exhibited a certain physical presence; just having them around made everyone feel safe. I also found these law enforcement professionals almost always soft-spoken but open and friendly, and very focused. Forsaith certainly embodies all these qualities. Patients and the industry as a whole are fortunate to have this former state trooper on duty protecting the physical security of drugs in the pharmaceutical supply chain.