Conversations

Are we doing enough to ensure the security of our nation’s pharmaceutical supply chain?

Contributors Respond

Marv Shepherd, Ph.D.

Marv Shepherd, Ph.D.

President, Partnership for Safe Medicines

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While the U.S. drug supply chain is the most secure in the world, that doesn’t mean there aren’t cracks in the system that are seized upon by criminals trafficking in counterfeit, unapproved or expired drugs, all of which can be dangerous or lethal to American patients.

One of the most disturbing trends I’ve been seeing recently is criminal enterprises posing as legitimate wholesalers purchasing drugs from patients or “closed door” pharmacies, for example those that service inpatient hospital facilities or nursing homes. These drugs are then illegally diverted and in some cases repackaged or relabeled (in the case of expired medicines) and sold to unsuspecting pharmacies and others for a large profit.

In order to ensure the security of our drug supply chain, legitimate pharmacies and others who purchase prescription medicines from wholesalers must be vigilant about only buying from approved, licensed distributors. While this requires taking the time to conduct some due diligence, this information is readily available and must be verified 100 percent of the time. In addition, purchasers of medicines from wholesalers must become more willing to report any activity they think is suspicious to the FDA and other authorities. The bottom line is that every pharmacist, doctor, nurse or staffer who is responsible for purchasing prescription medicines has a duty to ensure protecting patients is the number one priority.

With the huge profit margins involved in trafficking counterfeit and unapproved drugs, criminals are constantly innovating to find new ways to exploit the smallest cracks in our drug supply chain. In an era of skyrocketing healthcare costs, the temptation to risk patient health and safety for budget savings can become too great to ignore. It’s clear that much more must be done to educate pharmacies, doctors, nurses and hospital staff about the dangers of purchasing prescription medicines from shady sources at prices that seem too good to be true.

Anthony J. Maddaluna

Anthony J. Maddaluna

EVP, President, Pfizer Global Supply

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The industry is working to ensure the safety of the medicines we provide patients, and one of its most important efforts has been its support for a uniform national traceability law.   It appears that we are getting close to having Congress pass that law, which will go a long way to helping us ensure American’s are getting the medicines they need and are paying for. 

A national track-and-trace system would require that prescription drug products contain technology able to determine the product’s source and distribution history.  It would allow for ongoing enhancements and give the FDA the nationwide authority to keep the system safe from counterfeiters as well as ensure an efficient and cost-effective system applicable in all 50 states. 

A law like this will give us the nation-wide framework we need to do even more to combat those undermining the safety and integrity of the drugs those of us in the industry work so hard to develop and produce for patients around the world.

I want to thank those legislators who have understood how important this bill is to the well being of the American people and have been champions of it for so long.  It is good to see that we are getting close, and now I urge them to push it over the finish line as soon as possible.

Scott LaGanga

Scott LaGanga

VP, Public Affairs & Alliance Development, PhRMA

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Ensuring the safety and authenticity of innovative medicines must continue to be the biopharmaceutical industry’s top priority. Unfortunately, there are individuals who wish to do harm and/or benefit financially by proliferating counterfeit medicines, and such activities pose a direct threat to patients and the security of the industry’s supply chain. As someone who has been working on this issue for several years, it’s becoming increasingly clear that we’re in the midst of a “perfect storm” as it relates to the counterfeit drug trade. 

Put simply, criminals are getting savvier every day. Anyone who has viewed the end result of a counterfeiting operation knows that the tools and technologies exist to closely match the appearance of packaging and the medicines themselves. Consider the example of Asia: According to the Pharmaceutical Security Institute, there were 2,979 total incidents of counterfeiting, illegal diversion and theft in Asia between 2010 and 2012 (nearly half of the worldwide total). 

The good news is that the good guys are becoming more savvy as well: law enforcement and international bodies who are on the front lines of seizing counterfeit medicines and drawing attention to the broader issue. Operation Pangea VI, an initiative of INTERPOL and nearly 100 partner nations, seized 9.8 million doses of fake or illegal prescription medicines over the summer. More than 9,600 websites of fake online pharmacies were also closed.

All said, there’s much more work to be done and a common thread must continue to be developing public-private partnerships that empower all stakeholders. Doctors have just as much skin in the game as patients. The same goes for policymakers, law enforcement, consumer advocates and health care providers. Everyone has a role to play in identifying solutions that keep patients safe.

This is a borderless issue, but one that we will overcome through strong collaboration at all levels. We’re making progress and the opportunity to continue to chip away at counterfeit initiatives has never been more real.

Chip Meyers, Jr.

Chip Meyers, Jr.

Vice President, Corporate Public Affairs, UPS

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Unfortunately, we are not doing enough to ensure the security of our nation’s pharmaceutical supply chain and now is the time to act. It has been 25 years since the U.S. last enacted federal drug supply chain safety legislation, and counterfeit drugs have grown into a $75 billion annual global industry. Today the nation’s pharmaceutical supply chain is vulnerable due in part to the existing patchwork of state laws that fail to leverage uniform technology and policies. We also lack a comprehensive strategy that addresses this concern on a global level, leaving the U.S. more susceptible than we’d like to believe. A supply chain is only as strong as its weakest link, and the U.S. is an integral part of the global pharmaceutical supply chain.

We are fortunate in that the U.S. has one of the safest drug supply chains when considering other regions of the world. However, we are not immune to counterfeiters who constantly seek ways to expand their illegal trade for financial gain. The best time to address a potential threat is from a position of strength, as opposed to in response to a crisis.

On the heels of California passing the e-Pedigree legislation, which goes into effect in 2015, industry came together to form the Pharmaceutical Distribution Security Alliance. This coalition of stakeholders includes members from the full pharmaceutical distribution system, and works to develop and help enact a federal policy that will enhance the security and integrity of the pharmaceutical distribution system.  There is a need to balance safety, cost, technology and efficiencies, and a comprehensive national strategy is vital to achieving all of those needs in a swift and effective manner.

A wide variety of stakeholders have been and will continue to work with Congress and consumer groups to secure and implement uniform serialization technology. Serialized products would enhance supply chain visibility by putting a “license plate” on the drugs, allowing consistent visibility and tracking of all products. While the idea of a “pedigree” is definitely a step in the right direction, the reality remains that a pedigree or transaction statement can be counterfeited easier than the drugs themselves. As a key player in the global supply chain, the U.S. must act as a leader in implementing technology and policies that would effectively secure products at every step of the way in the global supply chain.

It is time to move beyond politics and vote to enact The Drug Quality and Security Act. This will put in motion a bipartisan, stakeholder-supported plan to ensure the security of our nation’s pharmaceutical supply chain and, ultimately, the end consumer.

Brian Hujdich

Brian Hujdich

Executive Director, HealthHIV

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From an HIV/AIDS treatment perspective, access to effective antiretroviral therapy is a critical component for helping patients living with HIV to maintain good health and a quality of life. This is especially true for HIV-positive older adults who are taking even more medications to manage multiple chronic conditions. Ensuring the safety, quality and integrity of pharmaceuticals that enter our nation’s supply chain is essential, since not having the right medication at the right time could have significant consequences.

Our nation’s pharmaceutical supply chain is one of the most secure in the world, and the Food and Drug Administration (FDA) works with industry to have multiple protections in place to ensure the medications we take are the authentic compound.  However, the Partnership for Safe Medicines has highlighted several instances in recent years where counterfeit HIV medications have entered the supply chain in the United Kingdom, Germany and other developed countries where criminal counterfeiters continually abuse their systems. In the U.S., according to a 2013 report by the Institute of Medicine, there is growing evidence of falsified and substandard medicines making their way into the nation’s supply chain, putting thousands of patients at risk.

In addition, some individuals are turning away from reputable pharmacies to the Internet in an effort to secure cheaper prescription medications from online pharmacies (most of which are not based in the U.S.). In doing so, consumers end up bypassing many of the safeguards that are necessary to verify a specific drug’s origin and authenticity.

HealthHIV recognizes that securing our Nation’s pharmaceutical supply chain is no simple task, and one that will require an ongoing re-evaluation of procedures and safeguards in order to remain ahead of criminal counterfeiters. The U.S. therefore needs a set of national standards to protect patients from counterfeit medications. For their part, patients, in order to have confidence that their medications are authentic and safe, should only purchase their medications through reputable and established pharmacies.

All of these challenges are greatly mitigated by both the Drug Supply Chain Security Act (S. 957) and the Drug Security Act (H.R. 3204).  HealthHIV looks forward to working to advance these measures in the 113th Congress. That’s why the U.S. needs a national set of drug security standards. HealthHIV will therefore do its part to ensure passage of the Drug Quality and Security Act.

Bill Arnold

Bill Arnold

CEO, Community Access National Network

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Patients living with HIV already have enough on their minds without having to worry about whether the medicines they are taking to keep them alive are legitimate. And although our supply chain is far more secure and reliable than most other nations, there are too many examples of fake drugs infiltrating our market to regard this issue as a mere anomaly. 

Given the complex nature of the multiple drug combination antiretroviral therapies used to treat HIV, even one missed dose as a result of taking a counterfeit or substandard drug could have serious consequences. These drugs must be taken at precise times and doses in order to be effective, making the security of the supply chain critically important for HIV patients.

Certainly, affordability and access to treatment for all patients are major issues that still need to be addressed by policymakers. Until these issues are resolved, our government needs to do everything possible to secure the supply chain and ensure that counterfeit and otherwise substandard medicines do not find their way into the medicine cabinets of American patients. Education certainly needs to be a major component of these efforts, with both the FDA and physicians and pharmacists sharing responsibility for making patients aware of the dangers of purchasing their medicines from nefarious sources. In addition, the United States must develop a reliable system to track prescription drugs from the manufacturer to the pharmacist, so that counterfeits are more easily detected and removed from the supply chain at the earliest possible moment. Lastly, we need more aggressive policing and enforcement to permanently shut down illegal phony online pharmacies and wholesalers and distributors who make a living selling counterfeit or unapproved drugs.

These issues require all stakeholders to remain vigilant in helping guard our nation’s drug supply chain. As advocates, it is our duty to raise awareness and alert patients about the risks and potential consequences of fake drugs. But raising awareness is not enough. It is up to policymakers and industry to work together and find solutions to ensure that one day, fake drugs will no longer be a concern to American patients.