This editorial by Libby Baney and Thomas E. Menighan, BSPharm, MBA, FAPhA was published in Drug Topics on October 16, 2018. Baney is a senior advisor to the Alliance for Safe Online Pharmacies. Menighan is executive vice president and chief executive officer of the American Pharmacists Association.
Lower Drug Prices Aren’t Worth Higher Health Risks
Everyone on the “buy side” wants lower cost medicines. But at what cost? As HHS tries to make medications more affordable, patient safety must not be sacrificed.
Directed by HHS, FDA convened a Working Group in August to examine potential prescription drug importation policies. Its recommendations would likely promote competition for certain off-patent sole-source drugs that cost more in the United States than elsewhere. Yet, foreign sellers can already increase competition by working with authorities to export FDA-approved products to the United States via the legitimate supply chain. While FDA is considering allowing foreign sellers to export to the United States to increase competition, they are doing so without directly addressing the core issue of domestic price spikes.
Pharmacists are willing to consider novel approaches to lower the cost of medications, but are concerned the Working Group’s potential recommendations will incentivize foreign sellers by relaxing importation requirements. These requirements protect patients and ensure safe and effective medications.
Demand for convenient lower-cost medications has created a new economic incentive for criminals to manufacture and sell dangerous counterfeit drugs. Counterfeits are often made in unsafe conditions; contain too much, too little, or no active ingredients; and/or may contain dangerous or deadly substances.
Drug counterfeiters regularly trade in the highest-cost, hardest-to-get, and most sought-after products in America. Whenever there is a drug shortage, public health crisis, or price spike, counterfeiters and criminals swoop in, and target patients by offering access, “deals,” and even “cures.” Should HHS authorize importation of high-cost and/or high-demand off-patent medicines, we should expect criminals to similarly flock to that new market.
Expanding mechanisms available to import foreign-sourced medicines to the United States would exacerbate an already unmanageable safety situation. Officials already struggle to stop dangerous fakes from entering the country. Counterfeit pills laced with fentanyl and other synthetic opioids that kill Americans are shipped into the United States in mass quantities from foreign sources. The FDA estimates that it is able to inspect 0.06% of all packages thought to contain drug products that enter international mail facilities.
HHS’s actions could also have the unintended consequence of suggesting to Americans that it’s safe to buy any medicine from foreign sources. This messaging matters.
U.S. consumers buying medications from Canadian online pharmacies rarely, if ever, receive the same regulator-approved products provided to Canadian consumers. The FDA has found that 85% of drugs promoted as Canadian came from 27 other countries. Just as criminals now pass themselves off as Canadian, allowing even a limited legal means of importation would cause criminals to pass themselves off as meeting the requirements of a new restricted importation policy.
Pharmacists can play an important role in educating patients about their buying options, including ways to identify and coordinate cost-effective regimens that consider treatment plans, payer policies, and other members of the care team. Pharmacists can help optimize the impact of patients’ medications, but cannot do this effectively when patients’ medications may not be safe or effective.