Last week the Pew Charitable Trusts program on drug safety released its final White Paper about the major threats to the U.S. drug supply, called After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs. Online pharmacies are not among the major threats, according to Pew. Rather, the globalization of drug manufacturing and Byzantine domestic pharmaceutical distribution processes are the crux of the problem.
According to Pew, a major threat to the U.S. drug supply comes from importing active pharmaceutical ingredients and finished prescription drug products from facilities that have not been inspected by the FDA and on which we otherwise have too little information. The other major threat is attributed to the complicated nature of our domestic drug distribution system, in which literally thousands of wholesalers buy and sell prescription medication in a domestic grey market marred by loose and inconsistent regulations, state and federal.
It’s clear that Pew does not view international online pharmacies as a major threat to the U.S. drug supply, but they did make a few points of caution. The report reads:
Online pharmacies are another way that problematic products can make their way into the United States. While not examined in depth in this paper, there is no doubt that by indiscriminately purchasing drugs from online sources, consumers expose themselves to a large safety risk. While many legitimate online pharmacies exist, there have also been documented sales of counterfeit, diverted, misbranded or adulterated medicine through online pharmacies.
We certainly agree that “indiscriminate” online purchases can be dangerous and that “many legitimate online pharmacies exist.” To be more thorough, the report’s authors should have mentioned, in addition to the NABP’s VIPPS program, the peer reviewed study on online pharmacy purchases found in Public Library of Science, which concluded that genuine brand name prescription drugs can easily be purchased from foreign and domestic online pharmacies approved by PharmacyChecker.com. The study’s author, Roger Bate, a scholar at the American Enterprise Institute, presented these findings at the Pew Conference On Drug Safety. By reporting the evidence, Pew would have gone farther in making sure government enforcement and regulations are geared toward the real threats and not waste time and taxpayer resources on public information campaigns and potential enforcement actions against safe non-U.S. online pharmacies. This is important considering the emphasis of the pharmaceutical industry, FDA, and NABP on the “dangers” of buying “foreign” medication online. As Pew reminds us (it’s not new information), almost all of our medication is already “foreign”.
It’s worth noting that the title of the report “After Heparin” was used because 238 Americans died in 2007 and 2008 after taking FDA-approved, yet substandard, heparin, bought in U.S. pharmacies and administered in U.S. hospitals (Note: There is a continuing debate over how many of the deaths were directly caused by the substandard heparin – See hyperlinked statistics for FDA details.). Pew points out that better pharmaceutical standards in Europe than in the U.S. may have limited adulterated heparin from entering the European market:
USP [U.S. Pharmacopoeia] leadership believes that European requirements for additional heparin tests likely helped limit the distribution of material in the European Union, but this was a complex situation that is still not entirely understood.
This is not to say that the EU has a safer drug supply that the U.S., but, as the Pew authors note about the heparin issue, it’s a complex situation that is still not entirely understood. We do not believe that there has been a single death or outbreak of sickness attributed to personal drug importation from properly verified online pharmacies, both because of the safety of the pharmacies we verify and the absence of any such reports from FDA, NABP, or the pharmaceutical industry.
The Pew report mentioned little about drug affordability: It read, “For an individual patient unable to afford drugs in the United States, the potential to obtain identical products at lower cost is understandably attractive.” This is an unfortunate understatement of the affordability problem. According to the U.S. Centers for Disease Control and Prevention, 25 million Americans did not take their prescribed medication due to cost in 2009, almost double the number from 1997. As we applaud Pew for its excellent coverage and reporting on drug safety problems within the U.S. drug supply, we assert and remind our audience that a bigger problem is Americans’ lack of access to affordable medication.Tagged with: After Heparin, Countefeit Drugs, Pew Drug Safety Report, Protecting Consumers, Substandard