Out of 7,310 prescription drugs legally dispensed to patients in the United States between January 2017 and December 2022, 70% (5,085) were being actively marketed and sold by illegal online pharmacies, according to a new report. The findings come from Assessing the impact of illegal online pharmacies in the U.S., a new report from the IQVIA Institute for Human Data Science, in collaboration with Translucent Datalab and IE University.
- An estimated total of 416 million prescriptions were provided to patients by these IOPs between January 2017 and December 2022, which represented 1.6% of the total prescriptions dispensed from both illegal online and legal pharmacies in the U.S. Between 2019 and 2022, the number of prescriptions dispensed annually through IOPs increased from 64 million to 85 million at a compounded annual growth rate of 10%;
- In particular, the start of the COVID-19 pandemic appears to have had a large impact on drug purchases through IOPs. The total prescriptions flowing through IOPs saw a sharp increase of 59% between January 2020 and April 2020, while the total prescriptions purchased through legal channels declined in this period;
- IOPs provided varying levels of total prescriptions over the past six years among the largest therapeutic categories. Out of the top 30 therapeutic categories by legal prescription volume, those categories with the highest volume share being sold through IOPs included drugs used as part of cancer treatment (including hormone therapies) at 10.4% of total volume; sex hormones 5.5%; dermatologics 3.4%; other cardiovascular drugs (including those used for erectile dysfunction) 3.7%; hormonal contraception, systemic and topical 2.7%; and ADHD 2.7%;
- The major behavioral drivers of those Americans purchasing prescription drugs through IOPs appear to be perceived lower prices, off-label use (i.e., use of a drug for purposes other than that approved by the FDA), and stigma. In the case of price, buyer perception of lower prices from IOPs is not always matched by actual prices available at legal channels and IOPs. For example, across a sample of 25 drugs, 20 were being sold at IOPs at lower price than the average out-of-pocket costs for cash method of payment, with discounts ranging from 10% to 95%, while five drugs carried higher average prices at the IOP. Similarly, 12 out of the 25 drugs had a lower price on the IOP web sites compared to prices on NABP accredited pharmacies, with discounts ranging from 7% to 88%, while the other 13 drugs were priced higher on the IOP websites;
- Purchasing of drugs for potentially off-label use was seen in the case of hydroxychloroquine, which was potentially being used for COVID-19 treatment despite not being approved for this purpose and witnessed a substantial increase in IOP purchasing when COVID-19 cases spiked. Drugs that are prescribed as hormonal therapy for patients with cancer also are potentially acquired through IOPs for off-label use;
- Drugs to treat diseases that have “stigma” associated with them, such as conditions associated with sex hormones and obesity, have a high market share of purchasing through IOPs. The use of drugs purchased through IOPs pose risks to patients and the overall public health system through increased levels of adverse events. Based on regression analysis to evaluate the relationship between legal and illegal sales and adverse events, drugs sold through IOPs are estimated to generate 10 times higher adverse event rates than drugs sold through legal pharmacies, which results in an estimated 12.6% of total extra adverse events in the U.S. being associated with drugs purchased through IOPs;
- These adverse events represent an estimated additional $67 billion cost for the U.S. healthcare system in addition to the healthcare consequences for patients. Assuming the drugs purchased through IOPs were sold legally in the U.S., the average annual economic value of these drugs between 2017 and 2022, using invoice level prices, is $28 billion, and aggregate value for the past six years totals $167 billion. This economic value is not realized by legal channels and impacts participants across the value chain, such as manufacturers, wholesalers, retailers, specialty pharmacies and others. This potential annual value loss has more than doubled between 2017 and 2022, rising from $16 billion to $34 billion. These losses represent 3.9% of the industry’s total revenue in January 2017 and 6.3% in December 2022.
- Out of the top 30 therapeutic categories, the highest lost value due to drugs being sold through IOPs between 2017 and 2022 included drugs used as part of cancer treatment (including hormone therapies) ($14.6 billion), drugs for mental health ($9.3 billion), dermatologics ($7.8 billion), ADHD ($7.8 billion) antidiabetics ($6.6 billion) and other CNS medicines ($5.3 billion).
- Multiple on-going efforts to stop illegal online pharmacies are underway with stakeholders such as international and U.S. regulatory agencies, law enforcement, national associations and nonprofit organizations involved. Efforts to reduce or minimize IOP activity have included demand-based approaches, such as consumer education and supply based approaches, such as regulatory oversight and legislation.
- Warnings letters sent by the FDA to IOPs have had a temporary effect on traffic to the IOPs, with volume declining by 44% over the first 15 months after the warning letter before rebounding back to the initial level over the subsequent six months. Between 2019 and 2022 (updated by the FDA up to 26 October 2022), the FDA mentioned a total of 29 drugs across 53 warning letters with tramadol, an opioid analgesic, appearing the greatest number of times in the warning letters; and
- New methodologies to monitor IOP activities are essential to curbing their impact and maintaining the safety and integrity of the United States pharmaceutical supply chain. Artificial intelligence/machine learning based approaches to understand the nature and use of IOPs offer significant benefits across multiple stakeholders. For example, government agencies, regulatory bodies, pharmaceutical manufacturers and distributors can assess the impact of various efforts to reduce IOP drug flow. Further research on IOP networks and links, impact of efforts to limit IOP use, drivers of demand, state level differences and IOP drug supply chain would help broaden the understanding of this critical and illegal online channel used by Americans to receive their medicines.