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Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online.
To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks.
We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs.
Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list.
FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing.
The US Food and Drug Administration (FDA), the American Hospital Association, and the American Society of Health-System Pharmacists have announced a growing crisis of drug shortages in critical areas such as cancer therapy, urgent care, infectious disease, hypertension, orphan disease, pediatric, and other key patient and disease treatment categories [
This crisis has hit a critical juncture, with shortages leading to loss of patient lives and gross overpricing. The US Institute of Safe Medication Practices has estimated that 15 patients have died in the span of a mere 15 months because of these drug shortages [
The dearth of access to these key drugs has resulted in their being sought outside the traditional drug supply chain at virtually any price and condition. Indeed, Institute of Safe Medication Practices notes that hospitals have turned to the risky secondary or “gray” market (secondary resellers outside of direct drug distribution channels) in an effort to address the drug supply concern [
However, of greatest concern is that, due to publicized profiteering, documented safety concerns, and diminishing availability of drugs in the gray market, patients affected by ongoing shortages may turn to a rapidly growing source: the Internet. However, the sale of drugs by illicit online pharmacies is of great concern, as they are a conduit for questionable therapeutic products for a wide range of treatments and diseases [
Indeed, purchasing drugs online is highly risky [
Yet the challenges of drug supply shortages and exorbitant costs may drive patients in great need to seek drugs online. Given this potential crisis, we examined the availability of drugs subject to shortages on the Internet. We investigated online vendors of identified FDA current drugs in shortage to determine the characteristics of these sellers. Specifically, we examined the prevalence of online drug seller sites and intermediary sites including those sites that sell shortage drugs direct to patients, sites that act as intermediaries for the purchase of drugs and market online drug seller sites, and user-generated content via forums and social media that link to online drug sellers. We also determined whether sellers were accredited by the NABP’s Verified Internet Pharmacy Practice Sites (VIPPS) accreditation program, the only accredited online pharmacies recommended by the FDA [
We also did not assess location of website registration or purported sourcing (other than as international or domestic), as these have been found to be forensically difficult to rely upon for assessment of risk characteristics [
We first identified the FDA current shortages list of drugs with an endpoint of September 23, 2011, which included 72 drugs (
Internet sales offers were characterized in two categories. The first identified websites as
For each identified online drug seller selling a shortage drug, we assessed whether the site was accredited by the NABP VIPPS program through review of the NABP VIPPS program website. We also assessed whether the online pharmacy was on the NABP Not Recommended Sites list, similarly reviewing the NABP Not Recommended Sites list on the NABP website [
Finally, for intermediary sites, we assessed whether links advertised “no-prescription” drugs, an inherent indication of patient and drug safety risk as well as a violation of US law. Note that we did not include the term
We identified 72 shortage drugs (
Most (n = 53, 58%) of the online drug sellers appeared to be of international origin, with Canada being the top purported source of these vendors (n = 32, 60%). We also found one online drug seller (online drug seller CB,
Several online drug sellers dominated offers for shortage drugs (
Finally, of the 68 drugs that were being offered for sale online, 58 (85%) were advertised for sale by at least one online drug seller (
US Food and Drug Administration Current Drug Shortages list and Internet sellers (September 23, 2011)
Name of drug | Sellers |
Acetylcysteine Inhalation Solution | Online drug sellers Aa, Ba, Ca, D, E |
Alcohol Dehydrated (Ethanol >98%) | Online drug sellers F, G, H |
Amikacin Injection | Online drug sellers I, Ja, L; forum link A |
Amino Acid Injection | Data aggregator 1; forum links B, C |
Aminocaproic Acid | Online drug sellers Ma, Na, Oa, Pa |
Ammonium Chloride Injection | Online drug seller Qa |
Ammonium molybdate injection | No sales offers |
Ammonul Injection 10%/10% | Online drug seller Qa; forum link D; PPDLsb 1 (2×), 4 |
Amphetamine Mixed Salts, ER Capsules | Online drug sellers R, CL, S, T; PPDL 2 |
Anadrol-50 tablets (Oxymetholone Tablets) | Online drug sellers U, V, Wa, X, Y |
Aquasol A, 50,000 units/mL, 2 mL ampule | PPDL 1; online drug seller Qa; forum link E |
Avalide | Online drug sellers Za, AA, AB, Aa, AD |
Bleomycin Injection | Online drug sellers AE, AI; forum links F, H, I |
Buprenorphine injection | PPDLs 1, 16; online drug seller AGa; data aggregators 2, 3 |
Calcitriol 1 mcg/mL Injection | Flickr 1; PPDL 3 (2×); online drug sellers Qa, Ca |
Calcium Chloride Injection | No sales offers |
Calcium Gluconate 100 mg/mL | Online drug sellers AHc, AI, AL, Ca |
Cerezyme (imiglucerase for injection) | Online drug seller Ca, Qa, AJa; data aggregators 4, 5 |
Cisplatin injection 1 mg/mL solution | Online drug sellers La, AK, AE; PPDL 4; data aggregator 5 |
Cyanocobalamin injection | Online drug sellers Aa, AM, E, ANa, AOa |
Cytarabine Injection | Online drug sellers APa, ACa, AQa, ARa, ASa |
Daunorubicin hydrochloride solution for injection | Online drug sellers CKa, Qa, Ja, K; data aggregator 6 |
Desmopressin Injection | Online drug sellers Aa, ATa, AUa, AE; data aggregator 5 |
Dexamethasone Injection | Online drug sellers AV, Ja, K, AW; PPDL 5 |
Digoxin Injection | Online drug sellers AJa, AX; PPDLs 1, 6; data aggregator 7 |
Diltiazem Injection | PPDLs 1, 7; online drug sellers AYa, AKa, AZa |
Doxorubicin (adriamycin) lyophilized powder | Online drug sellers Aa, BA, BBa, AHc |
Doxorubicin Liposomal (Doxil) Injection | PPDL 1 (2×); online drug sellers Qa, AG; data aggregator 8 |
Doxorubicin Solution for Injection | Online drug seller BC, BD, BEa, L |
Ethiodol (ETHIODIZED OIL) ampules | Online drug sellers Qa, BF; forum link F; PPDLs 4, 8 |
Etoposide solution for injection | Online drug sellers Ca, Aa; PPDL 9; forum link A |
Fabrazyme (agalsidase beta) | Online drug sellers Qa, AJa; data aggregator 4; PPDL 1 |
Fluorouracil Injection | Online drug sellers AS, L, AYa, AZa, BH |
Foscarnet Sodium Injection | Online drug sellers Ca, Qa; data aggregators 4, 6; forum link G |
Fosphenytoin Sodium Injection | Online drug sellers AS, Qa, AYa, AZa; data aggregator 4 |
Furosemide Injection | Online drug sellers APa, AJa; PPDL 9; data aggregator 9; Flickr 2 |
Haloperidol Decanoate Injection | Online drug sellers BIa, AHc; Flickr 3; PPDL 1 |
Intravenous Fat Emulsion | Online drug sellers Qa; data aggregators 6, 5; PPDL 1; forum link H |
Isoniazid Tablets | Online drug sellers AOa, BJa, D; forum links I, A |
Leucovorin Calcium Lyophilized Powder for Injection | Online drug sellers Ca, AGa, AJa, K; forum link J |
Leuprolide Injection | Online drug sellers ATa, Aa, BJa, Pa, AUa |
Levoleucovorin (Fusilev) 50 mg single use vials | Online drug sellers Qa, BG; PPDL 1 |
Lorazepam Injection | Online drug seller BK |
Magnesium Sulfate Injection | Online drug sellers BLa, Ja, K, L, AYa |
Methylphenidate HCl | Online drug sellers BMa, AGa, BN; forum links K, L |
Metoclopramide injection | Online drug seller AJa; forum links M, N, O; Flickr 4 |
Mitomycin Powder for Injection | Online drug sellers BOa, BPa, BQ, BEa, BR |
Multi-Vitamin Infusion (Adult and pediatric) | PPDL 11; data aggregator 5 |
Nalbuphine Injection | Online drug sellers BS, BMa, BT; forum link P; PPDL 12 |
NeoProfen (ibuprofen lysine) Injection | Online drug sellers AJa, AXa, BU; PPDL 13; forum link P |
Neostigmine methylsulfate injection | Online drug sellers Ja, AGa, K, AT; data aggregator 10 |
Neupro (rotigotine transdermal system) | Online drug sellers Aa, Qa, ATa, AJa, AOa |
Norepinephrine Bitartrate Injection | Online drug sellers Ca, Qa; data aggregator 6; forum links G, H |
Ontak injection | Online drug seller Qa; data aggregators 4, 5; forum link G; PPDL 1 |
Oxsoralen (methoxsalen) 1% topical lotion | Online drug sellers AGa, AOa; data aggregator 10; forum link Q |
Oxsoralen-Ultra (methoxsalen) 10 mg capsules | Online drug sellers Qa, AXa, BV, BW, AOa |
Paclitaxel Injection | Online drug sellers BIa, BX, L, BY, D |
Phenylephrine HCl Injection | PPDLs 14, 15 |
Potassium Phosphate Injection | No sales offers |
Procainamide HCL Injection | Online drug sellers BZ, CAa, Aa |
Propofol Injection | Online drug sellers Aa, Ca, ATa, Qa, BBa |
Sodium Chloride 23.4% | Online drug sellers Qa, AI, CC, CD, CBd |
Sodium Chloride 14.6% Injection | Online drug seller AHc |
Sodium Phosphate Injection | No sales offers |
Streptomycin for Injection, USP | Online drug sellers CFa, BEa, Qa, CE |
Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP) | Online drug sellers Qa, AJa, AXa, CG; data aggregator 11 |
Thiotepa for Injection | Data aggregators 4, 5 |
Thyrogen (thyrotropin alfa) injection 1.1mg/vial | Online drug sellers AJa, CHa, Qa; data aggregator 4; PPDL 4 |
Thyrolar Tablets | Data aggregator 4 |
Vasopressin Injection | Online drug sellers Ja, ASa, K, CI, CJa |
Vecuronium Injection | Online drug sellers Qa, AS, CM, AY; forum link G |
Vincristine Sulfate Injection | Online drug sellers Aa, AS, CM, L; PPDL 1 |
a On National Association of Boards of Pharmacy (NAPB) Not Recommended Sites list for online drug purchasing.
b Personal page data link.
c NAPB Verified Internet Pharmacy Practice Sites (VIPPS)-accredited site.
d Claims NABP VIPPS accreditation but not on NABP VIPPS accreditation list.
Unauthorized uses of Verified Internet Pharmacy Practice Sites (VIPPS) seal.
Shortage drug calcitriol injection advertised as an over-the-counter drug.
Characteristics of Internet shortage drug sellers
Online drug seller | Marketing event frequency | NABPa status | International/domestic (US) status |
Q | 23 | Not recommended | International |
A | 12 | Not recommended | Internationalb |
AJ | 10 | Not recommended | Internationalb |
C | 9 | Not recommended | International |
K | 7 | No information | |
L | 7 | No information | International |
J | 6 | Not recommended | Internationalb |
AG | 6 | Not recommended | |
AS | 6 | Not recommended | |
AO | 5 | Not recommended | Internationalb |
AT | 5 | Not recommended | Internationalb |
AY | 5 | Not recommended | Internationalb |
AH | 4 | VIPPSc accredited | US |
AX | 4 | Not recommended | |
AE | 3 | No information | Internationalb |
BJ | 3 | Not recommended | Internationalb |
D | 3 | No information | Internationalb |
AZ | 3 | Not recommended | Internationalb |
BE | 3 | Not recommended | International |
P | 2 | Not recommended | Internationalb |
AI | 2 | No information | |
AK | 2 | Not recommended | Internationalb |
AP | 2 | Not recommended | International |
AU | 2 | Not recommended | International |
BB | 2 | Not recommended | Internationalb |
BI | 2 | Not recommended | Internationalb |
BM | 2 | Not recommended | Internationalb |
CM | 2 | No information | Internationalb |
E | 2 | No information | Internationalb |
AP | 2 | Not recommended | |
BG | 2 | No information | |
N | 1 | Not recommended | Internationalb |
M | 1 | Not recommended | Internationalb |
B | 1 | Not recommended | Internationalb |
F | 1 | No information | |
G | 1 | No information | |
H | 1 | No information | |
I | 1 | No information | International |
O | 1 | Not recommended | International |
R | 1 | No information | |
S | 1 | No information | International |
T | 1 | No information | |
U | 1 | No information | |
V | 1 | No information | |
W | 1 | Not recommended | |
X | 1 | No information | |
Y | 1 | No information | International |
AA | 1 | No information | |
AB | 1 | No information | International |
AD | 1 | No information | |
AF | 1 | No information | |
AL | 1 | No information | |
AM | 1 | Not recommended | |
AN | 1 | Not recommended | Internationalb |
AQ | 1 | Not recommended | International |
AR | 1 | Not recommended | |
AV | 1 | No information | |
AW | 1 | No information | Internationalb |
BA | 1 | No information | International |
BC | 1 | No information | International |
BD | 1 | No information | International |
BF | 1 | No information | |
BH | 1 | VIPPS accredited | |
BK | 1 | No information | |
BL | 1 | Not recommended | International |
BN | 1 | No information | International |
BO | 1 | Not recommended | |
BP | 1 | Not recommended | Internationalb |
BQ | 1 | No information | Internationalb |
BR | 1 | No information | International |
BS | 1 | No information | |
BT | 1 | No information | |
BU | 1 | No information | International |
BV | 1 | No information | International |
BW | 1 | No information | Internationalb |
BX | 1 | No information | |
BY | 1 | No information | International |
BZ | 1 | No information | |
CA | 1 | No information | Internationalb |
CBd | 1 | Not recommended | |
CC | 1 | No information | |
CD | 1 | No information | |
CE | 1 | No information | |
CF | 1 | Not recommended | Internationalb |
CG | 1 | No information | Internationalb |
CH | 1 | Not recommended | Internationalb |
CI | 1 | No information | |
CJ | 1 | Not recommended | Internationalb |
CK | 1 | Not recommended | International |
CL | 1 | No information | |
Z | 1 | Not recommended | Internationalb |
a National Association of Boards of Pharmacy.
b Purported Canadian websites.
c Verified Internet Pharmacy Practice Sites.
d Use of VIPPS seal by nonaccredited vendor.
US Food and Drug Administration Current Drug Shortage list drugs found only on National Association of Boards of Pharmacy’s Not Recommended online drug seller sites
Drug |
Aminocaproic acid |
Ammonul |
Calcitriol |
Cerezyme |
Cytarabine |
Diltiazem |
Doxorubicin |
Etoposide solution |
Fabrazyme |
Foscarnet |
Furosemide |
Intravenous fat emulsion |
Leuprolide |
Magnesium sulfate injection |
Metoclopramide |
Neupro |
Norepinephrine injection |
Ontak injection |
Oxsoralen 1% topical |
Propofol |
Thyrogen injection |
Patients face considerable risks when attempting to procure FDA current shortage drugs online. We find that suspect vendors populate much of the online market for these drugs, and international online drug sellers identified by NABP as Not Recommended dominate this eHealth landscape. With more than 90% of these drugs being offered for sale by at least one NABP Not Recommended site, in effect if an online drug seller is selling an FDA shortage drug, there is virtually always an NABP Not Recommended site selling in that market. Indeed, with more than a third of all of these drugs, including cancer, emergency, orphan drug, and other lifesaving therapeutic products, being sold by
In addition, with 100% of the intermediary sites marketing these scarce medications as no-prescription drugs (see
These findings, in combination with previous work showing the extensive presence of illicit online drug sellers in other social media such as Facebook and Twitter [
It is particularly troubling that so few NABP VIPPS-accredited pharmacies appeared in the returns from a common Google search. Even if legitimate pharmacies are marketing shortage drugs, the overwhelming presence of NABP Not Recommended online drug sellers may crowd out their arising early or at all in search results. The tremendous dominance of suspect online drug sellers and the virtual absence of authorized VIPPS-accredited online pharmacies for drugs in short supply may have an immediate impact on patient safety. This is particularly true in the context of other work reporting similar findings for online availability of biologics in short supply, which also include absence of VIPPS-accredited vendors, as well as unauthorized use of the VIPPS seal and online drug seller marketing of shortage vaccines as over-the-counter drugs [
In addition, drug shortages, documented and publicized safety risks, and sales profiteering by gray market wholesalers not only may lead patients to attempt to procure shortage drugs through the Internet, but also may lead some providers to seek out shortage drug treatments from these online vendors. Not only is online purchasing from these vendors inherently dangerous, with compromised and counterfeit medications injuring and killing unsuspecting patients globally [
Indeed, even if these shortage drugs were authentic, Not Recommended online drug sellers, particularly international-based sites highly prevalent in this study, would be unlikely to have adequate knowledge and impetus to ensure proper transport [
The dominance of international online sellers should be of particular concern, as the FDA does not permit personal drug importation from international sites due to its lack of ability to control quality and oversight of foreign materials [
Moreover, it should also be noted that, from the patient’s perspective, drugs purchased from nondomestic sources are not eligible for public program reimbursement. Such purchases may lead to unnecessary patient expenditures, including remediation expenditures for additional care [
This online environment with its limited regulation and cloaked nature as reviewed by Orizio et al [
In response, at a minimum, risk management approaches should be considered. The US Customs and Border Protection agency is overwhelmed in attempting to monitor incoming drugs. It cannot destroy contraband suspect drugs coming through the mails due to international postal conventions. In general, it is limited to returning the package and contents to the original sender (for potential illicit resale) if not assessed within 24 hours, or simply allowing it to be sent on for delivery[
Intermediary site marketing products as no-prescription drug.
Flickr social media link for no-prescription shortage drug.
Providers seeking drugs in short supply should verify the authenticity of the drug pedigree (ie, its documentation of transport) and should take advantage of professional resources for safe sourcing of drugs [
This approach of listing and updating legitimate wholesale sources of drugs by a neutral, trusted entity should be considered as a strategy more broadly to allow rapid determination of vendor legitimacy on regional levels globally. These regional entities can then share information as to identified problematic vendors for information coordination, as well as determining and communicating best practices in promoting safety measures in the drug supply chain.
Patients should also be counseled about the dangers of counterfeit and substandard drugs when purchasing drugs online, and be advised to purchase only from verified NABP VIPPS-accredited online drug sellers as recommended by the FDA [
These drug shortages have historically been a problem in clinical care, and have been the subject of past calls for reform and attention due to their adverse impact on public health [
Beyond reactive approaches, organized, proactive planning by stakeholders to address this issue should be started as soon as possible. Existing calls for enhanced drug regulatory authority powers to address drug shortages, stronger regulation of pharmaceutical distribution and pricing incentives, and more stringent penalties against illegal profiteering activities should be supported by stakeholders’ joining together in public–private partnership models to plan for new challenges in pharmaceutical supplies and safety.
These public–private partnerships should include multisector engagement with pharmaceutical manufacturers (including both brand and generic industries), drug regulators, patient safety and advocacy groups, hospitals, group purchasing organizations, and professional societies to prioritize and develop organized responses to drug shortages. Domestic and regional best practices can be applied in proactive efforts as well, with shared systems planning and strategies among stakeholders integrated across geopolitical and health-delivery environments. At the outset, a risk management approach may be best for priority planning—for example, public–private partnerships organized around supplying chemotherapy drugs and emergency department treatments, whose absence may have the greatest potential adverse clinical impact. In addition, due to the security threat illegal pharmaceutical sales pose and the need to address drug shortages as a national emergency, national security agencies and legal authorities should also be included in these public–private partnerships.
Integrated industry, regulator, patient, and provider partnerships would be able to better anticipate potential shortages and their impact on patient safety, and to help develop information resources and responses for stakeholders that are currently lacking for these situations [
Finally, strategic plans for safe substitutions of shortage drugs that could be integrated into emergency planning for regional delivery systems, along with voluntary international coordination of emergency supplies, should be considered in particularly needed areas and populations (such as public health treatments for pandemics or other communicable disease events). These partnerships would be similar to local coalition efforts to reallocate drugs subject to shortages by borrowing, back-ordering, increasing surveillance and legal enforcement against potential counterfeits, and seeking safe alternative supply sources through greater regional coordination [
We note that this study has several limitations. It evaluates the drugs on the FDA Current Drug Shortages list as of one point in time, and its assessment of online availability similarly is limited to that period. Further, websites arise, change, and are taken down dynamically on the Internet, so the information and websites found in this study are necessarily limited as well. NABP VIPPS-accredited online pharmacies and NABP Not Recommended site designations also are limited in validity over time due to changes in the Internet and vendors. Finally, we did not determine the actual quality of products through test purchasing, as buying drugs for a fictional patient raises ethical and legal concerns.
Overall, drugs on the FDA Current Drug Shortages list are critical therapeutic tools in the medical arsenal. Because of the crisis of access to these drugs, sources such as the Internet may be considered convenient for procurement. However, suspect vendors appear to dominate online marketing of shortage drugs. This high-risk digital conduit of medicines should be addressed. Reactive and proactive risk management strategies should be engaged to ensure that providers render optimal, safe care to patients, and that patients who are considering purchasing online due to desperate circumstances do not become the next victims of the drug shortage. Extreme caution and caveat emptor may best describe the themes when approaching this eHealth market.
Food and Drug Administration
National Association of Boards of Pharmacy
personal page data link
BAL presented this work in part at the Global Drug Safety Roundtable, Council on Foreign Relations, December 5, 2011, and thanks that audience for useful comments. TKM is the 2011–2012 Carl L. Alsberg, MD, Fellow of the Partnership for Safe Medicines, the latter of which is not connected with the submitted work, and gratefully acknowledges that support.
None declared.