Counterfeit Drugs - American Medical Women's Association

Why it matters

Counterfeit drugs present a growing public health threat that is impossible to ignore. Headline articles about fraudulent cancer and HIV drugs or fentanyl-laced pills that have caused death in children are just the tip of the ice-berg. These issues were augmented by the COVID-19 pandemic, which caused a disruption in usual supply chains, leading to increased demand and opportunities for fraud at a time when economic pressures made costly medications even more unaffordable.

Online pharmacies advertise convenience and savings to consumers, yet 95.8% of these on-line outlets are out of compliance with state and federal laws and/or National Association of Boards of Pharmacy (NABP) standards. Such websites may sell unsafe drugs that are made with the wrong dose, no dose of medicine, or with toxic or harmful ingredients leading to adverse effects, treatment failure or resistance, or death.

Fake pharmaceuticals comprise a lucrative industry worth billions of dollars. Counterfeit suppliers may also contaminate the supply chain when pharmacists are seeking alternative suppliers of an expensive medication for which they’re unable to meet demand (for eg, counterfeit Tamiflu emerged in the U.S. during influenza season).

Counterfeit medicines are on the rise in most countries, but they are particularly widespread in under-resourced nations. The WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) estimates that in some regions, more than 30% of medicine on sale can be counterfeit. The World Trade Association

AMWA is working with the Partnership for Safe Medicines to promote education and awareness of fraudulent drugs.

Counterfeit Drugs: What Physicians Need to Know

The growing use of counterfeit drugs is a global problem worth billions of dollars (in 2008, GlaxoSmithKline valued fakes of its drugs at $11 million, a 5-year low)
No countries remain untouched, but in some developing countries, more than 30% of medicines on sale may be counterfeit
Counterfeit drugs are “deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product”
Counterfeit drugs may contain:
- No active ingredient
- An incorrect amount of the active ingredient
- An inferior-quality active ingredient
- A wrong active ingredient
- Expired products
- Toxic contaminantsThe consequences for patients may include treatment failure or death as well as contribution to increased anti-microbial resistance

96% of online pharmacies fail to comply with U.S. federal and state laws and pharmacy standards
55% of Americans report they have or would buy medicine online for cost savings or convenience
Younger consumers with higher incomes who frequently make online purchases are most likely to consider online drug purchase
Less than 5% of people know how to find safe pharmacy sites online

The Facts

The growing use of counterfeit drugs is a global problem worth billions of dollars (in 2008, GlaxoSmithKline valued fakes of its drugs at $11 million, a 5-year low)
No countries remain untouched, but in some developing countries, more than 30% of medicines on sale may be counterfeit
Counterfeit drugs are “deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product”
Counterfeit drugs may contain:
- No active ingredient
- An incorrect amount of the active ingredient
- An inferior-quality active ingredient
- A wrong active ingredient
- Expired products
- Toxic contaminants

The consequences for patients may include treatment failure or death as well as contribution to increased anti-microbial resistance
96% of online pharmacies fail to comply with U.S. federal and state laws and pharmacy standards
55% of Americans report they have or would buy medicine online for cost savings or convenience
Younger consumers with higher incomes who frequently make online purchases are most likely to consider online drug purchase
Less than 5% of people know how to find safe pharmacy sites online

What Physicians Can Do

Instruct patients to fill prescriptions at state licensed pharmacies in the U.S.
Immediately report suspected counterfeits, adverse events to the FDA
Educate patients about the inherent risks of buying drugs online, even from what appear to be legitimate pharmacies (eg, Canadian pharmacies)
- Lack of quality control
- Questionable safety or efficacy
Teach patients to recognize the warning signs of unsafe online pharmacies:
- Does not require a doctor’s prescription
- Is not licensed in the U.S. and by your state board of pharmacy
- Licensed pharmacist unavailable
- Offers deep discounts / prices “too good to be true”
- Spam emails offering discounts
- Location outside the U.S. or offer of worldwide shipping
- Sends medicines that appear different from that sold by your local pharmacy (damaged, description in a foreign language, no expiration date)
Encourage patients to visit the FDA’s BeSafeRx to determine if an online pharmacy is operating legally

How Patients Can Verify an Online Pharmacy

Check a pharmacy vendor’s license with a state board of pharmacy
Ensure that a valid prescription from a doctor or another licensed healthcare provider is required
Confirm the U.S. address and telephone number and that a U.S. state-licensed pharmacist is on staff to answer questions
Look for the National Association of Boards of Pharmacy’s (NABP) Verified Internet Pharmacy Practice Sites (VIPPS™) Seal, ensuring satisfaction of state licensure requirements (these sites have a “.pharmacy” domain)
Ensure exclusion from the National Association of Boards of Pharmacy’s “List of Not Recommended Websites”, although this list is continually growing so omission does not guarantee safety

CDC Warning to Travelers - 'Avoid buying medicine in other countries'

CDC Warning to Travelers – “Avoid buying medicine in other countries”

Read the CDC warning to travelers about not buying medicines in other countries.

FAQs

Are counterfeit drugs a problem in the U.S.?

Although estimates indicate that less than 1% of prescription medication sold in the U.S. are counterfeit, U.S. patients may purchase medicines from fraudulent online pharmacies
Counterfeit products may also enter the supply chain when legitimate suppliers of a high-demand, expensive medication cannot meet market demand, forcing pharmacists to seek alternative suppliers (for eg, Tamiflu during influenza season)

How do tainted drugs enter the U.S. supply chain?

Pharmaceutical companies typically sell their drugs directly to major authorized distributors who supply pharmacies and hospitals, however, drugs may also move from authorized distributors to middlemen or secondary wholesalers

Who is most likely to be impacted?

Younger patients of higher income levels who commonly purchase goods online are more likely to utilize online pharmacies for purchasing medicine

What kinds of drugs are most likely to be counterfeit?

Expensive prescription drugs including AIDS, cancer therapy, cardiovascular or psychiatric medications, as well as “lifestyle” medications including hormonal therapies or erectile dysfunction treatments

What do I do if a medicine looks suspicious?

Immediately report any suspicious drugs to the FDA

Are any online pharmacies safe?

Purchasing pharmaceuticals online is never as safe as purchasing directly from a state-licensed pharmacy due to scammers’ sophistication in their online representation as legitimate pharmacies

How do I verify online pharmacy safety if I must purchase online?

Check a pharmacy vendor’s license with a state board of pharmacy
Confirm the U.S. address and telephone number
Confirm that a U.S. state-licensed pharmacist is on staff to answer questions
Ensure that a valid prescription from a doctor or another licensed healthcare provider is required
Look for the National Association of Boards of Pharmacy’s (NABP) Verified Internet Pharmacy Practice Sites (VIPPS™) Seal, ensuring satisfaction of state licensure requirements (these sites have a “.pharmacy” domain)
Double check that the site of purchase is not included on the National Association of Boards of Pharmacy’s “List of Not Recommended Websites”, although this list is continually growing so omission does not guarantee safety

What are the red flags for a fake medicine?

The medicine has a different name than what was ordered
A foreign language is used on the label
The dosing recommendations differ from what is normally seen
The route of administration is different
The packaging looks different from what is usually received
The product fails to display a National Drug Code (NDC) number

Is it ever safe to purchase drugs from a pharmacy outside the U.S.?

Drugs purchased outside the U.S. may not be subject to the same rigorous standards and their authenticity cannot be guaranteed
The governments of numerous countries, including Canada, have said they cannot guarantee the safety of exported products

What is being done to protect the U.S. drug supply?

the FDA’s Counterfeit Alert Network alerts its health profession and consumer groups to specific counterfeit incidents in the United States; in the event of a confirmed counterfeit case in the U.S., the FDA will send an alert to these partners, including:
- American Medical Association
- American Academy of Family Physicians
- Partnership for Safe Medicines
- Physicians Coalition for Injectable Safety
the FDA has issued guidance on using standardized numeric identifiers to create a unique “license plate” to track individual drug packages in the supply chain
Pharmacists are encouraged to report suspected counterfeit medications through Medwatch
Pharmaceutical companies including Pfizer have called for more intense oversight of secondary wholesalers and repackagers as well as tougher penalties for those who fail to comply with measures of prevention

How do I report adverse events related to the use of suspect medicines?

Complete and submit the report online:
- fda.gov/MedWatch/report.htm, or

- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178