What Are They?
Prescription drugs are substances that are intended to diagnose, cure, treat, or prevent medical conditions or diseases. Before they can be legally marketed, they must undergo clinical studies on their safety and effectiveness and be approved by the FDA. The agency approves a drug if its experts determine that the benefits of the drug outweigh the risks associated with it.
But no drug is absolutely safe; there is always some level of risk.
Problem sites
One way that illegitimate Web sites violate the FD&C Act is by dispensing prescription drugs without a valid prescription. FDA leaves it to individual states to decide what is a valid prescription. Web sites cannot dispense drugs in violation of those laws or with no prescription at all.
In general, to be valid:
- a prescription must address a legitimate medical purpose
- be written by a physician or other health care provider authorized to prescribe medicine
- be based on a legitimate doctor-patient relationship
But some Web sites dispense drugs after customers simply fill out an online questionnaire or engage in some other similar cyber "consultation."
In June 2004, experts at the Government Accountability Office, reported that, as part of an investigation, they were able to obtain most of the prescription drugs they set out to order from various Internet pharmacy sites without needing to provide a prescription. Some of the drugs had special safety restrictions or were addictive narcotic painkillers.
The FDA has taken action against Web sites selling drug products that are unapproved, misbranded, or that make fraudulent health claims. Misbranded drugs include:
- those with misleading labeling
- those that aren't adequately labeled with directions for use of the product
Risks
When you buy drugs from a questionable Web site, you just don't know what you're actually getting. The main concerns are that the drugs could be:
- outdated
- contaminated
- too potent or not potent enough
- improperly manufactured and handled
- counterfeit
Between February 2004 and August 2004, the NABP received more than 100 consumer complaints alleging harm related to buying drugs online.
- consumers paid money but never received products
- consumers received medications different from what they ordered
- consumers experienced worsening symptoms after taking the drugs they ordered online
As for drugs imported from countries outside of the United States, the FDA can't assure their safety.
- Canada Pharmacy: Is Your Internet Order Really Coming From A Canada Pharmacy?
- Canada Drugs: To Buy Or Not To Buy?
Regulation
State medical boards regulate medical practice and state pharmacy boards regulate pharmacy practice. It is generally unlawful to prescribe or dispense drugs without a legitimate relationship between the health care provider and the patient. Penalties may include fines and license suspensions.
When Internet operators violate the FD&C Act, the FDA, sometimes in collaboration with other law enforcement agencies, may take enforcement action against a firm. Enforcement actions might take the form of:
- warning letters
- cyber letters
- import alerts
- seizure actions
- injunction actions
- criminal prosecution
Tips
- For consumers who want to buy prescription drugs online, the FDA recommends purchasing only from state-licensed pharmacies in the U.S. Legitimate sites require valid prescriptions
This helps to assure that the consumer will receive drugs that are manufactured, packaged, distributed, and labeled properly.
A Web site can look very sophisticated and legitimate, but actually be an illegal operation, consumers should be especially wary if:
- there is no way to contact the Web site pharmacy by phone
- prices are dramatically lower than the competition
- no prescription from your doctor is required
People should check with their state board of pharmacy or NABP to see if an online pharmacy has a valid pharmacy license and meets state quality standards.
- NABP's Verified Internet Pharmacy Practice Sites program, also known as VIPPS, is a voluntary program that verifies the legitimacy of Internet sites dispensing prescription drugs and gives a seal of approval to sites that apply and meet state licensure requirements and other VIPPS criteria.
- To find out if an online pharmacy is licensed and in good standing, contact NABP at www.nabp.net.
- Legitimate pharmacies that carry the VIPPS seal are listed at http://www.vipps.info/.
- For a list of state boards of pharmacy, visit http://www.nabp.net/boards-of-pharmacy
