Quiz: If you want to sell prescription-only weight-loss drugs, but want to avoid scrutiny as an Internet pharmacy, what do you do?

Answer: Claim to only sell “herbal” products…and then spike them with the prescription-only chemicals.

In a troubling new trend, some supposedly “herbal” diet pills, ordered mainly online, actually contain prescription substances, as well as cancer-causing agents, the FDA warned today. The FDA’s press release said:

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers’ health at risk.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke.

Here’s what’s going on: in order to escape classification and regulation as an online pharmacy, a website claims to sell only herbal or natural non-prescription products. But the pills actually contain the active ingredients from prescription drugs.

The FDA said that use of these products should be discontinued, and users should consult a physician immediately.

The tainted weight-loss pills include:

• Fatloss Slimming
• 2 Day Diet
• 3x Slimming Power
• Japan Lingzhi
• 24 Hours Diet
• 5x Imelda Perfect Slimming
• 3 Day Diet
• 7 Day Herbal Slim
• 8 Factor Diet
• 7 Diet Day/Night Formula
• 999 Fitness Essence
• Extrim Plus
• GMP
• Imelda Perfect Slim
• Lida DaiDaihua
• Miaozi Slim Capsules
• Perfect Slim
• Perfect Slim 5x
• Phyto Shape
• ProSlim Plus
• Royal Slimming Formula
• Slim 3 in 1
• Slim Express 360
• Slimtech
• Somotrim
• Superslim
• TripleSlim
• Zhen de Shou
• Venom Hyperdrive 3.0

LegitScript does not currently review websites that only claim to be selling herbal products. In light of this news, we are considering whether to list as “unapproved” and “rogue” websites that offer the above products.

The fifth LegitScript standard has to do with what it means to have a valid prescription for a prescription medication. Perhaps no other standard is the subject of so much debate (see, e.g., the Internet Drug Law blog), and no other issue has been so exploited by rogue Internet pharmacies for their own financial gain. We’ve tried to clarify the issue below.

Standard 5: Validity of prescription. The pharmacy shall dispense or offer to dispense prescription drugs only upon receipt of a valid prescription, as defined below, issued by a person authorized to prescribe under state law and, as applicable, federal law. The pharmacy must not distribute or offer to distribute prescriptions or prescription drugs solely on the basis of an online questionnaire or consultation without a pre-existing patient-prescriber relationship that has included a face to face physical examination, except as explicitly permitted under state telemedicine laws or regulations.

So what is a “valid prescription”? We collaborated with the National Association of Boards of Pharmacy to establish the following definition, which the Federation of State Medical Boards has also indicated to us that they support:

A valid prescription is one issued pursuant to a legitimate patient-prescriber relationship, which requires the following to have been established:

1. The patient has a legitimate medical complaint;

2. A face-to-face physical examination adequate to establish the legitimacy of the medical complaint has been performed by the prescribing practitioner, or through a telemedicine practice approved by the appropriate practitioner board; and

3. A logical connection exists between the medical complaint, the medical history, and the physical examination and the drug prescribed.

LegitScript requires, with no exceptions, that Internet pharmacies adhere to this standard.

But I know what drugs I need, I’ve been taking them for years. Why do I need to go through the hassle of getting a prescription when I can just order them online? Two reasons. First, the very definition of a “prescription” drug (as opposed to “over the counter”) is one that requires “medical supervision” because of possible side-effects, interactions with other drugs, and several other very well established reasons. Does that mean that the doctor who examines you needs to see you for every prescription he or she writes? No: it is perfectly okay for a doctor who has physically examined you before, and is familiar with your medical history, to determine that an over-the-phone consultation does the trick for certain drugs. By contrast, a doctor who has never met you and simply reviews an “online questionnaire” isn’t really your doctor: they’ve never met you in person, and simply can’t be familiar enough with you to provide any sort of “medical supervision.” Second, think about it this way: does an Internet pharmacy that doesn’t require a prescription really have your well-being in mind or just their bottom line? How can you be sure the drugs they sell are legitimate if they don’t follow the most basic protocol of requiring a valid prescription to dispense a prescription drug? If they are willing to violate this standard just to make a quick buck, you can bet that they are willing to take short-cuts with your health and safety as well.

Why is having a valid prescription important? There is a reason certain drugs require a prescription. Such drugs can be harmful if taken by people who don’t have a medical need for them or who have medical conditions or allergies that could interact dangerously with the drugs. The basis of having an in-person consultation with a physician is the understanding that the doctor will take into consideration a patient’s medical history and any underlying conditions when deciding the appropriate drug to prescribe. When patients bypass this protocol, self-diagnose and order drugs online without a prescription, they are taking serious risks with their own health.

What about the “online consultation” some Internet pharmacies offer? The online consultation, or medical questionnaire, is a tactic that rogue Internet pharmacies artfully employ to exploit the lack of common understanding of what constitutes a valid prescription. Many rogue Internet pharmacies claim that by answering a few questions about your medical history you may obtain a legitimate prescription prescribed by a “licensed doctor” who will review your questionnaire. In actuality, these questionnaires rarely get more than a one-second glance (if they are read at all), are not cross-checked and are not valid methods of obtaining a prescription. An apt analogy would be someone who knows little about cars filling out an online questionnaire to diagnose their car trouble, ordering a part, and then playing mechanic. It might work in some cases, but is it worth the risk?

Next up in our discussion of LegitScript standards is a seemingly simple, but very important standard.

Standard 4: Pharmacy location. The pharmacy must be domiciled in the United States.

What does it mean?

It may seem self-explanatory, but we’ve actually had a lot of inquiries about this being one of the standards we use to identify safe online pharmacies. LegitScript requires that an online pharmacy’s dispensing pharmacy be physically located within the United States in order to make our “approved” list. This requirement is based on the fact that it is currently against the law to ship prescription drugs into the United States from another country.

Wait, what about the 90-day rule? It’s okay to order from an Internet pharmacy outside of the US, as long as it’s a 90-day supply or less, right?

No. This is one of the fictions that Internet pharmacies outside of the US perpetrate. There is nothing in US federal law that makes this legal.

What does exist is an FDA policy that, in very specific circumstances not involving Internet pharmacies, allows an FDA or Customs agent the discretion to let the drugs through the border. That discretion exists only if all of these conditions are met:

1. The drug is for a condition that there is no approved treatment for available in the United States.
2. The drug isn’t being advertised to persons residing in the United States.
3. The drug doesn’t present an “unreasonable risk.”
4. The patient states, in writing, that it is for the patient’s own limited use (usually a 90-day supply or less), and provides the name and address of a doctor licensed in the US that will supervise the patient’s use of the drug (or, if the patient was first prescribed the drug in another country, and is simply continuing treatment).

Many Internet pharmacies have taken this FDA policy and misrepresented it as authorizing a “90-day supply” of prescription drugs from outside of the country. Additionally, Congress limited funds for the FDA to conduct some enforcement activities under this law, but that is different from saying that the import of these drugs is legal.

Does this even apply to Canadian Internet pharmacies?

Yes. Even Canada. This is not to say that drugs from Canada are necessarily inferior to drugs that come from the US: indeed, if you walked into a Canadian pharmacy in person, you would often receive the very same drug you would receive from a US pharmacy. The problem is, many online pharmacies claim to be Canadian when, really, the drugs are being manufactured and shipped from locations across the globe, usually third world countries. (This is unfortunately true for many Canadian Internet pharmacies licensed in Canada selling prescription drugs to US residents.) Since these “Canadian” Internet pharmacies, even if licensed in Canada, are located outside of the United States, the FDA has little or no jurisdiction to ensure that the drugs are genuine and safe, and actually come from the US or from safe sources in Canada. And that’s why it’s not legal.

So Canadian and other foreign pharmacies will never receive LegitScript approval?
As long as the practice is illegal and unregulated, No. However, LegitScript has consistently said that if Congress authorizes the import of prescription drugs from outside of the country, and if the FDA develops a system to ensure the safety and legitimacy of those drugs, we will open up our certification program to include pharmacies that adhere to those laws and safety standards.

The Bottom Line: If an online pharmacy is willing to cut corners with the law to make an extra buck, what makes you think they wouldn’t be willing to cut corners with your safety?

US pharmacies and pharmaceutical manufacturers are held to high standards established by the FDA to protect consumers. When you order from a legitimate, US-based pharmacy, you can be sure the medications you will be putting in your body, for your health, meet these standards. Ordering from pharmacies that intentionally ignore US regulations is a risk that we at LegitScript don’t think is worth taking.

Continuing the discussion of the standards LegitScript uses to approve safe online pharmacies, we’ll talk about our third standard.

Standard 3: Prior discipline. The pharmacy and its pharmacist-in-charge must not have been subject to significant recent and/or repeated disciplinary sanctions.

What does it mean?
This standard addresses a pharmacy’s history of adhering to safe medical practices as well as legitimate business practices. LegitScript takes a look at whether the pharmacy, or its pharmacist-in-charge, have been disciplined by a State Board of Pharmacy, or have faced other civil or criminal penalties. In making this determination, we consider whether the problem was “significant” and whether the discipline was “recent.”

Okay, what does “significant” mean?
To some degree, this is a judgment call. For example, some regulatory violations are comparatively minor, and are not inherently a threat to patient safety (i.e., failure by one of the pharmacists to renew a single state license on time three years ago, if the pharmacist missed the deadline by a couple of weeks). LegitScript is more concerned with violations that demonstrate a disregard for patient safety. An example of such a violation would be a pharmacist who has been charged with dispensing medication to patients without a valid prescription.

Generally, if there has been past discipline of a pharmacy, LegitScript will consult with other industry experts regarding the seriousness of the violation. The fundamental question we ask is: given the reason for the discipline, can we truthfully say that this pharmacy is safe? If not, we’ll generally decline to approve the online pharmacy.

Okay, what does “recent” mean?
Usually, we look to any discipline occurring within the last five years. However, if there is extremely serious discipline, or multiple instances of discipline, more than five years previous, LegitScript may consider that. On the other hand, if there was disciplinary problems three years earlier, but the ownership and staff have since changed, it’s likely that we’ll consider that in a positive light.

Why is this important?
One of the biggest hesitations people have about ordering their prescriptions online is that they worry about the integrity of a pharmacy they can’t see and a pharmacist they don’t know filling their prescriptions. LegitScript is committed to approving online pharmacies that are held to the same standards as brick-and-mortar pharmacies so you can be sure your prescription is handled with same professionalism and integrity as at your local pharmacy. In fact, most of our approved online pharmacies are brick-and-mortar pharmacies that simply offer the convenience of ordering prescriptions online.

More good news: the entire Meds-Easy network (except for a couple of straggler affiliates) has now been shut down. Meds-Easy.com was the main website; there were about 70 affiliates in total.

The Meds-Easy network was one of the worst: it was selling Oxycodone, Hydrocodone and other controlled substances without requiring a prescription. Meds-Easy was run by a guy in the Ukraine with an office in Belize. The drugs were mailed from Pakistan. Highly illegal and dangerous, Meds-Easy’s termination is good news for Internet safety.

Continuing with our latest blog project- letting you know why LegitScript is the best place to find safe online pharmacies- here’s our spiel on LegitScript Standard #2:

Standard II: DEA registration. The pharmacy, if dispensing controlled substances, must be registered with the US Drug Enforcement Administration (DEA).

What does it mean?

First, a word about controlled substances. Controlled substances are potentially addictive drugs regulated by the Controlled Substances Act (CSA). Controlled substances are broken down into five “schedules”, ranging from drugs with the most potential for abuse and no accepted medical use (Schedule I) to those with the potential for abuse but some recognized medical use (Schedules II through V, in decreasing potential for abuse). All other prescription drugs are classified as “non-controlled” or “legend” drugs.

So what are the Schedules? Schedules II – V include drugs you’d likely see offered by online pharmacies, while Schedule I drugs are those with “no accepted medical use” (think: street drugs). Schedule II includes drugs like Percocet, OxyContin and pure Codeine. Schedule III is where you’ll find your anabolic steroids and drugs like Vicodin, while Schedule IV is home to the popular Xanax and Valium. The drugs of Schedule V are a bit lesser known, but include anti-convulsants and some cough suppressants.

In order for pharmacies to lawfully dispense these dangerous drugs, they must be registered with the DEA. This registration authorizes a pharmacy to sell controlled substances and allows for a method of keeping tabs on who is selling these potentially addictive drugs.

What do we require?

In order for a pharmacy that sells controlled substances to become LegitScript approved, it must have a valid and current DEA registration number.

Why is this important?

DEA registration is important because any pharmacy that offers controlled substances is in possession of potentially very addictive drugs. DEA registration is required by law to help safeguard against potential abuse or diversion of these drugs. Pharmacies that are granted DEA registration have taken measures to assure that controlled substances will be dispensed with the appropriate precautions. These protective measures are an important means of preventing prescription drug abuse.

As a side note, controlled substances were the centerpiece of the recent Ryan Haight Act that imposes stricter regulations on pharmacy websites offering controlled substances.

You can be sure that LegitScript only approves online pharmacies with a valid DEA registration, if they are selling controlled substances.