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Online Drug Safety

Over the past couple of decades, US consumers have been purchasing prescription medications outside of the United States. Initially this was done physically in pharmacies, primarily in Canada and Mexico. Now with the Internet there has been an explosion of sites that offer prescription medications via online purchases.

This is posing serious problems.  Several groups have been looking at this.


National Association of Boards of Pharmacy

A report was released by the National Association of Boards of Pharmacy (NABP) in August 2017 on Canadian and other internet and “foreign” pharmacies.

The NABP is an independent, non-profit organization that “aims to ensure the public’s health and safety through its pharmacist license transfer and pharmacist competence assessment programs, as well as through its … accreditation programs.”

NABP’s member boards of pharmacy include all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, Australia, Bahamas, 10 Canadian provinces, and New Zealand.  It is headquartered near Chicago, IL.

The full report entitled “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: August 2017” is available here.  A brief summary is also available.

The report makes several very important points.


US FDA & Health Canada

The FDA has warned US consumers about online and foreign purchases. They have set up an extensive section (BeSafeRx) on their website for consumers explaining the risks of online ordering as well as offering pointers on how to avoid problems.

As with the NABP, FDA notes that:

The signs of a fake pharmacy are:

A good online pharmacy should:

This site also has links to the state boards of pharmacy where one can find approved pharmacies in the US.

Health Canada has also issued similar warnings.


Comments for Patients

Obviously, this is a very problematic situation.  Many consumers are looking for ways to decrease their pharmacy costs – which admittedly are sometimes outrageously expensive and not always covered well by insurance. One method is to purchase drugs either directly in person in pharmacies, particularly near the US border in Mexico and Canada. The other major method is Internet purchase which this report clearly notes can be very dangerous.

As noted above, this can lead to health problems as well as identity and monetary theft for the individuals purchasing online. It will be very hard for your doctor to determine this if you do not mention that the medications were sourced abroad.

Another public health issue is present.  The NABP also warned that such online purchases has led to increased purchase, without prescriptions, of antibiotics.  This may lead to increased antibiotic resistance and make treating infections much more difficult.  See their report here.


Comments for Pharmacovigilance Personnel

This situation is very problematic for pharmacovigilance (PV) and drug safety personnel both in government health agencies and companies.

In practice, it is very rare for PV personnel to ask patients or reporters of adverse events where the drug or drugs in question were sourced from. The usual questioning revolves around whether the product is branded or generic and not whether it was obtained by mail/internet or in person at a pharmacy in the US or abroad. In the US, many people obtain their prescription drugs through domestic Pharmacy Benefit Managers or large pharmacy chains’ mail order service. This is quite normal and frequent in the US and presents no particular issues or problems.

However, if a patient reporting an adverse event or serious AE (SAE) obtained the product from an online pharmacy or from a foreign pharmacy in person, the PV specialist should consider whether there may be an issue with product quality: counterfeit, subpotent, harmful excipients or additives etc. This is above and beyond all the usual issues involved in investigating the SAE such as dosing, drug interactions, etc.

Thus a PV specialist in the company or health agency may want to attempt to obtain the sourcing information. This may be difficult as the patient may not wish to admit that he or she obtained the product under risky or even illegal (in their eyes) ways.

One solution, which may be problematic also, is to ask the patient to send a sample of the product to the PV specialist for laboratory analysis. This should be made as easy as possible for the patient with prepaid mailers and such.

The PV specialist should also consider the products in question. Some drugs are so cheap and so easily obtained in the US that it is highly unlikely that patients will seek to purchase the drugs online. One pharmacy chain in the southeast of the US offers “free” two week supplies of certain antibiotics and diabetic drugs (with a prescription of course). Many generic drugs are now very inexpensive and hardly worth using an internet pharmacy. So attention should be paid to sourcing of expensive or hard to get products by the PV specialist.


Bottom line: Patients are obtaining drugs from Internet pharmacies, many of which, or even most of which, are shady operators. This can produce significant problems for patients, health care providers, pharmaceutical companies, health agencies and the public health.



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