Safety of Drugs Bought Abroad or Online
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 report makes several very important points.
- The NABP examined over 100 “pharmacy websites that used ‘Canada’ or ‘Canadian’ in their name or URL, or posted a Canadian contact address.” They found that three quarters of them (74%), obtained product from outside Canada. Consumers were able to purchase drugs without prescriptions.
- “Half of the so-called ‘Canadian’ websites source drugs from India or a combination of countries where counterfeit products are known to originate. Another 20% dispense drugs from unspecified foreign locations.”
- The sourcing countries do not have strict regulations at the level of those in the US or Canada.
- The danger is that the drugs may be counterfeit, contaminated or subpotent. Quality cannot be guaranteed.
- NABP and the Canadian National Association of Pharmacy Regulatory Authorities have examined nearly 12,000 such online pharmacy websites over the last decade.
- They found that “nearly 96% of these site were operating illegally, out of compliance with state and federal laws and/or NABP patient safety and pharmacy practice standards.”
- 2550 were outside the US, 1557 were inside the US and 6837 had no location identified
- 5613 sold foreign or non-FDA approved medications
- 1850 of the websites were not secure thus risking exposure to identity theft and theft of payments
- Neither the US nor Canadian governments are able to police or regulate these pharmacies.
- The NABP further notes: “The report is released amidst discussions on proposed legislation that would allow US consumers to legally import prescription medications from Canadian pharmacy sites. Without a tightly regulated international supply chain in place, it will be difficult to shield consumers from the risks associated with this type of policy.”
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:
- There may be counterfeit or substandard drugs
- Slight differences in the drugs may make a major difference in how the patient responds
- There are personal and financial risks
The signs of a fake pharmacy are:
- Allow you to buy drugs without a prescription from your doctor
- Offer deep discounts or cheap prices that seem too good to be true
- Send spam or unsolicited email offering cheap drugs
- Are located outside of the United States
- Are not licensed in the United States
A good online pharmacy should:
- Require a valid prescription from your doctor
- Provide a physical address and telephone number in the United States
- Have a licensed pharmacist to answer your questions
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.
Tags: adverse events, drug safety, FDA, Pharmacovigilance