“Dispense as Written” are the words found on prescriptions in the U.S. when the prescriber wants the patient to take the brand drug, not the generic. Many who read Katherine Eban’s new book – Bottle of Lies: The Inside Story of the Generic Drug Boom – will conclude that they would like to see “DAW” on their prescriptions.
Bottle of Lies teaches its readers that generic drugs are not as good as the FDA claims. It shows that poor manufacturing practices, mostly in India and China, but also in the U.S., are the leading cause of substandard drugs being sold in U.S. pharmacies and throughout the world. More ominously, India and China intentionally ship even lower quality and, in some cases, worthless drugs to poor countries in Africa and Southeast Asia where regulations are weak or non-existent.
Rochester Drug Cooperative, a large pharmacy wholesaler
accredited by the National Association of Boards of Pharmacy (NABP), pleaded
guilty last week to illegal sales of opioid drugs, including oxycodone and
fentanyl. The NABP operates a program called Verified Authorized Wholesale
Distribution (VAWD). According to its website, NABP VAWD accreditation helps
“ensure that the wholesale distribution facility operates legitimately, is
licensed in good standing, and is employing security and best practices for
safely distributing prescription drugs from manufacturers to pharmacies and
According to the FDA, in 2017, 80% of the active pharmaceutical ingredients used to make our medicines are imported. I can’t remember how many times I’ve read (and written) that over the past decade or so. Almost every time I read that particular statistic in the news, it’s often a story about drug quality problems, in which foreign APIs are reported as a growing problem. Flashback to the FDA in 1998: as reported by the U.S. Government Accountability Office, the percent of active pharmaceutical ingredients used to make medicines for sale in the U.S. is about 80%.
International online pharmacies process orders for prescription drugs that are mailed across borders. That’s a simple definition for myriad websites, good, bad and in between, that can be found selling medicine on the Internet. Patients looking online for affordable medicine from another country want to know they will receive a lawfully-manufactured medicine that works. At PharmacyChecker, we believe we’ve developed a system of standards, rules and policies, for evaluating such websites to determine if they are safe and the businesses involved properly licensed. Those online pharmacies that are not only eligible but also willing to accept our monitoring and oversight are verified in our Verification Program. Verified means that an online pharmacy meets our online pharmacy standards of practice and agrees to our monitoring and oversight protocols. PharmacyChecker-verified online pharmacies are eligible to publish a PharmacyChecker seal on their websites and list their pharmacy information and prices on our website.
This week, PharmacyChecker added information about Domperidone to our Domperidone drug price comparisons page to better educate people considering ordering this medicine. The product is also sold under the name “Domperidone Suspension” as well as the brand name “Motilium.” Exploring this drug and the U.S. Food & Drug Administration’s Expanded Access Program is key when looking at avenues of drug importation that are expressly permitted in the U.S. My aim in this post is to explain how this program works; differences of opinion about medical ethics related to Domperidone and other medications that may not be FDA-approved but are still of interest to doctors when treating their patients; and how this relates to the subject of personal drug importation overall.
Domperidone Treatment and Regulations in Different Countries
Domperidone is approved for sale in Canada and the United Kingdom, as well as other countries, but not the U.S. Unlike FDA-approved drugs sold in Canada and the UK, the FDA provides patients and their providers with a specific, permitted process to import Domperidone for personal use.
Domperidone is approved for sale in Canada for treating several gastrointestinal conditions; in the UK, it is only approved for the treatment of nausea and vomiting.
Domperidone increases lactation in breastfeeding mothers, but, due to serious potential side effects, it is not approved in any country for this purpose. However, in Australia and other countries, it is prescribed off-label to improve lactation. You can find an excellent discussion with points for and against this here: Off-label Prescribing of Domperidone
Expanded Access Programs
While the FDA has not approved it for sale in the U.S., Americans can access Domperidone under the federal agency’s Expanded Access Program. This program provides a permitted protocol to obtain drugs through an Investigational New Drug application (IND). Only FDA-approved drugs can be distributed in the U.S. INDs offer a path for drug companies who want to transport drugs that are not yet approved in the U.S. across state lines, usually for purposes relating to clinical trials of new drugs.
INDs are used by physicians to apply to the FDA to treat patients with Domperidone. While the FDA has not approved it for sale here, the FDA agrees that Domperidone may benefit people with severe gastrointestinal motility disorders when the potential benefits outweigh the risks.
In 2004, with an import alert on Domperidone, the FDA very strongly came out against use of Domperidone for lactation and does not allow imports for that purpose. The agency also stopped compounding pharmacies from making and dispensing the drug domestically. The FDA states that the drug substantially increases the risk of cardiac problems, which outweigh the benefits (including aiding lactation). Interestingly, as recently as 2015, the Pharmacy Compounding Advisory Committee met with the FDA to try and change the agency’s mind to allow them to compound Domperidone. The request was denied.
The FDA’s communications about this program are to physicians, patients and pharmacies – but patients cannot act without their providers. Unlike personal drug importation of FDA-approved drugs or foreign versions of FDA-approved drugs, to obtain drugs under the Expanded Access Program requires the participation of U.S. physicians, U.S. pharmacies, and the overseas manufacturers of the drugs.
The FDA has identified one pharmacy, called Dougherty’s Pharmacy, with two locations in Dallas, TX that ispermitted to import and distribute Domperidone. It’s not clear why there is only one company involved. The FDA communicates that other pharmacies can apply to distribute Domperidone.
The FDA does not permit physicians and their patients to use the program to import Domperidone for breastfeeding mothers having problems with lactation. Recall, it’s also not approved for that purpose in Canada or the UK – or anywhere. However, in Australia, it’s prescribed off-label for this purpose. Off-label prescribing is when a provider writes a prescription for a patient to treat a condition with a drug that has not been approved by the FDA (in the U.S.) for that condition. Off-label prescribing is both legal and very common in the U.S., although controversial. According to WebMD, 20% of prescriptions are written off-label.
If you do choose to buy Domperidone online from another country, be careful who you buy from. There are a lot of websites who will offer to sell this drug without a prescription. Many such sites are dangerous to order from. You can be more certain of obtaining the right medicine, dispensed by a licensed pharmacist, if you stick to ordering Domperidone from an online pharmacy verified through the PharmacyChecker Verification Program.
Prices for Domperidone 10mg range from 16 cents to 49 cents a pill: for 200 pills, that’s $32 vs. $98. The online pharmacies will likely decline to dispense it for lactation from certain countries, including Canada, but may do so from Australia where the drug is prescribed off-label.
FDA’s Path to Safe Personal Drug Importation
As this relates to personal drug importation overall, it’s interesting to note the reasoning the FDA provides for permitting it. Here are some highly relevant excerpts from the FDA’s website:
“The Expanded Access program facilitates availability of investigational drugs (such as Domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient’s disease or condition.
“To help facilitate the IND process, FDA has developed this packet, which includes instructions, templates, checklists, a protocol outlining the treatment plan (multi-patient INDs only), and summary of regulatory requirements. As sponsors of an active IND, physicians can prescribe Domperidone to qualifying patients.”
In view of the FDA’s positions here on availability and access, it provides a lot of room to defend lack of access based on affordability. It also shows how the FDA could engage healthcare providers in assisting patients with safe personal drug importation of FDA-approved drugs and foreign versions of FDA-approved drugs. For example, a doctor could fill out a form, similar to the one used to obtain Domperidone, to help a patient import a drug from Canada that the patient can’t afford domestically.
We know that doctors, nurse practitioners, and physician assistants—ones that recommend use of PharmacyChecker-verified online pharmacies—are concerned about the FDA’s actions against personal imports. They would appreciate a more organized pathway to help their patients obtain affordable drugs from Canada and overseas.
EpiPen, the emergency epinephrine auto-injector medicine, is in short supply in the U.S. and other countries, such as the U.K. and Canada. Now, parents of kids who need to carry around EpiPen Jr. are not just worried about the cost of EpiPen but if they can get it at all. If you are considering buying EpiPen online, here’s my warning:
Only Buy EpiPen from Verified Online Pharmacies
When it comes to fast-acting, life-saving products, buying online from a rogue online pharmacy can turn out to be deadly. If you get a fake or expired product, then it might not work. Enough said. The message is clear: do NOT buy from an online pharmacy that isn’t one associated with your neighborhood pharmacy. If you decide to buy online, stick to online pharmacies that are verified. That includes online pharmacies verified by us, PharmacyChecker, or LegitScript, the National Association of Boards of Pharmacy VIPPS program, or the Canadian International Pharmacy Association.
When it comes to cost and availability, you may not have to look internationally for savings. In the U.S., there’s a generic version made by the same company that makes the brand version, and it’s much less expensive. According to GoodRx, you can buy the generic with a discount coupon for almost half the price of the brand-name sold at Canadian online pharmacies: $125. The brand version in the U.S. is over $600!
Where are all the EpiPens?
According to Market Watch, manufacturing problems are causing EpiPen supply problems. The generic drug company, Mylan, has the license to market and sell EpiPen in the U.S. and Canada, but the brand-name drug company, Pfizer, owns and runs the plant that makes the drug. To make a very long story short, the FDA has cited problems with Pfizer’s protocols for assembling the drug. Pfizer is trying to up its game, but the process is taking some time.
There are epinephrine alternatives to EpiPen, brand and generic. They include Adrenally and Auvi-Q, which might be more affordable. Consumer Reports has a good article on these products, although I’m not sure about their current availability.
The Market Watch article suggests that you can still get the product, but they make it seem a lot more challenging than it should be. If you choose to buy it online, whether for availability or cost, stick to verified sites.