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Domperidone Imports Available Through FDA Expanded Access Program and Online

FDA Expanded Access ProgramThis 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.

Domperidone 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.

Here’s a general overview of the program to obtain Domperidone. Detailed instructions for this process are contained in the FDA’s Domperidone IND Packet.

Domperidone Importation Exceptions

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 is permitted 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.

Physicians are allowed to prescribe medication off-label based on their medical judgement. I believe that would include Domperidone. One doctor, Juliet Mavromattes, MD, makes a case for why it would be medically unethical to prescribe Domperidone for lactation in the U.S. – but OK for GI disorders, per FDA’s guidance. Here’s a vehement defense of prescribing Domperidone to improve lactation from a pediatrician in Canada.

Safety When Buying Domperidone Online

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.

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Warning About Buying EpiPen Online to Deal with Shortages

EpiPen ShortageEpiPen, 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.

You can buy brand-name EpiPen online from Canada using verified online pharmacies: a two pack for about $230.

Buy Generic EpiPen at U.S. Pharmacies

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.

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Big Pharma Forces Women to Choose Between Dry Vaginas or Dry Bank Accounts

Dry Vaginas CommonCosts of products that improve women’s sex lives by treating a dry vagina, a taboo yet common condition, are on the rise here in the U.S. It’s bad enough to face the unfair stigma of needing medication that has anything to do with your vagina, but Big Pharma has decided to make that experience even more difficult. American women deserve to know that those much-needed products are sold at international online pharmacies for a fraction of the price tag at their local pharmacy.

The New York Times’ Katie Thomas recently published an article, Prices Keep Rising for Drugs Treating Painful Sex in Women, that highlighted this quiet conversation in the corner of the drug prices crisis. Your EpiPens and asthma inhalers are perhaps easier to gripe loudly about than meds related to personal matters. “It’s just infuriating that the price has gone up and up and up for no good reason,” said Cynthia Pearson, the executive director of the National Women’s Health Network, who expressed frustration at the lack of attention due to the stigma.

Women have seen prices on drugs, such as Estrace cream and Estring, more than double in the last five years. The article goes on to report that one woman “has resorted to ordering her drug from overseas at a cost of about $80 for a three-month supply,” which is great news for that savvy lady, but unfortunately leaves the reader hanging on how to safely order their own medication from abroad. After all, shopping for medications online can be quite treacherous: the internet is a landmine of scammers and sellers of counterfeit medication. Peer-reviewed and independent research demonstrates that when consumers use PharmacyChecker-verified pharmacies to buy medications purchased online, they receive lawfully-manufactured, high-quality medication. Not to mention those meds are typically sold at a much lower price than available at local U.S. pharmacies.

Vagifem sold in the U.S., mentioned in the article, is actually manufactured in Denmark. At U.S. pharmacies, just 8 tablets of Vagifem 10 mcg can cost women around $200, but it’s sold at international online pharmacies for as low as $20, a 90% savings. Premarin Vaginal Cream is a whopping 98% cheaper if women order through an online pharmacy in the United Kingdom that’s been verified by PharmacyChecker. Premarin sold in the U.S. is manufactured in Canada.

Vagina may be a stigmatized word, but saving money on meds? Now, that’s something to shout about.

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Why Patient Safety is My Primary Focus

Dr. Shivam Patel, PharmacyChecker.comDear PharmacyCheckers,

I have seen, first-hand, the impact on patients due to rising medication costs. As a former community pharmacist in Massachusetts, my patients wouldn’t hesitate in expressing their shock at outrageous costs. I’d often hear a “Why do my meds cost so much?!” or “I’m certain I paid less for this last month.” Sadly, there wasn’t much I could do to help these patients. Some would reluctantly break their budgets to continue on with their drug therapy, while a heartbreaking majority would assure me they would be back with the money… and never return.

I am joining PharmacyChecker because it is my hope that I can lessen the number of these stressful situations for patients. I desire for patients to focus on getting better and staying healthy instead of worrying about how they will afford their medications. Throughout my pharmacy career, patient safety has always been the primary focus, and I relish the opportunity to bring that focus to PharmacyChecker. (more…)

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New FDA Tests Indicate Imported Drugs Are Safe

 

FDA Testing Lower-Cost Imported Medications

Tens of millions of people have bought medications from foreign pharmacies – despite the technical illegality of importing those medications. According to reporting by Kaiser Health News last month, the FDA tested imported medications, apparently to see if what Americans are doing is safe. All medications the FDA tested “contain[ed] the ingredients matching the medicines ordered.”

The Kaiser Health News reporting was focused on international pharmacy options offered by local governments and school. While that’s interesting, it’s not breaking news (I mentioned it here). The FDA testing imports and saying the medications are safe, albeit begrudgingly, is breaking news. (more…)

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International Pharmacies Safer Than Your Local Pharmacy? Blister Packs vs. Loose Pills

Blister Packs Better Than Loose PillsThe verdict is in: blister packs may be a safer bet for packaging your medication. In the U.S. and sometimes in Canada, however, medications are dispensed as loose pills.

According to the FDA, over 1.3 million people are injured each year due to medication mistakes, which include dispensing errors in U.S. hospitals and pharmacies. As discussed in a blogpost by Roger Bate, an economist at the American Enterprise Institute, it may be safer to receive your medications in blister packs, whether dispensed locally or from an international pharmacy by mail, and the FDA seems to agree.

(more…)

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