*Note: I am just a patient, a Gastroparesis patient searching for answers for a community which desperately needs attention, and this is just a copy of my Facebook post. My apologies if the following seems harsh or overly-aggressive, but my people are suffering, and the status quo is simply not going to cut it. Someone must speak out for radical change, and if not me, then who? Please, if I am wrong, offer clarity. Correct me and I will pass along the proper information.
One further comment -- a personal story really. My former GI, a motility specialist, prescribed Domperidone and instructed me to obtain it through a pharmacy in Canada or New Zealand. This physician actually handed me a prescription, along with printed information citing the pharmacies' contact information, and when I objected that this was not the technically legal path, a staff member responded to me: "What difference does it make. Are you running for political office?"
Is that the atmosphere you had hoped to create?*
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MUCH ADO ABOUT DOM
How is it that our "top" Gastroparesis clinics and motility specialists do not know the proper route for prescribing Domperidone? Good doctors, if I can find the information, you can, too!
When you advise patients to circumvent the legal process and purchase directly from overseas, you put your patients in the awkward position of choosing between following the FDA regulations or the advice of their doctor (who assumedly has their best interests at heart). Your patients trust that you are following the law and are directing them to legitimate sources of purchase -- and yet you are not. These people are stunned that they have been given misinformation by the very doctors whose advice they are expected to follow.
It would seem, good doctors, you are either uninformed of the FDA guidelines regarding Domperidone (which I find unlikely) or you are blatantly ignoring those guidelines either due to a desire to help your patients obtain the medication they need to survive through simpler (though illegal) routes or because you are unwilling to put forth the time and effort required to jump FDA hoops. I sympathize, but you must understand the consequences and the effect this has on your patients.
Your patients are often completely unaware that obtaining medications outside of the US is illegal and are shocked that you would advise them to pursue such a path. I frequently hear, "My doctor would not tell me to do something illegal. Why would he do that?" In fact, many times, your patients choose to put their faith in you and take your words as the final authority because they believe in you, and, after all, I am just an administrator in an online Gastroparesis support group. What do I know? And so they remain unaware that their medication may be confiscated at the border and that, if this should occur, they will be left without the medication they so desperately need, without an alternative source and adequate time to secure a replacement medication, and without any sort of refund for their purchase.
Beyond that, by breaking their trust in this one particular area, you have broken trust with them completely. How can you now convince them you are honest and upfront about other issues? Have you really researched the treatment option you are offering? Have you fully informed them of all the potential side effects and risks? Have you thought through the needs of your patient in all matter which so deeply affect their well-being? Why would they ever again believe you have told them the whole truth and are acting in their best interests?
I have addressed this Domperidone situation many times with the FDA. I have told them point-blank that people are confused as to why their doctors would give them misinformation and direct them to violate the law and that I am confused as to why this is allowed to continue. Their response to me, while sympathetic, has been that it is "disappointing" to hear that doctors are handing out such advice (and that they should not be) but that the FDA is not the body of enforcement. In other words, the FDA lays down the law but has little power in what happens after that. As I see it, the FDA has washed their hands of responsibility as have physicians.
Now, I do not like the FDA regulations. As a matter of fact, I detest them. But we have them. And if we are not going to do away with them anytime soon, then we need to find a way to help patients legally obtain their life-saving Domperidone. There is a process in place, and I am guessing most of the players (with the exception of patients) know the details of this process. Why are we playing games that ultimately harm the patient? While the powers that be "duke it out," my people suffer. Get on board with the process or change it.
And I say to you, good doctors, please stop placing your patients in a position where they must break the law to stay alive. It is UNACCEPTABLE! You know the proper route so advise your patients accordingly and put forth the necessary effort to help them obtain their medication. Cumbersome and time-consuming? Yes. But you have a duty to do what is best for those you serve. Take it up with the regulators, and, in the meantime, do what you must do to help your patients legally obtain Domperidone.
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For all who are interested, this is the post I generally share in the group. If I am the one who is misinformed, please, by all means, give me clarity...
Regarding DOMPERIDONE...
I am going to post the information (below) I post almost every time this medication comes up. I realize some of you dispute this. All I can tell you is that I have contacted the FDA 7 times now (yes, 7!), and this is what they have repeatedly told me. I have explained to them that I admin a group of more than 17,000 and, so, it is imperative I deliver accurate information, and they have assured me this is accurate.
I also realize doctors are not telling you this and are not prescribing in this manner. Again, all I can say is that, according to the FDA, they should be. It puts the patient in a very awkward position when the doctor is telling him/her one thing and an admin in a Facebook group somewhere is saying another. I have raised this issue with the FDA on numerous occasions, and their only response to me is that they are not responsible for oversight and execution but that doctors should NOT be operating in this manner.
Further, I know most of you obtain your Dom in ways other than the FDA's IND program. I make no attempt to direct your behavior; nor do I pass judgment on it. I clearly understand all the reasons for this. (In fact, personally, I detest the FDA regulations and fight every day for them to be changed.) But my goal is ALWAYS to provide the legal, most accurate, updated information possible, and so I post what I have been told to be correct by the very body which regulates all drugs in the US. And, in addition, I do not wish to see any group members in a situation where their medication has been confiscated and they have no recourse. I know many of you have ordered overseas (or from compounding pharmacies) for years with no issues, but I also know the FDA has begun cracking down on these practices rather severely lately. This can and HAS happened to members of this group.
If you doubt this information, I encourage you to see the FDA packet at https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/UCM520728.pdf or to call the FDA directly at 1-888-463-6332. I do not get paid to be their spokesperson, and I am certain they are tired of hearing from me.
So, here is the most up-to-date, accurate legal information I have. I will not engage in argument over this. You are free to believe as you wish. This is the best I can do. If you dispute it, please refrain from commenting; rather, please contact the FDA directly.
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According to the FDA, there is only one pharmacy (inside or outside the US) whereby patients may legally obtain Domperidone: Dougherty's Pharmacy in Dallas, Texas. You can find Dougherty's on the web at http://www.doughertys.com/ or reach them via telephone at (214) 373-5300. The FDA has stressed that this is the ONLY legal method for obtaining Domperidone available to US residents.
It is a common misconception (even among doctors) that Domperidone may legally be obtained outside the US, but this is not the case. US residents seeking to obtain Domperidone outside the US technically do so in violation of regulations and run the risk of having their Domperidone confiscated at the border. This can and has occurred. In this case, the patient does not receive his/her Domperidone, nor does s/he receive reimbursement for the order.
It is also a common misconception that Domperidone may be obtained through compound pharmacies in the US. Again, this is a violation of FDA regulations. Compounding pharmacies are prohibited from making and distributing Domperidone and do so at risk of being fined. The FDA fines these pharmacies and orders them to cease production/distribution once they have been made aware. Many patients have found that local compounding pharmacies which once filled/refilled their prescriptions for Domperidone have now been banned from this practice. When this happens, the patient is left with no recourse and no access to the medication.
Here is a link to the FDA's website regarding how to obtain Domperidone: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm368736.htm
Their website instructs, in part, "'Patients 12 years of age and older with certain gastrointestinal (GI) conditions may be able to receive treatment with Domperidone through an expanded access investigational new drug application (IND). These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients who are eligible to receive Domperidone have generally failed standard therapies. Expanded access INDs facilitate access to investigational drugs (such as Domperidone) for patients with serious diseases or conditions for which there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient’s disease or condition. In addition to other applicable requirements, an IND must be in effect prior to the importation, interstate shipment, and administration of Domperidone."
*Please note that we seek to provide you with the most accurate and up-to-date information possible, but we cannot and will not try to direct your behavior. Your choices are your own, and we make no attempt to control them. If you have any further questions, we would advise you to call the FDA directly at 1-888-463-6332.*
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