I have thought a lot about patient engagement over the last year. It is something I never really considered prior to being diagnosed with gastroparesis – never really had to. It is a priority topic now, though. Patient engagement largely refers to patients being involved with their own healthcare. It includes becoming informed about your condition, actively pursuing medical care and interacting with medical professionals involved in such care, and doing all you can to prevent and control your illness. You will often see it listed side-by-side with the term “shared decision-making.” This means that a patient works in conjunction with his doctor and other healthcare professionals to determine what the best approach is to treating his illness. And while it is all well and good to discuss your own role as a patient in this strictly medical side of the patient engagement equation, I believe we are remiss if we fail to consider another important factor in this equation: policy issues and the effect of governmental and regulatory bodies on your ability to engage in your own healthcare. Let me be blunter: How is a patient supposed to “engage” in his own health care if he cannot even understand or be included in the processes which ultimately affect the choices available to him?
In my view, patient engagement (and patient inclusion) should refer to more than simply having conversations with doctors and attending medical conferences. It must also include engagement in the process and policy development that ultimately affect your health and your ability to treat your condition as you see fit. It must include having a “place at the table” during governmental and regulatory body meetings, conferences, and discussions. But more than that, it must include being able to understand that process before ever being engaged in it – and here is where it gets tricky. What newcomer can possibly understand all the factors that affect healthcare? Don’t these bodies have an obligation to make the process both understandable and accessible to the general patient population?
I will offer two examples of the uphill battle for information that we in the gastroparesis community face. The first involves a medication called “Domperidone” which many take, but which is currently not approved by the FDA. I was told about this drug when I was first hospitalized and diagnosed. I was informed by the doctor at the hospital that this drug was not FDA-approved for everyone, that I had to get it from Canada, and that it came with serious heart risks. I refused this drug at first, but as my symptoms became truly life-threatening, I changed my mind. I called my doctor and asked to be put on this medication. Not that simple! He informed me that I needed an EKG to make certain I did not have pre-existing heart issues that might prevent me from taking it. He also informed me that since the drug was not FDA-approved except under certain conditions, he would need a little time to complete information with the FDA so that I could have a prescription. He also told me that I could expect it to take anywhere from two to six weeks for the medication to take effect. I assumed I would have to order the drug from Canada, as I was told in the hospital (which would mean further delays), but my doctor told me it could only be obtained in the US – from one pharmacy in Texas. After a couple of weeks, I was finally able to get my Domperidone, and fortunately for me, it began to take effect within the first couple of days. It has kept me alive; there is no doubt in my mind about this. Now, this doesn’t seem all that traumatic until we fast forward a few months later to a situation I encountered in my GP support groups.
I began to read posts about people who had been getting prescriptions of Domperidone filled but were suddenly being cut off, with no warning and with no advice as to how to obtain it. It seems that they were getting their medication from non-FDA approved pharmacies, but since some sort of new FDA crackdown had begun, these pharmacies were now being fined and forced to stop distributing it. Another segment of people in the group had been going to a pharmacy overseas to obtain their Domperidone – without a prescription – and were suddenly running into issues with this as well. Misinformation was running rampant. Some began posting that the FDA had suddenly banned Domperidone and that no one would ever be able to get it again. All were begging for help and information regarding if and how they could legally obtain their Domperidone. This was a very serious situation, as many of us believe our lives literally depend on continuing with our Domperidone.
I had already done some research on the Domperidone situation. I had previously consulted the FDA website and learned all I could about how and why it was restricted. I had learned that it could only be obtained as part of the Investigational New Drug (IND) program, that doctors were required to complete a packet to be able to prescribe it, and that only patients who had “failed standard therapies” and suffered from one of a list of conditions found on the FDA site could qualify to take it. I challenge anyone to read and make sense of this section on the FDA site (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm368736.htm). I suppose it could be more confusing, in theory, but I do not know how. God help the person who does not have a Ph.D. and/or a medical background in trying to decipher this! In any case, I could find nothing about which pharmacies were allowed to distribute Domperidone. I recalled the doctor in the hospital saying there were pharmacies in Canada that could do this, but my personal GI had said only the pharmacy in Texas could do this.
Wishing to help clear up the matter, and to assure my groups that Domperidone had not been banned entirely, I called the FDA – not just once, but four separate times. I was given four different answers each time I called. My first challenge was to reach a real individual with whom to speak. I had to go through a series of options during the phone call, and each time I chose the wrong one, I failed to reach a human being and had to start over. I finally managed to select the correct sequence of choices that allowed me to reach an actual person, and I was told that there were three pharmacies that could distribute Domperidone, one in the US, one in Canada, and one in the UK. The FDA representative could not reveal the names to me; I would have to get those from my doctor. (Apparently this is top-secret information!)
Some people in the groups questioned this information when I reported it, so I called the FDA a second time. This time I was told by the FDA that they could not give me an actual number or list of pharmacies allowed to distribute Domperidone, but that this information was in my doctor’s IND packet, and he could provide me with it. I continued to receive new questions and challenges in the groups, so I called a third time. This time, I was told the same thing I was told in the first call – three pharmacies, one in Texas, one in the UK, and one in Canada. Again, the representative said she could not give me the names.
I took the information back to my groups feeling pretty confident that there were indeed three pharmacies where we could obtain our Domperidone. I was hoping the matter would be closed at this point and that people would contact their doctors for more information. People did call their doctors, but they began complaining that their doctors were telling them that they had no idea which pharmacies were FDA-approved to distribute Domperidone. Their doctors, as it turns out, in almost every case, had been writing prescriptions to non-approved pharmacies, and these pharmacies had been filling them without hesitation. So, I placed a fourth phone call to the FDA with the intention of demanding pharmacy names. Guess what? The fourth representative I spoke with told me that contrary to what I had been told the first three times I had called, there was only ONE pharmacy from which we could obtain our Domperidone and that was the one in Texas. She told me that the Texas pharmacy could obtain it from Canada or the UK, but that we, as patients, had to get it from the pharmacy in Texas.
Can anyone honestly say for sure what I should do at this point? What should I tell my groups? The last representative with whom I spoke assured me that she indeed was the one giving me the correct information, but she seemed unconcerned that I had received “false” information from the previous three representatives. She also seemed less than upset that I could not get this basic information, in any kind of understandable format, from the FDA website. It did not bother her that I was walking away without yet having the name of the pharmacy we were “allowed” to use. She did not take any interest in my stories about people being suddenly turned away from sources where they had previously been able to purchase their life-saving Domperidone with no indication as to where they should now turn. She did not seem disturbed by the fact that doctors and pharmacies, in large part, do not know the rules regarding Domperidone prescriptions and sales. It did not bother her that I objected to being offered only one choice of pharmacies, and she told me plainly, “It shouldn’t be an issue. You won’t pay significantly more.” Excuse me? Do we actually believe in the market system here? And please don’t tell me what “shouldn’t” be an issue for me!
The FDA could easily clear up this whole situation. They could, of course, approve Domperidone. Short of that, they could post a clear and easily understandable explanation on their website as to how and where to obtain Domperidone. Why do they refuse to do this? How can I participate in my own healthcare when I cannot easily obtain basic information? I am not a healthy person. The people in my groups are not healthy people. We struggle to get through the day under normal circumstances. How can we spend hours of our time facing these sorts of obstacles? And in the end, after all my efforts, I still cannot be certain if I have accurate information regarding a situation I have tried to resolve FOUR different times! Surely I am trying to be an engaged patient. Am I not?
(To the FDA’s credit, I will say that gastroparesis was included for the first time in the FDA Functional Gastrointestinal Disorders Patient-Focused Drug Development Public Meeting on May 11, 2015. We were represented by a few panelists who suffer from this diagnosis and we have been allowed to make public comments via the docket. This is a good start.)
This is but one example of the difficulties we face. Please allow me to give you another. Many people in my groups wish to get gastroparesis listed as a disability in and of itself in the SSA’s “Blue Book” so that they are not forced to qualify for SSDI under provisions of a separate condition or based on equivalent severity of symptoms. (Please forgive me if I do not speak as clearly as I would like about this situation, as I do not yet fully understand the complete workings of this whole disability system.) In an attempt to ascertain how we might influence the policymakers and fate-determiners in our favor, some members of our advocacy group have been researching websites and writing to various policymakers and organizations in an effort to discover who really has control over which conditions make it onto this disability list. After months of contacting governmental, medical, and advocacy sources, we still have little idea where we need to direct our “lobbying” efforts.
We first targeted Congress and the SSA. We were told by each that they were not really the group we should be contacting. We were told at one point to contact state level Disability Determination Services agencies. We were then told by a particular congressman that we should be contacting the Institute of Medicine (IOM). None of us had ever heard of the IOM. Nevertheless, we started looking into this information, and we found that this might indeed be a helpful path. We took note of their next “open” meeting and tried to get involved. We were informed that we could not comment at their upcoming meeting and that we could not view it via webcast. We did have the option of calling in or attending in person (with security clearance), but since most of us cannot travel due to our illness, and since the meeting was an all-day event, these were not very viable options.
So, at this point, I would simply like to know how we are to be heard and participate in this process. How is it that an advisory committee can determine our fate without ever even hearing from us? Yes, I understand that they seek input from physicians and that they research the current literature and studies regarding our disease, but they also need to consult us. They need to get a clear picture of what we endure on a daily basis! I have read on their site that they are tasked with holding public outreach meetings where we may speak, but I cannot find the details regarding how this process works or when it will come about. Why should it be this difficult to determine the course we must take to be an influencing factor in the processes that affect our own lives? Why can we not find a straightforward path to participating in our own care? Why can this not happen? I believe it easily could if only the parties involved were willing to be upfront with information and truly sought to include us. Where is the outreach?
These are but two examples of the struggle we face in trying to be heard and considered in matters that directly affect us. I could give endless additional illustrations. There are boards and agencies, bills and regulations, policies and rules, and on and on and on – all affecting our very lives! Barriers, obstacles, and mazes of information abound! We are told to take an interest in our own healthcare, to participate and be proactive, and though that is possible to an extent, it is far more difficult in some areas than it should be. I am simply an inexperienced patient who, until a year ago, had never dealt with anything healthcare-related. And now I am trying to navigate some pretty harsh waters under less than ideal circumstances. We in the gastroparesis community are all very sick people who have little knowledge of processes and policies and who have little energy to fight; yet, we show up every day and continue to battle. We believe in patient engagement at all levels – including policy level. Could we get a little help, please?