Diabetes and Prescription Medications
"I heard it on NPR," is a common refrain when discussing something of importance in the news. As I was driving to one of my outpatient locations around the Washington Capital area beltway, I was so distracted listening to a report about diabetes and prescription medication (rather a lack of prescription required) that I almost missed my exit, and nearly had to go around the entire beltway again!
My first thought was: "Great, no more having to write thousands of prescriptions for diabetes-related items! My next thought was, "Oh no, there is great potential for dangerous misuse and major complications, and then my last thought became an even more practical one: expense.
Is the U.S. Food and Drug Administration/government allowing diabetes related medications and supplies to become "over the counter" in order to make it easier for those afflicted with diabetes mellitus (DM) to obtain these needed materials?
According to an FDA News release in March 2012, the FDA stated that they met with a pharmaceutical representatives to confer about helping clients to understand the risks of taking "over the counter" medication when they go to their pharmacy. Several options to provide further instruction were discussed including self-serve kiosks, interactive videos, or touch-screen technology.
However, the FDA emphasized, "Consideration of any over-the-counter change is still in the initial stages." The next steps include the FDA discussing the proposal at a public meeting before developing further guidance and instructions regarding these medications. If they should become "OTC," pharmaceutical companies would need to have to apply for each medication to place in a new category. According to the FDA, the most likely drugs to get approval for "OTC" would be the drugs that do not cause hypoglycemia such as insulin-sensitizers (Metformin) and the DPP-4 inhibitors.
However, what is the likelihood of the insulins becoming "over the counter?" Indeed, it is a little known fact to many that both NPH and regular insulin is already "over the counter." Indeed, no prescription is required to obtain either insulin.
Upon further reflection, I have major concerns should this possibility become a reality.
1. If diabetes related medication and supplies become "over the counter," how will medication, in particular, be regulated? Who will ensure that these drugs will be used safely? Diabetes, particularly insulin, is one of the most frequent sources of both user and even healthcare provider error in the world. If all insulins and other classes of oral diabetes medication becomes "OTC", it is extremely possible that there will be in an increase in the frequency of both hyper- and hypoglycemia and potential misuse of these agents.
2. Another concern is that people with diabetes may be less likely to follow-up with their diabetes team if insulin and related supplies are "OTC." Indeed, one way in which we ensure that our children/adolescents are seen more frequently is to only provide refills if they are seen in a timely manner in order for us to be able to evaluate the success of treatment.
3. Insulin (and even oral medication) requires frequent dosage adjustment. Will people with diabetes be less likely to follow-up with their diabetes team?
4. Lastly, and perhaps of even more practical importance, is expense. At this juncture, most insurance companies cover the majority of diabetes-related expenses. Some cover only a fraction of the costs. As we all know, diabetes and related supplies is a very expensive proposition. If diabetes related medications and supplies become over the counter, insurance companies will have yet another excuse not to pay.
My concern, therefore, is that people with diabetes will be faced with unbearable financial hardships in terms of obtaining medication and related materials. Many people with diabetes are already cost-cutting and performing less self-blood glucose monitoring in order to save money on glucose test strips. This will not work, especially, with those who need to monitor blood sugars frequently as with type 1 diabetes. What about glucagon prescriptions? Will people not purchase a glucagon emergency kit (or two, as we require a kit to be in the school nurses office) because most kits expire in a year because they are rarely used? I believe these are realistic concerns in view of the governmental cost of health care and the fact that insurance companies keep cutting back coverage. Will these medications and supplies become more affordable if they are over the counter?
In conclusion, although it does not appear imminent at this time, it is indeed a possibility that many diabetes related medications and supplies might become over the counter in the future. Should this become a reality, much will need to be worked out in order to keep both our children/adolescents/adults with diabetes safe and to actually enable them to purchase the items without facing bankruptcy.