Zero Tolerance: The Gluten In Medicine Disaster

In the United States today, there are an estimated 3 million people who suffer from celiac disease, which is the inability for the affected individual to properly digest anything which contains wheat, barley, or rye ingredients. The medical community estimates that, on top of that group, there are an untold number of people who are undiagnosed as well as another group numbering in the millions of people dealing with what is known as non-gluten sensitivity.

Those with non-gluten sensitivity do not test for celiac disease, yet their bodies cannot properly digest gluten containing substances without exhibiting some of the symptoms of celiac disease. In all of these cases, steps have been taken by the Food & Drug Administration and others to address proper labeling of food products, menu items in restaurants, and other items that may pose a risk to consumer safety.

However, with all the progress that has been made in recent years to designate products as gluten free, one area which remains without regulatory controls on the labeling is the pharmaceutical products area. This issue is most profound in the area of prescription pharmaceuticals, but it can extend into over the counter formulations as well.

The main area of concern centers primarily upon the inactive ingredients in these pharmaceutical products, especially when it comes to the binding agents used to make tablets of medication. The inactive ingredients listed, often times but not always the case, provides the word “starch” without identifying whether the starch is derived from wheat or gluten containing sources, or if it is derived from corn.

The patient with celiac disease or gluten sensitivity is left with the responsibility of having to contact the pharmaceutical manufacturer to determine if the medication is safe for them to take. Most people have the misconception that the prescribing physician or the pharmacist at the local Walgreens have access to a database which identifies the medications which contain certain allergens, such as gluten or lactose. The reality is that database does not exist and the prescribing physician and their staff do not have the time to make those phone calls.

The debate over whether or not that sort of database should exist is an issue which has become the topic of proposed legislation in Congress. The point being that the ingredients in pharmaceutical products should be disclosed into some sort of cohesive resource which can be accessed to eliminate patients from taking a prescription medication that could leave them feeling worse.

The confusion over the whole situation is intensified by the fact that the pharmaceutical manufacturers have no set protocol from the government or the FDA on how to handle these questions regarding the allergen questions which could arise. Each company has a different procedure for handling the question of gluten allergens in their product formulations. Some companies respond with a phone call, some with an email, and others with a faxed or hard mail letter that could take several days to procure.

Meanwhile, the patient is hanging in limbo without being able to know what prescription they can or cannot utilize to deal with whatever ailment brought them to their doctor in the first place. There has to be an easier way, especially with all of the technology accessible today, to streamline this process so that millions of people with celiac and other allergies can take a prescription pharmaceutical product with some peace of mind.

The debate surrounding this disclosure of ingredients in medications is also made more pressing by the emergence of so many generic drug manufacturers into the pharmaceutical industry. The way the system currently works, the patient has to contact the manufacturer to find a product which is acceptable to accommodate them, in this case, free of gluten containing material. Then, they have to find out which pharmacy carries the product made by that manufacturer. In the event that a scenario dealt with a frequently prescribed antibiotic now in generic form, the patient could be dealing with numerous companies just to identify which product is safe for their use.

Some drug manufacturers have different suppliers for the same product formulation because it may be manufactured at several different locations throughout the country. A deeper look into this issue reveals a scenario that is not just concerning for those with celiac disease or other allergies to components found in pharmaceuticals, but it is concerning to all patients: the controls on the ingredients sourced to make a particular medication.

The controls, especially in some of the generic manufacturing segments, are revealing especially to the average consumer. Some products are made with different ingredients depending on the lot, or batch, of the respective medication. These individual ingredients can be sourced from different areas of the world and could potentially cause a variation in the product.

The FDA does check the formulations because the generic formulation has to meet a certain standard of efficacy which is essentially within a certain range of the effectiveness of the branded drug formulation. The wide disparity in the sourcing for the ingredients is still a cause for consumer concern because it can create a huge quality assurance issue.

In the event that a certain product has reports of a quality issue the paper trail and the back tracking that must take place to determine what component of the generic product is potentially the source of the particular issue is a daunting task.

The overarching theme for the consumer with gluten allergies or sensitivity is the sheer amount of time needed to just determine if they can safely take the medication. Then, they have to invest more time to try to find where the “safe” version of the product is available.

Finally, they have to get to that pharmacy and fill that prescription, this is all while having some type of health issue or illness, not exactly an ideal scenario for the patient. The modern, smart phone, connected device age should have a far more conducive solution to this situation.

In my view, I do not have a magical solution to this whole mess of a situation with gluten in medications. I am a proponent of stricter controls on sourcing ingredients for generic drug products. I am also a proponent of some sort of “master list” or a database that the pharmacists have available to them so that they can advise the patient on the appropriate medication selection based upon any allergies or contraindications may be involved.

Those patients who have celiac disease, gluten sensitivity, or have other allergies and medical conditions are dealing with enough problems; they do not need to have undue stress over what medications they can take safely. I know that a solution exists, I know some measures can be taken to streamline this antiquated process, it just means that enough people have to care and voice those concerns. It is my hope that this commentary will motivate you to take action so that this situation can be improved for everyone, for future generations of children.