Should You Think Twice Before Your Health Insurance Makes You Change Medications?
Changing insurance companies due to new employment may mean you have to change your medication to a “comparable” drug that is on formulary with your new health insurance.
This is all too common in the United States where insurance companies negotiate deals with pharmaceutical companies to keep costs down. Sometimes this means changing to a generic medication and other times it means switching to a completely new drug within the same class of medication.
This shouldn’t matter as long as the drugs are comparable, right? But how similar are these medications really? Have you or anyone else experienced an issue when forced to change your medication?
I think it’s a more serious issue than most think and I’m going to tell you why. Through an understanding of the pharmaceutical process and stories that highlight adverse events, I will show how a simple change can be very troublesome, and sometimes dangerous, for patients.
Generic drugs are copies of brand-name drugs that have exactly the same dosage, use, effects, and side effects. However, these medications are not identical to the brand-name drugs. In order for the FDA to approve generic medications, they must be able to show bio-equivalence. Pharmaceutical companies are allowed a 20% variation in the active chemical structure and they only need to prove the similarity in the lab.
Many generics add “exipients” to the final preparations — substances that increase long-term stabilization, bulk up the medication for easier production, or increase absorption into the body.
The FDA assumes that a compound with similar properties, at least 80% similar, will act identical to the original drug. Once expedited approval is reached, the drug hits the market — no other questions asked.
But how do generics actually perform compared to their brand-name counterparts?
There are a number of studies that compare the equivalency of these medications in regards to measuring the level of the compound in the patient’s blood. These studies, some of which have been funded by the FDA, confirm rate and absorption to be similar.
However, other studies (1, 2, 3, 4, 5) shed light on a number of potential problems with generics including relapses of conditions, worsening outcomes, adverse effects, and decreased efficacy.
Studies and case reports highlight the potential danger with generics. Anecdotally, I have treated a number of patients presenting to the emergency department with symptoms that I believe to be related to generic medication changes. Three experiences highlight the issue. Though not statistically significant, other case reports have also emphasized issues with these generic drugs.
While working in the emergency department, a patient presented with significant fatigue and mild swelling throughout her body. Her only history had been thyroid disease for which most of her thyroid was removed surgically. She had been maintained on Synthroid for many years and had never had any major issues. As it turned out, her health insurance recently changed and required her to switch from the brand drug to a generic. Needless to say, her thyroid levels were low. She claimed to be taking the generic Synthroid daily.
Synthroid has revolutionized thyroid disease treatment by regulating the hormone. But there are other case reports of issues between the generic form and the brand name. If switching, it is imperative that levels be assessed regularly to make sure that the new formulation is effective with your unique physiology.
Lantus is a form of insulin that helps regulate blood sugar in diabetics. My patient was switched from Lantus to the generic form. Labwork showed his blood sugars to be significantly elevated. He was admitted to the hospital for further management of his condition. Could this have been avoided?
There have been case reports showing higher fluctuations in blood sugar with certain insulin preparations. Once again, it is important to check blood sugars regularly if required to change insulin medications.
Finally, a patient presented after switching to a generic form of the drug Warfarin. This medication is used to treat conditions that require the blood to be thinned out such as blood clots and atrial fibrillation. The drug has to be adjusted carefully for a small therapeutic range. INR is the blood level tested. If this is too low, the drug is not effective. Too high and bleeding can occur. Unfortunately for this patient, she had significant gastrointestinal bleeding and was found to have a high INR.
There have been other case reports that generic Warfarin preparations may not be metabolized in exactly the same way as the brand drug. If required to switch, make sure your INR is checked frequently to verify that new drug works the same in your body as the previous preparation.
While I do not oppose generic medications as substitutes for brand-name drugs, I do believe that a more rigorous process should be required to verify that these medications have similar outcomes to their counterparts.
However, it is likely that most generics meet appropriate standards to warrant their continued use as a financially viable alternative to the more expensive trade drugs.
If switching to a generic, especially those that have measurable blood tests to check efficacy, it would be advisable to have initial frequent testing to make sure the drugs are working as they should. This can avoid the downstream consequences described.
These medications are not copies but similar drugs in the same category. For example, lisinopril and enalapril are both blood pressure medications in the same class called ACE inhibitors. However, they have slightly different chemical structures and are thus not identical medications. Another simple example is ibuprofen and naproxen. Both are anti-inflammatory medications. However, some people claim one works better than the other likely related to differences in how their bodies metabolize the drugs.
In most instances, there is truly no major difference in comparable medications. However, before changing from one to another, realize that changes could cause unforeseen issues. These 2 examples highlight this potential problem.
One example of a medication change causing significant issues for one of my patients was a change in birth control medication. When her health insurance company changed, she was forced financially to change to a new birth control pill. Within 2 weeks of the switch, my patient started noticing some vaginal irritation. She didn’t think much of it. She started using more lubrication during intercourse, but the irritation increased until it became painful. She got to a point where intercourse was not possible. By the time I saw her the pain had become intolerable. The only change had been her birth control. Is it possible that the hormonal shift from this change could have caused her symptoms?
These are medications that treat colitis including ulcerative colitis and Crohn’s disease. They are anti-inflammatory medications that act directly on the gut where the problem occurs. They have been helpful for patients with these conditions. And the medications are very similar except that Sulfasalazine has a sulfa group as part of its structure. Unfortunately the sulfa group can cause side effects. This is exactly what occurred in a patient I recently treated. Her insurance changed and she was forced to switch from Mesalamine to Sulfasalazine. This caused an acute exacerbation of her symptoms, ultimately leading to the need for admission to the hospital and IV steroids.
I understand the hardships caused by health insurance formularies. Financially, switching medications is generally not an option, but a necessity for financial reasons. Most switches do not cause major issues. But it is still important to be aware of some problems that can occur. If a generic or comparable medication is not effective for your condition, you always have the option to appeal the insurance company to switch back to your previous medication.
Make sure you ask your doctor before switching drugs and understand the potential consequences that can occur. Not all medications are created equal but most will do just fine.
Should You Think Twice Before Your Health Insurance Makes You Change Medications?
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