Compounding Pharmacy Errors

FDA Warns of Compounding and Dosing Errors with Injectable Semaglutide Products

October 30, 2024 | Lebowitz & Mzhen

The United States has become increasingly heavier over the past half century — overall obesity rates have increased three-fold since the 1960s. Currently, more than two-thirds of U.S. residents are now, by definition, overweight with those individuals qualifying as obese making up more than 40 percent of the population. Even more disturbing is the fact that one in ten individuals meet the medical criteria for a person who is morbidly obese, which can be a life-threatening condition if not counteracted by a change of diet and exercise.

Sadly, this increase in national obesity hasn’t happened overnight; in fact, it’s been a gradual and relentless process that has seen the number of overweight individuals in this country tripling over the past 60 years. Furthermore, the incidence of severe (morbid) obesity has increased ten-fold since the 1960s, and shockingly the figures may actually be an underestimation of this nationwide problem. Here in Maryland, the obesity rate is slightly below the national average at 34.3 percent as of 2021, but that is hardly any consolation.

With such a large number of overweight individuals in the U.S., dieting and nutritional advice has become big business over the past several decades. So many people, hoping to shed excessive weight quickly and with less effort, have fueled an entire industry of weight loss programs, supplements and prescription drugs. Enter Semaglutide, an FDA-approved pharmaceutical marketed by Novo Nordisk under several different brand names, which is being used to help patients with Type 2 diabetes and chronic obesity. This latest answer to the country’s obesity epidemic has shown great promise since its introduction several years ago, but as with many medications there are potential pitfalls and dangers facing those who take advantage of this breakthrough drug.

Compounding Pharmacies Pose Serious Risk to Maryland Residents

February 25, 2020 | Lebowitz & Mzhen

Although they pose a risk to Maryland residents, most individuals do not know what a compounding pharmacy is. Compounding pharmacies mix, tailor, and create drugs on their own, to meet specific patients’ needs. These drugs may be helpful to individual patients, but often they are not approved by the FDA and, like any drug, can be dangerous to patients and are subject to pharmaceutical error. According to the International Academy of Compounding Pharmacists, there are over 55,000 compounding pharmacies in the U.S., with roughly 27,000 serving local patients and doctors directly.

Recently, a story of a compounding pharmacy error made headlines when it resulted in severe injuries to a healthy 54-year-old man, who ultimately lost his leg due to the error. According to a local news report covering the incident, the patient was regularly active, working out regularly and playing sports. To help his muscles recover from his workouts, he took injections of an amino acid drug from a compounding pharmacy. After ten months of taking the injections with no problem, he woke up one day drenched in sweat, with a raging fever and swollen leg. It turned out that he had mycobacterium abscesses growing in his leg, which is very rare and hard to treat.

The patient had to undergo 23 different surgeries over five months and was put on five different antibiotics, which caused rashes and nausea. He also began to experience a ringing in his ear, and was told by his doctor that he had to choose between saving his leg and saving his hearing, because he needed the antibiotic causing the ringing to save his leg. He decided to save his leg, because he wanted to continue to be active, but now lives with impaired hearing.

Maryland Medication Errors at Compounding Pharmacies

August 6, 2019 | Lebowitz & Mzhen

When most patients need prescription medication, their doctor can write a prescription that can be filled by the patient at any pharmacy. However, for patients with allergies or sensitivities, or for those who cannot take a standardized drug, compounding pharmacies create specific medications catered to a patient’s individual needs. While compounding pharmacies help a lot of patients, patients of these pharmacies are at an increased risk of falling victim to a Maryland pharmacy error.

Given the niche patient-base they serve, compounding pharmacies are necessary. However, there are some serious safety concerns with these pharmacies. For instance, the medications that compounding pharmacies create are not subject to FDA testing or approval. This lack of oversight increases the chance of a serious pharmacy error.

Recently, a woman ended up with a large hole in her arm as a result of an error made by a compounding pharmacy. According to a local news report, the woman developed a seizure disorder in 2014. Due to other medical issues, she could not take a standard medication, and so her doctor prescribed a B-12 shot that was to be filled by a local compounding pharmacy. For years, the woman took the medicine as specified with no issues.

Maryland Pharmacy Errors at Compounding Pharmacies

May 21, 2019 | Lebowitz & Mzhen

Most Maryland pharmacies receive medication from a manufacturer or reseller and then fill prescriptions as patients present them. For the most part, pharmacies are not responsible for creating the medications that they provide to patients. Some patients, however, have unique needs that are not met by commercially available drugs. For example, a young child may need a very small dose of a medication that is only available in adult doses, or a patient may be allergic to a particular ingredient in a medication.

While compounding pharmacies fill a much-needed role for some patients, they also present unique risks. Generally, compounding pharmacists attempt to mimic the effects of a particular medication while making some adjustments to the formulation. Because compounding pharmacies create custom prescriptions for patients on an as-needed basis, their product is not FDA-tested or approved.

A recent news report discusses a compounding pharmacy medication error that nearly claimed the life of the patient who thought she was taking the medication as directed. Evidently, the patient suffered from a rare disease called Hashimoto’s disease, a condition in which a patient’s immune system attacks the thyroid, resulting in insufficient hormone levels. As a result of her condition, the woman was prescribed thyroid medication by her physician.