Pharmacy Error Injury Lawyer Blog
Prescription errors can have devastating consequences, particularly when they involve compounded medications that do not undergo the same rigorous testing as FDA-approved drugs. A recent JAMA study highlights growing concerns about compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs), which have surged in popularity due to their effectiveness in treating diabetes and promoting weight loss. While compounding pharmacies play an important role in customizing medications for individual needs, errors in this process can result in serious health risks.
Understanding the risks associated with compounded drugs is essential for Maryland patients who rely on pharmacies to provide safe medications. When a pharmacy makes an error with a compounded medication, patients may suffer severe side effects, incorrect dosages, or exposure to harmful contaminants. Legal options exist for those harmed by prescription mistakes, but proving liability requires an experienced attorney who understands the regulations surrounding Maryland pharmacies and compounded drugs.
Understanding Compounded Medications and Their Purpose
Compounded drugs differ from standard prescriptions because they are custom-made rather than produced in large batches by pharmaceutical manufacturers. Traditional compounding pharmacies create medications for individual patients by adjusting ingredients, modifying dosage forms, or removing allergens. These services are intended to improve patient access, particularly when commercial drugs contain substances that cause allergic reactions or when alternative administration methods are needed.
However, compounding laws shift when a medication appears on the FDA drug shortage list. The JAMA study highlights how the shortage of GLP-1 RAs, including semaglutide, tirzepatide, dulaglutide, and liraglutide, has fueled an increase in compounded versions of these medications. While compounding pharmacies are allowed to produce copies of brand-name drugs during shortages, their safety and effectiveness are not regulated the same way as FDA-approved products. Patients receiving these versions may unknowingly be exposed to incorrect formulations, unverified dosages, or improper storage conditions.
Are Pharmacy Errors Common with Compounded Medications
Pharmacy mistakes involving compounded drugs increase the risk of serious harm. Unlike commercially produced medications, which undergo extensive testing and FDA oversight, compounded drugs are prepared in small batches or even single doses, making quality control more difficult.
Errors that commonly occur with compounded prescriptions include:
Incorrect dosages. Miscalculations in mixing medications may result in a dose that is too strong or weak.
Contamination. If a compounding facility fails to follow proper sterilization procedures, bacteria or fungi may enter the medication. The 2012 New England Compounding Center case resulted in 64 deaths due to contaminated drugs.
Unverified active ingredients. Some compounding pharmacies source ingredients from unreliable suppliers, increasing the risk of unsafe medications.
Labeling mistakes. When instructions or dosage amounts are incorrect, patients may unknowingly take the wrong amount or administer the drug improperly.
For individuals prescribed compounded GLP-1 RAs or any other medication, pharmacy errors can lead to serious side effects, hospitalization, or long-term health complications.
The Lack of Oversight for Compounded Drug Advertising
Compounded drugs operate in a regulatory gray area, particularly regarding marketing. The JAMA study notes that compounding pharmacies promoting GLP-1 RAs for weight loss are engaging in aggressive advertising strategies. Unlike pharmaceutical companies, which must comply with strict FDA marketing rules, compounding pharmacies face far fewer restrictions when promoting their products online.
Concerns about misleading marketing include:
Unverified safety claims. Compounding pharmacies may reference the FDA-approved label of the original drug, even though compounded versions do not meet the same manufacturing standards.
Lack of quality assurance. Patients may assume these medications are identical to brand-name versions despite the differences in formulation, potency, and purity.
Influencer endorsements. Some companies use social media influencers to promote compounded medications, creating demand for drugs that may not be appropriately tested or regulated.
Patients who suffer harm from these compounded versions may have legal claims against the compounding pharmacy, prescribing healthcare provider, or online distributor that marketed the product without disclosing potential risks.
What to Do If a Pharmacy Error Caused Harm
Patients who experience adverse effects from a compounded medication should take immediate action to protect their health and legal rights. If a pharmacy mistake, misfiled prescription, or mislabeled medication caused harm; the following steps can help build a strong case:
Seek medical attention. Document all symptoms and obtain records showing incorrect medication, dosage, or contamination.
Preserve evidence. Keep the prescription bottle, label, and pharmacy records in case they contain errors.
File a complaint. Report the incident to Maryland’s Board of Pharmacy and the FDA’s MedWatch program to help prevent future mistakes.
Consult with a Maryland pharmacy error attorney. A lawyer can review pharmacy records, consult with medical experts, and determine who should be responsible for the harm caused.
As demand for GLP-1 RAs and other medications grows, pharmacy safety concerns will only increase.
Contact the Dedicated Maryland Injury Lawyers at Lebowitz & Mzhen to Learn More
If you or a loved one was recently injured due to another’s negligence, it’s important you take a few minutes to learn about your rights and what you can do to hold the at-fault party accountable. At Lebowitz & Mzhen, we have decades of combined experience handling all types of personal injury, wrongful death, and medical malpractice lawsuits on behalf of clients throughout Maryland and Washington, D.C. To learn more and to schedule a free consultation today, give us a call at 800-654-1949. You can also connect with us through our secure online contact form.