The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as a “preventable event that may cause or lead to inappropriate medication use or patient harm”. It can occur while the product in question is being handled by a patient, physician, or clinician. Over 100,000 reports of suspected medication errors are received by the U.S. Food and Drug Administration (FDA) every year. Consumers, manufacturers, and healthcare professionals can report such events through the FDA’s MedWatch system.
A prescription drug error can result in an adverse drug event (ADE) such as hospitalization, disability, birth defects, life threatening situations, and death due to an issue with:
- Drug prescription
- Order communication
- Product labeling
- Drug packaging
- Patient use
A prescription drug error can occur at any point from when a medication is manufactured to when it is prescribed or in use by the patient. It may involve the commissioning of a prescription or omission of information.
The FDA carefully evaluates medications before they go on the market with the goal of reducing medication errors. Information is analyzed to determine if it should be revised in cases where proposed proprietary names can lead to confusion among product names. The agency also oversees container labels to ensure drugs in multiple strengths can be easily identified via bold numbering or lettering or with different colors. Directions for prescribing, preparing, and using a drug must also be accurate and legible.
In a general sense, an ADE does not always mean a patient has received poor care or there was a mistake. If a medication error reaches the patient, the event is said to be preventable (covering about half of ADEs). Potential ADEs are errors that don’t harm the patient because they were discovered before administration or out of sheer luck, while an ameliorable ADE is when the patient was harmed and the situation could have been mitigated.
However, an ADE can occur even if a prescription drug is prescribed and administered properly. These nonpreventable ADEs are more commonly referred to as side effects.
Because there are so many variables and different circumstances of ADEs, prescription drug errors come with various legal challenges. Nearly 700,000 emergency department visits and 100,000 hospitalizations are related to ADEs occur every year.
Consumers can protect themselves by knowing these risk factors:
- Taking more medications than necessary
- Elderly patients, who are more vulnerable to adverse effects
- Children, who are sensitive to dosages per body weight
- Patient literacy and numeracy
- Errors made by ambulatory patients or their caregivers
- Medications, with dangerous side effects, that look- and sound-alike
Clinicians can also prevent prescription drug errors by taking care when ordering a medication and when transcribing a paper-based prescription. Pharmacists can check for drug interactions and allergies as well as the correct form and quantity of a medication. In a hospital setting, nurses and other staff must provide the correct medication to the right patient at the right time.
Legal Consequences of Prescription Drug Errors
The legal consequences of a drug error include civil action, medical board discipline, and criminal charges against a physician. Prescription drug errors are one of the top 10 reasons for physicians to be sued for malpractice, according to the Texas Medical Liability Trust. If you or a loved one have been the victim of medical malpractice, The Law Offices of Jacob Emrani can help. Our experienced team can determine who is liable for a prescription drug error. Call us at 888-952-2952 for a no-cost evaluation.