Read about how to prevent medication errors and improve patient safety related to the use of nifedipine. Also in this issue: recent trends in patient safety data and the effect of AI on events and analysis, the impact of language barriers on patient safety in Pennsylvania, and more.
Nifedipine Errors and Serious Patient Harm: Insights From the Pennsylvania Patient Safety Reporting System and Potential Mitigation Strategies
The Patient Safety Authority (PSA) has received multiple reports in recent years via the Pennsylvania Patient Safety Reporting System (PA-PSRS) describing serious events involving nifedipine that resulted in serious patient harm, including death. Nifedipine is a dihydropyridine calcium channel blocker that dilates cardiac and smooth muscles to reduce peripheral vascular resistance, decrease systemic blood pressure, and increase oxygen delivery to the heart.1-3
Immediate-release (IR) formulation of nifedipine (e.g., Procardia) is currently available but no longer commonly used due to its potential to cause excessive reductions in blood pressure and other serious adverse events such as change in neurological status, myocardial infarction, and death.1,4-6 The U.S. Food and Drug Administration (FDA) and its committee have issued multiple warnings over the years about its potential adverse cardiovascular effects and recommended against its use to lower blood pressure.6,7 Currently, nifedipine IR is available in capsules and FDA-approved only for the treatment of vasospastic angina and chronic stable angina.1
To mitigate the adverse effects associated with the IR formulation, the extended-release (ER) formulation (e.g., Procardia XL) was designed for a more sustained drug delivery and once-daily administration. Currently, nifedipine ER is available in tablets, which should not be crushed, divided, or chewed.2,8 Inappropriate crushing of nifedipine ER, which rapidly releases the total daily dose, is associated with documented fatality.9 In 2018, PSA described a patient who experienced hypotension and lethargy, and required intubation and resuscitation after receiving inappropriately crushed nifedipine ER.10
The following examples of medication errors involving nifedipine have been reported to PA-PSRS in recent years.*
- Inappropriate prescribing, ordering, or administration of the IR formulation
Patient who was taking 30 mg [milligrams] of nifedipine ER for chronic hypertension presented to L&D [labor and delivery] triage and was inadvertently given 30 mg of nifedipine IR. Due to the onset of tachycardia and the patient’s past medical history, the patient was treated with activated charcoal and fluids, and required admission for further monitoring.
Patient was inadvertently ordered 30 mg of nifedipine IR instead of nifedipine ER. Patient subsequently experienced a drop in blood pressure and change in neurological status necessitating treatment with calcium gluconate and fluids. Patient who was on nifedipine ER 90 mg daily at home had the medication regimen erroneously changed to nifedipinen IR 30 mg three times daily. Patient experienced drops in blood pressure that correlated with the administration times of nifedipine IR doses.
- Inappropriate alteration (crushing, splitting, dividing, chewing) of the ER-formulation
Nifedipine ER 90 mg was erroneously crushed, mixed in apple sauce, and administered to the patient. It was not recognized that this was an extended-release formulation that should not be crushed. A rapid response was called when the patient was found obtunded. Despite pharmacological interventions, transfer to ICU, and cardiac resuscitation, the patient passed away.
After intubation, patient’s nifedipine ER 60 mg was not changed to accommodate the new route of administration via gastric tube. A nurse then crushed the ER tablet and administered it through the gastric tube despite the administration instructions “do not crush.” The patient became severely hypotensive with systolic blood pressure in the 60s and required norepinephrine infusion.
Facilities can mitigate the risk of nifedipine-related errors by implementing the following safety strategies.
- Restrict the accessibility, ordering, and dispensing of nifedipine IR exclusively to patient care areas with approved protocols (e.g., obstetric units).11
- Implement mandatory educational initiatives to educate and remind the providers that the IR formulation of nifedipine should never be substituted for the ER formulation to treat hypertension.1
- Mandate the use of full drug names by spelling out “Immediate-Release” and “Extended-Release” in the electronic health record (EHR) and automated dispensing cabinet (ADC).12 Consider adding descriptions such as “SHORT acting” or “LONG acting” to the product names to minimize confusion between formulations.12
- Require pharmacy verification of all nifedipine orders prior to dispensing and administration.11
- Implement multilayered warnings and alerts throughout the EHR and ADC to caution the user that nifedipine ER tablet should not be crushed, divided, or chewed.10,11
- Establish a standardized procedure to identify and document patients with existing feeding tubes and those with newly inserted enteral feeding tubes to minimize the risk of inappropriate alteration and administration of nifedipine ER.10
- Review the facility’s formulary and implement procedures to ensure that modified-release dosage forms, such as the extended-release and delayed-release dosage forms, are never altered before they are administered to patients.8,10,13
- Mandate the use of barcode medication administration (BCMA) technology to confirm the details of the medication prior to administration.10
- Consider formally designating nifedipine product(s) as high alert medication(s) based on facility-specific risk assessment findings and implement corresponding practices to prevent patient harm resulting from medication errors (e.g., preventing the override capability).
- Provide ongoing education to both providers and patients regarding the safe use of nifedipine and potential risks associated with it.10,11
The use of nifedipine IR in current practice is limited due to its potential to cause fluctuations in blood pressure and other adverse effects. To mitigate these risks, facilities should restrict access to nifedipine IR and reserve its use for specific, facility-approved indications and designated clinical areas. Furthermore, it is important to note that inappropriate alteration of nifedipine ER, such as crushing, splitting, or chewing, can result in the rapid release of the entire dose and increase the risk of severe patient harm. We encourage facilities to reassess their processes, implement risk mitigation strategies, and take proactive steps to prevent medication errors and improve patient safety related to the use of nifedipine.
References
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NIH National Library of Medicine. Label: NIFEDIPINE capsule. Dailymed.https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0cc236dc-95fa-49ccaeb8-6590de157585. Updated September 13, 2018. Accessed December 3, 2025.
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NIH National Library of Medicine. Label: PROCARDIA XL- nifedipine tablet, film coated, extended release. Dailymed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36- 9f94-9774b2a59e06. Updated December 16, 2025. Accessed December 23, 2025.
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Khan KM, Patel JB, Patel P. Nifedipine. In: StatPearls [Internet]. StatPearls Publishing; 2025.
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Furberg CD, Psaty BM, Meyer JV. Nifedipine. Dose-Related Increase in Mortality in Patients With Coronary Heart Disease. Circulation. 1995;92(5):1326-31. doi:10.1161/01.cir.92.5.1326; PubMed PMID: 7648682
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Burton TJ, Wilkinson IB. The Dangers of Immediate-Release Nifedipine in the Emergency Treatment of Hypertension. J Hum Hypertens. 2008;22(4):301-2. doi:10.1038/sj.jhh.1002324; PubMed PMID: 18239624
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Means L, Benken ST, Tesoro EP. Safety of Immediate-Release Nifedipine. J Cardiovasc Pharmacol. 2016;68(5):395-9. doi:10.1097/fjc.0000000000000425; PubMed PMID: 27525576
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Miller JL. FDA Committee Recommends Stronger Warnings Against Inappropriate Use of Immediate-Release Nifedipine. Am J Health Syst Pharm. 1996;53(6):599-600. doi:10.1093/ajhp/53.6.599; PubMed PMID: 8800958
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Therapeutic Research Center. Clinical Resource, Meds That Should Not Be Crushed. Pharmacist's Letter/Pharmacy Technician’s Letter/Prescriber Insights. Updated April 2025.
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Schier JG, Howland MA, Hoffman RS, Nelson LS. Fatality from Administration of Labetalol and Crushed Extended-Release Nifedipine. Ann Pharmacother. 2003;37(10):1420-3. doi:10.1345/aph.1D091; PubMed PMID: 14519033
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Ingram V, Gaunt MJ, Grissinger M. The Breakup: Errors When Altering Oral Solid Dosage Forms. Pa Patient Saf Advis. 2018;15(3).
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Billstein-Leber M, Carrillo CJD, Cassano AT, Moline K, Robertson JJ. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health-Syst Pharm. 2018;75:1493-617. doi:10.2146/ajhp170811; PMID: 30257844
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Shultz J, Strosher L, Nathoo SN, Manley J. Avoiding Potential Medication Errors Associated With Non-intuitive Medication Abbreviations. Can J Hosp Pharm. 2011;64(4):246-51. doi:10.4212/cjhp.v64i4.1036; PubMed PMID: 22479066; PubMed Central PMCID: PMCPMC3161798
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Klang MG. Developing Guidance for Feeding Tube Administration of Oral Medications. JPEN J Parenter Enteral Nutr. 2023;47(4):519-40. doi:10.1002/jpen.2490; PubMed PMID: 36847617; PubMed Central PMCID:PMCPMC10508335
Recent Trends in Patient Safety Data and the Effect of AI on Events and Analysis
Rebecca Jones, MBA, RN, director of Data Science & Research, Patient Safety Authority, recently spoke with Betsy Lehman Center for Patient Safety's Patient Safety Beat about the value of collecting data about events, incidents, and near misses, as well as how AI is being used to analyze this data and the potential impact of this emerging technology on patient safety and event reporting.
“For example, we recently conducted research on falls that occur on the day of discharge,” Jones says. “Having reports of both incidents and serious events allowed us to uncover a threat that had not been identified in any previous research.”
Read, watch, and share the interview at betsylehmancenterma.gov/news/rebecca-jones-on-recent-trends-in-patient-safety-data-and-the-effect-of-ai-on-events-and-analysis
Just Published in Patient Safety
The Impact of Language Barriers on Patient Safety in Pennsylvania: A Review of 336 Patient Safety Events
Communication during a medical encounter can be challenging, even when both the patient and their healthcare provider speak the same native language. So, imagine the added difficulty of discussing symptoms, diagnoses, and treatment when there’s a language barrier. Research shows that such communication issues can lead to longer hospital stays, greater risk of falls, delayed diagnosis and treatment, medication errors, and even death. An analysis of safety events reported in Pennsylvania—where more than 1.4 million residents speak a non-English language at home and more than 500,000 have limited English proficiency—reveals that language barriers continue to pose a risk to patient safety, despite policies requiring certified interpreters and translated materials be available to patients who need them.
Patient Safety Authority researchers identified 336 events reported to the Pennsylvania Patient Safety Reporting System (PA-PSRS) in 2024 relating to language barriers. The two languages most commonly involved in these reports were Spanish and Nepali, with issues including the lack of a certified interpreter, the lack of translated materials, and materials with inaccurate or incomplete translations. This study closely examines the interpretation and translation challenges faced by Pennsylvania patients and providers, and how they affect patient safety. It also provides strategies and recommendations for facilities to supplement available language services, such as hiring staff bilingual in English and the common languages of the service area and explaining common procedures with visual aids and pre-translated materials.
Lessons From Event Reports
Reducing Risk of Compounding Medication Errors
As part of a facility’s efforts to become a high reliability organization (which maintains high levels of safety, quality, and efficiency) to achieve zero patient harm, they turned their attention to addressing reports of medication errors related to preparing intravenous (IV) products. The standard practice at the root of the problem was that the preparer pulled back the syringe after completing the preparation to indicate the volume added, with no way to assure that the volume added agrees with the amount indicated in the pulled back syringe and that the correct amounts of each drug have been used.
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