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Medication Safety Roundtable - Dilantin: Pharmacy/nurse errors lead to fatal ADE Dilantin: Pharmacy/nurse errors lead to fatal ADE Snapshot: Make sure that Dilantin is prepared in your pharmacy, that the drug’s concentrationand administration rate are standardized, and that nurses check physician orders beforeadministering it. You otherwise may face the same problems Alameda (Calif.) County MedicalCenter did: a patient fatality, a state fine, numerous potential RFIs, and embarrassing publicity.
Below: Specific pharmacy and nursing errors at the hospital, the hospital’s corrections and lessonslearned.
Read the actual Statement of Deficiencies and Plan of Correction.
Dilantin is a high-alert drug rife with ADE potential. Failure to perform first-dose review, prepare thedrug in the pharmacy, or administer it according to a doctor’s order may lead to patient death,government fines and potential RFIs, as Alameda (Calif.) County Medical Center’s Highland Hospital,236 beds) recently found out.
A patient at the hospital died Oct. 7, 2009 after a nurse administered 1 gram of Dilantin by intravenouspush within 5 minutes. The drug “should have been given slowly over an hour as ordered by thephysician,” according to the California Dept. of Public Health. The ImmediateJeopardy condition cost the medical center $75,000 in an administrative fine “noncompliance withlicensing requirements (that) has caused, or was likely to cause, serious injury or death to patients.” A patient with a history of hypertension and end stage renal disease, identified by the state as Patient14, was admitted to the hospital Oct. 5 for sudden shortness of breath and chest pain. Whileundergoing hemodialysis two days later, the patient experienced seizures, high blood pressure andlung congestion that required intubation and a transfer to the ICU. A physician’s order specificallystated to “'give 1 gm (gram) Dilantin over 1 hr (hour). IV (into the blood through a vein access), don’tpush quickly,'” the Statement of Deficiencies says.
The nurse pushed the full 1 gram dose into the patient’s vein in 5 minutes.
Six minutes after the Dilantin was given, the Statement continues, “Code Blue was called in theintensive care unit” because the patient developed bradychardia (heart rate less than 60 per minute)with PEA (pulse less electrical activity of the heart). The resuscitation efforts failed….there was noheart activity. Patient 14 died at 10:24 p.m.” Aside from the fact that a drug intended to be administered over one hour was instead administeredin five minutes, multiple errors occurred during this incident, as the Statement of Deficiencies pointsout and medication safety and accreditation experts tell the Medication Safety Roundtable. Some ofthese are likely RFIs. Best practices ould have been used to avoid most. Here is a rundown: Mix all compounded IVs, high-risk drugs in particular, in the pharmacy. Failure to do so is aviolation of Joint Commission standard MM.05.01.07, EP 1 (A pharmacist, or pharmacy staff under the supervision of a pharmacist, compounds or admixes all compounded sterilepreparations except in urgent situations…). The hospital pharmacy instead had instructed thenurse to mix four ampoules of Dilantin 250 mg in a 250 ml bag of saline.
“If the pharmacy is open 24 hours, Dilantin should only be stocked in the pharmacy and thepharmacy should prepare all IV Dilantin solutions,” says Phil Klein, managing consultant,Pharmacy Healthcare Solutions, Solano Beach, Calif. “If the pharmacy is not open 24 hours, thepharmacist should be called in to mix the drug or if that is not possible, the drug should bestocked in the afterhours storage locations with the appropriate instructions, labels, auxiliarylabels, drug and IV bag, and require the order be double-checked by the nurse supervisor and www.medsafetyroundtable.com/templates/PrintArticle.aspx?DN=bf55355a-ec76-4927-b437-a1518c61afdc Medication Safety Roundtable - Dilantin: Pharmacy/nurse errors lead to fatal ADE labels, drug and IV bag, and require the order be double-checked by the nurse supervisor andthe nurse.”Perform first-order review. This basic medication safety requirement can be found in JointCommission standard MM.05.01.01, EP1 (…a pharmacist reviews all medication orders orprescriptions). “It was identified that the order written…was not reviewed by pharmacy…,” themedical center says in its Plan of Correction. The Statement of Deficiencies notes that “during aninterview on 11/19/09 at 9:30 a.m., the Director of Pharmacy acknowledged that Dilantin orderfor Patient 14 was not reviewed in advance of administration as required by the [hospital’s own]current policy and procedure on medication administration. There was no evidence that thepharmacy received and reviewed the scanned physician’s order for Dilantin….”Review and follow the medication order. The nurse who administered the Dilantin “failed toreview and follow the physician’s order to give Dilantin over an hour,” the Statement ofDeficiencies says. This is a violation of MM.05.01.07 (Medications are prepared and administeredin accordance with the orders of a licensed independent practitioner responsible for thepatient’s care…).
Standardize drug concentration and administration rate. This should be true for all IV drugs,not just Dilantin, says Klein, who adds that “their concentration, total volume and rate ofadministration should be readily available for reference on the patient care units.” Failure tostandardize drug concentrations violates MM.02.01.01, EP 6 (The hospital standardizes andlimits the number of drug concentrations available to meet patient care needs).
“There should be a hospital-approved list, through the P&T committee, that identifies the IVmedications acceptable for use in the hospital, who is authorized to administer them, thedilation that is required, the rate at which it can be administered, and any other cautions,” saysPatricia Kienle, director of accreditation and medication safety for Cardinal Health. She adds thatdissemination of the information “cannot be a stealth process” and should be formalized intopolicy that is regularly updated, with the date of the last update visible.
In the case at Alameda County Medical Center, the Statement of Deficiencies shows confusionbetween the nurse and the pharmacist involved as to how the Dilantin was to have beenadministered, each providing the state surveyor with a different version of what happened. Thenurse told the surveyor “she called the pharmacy and requested the pharmacy to mix Dilantin ….
the pharmacist instructed her to get ampoules of Dilantin 250 mg from the Pyxis and give themedication IV, without any recommendation on how to give it.” ’It shouldn’t have happened. I shouldn’t have listened to the pharmacist, and it didn’t soundright to give four vials IV push. I should have refused,’” the nurse, who the medical center sayshas since been placed on Do Not Return, told the surveyor.
The pharmacist told the surveyor the she instructed the nurse to mix the four Dilantin ampoulesin a 250 mg. bag of saline and use a 22 micron filter when administering it. The pharmacist,however, “failed to indicate the rate of administration,” the Statement of Deficiencies says.
Calls to the hospital’s chief quality officer, director of pharmacy, and the office of the director of nursingfrom The Roundtable were not returned.
Among the steps Alameda County Medical Center’s says it will take to correct the deficiencies are thefollowing: Add Dilantin to its high-risk medication policy and re-educate nurses.
All Dilantin will now be mixed in the pharmacy.
Remove Dilantin from Pyxis ADCs, since it will now always be prepared in the pharmacy.
Ensure that pharmacy will review Dilantin orders before administration.
The pharmacy will label Dilantin with the drug name, dose, route and administration rateICU will conduct 12-hour chart checks for nursing to check all medication administration records(MAR)for complete drug information, including drug, dose, route and rate of administration, aswell as compare the MAR to the physician’s orders. Nursing will review 30 charts each month todo the same.
Joint Commission compliance: Proper selection, preparation, review and administration ofDilantin address Joint Commission standards MM.02.01.01, EP 6 (The hospital standardizesand limits the number of drug concentrations available to meet patient care needs);MM.05.01.01, EP1 (…a pharmacist reviews all medication orders or prescriptions); andMM.05.01.07 (Medications are prepared and administered in accordance with the orders of alicensed independent practitioner responsible for the patient’s care…), in particular EP 1 (Apharmacist, or pharmacy staff under the supervision of a pharmacist, compounds or admixesall compounded sterile preparations except in urgent situations…).
www.medsafetyroundtable.com/templates/PrintArticle.aspx?DN=bf55355a-ec76-4927-b437-a1518c61afdc Medication Safety Roundtable - Dilantin: Pharmacy/nurse errors lead to fatal ADE For more best practices on preparation of medications, visit the Copyright 2013 DecisionHealth. All rights reserved.

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