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Based on record review and interview, the Hospital failed to ensure that that one Pharmacist informed the Physician regarding a potential high alert potential adverse drug reaction between Zocor and Clarithromycin for one of one sampled patient (Patient).

Findings included:

The physician order sheet, dated 3/10/10, included Zocor (Simvastatin) 80 milligrams (mg) daily.

The Pharmacy Medication Computer check sheet that was completed by the Pharmacist indicated that on 3/12/10, the Patient had an order for Clarithromycin 500 mg twice per day. The Pharmacy Medication Computer check sheet indicated that there was one interaction/incompatibility with Clarithromycin and Simvastatin. The Pharmacy Medication Computer check sheet indicated that there was no comment entered in the section titled Interaction Comment. The Pharmacy Medication Computer check sheet indicated that there was no comment entered in the section titled Order Override.

The Pharmacist was interviewed on 5/19/10, at 11:04 A.M. The Pharmacist said on 3/12/10, this Pharmacist entered the order for Clarithromycin into the Meditech System, which connected with the Pyxis system. The Pharmacist said although the alert on the computer screen indicated that there was a potential high adverse reaction from Simvastatin and Clarithromycin, this Pharmacist did not alert the hospitalist or physician, did not obtain an override for the Simvastatin, and the Clarithromycin was dispensed for the Patient

The Pharmacy Director was interviewed on 5/19/10, at 9:00 A.M. The Pharmacy Director said the only person, who had access to the potential high and medium drug alerts was the pharmacist, who entered the medication into the Pyxis system. The Pharmacy Director said the Pharmacist did not notify the Physician regarding the high alert potential drug reaction between Simvastatin and Clarithromycin and did not obtain an override for the Clarithromycin, prior to dispensing the Clarithromycin per the Hospital protocol regarding the potential adverse drug reactions.

The Pharmacy Director said there were 26,000 high drug alerts generated within the last 6 months at the 2 hospital campuses. The Pharmacy Director said some of the potential drug alerts involved potential adverse reactions between Coumadin and aspirin, which were routinely overridden by the physicians for cardiac patients. The Pharmacy Director said adverse drug reactions were monitored through the Hospital's Quality Assurance program.

Based on record review and interview, the Hospital failed to ensure that the potential high adverse drug interaction between Zocor (Simvastatin) and Clarithromycin was reported to the Physician per the Hospital protocol and an order to override the Clarithromycin was not obtained prior to dispensing the medication.

Findings included:

The Medication Review policy indicated that all medication orders underwent a formal professional review process prior to administration to the patient. The policy indicated that all medications were screened for possible drug interactions.

The Hospital History and Physical report, dated 3/10/10, indicated that the Patient had dark stools for one week and most likely had a gastrointestinal bleed. The Hospital History and Physical report indicated that the Patient's medications included Zocor (Simvastatin) 80 milligrams (mg).

The Medical Student's progress note, dated 3/12/10, indicated that the Patient had Helicobacter Pylori (H Pylori).

The physician order sheet, dated 3/12/10, included the ant-infective medications, Clarithromycin 500 mg twice per day and Amoxicillin 1 gram twice per day to treat H-Pylori.

The Primary Care Physician was interviewed on 5/24/10, at 2:30 P.M. The Primary Care Physician said although this Primary Care Physician was the Patient's Primary Care Physician in the community, this Primary Care Physician did not order the Clarithromycin and was not aware the Patient received Clarithromycin and Simvastatin until the Patient was readmitted to the Hospital.

The Primary Care Physician said this Primary Care Physician observed interactions between Zocor and Clarithromycin with other patients, prior to the Patient's admission to the Hospital that included severe muscle weakness and rhabdomyolysis, and therefore, was aware of the potential adverse effects from taking the 2 medications together. The Primary Care Physician said physicians, who had not observed adverse effects from the 2 medications taken together would probably not be aware of the potential adverse effects. The Primary Care Physician said the physicians relied on the pharmacists at the Hospital to inform them regarding potential adverse effects from medications. The Primary Care Physician said this Primary Care Physician's practice would most likely be to stop the Zocor while the Patient received the Clarithromycin.

The Pharmacy Medication Computer check sheet that was completed by the Pharmacist indicated that on 3/12/10, the Patient had an order for Clarithromycin 500 mg twice per day. The Pharmacy Medication Computer check sheet, indicated that there was one interaction/incompatibility with the Clarithromycin and Simvastatin. The Pharmacy Medication Computer check sheet, indicated that there was no comment entered in the section titled Interaction Comment. The Pharmacy Medication Computer check sheet, indicated that there was no comment entered in the section titled Order Override.

The Pharmacist was interviewed on 5/19/10, at 11:04 A.M. The Pharmacist said when entering medication orders into the Meditech system, many red alerts (potential for high drug reactions) were identified on the computer screen. The Pharmacist said the protocol was to page or call the hospitalist or physician, alert the person to the drug alert, and obtain an override to dispense the medication or discontinue or change the medication per the hospitalist or physician. The Pharmacist said the notification of the hospitalist or physician was to be documented in the computer and the override for the medication was to document in the computer. The Pharmacist said the hospitalist or physicians often did not return this Pharmacist's calls regarding potential adverse drug reactions.

The Pharmacist said on 3/12/10, this Pharmacist entered the order for Clarithromycin into the Meditech system. The Pharmacist said although the alert on the computer screen indicated that there was a potential high adverse reaction from Simvastatin and Clarithromycin, this Pharmacist did not alert the hospitalist or physician, did not obtain an override for the Simvastatin, and the Clarithromycin was dispensed for the Patient.

The Pharmacy Director was interviewed on 5/19/10, at 9:00 A.M. The Pharmacy Director said although there was not a formal policy regarding notification of a physician regarding potential adverse drug reactions, the Pharmacy practice entailed notification of the physician regarding all high potential drug reactions and obtaining an override for the drug from the physician prior to dispensing the medication or obtaining an order from the physician to discontinue or change the medication. The Pharmacy Director said the Pharmacist's documentation on the Pharmacy Medication Computer check sheet did not indicate that the Physician was notified regarding the potential high adverse reaction from Simvastatin and Clarithromycin and did not indicate that the Physician gave an override for the Clarithromycin to be dispensed to the Patient. The Pharmacy Director said the Pharmacist did not follow the Pharmacy protocol.

The Primary Care Physician said sometimes the benefit of a medication outweighed the risk of the medication. The Primary Care Physician said in such in such instances, the patient/responsible person were to be informed of potential side effects from taking medications prior to being administered the medications.

There was no evidence in the Patient's clinical record that the potential adverse effects with Clarithromycin and Zocor were discussed with the Patient or the family.

The Pharmacy Director said the only person, who had access to the screen on the computer indicating a potential adverse drug reaction with Simvastatin and Clarithromycin was the Pharmacist, who entered the drug into the Meditech system. The Pharmacy Director said the physician and nurses did not have access to that information.

The Hospital Discharge summary, dated 3/14/10, indicated that the Resident received Simvastatin 80 mg daily. The Hospital Discharge summary indicated that the Resident was started on clarithromycin 500 mg daily and Amoxicillin 1000 mg twice per day for a total of 14 days (stop date 3/25/10). There was no information in the Discharge summary regarding a potential adverse drug reaction of muscle weakness with Simvastatin and Clarithromycin or that the Hospital Physician was aware of the potential drug reaction and had given an override for the Patient to receive the medications.

The Skilled Nursing Facility (SNF) nurse's note, dated 3/14/10, indicated that the Patient was admitted to the SNF.

The SNF's Occupational Therapist's Plan of Treatment, dated 3/15/10 and the Physical Therapist's Plan of Treatment, dated 3/15/10, indicated that the Patient: was able to complete all bathing tasks requiring close supervision while standing at the sink; was able to complete all dressing tasks while standing with close supervision; was able to achieve balance on the toilet/commode utilizing no assistive device with stand by assistance; was able to safely perform all functional transfer activities requiring close supervision, and ambulated with close supervision.

The SNF Change in Condition note, dated 3/29/10, indicated that the Resident had increased bilateral lower leg weakness, required maximum assistance form 2 staff members for transfer activities, and the Family Member said the increased weakness occurred over the weekend. The Change in Condition note indicated that the Physician was notified and the Resident was transferred to the Hospital for an evaluation.

The Medication Reconciliation Order form, dated 3/29/10, indicated that the Simvastatin 80 mg daily was discontinued.

The Primary Care Physician's Consultation report, dated 3/30/10, indicated that the Patient's clinical presentation was highly suggestive of proximal myopathy likely related to statin therapy. The Primary Care Physician's Consultation report indicated that the Patient received Clarithromycin recently for H Pylori infection. The Primary Care Physician's Consultation report indicated that there was a potential interaction between macrolide antibiotics (especially Clarithromycin and Erythromycin) and statin medications that could affect the metabolism of the statin, and thus cause statin-induced myopathy. The Primary Care Physician's report indicated that the interaction was more severe with Simvastatin.