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Based on observation, staff interview and review of pharmacy records including policies and procedures, for 2 of 36 drugs/biologicals identified by the pharmacy to be in critical shortage, (1) Trace Elements and (2) Sodium Phosphate, both considered to be mineral salts and/or mineral products, the pharmacy failed to ensure these outdated drugs were not available for patient use, which involved, (1) observation during survey of 6 of 31 vials of outdated " Multitrace Concentrate " (Trace Elements) in a compounding area for intravenous (IV) mixtures of current patients on 08/13/13 (25 of the 31vials were observed outside of the compounding area) and, (2) observation of computerized photography (DoseEdge) along with pharmacy confirmation that 32 of 48 patients (Patients #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34, #35, #36, #37, #38) received outdated Sodium Phosphate on 23 of 66 days from 06/01/13 - 08/05/13.

Findings include:

For clarification, several trace elements are required in specific amounts by the human body, and when these are depleted due to illness and/or disease, they must be replaced which is usually accomplished through the addition of minerals and/or mineral salts administered orally or by IV. Sodium and phosphorus are chemical elements which, together in a mixture, form the salt called Sodium Phosphate.

Review on 08/13, 14, 15, 20/13 included the following pharmacy policies and procedures:

Policy # 730.02.20, Pharmacy and Therapeutics Committee, with an effective date of 07/14/11 included, "...A Pharmacy and Therapeutics Committee, whose membership will consist of at least two members of the medical staff ... the Director of the hospital pharmacy ...will be established ...Oversees hospital response to drug shortages, including efforts to limit medication use and identify therapeutic alternatives, according to policy 730.08.50 Medication Shortages..."

Policy #730.08.50, Medication Shortages, was provided by the hospital in a format of "Current Revision," undated, as Policy #MM-10, Medication Shortages which included, "...The purpose of this policy is to provide a common policy for the prevention and/or management of the procurement of medications that are either unavailable or in short supply due to manufacturing or wholesaler issues...Applicable Standards: The Joint Commission Standard - MM.02.01.01..."

Policy #730.06.02, DoseEdge, with an effective date of 05/25/10 included, "...Hospital uses DoseEdge to manage the preparation of compounded intravenous doses in the hospital pharmacy...processed at various workstations in the sterile compounding area(s)...Processing of doses on DoseEdge involves ...photography of products and preparation steps...Pharmacists check doses prepared using DoseEdge on line...doses are then scanned out of the IV room and into the pharmacy's distribution process...An authorized user is required to release the dose ...A pharmacist shall reject any dose for which the photographic evidence suggests that product selection or medication transfer was not performed appropriately..."

Policy #730.02.16, Handling Expired Medications, with an effective date of 07/06/11 included, "...The Joint Commission Medication Management standard MM.03.01.01 requires that the hospital removes all expired, damaged, and/or contaminated medications and stores them separately from medications available for administration...Inspecting for outdated drugs is a part of regular (monthly) inspections that pharmacy, or its delegates, performs at authorized drug storage areas. Expired drugs found at such inspections are confiscated by pharmacy personnel, returned to pharmacy, quarantined, and disposal 'disposed' of by return to supplier, reverse distributor, or local destruction..."

Observation of the pharmacy area occurred on 08/12/13 from 10:40 a.m. to 11:05 a.m. in the company of hospital staff including Director of Pharmacy (DP) A. The tour included observation of the sterile anteroom where DP A identified that staff replenished IV stock. An interview with DP A during the tour identified "DoseEdge" was a computerized management system that utilized cameras to take pictures of products, such as those put together in IV solutions, and can identify outdated drugs.

An interview with Director of Pharmacy (DP) A on 08/13/13 from 1:00 p.m. to 1:35 p.m. included a tour of the pharmacy area. When DP A asked pharmacy staff in the IV compounding room if there were any expired medications in the room, the staff provided a plastic bin with six vials of "Multitrace Concentrate," 10 milliliter (ml) vials, with expiration dates of May, 2013. There was no explanation why the outdated product remained in the IV prep room, available for patient use, greater than two months beyond the expiration date. Observation also included a quarantine shelf located in the general pharmacy area bearing a sign that stated, "DO NOT USE," with an unopened box of 25 "Multitrace Concentrate" 10 ml vials and expiration dates of May, 2013. Purchasing specialist (PC) C was present and stated she normally takes expired products from the shelf to the locked quarantine cabinet approximately two times a week. There was no explanation why the outdated product remained on the open shelf greater than two months beyond the expiration date. Observation also included the contents of the locked quarantine cabinet. There were no outdated vials of Multitrace Concentrate or Sodium Phosphate observed in the locked cabinet.

An interview with Director of Pharmacy (DP) A and Pharmacy Manager (PM) G on 08/14/13 from 1:05 p.m. to 2:10 p.m. identified they were both unaware, until surveyor discovery on 08/13/13, that there was outdated Multitrace Concentrate and outdated Sodium Phosphate available for patient use. Both stated they were unaware of any patient use regarding the outdated trace elements (Multitrace Concentrate) but did confirm that outdated Sodium Phosphate had been utilized for patients in the months of June, July and August, 2013. Both identified they had been unaware staff continued utilizing the outdated Sodium Phosphate after July 12, 2013, as Glycophos (a product imported from Norway that was similar to the U.S. form of Sodiium Phosphate) was available for use at that time. DP A confirmed that 47 patients received the outdated Sodium Phosphate during that time. Following surveyor review, on 08/21/13, of the DoseEdge computerized pictures of the outdated Sodium Phosphate and review of pharmacy confirmation, it was identified that 32 patients, Patients #7 through #38, had orders for Sodium Phosphate with compounding completed utilizing the outdated Sodium Phosphate, and were dispensed for patient administration on 23 of 66 days from 06/01/13 - 08/05/13.

During the interview on 08/14/13 from 1:05 p.m. to 2:10 p.m., Director of Pharmacy (DP) A confirmed the outdated Sodium Phosphate was most recently utilized for patients (#13, #24, #34) on 08/03/13 and 08/05/13.

Review on 08/13/13 of a document listing the pharmacy's current drug shortages identified 36 products that were "Tier 1 - Mission Critical" (prioritized as the most critical for potential or actual shortages) including Sodium Phosphate and Trace Elements.

An interview with IV Room Technician (IRT) B on 08/13/13 from 10:40 a.m. to 10:50 a.m. identified she worked exclusively in the IV room. IRT B stated there were regularly two staff in the IV room. When asked about the pharmacy's policy/procedure related to expired medications, IRT B stated they were to be quarantined and then placed in a locked cabinet, adding that Purchasing Specialist (PS) C then deals with the expired medications. When asked about any current drug shortages, IRT B stated there were a few Total Parenteral Nutrition (TPN) additives that were in short supply and that the pharmacy was searching for equivalents (TPN is an IV supplemental nutritional mixture that includes various trace elements).

An interview with IV Room Technician (IRT) D on 08/13/13 from 10:52 a.m. to 11:00 a.m. identified he worked with DoseEdge in the IV room. When asked about the pharmacy's policy/procedure related to expired medications, IRT D stated there were "expired bins" which were separated by the specific manufacturer. IRT D stated the expired medications were placed into a locked cabinet when the bins were full or at the end of each day.

An interview with Staff Pharmacist (SP) E on 08/13/13 from 11:00 a.m. to 11:24 a.m. identified he was familiar with the DoseEdge system which takes pictures of drugs utilized in compounding for IV orders which includes the name of the drug, the expiration date and the lot number. With regards to Trace Elements, SP E stated their use was restricted to TPN patients and added that Staff Pharmacist F would have more information regarding TPN patients. SP E confirmed that he had been involved in using Sodium Phosphate "a couple months ago." SP E stated the use of the expired Sodium Phosphate was authorized by the Pharmacy and Therapeutics (P & T) Committee. SP E stated he had low concern for an expiration date of a couple months.

An interview with Clinical Lead Pharmacist (CLP) H on 08/13/13 from 12:30 p.m. to 12:50 p.m. identified he was a user of DoseEdge which increased safety by adding a bar code ensuring the right drug, right concentration, right fluid, and drugs that were not expired. CLP H stated the DoseEdge system will "kick" out expired medications or biologicals, not allowing the product to be scanned. CLP H confirmed there was currently expired Sodium Phosphate onsite, kept in the IV room, last used for a patient approximately just over one week ago.
An interview with Physician J on 08/13/13 from 2:30 p.m. to 2:45 p.m. identified he was Medical Director of Dialysis, Chairman of Nephrology Department and a member of the P & T Committee. Physician J stated the hospital has had a shortage of various medications for the past year which was discussed monthly at the P & T meetings. Physician J stated that in the past six months, there had been discussion regarding the potential use of expired medications. Physician J stated that when the pharmacy was unable to obtain certain drugs/products, it was possible to use substitutes but when that was not possible, the option was to use an expired product or not use anything.

An interview with Physician I on 08/13/13 from 3:45 p.m. to 4:10 p.m. identified he was Chair of the P & T Committee. Physician I stated the drug shortage problem for the hospital started approximately four years earlier but in the past year the most critical shortage became that of various minerals. Physician I stated Physician J and Director of Pharmacy (DP) A took part in the decision-making regarding the use of outdated minerals, but added it was ultimately his decision.