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Based on observation, interview, and record review, the hospital failed to ensure that nurses compounding and administering high risk drugs (medications that have a high potential for harm to a patient if prepared or administered incorrectly) had the designated training to compound medication outside of the pharmacy. This failure had the potential for increasing patient risk for adverse events, related to potential contamination of sterile IV medications, dosing errors and other type of medication administration errors.

Findings:

On May 27, 2015 at approximately 9:35 AM, a medication pass was observed on the 5200 unit of the hospital. Registered Nurse 1 (RN 1) was observed to prepare hydromorphone (a potent pain medication) injection in the medication room for Patient 15. She removed hydromorphone 1mg (milligram)/1 mL (milliliter) ampule from the AcuDose machine (an automated dispensing cabinet used for storing and dispensing medications) and used an empty 1mL syringe with filter needle attached to remove approximately 0.5mL from the ampule. She then used an empty 3mL syringe and withdrew approximately 0.7mL of normal saline (a medication solution commonly used for intravenous (in the vein) use into that syringe. She then transferred the hydromorphone from the original syringe to the syringe containing normal saline to create a new compound of approximately hydromorphone 0.5mg in 1.2mL. RN 1 then labeled the medication with hospital policy required information (name, date, medication, etc) and took it to Patient 15's room to administer.

On May 27, 2015 at approximately 11:30 AM, an interview with Pharm 1 (pharmacist) was conducted. The concern regarding why nursing staff are compounding medications on the nursing unit, instead of the pharmacy department, was addressed. Pharm 1 was asked what the hospital considers compounding of medications. She stated they refer to USP (United States Pharmacopeia - a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines) 797 (a document created by USP to describe the standard for sterile compounding of medications) and the California Board of Pharmacy definitions.

USP defines compounding in an official document referred to as USP 795 (a document created by USP to describe the standard for non-sterile compounding of medications). Under "Definitions" it reads, "COMPOUNDING-The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner ' s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following: Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients."

According to the California Board of Pharmacy Laws & Regulations, under "Article 4.5 Compounding", states the definition of compounding. Listed under the California Code of Regulations 1735(a), it states, ""Compounding" means any of the following activities occurring in a licensed pharmacy, by or under the supervision of a licensed pharmacist, pursuant to a prescription:
(1) Altering the dosage form or delivery system of a drug
(2) Altering the strength of a drug
(3) Combining components or active ingredients
(4) Preparing a drug product from chemicals or bulk drug substances"

On May 28, 2015 at approximately 11:30 AM, an interview with the Director of Pharmacy (DPH) was conducted. He was asked what the hospital considers compounding of medications. He stated, "I looked up the definition on the internet and the FDA (Food & Drug Administration - a federal govement organization that regulates food and drugs) says 2 products mixed together is compounding." When asked if normal saline is considered a drug, he stated, "Normal Saline is a drug. It has Rx on the label." When asked if he thought mixing hydromorphone with normal saline is compounding, he stated that it was.

On May 28, 2015 at approximately 12:30 PM, an interview with the Executive Director of Pharmacy Services was conducted. He stated that he contacted the California Board of Pharmacy and they confirmed that adding normal saline to a drug, such as in the situation of adding normal saline to hydromorphone solution, is considered compounding.

In a review of the hospital's policy on compounding, effective date "11/2014", titled "Low Risk and Medium Risk Compounding Requirements (Sterile to Sterile Transfer)", the policy refers to USP 797 in multiple areas indicating that the hospital refers to USP 797 for compounding guidance and requirements.

A review of the the hospital's policy regarding compounding in the patient care areas titled, "IV Admixture in Patient Care Areas" with an effective date of "11/2014". It stipulates, "1. All intravenous medications shall be compounded in the Pharmacy, except in the following areas:
1.1 Intensive Care Units
1.2 Perianesthesia (before or after administering a medication to create insensitivity to pain) areas, e.g. OR (operating room), Recovery
1.3 Emergency Department & Urgent Care
1.4 Observation areas associated with OR and ED (emergency department)
1.5 Transport Team
1.6 Cardiovascular Lab
1.7 Radiology
2. Designated staff shall be trained in proper compounding technique and successfully complete the required competency. The competencies shall be registered into the database when completed."

During an interview with Pharm 1 on May 27, 2015 at 11:30 AM, she stated that the 5th floor units, 5100, 5200, and 5300 were not included in the areas designated by the policy. She further stated that the 5th floor units are pediatric acute care units and compounding is not allowed according to the policy. When asked for the training competency for Nurse 1, which is required for nurse's in the allowed units to compound, Pharm 1 stated, "There won't be any because they aren't supposed to be doing that in those areas (referring to the 5th floor units)."

A review of Nurse 1's training history from January 1, 2010 to May 28, 2017, indicates that Nurse 1 did not receive training for compounding medications outside of the pharmacy. On May 28, 2015 at 3 PM, Pharm 1 confirmed that RN 1 did not receive the training for compounding and the training was not listed on RN 1's training history.

An interview with Registered Nurse 2 (RN 2) was conducted on May 28, 2015 at 3:30 PM regarding the administration of morphine (a potent pain medication) solution for injection for Patient G on the 5200 unit. Patient G's order was for "Morphine 2.6mg IV (intravenous) every 2 hours PRN (as needed) for breakthrough pain". She confirmed that she gave Patient G a dose earlier in the day. When asked to explain how she prepared the medication, she stated that she withdrew 1.3mL of morphine from 2 separate 2mg/1mL syringes. RN 2 then stated that she added 1mL normal saline to the morphine syringe for a total of 2.3mL. She further stated that she has "done this every time" for every administration. When asked if she has received any training from the pharmacy in regards to compounding mediations, RN 2 stated that she had not.

An interview with RN 3 was conducted on May 28, 2015 at 4:10 PM regarding the administration of morphine solution for injection for Patient 16 on the 5100 unit. Patient 16's order was for "Morphine 1mg IV every 3 hours PRN for Severe Pain 7-10". She confirmed she gave Patient 16 a dose earlier in the day. When asked to explain how she prepared the medication, she stated that she withdrew 0.5mL of morphine from a 2mg/1mL syringe. RN 3 then stated that she withdrew 2mL of normal saline from a 10mL normal saline vial into the syringe with morphine for a total mixed quantity of 2.5mL.

During the same interview with RN 3, she was asked to explain how she prepared an order for morphine for Patient F on the 5100 unit. The patient's order was for "Morphine 0.36mg IV every 2 hours PRN for Moderate Pain 4-6, Severe Pain 7-10". She stated that she added normal saline to the morphine prior to administration. In addition, RN 3 was asked to explain how she prepared an order for hydromorphone for Patient 24 on the 5100 unit that she gave earlier in the day. The patient's order was "Hydromorphone 0.492mg IV every 4 hours PRN for Severe Pain 7-10". She stated that she withdrew approximately 0.492mL from a hydromorphone 1mg/1mL ampule and added 2mL of normal saline to the syringe. She also stated that had not received any training from the pharmacy in regards to compounding medications.

An interview with Registered Nurse 4 (RN 4) was conducted on May 28, 2015 at 4:55 PM regarding the administration of morphine solution for injection for Patient K on the 5300 unit. The order for the patient was "Morphine 0.52mg IV every 3 hours PRN for Moderate Pain 4-6". She stated that she withdrew 0.26mL from a morphine 2mg/1mL syringe. She then stated that she took a 10mL normal saline syringe for flushing (a procedure to clear IV lines to keep them clean and sterile) and wasted 5mL from that syringe. RN 4 further stated that she added the morphine to the 5mL in the normal saline syringe for a total volume of 5.26mL. When asked if she had received any training from the pharmacy on compounding medications, she stated that she had not.

A review of training histories for RN 2, RN 3, and RN 4 confirmed that none of them had received training for compounding medications outside of the pharmacy.

The hospital failed to ensure the Condition of Participation: CFR 482.25 Pharmaceutical Services was met by failing to promote a safe medication or biologicals use process as evidenced by:

1. The hospital failed to ensure that all compounding of drugs be under the supervision of a pharmacist. This failure had the potential for increasing patient risk for adverse events, related to possible unlabeled or mislabeled syringes, potential contamination of sterile IV medications, dosing errors and other type of medication administration errors. On May 29, 2015 at 8:47 AM, Immediate Jeopardy was called due to the facility's failure to ensure all compounding (mixing/combining) of medications be under the supervision of a pharmacist. This failure had the potential for increasing patient risk for adverse events, related to possible unlabeled or mislabeled syringes, potential contamination of sterile IV medications, dosing errors and other type of medication administration errors (See A-0501).

2. The hospital failed to monitor temperature for the medications stored in a refrigerator in accordance to facility policy and the manufacturers' requirement. This failure had the potential to have significant impact on patient care since numerous medications have minimal tolerance for temperatures outside of a narrow range. The products may then be rendered less than optimally effective or ineffective. (See A-0491)

3. The hospital failed to ensure potentially deteriorated medications were not available for patient use in the hospital and other clinics under the hospital's license. These failures could result in the loss of integrity of the medications, and potentially harm patients by not providing the expected therapeutic effect. (See A-0505)

The cumulative effect of these systemic practices resulted in the failure of the hospital to meet the needs of the patient's therapeutic goal, which created noncompliance with the Condition of Participation: Pharmaceutical services.

Based on observation, interview, and record review, the hospital failed to monitor temperature for the medications stored in a refrigerator in accordance to facility policy and the manufacturers' requirement. This failure had the potential to have significant impact on patient care since numerous medications have minimal tolerance for temperatures outside of a narrow range. The products may then be rendered less than optimally effective or ineffective.

Findings:

During an inspection visit of the main inpatient pharmacy on the second floor of hospital with Pharm 1 and Pharm 2 on May 28, 2015 at 4:30 PM, a refrigerator containing temperature sensitive pharmaceutical products such as Havrix (vaccine for active immunization against disease caused by hepatitis A virus (HAV) for persons =12 months of age) and Pneumococcal 13-valent conjugate vaccine or PCV13 (vaccine for prevention of Pneumococcal Disease) were found inside the pharmacy. The refrigerator was named "Center Counter Refrigerator" according to Pharm 2.

Review of the current month's (May 2015) temperature log report for this refrigerator provided by Pharm 2 revealed temperature monitoring was not consistently carried out by staff and was missing on the following dates: May 2, May 3, May 6, May 16, May 17, May 20, and May 21 of 2015. The manufacturers of Havrix and PCV13 stipulated on their packaging to store these vaccines in a refrigerator between the temperature ranges of 2° to 8° C (36º to 46º F)."

During an interview with the Pharm 2 on May 28, 2015 at 4:45 PM, he acknowledged temperatures of the Center Counter Refrigerator in the main pharmacy should have been manually monitored and recorded twice daily on the above dates to ensure acceptable storage condition was met.

Review of the hospital's policy and procedure entitled, "Refrigerators and Freezers in Patient Care Areas" dated November 2014, showed on page 1 "...and the temperature shall be checked and recorded daily (medication refrigerators - twice daily if vaccines are kept in the fridge)..."

Based on observation, interview, and record review, the hospital failed to ensure that nurses compounding and administering high risk drugs (medications which have a high potential for harm to a patient if prepared or administered incorrectly) had the designated training to compound medication outside of the pharmacy. This failure had the potential for increasing patient risk for adverse events, related to potential contamination of sterile IV medications, dosing errors and other type of medication administration errors.

Findings:

On May 27, 2015 at approximately 9:35 AM, a medication pass was observed on the 5200 unit of the hospital. Registered Nurse 1 (RN 1) was observed to prepare hydromorphone (a potent pain medication) injection in the medication room for Patient 15. She removed hydromorphone 1mg (milligram)/1 mL (milliliter) ampule from the AcuDose machine (an automated dispensing cabinet used for storing and dispensing medications) and used an empty 1mL syringe with filter needle attached to remove approximately 0.5mL from the ampule. She then used an empty 3mL syringe and withdrew approximately 0.7mL of normal saline (a medication solution commonly used for intravenous (in the vein) use) into that syringe. She then transferred the hydromorphone from the original syringe to the syringe containing normal saline by injecting the hydromorphone into the open end of the normal saline syringe where a needle can be attached, to create a new compound of approximately hydromorphone 0.5mg in 1.2mL. RN 1 then labeled the medication with hospital policy required information (name, date, medication, etc), attached a needle to the hydromorphone compound, and took it to Patient 15's room to administer.

On May 27, 2015 at approximately 11:30 AM, an interview with Pharm 1 (pharmacist) was conducted. The concern regarding why nursing is compounding medications on the nursing unit, instead of the pharmacy, was addressed. Pharm 1 was asked what the hospital considers compounding of medications. She stated they refer to USP (United States Pharmacopeia - a scientific nonprofit organization sets standards for the identity, strength, quality, and purity of medicines) 797 (a document created by USP to describe the standard for sterile compounding of medications) and the California Board of Pharmacy definitions.

USP defines compounding in an official document referred to as USP 795 (a document created by USP to describe the standard for non-sterile compounding of medications). Under "Definitions" it reads, "COMPOUNDING-The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner ' s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following: Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients."

The California Board of Pharmacy Laws & Regulations, under "Article 4.5 Compounding", indicates the definition of compounding. Listed under the California Code of Regulations 1735(a), it indicates, "Compounding" means any of the following activities occurring in a licensed pharmacy, by or under the supervision of a licensed pharmacist, pursuant to a prescription:
(1) Altering the dosage form or delivery system of a drug
(2) Altering the strength of a drug
(3) Combining components or active ingredients
(4) Preparing a drug product from chemicals or bulk drug substances"

On May 28, 2015 at approximately 11:30 AM, an interview with the Director of Pharmacy (DPH) was conducted. He was asked what the hospital considers compounding of medications. He stated, "I looked up the definition on the Internet and the FDA (Food & Drug Administration - a federal goverment organization which regulates food and drugs) says two products mixed together is compounding." When asked if normal saline is considered a drug, he stated, "Normal Saline is a drug. It has Rx on the label." When asked if he thought mixing hydromorphone with normal saline is compounding, he stated it was.

On May 28, 2015 at approximately 12:30 PM, an interview with the Executive Director of Pharmacy Services was conducted. He stated he contacted the California Board of Pharmacy and they confirmed adding normal saline to a drug, such as in the situation of adding normal saline to hydromorphone solution, is considered compounding.

In a review of the hospital's policy on compounding, effective date "11/2014", titled "Low Risk and Medium Risk Compounding Requirements (Sterile to Sterile Transfer)", the policy refers to USP 797 in multiple areas indicating the hospital refers to USP 797 for compounding guidance and requirements.

A review of the the hospital's policy regarding compounding in the patient care areas titled, "IV Admixture in Patient Care Areas", with an effective date of "11/2014". It stipulates, "1. All intravenous medications shall be compounded in the Pharmacy, except in the following areas:
1.1 Intensive Care Units
1.2 Perianesthesia (before or after administering a medication to create insensitivity to pain) areas, e.g. OR (operating room), Recovery
1.3 Emergency Department & Urgent Care
1.4 Observation areas associated with OR and ED (emergency department)
1.5 Transport Team
1.6 Cardiovascular Lab
1.7 Radiology
2. Designated staff shall be trained in proper compounding technique and successfully complete the required competency. The competencies shall be registered into the database when completed."

During an interview with Pharm 1 on May 27, 2015 at 11:30 AM, she stated the 5th floor units, 5100, 5200, and 5300 were not included in the areas designated by the policy. She further stated the 5th floor units are pediatric acute care units and compounding is not allowed according to the policy. When asked for the training competency for Nurse 1, which is required for nurse's in the allowed units to compound, Pharm 1 stated, "There won't be any because they aren't supposed to be doing that in those areas (referring to the 5th floor units)."

A review of RN 1's training history from January 1, 2010 to May 28, 2017, indicated RN 1 did not receive training for compounding medications outside of the pharmacy. On May 28, 2015 at 3 PM, Pharm 1 confirmed RN 1 did not receive the training for compounding and the training was not listed on RN 1's training history.

An interview with Registered Nurse 2 (RN 2) was conducted on May 28, 2015 at 3:30 PM, regarding the administration of morphine (a potent pain medication) solution for injection for Patient G on the 5200 unit. Patient G's order was for "Morphine 2.6mg IV (intravenous) every 2 hours PRN (as needed) for breakthrough pain". She confirmed she gave Patient G a dose earlier in the day. When asked to explain how she prepared the medication, she stated she withdrew a total of 1.3mL of morphine from 2 separate 2mg/1mL syringes. RN 2 then stated she added 1mL normal saline to the morphine syringe for a total of 2.3mL. She stated she has "done this every time" for every administration. When asked if she has received any training from the pharmacy in regards to compounding mediations, RN 2 stated she had not.

An interview with RN 3 was conducted on May 28, 2015 at 4:10 PM, regarding the administration of morphine solution for injection for Patient 16 on the 5100 unit. A review of Patient 16's medication profile on May 28, 2015, indicated an active order for "Morphine 1mg IV every 3 hours PRN for Severe Pain 7-10". She confirmed she gave Patient 16 a dose earlier in the day. When asked to explain how she prepared the medication, she stated she withdrew 0.5mL of morphine from a 2mg/1mL syringe. RN 3 then stated she withdrew 2mL of normal saline from a 10mL normal saline vial into the syringe with morphine for a total mixed quantity of 2.5mL.

During the same interview with RN 3, she was asked to explain how she prepared an order for morphine for Patient F on the 5100 unit. A review of Patient F's medication profile on May 28, 2015, indicated an active order for "Morphine 0.36mg IV every 2 hours PRN for Moderate Pain 4-6, Severe Pain 7-10". She stated she added normal saline to the morphine prior to administration. In addition, RN 3 was asked to explain how she prepared an order for hydromorphone for Patient 24 on the 5100 unit which she gave earlier in the day. A review of Patient 24's medication profile on May 28, 2015 indicated an active order for "Hydromorphone 0.492mg IV every 4 hours PRN for Severe Pain 7-10". She stated she withdrew approximately 0.492mL from a hydromorphone 1mg/1mL ampule and added 2mL of normal saline to the syringe. She stated she had not received any training from the pharmacy in regards to compounding medications.

An interview with Registered Nurse 4 (RN 4) was conducted on May 28, 2015 at 4:55 PM, regarding the administration of morphine solution for injection for Patient K on the 5300 unit. A review of the Patient K's medication profile on May 28, 2015 indicated an active order for "Morphine 0.52mg IV every 3 hours PRN for Moderate Pain 4-6". She stated she withdrew 0.26mL from a morphine 2mg/1mL syringe. She stated she took a 10mL normal saline syringe for flushing (a procedure to clear IV lines to keep them clean and sterile) and wasted 5mL from that syringe. RN 4 further stated she added the morphine to the 5mL in the normal saline syringe for a total volume of 5.26mL. When asked if she had received any training from the pharmacy on compounding medications, she stated she had not.

A review of training histories for RN 2, RN 3, and RN 4 confirmed none of them had received training for compounding medications outside of the pharmacy.

On May 29, 2015 at 8:47 AM, Immediate Jeopardy was called in the presence of the Chief Operating Officer, Chief Nursing Officer, Chief Quality and Patient Safety Director, Director of Pharmacy, Pharmacy Quality Management, facility Pharmacist Children's Hospital Quality Management personnel due to the facility's failure to ensure all compounding (mixing/combining) of medications be under the supervision of a pharmacist.

On May 29, 2015 at 1:55 PM, the IJ was abated.

Based on observation, interview and record review, the hospital failed to ensure potentially deteriorated medications were not available for patient use in the hospital and other clinics under the hospital's license. These failures could result in the loss of integrity of the medications, and potentially harm patients by not providing the expected therapeutic effect.

Findings:

1. The inpatient Operating Room (OR) unit of the hospital was visited on May 27, 2015, with the Director of Pharmacy (DPH), starting at 4:10 PM. Medications inside an anesthesia automatic dispensing cabinet (ADC) in Suite 5 of the OR were randomly selected for inspection. In drawer #2 of the anesthesia ADC, there were two multi-dose vials (MDVs) of Dexamethasone sodium phosphate (anti-inflammatory or immunosuppressant agent) 20 mg (milligram) per 5ml (milliliter), one MDV of Glycopyrrolate (medication that inhibits salivation and excessive secretions of the respiratory tract preoperatively) 1mg per ml, one 10 ml MDV of Neostigmine methylsulfate (medication that reverses the effects of nondepolarizing neuromuscular blocking agents after surgery) 1mg per 10ml, and one 20 ml MDV of Lidocaine (local anesthetic agent) 1% were identified with exposed rubber stoppers (an unused, sealed vial contains a metal seal on top of the rubber stopper. In order to access the medication in the vial this metal seal must be removed exposing the rubber stopper). However, none of the MDVs had any visible marking or label on them to specify a new expiration date for these medications.

In an interview with the DPH on May 27, 2015 at 4:28 PM, he acknowledged that all of these opened MDVs in the ADC should be labeled to expire in 28 days.

Review of the hospital Policy and Procedure entitled "Singles/Multiple Dose Vials and Containers" dated on November 2014, showed on page 1, it read "4. Used or open MDV with preservatives shall be: ...4.2 dated for expiration at 28 days from the date first opened or taken from the refrigerator, unless the manufacturer lists a shorter time frame."


2. On May 27, 2015 11:25 AM, during a visit to the inpatient pharmacy on the 5th floor of the hospital with the Director of Pharmacy (DPH), one bottle of the Baxter branded intravenous (IV) Nitroglycerin (medication to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels)) were stored exposed to light in a blue bin on the bottom shelf of the pharmacy counter. The bottle did not have an expiration date other than the manufacturers' and the DPH was unable to determine if the medication was not deteriorated.

The manufacturer of nitroglycerin stipulates on its package insert (a document provided along with a prescription medication to provide additional information about that drug) under "How Supplied" section of the document, it read in part, "Exposure of pharmaceutical products to heat should be minimized...Protect from light until time of use."

In an interview with DPH on May 27, 2015 11:43 AM, he confirmed the IV nitroglycerin bottle was not adequately protected from light and acknowledged the medication should be placed in a light resistant bag to prevent deterioration of its potency.

3.On May 26, 2015 at 10:37 AM, during a tour of the 5200 unit of the hospital, the medication room refrigerator was inspected. An open vial of Humalog insulin (a medication used to treat diabetes mellitus (a disease that causes high blood sugar levels)) was found with a label that indicated it was opened on May 26, 2015 and an expiration date of June 28, 2015. This expiration date provides 33 days of total use.The labeled dates were confirmed by the Educator - Clinical Services, Pediatric Acute Care.

The Humalog package insert (a document provided along with a prescription medication to provide additional information about that drug) under the "Storage and Handling" section of the document, reads in part, "In-use Humalog vials......should be stored at room temperature, below 86 degrees Fahrenheit (30 degrees Celsius), and must be used within 28 days or be discarded".

In an interview with the Director of Pharmacy on May 28, 2015 at 3 PM, he was asked what drug reference the hospital uses. He stated that they use LexiComp (a medication reference database that hospitals can access to retrieve drug information). A review of the drug profile for Humalog on LexiComp, under the Storage/Stability section, indicates that "Once punctured (in use), vials may be stored under refrigeration or at room temperature <30°C (<86°F); use within 28 days."

A review of the hospital's policy and procedure, labeled as "Category: Pharmaceuticals" and "Subject: Single/Multiple Dose Vials and Containers", effective "11/2014", reads, "4. Used or open MDV with preservatives shall be: ...4.2 dated for expiration at 28 days from the date first opened or taken from the refrigerator, unless the manufacturer lists a shorter time frame."



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4. During an initial tour of the Pediatric Specialty Team Clinic with the Clinic Nurse Manager (PSTCNM) and Clinic Patient Care Supervisor (PSTCPCS) on May 26, 2017 at 2:56 PM, inside medication room refrigerator was multiple dose vial (MDV) of Poliovirus Vaccine Inactivated - IPOL (a biological preparation that provides immunity to polio or infantile paralysis), that was undated and without initials.

During a concurrent interview with the PSTCNM, the PTSCNM stated that the nurse who opened it should have labeled the MDV with the date and initial it.

The facility policy and procedure titled, "Single/Multiple Dose Vials and Container's" dated November 2014, indicated: "...4. Used or open MDV with preservatives shall be: ...4.2 dated for expiration at 28 days from the date first opened or taken from the refrigerator, unless the manufacturer lists a shorter time frame. 4.3 labeled by Pharmacy if the expiration date date from the time first opened or taken from the refrigerator is less than 28 days..."