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Based on documentation, the hospital failed to analyze and track an incident involving the diversion of narcotics from the hospital.

Findings:

On 5/19/10 the hospital discovered a tampered Dilaudid (controlled substance for pain) carpuject (syringe system of prefilled cartridges that are loaded in to a syringe holder with a tamper seal) in a pyxis machine (automatic dispensing cabinet). Further investigation revealed that 4 other Dilaudid carpujects were compromised, two of the four were empty of medication and the tamper seal was placed back in its original position. The discrepancies were reported to the director of pharmacy (RPH A) on 5/20/10 who conducted his own investigation into the missing narcotic.

A review of the pharmacy investigation revealed staff did not implement the hospital policy on controlled substance diversion, as required which states, "all pyxis machines in other service areas will be investigated for potential diversion/loss." The RPH A, who was interviewed on 7/12/10, said the pharmacy technician only checked the pyxis for the carputjets and not other drugs, stating this was a communication error. Additionally it was found the technician did not check all the pyxis units as directed but only on one floor stating he was called off during the inspection to return to the pharmacy.

In the interim, although staff were being interviewed there appeared to be no organization to the investigation, as only nursing staff was interviewed not taking into account other disciplines that could have been involved e.g. pharmacy staff. Furthermore, a computer generated report indicating how many times the Dilaudid carpuject was withdrawn from the pyxis unit was done. Although there were 11 withdrawals, there was no verification as to whether the medication was appropriately withdrawn for the patient's condition, as no patient charts were reviewed for comparison.

This system of investigation made it difficult for administration to analyze and track the diversion of drugs in the hospital.

Based on observation, interview, and record review, the hospital's pharmacy failed to assure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The hospital did not conduct a thorough investigation of missing controlled substance in a timely manner and did not check other service areas for potential diversions/losses in accordance with the hospital's policy and procedure (cross-reference A 500).

2. The hospital failed to ensure the safe and appropriate prescribing, dispensing, and administration of the fentanyl transdermal patches by failing to evaluate and assess the appropriateness of the use in accordance with manufacturer's instructions, the FDA black box warning (BBW) for two of four patients (Patients 1 and 2). The hospital did not have a safeguard in place to promote the safe and effective use of this medication (cross-reference A 500).

3. The hospital did not have a policy and procedure addressing the appropriate return or destruction of unused narcotic medications to promote consistent practice within the hospital (cross-reference A 500).

4. The hospital failed to maintain the temperatures in all medication refrigerators in accordance with the hospital's policy (36 to 46 degrees Fahrenheit (?F) or 2 to 8 degrees Celsius (?C) (cross-reference A 491).

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, and record review, the hospital failed to maintain the temperatures in all medication refrigerators in accordance with the hospital's policy (36 to 46 degrees Fahrenheit (?F) or 2 to 8 degrees Celsius (?C)). Findings:

On 7/12/10 at 9:50 a.m., during the visit to the inpatient pharmacy, the director of pharmacy (RPH A) stated the engineering department monitored temperatures for all medication refrigerators in the hospital through the electronic temperature monitoring system. He said engineering would call the pharmacy if there were any problems or out of range temperatures.

During a visit to the engineering department on 7/13/10 at 2:40 p.m., an Engineering Staff (ENGR A) said he was one of the staff who monitored the refrigerators including the medication refrigerators for the hospital. When asked for temperature parameters at which the hospital maintained the medication refrigerators at, he showed a computer monitor which it read: "1?C to 8?C" (1?C equals to 33.8?F). ENGR A stated that such temperature parameters had been set since the installation of the electronic monitoring about two years ago.

The hospital's policy and procedure on "Patient Food/Drug Refrigerator Temperature Control and Monitoring", dated 6/3/09, indicated the medication refrigerators would be maintained at 36?F to 46?F or 2?C to 8?C.

Based on staff interviews and clinical record reviews, the hospital failed ensure the safe and effective use of medications evidenced by:

1. The hospital did not conduct a thorough investigation of missing controlled substance in a timely manner and did not check other service areas for potential diversion/losses in accordance with the hospital's policy and procedure.

2. The hospital failed to ensure the safe and appropriate prescribing, dispensing, and administration of the fentanyl transdermal patches by failing to evaluate and assess the appropriateness of the use in accordance with manufacturer's instructions, the FDA black box warning (BBW) for two of four patients (Patients 1 and 2). The hospital did not have a safeguard in place to promote the safe and effective use of this medication.

3. The hospital did not have a policy and procedure addressing the appropriate return or destruction of unused narcotic medications to promote consistent practice within the hospital.

Findings:

1. On 5/21/10, the hospital reported an unusual occurrence to the California Department of Public Health (CDPH). It was reported that on 5/19/10, the oncology unit's evening head nurse discovered a tampered Dilaudid (a potent controlled substance for pain management) 4 mg/ml (4 milligrams/milliliter) carpuject while she was pulling it for patient use from the Pyxis (the automatic dispensing cabinet). [Carpuject is a syringe system consisting of prefilled cartridges that are loaded into a syringe holder.] Looking further, she found four Dilaudid carpujects were compromised and two of four were empty of medication. It was discovered that the tamper-evident seal at the top of the carpujects had been broken, the medication was emptied, and the seal was placed back in its original position. Without examining the product closely, the tampered product could be easily overlooked as being intact.

The CDPH conducted the complaint investigation on 6/10/10, 21 days after the incident. During a meeting with the director of pharmacy (RPH A) and the oncology unit director (DIR A) on 6/10/10 starting at 9:55 a.m., RPH A stated the hospital did not identify who diverted the Dilaudid medication. He said the Pyxis had a drawer failure on 5/15/10 and a new Dilaudid supply was replaced on the same day by the pharmacy technician. He stated the hospital investigated the diversion by interviewing nursing staff who had Pyxis activities during the period between 5/15/10 and 5/19/10 and conducting the inventory of the products for drug integrity within the two Pyxis medstations on the oncology unit.

During the above meeting, DIR A stated the hospital had not finished interviewing nursing staff who had access to the Pyxis as of 6/10/10. When asked if the hospital had looked at the Pyxis medstations in other service areas of the hospital to explore if additional diversion occurred, RPH A said no. When asked if he had examined the Dilaudid Carpujects in the CII Safe (controlled II Safe) from which the Dilaudid supply came, RPH A said he did not.

On 6/10/10 at 11:30 a.m., review of the Pyxis activity report during the four-day period from 5/15/10 to 5/19/10, indicated Dilaudid carpuject 4 mg/ml was withdrawn 11 times for one patient. When asked if the hospital looked into whether the medication was appropriately withdrawn and administered to the patient and checking the pain relief documentation following each administration, RPH A said, "No, we did not."

During an interview on 7/12/10 at 9:40 a.m., RPH A said the hospital still had not identified who diverted the Dilaudid Carpujects and had no suspected employee(s). He also said the hospital had two more reported incidents involving morphine and Valium Carpujects (controlled substances) when the tamper-evident seals were found broken on two different nursing floors. RPH A stated that every time an incident was reported, he would have his pharmacy staff run a 30-day activity report from all Pyxis stations of the hospital to look for further potential diversion and the affected products were sent out for testing. He was asked to provide documentation of those reports.

On 7/12/10 at 11:20 a.m., RPH A stated on 6/11/10, a pharmacy technician was directed to go through all Pyxis medstations on the nursing units to visually inspect all narcotic carpujects (medications that came in carpuject form) for medication package integrity. However, he did not remember to whom he assigned the task and did not have documentation of the pharmacy technician's report of findings. When asked why the hospital did not check other controlled substances, such as those available in liquid form, intravenous solutions, powder or tablet forms, RPH A said the hospital only thought of investigating the carpujects.

On 7/12/10 at 3:45 p.m., RPH A said he ran the Pyxis activity report which indicated the pharmacy technician only conducted the visual inspection of the narcotic carpujects on one floor and not all the nursing floors (the hospital had five patient care floors) on 6/11/10. His phone interview with the technician revealed the technician was called off during the inspection to return to the pharmacy. He said there were no findings as the result of the inspection but he could not provide documentation of such report. RPH A stated it was his mistake for not making sure the investigation was followed through.

On 7/20/10, a review of the pharmacy investigation records indicated during inventory check on 6/17/10 on the ortho/neuro unit, one morphine 4 mg/ml carpuject was found with a broken seal. As the result, the pharmacy staff ran the 30 day report and checked morphine 4 mg/ml carpuject supply of all Pyxis medstations on 6/18/10. Other narcotic medications were not checked.

On 6/20/10, two Valium 10 mg/ 2ml carpujects were found with broken seals during narcotic inventory on the Comprehensive Cancer Center. On 6/21/10 the pharmacy staff performed the drug inventory report on all Pyxis machines on the floor, but only for morphine 4 mg/ml and Valium 10mg/2ml carpujects.

Medications that were available in carpujects included Dilaudid 2mg/ml and 4mg/ml; Valium 10mg/2ml; Demerol 25mg/ml, 50mg/ml, 75mg/ml and 100mg/ml; and morphine 2 mg/ml, 4 mg/ml, 10 mg/ml, and 15 mg/ml.

The records indicated only narcotic carpujects on one floor were inventoried for package integrity on 6/11/10 and only morphine 4mg/ml and Valium 10mg/2ml carpujects on nursing units were inventoried as of 6/21/10. Thus, as of 7/12/10, narcotic carpujects on the other four floors were not inventoried. Additionally, non-carpuject controlled medications were not checked for drug integrity and potential diversion/losses.

The hospital's policy and procedure, "Controlled Substances Managements", dated 4/08, had an algorithm for conducting suspected or actual diversion. It indicates, "Run 30 day activity report from ALL PYXIS Stations for suspected employees" and "All PYXIS machines in other service areas will be investigated for potential diversion/losses."

2. The fentanyl (Duragesic) transdermal patch is a medication containing a very potent narcotic (opioid) pain medicine which is applied to the skin. Fentanyl patches are only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. Patients who are opioid-tolerant are more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally take these medicines.

For patients who are not opioid-tolerant (or opioid-naive), the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death (www.fda.gov/drugsafety).
The 10/8/09 ISMP Alert of the Institute for Safe Medication Practice (WWW.ISMP.ORG) reported "Fentanyl ranked first among drugs causing serious, disabling, and fatal ADEs (adverse drug events) specially described as medication errors. Of the 80 reported cases, 75 (94%) involved fentanyl patches."

Due to numerous reports of adverse events with fentanyl patches, including fatalities, caused by inappropriate prescribing, dispensing, and administration of the drug, the Food and Drug Administration (FDA) issued a public advisory containing important safety information about using fentanyl transdermal patches, "Deaths and overdoses have occurred, and the directions for the use of this medication must be followed exactly to prevent death or serious side effects."

Additionally, the FDA required pharmaceutical companies who manufacture fentanyl patches to place a boxed warning (black box warning) on the labeling. A boxed warning is the strongest warning that the FDA requires. When a medication's labeling includes a boxed warning it means that medical studies indicate the medication carries a significant risk of serious or even life-threatening adverse effects. A boxed warning provides a brief, concise summary of the information that is critical for which a prescriber is to be aware, including any restriction on distribution or use.
To date, the Duragesic (fentanyl) package insert indicates the following: "Because serious or life-threatening hypoventilation could occur, fentanyl transdermal system (patch) is contraindicated:
? in patients who are not opioid-tolerant
? in the management of acute pain or in patients who require opioid analgesia for a short period of time
? in the management of post-operative pain, including use after out-patient or day surgeries
? in the management of mild pain
? in the management of intermittent pain."

The package insert further indicates that fentanyl patches should "ONLY be used inpatients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl 25 mcg/hr (micrograms per hour). Patients who are considered opioid tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid."

On November 5, 2007 the California Department of Public Health (CDPH) released an "All Facilities Letter" (used to notify healthcare institutions licensed by the CDPH of recurring problems that had resulted in licensing and federal noncompliance determinations) entitled "MEDICATION SAFETY: USE OF MEDICATIONS WITH "BOXED WARNINGS." This letter documented that: "It is the Department's expectation that appropriate safeguards for all medications are in place that acknowledge and manage each the medication's inherent risks with its benefits. Medications that have a boxed warning pose an additional challenge to promote safe use in light of their potential for serious adverse consequences."

During a visit to the inpatient pharmacy on 7/12/10 at 11:15 a.m., the assistant director of clinical services (RPH B) stated the pharmacists reviewed and verified the orders for Duragesic (fentanyl) patches before they were available in the Pyxis for nursing access for patient administration. She stated the pharmacists would follow the manufacturer's instructions ensuring the patients had appropriate diagnosis of persistent moderate to severe pain and would make sure that the patients were opioid tolerant before the patches were verified. She said if a patient did not meet these criteria, the order-entry pharmacist would call the physician asking for an alternative pain medication and such intervention would be recorded in the pharmacy computer system. When asked if there were specific guideline or protocol related to fentanyl patch verification by which the pharmacists had to follow, RPH B said, "No, we don't."

On 7/12/10 at 2:30 p.m. during a visit to the 5th Floor Med/Surg Unit, a review of Patient 1's record with the unit director (DIR A) and the unit charge nurse (RN A) indicated Patient 1 was an 88 year old who was admitted for altered mental status and general weakness. Her record indicated she had the primary diagnoses of congestive heart failure and pneumonia. The physician's progress notes indicated the patient was intermittently moaning, groaning, yelling out, and exhibited symptoms of pain when moved but there was no documented type of pain nor chronic pain indication.

Patient 1's medical record indicated she was only taking tramadol (no specified dose or frequency) for pain prior to hospitalization. (Tramadol is a medication pain relief and is not one considered used to calculate equianalgesic to fentanyl patches.) There was no documented history use of fentanyl patch nor any other opioid medication use prior to hospitalization. On the day of admission, Patient 1 was prescribed fentanyl 12 mcg/hr patch to be applied every 3 days, in the absence of persistent, moderate to severe pain diagnosis and the establishment of opioid-tolerance (the must-have criteria for prescribing fentanyl patches).

During this visit, when asked for the indication for the use fentanyl patch, RN A stated it was for "congestive heart failure and pneumonia". She could not provide a specific indication for pain.

On 7/13/10 at 10:05 a.m., during a visit to the 5th Floor Oncology Unit, a review of Patient 2's record with DIR A revealed the hospital admitted the patient on 6/28/10 for abdominal pain. He was 77 years old, and had diagnoses including gallstones and masses in the liver. The 6/28/10 physician's progress notes indicated the patient only was taking Vicoprofen (hydrocodone and ibuprofen for short-term management of moderate-to-severe acute pain) on as needed basis (no dose or frequency specified) for pain prior to hospitalization. There was no documented history of fentanyl patch or other narcotic medication use.

On 6/29/10 (a day after admission), Patient 2 was prescribed fentanyl 25 mcg patch to be applied every 3 days. Thus, Patient 2 was prescribed fentanyl patch without demonstrated opioid tolerance due to lack of documented history of narcotic medication use.

On 7/13/10 at 10:50 a.m., interview with the staff pharmacist (RPH C) in the intensive care unit revealed it was the responsibility of the pharmacist to ensure clinical indications and prescribing criteria for fentanyl patch were met before making it available for removal from the Pyxis. If the criteria were not met, the pharmacist would call the physician to discuss an alternate method for pain control. The pharmacy intervention would then be documented in the pharmacy computer system. However, she confirmed the hospital did not have a guideline or protocol related to fentanyl patch use.

On 7/13/10 at 12:20 p.m., the director of pharmacy (RPH A) acknowledged fentanyl patches were prescribed without an appropriate indication for Patient 1 and without demonstrated opioid tolerance for Patients 1 and 2. He also stated he did not have any documented pharmacy interventions from the two pharmacists who verified the fentanyl patch orders for the two patients.

3. On 7/12/10 at 9:40 a.m., RPH A said the hospital had another incident of possible tampered narcotic carpuject which was discovered the day before on 7/11/10. The product was sent out for testing to rule out tampering.

He stated the interview with the involved nurse revealed the nurse had pulled the medication for patient use. She broke the seal at the top of the carpuject to prepare the medication for administration. However, the patient refused the medication and the nurse recapped the carpuject and returned the medication to the Pyxis.

During the interview above, RPH A said he had instructed the nurses not to return the medication if it was refused and they were supposed to waste the drug.

The interview with the emergency department staff on 7/12/10 at 12 p.m. revealed that if a narcotic medication was refused, the compromised medication would be returned to the Pyxis' return bin.

On 7/12/10 at 1 p.m., during a group interview, RPH A confirmed the hospital's current policy and procedure on Controlled Substance Mananagement did not address the procedure on what to do with the unused compromised medication, to promote consistent practice within the hospital.