FDA Inspections Find Issues at Compounding Pharmacies

By Kim Smiley

Unsafe practices at compounding pharmacies were found during recent Federal Drug Agency (FDA) inspections.  The FDA visited about 30 pharmacies in 18 different states, focusing on the production of sterile drugs which was determined to be the highest risk to patient safety.   The inspection findings include a number of potential contamination issues such as inadequate ventilation, unidentified particles in vials of supposedly sterile medications, cleanliness issues in clean rooms such as rust and mold, and insufficient microbiological testing. Interest in compounding pharmacies was increased after the fall 2012 outbreak of fungal meningitis that killed 50 and sickened hundreds was traced back to compounded injectable steroid medication that had been shipped across the country.

A root cause analysis of the issues at compounding pharmacies can be done by building a Cause Map.  A Cause Map visually lays out the different causes that contribute to an issue and is a way to intuitively illustrate the problem.  Compounding medications are an issue because they can pose both indirect and direct risks to patient safety and patients are using them.   The indirect risk is that patients may inadvertently use an ineffective medication.  Compounded medications are not regulated by the FDA and have not gone through a formal approval process that requires extensive testing.  Medications that are compounded can also be a direct risk to patient safety if they are contaminated or sub- or super-potent.  As the fatal fungal meningitis outbreak unfortunately demonstrated, contamination of supposedly sterile drugs can have deadly consequences. Compounded drugs are receiving more attention than traditionally manufactured drugs because some of the facilities may have less oversight and the recent investigations found more issues with the work processes at the compounding pharmacies than is typically discovered at drug manufacturing facilities.

Many are asking questions about how compounding pharmacies are regulated and overseen.  Compared to drug manufacturers, the FDA’s regulatory authority over compounding pharmacies is limited.  Compounding pharmacies are not generally even required to inform the FDA what drugs they are making or register with the FDA.  State boards of pharmacy regulate the compounding pharmacies and the FDA typically becomes involved only to do for-cause inspections upon receiving reports or complaints or when states have requested assistance.

It’s worth noting that compounding pharmacies do serve an important need.  Some individuals cannot be treated with standard manufactured medication.  An example of this is when somebody is allergic to an inactive ingredient, such as a dye, in an approved medication.  The real concern is that the creation and  use of compounded medications seems to be changing from its traditional function.  According to Ilisa Bernstein, acting director of Center for Drug Evaluation and Research’s Office of Compliance, “Some aspects of these firms’ operations appear more consistent with those of drug manufacturers than with those of traditional pharmacies. Some firms make large amounts of drugs that appear to be copies of FDA-approved, commercially available drugs when it does not appear that there is a medical need for an individual patient to receive a compounded version of the drug.”

There have been a number of voluntarily recalls as a result of the recent inspections.  The FDA and state regulatory boards are working together to address the issues that were uncovered.  Additionally, the FDA is pushing for new legislative authority over the highest-risk compounding pharmacies, but there isn’t agreement on whether changes are necessary and it’s not clear what the outcome will be.

For more information about compounded medications, please visit the FDA website.

Successful Emergency Response to Boston Bombing

By ThinkReliability Staff

The successful activation of emergency plans allowed 8 hospitals in the Boston area to treat 144 trauma patients injured in the bombings that occurred April 15, 2013 near the finish line of the Boston Marathon.  Even with that heavy burden, these hospitals ensured the continued safety of patients and staff during a very unsure time, as well as assisting the police and Federal Bureau of Investigation (FBI) with the ongoing investigation.

While details on the bombings themselves are still being determined and disseminated, it’s apparent that emergency planning and preparedness processes within the area Boston hospitals were successful in allowing an ‘unprecedented’ response.  We can view the response to the bombings by the area hospitals in what we like to call a root cause “success” analysis.  After all, lessons can be learned not only from what didn’t go well, but also what did.  Hospitals around the country can learn from the response by the Boston area hospitals to this trauma.

When Massachusetts General asked hospital staff from Israel, who unfortunately see this kind of trauma on a far more regular basis, to give emergency response training they likely did not suspect their hospital to be the site of a horrific mass trauma like that experienced in Boston.  The hospital’s experience with war-style trauma was certainly extremely helpful in dealing with the aftermath of this kind of trauma, rarely seen outside of war zones.  As Dr. Ron Walls, the chairman of the Department of Emergency Medicine at Brigham and Women’s Hospital stated, “For many, many people in emergency medicine who are practicing domestically and not in the military, these are once-in-a-lifetime events.”

For once-in-a-lifetime events, facilities have to hope that the training and education they’ve provided to their staff, and the processes that they’ve developed for dealing with emergencies, can stand up to the tragedy.  In this case, these Boston hospitals (once they have time to take a breath, which may not be for a while), should give themselves a pat on the back for their amazing handling of a tragic event.  Hospitals elsewhere should take note and ensure that their emergency procedures will allow the same sort of successful response.

A pat on the back should also go out to the staff in the medical tent at the finish line, whose quick actions and extensive equipment allowed on-scene stabilization and quick transfer of the severely injured to the area hospitals.  Lastly, the many spectators who kept their cool and assisted on scene should also be commended.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to learn more about the emergency procedures at Massachusetts General.

Lead Poisoning Still An Issue for US Children

by Kim Smiley

Lead poisoning has once again hit the news with scary headlines such as “Blood Lead Levels High In 535,000 Kids In The USA” and “Despite Big Progress, Many Kids Have High Lead Levels in Blood“.   But what do these articles actually mean in context?  What does “many kids” refer to and how alarmed should we be?

A tool like a Cause Map, a visual method for performing a root cause analysis, can be useful to analyze issues like this one.   The first step in the Cause Mapping process is to define the problem and that alone can help clarify an issue.   Part of defining the problem is to determine which overall organizational goals are being impacted by the problem.   In this example, it becomes clear that there are really two different, but related goals that need to be considered.  The most basic goal is the safety goal.  The safety goal is being impacted because children are still being negatively impacted by exposure to lead in the United States, despite decades of work to dramatically reduce lead in the environment.  The second issue is that 2.6% of children in the US have blood lead levels (BLLs)  higher than the levels set by the Center for Disease and Control (CDC), an impact to the regulatory goal.

It’s clear why exposure to lead remains a concern. Ingestion of lead is dangerous, especially to small children. High levels of lead in the body can have severe and immediate consequences such as coma, convulsions and even death.  Lower levels of lead have been shown to cause lower IQs, behavior issues, hearing problems and a number of problems in organs in the body.  Problems with lead exposure are well known and the use of lead has been dramatically reduced.  Use of lead in household paints, one of the most common sources of ingested lead, was banned in 1978.  However, paint is still one of the primary sources of lead contamination because many children live in houses built before 1978.  Paint chips containing lead can still be an issue, especially if an older house has loose paint or is undergoing a renovation.  Use of lead in gasoline, a common source of soil contamination, was phased out by the end of the 1980s.

The second issue of concern is that 2.6% of children have blood lead levels above the limit set by the CDC.  What does this mean?  If this problem is hitting headlines, are things getting worse?  One important piece of data is that the CDC lowered the limit for young children in 2012 to 5 µg/dL from 10 µg/dL.  Why was the limit lowered?  The limit was lowered because no amount of lead has been determined to be safe for young children and less lead is always better.  The new limit of 5 µg/dL was based on lead levels in the 2.5% of children with the highest levels.  It was a way to target the children most at risk and it marked a shift towards a more prevention-based approach.

Is it okay that 2.6% of children still have blood lead levels above the target?  Of course not.  Is there still work to do in preventing lead exposure?  Many people believe there is.  But the alarming headlines may not tell the whole story.  Here are some other facts that help put the issue of lead exposure in historical context: an estimated 88% of children aged 1 to 5 had blood lead levels at or above 10 mcg/dL from 1976 to 1980; from 1991-1994 it was 4.4% , from 1999-2002 it was 1.6% and it dropped to 0.8% in 2007-2010.    Lead exposure is a still an issue, but it’s an issue that has been drastically improved.

To view a Cause Map of this issue, click on “Download PDF” above.  For more information, click here to visit the CDC’s information page about lead.


Reuse of Insulin Pens May Have Spread Hepatitis

By ThinkReliability Staff

After a similar incident at a Veterans hospital, a hospital in New York reviewed its insulin injection procedures and discovered that insulin pens may have been used for more than one patient.  Re-use of insulin pens for more than a single patient carries a small risk of cross-contamination, which can result in a patient being infected with a communicable disease, such as hepatitis B, hepatitis C, or HIV.

The hospital notified 1,915 patients who had received injections between November  2009 and January 2013 of the possibility for contamination and recommended testing.  Twelve patients have tested positive for Hepatitis C, and one has tested positive for Hepatitis B, though an investigation is ongoing to determine if this is related to the injections.

The use of insulin pens resulted in 30 outbreaks from syringe or needle reuse over ten years, from 2001-2010. So, although the possibility for cross-contamination is considered low, the risk for the spreading of communicable diseases is unacceptably high.

The potential for spreading communicable diseases is an important impact to the patient safety and environmental goals.  We can examine these impacted goals and the cause-and-effect relationships that led to these impacts, in a Cause Map, or visual root cause analysis.

We begin by defining the impacts to the goals.  In addition to the patient safety goal, the compliance goal is impacted because re-using insulin pens is against recommendations by the FDA and CDC.  The organizational goal is  impacted due to a lawsuit from the patients who have tested positive for Hepatitis B and Hepatitis C.  Patient services are impacted due to the improper reuse of the insulin pens, and the labor and property goals are impacted by the additional follow-up, testing and potential treatment for the almost 2,000 patients affected.  Once we have determined the impacts to an organization’s goals, we can ask “Why” questions, which helps develop cause-and-effect relationships that resulted in these impacts.

Insulin pens are designed for multiple injections, meaning that there is stored insulin within the cartridge after a single injection is given.  Backflow of blood into the pen can result in the remaining insulin being contaminated.  This can result in the spread of communicable disease if the pen is then used on a different patient for subsequent injections.

Because it is known that insulin pens should not be used on multiple patients, it is evident that there was an issue with the procedure or policy regarding use of insulin pens.  It is unclear what the specific issues were relating to this incident, but the hospital involved has reviewed and reinforced policies and procedures related to insulin injection.

Many facilities, including the hospital discussed here, which discovered the potential for re-use during a review after a similar incident at a Veteran’s hospital, have discontinued the use of insulin pens due to the potential for cross-contamination.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read the hospital’s press release.

Click here to visit our previous blog about about hepatitis B and C.

Click here to visit our previous blog about a different contamination issue involving hepatitis C.