Concern Over Rising Costs of Specialty Drugs

By Kim Smiley

The good news is that more and more specialty drugs that show promise for treating serious medical conditions are becoming available.  The bad news is that some of these drugs are really expensive, both for insurance companies and individuals.

The new issues swirling around specialty drugs are illustrated well by the new drug for treating hepatitis C from Gilead Sciences.  The new drug is a significant improvement over previous treatment with a higher cure rate, a shorter duration and fewer reported side effects, but it carries an equally significant price tag.  The pills cost $1,000 each with a typical course of treatment costing $84,000.  The pills are in high demand and Gilead has reported a record breaking $2.3 billion in sales of their new hepatitis C drug during its first full quarter on the market.  But on the flip side, UnitedHealth Group, one of the largest US insurers, has reported it has spent $100 million to cover the hepatitis C drug and had their stock prices decrease.

An insurance company losing money may not seem like a source of concern, but more of the burden of the cost of specialty drugs is being passed along to patients as insurance companies figure out how to deal with the high price of specialty drugs.  Some insurance plans require patients to cover twenty percent of the cost of specialty drugs and 20 percent of $84,000 is beyond the means of many patients.  And some specialty drugs are even more expensive.  Also, financially healthy insurance companies are also vital if they are going to provide medical insurance at prices people can afford.

So why are these drugs so expensive? There are a number of factors that make specialty drugs so expensive.  One of them is that they generally treat a condition that relatively few people suffer from.  When more people take a particular drug, the development costs of the drug can be spread out and recouped over a larger population making the overall cost less for each individual.  The opposite occurs when there are fewer people who will take a particular medication: the development costs are more concentrated, making drugs for less common conditions more expensive in general.

There is also not usually a generic alternative available for specialty medication.  Many of the expensive specialty medications are newer and still protected by patents so that generics can’t be manufactured.  Most specialty medications are also biologics, meaning they are derived from living organizations, and they can’t be duplicated.  Medications with generic versions available tend to be chemically-based and easier to replicate.

Only time will tell how specialty medications will continue to shape the healthcare system, but their presence is only likely to grow as more drugs are developed.  Solutions will need to be developed to allow patients reasonable, affordable access to specialty medications, but also keep insurance and drug companies in business.

To see a Cause Map, or visual root cause analysis, of this issue, click on “Download PDF” above.

Lack of Available Treatment Leads to Fatal Heroin Overdose

By ThinkReliability Staff

The death of a young man in New Jersey on September 23, 2010 from a heroin overdose was tragic, but part of a trend becoming more and more common.  His death mirrors many of the other fatal heroin overdoses and by examining the issues that led to this fatality, solutions that could reduce the death rates from heroin overdoses across the country (and perhaps beyond) can be developed.

We will examine this particular case in depth by using a Cause Map, or visual root cause analysis. First we capture the particulars of the issue – what, when and where – as well as the impact to the goals.  The fatality is an impact to the patient safety goal, while insufficient help being available is captured as an important difference, and is also an impact to the patient services goal.

Beginning with an impacted goal (in this case, the patient safety goal), we ask why questions to determine the cause-and-effect relationships that led to the impact.  In this case, the death resulted from a heroin overdose.  Overdoses typically result from use of this specific drug, with which overdoses are not uncommon.  Though it is not clear if this played a role in this particular death, heroin overdoses can occur after a user attempts to get clean and relapses.  If the user goes back to the dose from before ending use of the drug, the body (if it has been drug free for some period of time) is unable to handle it, resulting in the overdose.

In order to overdose, heroin use has to begin.  The use of heroin is rapidly increasing, with an estimated 669,000 users by 2012.  First-time users increased from 90,000 in 2006 to 156,000 in 2012.  The reason for the increase is believed to be the comparatively inexpensive cost compared to prescription opiates.  While a gram of heroin might sell for $100, crackdowns against prescription drug “pill mills” have increased the cost of prescription opiates (like OxyContin) to $1,000 a gram.

Once heroin use has begun, quitting is extremely difficult.  While withdrawal symptoms are not life-threatening, they are extremely unpleasant (to use a massive understatement).  Because they are not life-threatening, emergency care is limited (the victim in this case was unable to be admitted to the hospital) and many insurance companies won’t cover treatment, which can be extremely expensive.  In 2012, only 2.5 million of the 23.1 million Americans who needed drug or alcohol treatment received aid at a special facility.

Hope for overdose victims is available in the form of naloxone.  Since 2001, the use of naloxone by emergency responders resulted in reversal of over 10,000 overdoses.  The Affordable Care Act should improve insurance coverage for treatment, though it may take years for this to be in effect and, with the treatment availability shortage, likely means that not everyone will get the help they need.

However, solutions that address the problem of heroin use itself are being developed.  According to Attorney General Eric Holder, “Confronting this crisis will require a combination of enforcement and treatment.  The Justice Department is committed to both.   Since 2011, the DEA has opened more than 4,500 investigations related to heroin.  And as a result of these aggressive enforcement efforts, the amount of heroin seized along America’s southwest border increased by more than 320 percent between 2008 and 2013.   Of course, enforcement alone won’t solve the problem.  That’s why we are enlisting a variety of partners – including doctors, educators, community leaders, and police officials – to increase our support for education, prevention, and treatment.”  With the help of the federal and local governments, as well as dedicated families of users, it is hoped that the tide of heroin use will be turned.  This will be the most effective way to stop overdose deaths.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Hundreds Affected in ‘Unprecedented’ Ebola Outbreak

By ThinkReliability Staff

The ongoing Ebola epidemic in Africa is “unprecedented” due to its high mortality rate (up to 90%), geographic spread (at least 5 countries have reported cases of the disease, which has spread to urban areas as well), and difficulty enforcing quarantines that would reduce the spread.  As with many outbreaks, the factors involved are complex and wide-ranging.

We can address the issues contributing to the outbreak by capturing them in a Cause Map, or visual root cause analysis. This intuitive method ties impacted goals to cause-and-effect relationships, allowing development of solutions to all aspects of an issue.

First we begin with the impacts to the goals.  The outbreak began in Guinea at some point in early 2014, but was reported to the World Health Organization (WHO) on March 23, 2014.  The outbreak is still ongoing and has impacted Guinea the most, but has also spread to neighboring countries.  The strain involved is the Zaire Ebola virus, which is spread by bodily fluids.

At the date of publication, the virus has killed at least 101 out of 157 infected in Guinea alone.  The infections and deaths, as well as the spread of the disease, can be considered impacts to the public safety goal.  This is the first outbreak to have impacted urban Guinea, though there have been dozens of outbreaks in Africa over the past 40 years.

“Why” questions are used to determine the cause-and-effect relationships that resulted in the impacted goals.  Death typically results from bleeding or shock, which occurs due to infection with the virus and insufficient treatment. Infection results from the initial transmission (caused by eating raw infected meat), and the spread of the disease.  The spread in this case has resulted from the unusual migratory pattern, both because of the easy and frequent travel between countries but also due to an as-yet-unknown factor.  Normal outbreaks involve a much smaller geographic area.) Victims are contagious for a long time, meaning the disease is easily spread, and it has been difficult to enforce quarantine, because of mistrust of local authorities and foreign aid workers.  According to Stéphane Hugonnet  of WHO, “The mortality rate is extremely important.  Nine out of ten patients will die.  If we look at this from the population’s perspective, why would you go to a hospital if you have almost zero chance of getting out of it.”  However, with effective care, there is a chance of surviving Ebola.

However, providing that care is another challenge.  There is no cure for Ebola, possibly because financial incentives to develop a cure for a rare disease that primarily strikes poor African villages isn’t there. Care essentially involves keeping a person alive long enough for their body to be able to fight back, difficult in a country that has 0.1 physicians for every 1,000 people fighting a disease that rapidly replicates and – through an unknown mechanism – disables the immune system.

So what’s being done to end this outbreak?  Medical teams from Doctors without Borders (or Médecins Sans Frontières) and WHO have been dispatched to the area.   These medical teams may include anthropologists, to better address local concerns regarding the disease.  WHO has also recommended limiting personal contact and a on raw bush meat.  Meanwhile, researchers are working on a vaccine to prevent  transmission of Ebola.  It is hoped that these steps together will end this outbreak – and prevent future outbreaks as well.

To view the Outline, Cause Map and Solutions, please click “Download PDF” above.

CDC Finds that 1 in 25 Patients Acquire an Infection While in the Hospital

By Kim Smiley

A recent headline from the New York Times reads “Infections at Hospitals Are Falling, CDC Says”.  That sounds like fantastic news right?  Well, what about this one from the same day from the Washington Post: “One in 25 patients has an infection acquired during hospital stay, CDC says.”  One in 25 doesn’t seem like great odds to me.  The two headlines give very different impressions of the problem, so which one is right?

The truth is that both statements are accurate, but neither tells the complete story.  To really understand the situation, you need to read a lot more than just the headlines. This is a good analogy for what happens in meetings every day.  Something goes wrong and everybody thinks they know what THE problem is or what is THE root cause.  Many times when people argue they aren’t really in disagreement, they are just focused on different parts of the same puzzle.

Building a Cause Map, a visual format for performing a root cause analysis, can help reduce miscommunication.  The first step in the Cause Mapping process is to fill in an Outline.  The top of the Outline lists the basic background information.  At the bottom of the Outline, there is space for listing the specific impacts to the overall goals.  People may argue about what THE problem is, but it’s hard to argue when specifically listing how the problem impacts goals.  For example, most people would agree that increased cost of healthcare is an impact to the overall economic goal of a hospital.  It may sound counterintuitive, but adding detail helps clarify the situation, when defining the problem and when actually determining what went wrong.

In the case of those headlines listed above, both refer to a recent study by the Center for Disease Control and Prevention that found that about 1 in 25 patients in US hospitals in 2011 acquired at least one infection based on data from 11,282 patients treated at 183 hospitals in 10 states.   (The total number of patients who acquired at least one infection is over 700,000.) The study estimated that around 75,000 of these patients died, but didn’t provide information on whether the deaths directly resulted from the infections.  The study also didn’t include nursing homes, emergency departments, rehabilitation hospitals and outpatient treatment centers.  Previous estimates put the number of infections each year at 2.1 million in the 1970s and 1.7 million from 1990 through 2002. The rate of infections also varies widely from hospital to hospital.  There is uncertainty in the data available, but the trend seems to be going in the right direction, even though the problem of hospital-acquired infections remains significant.  Before working to reduce the risk of a problem, it’s important to lay out all the facts and understand what exactly the problem is.  That generally requires more than a simple statement, which is why the Cause Mapping uses a formal Outline to define a problem.

After the Outline is completed, the next step is to analyze the issue by building a Cause Map by asking “why” questions starting with one of the impacted goals.  Hospital acquired infections are an impact to the patient safety goal so we could begin by asking “Why are patients getting infections in hospitals?”  This occurs because they are exposed to a pathogen.  Why?  There are pathogens at the hospital because many sick people are there for treatment.  Inadequate cleanliness also plays a role.  Additionally, the pathogen is able to infect the patient.  You would continue asking questions to determine why patients are being infected until you reach the desired level of detail.  Generally, the bigger the problem, the greater level of detail is needed.

To view a completed Outline and a Cause Map of this issue, click on “Download PDF” above.