Tag Archives: cancer

Root Cause Analysis

What’s the best way to screen for breast cancer? Opinions differ.

By ThinkReliability Staff

In 2015, there were 40,000 deaths from breast cancer and 232,000 new cases of breast cancer in the United States. It is the second-leading cause of cancer death in women in the United States. The very high level cause-and-effect is that people (primarily women) die from breast cancer due to ineffective treatment. The later the cancer is detected, the later the treatment begins so early detection can help prevent breast cancer deaths. Currently the best solution for detecting breast cancer is a mammogram. But the matter of when mammograms should occur is based on risk-benefit analysis.

There’s no question that mammograms save lives by detecting breast cancer. This is the benefit provided in the analysis. Lesser known are the risks of mammograms. Risks include false negatives, false positives, unnecessary biopsies, and unnecessary treatment. The radiation that may be used in treatment can actually be a cause of future breast (and other types) of cancer.

On January 11, 2016, the United States Preventive Services Task Force (USPSTF) issued an update of their guidelines on mammogram starting and ending age (as well as other related recommendations). To develop these recommendations, the task force attempted to quantify the risks and benefits of receiving mammograms at varying ages.

For women aged 40 to 49, the task force found that “there is at least moderate certainly that the net benefit is small.” The net benefit here reflects the benefits of screening (~.4 cancer deaths prevented for every 1,000 screened and an overall reduction in the risk of dying from breast cancer from ~2.7% to ~1.8%) compared to the risks of screening. Risks of mammograms every other year for women aged 40 to 49 include ~121 false positives, ~200 unnecessary biopsies, ~20 harmless cancers treated, and ~1 false negative for every 1,000 women screened. The task force determined that in this case, the benefits do not significantly outweigh the risks for the average woman. Thus, the recommendation was rated as a C, meaning “The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences.” (Women who are at high risk or who feel that in their individual case, the benefits outweigh the risk, may still want to get screened before age 50.)

For women aged 50 to 74, the task force found that “there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” The types of benefits and risks are the same as for screening women ages 40 to 49, but the benefits are greater, and the risks are less. For women aged 50 to 74, there are ~4.2 cancer deaths prevented for every 1,000 screened and an overall reduction in the risk of dying from breast cancer from 2.7% to ~1.8%.   Risks of mammograms every other year for women aged 50 to 74 include ~87 false positives, ~160 unnecessary biopsies, ~18 harmless cancers treated, and ~1.2 false negatives for every 1,000 women screened. The task force determined that for women aged 50 to 74, the benefits of mammograms every other year outweighs the risk. Thus, the recommendation was rated as a B (the USPSTF recommends the service).

The task force determined it did not have enough evidence to provide a recommendation either way for screening women over age 74.

Comparing these risks to benefits is a subjective analysis, and some do not agree with the findings. Says Dr. Clifford A. Hudis, the chief of breast cancer medicine at Memorial Sloan Kettering Cancer Center, “The harm of a missed curable cancer is something profound. The harm of an unnecessary biopsy seems somewhat less to me.” To those that disagree, the task force reiterates that personal preference should determine the age screening begins. However, insurers may choose to base coverage on these recommendations. (Currently, private insurers are required to pay for mammograms for women 40 and over through 2017.)

Determining these recommendations – like performing any risk-benefit analysis – was no easy task and demonstrates the difficulty of evaluating risks vs. benefits. Because these analyses are subjective, results may vary. To view the risk vs. benefit comparison overview by the task force, click on “Download PDF” above.

Root Cause

Health Declines as Veterans Wait for VA Care

By ThinkReliability Staff

On September 5, 2014, a tragic story was released of a man who lost most of his nose due to spreading cancer.   When diagnosing cancer, it’s generally acknowledged that the earlier the cancer is caught, the less the risk of the cancer spreading.  In this case, the veteran waited over two years for a biopsy.  He is one of thousands of patients who have had to wait unreasonable amounts of time for care through the Veterans Administration (VA) system.

Although the issues with delay of veterans care appear to be nationwide, looking at one particular incident can help shed some light on not only what went wrong, but possibilities for reducing the risk of it happening in the future.  The Inspector General examined dozens of cases of patients who died while waiting for care at the Phoenix VA hospital in order to determine the impacts of the delayed care, the causes related to it, and recommendations for fixing the problem.  We can also examine the impact, causes and potential solutions for the care issue by performing a root cause analysis based on the story of this particular patient.  (His case was not covered in the IG report, which primarily examined deaths of veterans while waiting to be seen at VA facilities.)

We can capture the analysis in a Cause Map, which visually lays out the cause-and-effect relationships that resulted in an incident in order to provide the maximum opportunities for improvement.  After the what, when and where of the incident are captured, it’s important to determine the impacts to the goals resulting from a particular issue.  In this case, the patient’s safety was endangered because of the spread of cancer.  The patient services goal was impacted because the patient lost most of his nose as a result of inadequate treatment at the healthcare facility.  The schedule/operations goal is impacted due to the delay in treatment of the patient.  In order to better quantify the effects of an overarching issue such as this one, a frequency of events is essential.  In this case, the Inspector General found that delayed treatment was clinically significant for at least 28 other veterans at the same VA hospital.  (The Inspector General also found that 40 veterans died while waiting for appointments but was unable to determine if the deaths were due to the delays.)

Beginning with an impacted goal, asking “Why” questions adds detail to the Cause Map.  The spread of the patient’s cancer was caused by a delay of treatment.  Treatment was delayed due to the exceptionally long wait for a biopsy (two and a half years) as well as the wait between the diagnosis and treatment (surgical removal).  Insufficient capacity and large numbers of veterans seeking care at the VA hospital resulted in veterans waiting months or even years for care.  Because (as described by a whistleblower physician from the site) the site used “secret” waiting lists (where patients were effectively put on a non-official waiting list for the waiting list so that the reported wait was within an acceptable time frame), oversight of the facility was minimal.  As in this case, many veterans prefer to get care at a VA facility and/or don’t have another type of insurance that would cover the costs incurred for healthcare needs.

As expected, the results of these investigations have resulted in a number of personnel being removed from their positions in the VA.  The “secret” waiting lists were used to hide the fact that the VA hospitals don’t appear to have the capacity for the number of veterans that need treatment.  Significant additional funding is being directed towards the VA in order to build more hospitals and hire additional medical staff.   In the meantime (and possibly continuing into the future if capacity continues to be inadequate), arrangements for veterans to receive covered care at other facilities are being made.

In light of these highly publicized issues, hopefully the VA will receive the funding and oversight it needs so that the nation’s veterans can receive the care they deserve.

Root Cause

Surgical Tool May Spread Cancer

By ThinkReliability Staff

Women who suffer from painful uterine fibroids may have their uterus removed for relief.  The most common hysterectomy procedure involves a 3-to-7-inch incision through which the entire uterus is removed intact.  Surgeries that can be performed laparoscopically through a smaller incision offer less scarring, fewer complications and shorter recovery time.  In order to remove the uterus through a smaller incision, it first has to be cut up into pieces.  This is performed using a laparoscopic power morcellator.  The device can also be used to remove fibroids only (called myomectomy) in a laparoscopic procedure.

On April 17, 2014, the Food and Drug Administration (FDA) issued a statement saying it “discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.” An advisory panel then provided a variety of recommendations, some going so far as to recommend completely banning the use of the device.

The issues surrounding the use of the morcellator can be examined in a Cause Map.  The Cause Map allows a visual diagram of cause-and-effect relationships that include the impacts associated with a particular issue.  In this case, the use of the power morcellator is found to increase the risk of spreading cancer, a clear impact to the patient safety goal.  Concerns about the delay in determining the safety risk (morcellators have been used since the 1990s) can be considered an impact to the patient services goal.  Sales of morcellators have been stopped, and as discussed above, the use of morcellators is being questioned by the FDA.

Beginning with the impacted goals, we can ask “Why” questions to determine the cause-and-effect relationships.  The risk for spreading cancer results from undetected cancer in tissues that are then cut up inside the body.  Uterine cancer is difficult to detect with available testing and can be difficult to distinguish from fibroids.  Additionally, cases have been found where cancer was missed in testing prior to surgical treatment.  Recent studies have shown that women who seek such surgeries have a higher incidence rate of uterine cancer (1 in 368 post-hysterectomy patients were found to have uterine cancer versus 1 in 10,000 for the general population).

The morcellator cuts up tissue so it can be removed laparoscopically in a minimally invasive hysterectomy or myomectomy for fibroids.  Until recently, there was no data or warning indicating that morcellators weren’t safe to use.  The device did not provide clinical trial data, which is not required for new products considered “substantially similar” to existing products that are already marketed.  The FDA does not believe that the cancer risk would have been discovered even with a higher level of scrutiny.  The FDA depends on a database of medical-device problems reported by doctors.  However, doctors are not required to report issues.  In addition, it’s not clear that many made the link from the spread of cancer after the use of the morcellator.  Or, some healthcare professionals say they didn’t report it because they believed the undetected cancer – not the use of a device – was to blame.

The link over spreading cancer has now clearly been established.  (Data is still being examined to see if the device worsens cancer as well.)  The FDA is working to determine what – if any – restrictions will be placed on morcellator use.  It’s pretty clear to some, especially given that this treatment for fibroids is considered elective and there are alternatives, including a traditional hysterectomy.  Says Dr. Craig Shriver, surgical oncologist at Walter Reed National Military Medical Center, “There is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery.”

However, others think the tool still has a place for minimally invasive surgery and that patients should be able to determine for themselves if the risk is worth taking.  According to Dr. Jason D. Wright, the lead author of a study regarding morcellators published in the Journal of the American Medical Association study, “I don’t know that necessarily morcellation should be banned. But this data is important to allow people to make decisions.”

In the meantime, some facilities are attempting to enclose the uterus in a protective bag before morcellation to minimize the risk of tissue remaining in the body, but there is no evidence that this reduces the risk of cancer spread.  Until the FDA’s final decision, each patient and healthcare facility will have to do their own risk assessment to determine whether or not the tool should be used.

 

Root Cause

Patient Gets MRI (and a Diagnosis) Only After 24 Visits to 13 Doctors

By ThinkReliability Staff

In a tragic case of incorrect diagnosis, a 16-year-old patient died January 24, 2013, eleven months after being diagnosed with “migraines”.  In fact, the patient had a rare brain tumor (known as a disseminated oligodendroglioma-like leptomeningeal tumor).  She died eight days after receiving an MRI that finally properly diagnosed the causes of her headaches, numbness, nausea and eyesight problems.

It’s unclear if earlier diagnosis would have saved the life of the patient.  Though the prognosis is poor for a leptomeningeal tumor, a oligodendroglioma that is treated before it is disseminated gives a long-term survival chance to 80-100%.  The tumor had disseminated once it was found on the MRI, eleven months after the patient was diagnosed with migraines.  However, even if her prognosis was poor, the patient could have spent the last eleven months of her short life enjoying time with her family and friends, instead of making 24 trips to 13 different doctors and, in one particularly devastating appointment, being accused of “putting the symptoms on”.

Although the coroner at the inquest said there was no need to make a formal recommendation for changes at the hospital that failed to diagnose the patient, a spokesperson for that hospital said “In the next few weeks, many of the clinicians who looked after Natasha will be meeting to discuss this sad case and ensure that any opportunities for learning are not missed.”

It is hoped that these opportunities for learning can reduce the possibility of another patient suffering as this patient did, due to a misdiagnosis.  Misdiagnosis is a common source of medical error.  According to an article by Michael Astion, MD, PhD, “Available data suggests that misdiagnoses occur in 15% or more of clinical cases, but overall there is very limited data on the frequency of misdiagnosis in medicine.”  Especially in rare clinical cases such as this one, sharing details of the disease and diagnosis may help other clinicians in the same position.

In order to effectively determine lessons learned and improvements that can be made, the details of a case need to be presented clearly and concisely.  I’ve put together the details of the case in a Cause Map, which uses cause-and-effect to demonstrate the linkage of the issues that led to the tragedy discussed here.

In a blog discussing the cases and possible responses, Suzanne Leigh suggests that if an MRI was denied, other cheaper alternatives, such as a CT scan, be considered.  She also suggests a much more thorough review to “ensure that in the future, scans are  not withheld from patients with potentially life-threatening conditions”  and that the hospital involved should “study the flaws in the system and human errors that led to the failure of 13 doctors to order a diagnostic MRI that would have resulted in emergency treatment earlier in the disease’s progression”.  Given the tragedy of this case, the suggestions seem far more appropriate than the treatment of the patient over the last year of her life.

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

Root Cause

New Prostate Cancer Tests Look Promising

By Kim Smiley

One in six American men will be affected by prostate cancer during their life making prostate cancer the most common non-skin cancer.  Despite the number of people impacted by this disease, screening and treating prostate cancer remains problematic and even controversial at times.

This issue can be analyzed by building a Cause Map, an intuitive format for performing a root cause analysis.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information.  How the issue impacts the overall goals is also documented in the Outline.  In this example, there are several significant impacts that need to be considered.  The first is that it’s estimated that about 30,000 men will die from prostate cancer in the US in 2013.  The second major issue is that many men are treated unnecessarily for prostate cancer.  Unnecessary treatments are a waste of resources and the side effects cause significant suffering.  The next step of the Cause Mapping process is to build the actual Cause Map by asking “why” questions and laying out the causes visually to show the cause-and-effect relationships.  (To see a high level Cause Map for this issue, click on “Download PDF” above.)

One of the factors that leads to so many deaths from prostate cancer is that it is generally found at later stages.  Most patients have few symptoms with early stage prostate cancer and current screening methods for prostate cancer are far from perfect.  Conditions other than prostate cancer, such as enlarged prostates, can result in positives during blood tests for prostate cancer.   The positive indications of cancer then trigger needle biopsies in areas of the body no one wants biopsied.  Less than half of these follow up biopsies find cancer cells. Physical exams for prostate cancer are uncomfortable and usually only find larger cancers.  Additionally, many prostate cancers grow so slowly that they will not impact a patient’s life span and do not require treatment, but there is currently no test that can accurately determine whether a prostate cancer is dangerous.

This inability to distinguish between types of prostate cancer is what leads to so many being treated unnecessarily for prostate cancer.  Many patients opt for treatment once prostate cancer is found because they have no way of really knowing whether it’s safe to leave the cancer untreated.   But treatment is not without significant costs, both financially and in suffering.  Many of the prostate cancer treatments, such as radiation or surgery, can cause major side effects such as  incontinence or sexual dysfunction.  Most patients will willingly undergo treatment for life threatening cancers, but it’s terrible that some patients endure cancer treatments without need.

The final step in the Cause Mapping process is to find solutions.  In this example, the good news is that many researchers are working to develop better prostate cancer tests, which would rapidly lead to better patient care.   Better tests could save lives by finding prostate cancers earlier and could help reduce unnecessary treatment by identifying the more dangerous cancers.  A urine test for prostate cancer is now available that has been found to be more accurate than current screening methods.  Other research groups are working to develop other urine prostate tests with a focus on developing accurate, low cost tests that can be performed at home.  None of these tests are perfect yet, but they are a significant step in the right direction.

 

Root Cause

Patient Receives Unneeded Mastectomy

By ThinkReliability Staff

Information about a lab mix-up that resulted in a patient receiving an unnecessary mastectomy was recently released by a health authority in Nova Scotia, Canada.  The authority has conducted an investigation into the error and how it occurred.  We can look at some of the information that will need to be considered in order to reduce the risk of a similar issue recurring.

First, we capture the “What”, “When”, and “Where” of the incident.  In this case, a switch of pathology results occurred in late April, 2013 at a cancer center in Nova Scotia.  The error was caught as a result of oversight analysis of tissue samples.

We can capture the goals impacted as the result of the issue.  In this case, the patient safety goal was impacted because a patient (Patient 1) received an unnecessary surgery (mastectomy).  In addition, the patient safety goal was impacted because another patient (Patient 2) did not receive a necessary surgery.  The staff employees are impacted because they are reportedly devastated, as frequently happens in cases like these.  The organization goal is impacted due to the apology given to the public as a result of this issue.  The patient services goal is impacted due to a switch of the tissue samples.  The property goal is impacted because an unnecessary procedure was performed, and the labor goal is impacted due to the extensive investigation that is taking place.

Asking “Why” questions can help determine the cause-and-effect relationships that led to the impacted goals.  In this case, the patient safety impacts are due to the switching of the patient’s sampling.  This occurred due to the results being recorded into the wrong records.

While trying to solve a problem, it can be helpful to examine the related processes.  In this case, we look at the tissue sampling process.  Any process is meant to get from point A to point B. In this case, the process ideally takes us from a tissue sample being taken (point A) to a diagnosis (point B).  We know that we did not get to point B in this case (i.e. the diagnosis was incorrect).  Looking at the steps in more detail can help us determine which specific part of the process did not go as intended, which will allow us to identify process-specific solutions.

A sample is taken from a patient, labeled, and sent to the lab.  The lab tests the sample, obtains the results, then delivers them to the patient’s physician or care center.  At that point, the results are recorded in the patient’s records and then used to make a diagnosis.  The error reportedly occurred at the point where the results were entered into the patients’ records.

Once we’ve identified the specific point where the error occurred, we can identify potential solutions.  In this case, the facility involved is implementing bar-coding and moving towards an automated system.  Although there is still the potential for error, it is reduced with automated systems and bar codes because the data has to be transcribed fewer times. As the Premier of Nova Scotia stated, “Human error is always a possibility. But one of the things we strive for is to ensure there are appropriate controls in place to ensure that the risk of these things is absolutely minimized.”

To view the Cause Map and Process Map, please click “Download PDF”.

Root Cause

Promising New Cancer Drugs Use the Immune System

By Kim Smiley

A promising and potentially powerful new type of cancer treatment uses the immune system to fight tumors.   The drugs are still in early testing, but reports are that they shrunk tumors significantly in 15 to 50 percent of patients.  Patients with different types of cancer have also responded, which is an encouraging sign that the new treatment may have wide spread applications.

A Cause Map, or visual root cause analysis, can help illustrate how these new drugs work and explain why researchers and the companies developing them are so excited about them.  It may seem strange to use a root cause analysis technique on something positive, but it can be just as beneficial to understand why things are going well as it is investigate when problems crop up.  If you understand why a success occurred, the information may be used to reproduce it.   Building a “success” Cause Map is the same as any other Cause Map.  You start by identifying the impacted goals and then ask “why” questions.

In this example, the safety goal was impacted because the new type of cancer treatment shows promise, and the economic goal was impacted because the stock for the companies developing the new cancer drugs rose.   The new cancer treatment being developed shows promise because patients are responding to it and it is completely different from anything being used today.  The new immunotherapy treatments use the body’s own defenses, the immune system, to fight cancer.

You may wonder why drugs are needed at all if the immune system has the ability to fight cancer.  The answer lies in a  cancer tumor’s ability to hide from the T cells, the part of the immune system that detects bacteria and other “invaders”.  Tumors produce a protein on their surface that prevents T cells from detecting them so the immune system never even knows they are there.  A very simplified explanation is that the new drugs block the protein that hides tumors and allow T cells to detect them.   Once detected, the immune system will attack the cancer.

If immunotherapy is successfully developed, it would give doctors more options in treating cancer, especially those that don’t respond to the conventional treatments.  So far the side effects have also been minimal, far less than what is generally seen with chemotherapy and radiation treatments.

Much more research is needed before this type of drug is widely available, but the findings so far are positive enough to increase stock prices and excite experts in the field.   I have my fingers crossed that the end result is everything researchers are dreaming it will be.

Root Cause Analysis

The Low Survival Rate of Pancreatic Cancer

By Kim Smiley

Sally Ride, the first US woman in space and a national hero, died after a 17-month battle against pancreatic cancer on July 21, 2012.  Pancreatic cancer is a particularly deadly cancer with only a 6% five-year survival rate.  This disease also affects many people.  In 2010 alone, an estimated 43,000 people in the US were diagnosed with pancreatic cancer.

The reasons that pancreatic cancer is so deadly can be explored by building a Cause Map, a visual root cause analysis.  The first step in building a Cause Map is outlining the problem which includes defining how the problem impacts the organizational goals.  In this example, the primary goal considered is the impact to the safely goal since pancreatic cancer has such a low survival rate.

In order to build the Cause Map, “why” questions are asked and the answers are added to the Cause Map.  Why does pancreatic cancer have such a low survival rate?  The survival rate is low because the cancer has usually spread beyond the pancreas by the time it is detected and pancreatic cancer is difficult to treat.  The cancer has typically spread before detection because there are very few symptoms in the early stages of the cancer and any symptoms that do exist are usually vague, like aches and pains that could easily be attributed to other illnesses.  There is also no screening test like there are for breast or prostate cancer to detect pancreatic cancer at this time.

Pancreatic cancers are difficult to treat for several reasons.  First, pancreatic cancers are resistant to chemotherapy.  The best course of treatment is typically removal of the tumor, but many cases are caught too late for the tumor to be removed because the cancer has usually spread by the time it is detected.

Researchers are working on improving the survival rate for pancreatic cancer.  There are some promising studies that show it may be possible to develop a screening test that could detect pancreatic cancer at earlier stages, which could significantly improve the chances for survival.

To view a high level Cause Map of this issue, click on “Download PDF” above.

Root Cause Analysis

Shortage of Life Saving Cancer Drug

By Kim Smiley

Shortage of a lifesaving cancer drug, methotrexate, has hospitals scrambling to find enough drugs to treat patients. Methotrexate has long been a treatment for acute lymphoblastic leukemia, or ALL, and a type of bone cancer called osteogenic sarcoma.  A particular form of methotrexate without alcohol-based preservatives is needed to treat ALL because a high dose must be injected directly into the spines of patients and preservatives can be toxic and cause paralysi at such a high dose.  With treatment, ALL can be cured more than 90 percent of the time.  What makes this drug storage particularly heart breaking is that ALL most often strikes between ages 2 to 5.  If hospitals don’t have adequate supplies of preservative free methotrexate, children will die from a disease that is largely curable.

This issue can be analyzed by building a Cause Map, an intuitive, visual root cause analysis.  A Cause Map is built by determining the impact to the overall goals and then asking “why” questions to add causes that contributed to the issue and show the cause-and-effect relationships between the causes.  In this example, the safety goal is clearly impacted because there is a risk of patient death.

To begin adding causes to the Cause Map, we could ask why that is true.  Patients may die because they have cancer, the doctors may not be able to treat the cancer and the cancer is fatal if untreated.  Why might the doctors be unable to treat the cancer?  There is a shortage of the required medication because the plant that was the primary supplier for US is shut down.  The plant is voluntarily shut down so that significant manufacturing and quality issues can be addressed.  In order to understand the issues, it is also worth asking why one plant manufactured so much of the supply of methotrexate.  As much detail as necessary can be added to the Cause Map.  Once the Cause Map is built, the information can be used to brain storm solutions and determine which should be implemented.  To view a high level Cause Map of this issue, click on “Download PDF” above.

In this example, the FDA is currently negotiating with five plants that are approved to manufacture methotrexate to increase their production of the drug.  In the meantime, the plant that was shut down has worked with the FDA to allow distribution of some of the methotrexate that was manufactured, but not shipped prior to the shutdown.  Hospitals still have a smaller supply of methotrexate than would be desired, but all patients’ needs are currently being met.

 

Root Cause Analysis

Drug Shortages in the US

By Kim Smiley

The FDA has reported a record number of drug shortages in 2010 that is continuing to increase into 2011.  Some of the drugs included in this shortage are chemotherapy drugs.  Providers across the U.S. are reporting that the shortages may endanger patients if they are unable to receive the necessary drugs.  In some cases, drugs that are more expensive, less effective, or both are being used.  Or, patients are turning to the “grey market”, buying drugs of questionable safety that have, in most cases, been significantly marked up.  Additionally, because already approved drugs are needed for clinical trials, some clinical trials have been delayed, limiting the addition of new medications.

We can look at this issue in a Cause Map, a visual root cause analysis.  A Cause Map connects the impacts to the goals of an organization, or in this case, the U.S. healthcare system.  The patient safety goal is impacted because of the risk to patient health.  The organization goal is impacted because of delayed clinical trials.  The patient services goal is impacted because of the lack of needed medication.  Also, the property goal is impacted because of the replacement with more expensive medications.  We use these goals as the basis for our Cause Map, then ask “Why” questions to complete the analysis.

Insufficient supply is caused by demand greater than supply.  Both of these factors can contribute to the overall effect.  Although there are several reasons for increased demand, the most pertinent to this issue appears to be hoarding – where physicians hear of shortages and are attempting to create a stockpile for their patients.   However, increased insurance coverage and general increased need for medication for diseases such as cancer are also likely contributing.

Reduced supply is also contributing to the shortage.  Shortage of raw ingredients is considered to account for about 10% of the issue, with quality issues and insufficient production accounting for the rest.  In some cases, manufacturers are believed to be limiting their production – or ending it all together – because the drugs do not provide much profit.  Many of the limited drugs are generics, which do not provide as much profit as name brand drugs, especially as drug profits were limited by the Medicare Prescription Drug, Improvement and Modernization Act of 2003, which limited price increases in an attempt to limit Medicare spending.  The resulting drug shortage – which is sometimes resulting in paying for much more expensive drugs – is certainly an unintended consequence of this act.

Despite best intentions, changes made to fix an identified problem may in fact cause another one – sometimes one that is far greater.  This is why follow-up to implemented solutions must occur at regular intervals, and must include a comprehensive assessment of whether the solutions are effective.

Some of the solutions recommended to prevent the issues caused by these drug shortages are to create a national stockpile of certain kinds of drugs and requiring notification to the FDA of  supply shortages.  In the meantime, the FDA is providing guidance to patients and providers to attempt to ease the ongoing issues.