6 Dangers of Pharmacy Compounding: What Patients Need to Know

For millions of Americans, prescription drugs provide the help they need to live healthy, independent, pain-free lives. The Food and Drug Administration (FDA) carefully examines each new drug before allowing pharmaceutical companies to release them onto the market.

However, patients sometimes have special needs that standard prescription medications cannot meet. Compounding pharmacies present solutions to these anomalies, creating customized formulations or delivery methods for patients with allergies or other special considerations. Since a licensed pharmacist must change the ingredients of a medication to meet individual needs, the practice comes with heavy inspections and heightened accountability. Unfortunately, many compounding pharmacies fail to protect public health adequately.

Compound drugs can and do save lives. However, when pharmaceutical companies engage in unapproved compounding practices, the ramifications for patients can include:

•    Contamination. Individual or small batches of medication are more vulnerable to harmful fungi or other particles.

•    Incorrect potency. While FDA-approved formulations have been shown to produce consistent results, custom mixtures may be too weak or strong for patients.

•    Diminished quality. Drugs mixed at independent compounding facilities often lack the quality control of major pharmaceutical manufacturers.

•    Impurities. Outside agents in compound drugs often reduce their efficacy.

•    Exacerbated illness. Patients with serious health issues often receive compound formulations. These can fail to adequately treat conditions, and their side effects can in turn severely impact an individual’s wellbeing.

•    Higher costs. An unfortunate number of compounding pharmacies take advantage of insurance billing policies by loading compound drugs with expensive ingredients. Prescription plans often pass these costs to customers or refuse to cover medications.

When patients receive compound medications from pharmacies, they expect these drugs to perform as indicated without causing unexpected side effects or illnesses. If a compound medication has harmed you or a loved one, a Washington D.C. medical malpractice attorney can help you hold the pharmacy accountable and obtain the compensation you deserve.

Curious about the diverse dangers of the compound pharmacy industry? Read Pharmaceutical Compounds: Investigating and Regulating Their Use (Part 2)

Posted In Medications
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Former Compounding Center Supervisor Arrested Over Meningitis Outbreak

On September 4, authorities detained Glenn Chin at the Logan International Airport in Boston, as he tried to board a flight to Hong Kong with his family. His arrest can be traced back to a 2012 meningitis outbreak caused by tainted drugs from the New England Compounding Center. Chin served as a supervising pharmacist of the now defunct company.

The outbreak, one of the deadliest in recent history, occurred when a batch of the company’s painkilling, injectable drugs was contaminated. Before its recall and the subsequent closure of the plant, the drug devastated families across the U.S. The corruption-created outbreak caused diverse problems, including:

  •  750 cases of meningitis
  •  64 deaths
  •  20 states impacted by contamination-related illness

Of these meningitis cases, “217 infections and 15 deaths” allegedly had been a direct result of Chin’s signing off on a batch of drugs. After an inspection of the New England Compounding facilities, federal and state health investigators reported considerable faults with sterility and maintenance – both areas of Chin’s responsibility as supervisor.

Several pending lawsuits name Chin as a defendant in Boston federal court. The criminal investigation is still in progress, which is why law enforcement officials detained Chin as he attempted to leave the country. Although Chin was not the only individual allegedly responsible for the outbreak, authorities have placed a high priority on holding all former staffers and supervisors from the New England Compounding Center accountable for their actions.

In both traditional pharmacies and compounding facilities, pharmacists assume legal responsibility to keep the medicines they distribute untainted. The recent meningitis outbreak serves as a tragic example of the devastating consequences that can happen when medical professionals fail in their duties.

If you or a loved one became ill due to a pharmaceutical error, you may be entitled to compensation for lost wages, medical bills, pain and suffering and other damages. Contact a Washington D.C. medical malpractice attorney today to discuss your legal options.

Explore more info about these pharmacies (and their dangers) by checking out Pharmaceutical Compounds: What They Are and How They Cost Consumers (Part 1)

Posted In Medications , Patient Safety , Public Health
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Pharmaceutical Compounds: Investigating and Regulating Their Use (Part 2)

In our last post, we discussed how pharmaceutical companies have begun to profit from the proliferation of compound drugs, as reported by the New York Times. Today, we will examine the measures various entities have taken to investigate and regulate these products.

Catamaran, a pharmacy benefits manager, discovered their spending on compounded drugs had increased fourfold over the past two years. The company is now making a concerted effort to examine such claims to determine their validity. Similar companies – including Blue Cross Blue Shield, Harvard Pilgrim, and state workers’ compensation plans – are now doing the same.

Express Scripts, meanwhile, recently decided to stop payments for over 1,000 of the ingredients compounders commonly use. This 95 percent reduction in spending has saved money for consumers, health plans, and employers alike, while cutting into the profit margins of compounding pharmacies.

According to Dr. Sumit Dutta, Catamaran’s chief medical officer, such measures remove the “profit motive” driving these companies to produce more complex and expensive medications.

In Southern California in June, 15 individuals -- including financial brokers, doctors, chiropractors, and pharmacists -- were indicted for participating in a “kickback scheme” targeting workers’ compensation plans. Kareen Ahmed of Landmark Medical Management allegedly helped to purchase accounts receivable from health providers awaiting payment for workers’ compensation related services.

Some states have responded to the compounding pharmacy problem by imposing payment limits (Ohio) and limits on the number of ingredients payable per prescription (Georgia).

However, the compounding industry refuses to go down without a fight. The new Patients and Physicians for Rx Access, founded in June, advocates for compounding pharmacies, claiming that patients need compound drugs -- that standard medications often do not meet their health needs.

Have you or a loved one experienced negative effects as a result of a contaminated or incorrectly formulated compounded drug? Call a D.C. medical malpractice attorney today to discuss your legal options.

Want to learn more? Check out: Compounding Pharmacy Report Reveals Limited Regulation

Posted In Medications
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Pharmaceutical Compounds: What They Are and How They Cost Consumers (Part 1)

The rising costs of health care in the United States are no secret to doctors, patients, or pharmacists. Lifesaving drugs, procedures, and equipment continue to place a high cost burden on consumers and their insurers.

Among the fastest-growing and most expensive treatments patients received as of late are compounded drugs, according to a recent article by the New York Times. These formulations consist of custom ingredients to meet the unique needs of patients, from diaper rash to pain and scarring.

Created by compounding pharmacies, these drugs present alternative treatments for individuals unable to take mass-produced drugs due to ingredient intolerances, an inability to take oral doses, or other complications. Pharmaceutical compounds frequently cost exponentially more than their standard counterparts, reaching into hundreds or thousands of dollars.

Compounding companies claim the prices of their products have increased due to rising oversight of their international chemical suppliers. However, a change in 2012 to how pharmacists bill insurers for compound medications likely points to a more compelling reason.

Whereas pharmacists used to submit claims based on the price of the main ingredient in a compound, they now bill based on each ingredient in a compound. Incidentally, the number of ingredients in each compound has begun to increase.

Not only are insurance companies and patients bearing the brunt of these excessive costs – the safety of pharmaceutical compounds has also recently been called into question. A recent high-profile example was a steroid injection that sickened 750 and killed 64 after being tainted with a fungus at the New England Compounding Center.

This troubling news comes as pharmacy benefit managers note compounded drugs often yield no more benefits to patients than their mass-marketed equivalents. In addition, compounds require no FDA approval, putting their safety and efficacy further into question.

In Part 2, we will discuss how the medical and legal communities have reacted to the high costs of compound drugs.

If you or a loved one have experienced injury or illness due to faulty pharmaceuticals, contact a D.C. medical malpractice attorney today.

Want to read more? Check out this article: Senate Drafts Bill to Regulate Compounding Pharmacies

Posted In Medications , Patient Safety
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New Research Casts Doubts on Benefits of Niacin for Heart Health

Although many physicians have prescribed niacin, or vitamin B3, to treat high cholesterol levels, a recent study shows the compound may cause more problems than it prevents.

In its July 17 issue, the New England Journal of Medicine details a major clinical trial scientists conducted to explore the benefits of niacin in patients with hardened arteries. Researchers found it did slightly raise HDL (“good”) cholesterol in subjects but presented no apparent cardiovascular benefits.

In the study, researchers at Oxford gave half of the 26,000 study participants a pill composed of niacin and laropiprant, while providing the other half with a placebo.

According to Jane Armitage, senior author of the study and professor of clinical trials and epidemiology at Oxford, niacin intake also heightened the risk of dangerous side effects, such as increased blood sugar in diabetics, higher numbers of new diabetes diagnoses, and a proliferation of skin problems, gout, infections, diarrhea, excess bleeding and liver problems. These side effects led to several hospitalizations.

More notably, 9 percent more patients died when taking niacin compared to the control group. Although researchers note this percentage is not statistically significant, it represents a “deal breaker” to Dr. Donald Lloyd-Jones, who penned the editorial accompanying the study.

Researchers concluded niacin use is unlikely to create the effects for which doctors have prescribed it, such as increasing HDL cholesterol and reducing stroke and heart attack. They recommend any individuals currently taking niacin contact their physicians to discuss switching to statins, which have proven safer and more effective.

Constant discoveries in the medical field often uncover complications and dangers presented by commonly-prescribed medications. Although medical professionals do their best to provide the best care based on the information available to them, they must be held accountable when their recommendations lead to negative effects in their patients.

If you or a loved one have suffered as a result of an inappropriately prescribed medication, contact a DC medical malpractice attorney today to discuss legal options.

Have you talked with your doctor regarding the safety of your medications?


Posted In Medications
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What Does the FDA Say about Sunscreen Labels?

Spending time in the sun represents one of the most enjoyable parts of summer, but the risk of sunburn, early aging and skin cancer do not. To mitigate these risks while keeping individuals more comfortable all season long, numerous sunscreens exist.

In the past, these products have made claims on their packaging that have failed to bear out in regular use. Those believing they were providing themselves with superior sun protection often put stock in misleading claims, leading users to purchase products less effective than advertised and use them less liberally than intended.

To combat widespread misunderstanding about the nature and efficacy regarding sunscreen, the FDA recently released new labeling guidelines to reduce the ambiguity of packaging claims. These new restrictions include:

1.    Cancer risk statements.
On products providing SPF below 15, the FDA now requires companies to provide a disclaimer stating they do not provide sufficient protection from early skin aging or cancer.

2.    Water resistance clarifications.
To reflect the inability of any sun protection product to provide “all day protection” or “sweat-proof” or “waterproof” qualities, sunscreens may now designate themselves only as “Water Resistant (40 Minutes)” or “Water Resistant (80 Minutes).”

3.    Limits on SPF levels. Although sunscreens once designated themselves as high as SPF 100, few products offer more than SPF 50 protection, which blocks close to 100 percent of the sun’s rays. Most highly-rated sunscreens will now advertise as “SPF 50+.”

4.    Tighter restrictions on broad-spectrum.
The term “broad-spectrum” refers to products providing protection from UVA as well as UVB rays. Companies must now pass a wavelength test to ascertain their protection from UVA rays.

5.    Elimination of “sunblock.” This previously used term misled many consumers into believing a product provided full protection from UV rays, leading the FDA to designate all sun protection products as sunscreen.

The FDA’s new regulations have provided additional oversight in an industry prone to ambiguous claims.

When manufacturers use dishonest advertising to sell products, significant injuries and illnesses may result. DC product liability attorneys help those affected by such claims hold companies accountable for their actions.

Are the products you use living up to the claims they make?

Do you need to go to the hospital for a skin condition or sunburn? Read these 10 tips to stay safe.

Posted In Product Liability , U.S. Food and Drug Administration Warnings
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CDC Admits to Improper Handling of Pathogens

Recent revelations out of the Centers for Disease Control (CDC) may raise doubts among citizens regarding the organization’s ability to keep the public safe from harmful pathogens.

According to the Washington Post, several Alabama laboratories run by the federal government failed to follow protocol five times in the past decade when they sent anthrax, bird flu, and botulism bacteria to partner laboratories.

In response to these incidents, the CDC halted operations at labs specializing in influenza and rapid bioterrorism responses. They also temporarily suspended other CDC labs from sending out any biological materials until they complete a full investigation.

Although up to 84 employees faced potential anthrax exposure during the incident, no illnesses or infections have resulted to date. In addition, the organization has disposed of the organisms in question.

How These Lapses Could Affect the Public

It seems as though the CDC is currently working to manage the situation and prevent similar mistakes from occurring in the future. However, individuals across the country ought to be aware of the potential risks associated with past or future errors in handling these dangerous pathogens.

In the wrong hands, only one package of transmittable organisms could result in widespread infection and disease. With more of the population embarking travel across the country and the world, one infected individual could begin a global chain reaction difficult to control or reverse.

Legislators and public interest groups alike will certainly continue to monitor conditions at the CDC in the expectation they will more thoroughly and strictly enforce safety procedures in the future.

Organizations such as the CDC assume a major responsibility in ensuring the health and safety of the public. When these entities experience security breaches and failures, the potential for devastating effects on citizens is far-reaching.

If you or a loved one has experienced illness or infection due to the failure of an organization charged with public health, contact a Washington, D.C. public health attorney to obtain help fighting for the justice you deserve.

Posted In Public Health
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Do Medical Malpractice Lawsuits Impact the Quality and Outcomes of Surgeries? [An Analysis of a Recent Study]

In February, Christina A. Minami and her colleagues published an article in the journal of the American College of Surgeons about the impact of medical malpractice lawsuits and litigation on surgeries in the United States: “Impact of Medical Malpractice Environment on Surgical Quality and Outcomes.” (links to abstract only)

The authors aimed to “perform a systematic review of the literature to examine the association between malpractice environment and outcomes in surgical specialties.”

What did they conclude, and why?

Before we analyze the paper, let's take a look at some interesting assumptions they made at the beginning of the research project. They wrote: “the annual cost of the medical malpractice system has been estimated to be $55 billion. The medical malpractice crisis that began unfolding in the late part of the 20th century continues to be a major concern. The intent of the malpractice system, based on classic tort deterrence theory, assumes that the looming threat of a malpractice suit will deter poor care because providers will be more vigilant and responsible. Proponents of the liability system believe that the threat of malpractice suits will encourage providers to adhere to standards of care, which, in turn, should lead to better patient outcomes.”

They also describe a recent study that “found that one-quarter of American surgeons had been the subject of a malpractice suit over the preceding two years.” They mention that some analysts worry that these lawsuits “may force providers to leave high malpractice risk environments.”

In other words, surgeons might be deterred from engaging in risky, but important medical practices because they don’t want to get sued.

There are several potentially problematic implications here.

First of all, when discussing the medical malpractice “environment,” you cannot leave out the Goliath role played by insurance companies. Many advocates of so-called tort reform want to blame trial lawyers for escalating insurance costs – and thus for indirectly creating stress for medical practitioners. However, a compelling case can be made that trial lawyers are not to blame; rather, insurance companies control the financial dynamics that make circumstances miserable for doctors.

Secondly, there's a troubling subtext in this article: a suggestion that lawsuits against surgeons are out of control. The authors wrote: “One quarter of American surgeons have been the subject of a malpractice suit over the past preceding two years,” thus seeming to imply that lawyers are going crazy and filing spurious suits against surgeons.

Compelling evidence, however, paints a decisively different picture. As recent Harvard University review of medical malpractice cases found, the vast, vast majority of malpractice cases are well-grounded. In fact, it’s likely that the lion's share of medical malpractice incidences go un-litigated and unpunished.

If you or somebody you love believes you’ve been the victim of some kind of malpractice, we invite you to contact the Regan, Zambri & Long team today for a free consultation with our DC medical malpractice lawyers at (202) 463-3030.

Posted In Medical Malpractice
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Common Signs of Sports Concussions in Adolescents

As a parent of a child involved in one or more sports activities, would you know how to detect a possible concussion?

Understand the signs and symptoms of this potentially serious head injury to keep your kids safe and healthy.

After a forceful jolt, bump, or blow that causes trauma to his or her head, a child athlete may begin exhibiting changes in their thinking, behavior, or physical functions. Ignoring such signs and symptoms can exacerbate a concussion and put the athlete at risk for further injury.

How to Detect a Potential Athletic Concussion

Several signs may indicate a child has sustained a sports concussion. These symptoms include:

•    Sudden nausea or vomiting

•    Sluggishness or a sense of “haziness” or fogginess

•    Forgetfulness related to instructions or events before or after the trauma

•    Loss of consciousness

•    Clumsy movement

•    Slow, labored speech

Should one or more of these indicators manifest in a child after a head injury, immediately remove him or her from play and seek medical treatment.

How Treatment Guidelines Differ between Children and Adults

Quick and thorough examination following a head injury is the best way to prevent lasting damage. Furthermore, new treatment guidelines from the American Academy of Pediatrics present differences in how adolescents heal from concussions compared to adults.

According to these guidelines, children under 18 years of age require an average of 7 to 10 days to recover fully from a concussion, a longer timeframe than that of the typical adult. As a result, adolescents with signs of concussion should stop engaging in activity immediately and not resume until whatever comes first – 24 hours without symptoms or a doctor’s permission.

Sports injuries may be common in young athletes, but with prompt and careful treatment, children can recover fully and return to their favorite activities.

Have the actions of another individual contributed to your child’s injury while playing sports? To learn whether you have a viable legal case, contact a Washington D.C. child safety lawyer.

Posted In Patient Safety , Pediatrics
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Have Medical Malpractice Lawsuits Caused a Dangerous Rise in C Sections? (Part 2)

In our last post, we discussed the curious implications of a highly cited, provocative medical paper, Yang et. al's "Relationship Between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean Section," which obliquely blames medical malpractice attorneys for skyrocketing rates of C-Sections.

The New York Post also recently brazenly asked: “Do Medical Malpractice Threats, Real Or Imagine, Lead to More C-Sections?”

As tantalizing as the thesis that "pressure from medical malpractice attorneys --> more C-Sections" may seem based on superficial analysis, upon deeper inspection, it just doesn't hold up.

There are two compelling problems with the thesis.

Problem #1. The correlation could be spurious.

Just because two trends “go together” does not mean that one causes the other. Correlation, as they say, does not imply causation. Spurious correlations happen all the time, for many different reasons. A popular website, http://www.tylervigen.com/, lists a whole bunch of ridiculous correlations. For instance, the consumption of organic food has been correlated very, very tightly with increasing rates of childhood autism over the past decade. But no one would say that eating more organic food causes babies to be autistic or that autistic children somehow make people more crave organic food. The correlation is just an odd statistical artifact with no meaning.

Problem #2. We could be overlooking other, better explanations for the trend.

In some cases, one unseen driver can cause both trends. In other words, some third force can lead to more malpractice pressure AND more C-Sections at the same time. That would nicely explain any correlation. Tellingly, Yang et al included, as one of their metrics, "increased malpractice insurance premiums."

So maybe the insurance companies' decisions to raise their rates -- which may or may not have been caused by any actual, real changes in lawsuits filed -- caused both the "increase in malpractice pressure" and the spike in C-Sections. By this read, the real "bad guys" would be the insurance companies, not the trial lawyers.

As this blog and many other more objective sources have confirmed, insurance companies have their own agenda and often work very hard to blame malpractice attorneys for problems that they, themselves, either create or exacerbate.

Perhaps the insurance companies raised premiums for their own insurance company reasons, which in turn scared doctors into taking overly-precautionary methods (such as opting for C-Sections instead of VBACs). Meanwhile, the medical malpractice attorneys were innocent. The broader point is that, to understand the cause and effect relationships in complex systems, you need hard science, not just epidemiological observations. (For a more detailed explanation of the problems with many epidemiological studies, see journalist Gary Taubes' fascinating 2007 New York Times piece, "Do We Really Know What Makes Us Healthy?")

For thorough, effective assistance dealing with your potential case, call the medical malpractice attorneys here at Regan, Zambri & Long for a confidential consultation at (202) 463-3030.

Posted In Medical Malpractice
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