Patient Safety

Forum Guidance Leads FDA to Help Reduce Medication Errors

July 26, 2010 | Lebowitz & Mzhen

According to recent news that our Washington D.C. pharmacy error injury attorneys have been following, the U.S. Food and Drug Administration (FDA) has committed to reduce medication mistakes by publishing a draft guidance by the end of this fiscal year. The FDA states that one third of medication errors, including 30% of errors ending in deaths that are reported to the Institute of Safe Medication Practices (ISMP), may occur as a result of drug labeling and packaging.

The FDA reportedly claimed that medication errors often happen as a result of names that look alike or sound alike, encoded numerals, failure to recognize active ingredients, dangerous medical abbreviations, and name length.

In a FDA workshop last month, Carol Holquist, RPh and director of FDA’s Division of Medication Error Prevention and Analysis reportedly claimed that guidance on these medication mistake issues is an important first step to developing a consensus to form new FDA regulations, which can take around 10-15 years.

The American Society of Health-System Pharmacists (ASHP)’s director of Medication Use Quality Improvement, Bona Benjamin, also reportedly told the workshop group that the ASHP’s 2007 recommendations for the FDA are still current—that human factoring should be applied scientifically to drug packaging and labeling, and barcode verification should be encouraged, as nearly 20% of hospitals are using barcode medication verification.

Woman Sues Walgreens for Seizure Medication Pharmacy Error

July 14, 2010 | Lebowitz & Mzhen

In recent news that our Baltimore, Maryland pharmacy error injury lawyers have been following, a Texas woman filed a lawsuit against Walgreens last week, claiming that a pharmacist mislabeled her medication—a mistake the woman claims, that could have caused her wrongful death.

According to Jessica Soliz, a Walgreens pharmacist made a major pharmacy error when labeling her prescription for seizure medication. After Soliz picked up her prescription drugs from the pharmacy and began taking them, she reportedly became very ill. The prescription error wasn’t discovered until a nurse looked at the label, and realized that prescription was mislabeled to read that each pill contained 25 milligrams of Lamictal, when in fact each pill in the bottle contained 100 milligrams or the drug.

According to the FDA, the most common medication errors are due to wrong doses, incorrect drugs, or the incorrect administration of drugs. The Institute of Medicine reports that there are around 1.5 million medication error injuries that happen every year, with at least 7,000 deaths.

In Soliz’s case, Walgreens responded that they were sorry that this pharmacy error occurred. They stated that they take pharmacy safety seriously, and are constantly working to improve the quality, accuracy and service of all pharmacy orders, to prevent pharmacy error injury or wrongful death.

“July Effect” Study—Report Suggests July is the Worst Month for Fatal Medication Errors

June 21, 2010 | Lebowitz & Mzhen

Researchers from the University of California, San Diego recently published a study in the June issue of the Journal of General Internal Medicine, examining the myth of the “July Effect”—a legend that considers July a dangerous month for hospital patients to undergo treatment.

The study found that fatal medication errors in hospitals are at their highest in July, especially in teaching hospitals. July is reportedly the month when recent medical students graduates report to residencies in teaching hospitals and are given new responsibilities for patient care.

In their research, Dr. David Phillips and Gwendolyn Barker studied the relationship between medication error and inexperience in July, when thousands of medical residents begin their residencies. The research focused on the changes in the total number of medication mistakes; which includes medicine given and taken in error, accidental drug overdose, accidental medication errors in medical and surgical procedures, and drugs taken accidentally.

The study inspected 244,388 death certificates across the country, focusing on fatal medication errors that were recorded as the primary cause of death between 1979 and 2006—comparing the July death numbers with the number of events that are expected in any month in any year.

FDA Accuses Franck’s Pharmacy of Illegal Compounding

May 21, 2010 | Lebowitz & Mzhen

In a highly publicized pharmacy error case from last year that our Washington D.C. Pharmacy Error Attorneys covered in a blog, 21 Venezuelan polo team horses tragically died after being given a drug mixed by Frank’s Pharmacy Compounding Lab, aimed to replicate Biodyl, a vitamin and mineral supplement that is often used to treat muscle fatigue in horses. The drug concoction was allegedly too strong, causing a medication error that lead to the death of the horses at the International Polo Club of Palm Beach in Florida.

This week, Franck’s Pharmacy voluntarily suspended all veterinary compounding in the lab, after reportedly being threatened with an injunction by the U.S. Food and Drug Administration (FDA). Last month, the FDA filed a complaint that Franck’s was going around the law by producing and selling misbranded and adulterated drugs and pharmacy compounds that were too similar to drugs that are FDA-approved.

According to the FDA, compounded drugs are not reviewed by the FDA for effectiveness and safety. Drug compounding has been criticized for lack of oversight—especially when both human and animal patients could be exposed to unapproved medication, that could result personal injury or even in this case death. In an FDA Compliance Policy Guide from 2003, the agency stated concerns about the risks posed by pharmacists and veterinarians who manufacture, distribute, and mass-markets animal drugs that are unapproved.

The FDA has reportedly had a strong interest in this case, as the deaths of these horses were caused by pharmacy error—from the same pharmacy that produces drugs for humans.

Second Major Recall for J&J—FDA Found Manufacturing Violations in Children’s OTC Drugs

May 6, 2010 | Lebowitz & Mzhen

In a recent blog, our Washington D.C. Pharmacy Error Attorneys discussed the U.S. Food and Drug Administration’s (FDA) push for a broad recall of over-the-counter (OTC) products by Johnson & Johnson (J&J) in January—in an effort to maintain the health and safety of the consumer and to prevent OTC medication errors, after customers complained of moldy, musty smells in the drugs, that were caused by trace amounts of a chemical used when shipping the products.

The FDA announced this week that the administration has pushed J&J to begin another recall of certain children’s OTC liquid medicines—because of reported manufacturing deficiencies and violations found by federal health regulators during a routine inspection at a drug facility in Washington Pa—that could affect the quality, purity and potency of the products.

According to the FDA and the J&J unit, McNeil Consumer Healthcare, consumers should stop using all unexpired lots of both children’s and infant’s Tylenol, Zyrtec, Benedryl, and Motrin, because some the drugs reportedly may contain a larger concentration of the active drug than specified on the package. The recall also includes products that may contain inactive ingredients, other potentially solidified product ingredients, or other manufacturing residues that could include particles like tiny metal specks—that may not meet the testing requirements.

McNeil stated although there is only a remote possibility for serious medical problems, consumers should stop using the drugs, to avoid personal injury or illness in children.

Study Shows E-Prescribing Significantly Reduces Prescription Errors

April 29, 2010 | Lebowitz & Mzhen

In a recent news that our Baltimore, Maryland Attorneys have been following, doctors are reportedly increasingly leaving behind paper when prescribing medications, and depending more and more on electronic prescriptions, or “e-prescriptions”—in an effort to avoid pharmacy misfills and medication errors, along with hard-to-read doctor handwriting, or even prescription fraud, as our attorneys reported on in our last blog.

E-prescribing immediately sends the prescriptions to the pharmacy in a digital format through a secured Internet network, from a handheld device or from their computers. The doctor simply selects the drug from a computerized list, with other symbols indicating the best drug option, different dosages, and either generic or name-brand medicine, instead of hand-writing the prescription, which can lead to medication error. Some e-prescribing programs give symbols in the form of colored or smiling faces, delineating between cheapest, preferred, or less desirable drug options.

According to the Wall Street Journal, the number of e-prescriptions almost tripled last year, from 68 million in the previous year, to 191 million in 2009. Surescripts, LLC, the company that handles the majority of the electronic communications in e-prescribing, reports that this represents 12% of the 1.63 billion original prescriptions, which excludes refills. The first three months of this year showed that one out of every five prescriptions is being filed electronically—a number that is rapidly growing, as nearly 25% of doctors based in offices already have the technology to e-prescribe.

In a study published in the Journal of General Internal Medicine in February of this year, e-prescribing was found to reduce common hand-written prescriptions errors significantly, including pharmacy misfills containing the wrong dosage, or incorrect usage instructions that could lead to patient injury or even wrongful death.

Hollywood Prescription Drug Abuse —Illegal Drug Rackets and “Doctor Shopping”

April 26, 2010 | Lebowitz & Mzhen

In a blog from last week, our Washington-D.C. area Pharmacy Error Attorneys at Lebowitz and Mzhen covered the topic of illegal prescription drugs, after a Maryland pharmacist was sentenced to federal prison for selling illegal painkillers to a drug dealer—drugs that were meant to be used under the supervision of a doctor, that could lead to personal injury, drug overdose and death.

According to the Baltimore Sun, prescription drugs are currently the number one cause of death overdose in the country. The Office of National Drug Policy claims that in his past year of drug abuse, prescription pain killers now rank second, behind marijuana as the nation’s most prevalent illegal drug problem. The National Institute of Medicine reports that 20 percent of people in the United States have used prescription drugs for non-medical reasons, leading to addiction.

In a recent Hollywood tragedy, Corey Haim, star of the 80’s film The Lost Boys, died in what officials from the Los Angeles Police Department claim was an accidental overdose of prescription drugs. After an investigation, Haim’s name surfaced in connection with an illegal prescription drug ring in Southern California with the painkiller OxyContin. The drug ring was linked to as many as 5,000 prescriptions—by ordering prescription pads from authorized vendors and stealing doctors’ identities.

Prescription drug overdose has been ruling news headlines over the past few years, after deaths of high profile celebrities like Michael Jackson, Heath Ledger, Anna Nicole Smith.

Many addicts are reportedly getting their prescriptions drugs by “doctor shopping,” or going from doctor to doctor to collect prescriptions. According to the Sun, Maryland needs a system to monitor the number of prescriptions that are written for every patient, which if abused by “doctor shopping” can lead to medication error and injury. The Sun calls for Maryland Legislators to set up a drug task force to better monitor and control this drug epidemic.

Doctors Discover Millions of Patients Got Heart Pills Unapproved by F.D.A.

April 1, 2010 | Lebowitz & Mzhen

In a recent article from the New York Times that our Washington D.C. Pharmacy Error Injury Attorneys have been following, U.S. doctors who have written over four million nitroglycerin tablet prescriptions, the drugs frequently used to reduce chest pain and stop heart attacks, have recently discovered that a large percentage of the drugs that have been sold to patients have not been approved by the Food and Drug Administration (F.D.A.) for sale, safety, or effectiveness.

According to the article, many doctors have recently discovered that their patients were given unapproved heart medication tablets, and they are unable to know whether the patients have experienced suffering, or any unnecessary personal injury as a result of the unapproved drugs. Dr. Harry M. Lever from the Cleveland Clinic claimed that if angina patients took nitroglycerin tablets that were possibly ineffective or substandard, they may not experience a diminishing of the pain, and the heart problem could lead to a heart attack, or wrongful death.

Nitroglycerin is regularly prescribed for relieving chest pain that comes with coronary artery disease. When the tablet is placed under the tongue, the medicine dissolves into the bloodstream quickly and dilates the coronary artery, which can decrease blood pressure slightly and reduce the heart’s exertion. When patients take nitroglycerin at the first signs of chest pain, cardiologists claim that heart attacks can be prevented.

The F.D.A. sent letters last week to two major nitroglycerin drug makers, Konec Inc., and Glenmark Generics Inc., warning them that they must stop selling the unapproved drugs. Although the F.D.A. claims that it has not examined the quality of the unapproved nitroglycerin products in question, it does have documented problems of other nitroglycerin products in the past.

AHRQ Tips for Preventing Medical Mistakes with Children

March 30, 2010 | Lebowitz & Mzhen

In yesterday’s blog, our Baltimore, Maryland Medical Mistake Attorneys discussed leading causes of medical mistakes with children in this country, and important ways to prevent medical errors from happening.

According to the Massachusetts College of Pharmacy and Allied Health Sciences, 88% of medication errors involve the wrong dosage or incorrect drug. The Agency for Healthcare Research and Quality (AHRQ), the lead Federal agency that supports research to improve the quality of healthcare, addresses the importance of patient safety and the cause of many medical errors in a recently published press release.

In the press release, the AHRQ addresses the large problem of medical mistakes with children in this country, and gives parents and guardians tips on how to prevent these medical errors from happening with children, to avoid personal injury.

According to the AHRQ:

• Being involved in your child’s healthcare is the most important way to prevent medical errors or pharmacy misfills. The AHRQ stresses that it is extremely important for parents or guardians to take part in every decision that is made regarding the healthcare for a child.

• Make sure that your child’s doctors know every detail regarding the history and statistics (height and weight) of your child, every prescription, all over the counter medications, and any vitamins or dietary or herbal supplements, as well as any known allergies to any medication.

• At least once a year, bring a bag of everything your child is taking and go through each one with the doctor to ensure that there is no problem or conflict with any medication.

• Make sure you can read every prescription that the doctor writes. Double check the name and dosage, or if there is any question, have the doctor re-write the prescription in capital letters, printing the name of the drug and the dosage. If you can’t read the doctor’s handwriting, chances are the pharmacist will not be able to either.

Keeping Children Safe—Eliminating Mistakes from the Children’s Healthcare Industry

March 29, 2010 | Lebowitz & Mzhen

In our last blog, our Maryland Attorneys from Lebowitz and Mzhen Personal Injury Lawyers, discussed a recent pharmacy misfill, where an 8-year old boy received the wrong dosage of a medication that could have caused the child serious personal injury or even wrongful death.

According to the Agency for Healthcare Research and Quality (AHRQ), medical errors are one of the leading causes of injury and death in this country. The AHRQ reports that in a recent study, rates for potential adverse drug events in hospitals were three times higher with children than adults, with an even higher rate for infants in intensive care units.

The National Coordinating Council for Medication Error Reporting and Prevention, (NCCMERP), estimates that nearly 98,000 people experience death from medical errors that occur in hospitals every year. Medication errors can happen at any point in the healthcare process and system and can result in injury—from miscommunication with doctors, to prescribing the drug, dispensing drugs at the pharmacy, or in the administering or the process of monitoring the drugs.

The AHRQ recommends that single most important way to prevent medical errors from happening to your child, is to be an active participant with the healthcare team that is caring for your child. Research shows that parents who are involved in all aspects and decisions of a child’s care experience better and safer results.