Pharmacy Error Injury Lawyer Blog

Hospitals and Pharmacies Hit by Nationwide Drug Shortages

November 3, 2011 | Lebowitz & Mzhen

A shortage of commonly-used drugs is impacting care in hospitals nationwide. Reports released by the American Hospital Association and the American Journal of Health-System Pharmacists indicate a chronic shortage of crucial medications, with over 800 AHA-member hospitals reporting shortages. Shortages can appear quite suddenly in a hospital environment, with the need for a specific drug suddenly spiking to an amount greater than the supply. Hospitals and pharmacies struggle to compensate for these shortages, sometimes by prescribing alternative drugs, and sometimes by turning to less-than-scrupulous vendors with uncertain records of quality. The possibility for errors, both in prescribing and dispensing medications, is great in such situations.

In a report published by the Patriot-News, one Pennsylvania hospital stated that, out of around three thousand prescription medications commonly used, it experienced shortages of 211 drugs in 2010, up from 70 in 2006. This mirrors conditions in hospitals all over the country. Healthcare administrators around Pennsylvania have reported shortages of fifty or more medications in their facilities, often stating that the shortages are the worst in at least twenty years. This puts significant pressure on doctors, nurses, and pharmacists to identify and locate acceptable substitute medications, often with very little time to spare.

The Food and Drug Administration reported shortages of 178 drugs in 2010. The majority of the shortages are of older drugs administered in hospitals by injection or intravenously. Shortages can result from problems with raw materials and problems arising in the process of producing and distributing drugs. Some drugs may be held up by new regulations, but many drugs fall by the wayside if manufacturers find them not to be profitable.

When a particular drug is unavailable due to a shortage, medical professionals must locate another treatment. This often involves an alternative medication that may not be as effective, that may not be recommended for a particular use, or that may not have equally good quality control. Nine patients died at Alabama hospitals earlier this year, allegedly due to a substitute drug contaminated with bacteria commonly found in tap water and bathrooms.

Patient Safety Initiatives in Maryland and Oregon are Showing Signs of Success

October 26, 2011 | Lebowitz & Mzhen

Pharmacy and medication errors in hospitals and elsewhere in the health care system create substantial risks to patients, along with errors in diagnosis and treatment, equipment problems, and others. State governments often work to promote and improve protection of patient safety in health care. Oregon, as an example, has taken a step towards improving patient safety by encouraging self-monitoring and reporting by hospitals, doctors, and pharmacies statewide. The Oregon Legislature passed a bill in 2003 that created the Oregon Patient Safety Commission, a collaboration between the health care industry and state agencies to prevent medical errors. The state estimates that, last year, at least 34 deaths throughout Oregon resulted from medical errors. The program encourages the submission of detailed reports on medical errors to the Commission, which compiles the data and keeps track of statistics and trends.

Oregon has 58 community hospitals, and all of them have agree to submit reports. Most of the state’s hospitals have been reporting since the program started in 2007, and only two hospitals were still holding out as of last year. According to the Oregon Association of Hospitals and Health Systems, hospitals are reporting errors at a rate to similar to that in states that mandate reporting. The system is far from perfect, though. Because of its voluntary nature, hospitals do not always provide patients with notifications of errors, even if they report those errors to the state. Hospitals also do not report every error known to have occurred.

Pharmacies and surgical centers in Oregon have some catching up to do. According to an investigation by the Oregonian newspaper, the state’s pharmacy board receives about 600 complaints per year, but the Commission only received six error reports from pharmacies between the fall of 2008 and the summer of 2011. About half of Oregon’s licensed surgical centers have agreed to participate with the Commission, and of those who have agreed, only two-thirds actually reported anything in the past year.

Study Shows Further Links between DES Exposure and Cancer in Women Exposed In Utero

October 19, 2011 | Lebowitz & Mzhen

A study recently published in the New England Journal of Medicine has expanded on the links between diethylstilbestrol (DES) and many forms of cancer. Researchers looked at 6,500 women, 4,600 of whom received exposure to DES while in the womb. They found substantially higher risk of cancer, including breast cancer and adenocarcinoma. They also found a higher risk of infertility and neonatal death. The study serves as a reminder of the risks posed during widespread use of DES decades ago, which led to a landmark court decision regarding liability for drugs that cause medical complications.

DES is a synthetic form of estrogen first developed in 1938 and used to treat breast and prostate cancers, among other uses. The U.S. Food and Drug Administration approved it in 1941 to treat menopausal symptoms, vaginitis, and to suppress lactation after childbirth. It was used from the 1940’s to the 1980’s in estrogen-replacement therapy. It was a standard treatment for prostate cancer for 40 years, until more effective treatments were approved in the 1980’s. DES was also a common treatment for breast cancer from 1960 to 1977.

For a period of about 30 years, doctors gave DES to pregnant women believing it could reduce the risk of complications or losses in pregnancy in women with a history of miscarriage. The FDA approved DES for this use in 1947, but withdrew it from use with pregnant women in 1971 after studies linked it to certain tumors in girls and women exposed to the drug in utero. Further study showed medical complications in people exposed after birth. Women exposed to DES in the womb have been encouraged by the National Cancer Institute to seek regular specialized medical examinations to look for complications due to the drug.

Women who took DES while pregnant have shown a slightly higher rate of breast cancer. Women exposed in the womb, known as “DES daughters,” have shown a wide array of health complications, including multiple types of cancer. In addition to its carcinogenic properties, DES is considered a teratogen, meaning it can cause malformations in children exposed in utero. Men exposed to DES in utero have shown elevated rates of testosterone deficiency and neurological issues.

Once negative publicity developed around DES, multiple lawsuits were filed against the drug’s manufacturers across the United States in the 1970’s. This led to the California Supreme Court’s 1980 decision in Sindell v. Abbott Laboratories, which demonstrated the legal doctrine of market share liability. The plaintiff had developed cancer because of her mother’s use of DES. Due to the number of years that had passed from the time the mother took the drug to the time the daughter learned of her injuries, she could not identify the specific manufacturer of the pills her mother took. The doctrine put forth by the California court made all manufacturers of the drug liable in proportion to their share of the drug’s market at the time of use. Since then, courts have only applied the market share doctrine to cases involving pharmaceutical products.

Pharmacists Compete With Pill-Packing Robots for Patient Safety

October 11, 2011 | Lebowitz & Mzhen

A new machine at the University of California at San Francisco may permanently change the way pharmacies operate, hopefully to the benefit of patient safety. The machine is a “robot pharmacist” named PillPick, and it does much of the work ordinarily performed by pharmacists and pharmacy technicians. So far, as shown in this video, it has been able to do the work with a far lower error rate than human pharmacists.

PillPick cost around $7 million to install, which is less than the amount UCSF spends in a year on pharmacist salaries. People must periodically stock the machine with medications, but PillPick is largely autonomous after that. Medications are stored in bins and marked with bar codes. The machine identifies the correct medication and uses a suction-powered arm to remove pills from bins. Its programming allows it to recognize when its arm has failed to pick up a pill or has picked up too many. It sorts the correct number of pills to fill a prescription and applies labels with the identifying prescription information. At full capacity, it can dispense more than 10,000 medication doses in a day. UCSF reports that PillPick has freed its pharmacists to work in other areas of the hospital, such as managing IV medications and patient drug treatments. In over 350,000 doses, it apparently has not made any errors. A pharmacy robot suitable for retail use costs around $200,000, making it a tempting investment for many pharmacies.

The role of the pharmacist has changed considerably as technology has advanced. With computers and newer systems of packing and distributing medications, pharmacists now spend much of their time supervising the dispensing of pre-packaged medications rather than actually preparing medicines. Machines like PillPick are in many ways a continuation of these changes, with the goals of improving efficiency, cutting costs, and reducing the risks of human error in dispensing medications. Human error is the single largest factor in pharmacy errors, occurring in as much as two percent of all prescriptions nationwide.

Unfortunately, it is impossible to ensure that pharmacy errors never occur, whether a pharmacy is managed by a human or robotic pharmacist. The legal requirement that a licensed pharmacist dispense medication is sometimes the only reason human pharmacists are directly involved in the process. The presence of a licensed pharmacist lends a sense of professionalism to a pharmacy, but more important, it gives the appearance of accountability. In the event of an error, someone is in charge to handle the problem or take the liability. The use of robotic pharmacists creates interesting legal questions relating to liability for errors. Where a human pharmacist’s error creates an issue of professional negligence or malpractice, a machine replaces it with issues of proper operation or maintenance as well as product defects.

Preventing Medication Mix-Ups at the Pharmacy

October 5, 2011 | Lebowitz & Mzhen

Several recent events have illustrated the importance of carefully reviewing prescriptions and medications at pharmacies. Errors in filling prescriptions, either by giving a person the wrong medication entirely or giving a person someone else’s medication, can have serious and even fatal consequences. Patients can take steps to protect themselves from pharmacy errors, and in the event of a medication mistake causing injury, they have remedies under the law.

This Pharmacy Error Injury Lawyer Blog has reported on the case of Mareena Silva, the Denver, Colorado woman who received the wrong medication at a Safeway pharmacy. Silva, who was six weeks pregnant at the time, tried to fill a prescription for antibiotics. Because of the similar-sounding name, the pharmacy gave her medication intended for Maria Silva. Instead of antibiotics, she received methotrexate, a cancer drug which can also be used in certain circumstances as an abortion drug. Silva realized the mistake only after she had taken one pill and began to feel nauseous. Doctors advised her to induce vomiting, and she received treatment at a nearby hospital. The outcome of this incident is still unknown, but could have serious consequences for the baby. The pharmacy formally apologized and offered to pay all medical expenses.

Another recent case occurred in St. Louis, Missouri, where a man, Ron Apenbrinck, has filed suit against Walgreens Pharmacy after he picked up a prescription with his name on the bag, but with another patient’s prescription bottle inside. Both the bag and bottle were correctly labeled, but the bottle was placed in the wrong bag. Instead of the painkiller hydrocodone, Apenbrinck allegedly received Amlodipine Besylate, a heart medication. He took the medication for several days until he collapsed in pain, suffering what he has described as a “mini stroke.” Apenbrinck now claims that he suffers from an irregular heartbeat and permanent damage to his nervous system, as well as his head, neck, and back. Walgreens issued a statement saying it called Apenbrinck to apologize, and that errors such as this are very rare.

Pharmacists owe a duty to customers to accurately and diligently review and fill all prescriptions. The Maryland Board of Pharmacists regulates the licensing of all pharmacists in the state, and it handles complaints and discipline for pharmacists who make errors in filling prescriptions. We previously reported on the duty of Maryland pharmacists to educate patients and prevent medication errors.

Patient Death During California Nurse Strike Possibly Due to Medication Error

September 28, 2011 | Lebowitz & Mzhen

A patient at Alta Bates Summit Medical Center in San Francisco, California died over the weekend, allegedly due to an incorrect medication dosage from a replacement nurse. About 23,000 nurses across California went on strike on Thursday, September 22, 2011 due to a dispute between the nurses’ union and the healthcare network that runs Alta Bates and other hospitals. The strike was meant to last one day, but the nurses found themselves locked out when they tried to return to work Friday. The lockout continued through the weekend. The hospital brought in replacement nursing staff to cover the shifts for the union nurses.

The patient was a 66 year-old Oakland resident who had been receiving treatment at Alta Bates since July 2011. Preliminary findings indicate that her death resulted from the wrong dosage of a medication, which was administered by one of the replacement nurses.

The nurses’ union, the California Nursing Association, has questioned the qualifications of the replacement nursing staff. The American Nurses Association, which represents nurses nationwide, allows nurses to strike if the intent is to advocate for changes in hospitals to benefit patient health. The ANA’s ethics rules requires nurses going on strike to provide advance notice of their plans and to take steps to minimize any potential harm to patients. The purpose of Thursday’s strike was to protest contract concessions demanded by the healthcare network that, according to the union, would negatively affect patient safety.

Hospital officials have defended the replacement nursing staff, saying that they are all highly experienced, and that the hospital “did not skimp on any of the nurses.” While the question of liability and “fault” may take some time to resolve, this incident clearly demonstrates the difficulties inherent in patient safety in hospitals, especially where medications are concerned. A hospital mired in confusion carries a great risk of pharmacy errors.

This Pharmacy Error Injury Blog has previously noted the high rate of risks for medication errors in hospitals despite efforts at accountability among doctors and nurses. This incident in San Francisco demonstrates a phenomenon noted by a recent study from Johns Hopkins, which found an increased risk of medication errors in hospitals that use temporary doctors and nursing staff. The study concluded that a lack of familiarity with a particular hospital’s systems and procedures among temporary staff can lead to an increased number of medication errors.

“Good Catch” Program Hopes to Encourage the Reporting of Pharmacy Errors Before They Occur

September 20, 2011 | Lebowitz & Mzhen

A system developed at Johns Hopkins Medicine in Baltimore, Maryland intends to prevent accidents before they happen by encouraging clinicians to report situations that might lead to dangerous or even life-threatening incidents for patients. Known as the “Good Catch Awards,” the program distributed 27 honors in its first two years for reports that led to positive changes in patient safety. Such changes ranged from modifications in pharmacy order sheets to a national recall of improperly-labeled drugs.

The “Good Catch” program operates on the theory that, instead of errors being attributable to one individual, most errors result from a flawed system in a hospital. It stresses to doctors and other medical practitioners that its purpose is to find solutions to common errors, not to assign blame for those errors. Not all doctors and others have embraced the system yet, but most acknowledge that it is a vast improvement over safety systems at most hospitals. Robert Stoelting, MD, president of the Anesthesia Patient Safety Foundation, compared the system to those used in nuclear plants and airlines, where the responsibility for safety is shared by everyone. He suggests the creation of a national database to collect hospitals’ self-reports of “errors and so-called near misses” in order to better share safety information and create greater opportunities to improve patient safety.

Other hospitals have implemented their own “Good Catch” programs, inviting clinicians to share examples of near misses that could have resulted in patient injury but did not. The University of Connecticut Health Center offers a “Good Catch” award for near misses that lead to improvements in patient care. The Minnesota Hospital Association awards a “Good Catch for Patient Safety Award” to clinicians “who demonstrate their commitment to keeping patients safe by ‘speaking up’ to prevent potential harm to a patient.” The Brantford Community Healthcare System in Brantford, Ontario, Canada solicits stories from its medical staff about incidents that contribute to its “culture of safety.”

Hospital Patients are Subject to an Average of One Medication Error per Day

September 14, 2011 | Lebowitz & Mzhen

A report from the Institute of Medicine finds that hospital patients in the U.S., on average, experience one medication error per day. Errors may include incorrect dosages, administering a drug with the incorrect method, or administering the wrong drug altogether. Some errors involve prescription of a drug with incomplete information about a patient’s health history or allergies, leading to harmful reactions. Researchers also found instances of errors in which doctors and nurses did not have up-to-date information on the drugs they were prescribing and therefore did not know of newly-discovered risks. The report found a hospital medication error rate of eleven percent in its study and estimated that hospital patients receive an average of ten medication dosages each day.

Current estimates place the total number of annual deaths due to hospital medical errors at 7,000, and the total number of injuries at 1.3 million. Research shows that medication errors can lead to extensions of hospital stays of 8 to 12 days on average, leading to additional costs of $16,000 to $24,000 for the patients. Studies have found medication errors to occur in up to 3.7 percent of all hospitalizations. The total cost of injuries and deaths due to medication errors could be as high as $5.6 million per year per hospital.

Researchers have proposed many possible reasons for the number of medication errors known to occur. A 2002 study in the Journal of the American Medical Association linked a patient’s chancing of dying during routine hospital procedures to lower nurse-to-patient ratios, finding that the risk decreased as the number of patients assigned to each nurse in a hospital decreased. A recent study from Johns Hopkins University found a connection between medication errors and widespread use of temporary staff, including temporary doctors and nurses, in hospital emergency rooms. Johns Hopkins researchers concluded that errors may result from temporary staff’s lack of familiarity with a particular hospital’s systems and procedures. A 2006 study from the University of California at San Diego found a ten percent increase in fatal medication errors in area with teaching hospitals during the month of July. July is the month when medical school graduates first report to teaching hospitals. The study seems to confirm anecdotal evidence of the “July Effect,” where injuries and deaths in hospitals allegedly spike during the summer months.

Regardless of the conditions of hospital facilities or staff, hospitals, doctors and nurses have a duty of care to their patients to provide competent service, and this includes taking care to ensure correct prescription, dosage, and administration of medications. The fast-paced and often overcrowded nature of many hospitals creates a risk of error, and while a patient should certainly exercise diligence in monitoring their own treatment and medication as much as possible, the responsibility mainly lies with the nurses and doctors and the hospitals that employ them.

Fosamax Lawsuit in New York May Proceed, but With Limitations

September 8, 2011 | Lebowitz & Mzhen

A New York federal judge is allowing a lawsuit over the osteoporosis drug Fosamax to go forward, but with limitations. Judge John Keenan will allow plaintiff Linda Secrest to pursue her claim against Merck & Co., but she will not be able to claim punitive damages or to argue that Merck failed to warn her about potential risks in taking the drug. Secrest claims that a defect in Fosamax caused osteonecrosis of the jaw (“ONJ”), a condition in which the tissue in her jaw decayed. Secrest’s lawsuit is the fourth bellwether case against Merck over Fosamax, and the outcome will affect thousands of other Fosamax claims. Significantly, Judge Keenan stated in his decision that he found no evidence that any warning label would have caused Secrest’s prescribing physician to take her off the medication.

Fosamax, or its generic equivalent alendronate, treats and prevents osteoporosis, a condition in which the bones weaken and can easily break. It first came on the market in 1995. The drug works by inhibiting bone resorption, the process by which bones break down with age. Doctors often prescribe the drug for women who have gone through menopause.

The FDA began to collect reports of ONJ as far back as 2000, and other complaints such as broken legs began to come in as well. A 2008 finding from the FDA indicated a possible link between the drug and certain cases of esophageal cancer. A report from the American Dental Association followed soon after that suggested a connection between ONJ and medications in the same class as Fosamax. A 2010 press release from the FDA warned of a possible elevated risk of thigh bone fractures. These correlations led quickly to litigation.

Secrest’s lawsuit began in Florida, and in August 2006 it moved to the U.S. District Court for the Southern District of New York to be consolidated with other similar lawsuits. Secrest, along with dozens more plaintiffs around the country, filed suit against Merck, Novartis Pharmaceuticals, Procter & Gamble Pharmaceuticals, Aventis Pharmaceuticals, Sanofi-Aventis, Walgreen Co. and Mouhannad Budeir DDS. The lawsuit, styled In Re: Fosamax Products Liability Litigation, seeks tort damages for personal injury and products liability. Three bellwether cases preceded Secrest’s case. Merck one two of those cases at trial, and the third resulted in am $8 million jury verdict against Merck, which Judge Keenan reduced to $1.5 million.

Reducing Medication Error Injury by Keeping Health Record Journals

August 30, 2011 | Lebowitz & Mzhen

Our Prince George’s County, Maryland pharmacy error lawyer blog recently reported on the important role communication plays between patients and their healthcare providers—in order to reduce the risk of medication errors or pharmacy misfills, and to promote the safe and effective use of drug therapy.

Every year, 1.5 million Americans experience medication-related injuries, according to a study by the Institute of Medicine. In order to prevent medication errors, the American Pharmacists Association (APhA) reports that it is important for patients to keep accurate health records with them when visiting the doctor and pharmacist, including current prescription medication lists detailing the dosage information along with all health conditions that the medication is treating.

Patient medication lists can reduce the risk of pharmacy misfills, incorrect dosages, medication duplication, allergy interaction, and any harmful side effects from potential dangerous drug interactions. The APhA also states that by keeping drug lists with them at all times, patients can prevent medical error by providing emergency staff and hospital pharmacists with important information that could saves lives in an emergency.

According to a recent Chicago Tribune article, doctors are now recommending that individuals turn the medication lists into a comprehensive health journal, to keep healthcare providers informed and to prevent medication error injury.