Posted On: October 26, 2011

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

portugepunk_1473230828_992a1ae752_o_10262011.jpgPharmacy 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.

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Posted On: October 19, 2011

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

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.

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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.

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Posted On: October 11, 2011

Pharmacists Compete With Pill-Packing Robots for Patient Safety

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.

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Posted On: October 5, 2011

Preventing Medication Mix-Ups at the Pharmacy

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.

cohdra_100_9294-10052011.jpgThis 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.

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