In one hospital pharmacy error in Oakland, California, a 90-year old emergency room patient at Kaiser Foundation Hospital, received a variety of blood pressure and stomach ulcer medications that were meant for another patient. The emergency room staff did not double check the medication orders sent from the pharmacy, and the patient went into severe respiratory distress after receiving the potassium chloride by mistake.

A rapid response team was sent in and the patient was reportedly breathing four to six breaths per minute with a fluctuating blood pressure. The man was intubated and put on a ventilator for breathing. Further testing proved that the patient lost brain function from the medication error. A physician interviewed by the California Health investigators claimed that he could not rule out the possibility that the medication mistake caused a severe change in the patient’s health.

In another case, at California Hospital Medical Center in Los Angeles, a patient was incorrectly given the drug Methotrexate, or chemotherapy, as a treatment for ectopic pregnancy—even though the patient was not in fact pregnant. Over the following week, the patient reportedly developed immune suppression, renal function decline, severe leukopenia and neutropenia, and oral, skin and esophageal ulcerations due to the medication error. The investigators reported that using chemotherapeutic medication on a patient who was not pregnant subjected the patient to serious health complications, physical harm, and injury.

According to the lawsuit filed in 2008, Reva Tosh received a prescription for a pain medication on November 11, 2006. When Tosh dropped off the prescription to the Rite Aid pharmacy two days later, the pharmacist misfilled the order with the steroid dexamethasone—a steroid with severe side effects often prescribed during cancer treatments.

Rite Aid Pharmacy allegedly gave Tosh more than seven times the regular dosage of the steroids for a period of 28 days, and she claimed to have developed a disorder of the adrenal glands called Cushing’s Syndrome, that caused her to suffer physical ailments, personal injury, and mental disorders, that confined her to a wheelchair.

During the trial, the the central issue was whether Tosh’s injuries were caused by the pharmacy misfill, or due to her preexisting illness of rheumatoid arthritis.

Reva Tosh was awarded $2 million in damages by the jury, and her husband Gerald Tosh received $500,000 for the his loss of her companionship.

Mable Mosley was taken to the Brandon Regional Hospital last year complaining of neck and shoulder pain. She checked into the hospital on a Saturday, and within a few days stopped breathing. Mosley was put on life support, and died days later.

Mosley’s husband is suing the hospital, the hospital owners, and seven individual pharmacists in the case, claming medication negligence and wrongful death—that his wife was given enough pain medicine to end her life.

The drug in question that Mosley received is called Duragesic, a patch containing large concentrations of opioid fentanyl, a potent narcotic approved in 1990 by the FDA for use in patients that have become opioid-tolerant from using another strong narcotic pain medication for a week or longer.

Opioids are chemicals that are commonly prescribed because of their pain relieving properties. Opioids work by attaching to opioid receptors, or proteins, found in the brain, spinal cord and gastrointestinal tract. When the drugs attach to the opioid receptors, they can block out the body’s perception of pain.

The company has recalled these drugs based on consumer complaints of an unusual moldy, musty smell that reportedly caused nausea, vomiting, diarrhea and gastrointestinal pain. The smell was found to be caused by trace amounts of the chemical 2, 4, 6-tribromoanisole (TBA)—a chemical often applied to wood pallets that are used in the transportation and storage of the materials used for product packaging.

The FDA has criticized J&J for not reacting quickly enough to customer complaints, and for failing to fix the problem, a problem that has been familiar to J&J. Customers have reportedly been complaining since 2008 about their pills having a mildew-like odor. In December of 2009, Tylenol Arthritis Pain medication was also recalled related this same issue.

According to the FDA, J&J and McNeil did not conduct a quick and comprehensive investigation into the problem, and failed to provide high quality products to consumers—responsibly protecting them from personal injury or illness. Many consumer complaints were received as early as 2008 and 2009, and the test results indicating TBA contamination were not shared with the FDA until after an inspection.

According to the ISMP Error Alert article, nearly everyone in the healthcare industry uses shortcuts, like abbreviations and symbols, in an effort to save time when handwriting specifics for the prescription—including phrases, units of measure and words. Some shortcuts can in the end can be very time consuming, as they need to be checked and verified for accuracy on the receiving end. These verifications could also reportedly cause a greater chance for medication error than if the prescription was written out without abbreviations or symbols. The article claims that it is important to prevent future misunderstandings now, instead of waiting until medical abbreviations, dose designations or symbols lead to a patient injury.

The article lists a few common error-prone abbreviations, symbols and dosage misunderstandings that take more time for the pharmacist to check, and could cause medication mistakes:

• Some abbreviations that indicate the frequency of when to take the drug, can be difficult to understand, and can lead to error. In one prescription for “Penicillin VK 500 mg Q1D X 7D,” the physician accidentally typed “Q1D” (once a day) instead of “QID” (four times a day). The pharmacist realized the mistake, and that the patient was supposed to be taking the penicillin four times a day for seven days (7D). Another example of frequent error comes in the abbreviation for “D” (days), where it can also be mistaken for “doses.”

According to reports, 21 of the 25 horses of the Venezuelan polo team were allegedly given an a drug mixed to replicate the name-brand supplement Biodyl—a concoction of vitamins and minerals often used to treat muscle fatigue in horses. Biodyl is reportedly used safely around the world, but hasn’t been approved by the U.S. Food and Drug Administration for this country.

The drug concoction was prepared by Franck’s Pharmacy Compounding Lab in Ocala, and the mixture allegedly contained a strength of an ingredient that was incorrect—making the horses sick and causing their tragic death at the International Polo Club of Palm Beach in Wellington, Florida. Only the horses treated with the medication mistake became sick and died within hours of treatment, after collapsing, as they were unloaded from their trailers where they were scheduled to play in the U.S. Polo Open.

Fox News reported that veterinarians commonly turn to compounding pharmacies for medications that aren’t readily available on pharmacy shelves. The Lechuza polo team said in a statement that a Florida-based veterinarian wrote a prescription for the pharmacy to create a compound similar to Biodyl, after using the manufactured version of the drug for many years without problems.

The article revealed how the possible errors are made and also discussed what steps pharmacies are making to try and prevent these errors, and reduce the number of pharmacy mistakes and patient injuries that could happen in the future.

Pharmacies are trying to prevent errors by:

• Encouraging improved communications between doctors and pharmacies.

• Encouraging doctors to write the prescriptions in full length, instead of using medical codes or abbreviations.

• Trying to transition from prescriptions that are handwritten to electronic prescribing—where a doctor sends the prescription directly from the doctors’ offices to the pharmacy computers.

• Computers are being used to aid the prescribing process, with more alerts for drug interactions, allergies, or patient’s illnesses.

• Other computer safety features include popup boxes when a technician enters or confuses a drug name with similarly named drug. After the popup appears, the technician has to initial the box to show he checked the drug.

In the research, USA Today interviewed pharmacy experts and toured two pharmacies, a CVS and Walgreens, to study the six steps of the prescription filling process, and the potential errors that can happen along the way, as well as real cases that have caused actual injuries or death.

Step 1: Prescription received
When the customer drops off the prescription to the technician, or the doctor’s office calls in the prescription, errors can occur if a technician misunderstands a doctor's handwriting, prescription codes and abbreviations or misunderstands the oral instructions over the phone. In one case, a doctor’s prescription for methadone read “sig 4 tablet BID for chronic pain,” which means “Please label (sig) this drug to say: take 4 tablets twice per day (BID) for chronic pain. The technician typed, “Take 4 tables by mouth as needed for chronic pain.” The patient allegedly died of an overdose of methadone.

Step 2: Prescription entry
A technician then scans the original prescription into the computer and manually enters the patient’s personal data, like name, address, date of birth and phone number, as well as drug information, strength, dosage instructions and quantity. If a technician incorrectly types the prescribed drug dosage, formulation or the patient’s medical condition, history or allergies into the computer, then serious errors can occur, including personal injury. Also if the wrong drug code is chosen in the computer system, it can be mistaken for a similarly named drug. In one instance, a pharmacy was asked to fill a prescription for compazine, an anti-nausea drug, (COM) and accidentally gave the patient a generic substitute for coumadin, a blood thinner (COU).

According to the suit, Sheridan was prescribed Temodar, a powerful drug for brain tumors that was part of his treatment of cancer in September 2007. The prescription was allegedly written incorrectly, and Sheridan was wrongly prescribed 10 times the correct dosage—he reportedly took the medicine daily when it was only to be used every other week. Rite Aid Pharmacy allegedly dispensed the drug to Sheridan, without checking with Sheridan’s oncologist for a second opinion to clarify the prescription mistake.

The lawsuit accuses a Rite Aid pharmacy for contributing in the wrongful death of Sheridan, who reportedly had consumed toxic doses of the cancer medication. According to the Associated Press, the doctor who wrote the incorrect prescription has settled with Sheridan’s estate.

According to a 2006 report from the Institute of Medicine, at least 1.5 million Americans are injured by medication mistakes every year, and nearly 7,000 people die every year from medication errors annually.

The recall dosages are single-dose pre-filled syringes containing the vaccine specifically created for children ages 6 to 35 months. It is a voluntary, nationwide recall by Sanofi Pasteur.

During testing at the time of the vaccine’s manufacture, the doses contained 7.5 micrograms of antigen, the recommended dosage used to stimulate immunity in children. But later testing showed degradation of the vaccine, making it less potent than desired. This proved to be the case with four lots of the vaccine, totaling 800,000 doses.

According to the Centers for Disease Control Prevention (CDC), this recall is part of a routine quality assurance program and is non-safety related. Children who received the vaccine do not need to be re-immunized, but with future immunizations, children should be given the proper vaccination dosage. With children who have only received one vaccine dose, they should get the get their scheduled second dose.

According to the article, published in August 2009, a medication error is a failure in the process of treatment that can lead to the harming or personal injury of a patient. Medication errors can often occur in:

• Prescribing faults: ineffective prescribing, irrational or inappropriate prescribing, under-prescribing and over-prescribing when deciding which treatment and dosage plan to take.

• Prescription writing: illegibility

• Formulation manufacturing: incorrect strength, misleading packaging

• Drug formulation dispensing: incorrect drug, formulation and label

• Administering the medicine: incorrect dosage, wrong directions for frequency, invalid duration of treatment

• Monitoring drug therapy treatment and drug treatment alteration when required

Medication errors can be classified, according to the article, by the use of psychological error classifications—knowledge-errors, rule-errors, action-errors, and memory-based errors. It is important to detect the medication mistakes, that can range from trivial to serious, and to create a working environment that is free of blame, and encourages the reporting of errors.

The article also recommends, “balanced prescribing” to avoid medication errors. In balanced prescribing, the mechanism of action of the drug should complement the pathophysiology of the disease—optimizing the balance of benefit to harm.

When Wilma O’Neill picked up the prescription for her daughter earlier this month, she expected to administer an antiviral medication to help her child’s swine flu symptoms. Over the next 24 hours, O’Neill gave her daughter two doses of the Walgreen’s prescription, and only stopped the medication after the drugstore called, claiming that there had been a pharmacy medication mistake, and someone had received the wrong prescription.

O’Neill brought the prescription back to the pharmacy, where they discovered that her daughter had been given the liquid pediatric medication Amiodarone by mistake—a drug used to treat irregular rapid heartbeats. According to Medline Plus, the U.S. National Library of Medicine on-line service, Amiodarone is used to treat and prevent life-threatening abnormal heart rhythms by relaxing overactive heart muscles, and is used only when other medications are not tolerated. The first few doses should reportedly be administered in a hospital setting, as the medication could cause fatal side effects. The child had been given two times the normal dosage of the actual heart medication, which could have resulted in pharmacy error injury.

O’Neill’s daughter was raced to the emergency room, and monitored carefully. Her EKG was initially normal, and then irregular a day later. O’Neill believes that had the mistake not been realized, the outcome could have been much worse, as her daughter was also very sick with the H1N1 virus.

Walgreen’s acknowledged the mistake and apologized for the error. The company didn’t disclose how the error was discovered, but claimed to have numerous safety checks in place in the drugstore to reduce the possibility of human error. In 2007, Walgreen’s was profiled in a the news program “20/20” for making prescription drug errors, after a child was mistakenly given an adult blood-pressure drug by the pharmacy. The child was rushed to the emergency room after weeks of taking the medicine with delirium symptoms and shaking limbs.

According to the agency alert, the FDA has received reports that the Tamiflu (oral suspension) dosing instructions for the patient do not match the dosing dispenser. U.S. health providers often write liquid medicine prescriptions in teaspoons or milliliters (mL), while the dosage of Tamiflu is in milligrams (mg). Prescribers and pharmacists have been warned that Tamiflu's dosing dispenser included in the package has markings only in mg—30, 45, and 60.

The alert recommends that:

• If the dosing dispenser included with the drug is in mg, prescribers should write doses in mg

• Pharmacists should also ensure that the unit measurements on the instructions of the prescriptions match the dosage dispenser included.

• If the prescription instructions specify that the drug is administered using mL, the dosing device should be replaced with a new measuring device and calibrated in mL.

Tamiflu (oseltamivir) is an antiviral drug that slows the spreading of the influenza virus in the body. According to the Centers for Disease Control and Prevention (CDC), 22 million Americans have become ill with the H1N1 virus in the past six months, and 3,900 have died— 540 of which were pediatric deaths. The number of people who have been hospitalized is reportedly 98,000, with 36,000 patients younger than 17. The largest majority of deaths have been between the ages of 18 and 64—around 2,920.

Maryland’s Department of Health and Mental Hygiene reported last week that six more people have died in Maryland in the past four weeks from the swine flu, bringing the total death toll to 19 since the pandemic began. The H1N1 virus has also hospitalized 664 people in Maryland.

The Los Angeles Times reported that in the last week of October, 587,960 prescriptions for Tamiflu and other antiviral drugs were filled in the United States— according to Wolters Kluwer Pharma Solutions of Bridgewater, N.J., the company that tracks FDA prescription data.

If you or someone you know has been injured by a medication mistake or pharmacy misfill in Maryland or the Washington, D.C. area, contact the attorneys at Lebowitz and Mzhen, LLC for a free consultation. Call us today at 1-800-654-1949.

FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral Suspension

New CDC Estimates Show What Toll Swine Flu is Taking in U.S., Wasington Post, November 13, 2009

Booster Shots: Swine Flu Continues Slow Climb on College Campuses, The Los Angeles Times, November 13, 2009

Swine Flu Kills 6 More People in Maryland: All Had Underlying Conditions, Baltimore Sun, November 13, 2009

Related Web Resources:

U.S. Food and Drug Administration, (FDA)

The current NCCMERP list of dangerous abbreviations commonly made by prescibers include:

• Mistaking “µg” for “mg” or milligrams, resulting in an overdose

• “U” is mistaken for zero or a 4, which also results in an overdose. “U” is intended to mean “Units” but with poor handwriting, it can also be mistaken for “cc” or cubic centimeters.

• “Q.D.” means “every day” in Latin. The period after the “Q” is sometimes mistaken for an “I”—and the drug is given “QID” (four times daily), which results in an overdose.

• “T I W” means three times a week. This is often misinterpreted as “three times a day"

• “IU” means International Unit, and is often mistaken for “IV” or intravenous

• “AU, AS, AD” are the Latin abbreviations both ears, left ear and right ear. These are often misinterpreted as the Latin abbreviation “OU” (both eyes), “OS” (left eye), and “OD” (right eye)

The Council also recommends that in order to enhance the accuracy of prescription writing and communications, doctors, nursing and pharmacy staff should:

• Make sure all prescriptions are legible and include notes on medication purpose—like cough, or allergies—maintaining that the proper medication is dispensed.

• All prescription orders should be written in the metric system, except for orders that use standard units like vitamins or insulin. Units should also be written out, rather than abbreviated with “U”

• Medication orders should include the exact drug name, metric weight or concentration, dosage form, with strength and concentration expressed in metric amounts.

• The NCCMERP reports that numerous errors in drug strength and dosage have occurred with the use of decimals—due to the trailing zero (1.0 mg) or the lack of a leading zero (0.1 mg). A leading zero should always be used before a decimal, and trailing zeros should never be used.

According to the National Coordinating Council for Medication Error Reporting and Prevention, (NCCMERP), injury from medication error is an urgent, a widespread public problem, that needs to receive far more public attention. The NCCMERP estimates that 98,000 people die annually from medical errors that occur in hospitals—an amount that is greater than deaths from motor vehicle accidents, breast cancer, AIDS, even workplace injuries. Medication error can happen at any point, and result in injury—from communication, distribution, prescribing, dispensing, administering or monitoring.

A medication error is defined by the the NCCMERP as any event that is preventable, and may cause medication misusage or patient harm while the medication is being controlled by the health care professional, consumer or patient. Medication errors can happen in professional practices and during procedures, as well as in the systems of prescribing, ordering, the labeling of a product, packaging, dispensing, education, monitoring, usage, and naming conventions.

The FDA states that common causes of medication error stem from poor communication between doctor, pharmacist, and patient, with unclear product names or suffixes, medical abbreviations or handwriting, poor techniques or procedures, or a lack of understanding of directions for patient usage. Job stress or lack of training or knowledge can also lead or contribute to pharmacy error injury or misfills.