Parker Waichman LLP Injury Alerts
DRUG ERRORS Regardless of how safe or effective a drug may be, there are all types of errors that can have dangerous or even deadly consequences.Jun 1, 2007
Whether it is something as simple as a typographical error on a prescription label or as complex as a drug interaction, each year “drug errors” injure or kill thousands of people in this country and around the world.
Drug errors take many forms and include the following
- Unintentional overdoses due to patient error (especially in situations involving the elderly or infants);
- Unintentional overdoses due to pharmacist error;
- Unintentional overdoses due to doctor error;
- Prescribing errors caused by confusing one drug with another having a similar sounding name;
- Inadequate instructions to the patient regarding potentially dangerous interactions between a prescription medication and particular foods (i.e., grapefruit juice), alcoholic beverages, over-the-counter (OTC) remedies (i.e., antacids), or even sunlight (with certain antibiotics);
- Physician or pharmacist error resulting from a failure to keep abreast of the latest medical information concerning potentially dangerous drug interactions;
- Using expired medications;
- Patients allowing others to use their prescription medications without proper medical approval or without even knowing if the other person is suffering from the same medical condition;
- Prescribing drugs that are contraindicated for certain patients due to age, medical conditions, or other risk factors;
- Off-label prescribing of drugs for conditions or groups of patients that have not received FDA approval or for which there has not been adequate clinical testing;
- Unintentional abuse of OTC medications;
- Discontinuing the use of a prescription drug before completion of the recommended or prescribed cycle; and
- Abruptly stopping a drug that requires a weaning process when being discontinued.
Last month, the American Pharmacists Association (APhA) held its annual meeting in Atlanta, Georgia, which was attended by more than 7,000 pharmacists in all practice settings. The purpose of the meeting was to review and update important information regarding situations that pharmacists encounter in their daily practice.
Pharmacists were instructed on how to establish medication therapy management (MTM) programs. They also discussed medication errors and adverse events, specifically which drugs were to be avoided and how to prevent potentially dangerous medical situations.
The APhA generated a list of the “Top Ten” drug errors and how they can be prevented. Michael R. Cohen, the author of Medication Errors, a critically acclaimed book on drug errors, attended the conference to discuss his book. Those in attendance learned about common medication errors, how to avoid or eliminate them, strategies for clear communication with prescribers, and ways to identify and decrease stressful situations in the pharmacy workplace that may contribute to medication errors.
In 1999, the Institute of Medicine (IOM) published a report entitled: “To Err Is Human: Building a Safer Health System,” which revealed that roughly 7,000 Americans die from medication errors annually. Then, in July 2006, the IOM released a new report, "Preventing Medication Errors," in which it stated that the number of adverse events related to medication errors was still incredibly high.
It is important for consumers to know which drugs are most commonly associated with adverse events and which are associated with medication errors. At the APhA conference, Matthew Grissinger, a medication safety analyst with ISMP, led a discussion entitled "The Top 10 Adverse Drug Reactions and Medication Errors.” Grissinger referred to a study that identified the 10 drugs most commonly associated with adverse events that required treatment in a hospital emergency department (ED). The study also documented the frequency with which each of the 10 drugs was involved
- Insulin (8%);
- Anticoagulants (6.2%);
- Amoxicillin (s) (4.3%);
- Aspirin (2.5%);
- Trimethoprim-sulfamethoxazole (2.2%);
- Hydrocodone/acetaminophen (2.2%);
- Ibuprofen (2.1%);
- Acetaminophen (1.8%);
- Cephalexin (1.6%); and
- Penicillin (1.3%).
The elderly account for almost 34% of all written prescriptions and thus there is a greater chance of adverse drug reactions and medication errors. The average number of prescriptions for an elderly person in the United States in 2000 was 28.5 per year and it is expected that, by the year 2010, that number will reach 38.5 per year. Each year, almost 250,000 seniors are hospitalized as a result of dangerous reactions between prescription and over-the-counter (OTC) medications.
Other documented reasons for medication errors include taking incorrect doses, taking doses at the wrong times, forgetting to take doses, or discontinuing the use the medication too soon.
There is a separate list of drugs that are most commonly associated with medication errors as opposed to adverse events. This list identifies drugs that are most commonly misused or mishandled by healthcare professionals. The list is compiled by the United States Pharmacopoeia (USP) from its database of anonymously-reported information:
- Insulin (4% of all medication errors in 2005);
- Morphine (2.3%);
- Potassium chloride (2.2%);
- Albuterol (1.8%);
- Heparin (1.7%);
- Vancomycin (1.6%);
- Cefazolin (1.6%);
- Acetaminophen (1.6%);
- Warfarin (1.4%); and
- Furosemide (1.4%).
Insulin tops the list of error-causing medication. In 1998 an ISMP study found that 11% of all serious medication errors were a result of the incorrect administration of insulin such as mixing up products with similar packaging or names, confusing generic listings on computer databases, and confusing the abbreviation "u" for units with the number 0. According to ISMP reports, these errors have been prevalent for over 30 years.
In this context it is critical to remember that a misplaced decimal point or one less 0 (zero) can mean an error of 10, 100, or even 1000 times in magnitude. Such errors are often fatal, especially when the drug is a powerful narcotic, anti-psychotic, or chemo-therapy agent.
The second drug on this list is morphine, which can be extrapolated to include all opioids, Grissinger said. Opiods with similar sounding names as well as different classes of drugs with similar names often cause confusion between generic as well as brand names, such as:
- Avinza and Evista;
- Morphine and hydromorphone;
- Oxycontin and MS Contin;
- Hydrocodone and oxycodone;
- Oxycodone and codeine;
- Zyprexa and Zyrtec;
- Adderall (acetohexamide) and Inderal (acetazolamide);
- Alupent (amiodarone) and Atrovent (amrinone);
- Ambien (bupropion) and Amen (buspirone);
- Asacol (chlorpromazine) and Os-Cal (chlorpropamide);
- Cardizem (clomiphene) and Cardiem (clomipramine);
- Celebrex (cyclosporine), Celexa (cycloserine), and Cerebyx;
- Dynacin (daunorubicin) and DynaCirc (doxorubicin);
- Flomax (dimenhydrinate) and Fosamax (diphenhydramine);
- Flomax and Volmax;
- Indinavir (dobutamine) and Denavir (dopamine);
- Lamictal (glipizide), Lomotil (glyburide), and Lamisil;
- Lanoxin (hydralazine) and Lonox (hydroxyzine);
- Levbid (methylprednisolone), Lopid (methyltestosterone), and Lithobid;
- Levoxyl (nicardipine) and Luvox (nifedipine);
- Lovenox (prednisone) and Lotronex (prednisolone);
- Nizoral (sulfadiazine), Nasarel (sulfisoxazole), and Neoral;
- Remeron (tolazamide) and Zemuron (tolbutamide); and
- Vioxx (vinblastine) and Zyvox (vincristine).
Another common mistake is mixing up different forms of the same drug such as oxycodone and oxycodone ER (extended release), especially in handheld device order entry.
Acetaminophen also causes many problems as it is available in a variety of different strengths. It is also found in many combination medications, both prescription and OTC. Prescription labels of combination products with acetaminophen can be potentially confusing for the patient. For example, hydrocodone 10/650 has 650 mg of acetaminophen, but many patients are not sure what that means.
At the conference, Grissinger reminded those in attendance that acetaminophen can be toxic, even though it can be purchased over-the-counter and that acetaminophen-induced liver toxicity accounts for more than 40% of all cases of acute liver failure in the United States.
Recent TV advertisements for Tylenol told viewers that the makers of the drug would rather you not take it than take more than the recommended dose.
Antibiotics are also associated with a large percentage of medication errors. Like opioids, the liquid dose concentrations create an increased risk for pharmacy mistakes. Confusion about proper measurements and dosage can cause significant overdoses and underdoses if undetected. Reconstituting antibiotics can also be problematic. For example, pharmacists have mistakenly reconstituted liquid antibiotics with alcohol instead of distilled water.
Morphine oral solutions cause many problems because of the multiple concentrations that are available; all stored close to each other. For example, it would be easy to confuse "mL" with "mg"; using 5 mL of morphine 20 mg/mL (100 mg) instead of the prescribed 5 mg (0.25 mL) would lead to overdosing the patient. Alternatively, an intended dose of 1 mL of morphine 20 mg/mL (20 mg) might be given as 1 mL of 10 mg/5 mL (2 mg), thus underdosing the patient. Grissinger also reported a case in which Avinza (morphine ER caps) 30 mg was misinterpreted and dispensed as "qid" (4 times daily) instead of "qd" (once daily), causing a near-fatal overdose.
INFANTS AT RISK
Initially, in November 2005, findings were released by the Montgomery, Ohio, Coroner’s Office after an investigation unearthed a rash of infant deaths linked to improper medicating with cold remedies that were intended for older children. This prompted health officials in other states as well as at the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) to start their own inquiries into the apparent harmful and often deadly confusion between “pediatric” and “infant” dosages for OTC cold medications.
At the time, the Coroner’s Office said that they encountered 10 deaths over an 8-month period in infants less than 12 months old with toxicology findings that included a variety of drugs commonly found in OTC cold medications.
The drugs detected were ephedrine, pseudoephedrine, dextromethorphan, diphenhydramine, chlorpheniramine, brompheniramine, ethanol, carbinoxamine, levorphanol, acetaminophen, and the anti-emetic metoclopramide.
Toxicology findings were confirmed in 2 different matrices in 9 of the 10 cases and by 2 different analytical methods. The majority of these deaths were either toxicity from the OTC cold medications directly or as a contributory factor in the cause of death.
The toxicologists involved in the investigation said that these specific cases demonstrated that the administration of some OTC cold medications is not safe and can result in fatal levels of toxicity in infants who have been exposed to contraindicated doses of such drugs or their active ingredients.
Since 2005, there have been two other major occurrences of infant deaths linked to improper dosages of over-the-counter medications, causing physicians and medical professionals to advise patients to seek medical advice from a professional even in regards to OTC medications when it comes to infants and children. When mistakes can be fatal, parents and caregivers can never be too cautious and sometimes interpreting labels can be more difficult than it seems.
On February 26, 2006 the Chicago Tribune ran a story regarding the deaths of two Kane County infants within a 24-hour period and attributed these deaths to accidental overdoses of prescription cold medicines.
The coroner for Kane County requested that the FDA join the investigation because there appears to be a “trend” developing in the form of a dramatic increase in the number of “troubling” deaths in which accidental overdosing may have been involved.
An FDA spokesperson acknowledged that it was aware of the cases and that the agency was actively participating in the investigation.
Although the Illinois deaths are troubling in and of themselves, recent reports from around the U.S. indicate that accidental overdosing of infants is a serious and growing problem. Moreover, the problem is not limited to prescription drugs, as life-threatening overdoses of OTC medications also appear to be on the rise.
The Chicago Tribune article noted a similar situation to the Ohio deaths in at least one of the deaths in Kane County where “the prescribed dosage of medicine was 0.2 milligrams, he said, but the dropper that was used, which measures 1 milligram when full, could lead a confused caregiver to deliver 2 droppers-full of medicine instead of just two-tenths of one dropper.”
Researchers in Atlanta found that prescription and over-the-counter cough and cold remedies were responsible for the deaths of three infants.
The autopsies of two boys and one girl, between the ages of one to six months, revealed that all three children had high levels of the nasal decongestant pseudoephedrine in their blood.
According to the investigators, the cough suppressant dextromethorphan and Tylenol (acetaminophen), were noticeably present in the blood of two of the infants. In addition, the blood levels of pseudoephedrine found in the children were nine to 14 times higher than the recommended doses of the decongestant for children who are ages two to 12 years.
"Because of the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children ages younger than 2 years, parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting a health-care provider and should follow the provider's instructions precisely," the investigators wrote.
Sadly, all three infants had ingested cough-and-cold remedies containing pseudoephedrine, and one had even been given both a prescription preparation and OTC medication containing the vasoconstricting decongestant.
Two of the children had also been given prescriptions containing the antihistamine carbinoxamine. Carbinoxamine was banned by the FDA following the reports of these infant deaths, citing that it contained medications that they had never approved. Since those deaths occurred, the FDA banned the manufacture of carbinoxamine-containing medications that the agency had not specifically approved.
Infants, children, adolescents, adults, and the elderly are differentiated between when it comes to how much of a drug can be tolerated at any given time as well as if taking a particular drug is even proper in the first place.
Dosage variations or restrictions based on age and/or weight differentials are commonly included in “dosing charts” on a drug’s package or information label. Pharmacists also provide computer printouts of this data when necessary.
While healthcare professionals always have access to this information and are expected to adhere to it when prescribing a medication or suggesting an OTC remedy, the same cannot be said of consumers, however.
All to often, patients “share” prescription medication with friends or relatives believing that it is safe as long as the other person has (what appears to be) the same medical problem. Thus, it is not uncommon for some very powerful (and dangerous) prescription medication to find its way to people who should not be taking it at all or who need a completely different dosage (or drug) because of their age or weight.
The problem with OTC medications is even more serious since there is usually no medical professional involved in the decision as to which product is taken and how much of it is used. Dosing charts are often ignored, thrown away, or misunderstood. There may even be problems with the clarity of the instructions or the accuracy of measuring devices included with the product. This problem is only getting worse as more and more prescription drugs are being approved in OTC varieties or dosages.
In August of 2005, for example, the FDA announced that Perrigo Co., was voluntarily recalling all lots of four types of its concentrated infants’ liquid pain, cough, and cold drops that come packaged with syringes that could cause the youngest infants to receive overdoses of the various active ingredients including acetaminophen.
The oral syringes which Perrigo distributed with these over-the-counter liquid medications were not marked to measure doses of less than 1.6 milliliter which may be prescribed for children younger than 2 and less than 24 pounds. Ingesting too much acetaminophen, a pain-relieving ingredient, may cause liver damage. Previously, the medications had been distributed with droppers that had different markings. The new markings "caused some confusion among consumers and health-care professionals and may lead to improper dosing," the FDA said.
Taking a few extra OTC painkillers to get relief, multiplying or dividing recommended dosages depending on a child’s weight, or ignoring warnings concerning dangerous interactions can, it seems, be deadly.
Each year, OTC drug overdoses and interactions send thousands of people to hospital emergency rooms and kill scores of others. When a parent or caregiver decides, without any medical advice, that half a dropper of a children’s cold remedy is perfectly fine for a 18-pound, 10-month-old infant simply because the recommended dose for a much heavier 2-year-old child is one full dropper, the stage is set for a potentially deadly overdose. An infant’s developing bodily systems are often far too immature (or even undeveloped) to expose to toxic medications without specific medical advice and supervision.
- Patient information (age, weight, allergies, diagnoses, and pregnancy status);
- Drug information (up-to-date information readily available);
- Communication (collaborative teamwork between all healthcare members and the patient);
- Drug labeling, packaging, and nomenclature (limit look-alike and sound-alike drug names, confusing packaging);
- Drug standardization, storage, and distribution (restricting access to high-alert drugs);
- Medication delivery device acquisition, use, and monitoring;
- Environmental factors (poor lighting, cluttered work spaces, noise, interruptions, nonstop activity, and deficient staffing);
- Staff competency and education;
- Patient education; and
- Quality processes and risk management (systems are needed for identifying, reporting, analyzing, and reducing the risk for medication errors with a nonpunitive culture of safety).
- Failure to detect a disease state contraindication to the drug therapy;
- Failure to detect a significant drug interaction;
- Failure to detect a significant drug allergy;
- Failure to prescribe the correct dose for a specific patient;
- Failure to monitor drugs with narrow therapeutic indexes; and
- Patient knowledge deficits.
Pharmacists should always identify the issues “clearly and concisely,” when communicating with prescribers. Marialice Bennett, RPh, FAPhA, Professor and Pharmacy Director of the University Health Connection at Ohio State University in Columbus, Ohio offered these suggestions:
- Outline the specifics of the problem;
- Keep focused on the patient;
- Provide possible solutions;
- Ask for prescriber feedback; and
- Document the final decision.
While many patients put their faith in their physicians and pharmacists, it is important to always double-check your medications when leaving the pharmacy. If you are uncertain about the name or dosage of a medication, consult with your pharmacists AND physician to make sure that an error did not occur either before or after the prescription was filled.
After leaving the pharmacy and returning home, consumers should still be aware that mistakes can be made. If there are more than one prescription medications in a cabinet, make sure you read the label before taking anything and be careful not to rely on others to handle medication as they may not know what to look for in the label.
As always, if you, the patient, ever feel an adverse or even different effect after taking any medication, immediately consult a medical professional. It is better to be safe than sorry.
As always, the attorneys at Parker Waichman LLP are dedicated to bringing the public the most up-to-date information regarding pharmaceutical products, medical devices, toxic substances, and other consumer products with the potential to inflict serious injuries or death. If you or a loved one has suffered an injury (or death) that may be attributable to any product, do not hesitate to contact us at www.yourlawyer.com for a free and thorough case evaluation.