Almost everyone takes medication at one time or another. Recent studies reveal that in any given week four out of every five U.S. adults will use prescription medicines, over-the-counter drugs, or dietary supplements of some sort, and nearly one-third of adults will take five or more different medications. What is shocking is the number of people injured by medication mistakes.
MEDICATION ERROR STATISTICS
• Conservatively, at least 1.5 million people per year are harmed by medications. Many medication mistakes are never reported.
• 100,000 people die each year as a result of medication errors.
• At least 400,000 drug-related injuries occur each year in hospitals or approximately one medication error per patient per day. These drug-related injuries result in at least $3.5 billion in extra medical costs.
• Another 800,000 drug-related injuries occur in long-term care settings, such as nursing homes.
• It is estimated that 51.5 million medication errors occur during the filling of 3 billion prescriptions each year.
• Approximately 530,000 medication errors occur just among Medicare recipients in outpatient clinics.
• In a recent survey, over 40% of those questioned said either they or someone they knew had suffered injury because of a medication mistake.
Medication error is defined as any preventable event that may cause, or has caused patient harm while the medication is in control of a health care professional (e.g., doctor, physician’s assistant, pharmacist, or nurse) or patient. Such events may be related to professional practice, order communication, product labeling, packaging, compounding, dispensing, distribution, administration, education, and use.
Types of Medication Errors
Medication errors can be broadly classified as prescribing, dispensing or drug administration errors.
Prescribing errors account for somewhere between 20%-60% of all medication errors. These errors are made prescribers, including doctors, physician’s assistants, or nurse practitioners.
The numerous types of prescribing mistakes include:
• Failure to alter drug therapy in patients with impaired kidney or liver function. This mistake leads to an excessive dose of the prescribed drug.
• Failure to notice a patient’s history of allergy to the prescribed drug class or missing critical information about a patient’s known drug allergies.
• Use of the wrong drug name (e.g., sound-alike or look-alike drug names), wrong dosage form (e.g., intramuscular v. intravenous injection), wrong abbreviation (e.g., “qd” [everyday] instead of “qid” [4 times per day].
• Incorrect dosage calculations, including wrongly placed decimal points and wrong rate or frequency of administration.
• Failure to prescribe when there is a medical indication or prescribing a drug without an indication (e.g., use of antibiotics to treat a cold).
• Incorrect drug selection for a patient.
• Failure to take into account drug-drug or drug-food interactions or duplicative therapies.
Prescribing errors are caused by:
• The doctor’s, physician’s assistant’s, or nurse practitioner’s insufficient knowledge about the medication and its correct use.
• The doctor’s, physician’s assistant’s, or nurse practitioner’s lack of knowledge about the patient (e.g., incomplete medical history).
• Miscommunication among doctors, nurses, and pharmacists (e.g., illegible handwriting on written orders/prescriptions, misunderstanding of verbal orders, mistakes using electronic ordering).
• Doctors or other prescribers not following policies and procedures.
• Incorrect record-keeping or charting.
Dispensing errors account for 6%-12% of all medication mistakes. These mistakes are made by pharmacists or pharmacy technicians. In a study of 500 pharmacist malpractice claims, over 85% of dispensing errors could have been prevented.
Common dispensing mistakes made by the pharmacy staff include:
• Dispensing the wrong drug: This happens when the patient’s doctor prescribed the correct medication, but the prescription was filled by the pharmacist with the wrong medication.
• Dispensing a prescription to the wrong patient: Here the prescription is filled correctly, but is given to the wrong patient by the pharmacy staff.
• Dispensing the wrong dosage of the prescribed drug: In this case the doctor prescribed the correct dose, but the wrong dose was dispensed.
• Confusing drugs that have similar sounding names or look alike: This is a common mistake. Examples of this include Glyburide, Glipizide; Quinine, Quinidine; Serzone, Seroquel; Lamictal (for epilepsy), Lamisil (for nail infections).
• Failing to verify a drug name or dosage with the prescribing doctor.
• Failing to protect against harmful drug interactions: This occurs when a pharmacist does not check if a patient is currently taking other medications that can affect the efficacy, side effects or action of the prescribed drug. This includes not only interactions between two or more medications, but also the harmful combination of a drug with certain foods or beverages.
• Failing to identify patient drug allergies: This occurs when the pharmacist fails to determine whether the patient is allergic to the prescribed medication, its ingredients or any of the substances from which the drug may be made.
• Failing to give the correct directions for taking the prescribed medication.
• Mislabeling a prescription: This occurs when a label has improper use instructions or inadequate or erroneous warnings.
• Failing to provide adequate counseling to the patient.
Common causes of pharmacy error include:
• Inadequately trained personnel.
• Improper abbreviations used in prescribing.
• Inappropriate use of decimals.
• Illegible handwriting: illegible handwriting on prescriptions or orders alone count for 15-25% of all medication errors.
• Inaccurate drug history taking.
• Labeling errors.
• Insufficient filling time/excessive workload.
Regarding chain drug stores in particular, a 2008 USA Today Investigation found evidence that corporate policies such as allowing or encouraging pharmacists to fill hundreds of prescriptions daily and rewarding fast work-can contribute to serious or fatal pharmacy errors.
• Lapses in individual performance.
• Poor oral and written communication between prescriber and pharmacist: one in ten medication errors results from an incorrect name, misinterpretation of dosage, misunderstanding of an abbreviation or misinterpreting the decimal point placement.
• Interruptions and distractions are highly correlated with dispensing errors. Almost 26% of pharmacists’ time is spent dealing with interruptions related to third parties and miscellaneous tasks.
• Drug reference files, texts, and/or other database systems may not be current, resulting in errors associated with outdated and incorrect information.
Drug administration errors are made by nursing personnel and occur when one or more of the “five rights” is wrong.
The “five rights” have long been the basis for nurse education concerning drug administration, i.e. giving the right dose of the right drug to the right patient at the right time by the right route.
These errors are made by nursing personnel in acute care hospitals, in long-term facilities, and during home care. In many of these settings, the environment for nurses is demanding, characterized by long hours, staffing shortages, high patient and staff turnover, and constant interruptions. These errors also are made by the patient or patient’s caregiver at home.
EXAMPLES OF MEDICATION ERROR
• One patient died because a dose of 20 units of insulin was abbreviated as “20 U,” but the “U” was mistaken for a “zero.” As a result, a dose of 200 units of insulin was accidently injected.
• A patient developed a fatal hemorrhage when given another patient’s prescription for the blood thinner warfarin.
• Another patient died after the pharmacy mistakenly gave her a blood thinner 10 times stronger than prescribed.
• An elderly patient with rheumatoid arthritis died after receiving an overdose of methotrexate. A 10-milligram daily dose was dispensed instead of a 10-milligram weekly dose. This illustrates how some dosing mix-ups have occurred because daily dosing of methotrexate is typically used to treat people with cancer, while low weekly doses of the drug have been prescribed for other conditions, such as arthritis, asthma, and inflammatory bowel disease.
• A high school wrestling coach died from an interaction between tramadol and methadone, painkillers dispensed at different times by the same pharmacy. The pharmacist neither warned the patient about the potential drug interaction nor double-checked the second prescription with the doctor.
• Actor Dennis Quaid’s twins each received 10,000 units of heparin (an anticoagulant used to keep blood from clotting) instead of the 10 unit dose of heparin to flush (or keep open) the intravenous lines. This error was due to the similar packaging of the two doses of heparin and that they were stored near each other.
GROUPS AT MOST RISK FOR MEDICATION MISTAKES
Experts agree medication errors have the potential to cause harm within the pediatric population at a higher rate than in the adult population. Medication dosing errors are more common in pediatrics than adults because of weight-based dosing calculations (milligram/kilogram of patient weight), fractional dosing (e.g. milligrams v. grams), and the need for decimal points.
Research shows that the potential for adverse drug events within the pediatric inpatient population is about three times as high as among hospitalized adults. A new study identified an 11.1 % rate of adverse drug events in pediatric patients. The study also showed that 22% of those adverse drug events were preventable, 17.8 percent could have been identified earlier, and 16.8 percent could have been mitigated more effectively.
In April 2008, the Joint Commission issued a report concerning pediatric medication errors. The report went on to explain that children are more prone to medication error and resulting harm because:
• Most medications used in the care of children are formulated and packaged primarily for adults. Therefore, medications often must be prepared in different volumes or concentrations within the health care setting before being administered to children. The need to alter the original medication dosage requires a series of pediatric-specific calculations and tasks, each significantly increasing the possibility of error.
• Most health care settings are primarily built around the needs of adults. Many settings lack trained staff oriented to pediatric care, pediatric care protocols and safeguards, and/or up-to-date and easily accessible pediatric reference materials, especially with regard to medications. Emergency departments may be particularly risk-prone environments for children.
• Young children, especially sick and small children, are usually less able to physiologically tolerate a medication error due to still developing kidneys, immune and liver functions.
• Very young children cannot communicate effectively to providers regarding any adverse effects that medications may be causing.
Further, a recent study of pediatric medication errors found that the errors were most often caused by:
• Performance deficit (43.0%)
• Knowledge deficit (29.9%)
• Procedure/protocol not followed (20.7%)
• Miscommunication (16.8%)
• Calculation error, computer entry error, inadequate or lack of monitoring, improper use of intravenous infusion pumps, and documentation errors.
• Finally, the study revealed that approximately 32.4% of pediatric errors in the operating room involve an improper dose/quantity compared with 14.6% in the adult population and 15.4% in the geriatric population.
A recent study in the Journal of the American Medical Association found that medication errors with the potential to cause harm are 8 times more likely to occur in neonatal intensive care units compared with hospital patient care areas for adults. When newborns receive pharmacy services from a hospital pharmacy department that also serves older children, look-alike and sound-alike medication dispensing errors are always a possibility. Such errors are caused by the wide variety of dosage forms and concentrations the hospital pharmacy is required to stock to meet all its patients’ needs and by the different concentrations of the same medications that are manufactured in very similarly appearing packages. A well-known example is the dosage administration error involving Dennis Quaid’s twins wherein each twin received 10,000 units of heparin (an anticoagulant) instead of the 10 unit dose of heparin to flush the intravenous lines.
Recent data reports found that one-third of hospital medication errors that reach the patient involve elderly patients. Harmful medication mistakes in the geriatric population occurred more often than harmful errors for all populations overall and more than half the reported fatalities involved seniors.
A 75-year-old female who had a history of hypertension (high blood pressure) was transferred from the operating room to a surgical intensive care unit SICU). The attending surgeon wrote a postoperative order for the antidepressant maprotiline 50 milligrams BID (twice a day). The nurse caring for the patient sent the order on to the pharmacy, where the order was entered into the pharmacy computer system as the beta-adrenergic blocking drug metoprolol 50 mg BID.
The next day the family asked about the patient’s antidepressant drug. The nurse for the patient approached a surgical resident and obtained an order to start maprotiline 50 mg BID. On day three, while preparing the patient for transfer from SICU (surgical intensive care unit) to a general surgical unit, the nurse found the patient with a slow heart rate, hypotension, shortness of breath and epigastic pain. An on-call resident was called, and additional diagnostic tests indicated that the patient was experiencing an acute myocardial infarction (aka heart attack).
Upon review of the medical record, the resident discovered the error. The patient’s stay in the SICU was extended and additional lab and radiological diagnostic tests were required. The patient was eventually discharged from the hospital and made a full recovery.
An analysis of the case concluded that the error was a prescribing error caused by illegible handwriting by the physician. Other causes included look-alike and sound-alike drugs, maprotiline 50 mg BID and metoprolol 50 mg BID.
EMERGENCY DEPARTMENT PATIENTS
Emergency departments have a greater rate of medication errors than any other health care setting. This is not surprising given that doctors and nurses working in the emergency room must work very quickly under enormous pressure in an environment that can be extremely hectic. Almost twice the number of medication mistakes is not caught before they reach the patient compared to other areas in the hospital.
Several types of medication errors can occur in the emergency room:
• Prescribing errors: the physician’s failure to prescribe the correct medication.
• Omission errors: failure of the nurse or doctor to administer the prescribed drug to the patient.
• Improper dosage errors: failure to provide or administer correct dose of medication. This is especially prevalent in children or babies.
• Wrong medication administered: a medication was administered to the patient that was not prescribed by the doctor.
You can help protect yourself and loved ones from medication mistakes in the emergency room by:
• Bringing a list of current medications, prescription and over-the-counter, including vitamins and supplements,
• Listing any medication or food allergies and making sure the doctor and nurse know about these allergies,
• Knowing the current weight of a baby or child since many medications for children are dosed based on body weight,
• Asking what drug is being administered to the patient and why the drug is being used.
HOW YOU CAN HELP PREVENT MEDICATION ERRORS
Take an active role in the management of your medications. Experts agree that medication errors will be on the rise as the population ages and more people require medication. Statistics show that prescription volume has risen dramatically over the past ten years. This fact, coupled with the shortage of pharmacists and cost-cutting measures employed by chain drugs stores and hospitals, requires that patients take an active role in the management of their medications. The Institute of Medicine Report on Preventing Medication Errors repeatedly states that one of the most effective ways to reduce medication errors is to move toward a model of health care where there is more of a partnership between the patients and health care providers. That is, patients should understand more about their medications and take more responsibility for monitoring those medications, while doctors, physician’s assistants, pharmacists and nurses should take steps to educate, consult with, and listen to patients.
• Ask questions of your physician and pharmacist. Do not leave your doctor’s office or the pharmacy confused or uncertain about your medications. Insist that your doctor clarify specific aspects of the medication regimen (drug name, purpose, dosage, strength), identify possible side effects and what actions to take should they occur, and understand possible interactions with other medications and/or foods and beverages.
• Keep an up-to-date medication list that includes prescription medications, over-the-counter drugs, and dietary supplements. According to the Institute of Medicine Report, this is the single most important contribution patients can make to medication safety and good medication self-management. This list should include:
o The name of the drug or supplement;
o The reason for taking the product;
o The strength, dose and frequency of administration of the product;
o All known drug or food allergies
• Carry this medication list with you at all times in case emergency care is needed. You should have the doctor verify the list each time you visit him or her.
• Patients have a responsibility to provide information about medications they are taking to their doctors and pharmacist to help prevent adverse drug events and drug-drug interactions.
• This medication list is especially important for those who have chronic conditions, see multiple doctors, or take several medications and dietary supplements.
When you go to your doctor’s office or clinic:
• Take your medication list with you and show it to your doctor.
• Have the doctor write down the name of any new drug he or she is prescribing (brand and generic, if available), what the drug is being used for, its dosage, and how often to take it, or provide other written material with this information.
• Have the doctor explain how to use the drug properly.
• Ask about the drug’s side effects and what to do if they experience a side effect.
When you pick up a prescription at the pharmacy:
• First, get your prescriptions filled at the same pharmacy. California law requires that pharmacists keep a patient medication profile on each patient who gets a prescription filled at the pharmacy. An accurate medication profile allows the pharmacist to check for drug interactions, side effects, and other clinical information that may affect the efficacy of the drug prescribed.
• Immediately after you receive a prescription from the pharmacy, look at the prescription label, open the prescription vial and look at the medicine dispensed to you. If the directions for use are different, the medicine looks different than what you have received before or you have any questions, tell/ask the pharmacist before you leave the pharmacy.
• Make sure the name of the drug (brand or generic) and the directions for use received at the pharmacy are the same as what is written down for you by the doctor.
• Know that you can review your list of medications with the pharmacist for additional safety.
• Know that you have the right to counseling by the pharmacist if you have any questions. You can ask the pharmacist to explain how to take the drug properly, what side effects it has, and what to do if they experience a side effect (just as you did with the doctor).
• Ask for written information about the medication.
• Know how you should store the medication at home.
When you are a patient at the hospital:
• Ask the doctor or nurse what drugs are being given in the hospital.
• Do not take a drug without being told the purpose for doing so.
• Exercise the right to have a friend or family member present whenever you are receiving medication and are unable to monitor the medication-use process yourself.
• Prior to surgery, ask whether there are medications, especially prescription antibiotics, that you should take or any medicine you should stop taking before surgery.
• Prior to discharge, ask for a list of the medications you should be taking at home, have your doctor review them, and be sure you understand how these medications should be taken.
News coverage of the serious and sometimes fatal side effects caused by medication has been alarming to the public as well as health care professionals.
One job of the Food and Drug Administration (FDA) is to evaluate new drugs before they can be sold. The evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The FDA is directed to ensure that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
Drug companies seeking to sell a drug in the United States must first test it. These tests are performed by the companies in human volunteers. The company then sends the FDA the evidence from these tests to prove the drug is safe and effective for its intended use. If the FDA, through a team of physicians, statisticians, chemists, pharmacologists and other scientists, establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale.
Even after the drug is authorized to be sold, drug companies still remain responsible for reporting to the FDA any side effects or problems that are occurring when the drug is used in a wider patient population.
Drug companies spend millions of dollars in the research, development, testing and marketing of new drugs. As recent news stories detail, sometimes the drug companies fail to report or cover up side effects, including potentially fatal ones, that surface during initial human testing or post-FDA approval.
If you have taken prescription drugs in the past and have experienced serious side effects, you may be entitled to a portion of the large settlement awards from the responsible drug manufacturer. Even if you have used the drugs without side effects, you may be eligible for some form of award because of the drug’s potentially fatal effects.
All Rights Reserved
Andrea Cook & Associates