medication error...
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Introduction
Pharmacovigilance is about making drug products, as well as their use, safer. While the set-up for ADR monitoring catches product problems, it may also be a good system to detect if such a product was not being properly used. Medication error is one such problem. Lessons from medication error detection may help prevent future errors and protect health professionals and ultimately, their patients.
Generally, there is difficulty in obtaining the correct statistics on medication errors. Many of these errors are neither recognized nor reported. A study was published in the Archives of Internal Medicine based on data collected since 1999. In the United States, more than 40 potentially harmful errors a day were found on average in hospitals. The most common mistake is giving medicines at the wrong time, completely omitting the dosage, and over-dosing. Errors occurred in one of five doses in a typical 300-bed hospital. This translates to an average of 2 errors per patient daily. Although not all of these errors are dangerous, 7% of the errors were considered potentially harmful.
Medication errors can lead to manslaughter charges. The topic of medication error will make pharmacovigilance instruction more relevant and interesting. It will help prevent malpractice litigation and promote public health safety and awareness. While it is the drug regulator’s role to help improve the quality of drug and drug use by providing standards, medication errors can be minimized, if not completely eradicated at the clinical side. Its occurrence reflects on the quality of health care.
Causes of Medication Errors and some examples:
Errors originating from the drug industry:
1. Mistakes can happen in the manufacture of medicines (e.g. using the wrong excepients)
2. Proper storage procedures are not observed, making the drugs
useless. Using expired tetracycline has been known to cause Fanconi’s
syndrome, for instance.
3. Failure to provide the correct
prescribing information. For example 10 mg/kg 6 hourly could mean: 10
mg/kg per dose given every 6 hours, which is the wrong interpretation,
or 10 mg/kg/day to be divided every 6 hours which is correct.
4. Failure to do Post-Marketing Surveillance by manufacturers. And, if done, not communicating these data.
5. Misleading health and treatment claims by the industry.
Errors arising from medical doctors’ prescriptions
1. Prescribing the wrong drug
2. Writing illegibly
3. Confusing the name of one drug with that of another
4. Prescribing the wrong dose
5. Writing wrong dose
6. Wrong route of administration as listed in the prescription
7. Prescribing the wrong formulation (an example is using slow
release drugs inadvertently when the doctor meant ordinary tablets)
8. Prescribing the duration of treatment incorrectly
9. Prescribing wrongly for a given individual
10. Error in identity of the patient.
11. Failing to account for pre-existing disease
12. Failing to account for concurrent therapy
13. Prescribing with inadequate or incorrect instructions
14. Prescribing without informed consent of the patient
15. Off-label use of drugs
Errors arising from pharmacists’ dispensing
1. Dispensing errors – for example, giving 250 mg/5mL paracetamol instead of the prescribed 125 mg/5 mL preparation.
2. Misinterpreting doctor’s prescription and failure to confirm with the prescriber.
3. Failure to provide advice to patients at the outlet level. In poor
resource countries, patients sometime purchase only a few tablets
because they cannot afford a complete course of treatment. The
pharmacist or store clerk sells the medicines by cutting the medicine
strips. As a result, the expiry dates are sometimes no longer
indicated on the purchased portion and product information leaflets
are rarely provided in such instances.
Errors arising from nurses’ administration of drugs
1. Errors in drawing up and giving medicines
2. Wrong drug
3. Correct drug, wrong dose
4. Correct drug, wrong dilution
5. Correct drug, wrong formulation
6. Entraining air, particles or other contaminants with the drug
7. Errors in administration (interchanging IV, IM, intrathecal, oral, sublingual route)
8. Giving a drug outside or against currently accepted practice (off-label usage)
9. Wrong route, wrong site, wrong rate, wrong patient
Errors arising from patient’s drug intake:
1. Misunderstanding medication instructions.
2. Poor patient compliance, not completing dosage regimen.
3. Drug paroxysm. This is when a patient takes a medicine but later
becomes confused whether he actually took the medicines and ends up
taking a second dose erroneously. This is not restricted to geriatric
patients.
To counteract these possible errors, good prescribing practice guidelines are advocated:
• If it is possible to write the dose as a whole number, then do so.
• If it is impossible or more confusing to write the dose as a whole
number, then ensure that a zero precedes the decimal point. Place the
decimal point properly; a shift can mean 10 times more the intended
dose, or can mean receiving only 10 percent of the intended dose. Use
Gm for gram and gr for grain when specifying quantity. The best is to
carefully spell out the whole word and dot the i. If grams are given
instead of grains, the patient will receive approximately 15 times the
dose intended.
• Communicate clearly. New technology like mobile
phones and short message sending (texting) can lead to errors. Hospital
should set up clear policies on telephone orders to prevent mistakes.
Among the doctors, nurses and pharmacists, when transmitting orders,
clear pronunciation of medical terms and listening carefully can
preventmistakes of similar sounding drug names.
• Write a
prescription clearly and give the instructions to patients or their
responsible companions. There was a case of an obese diabetic patient
who was being managed with oral hypoglycemic medicine and instructed to
decrease weight in a vague manner. The patient decided to skip
breakfast as a “diet control” measure but continued taking her medicine,
leading to symptomatic hypoglycemia.
• Prescription should have
all the essential information like dosage strength, the number of
tablets, frequency of administration, route.
• Be conservative.
Prescribe only when absolutely needed. Don’t satisfy the whims of
patients who request antibiotics to treat common colds.
• Know your patient’s conditions well before prescribing any drugs.
• Prescribe a medicine which you are thoroughly familiar with
(adverse effects, contraindications, warnings). Do not be tempted to
prescribe new medicines which are being promoted aggressively by drug
companies.
• If you want to prescribe a generic drug, it is better
to indicate the particular company source you trust, for two reasons:
substitution of another company’s generic product can mean lower drug
levels (for drugs with serious bio-availability variations) and, in some
countries, there are substandard generic products in the market.
•
Avoid overprescribing because this is costly and can lead to
accidental overdose. Sometimes, an expired drug is unintentionally
taken. Also, warn patients not to recommend an effective drug which
they may have in excess at home to a member of the household or a
neighbor without consulting a health professional.
• Avoid
polypharmacy. Although not all polypharmacy is bad when these
medicines are actually needed, be attentive to those with potential for
harmful interactions. Be wary of drug-drug interactions.
• Spend
time to educate a patient about the drug-- when to take it, when to
stop, what to expect (e.g., will it change the color of their urine?),
how to recognize drug reactions and what to do, expiration dates, drug
interactions and storage conditions. Patients should be made to
understand that when they take medicines, they are essentially betting
that the benefits derived from using the drug outweigh the harmful
risks from the medicine and the consequence of the untreated disease
condition. There are some medicines which, when started, should be
continued for a long time (e.g. Anti-TB drugs and prevention of
resistance).
• There are some drugs which, when taken for a long
time, should not be stopped abruptly (e.g. Anticonvulsants, steroids,
sedative hypnotics)
• There are also some drugs which, when taken long term, may lead to drug dependence and abuse.
• Pay serious attention to the patient’s history, such as records of
hypersensitivity, allergies, idiosyncracies to medicines, or medical
conditions that are considered contraindications to drugs. Note these
in patient’s records and review them when necessary before
prescribing. Take note of the patient’s occupation and possible risky
interactions with his medicines.
Drug safety and rational drug use
Due care must be exercised when handling drugs and treating patients. Negligence may lead to fatality, and commonly, a health professional may be charged with acts or omissions such as:
a. Not using available, objective and
updated drug information and relying solely on drug industry detail
person for this information.
b. Miscommunications on drug orders
like poor penmanship, confusion between drug names, misuse of zeros
and decimal points, wrong dosing units, and incorrect abbreviations.
c. failure to obtain consent from a patient for the use of a drug in a manner not officially approved (off-label)
d. treatment of a condition with a drug not suitable for the condition
e. failure to note a history of drug hypersensitivity, concurrent medications, contraindicated medical conditions.
f. failure to test patient for sensitivity to drugs like penicillin
g. improper injection techniques
h. failure to stop a medicine suspected to cause a reaction
i. failure to provide adequate intervention to counteract an adverse reaction
j. failure to communicate with patients.
k. lack of correct labeling when drugs are repacked into smaller units
It is by recognizing possible errors that we can find suitable ways to prevent them.
http://www.pcp.org.ph/index.php?option=com_content&view=article&catid=100&id=211&Itemid=150
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Medication Errors in Hospitals: An Analysis
Reducing medication errors has become a topic of top priority in our nation, with primary emphasis on improving patient safety. According to the National Coordinating Council for Medication Error Reporting and Prevention, a medication error is defined as a "preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."1 Just as drugs can save lives, they can lead to harmful events affecting not only the patient, but also health care in general.
An array of studies has addressed the subject, as a large number of Americans die each year due to medication errors. In fact, according to the report of the Institute of Medicine (IOM) entitled "To Err Is Human: Building a Safer Health System," between 44,000 and 98,000 people die in hospitals as a result of medical errors, which, according to major studies, could have been prevented.2
For decades, minimizing adverse drug events and medication errors has been a goal in health care. Nevertheless, it is highly recognized that competent and caring professionals will make mistakes. When analyzing medication errors, the trend in the past has been to place possible negligence on the health care provider. Yet, today we realize that many medication errors result from inadequate systems leading to serious mistakes by providers.
Errors can occur during any stage of the medication process. Rather than upholding a punitive approach, however, now the focus is to concentrate on "prevention" and to devise strategies to minimize errors and adverse medication events. Although providers are still held to a high standard and must be responsible for the decisions they make, placing blame on an individual seldom leads to positive outcomes.
Medication Errors?An Overview
In an article published in the Journal of Clinical Pharmacology, David M. Benjamin, PhD, FCP, outlines "5 rights" in delivering drug therapy: (1) the right drug, (2) the right dose, (3) the right route, (4) the right time, and (5) the right patient.3 Yet, the system is far more complex. The incidence of medication errors in hospitals is at an all-time high, resulting in hospital administrators exploring new interventions conducive to an overall improvement in safety.
The report from the IOM states that patient awareness, based on patient education prior to discharge, also can provide a "major safety check" in hospitals. The aim is for patients to become familiar with the appearance of their medication, possible side effects, and the purpose for taking the medication?in essence, to create an awareness and a proactive approach to therapy on the part of patients.
Factors Contributing to Errors
The work environment in general can lead to errors?interruptions, an inadequately trained staff, sleep deprivation, language barriers, medication sound-alike names, and lack of data concerning a patient can become risks. A recent review article, "Medication Errors: A Bitter Pill" by Kathleen C. Ashton and P. W. Iyer of Rutgers University, outlines certain factors that lead to adverse medication events4:
- Ordering errors. These errors occur when the physician orders the wrong drug, wrong dose, a drug to which a patient is allergic, or duplication in therapy. The nurse may then perpetuate the error by not questioning the physician. In addition, handwritten prescriptions can lead to catastrophic results, due to sloppy handwriting and confusion about decimal points.
- Administering errors. These errors encompass the wrong drug, the wrong patient, and the wrong route. A common error in hospitals involves patient-controlled analgesia pumps. Although the advantage of the pump is the ability of the patient to obtain the right dose, if the pump has not been programmed correctly the patient may risk serious side effects.
- Transcription errors. Entering incorrect data onto the medication administration record by nonmedical personnel can be a factor. Thus, nurses on duty need to have systems in place to detect potential errors.
- Dispensing errors. Many of these errors involve the pharmacy's supplying an incorrect medication or dose; or they may occur when the pharmacy is closed. In her study, Dr. Ashton reported that the Joint Commission on the Accreditation of Healthcare Organizations now discourages access to the pharmacy by nurses after the pharmacy is closed.4
Implementing Crucial Systems Nationwide
Hospitals nationwide are exploring and developing systems for the purpose of reducing medication administration errors. The Valley Hospital, a 451-bed acute care facility in New Jersey, has worked diligently in developing a system to reduce medication administration errors. M. Mutter, of Clinical Systems and Quality Improvement, has determined certain factors that are necessary to achieving goals, namely (a) becoming familiar with the actual errors?concentrating on how, when, and why they were committed; (b) establishing a "nonpunitive" (whereby no punishment or disciplinary action is imposed for any specific error) approach whereby reporting of errors or "near-miss errors" (a process variation that does not affect an outcome but for which a reoccurrence carries a significant chance of a serious adverse effect) is encouraged; (c) identifying areas of concentrated errors; (d) standardizing steps in the identification of errors; and (e) selecting the proper technology to correct these errors.
A medical facility that represents a model in the area of reducing medication errors is the Kendall Regional Medical Center in Miami, Fla. Kendall Regional is highly committed to protecting patients and their well-being. Ana Caldera, director of pharmacy services, describes the system as one that prevents errors generated "from the dispensing as well as the administration end."
Kendall Regional has gone to great lengths to institute a system that encompasses a pharmacy robotics system to automate the dispensing of inpatient medications, as well as a barcode electronic medication administration system that ensures accuracy in administering the correct medication to the right patient, in the right dosage, and at the right time. Whereas many institutions utilize one or the other of these systems, Dr. Caldera has stated that Kendall Regional is the only hospital in South Florida that uses both systems in tandem to ensure optimal patient safety.
The robotic system at Kendall is called Serving Patients on Command (SPOC). Peter Jude, director of marketing and public relations at Kendall, has explained that each medication is prepared for the system by separating it into an individual unit dose. It is then sealed in an individual bag, labeled with a specific bar code, and prepared for retrieval and dispensing by SPOC.
The nurse on call later scans the bar code on the unit dose and matches it with the patient's bar-coded identification wristband. The verification process is performed via the "Electronic Medication Administration Record" to confirm that the medication is what is to be administered to the patient. Whereas Kendall Regional has devised its own effective system, many institutions nationwide have implemented ways to dispense medication with little or no error.
Role of the Pharmacist in Preventing Adverse Drug Events
The role of the pharmacist in reducing medication errors has been emphasized in various studies. A study conducted by Drs. La Pointe and Jollis, of the Division of Cardiology at Duke University Medical Center, found that many medication errors have occurred in hospitalized cardiovascular patients (eg, the wrong drug or dose).5 The authors concluded that the participation and contributions of a pharmacist on rounds have resulted in a decrease in errors. The value of a pharmacist on board was reiterated in a study by the Department of Pharmacy Services of Henry Ford Hospital, which found that the role of the pharmacists on rounds also has had a positive effect on preventing adverse drug events.6
Conclusion
Certainly, reducing medication errors requires a process that identifies where most errors occur and that implements a quality improvement system to minimize the risk of errors and develop the means to make adequate changes. The emphasis on reporting errors by employees in a good-faith, nonpunitive environment will lead to improved patient safety.
Dr. Pelegrin is the pharmacy manager of a Publix Pharmacy in Miami, Fla.
For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Stahl, Pharmacy Times, 241 Forsgate Drive, Jamesburg, NJ 08831; or send an e-mail request to: ast...@mwc.com.
Medication Errors in Hospitals: An Analysis
Reducing medication errors has become a topic of top priority in our nation, with primary emphasis on improving patient safety. According to the National Coordinating Council for Medication Error Reporting and Prevention, a medication error is defined as a "preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."1 Just as drugs can save lives, they can lead to harmful events affecting not only the patient, but also health care in general.
An array of studies has addressed the subject, as a large number of Americans die each year due to medication errors. In fact, according to the report of the Institute of Medicine (IOM) entitled "To Err Is Human: Building a Safer Health System," between 44,000 and 98,000 people die in hospitals as a result of medical errors, which, according to major studies, could have been prevented.2
For decades, minimizing adverse drug events and medication errors has been a goal in health care. Nevertheless, it is highly recognized that competent and caring professionals will make mistakes. When analyzing medication errors, the trend in the past has been to place possible negligence on the health care provider. Yet, today we realize that many medication errors result from inadequate systems leading to serious mistakes by providers.
Errors can occur during any stage of the medication process. Rather than upholding a punitive approach, however, now the focus is to concentrate on "prevention" and to devise strategies to minimize errors and adverse medication events. Although providers are still held to a high standard and must be responsible for the decisions they make, placing blame on an individual seldom leads to positive outcomes.
Medication Errors?An Overview
In an article published in the Journal of Clinical Pharmacology, David M. Benjamin, PhD, FCP, outlines "5 rights" in delivering drug therapy: (1) the right drug, (2) the right dose, (3) the right route, (4) the right time, and (5) the right patient.3 Yet, the system is far more complex. The incidence of medication errors in hospitals is at an all-time high, resulting in hospital administrators exploring new interventions conducive to an overall improvement in safety.
The report from the IOM states that patient awareness, based on patient education prior to discharge, also can provide a "major safety check" in hospitals. The aim is for patients to become familiar with the appearance of their medication, possible side effects, and the purpose for taking the medication?in essence, to create an awareness and a proactive approach to therapy on the part of patients.
Factors Contributing to Errors
The work environment in general can lead to errors?interruptions, an inadequately trained staff, sleep deprivation, language barriers, medication sound-alike names, and lack of data concerning a patient can become risks. A recent review article, "Medication Errors: A Bitter Pill" by Kathleen C. Ashton and P. W. Iyer of Rutgers University, outlines certain factors that lead to adverse medication events4:
- Ordering errors. These errors occur when the physician orders the wrong drug, wrong dose, a drug to which a patient is allergic, or duplication in therapy. The nurse may then perpetuate the error by not questioning the physician. In addition, handwritten prescriptions can lead to catastrophic results, due to sloppy handwriting and confusion about decimal points.
- Administering errors. These errors encompass the wrong drug, the wrong patient, and the wrong route. A common error in hospitals involves patient-controlled analgesia pumps. Although the advantage of the pump is the ability of the patient to obtain the right dose, if the pump has not been programmed correctly the patient may risk serious side effects.
- Transcription errors. Entering incorrect data onto the medication administration record by nonmedical personnel can be a factor. Thus, nurses on duty need to have systems in place to detect potential errors.
- Dispensing errors. Many of these errors involve the pharmacy's supplying an incorrect medication or dose; or they may occur when the pharmacy is closed. In her study, Dr. Ashton reported that the Joint Commission on the Accreditation of Healthcare Organizations now discourages access to the pharmacy by nurses after the pharmacy is closed.4
Implementing Crucial Systems Nationwide
Hospitals nationwide are exploring and developing systems for the purpose of reducing medication administration errors. The Valley Hospital, a 451-bed acute care facility in New Jersey, has worked diligently in developing a system to reduce medication administration errors. M. Mutter, of Clinical Systems and Quality Improvement, has determined certain factors that are necessary to achieving goals, namely (a) becoming familiar with the actual errors?concentrating on how, when, and why they were committed; (b) establishing a "nonpunitive" (whereby no punishment or disciplinary action is imposed for any specific error) approach whereby reporting of errors or "near-miss errors" (a process variation that does not affect an outcome but for which a reoccurrence carries a significant chance of a serious adverse effect) is encouraged; (c) identifying areas of concentrated errors; (d) standardizing steps in the identification of errors; and (e) selecting the proper technology to correct these errors.
A medical facility that represents a model in the area of reducing medication errors is the Kendall Regional Medical Center in Miami, Fla. Kendall Regional is highly committed to protecting patients and their well-being. Ana Caldera, director of pharmacy services, describes the system as one that prevents errors generated "from the dispensing as well as the administration end."
Kendall Regional has gone to great lengths to institute a system that encompasses a pharmacy robotics system to automate the dispensing of inpatient medications, as well as a barcode electronic medication administration system that ensures accuracy in administering the correct medication to the right patient, in the right dosage, and at the right time. Whereas many institutions utilize one or the other of these systems, Dr. Caldera has stated that Kendall Regional is the only hospital in South Florida that uses both systems in tandem to ensure optimal patient safety.
The robotic system at Kendall is called Serving Patients on Command (SPOC). Peter Jude, director of marketing and public relations at Kendall, has explained that each medication is prepared for the system by separating it into an individual unit dose. It is then sealed in an individual bag, labeled with a specific bar code, and prepared for retrieval and dispensing by SPOC.
The nurse on call later scans the bar code on the unit dose and matches it with the patient's bar-coded identification wristband. The verification process is performed via the "Electronic Medication Administration Record" to confirm that the medication is what is to be administered to the patient. Whereas Kendall Regional has devised its own effective system, many institutions nationwide have implemented ways to dispense medication with little or no error.
Role of the Pharmacist in Preventing Adverse Drug Events
The role of the pharmacist in reducing medication errors has been emphasized in various studies. A study conducted by Drs. La Pointe and Jollis, of the Division of Cardiology at Duke University Medical Center, found that many medication errors have occurred in hospitalized cardiovascular patients (eg, the wrong drug or dose).5 The authors concluded that the participation and contributions of a pharmacist on rounds have resulted in a decrease in errors. The value of a pharmacist on board was reiterated in a study by the Department of Pharmacy Services of Henry Ford Hospital, which found that the role of the pharmacists on rounds also has had a positive effect on preventing adverse drug events.6
Conclusion
Certainly, reducing medication errors requires a process that identifies where most errors occur and that implements a quality improvement system to minimize the risk of errors and develop the means to make adequate changes. The emphasis on reporting errors by employees in a good-faith, nonpunitive environment will lead to improved patient safety.
Dr. Pelegrin is the pharmacy manager of a Publix Pharmacy in Miami, Fla.
For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Stahl, Pharmacy Times, 241 Forsgate Drive, Jamesburg, NJ 08831; or send an e-mail request to: ast...@mwc.com.