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August 1, 2010



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REDUCING PRESCRIPTION MEDICATION ERRORS: What You Need To Know and What Your Patients Should Be Told


It has been almost a decade since the Institute of Medicine (IOM) report entitled To Err Is Human: Building a Safer Health System drew national attention to the occurrence, clinical consequences, and cost of medical errors in the United States.1 The report estimated that between 44,000 and 98,000 deaths result each year from medical errors.1 Additionally, medication errors alone account for over 7,000 deaths annually.1 In response to this report, the US health care system re-evaluated and strengthened error reduction strategies to improve patient safety. Nevertheless, medication errors remain a national concern. In 2006, the IOM report, Preventing Medication Errors, estimated that at least 1.5 million patients are harmed each year by medication errors, costing the health care system billions of dollars.2

The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) defines a medication error as “any 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.”3 This definition recognizes that errors can occur at any point in the medication use process and in any setting. Therefore, every component of the health care system, including health care professionals and patients, has a role in preventing medication errors. By preventing these errors, patient safety is improved and the potential for subsequent legal consequences is decreased. To assist pharmacists and pharmacy staff in further understanding the importance of their role in medication error prevention, this article will provide information on the various types and causes of prescription medication errors, strategies to reduce them, as well as the potential legal consequences that may arise when prescription medication errors occur.

TYPES OF MEDICATION ERRORS

Medication use is a complex, multi-step process that involves several individuals at various locations. There are six basic steps in the medication use process: prescribing, transcribing, dispensing, administration, monitoring, and patient education (Table 1).4 Every step has the potential for error and the risk to patient safety. Given that pharmacists have a role in managing and improving each step of the medication use process, they should be familiar with the various types of medication errors that could occur.

Table 1. Types of Medication Errors5,7,19,21

Type of Medication Error Description
Prescribing The inappropriate selection of a drug or drug therapy by the prescriber, or incorrect or inadequate instructions for use
Transcription
The failure to transcribe information or the improper entry of an order into an information system
Dispensing The failure to dispense medication as prescribed, or to provide appropriate labeling
Administration A discrepancy between the drug therapy received and the drug therapy intended
Monitoring The failure to review a prescribed regimen for appropriate treatment or to assess patient response to therapy
Patient Adherence Failure by a patient to take medication(s) as prescribed

Prescribing errors involve the prescriber inappropriately selecting a drug (based on indication, contraindication, known allergies, existing drug therapy, and other factors), dose, dosage form, quantity, route of administration, concentration, rate of administration, or providing inappropriate or inadequate instructions for use.5 Errors and deficiencies in the prescribing step of the medication use process are common and account for a large proportion of the preventable injuries due to medication errors.6

Transcribing errors involve either the failure to transcribe information or the improper entry of an order into an information system.7 In regards to pharmacy practice, transcribing errors result when the prescription is transmitted to the pharmacy, including oral prescription orders, or as part of the dispensing process, when the prescription data are entered into the pharmacy system.8 In one study analyzing medication errors in community pharmacies, it was determined that the majority of errors that reached the patient occurred during the transcribing stage.8

Dispensing errors can happen during any stage of the dispensing process, from the receipt of a prescription in the pharmacy through the supply of the product to the patient. A dispensing error involves the failure to dispense a medication; dispensing of an incorrect drug, dose, or dosage form; failure to dispense the correct amount of medication; inappropriate, incorrect, or inadequate labeling of medication; incorrect or inappropriate preparation, packaging, or storage of medication prior to dispensing; or dispensing of expired, improperly stored, or physically or chemically compromised medications.5 The most common types of dispensing errors involve the patient receiving the wrong drug or the wrong strength.9,10

In 2006, community pharmacies dispensed over 3.4 billion prescriptions in the US.11 Since pharmacists have direct responsibility for accurately dispensing prescription orders, dispensing errors are a critical concern for the practice of pharmacy. Although published studies regarding medication errors in community pharmacies are limited, it has been estimated that overall dispensing error rates range from 0.26% to 24%.9,12-14 Furthermore, 0.1% to 4% of prescriptions dispensed had the potential to contain clinically significant errors that could cause patient harm or discomfort.12,13 Using a conservative estimate of a 1% overall dispensing error rate, this would translate to over 30 million dispensing errors in the US each year. An increased awareness of (or attention to) this issue has placed the pharmacy profession under a microscope, and has caused the profession to be scrutinized nationally.15-18

Drug administration errors involve a discrepancy between the drug therapy received by the patient and the drug therapy intended by the prescriber.19 Examples of drug administration errors include timing errors, omissions, incorrect drug administration technique, wrong route of drug administration, and administration of an improper dose.20 Drug administration errors are one of the most common types of medication errors and are a major source of harm to hospitalized patients.20

Monitoring errors include failure to review a prescribed regimen for appropriate treatment or failure to use appropriate clinical or laboratory data for adequate assessment of patient response to the prescribed therapy.5 Studies suggest that up to 3% of hospitalized patients could experience preventable injuries due to monitoring errors.2

In addition to the previously mentioned medication errors, there are also opportunities for patient adherence errors once the patient leaves the prescriber’s office, pharmacy, or hospital. Patient adherence with a medication regimen is generally defined as the extent to which patients take medications as prescribed by their health care providers.21 Poor adherence to medication regimens is common and contributes to substantial increases in disease, death, and health care costs.21 Nonadherence, or medication misuse, may be exhibited by patients in many ways, such as not having a prescription initially filled or refilled, missing doses, taking the wrong dose, taking the dose at the wrong time, and/or stopping a medication without the advice of a health care professional.22

CAUSES OF MEDICATION ERRORS

A medication error is frequently the end result of multiple factors within a complex health care system. Medication errors may result from problems in practice, products, procedures, or systems. A proper understanding of the factors that may cause or contribute to medication errors is an essential step in preventing them. Various resources, including the FDA, provide lists of known factors that may cause or contribute to medication errors.9,22-27These are detailed in Table 2.

Table 2. Known Factors That May Cause
or Contribute to Medication Errors


  • Unavailable drug information (such as lack of up-to-date warnings)
  • Miscommunication of drug orders, which can involve poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and other dosing units, and inappropriate abbreviations
  • Lack of appropriate labeling when a drug is prepared and repackaged into smaller units
  • Environmental factors such as lighting, heat, noise, and interruptions that can distract health care professionals from their medical tasks
  • Complex or poorly designed technology
  • Poor procedures or techniques
  • Job stress
  • Dose miscalculations
  • Deficiencies related to knowledge of drug therapy
  • General failure to act in accordance with education and training
  • Incorrect diagnosis
  • Patient misuse of medication due to lack of patient information or education

STRATEGIES TO REDUCE MEDICATION ERRORS

With the potential for medication errors to originate and occur in every stage of the medication use process, the entire health care system, including health care professionals and patients, has a role in preventing medication errors. Various types and causes of medication errors are well documented, and strategies can be implemented or enhanced to help reduce and avoid future medication errors (Table 3).

Table 3. Strategies To Avoid Medication Errors


  • Verify if patients have any allergies and/or reactions to medications
  • Inquire of patients if they have any current medical conditions, particularly diabetes, kidney disease, liver disease, cardiovascular disease, and psychiatric disease
  • Ask patients about medications they are currently taking, including any nonprescription products, vitamins and minerals, and herbals
  • Try to standardize use of height and weight measurements, preferably using metric units
  • Make sure drug information databases are up to date
  • Compile a list of high-alert medications, ie, medications that require extra precautions when administered, prescribed, dispensed, or refilled.
  • Compile a list of similar drug names and circulate it among pharmacy staff, and do not store these drugs near each other
  • Ensure patients are aware of the indication for which a drug is prescribed

For pharmacists and their staff, there are three general strategies that, when used together, can help to prevent medication errors and improve patient safety. These strategies include appropriate and enhanced education, reporting of medication errors, and quality assurance programs.

Appropriate and Enhanced Education
Pharmacists and their staff should continue to pursue educational opportunities that will enhance their knowledge of medication errors and provide them with specific strategies that can be utilized to prevent future errors. There are several organizations and agencies, such as the FDA, the Institute for Safe Medication Practices (ISMP), and the United States Pharmacopeia (USP), that provide educational and informational materials related to medication errors, as well as guidance and strategies to improve patient safety. The FDA has a Medication Errors website, available at www.fda.gov/CDER/drug/MedErrors/default.htm, which provides basic information on medication errors, specific drug products associated with medication errors, medication safety videos, how to report medication errors, and links to additional national organizations that also provide medication error and patient safety resources. Likewise, the ISMP and USP websites, available at www.ismp.org and www.usp.org, respectively, provide education and awareness for health care providers and consumers, as well as medication safety tools and resources.

One particular example of a medication safety resource available through the ISMP includes a list of high-alert medications that bear a heightened risk of patient harm when they are used in error. In addition to the list, special safeguards to reduce the risk of errors are suggested, and include strategies such as improving access to information about the listed drugs; limiting access to high-alert medications; using auxiliary labels and automated alerts; standardizing the ordering, storage, preparation, and administration of the listed products; and employing redundancies such as automated or independent double-checks when necessary.

Educational and informational resources regarding medication errors will also likely be available from the health care organizations or companies that employ pharmacy practitioners, as well as local, state, and national pharmacy organizations. For some pharmacy practitioners, these programs may be mandatory for employment or professional licensure. Currently, numerous states require specific health care professionals, such as pharmacists, to complete educational programs on medication error prevention in order to obtain or maintain professional licensure.

Medication Error Reporting
The primary reason to report medication errors is for the health care system to learn how to improve the medication use process. Medication error reporting is critical in the identification of system deficiencies that can be corrected to prevent future errors. At the national level, anyone can voluntarily and confidentially report medication errors, or near misses, to either the USP-ISMP Medication Error Reporting Program (MERP), available at www.usp.org or www.ismp.org or to the FDA MedWatch Program, available at www.fda.gov (Table 4).

Table 4. Sites To Report Medication Errors

Reporting Programs How to Report
FDA MedWatch Online: www.fda.gov
Phone: 1-800-FDA-1088
Fax: 1-800-FDA-0178
USP-ISMP Medication Error Reporting Program Online: www.ismp.org or www.usp.org
Phone: 1-800-23-ERROR
Fax: 301-816-8532

Reported medication errors are entered into a network of databases that analyze the information and then allows patient safety organizations to share recommendations with drug manufacturers and health care providers regarding guidelines, protocols, or best practice steps to take to minimize future occurrences. In addition to reporting medication errors voluntarily, pharmacists should also verify with their employers and state administrative agencies if there are additional medication error reporting requirements.

Quality Assurance Programs
For pharmacists and their staff, medication error prevention should also include a comprehensive quality assurance program. The importance of undertaking quality improvement initiatives related to pharmacy practice has been recognized at the national level, and is mandated by various federal and state administrative agencies. An example of a quality assurance process used by pharmacies across the country has been termed CQI, or continuous quality improvement. CQI programs are a comprehensive approach to improve patient safety that allows pharmacies to create a proactive, non-punitive environment that encourages the identification of error, evaluating causes, and designing systems to prevent future errors. CQI is a systems-based solution that recognizes that the systems that cause or contribute to errors can be modified and improved to be more efficient and effective.

Quality assurance programs should involve pharmacies internalizing new safety strategies and improving systems for their practice. As a result of published reports and studies, including research from national organizations, valuable information has been provided that can help to guide pharmacists and other health care practitioners in their quality assurance and performance improvement initiatives. Examples of specific strategies that have been recommended for pharmacies and pharmacists include implementing professional standards and training; incorporating automation and computer cross-checks; educating pharmacy staff on look-alike and sound-alike drug names; incorporating electronically generated prescriptions; redesigning pharmacy dispensing areas; incorporating computerized systems that provide alerts on potential errors; and making verbal counseling a part of each prescription dispensed.2

By implementing these and other nationally recommended strategies, pharmacy practice sites can improve patient safety by avoiding many of the known factors that cause or contribute to medication errors. For example, dispensing errors can be reduced by rearranging product inventory to differentiate between look-alike and sound-alike medications, and by designing pharmacy dispensing areas that address environmental conditions and minimize distractions. Likewise, incorporating electronically generated prescriptions can help to decrease miscommunications and deficiencies that could occur in the prescribing and transcribing steps of the medication use process. Furthermore, by incorporating patient education and counseling, pharmacists can improve patient adherence and decrease medication errors associated with improper medication use.

When it comes to medication safety at home, community pharmacists can be a valuable asset. Providing patient education and counseling is one of the most vital professional roles of a pharmacist. The patient is usually the last individual in the medication use process, and pharmacist-patient interactions, such as counseling, have a significant role in identifying medication errors before they occur.

Pharmacists should view counseling as an opportunity to educate patients about their medications and to verify the accuracy of dispensing and the patient’s understanding of proper medication use. Counseling can help patients to understand the reason they were prescribed the medication, how to properly take the medication, the intended effects and potential side effects associated with the medication, the importance of adherence, and when to seek assistance from a health care professional. In particular, helping patients understand how to properly take their medication is extremely important given that certain patients, including the elderly and patients with low health care literacy, may have trouble understanding and acting on the instructions found on prescription medication labels.22

Because patient misunderstanding of health-related information is one reason that patients misuse medications, pharmacists should take steps during the counseling process to verify that patients fully understand their medication therapy (Table 5). There are multiple patient counseling models available to assist pharmacists that can be used for new and/or refill medications. The Indian Health Service Counseling Model provides the following three prime questions to ask patients who are receiving a new prescription: (1) What did your doctor tell you the medication is for?; (2) How did the doctor tell you to take it?; and (3) What did the doctor tell you to expect?28 In addition, pharmacists can ask patients to show and tell how they are going to take the medication to further verify patient comprehension.28 The show and tell strategy for patients receiving a refill medication includes asking: (1) What do you take the medication for?; (2) How do you take it?; (3) What kind of problems are you having?28 Furthermore, if possible, the show and tell strategy should also include pharmacists requesting patients to demonstrate administration of medications such as inhalers, nasal sprays, or eye drops.

Table 5. Avoiding Prescription Medication Errors: What Your Patients Should Be Told


Patients and pharmacists need to work together to reduce the occurrence of medication errors. The key is enhanced communication, in which pharmacists inform patients about the medications they are prescribed. Listed below are some examples of information pharmacists should provide.

  • The name of the drug and its indications
  • Correct dosing, including time to take it and whether or not to take with food
  • Common side effects
  • Possible drug-drug interactions, including with OTCs
  • Possible food-drug interactions
  • To have patients check the medication label prior to leaving the pharmacy to ensure they are receiving the correct medication

Although patient education efforts can help to prevent medication errors, a vast number of patients take prescription medications without being fully informed about them.2 With the large number of prescriptions dispensed each year in the US, coupled with pharmacist shortages, the time pharmacists have to routinely educate and counsel patients may be limited.22 Therefore, pharmacists need to be proactive in providing both verbal counseling and written drug information to the patients.

In addition to helping patients understand their individual drug therapy, pharmacists can also help patients to comprehend their overall role in medication error reduction. Pharmacists need to engage dialogue with all patients, and encourage their involvement as partners in the medication use process. In particular, pharmacists should encourage patients to take steps to protect themselves from potential medication misadventures, including to know the different types of medication errors; to recognize what their medications should look like and visually inspect them upon each fill or refill; to utilize only one pharmacy; to check periodically their medications for expiration dates and to properly discard expired medications; to seek assistance when purchasing over the counter (OTC) medications; to keep a list of known allergies and all current medications, including OTC medications and dietary supplements; and to ask questions if there is ever any doubt.17,22,25

Facts About Medication Errors


  • Patients who suffered unintended drug events remained in the hospital an average of 8 to 12 days longer than patients who did not experience such mistakes. These added days mean their hospital stays cost $16,000 to $24,000 more.1
  • A study of medication errors in 36 facilities (hospitals and skilled nursing facilities) indicated a 20% error rate, with 7% of those medication errors capable of producing harm.2
  • In a recent survey, one-third of US patients reported a medical, medication, or laboratory error over a two-year span.3
  • Since 2000, the FDA has received more than 95,000 reports of medication errors.4
  • 530,000 preventable adverse drug events occur each year among outpatient Medicare beneficiaries.5

1 Agency for Health Research and Quality, 2001.
2 Barker, KN, et al. Medication errors observed in 36 health care facilities. Arch Intern Med. 2002;162:1897-1903.
3 The Commonwealth Fund Commission on a High Performance Health System, Why Not the Best? Results from a National Scorecard on U.S. Health System Performance, The Commonwealth Fund, September 2006.
4 FDA. FDA 101: Medication Errors.
5 Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older adults in the ambulatory setting. JAMA. 2003;289:1107-1116.

LEGAL CONSEQUENCES OF PRESCRIPTION MEDICATION ERRORS

Undoubtedly, when a prescription medication error occurs, there is the possibility for a number of consequences to follow. In addition to the concerns of patient harm and increased cost to the health care system, health care providers should also be aware of the potential exposure to legal consequences, which include civil malpractice actions, administrative actions, and/or criminal actions. Therefore, it is important for pharmacists and pharmacy providers to understand the potential legal consequences that may arise from prescription medication errors, and to take proactive risk management steps to avoid them (Table 6).

Table 6. Potential Legal Consequences Associated With Prescription Medication Errors


Civil
Malpractice action where injured patient sues the pharmacy/pharmacist for harm caused by a medication error. If successful, the patient will receive a monetary award.

Administrative
Actions taken by the state board of pharmacy against professional license. Discipline could result in public reprimand; monetary fine; and/or license probation, suspension, or revocation.

Criminal
Involves criminal charges, such as manslaughter or reckless homicide, against the pharmacist as a result of a medication error that caused patient death. If convicted, penalties could involve probation or jail sentence.

Civil Malpractice Actions
The most common type of legal claim involving pharmacists is professional negligence, or malpractice claims. According to reported judicial opinions, the most common type of prescription medication error leading to pharmacist liability for malpractice is the straightforward misfilling of a prescription with a drug other than what the prescriber intended. Previous legal cases have clearly established that pharmacists have a legal duty to their patients to accurately fill prescriptions. Therefore, if there is a dispensing error and the patient, or plaintiff, bringing the lawsuit proves that the error caused harm, the patient or plaintiff will likely be successful in the malpractice action.

It is less clear from a legal perspective whether pharmacist involvement with other types of medication errors, including prescribing and patient adherence errors, will lead to civil liability. An increasing number of allegations being brought forward against pharmacists involve scenarios in which the pharmacist filled the prescription as ordered, but failed to detect that the prescriber had written for an inappropriate dose or duration of therapy, or where the pharmacist failed to perform a drug review or counsel the patient about potential side effects. In contrast to dispensing errors, which are considered mechanical errors, these types of cases allege intellectual errors. Numerous state courts have addressed cases considering whether pharmacists can be civilly liable for allegations of intellectual errors; however, the decisions have been inconsistent. Although some state courts have declined to allow civil liability, others have held that pharmacists can be liable for such errors.

Often when plaintiffs initiate civil actions alleging intellectual errors, they base their legal claims on state administrative laws and regulations passed as a requirement under the Omnibus Reconciliation Act of 1990 (OBRA 90). OBRA 90 was a federal law that recognized pharmacy services extend beyond oversight of drug distribution, and required pharmacists to actively resolve potential problems with a patient’s prescription order at the point of dispensing. Under OBRA 90, pharmacists are required to screen prescriptions before dispensing, offer patient counseling, and document relevant patient information.

In regards to counseling, OBRA 90 provides guidance for pharmacists on important matters that the pharmacist may discuss with patients (Table 5). These matters include the name and description of the medication; the route, dosage form, dosage, route of administration, and duration of drug therapy; special directions and precautions for preparation, administration and use by the patient; common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; techniques for self-monitoring drug therapy; proper storage; and prescription refill information.

Administrative Actions
To practice pharmacy and provide pharmacy services, pharmacies, pharmacists, and in some states pharmacy interns and technicians, must obtain a license through their respective state board of pharmacy. Obtaining a license to practice pharmacy is a privilege, and medication errors have the potential to adversely impact this privilege.

State boards of pharmacy are administrative agencies that have the authority to regulate the practice of pharmacy and to protect and promote public health within their state. Many state boards of pharmacy have determined that medication errors constitute professional misconduct, a direct violation of state pharmacy regulations. Certain types of medication errors may also be considered a violation of additional state or federal laws and regulations. One example would be a misbranding violation for dispensing errors.

State boards of pharmacy may learn of medication errors via reporting requirements or patient complaints. Typically, once a pharmacy board becomes aware of a medication error, it will make a decision if further administrative action is necessary. Administrative actions and proceedings, such as investigations, hearings, and disciplinary action, are separate from any malpractice actions that the pharmacy or pharmacist may face from the injured patient as a result of the same medication error. In addition, unlike malpractice actions that require the plaintiff to prove harm, administrative actions do not require actual patient harm to proceed.

If the state board of pharmacy concludes that the licensee (eg, pharmacy, pharmacist, pharmacy intern, and/or technician) violated administrative regulations, then it will have to determine appropriate disciplinary action. Depending on the nature of the offense and any mitigating or aggravating circumstances, licensees may receive various levels of discipline. Actual examples of state board of pharmacy disciplinary sanctions resulting from medication errors include public reprimand; monetary fine; and license probation, suspension, and/or revocation.

FDA and ISMP Campaign to Reduce Medication Mistakes Caused by Unclear Medical Abbreviations


The FDA and the Institute for Safe Medication Practices (ISMP) continue to support an educational campaign focusing on eliminating the use of potentially confusing abbreviations by health care professionals, medical students, medical writers, the pharmaceutical industry, and FDA staff. The program addresses the use of mistake-prone abbreviations in all forms of medical communication, including written medication orders; computer-generated labels; medication administration records; pharmacy or prescriber computer order entry screens; and commercial medication labeling, packaging, and advertising. The ISMP has developed a list of acceptable abbreviations. Further information can be found at www.ismp.org/tools/abbreviations.

Criminal Actions
While civil law addresses situations in which people have been harmed and a monetary award might help to remedy the situation, criminal law addresses the need to investigate crimes, prosecute those that commit crimes, and hold them accountable, usually through jail or probationary sentences. Generally, to be found guilty of a crime, the person accused must have committed a criminal act and had criminal intent. This is usually met when the accused person purposely, knowingly, or recklessly does an act prohibited by law.

Health care professionals, including pharmacists, are not immune to criminal actions. It is not uncommon to see criminal actions against pharmacists that involve allegations of state or federal controlled substance laws being violated, such as a pharmacist being intentionally or recklessly involved in drug diversion. If a pharmacist is involved in a medication error there is also the remote possibility that criminal charges may result.

To date there have been various criminal cases against health care providers, including pharmacists, in which a medication error resulted in the death of a patient. One published court case, People v. Stuart, involved a pharmacist who compounded a prescription with a misbranded or mislabeled drug. Specifically, the pharmacist unknowingly used a compound from a bottle which was labeled sodium citrate but actually contained a mixture of sodium citrate and sodium nitrate, and a child died as a result of the mistake.29 The pharmacist was charged and convicted of manslaughter after it was alleged that he committed an “unlawful act” that resulted in the death of a human being. Ultimately, the manslaughter conviction was not upheld; however, the case highlights that criminal actions against pharmacists are possible when unintentional medication errors occur and result in patient death. Over the past decade alone there have been multiple cases in the news in which health care providers, including pharmacists, were criminally charged for their involvement in a medication error.

Given the potential legal implications that may arise from medication errors, it is imperative that pharmacists take proactive risk-management steps to avoid them. In addition to implementing strategies to prevent errors, it is also important for pharmacists to comply with federal and state laws and regulations pertaining to pharmacy, including OBRA 90. Furthermore, as pharmacists experience increasing malpractice claims involving intellectual decisions, effective documentation of professional judgment decisions is essential. Documentation should be readily available if needed and can be completed on either the hard copy prescription, in a journal, or in a computer system. Documented information should be clear and concise, completely truthful, and include the names, dates, and times of those involved and when events occurred. A proper recollection of the facts that led to a decision is important if legal action is pursued at a later time.

ISMP’s Medication Error Prevention Tool for Community/Ambulatory Pharmacies


The Institute for Safe Medication Practices (ISMP) has designed a medication safety self-assessment tool for community/ambulatory pharmacies to heighten awareness of distinctive characteristics of safe pharmacy systems and to create a baseline of pharmacy efforts to enhance the safety of medications and evaluate these efforts over time. This comprehensive tool also enables assessment of the safety of medication practices in community/ambulatory pharmacies and identifies opportunities for improvement.

The self-assessment tool is divided into ten elements that most significantly influence safe medication use. Each element is defined by one or more core distinguishing characteristics of a safe pharmacy system, which are further divided into individual items to meet that characteristic and key element. Self-assessment characteristics are provided to help evaluate success with each of the core distinguishing characteristics.

Individual staff (including managers, staff pharmacists, technicians, and other support staff ) within each pharmacy site should be provided with a copy of the assessment and asked to complete the items either as a group or individually. A consensus on the responses should then be gathered and opportunities for improvement should be discussed. A plan with goals including system changes with resources needed should be developed and implemented to achieve short- and long-term improvements in medication safety.

It should be noted that the ISMP is not a standards setting organization. The ISMP emphasizes that the self-assessment characteristics represent the ideal and are not purported to represent a minimum standard of practice and should not be considered as such. In fact, some of the self-assessment criteria represent innovative practices and system enhancements that are not widely available in pharmacies today. However, their value in reducing errors is grounded in expert analysis of medication errors, scientific research, or strong evidence of their ability to reduce errors.

Further information on this self-assessment tool for community/ambulatory pharmacies can be found at www.ismp.org/Survey/NewMssacap/Index.asp.

CASE EXAMPLES

The following two actual legal cases are provided to help to illustrate the potential legal concerns that pharmacists and pharmacy providers may be exposed to as a result of medication errors.

Case 1
A patient had been taking theophylline under the care of his family physician. On a subsequent visit to the same physician, the patient was prescribed ciprofloxacin, even though the physician knew the patient was already taking theophylline. The patient took the ciprofloxacin prescription to the same community pharmacy that had just dispensed the theophylline a few days prior. In addition to the computer system alerting the pharmacist of the drug interaction, the pharmacist also later testified that he was aware of the potentially dangerous drug interaction between theophylline and ciprofloxacin. When the patient picked up the ciprofloxacin prescription, he declined the offer to speak to the pharmacist and was only provided written patient information that warned in fine print about the potential drug interaction. During the dispensing and distribution of the ciprofloxacin the pharmacist never contacted the physician or orally counseled and warned the patient about the potential drug interaction.

In a civil malpractice action against the prescribing physician, community pharmacy, and dispensing pharmacist, the patient alleged that he sustained injuries caused by the adverse drug interaction between theophylline and ciprofloxacin. The defense lawyers for the pharmacy and pharmacist requested the court to dismiss the lawsuit, arguing that the pharmacist had no legal duty to the patient under the circumstances, and that it was the physician who had the responsibility to either not concomitantly prescribe the medications or to warn the patient of the potential interaction. The court disagreed and decided the pharmacist was aware of the patient already taking theophylline when the ciprofloxacin prescription was filled, and that this posed an increased danger to the patient. Therefore, with regards to the pharmacy and pharmacist, the court allowed the civil malpractice action to proceed.30

This particular case illustrates that in the area of pharmacy malpractice litigation, the pharmacist’s legal responsibility may go beyond accurately dispensing prescription medications. In this case, where a prescribing error occurred, the pharmacist could have utilized specific medication error reduction strategies that may have prevented patient harm, including acting upon the computer alert, contacting the prescriber, and/or counseling the patient about the potential interaction between the two drugs.

Case 2
A hospital pharmacist received a prescription order for etoposide with a base solution of 0.9% sodium chloride. A pharmacy technician compounded the prescription using a base solution of 23.4% sodium chloride, and the pharmacist failed to identify the error and properly label the product with the base solution that was used. The compounded prescription was administered to a two-year-old patient who subsequently died as a result of the medication error. As a result of the incident, the hospital terminated the pharmacist and technician. After being dismissed from the hospital, the pharmacist obtained employment at a community pharmacy where he was also involved in additional dispensing errors.

The etoposide medication error resulted in the initiation of all three legal actions: civil, administrative, and criminal. Although the civil action against the hospital settled out of court, the pharmacist had administrative and criminal charges to contend with. With respect to the administrative action, the state board of pharmacy concluded that the multiple dispensing errors, in both the community and hospital settings, constituted misbranding and unprofessional conduct by the pharmacist. These state board of pharmacy regulatory violations, in addition to the pharmacist’s disturbing demeanor and mental state during testimony to the board of pharmacy, led the state board to permanently revoke the pharmacist’s license. In addition to the loss of his pharmacy license, the pharmacist was criminally indicted (charges still pending) for manslaughter and reckless homicide in the death of the two-year-old child.31,32

This case exemplifies the devastating consequences that can result from a single medication error. In addition to demonstrating how unnecessary patient harm or death can occur, it also illustrates that one medication error can result in civil, administrative, and criminal actions for pharmacists.

CONCLUSION

Pharmacists have a vital role in managing and improving each step of the medication use process. It is imperative for pharmacists to be familiar with the types and causes of medication errors, as well as strategies that can be implemented to prevent them. Strategies that should be utilized include appropriate and enhanced education, medication error reporting, and quality assurance programs that incorporate national recommendations specific to pharmacy practice. In particular, by implementing counseling into daily practice, pharmacists can further prevent medication errors and improve patient safety.

It is also important for pharmacy providers to understand the potential legal consequences that may arise from medication errors. In addition to civil malpractice actions, pharmacists may also have to contend with administrative and criminal actions. By preventing medication errors, patient safety is improved and the potential for subsequent legal consequences is decreased.

REFERENCES

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  2. National Institute of Medicine. Preventing medication errors. Washington, DC: National Academy of Sciences; 2007.
  3. National Coordinating Council for Medication Error Reporting and Prevention. About medication errors. Available at: http://www.nccmerp.org/aboutMedErrors.html.
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