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Risk Management From a Collaborative Perspective
PHARMACY LAW
Risk Management From a Collaborative Perspective Closer working relationships with other health care providers can reduce medication errors and the harm they can cause.
“Fallibility is a condition of the human existence…. Each [member of the medical community] has an affirmative duty to be, to a limited extent, his brother’s keeper…. It is not for the judiciary to dismantle the safety net and leave patients at the peril of one man’s human frailty.”1 With those words, an appeals court in 1986 began the move toward holding pharmacists and pharmacies to a higher legal standard of practice than just putting correct tablets into a properly labeled bottle. In the current pharmaceutical care era, this trend has grown, with courts recognizing the collaborative system through which pharmacists take on new roles and therefore responsibilities. Such collaborations are now increasingly formalized through written legal agreements under which pharmacists and physicians agree to apply each of their skills within certain parameters. In this APhA2003 session, pharmacist–attorney Kenneth R. Baker, JD, relied on his professional malpractice perspective to describe how the following elements of risk management can be used by pharmacists who are working closely with their medical colleagues: identify potential risks, select and implement techniques for addressing possible errors, monitor the system, and make changes as necessary.
Claims Reflect Harm From Errors Analyses of claims against pharmacists present different views than do medication error studies that are more frequently published in the medical literature. This is because claims studies show what kinds of medication errors are causing harm, Dr. Baker explained, rather than just what mistakes are made. For instance, the medication most frequently involved in litigation—warfarin— is not even in the top 25 in terms of medication errors. “We make relatively few mistakes with warfarin,” emphasized Dr. Baker. “Yet it is Number 1 in claims, because if we make a mistake with warfarin, we are more likely to cause harm.” Based on a presentation by Kenneth R. Baker, JD, vice president and general counsel, Pharmacists Mutual Insurance Company, Algona, Iowa.
S54
Supplement to the Journal of the American Pharmacists Association (www.japha.org)
Claims also commonly involve incorrect dispensing of otic instead of ophthalmic drops. While pharmacists sometime inadvertently dispense ophthalmic drops when otic formulations were intended, no claims or suits arise, since no harm is done. But a Pharmacists Mutual Insurance Company analysis of claims against pharmacists showed that an astounding 2% were caused by dispensing otic drops rather than the prescribed ophthalmic drops (see Figure 1). Claims based on failure to perform drug review adequately were almost unheard of in the 1980s and early 1990s, Dr. Baker explained. By 1997, drug review allegations were involved in about 12.5% of claims against pharmacists. These have now leveled off at about 8.5% of claims. An 11-year study by the Pharmacists Mutual Insurance Company categorized claims against pharmacists from 1988 through 1999. Almost one half resulted from putting the wrong drug into the bottle, another 25% involved incorrect product strength, and 8% cited incorrect directions. Emerging pharmaceutical care activities were involved in 12.5% of claims during this period, with 7.5% of claims involving inadequate drug review (medication overuse, underuse, allergy, or contraindication) and 5% involving failure to counsel patients about medications properly. Personal injury—which can involve slander, libel, or breach of confidentiality—have traditionally made up 3% of claims, but Dr. Baker said these will likely increase now that the Health Insurance Portability and Accountability Act of 1996 has created presumptive standards for how pharmacists must handle protected personal information.
Techniques for Making Changes Taking a cue from television’s Late Night With David Letterman, Dr. Baker presented a Top 5 list of techniques that pharmacists and the medical community can use to prevent medication errors. Number 5. Listen, Learn, Think. A variety of approaches for reducing medication errors, many of them recommended by the
September/October 2003
Vol. 43, No. 5, Suppl. 1
Risk M anagem ent PHARM ACY LAW
Vol. 43, No. 5, Suppl. 1
September/October 2003
Figure 1. Top 10 Drugs/Drug Classes Involved in M echanical Error Claim s Against Pharm acists, 1996–99 7 6 Percent of Claims
Institute for Safe Medication Practices Web site (www.ismp.org), were cited by Dr. Baker: n Ask physicians to help reduce the possibility of error by never using the abbreviation “QOD” for every other day, because it is often misinterpreted as once daily, or more commonly, four times daily. n Have all pharmacy staff members use the “echo and verify” system of reading oral medications orders back to physicians and their staffs. n Check each prescription three times, as taught in pharmacy schools, but then also check the national drug code number manually or with a bar-code reader. Pharmacists also can show the medication to the patient, during the counseling session and in a sufficiently private area, thereby facilitating a final check of the product. Number 4. Monitor, Check, Reevaluate. State laws require that pharmacists—not their computers—perform drug-use reviews. While the computer generates useful alerts, the human brain works differently. The pharmacist should pull up the patient profile for problems and interactions before dispensing prescriptions, especially new ones, but also refills whenever possible, Dr. Baker said. Look at what other medications the patient is taking, and check for potential problems involving overuse, underuse, allergies, and contraindications. Number 3. Document, Chart, Read. Procedures (such as the triple check of prescriptions) and specific communications (such as notations that orally conveyed prescriptions were “echoed and verified”) must be documented by pharmacists and other pharmacy staff members. In addition, as part of collaborating with prescribers, emphasize the importance of their reviewing patients’ charts thoroughly before prescribing medications and of communicating routinely when patients have new diagnoses, allergies, or adverse drug events. Number 2. Talk, Smile, Communicate. Research has shown that primary care physicians with fewer claims against them talked to patients an average of 3 minutes longer, smiled more during the day, and tended to tell more jokes, Dr. Baker noted.3 Pharmacists could emulate these behaviors by maintaining a friendly demeanor and asking patients questions such as, “What did your doctor tell you this was for?” and “Did he explain the possible side effects?” Such information not only encourages conversation, but it helps direct the type of counseling needed, and it could flag a misinterpretation of the physician’s medication order. Number 1. Establish a System of Quality Management: Workflow and Continuous Quality Improvement. Dr. Baker’s top recommendation for reducing medication errors was to learn from mistakes that have been made. When an error occurs, apologize to the patient. In the case of an obvious error, it is fine to admit the mistake, but do not admit liability—that is, that the mistake caused a certain injury. It is also acceptable to refund the patient’s money, but do not offer a settlement. Then begin looking at how the error can be prevented for future patients by following the principles of continuous quality improvement.
5 4 3 2 1 0 Drug/ Drug Class Warfarin
Amitriptyline
Carbamazepine
Antidiabetic Agents
Otic Drops
Amoxicillin
Digoxin
Prednisone
Insulin
Levothyroxine
Source: Pharmacists Mutual Insurance Company.
Summary Medication error studies, which reveal mistakes that occur, are different from claims analyses, which show the medication errors that cause harm. n Warfarin and other high-risk and narrow therapeutic index agents are more frequently involved in claims because errors, whether frequent or not, are more likely to result in harm. n Pharmacists in collaborative relationships with physicians can reduce medication errors by identifying potential risks, selecting and implementing techniques for addressing possible errors, monitoring the system, and making changes as necessary using continuous quality improvement principles. n Five recommended approaches for preventing medication errors include listening, learning, and thinking; monitoring, checking, and reevaluating; documenting, charting, and reading; talking, smiling, and communicating; and implementing a system of quality management. n
References 1. Riff v. Morgan Pharmacy. No. 935 Philadelphia, 1985, Superior Court of Pennsylvania. 508 A.2d 1247 (1986). 2. Levinson W, Roter DL, Mullooly JP, et al. Physician–patient communication. The relationship with malpractice claims among primary care physicians and surgeons. JAMA. 1997;277:553–9.
This symposium was developed in consultation with the American Society for Pharmacy Law.
Supplement to the Journal of the American Pharmacists Association (www.japha.org)
S55
Risk Management From a Collaborative Perspective Closer working relationships with other health care providers can reduce medication errors and the harm they can cause.
“Fallibility is a condition of the human existence…. Each [member of the medical community] has an affirmative duty to be, to a limited extent, his brother’s keeper…. It is not for the judiciary to dismantle the safety net and leave patients at the peril of one man’s human frailty.”1 With those words, an appeals court in 1986 began the move toward holding pharmacists and pharmacies to a higher legal standard of practice than just putting correct tablets into a properly labeled bottle. In the current pharmaceutical care era, this trend has grown, with courts recognizing the collaborative system through which pharmacists take on new roles and therefore responsibilities. Such collaborations are now increasingly formalized through written legal agreements under which pharmacists and physicians agree to apply each of their skills within certain parameters. In this APhA2003 session, pharmacist–attorney Kenneth R. Baker, JD, relied on his professional malpractice perspective to describe how the following elements of risk management can be used by pharmacists who are working closely with their medical colleagues: identify potential risks, select and implement techniques for addressing possible errors, monitor the system, and make changes as necessary.
Claims Reflect Harm From Errors Analyses of claims against pharmacists present different views than do medication error studies that are more frequently published in the medical literature. This is because claims studies show what kinds of medication errors are causing harm, Dr. Baker explained, rather than just what mistakes are made. For instance, the medication most frequently involved in litigation—warfarin— is not even in the top 25 in terms of medication errors. “We make relatively few mistakes with warfarin,” emphasized Dr. Baker. “Yet it is Number 1 in claims, because if we make a mistake with warfarin, we are more likely to cause harm.” Based on a presentation by Kenneth R. Baker, JD, vice president and general counsel, Pharmacists Mutual Insurance Company, Algona, Iowa.
S54
Supplement to the Journal of the American Pharmacists Association (www.japha.org)
Claims also commonly involve incorrect dispensing of otic instead of ophthalmic drops. While pharmacists sometime inadvertently dispense ophthalmic drops when otic formulations were intended, no claims or suits arise, since no harm is done. But a Pharmacists Mutual Insurance Company analysis of claims against pharmacists showed that an astounding 2% were caused by dispensing otic drops rather than the prescribed ophthalmic drops (see Figure 1). Claims based on failure to perform drug review adequately were almost unheard of in the 1980s and early 1990s, Dr. Baker explained. By 1997, drug review allegations were involved in about 12.5% of claims against pharmacists. These have now leveled off at about 8.5% of claims. An 11-year study by the Pharmacists Mutual Insurance Company categorized claims against pharmacists from 1988 through 1999. Almost one half resulted from putting the wrong drug into the bottle, another 25% involved incorrect product strength, and 8% cited incorrect directions. Emerging pharmaceutical care activities were involved in 12.5% of claims during this period, with 7.5% of claims involving inadequate drug review (medication overuse, underuse, allergy, or contraindication) and 5% involving failure to counsel patients about medications properly. Personal injury—which can involve slander, libel, or breach of confidentiality—have traditionally made up 3% of claims, but Dr. Baker said these will likely increase now that the Health Insurance Portability and Accountability Act of 1996 has created presumptive standards for how pharmacists must handle protected personal information.
Techniques for Making Changes Taking a cue from television’s Late Night With David Letterman, Dr. Baker presented a Top 5 list of techniques that pharmacists and the medical community can use to prevent medication errors. Number 5. Listen, Learn, Think. A variety of approaches for reducing medication errors, many of them recommended by the
September/October 2003
Vol. 43, No. 5, Suppl. 1
Risk M anagem ent PHARM ACY LAW
Vol. 43, No. 5, Suppl. 1
September/October 2003
Figure 1. Top 10 Drugs/Drug Classes Involved in M echanical Error Claim s Against Pharm acists, 1996–99 7 6 Percent of Claims
Institute for Safe Medication Practices Web site (www.ismp.org), were cited by Dr. Baker: n Ask physicians to help reduce the possibility of error by never using the abbreviation “QOD” for every other day, because it is often misinterpreted as once daily, or more commonly, four times daily. n Have all pharmacy staff members use the “echo and verify” system of reading oral medications orders back to physicians and their staffs. n Check each prescription three times, as taught in pharmacy schools, but then also check the national drug code number manually or with a bar-code reader. Pharmacists also can show the medication to the patient, during the counseling session and in a sufficiently private area, thereby facilitating a final check of the product. Number 4. Monitor, Check, Reevaluate. State laws require that pharmacists—not their computers—perform drug-use reviews. While the computer generates useful alerts, the human brain works differently. The pharmacist should pull up the patient profile for problems and interactions before dispensing prescriptions, especially new ones, but also refills whenever possible, Dr. Baker said. Look at what other medications the patient is taking, and check for potential problems involving overuse, underuse, allergies, and contraindications. Number 3. Document, Chart, Read. Procedures (such as the triple check of prescriptions) and specific communications (such as notations that orally conveyed prescriptions were “echoed and verified”) must be documented by pharmacists and other pharmacy staff members. In addition, as part of collaborating with prescribers, emphasize the importance of their reviewing patients’ charts thoroughly before prescribing medications and of communicating routinely when patients have new diagnoses, allergies, or adverse drug events. Number 2. Talk, Smile, Communicate. Research has shown that primary care physicians with fewer claims against them talked to patients an average of 3 minutes longer, smiled more during the day, and tended to tell more jokes, Dr. Baker noted.3 Pharmacists could emulate these behaviors by maintaining a friendly demeanor and asking patients questions such as, “What did your doctor tell you this was for?” and “Did he explain the possible side effects?” Such information not only encourages conversation, but it helps direct the type of counseling needed, and it could flag a misinterpretation of the physician’s medication order. Number 1. Establish a System of Quality Management: Workflow and Continuous Quality Improvement. Dr. Baker’s top recommendation for reducing medication errors was to learn from mistakes that have been made. When an error occurs, apologize to the patient. In the case of an obvious error, it is fine to admit the mistake, but do not admit liability—that is, that the mistake caused a certain injury. It is also acceptable to refund the patient’s money, but do not offer a settlement. Then begin looking at how the error can be prevented for future patients by following the principles of continuous quality improvement.
5 4 3 2 1 0 Drug/ Drug Class Warfarin
Amitriptyline
Carbamazepine
Antidiabetic Agents
Otic Drops
Amoxicillin
Digoxin
Prednisone
Insulin
Levothyroxine
Source: Pharmacists Mutual Insurance Company.
Summary Medication error studies, which reveal mistakes that occur, are different from claims analyses, which show the medication errors that cause harm. n Warfarin and other high-risk and narrow therapeutic index agents are more frequently involved in claims because errors, whether frequent or not, are more likely to result in harm. n Pharmacists in collaborative relationships with physicians can reduce medication errors by identifying potential risks, selecting and implementing techniques for addressing possible errors, monitoring the system, and making changes as necessary using continuous quality improvement principles. n Five recommended approaches for preventing medication errors include listening, learning, and thinking; monitoring, checking, and reevaluating; documenting, charting, and reading; talking, smiling, and communicating; and implementing a system of quality management. n
References 1. Riff v. Morgan Pharmacy. No. 935 Philadelphia, 1985, Superior Court of Pennsylvania. 508 A.2d 1247 (1986). 2. Levinson W, Roter DL, Mullooly JP, et al. Physician–patient communication. The relationship with malpractice claims among primary care physicians and surgeons. JAMA. 1997;277:553–9.
This symposium was developed in consultation with the American Society for Pharmacy Law.
Supplement to the Journal of the American Pharmacists Association (www.japha.org)
S55