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If you're waffling on the idea of taking out professional liability insurance, read this and think again.
Quality improvement systems and multiple levels of check-offs are critically important to help pharmacies catch errors before they reach patients, according to a 10-year study of closed claims and several pharmacy industry experts.
A collaboration between the pharmacy underwriter group CNA and Healthcare Providers Service Organization, the study, titled “2013 Pharmacist Liability: A Ten-Year Analysis,” examined data from CNA’S closed claims, finding that 75.3% arose from patients receiving either the wrong drug (43.8%) or the wrong dose (31.5%).
In resulting injuries reported in the closed claims filed between Jan. 1, 2002, and Dec. 31, 2011, overdose occurred 13.6% of the time and death, 11.7%.
Jennifer Flynn, HPSO’s manager, healthcare risk management, said the analysis was prepared to educate pharmacists on their risk exposures and to increase patient safety. HPSO insures more than 70,000 pharmacists nationwide.
“We wanted pharmacists to be aware of the top allegations made against them in malpractice lawsuits, so that they could incorporate strategies into their daily custom and practice to help manage their own risks,” she said in an e-mail to Drug Topics.
Errors involving prescriptions for minors resulted in an average paid indemnity of more than $196,000, although only 15.4% of the claims studied involved children. The highest percentage of claims involved adults ages 18 to 64, with an average paid indemnity of $52,031. Claims involving mistakes in prescriptions for seniors, 29.6% of those in the study, resulted in an average paid indemnity of $78,321.
The analysis also showed that independent or individually owned pharmacies or pharmacy franchises accounted for 46.3% of the 162 claims studied, while national or regional chain pharmacies accounted for 34.6%. The next-highest number of claims involved hospital inpatient pharmacy with 4.3%.
However, Flynn noted, the report should not suggest that certain types of pharmacies are more likely to experience a claim. The conclusion is “just a function of the mix of pharmacy types we see in our program,” she said.
Severe patient harm
An equal percentage of mistakes (11.7%) cited in the study resulted in permanent patient harm and death.
Of mistakes resulting in permanent harm, three claims were resolved at policy limits:
• A child suffered permanent brain damage because of infusion of improperly compounded total parenteral nutrition.
• An adult suffered permanent brain damage following simultaneous overdoses of promethazine and fentanyl.
• An infant was born prematurely and with permanent brain damage when a Prostin suppository was dispensed instead of the progesterone suppository that was ordered.
Two children died, one from a clonidine compounding error and the other when propylthiouracil was dispensed instead of 6-mercaptopurine, which resulted in the child receiving no chemotherapy for leukemia. An adult patient wrongly received intrathecal morphine and died.
Some 9.3% of claims required an intervention to sustain the patients’ lives following dispensing errors. In one case, a wrong dose of tacrolimus led to the failure of a patient’s transplanted liver, requiring the patient to undergo a second transplant.
Dispensing the wrong drug - which often involved the substitution of another drug with a sound-alike name - accounted for 43.8% of all claims paid as a result of the injuries caused.
In this study, the highest amount paid was $1 million for the claim arising from a premature infant’s permanent brain damage caused by the wrong suppository. The overall average paid indemnity was $87,174.
The study cited clonidine prescriptions as the most commonly mistaken; they were erroneously replaced with Klonopin, clonazepam, and glipizide. Other errors occurred when Aricept was dispensed instead of Aciphex, clomipramine instead of clomiphene, prednisone instead of primidone, and Toprol instead of Topamax.
When Diabinese was dispensed instead of the prescribed Diamox, the patient developed a rare series of adverse effects and subsequently suffered permanent, significant vision loss. The claim was settled with a $275,000 payout.
In another case, when theophylline was dispensed instead of Tegretol, the patient suffered grand mal seizures, resulting in a $200,000 settlement.
Worse, glipizide was dispensed in one case instead of isosorbide, and the patient suffered a hypoglycemic event that caused brain damage and death. The claim was settled with a payment of $185,000.
When Tambocor was dispensed instead of Tarceva, the patient did not receive the prescribed antineoplastic treatment, lost the last and best chance for treatment of his lung cancer, and died. The claim was resolved with a settlement of $100,000.
The report details nine cases that resulted in significant injury and higher-than-average indemnity payouts.
In one case, an improperly compounded TPN potassium dosage resulted in cardiac arrest and profound brain damage in a young child. Another claim involving simultaneous overdoses of both Phenergan and fentanyl, resulting in profound brain damage. Both cases paid out at full policy limits.
Yet another case involved the infusion of the wrong form of amphotericin B into a minor patient for about an hour before a nurse discovered the error. The patient suffered acute multisystem organ failure with chronic renal damage, resulting in a claim resolved “in the mid-six-figure range,” the report states.
Some cases were costly in other ways. A mix-up in which a patient received human chorionic gonadotropin IM instead of the prescribed progesterone oil IM resulted in nonimplantation of the last fertilized egg that was a genetic match with her living children. For her prolonged emotional distress, the insurance company paid $42,500.
Most mistakes are simply the result of human error, said Ken Baker, a Phoenix pharmacist and lawyer who analyzes and designs pharmacy quality improvement systems.
“By and large, most mistakes are just through inadvertence,” said Baker, who is also a columnist for Drug Topics. “Plain human error.” Often two or more drugs will have similar-sounding names, or a technician simply grabs the next drug on the shelf from the one he or she intended to take, he said.
Other sources of dispensing mistakes, said Baker, include:
• A very small number of errors caused by reckless conduct, where the risk is not perceived to be as big as it is.
• An even smaller number caused by reckless disregard; in those instances employees know there is a risk but they act anyway.
• Pressure to work too quickly, particularly when there’s a long line of patients. However, Baker said, that should not be the pharmacy’s concern.
“It has always been my position that 23 people in line is not a safety concern, it’s an economic concern,” he said. “Pharmacists need to know how to pace themselves. If it takes too long, the guy at the back of the line will go to the next pharmacy down the street. We make it a safety issue because of the pressure we put on ourselves when we see the long line.”
Baker discounted any correlation between the size of a pharmacy and the number of errors made, although he said some people prefer working at a faster pace than others. “The owner or manager needs to know which people work best in which environment,” he said.
• Patient misidentification. Allen J. Vaida, PharmD, executive vice president, Institute for Safe Medication Practices, said misidentification is responsible for many errors that often result in complaints but not insurance claims. For example, a son might be dispensed his father’s medication because they share the same name. Mail-order pharmacies are particularly susceptible to such confusion, he said, because they deal in such volume that they are likely to encounter patients with the same name and perhaps even the same birthdays.
• Declined counseling. A consumer will correct a pharmacist who begins to explain the side effects of a blood pressure medication, for example, if he or she is expecting something different, Vaida said. Pharmacies should consider required counseling, he added.
• Improper computer coding and wrong selectionsby the provider during use of electronic medical records. These can also result in dispensing mistakes, Vaida said. “It would be nice (if the provider would) send the indication with the medicine (ordered), so even if there’s a mistake on the prescribing end because they picked the wrong one from a dropdown screen, they’d be putting in the right indication,” he said.
Mistakes will happen, but it is incumbent upon every pharmacist, pharmacy technician, and pharmacy owner to ensure that quality-control systems are in place and consistently followed, the experts say.
“Every prescription needs a quality check,” Baker said. “The system is designed to catch a mistake before it’s made or to catch it before it gets to the patient.”
Baker advocates a workflow that involves as many as seven or eight stations, and every station checks the accuracy of the preceding work.
An example of such a system might include the following steps.
Station 1: Receives the prescription, verifying the patient’s birth date, phone number, and address.
Station 2: Enters data into the computer, checking that the first information was entered correctly.
Station 3: Selects the drug from the shelf, labels the bottle, counts the doses, and puts them into the bottle, checking the directions for accuracy and the preceding data entry. “We’ve found 41% of mistakes are made at the computer entry station,” Baker said.
Station 4: Pharmacist check. “It’s the pharmacist’s obligation to check everything: the drug, strength, dosage, everything up to that point,” Baker said.
Station 5: Prospective drug review, or patient counseling.
Vaida recommended that pharmacies keep “high-alert lists” of drugs with similar-sounding names. Baker suggested that such lists also should draw attention to prescriptions for patients in the most vulnerable population, so that all pharmacy staff know to check one more time for accuracy.
The last step, Vaida added, should be to check the prescription bottle against what’s on the bag before the patient leaves. “By doing that step, you decrease wrong drug errors, or drugs going to the wrong patient, by a tremendous amount,” he said.
Pharmacies also should chart the number of prescriptions filled each month, how many errors were made, and how many got through to the patients. “Every technician and every pharmacist ought to know that this was our percentage this month, and last month, and the month before,” Baker said. “And you say, ‘I want to do better this month than last month.’”
With the influx of patients newly covered thanks to the Affordable Care Act, pharmacies are under greater pressure than ever to fill prescriptions and counsel patients, some of whom present with co-morbidities.
“The new pressures and demands mean an increase in the potential liability, which, in the event of a patient injury, could lead to a professional liability claim,” said HPSO’s Flynn. “It will be more important than ever that pharmacists be aware of their state scope of practice, review and understand their pharmacy’s policies and procedures, work closely and communicate effectively with the patient’s primary provider, understand new patient populations, and proactively utilize medication safety activities and tools to minimize pharmacy medication errors.”
Jennifer Webbis a freelance writer in Medina, Ohio.