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1 /%0(12(&-!34,5('2!6!78%!9%2:')&%!)1!,! 34,5('2!;::40,&$%!<2:'%*!!!"#$%&% '()#(*)+%,-%.)/*0"$*,1%2##,#3%*1%!4"#5"0*)3%"1/%&1$#,/60$*,1%,-%$4)%!788%9: ;%!4"#5"0)6$*0"<%76$4)1$*0"$*,1%8)13,#%8=3$)5% Kenneth R. Baker, BS Pharm, JD!"#$%&"'()*+,"-*$.+%%/$0(1"23&4"5"67/*%&8",$"0$"9(*:;<""" The modern pharmacist has more professional duties than were dreamed of a generation ago. Today s pharmacists do more than fill their patients prescriptions as ordered by the prescriber. New prescriptions are reviewed for, among other things, contra-indications, allergies and drug incompatibilities. If a question arises during the pharmacist s prospective drug review, the pharmacist contacts the prescriber and resolves the question and/or warns of any suspected problems. While the final decision is usually in the province of the prescriber, the pharmacist s knowledge and experience often directs the final decision. In addition to working with the prescribers, pharmacists today are expected to counsel their patients on issues such as when and how to take their medication for best effect. When patients have questions regarding their drug therapy, it is often the pharmacist who receives the first call. With all of the new responsibilities of the modern pharmacist, the overriding duty today is still one the pharmacists forbearers would easily recognize. The pharmacist s most sacred duty remains, First, do no harm. Pharmacists fill more prescriptions today than at any time in the history of the profession. The Kaiser Family Foundation estimates there are over three and one half billion prescriptions filled by pharmacies annually. 1 That many prescriptions provide many opportunities for errors. According to a study by the Auburn University College of Pharmacy, community pharmacies make an average of four errors for every two hundred and fifty prescriptions filled a 1.8% error rate. 2 In order to discount for those mistakes that were unlikely to cause harm, such as filling the prescription with the incorrect quantity of a drug, the Auburn study assembled a panel of pharmacist experts to determine the number of those total errors that were likely to cause serious injury or death. This resulted in a significant error rate of 0.1%. 3 This significant error rate means that according to the Auburn Study, on average, for every one thousand prescriptions dispensed, a pharmacy in the United States will dispense one prescription that contains an error with, at least, the potential to cause serious injury or death. """#$%&'($%#$)*! +,-%!.!

2 Set in positive terms, this significant error rate corresponds to an impressive sounding accuracy rate of 99.9%. It is less impressive when it is realized that this corresponds to three and one half million 4 potentially serious errors dispensed by retail pharmacies every year in the United States. For a relatively small pharmacy, filling one thousand prescriptions per week, a 99.9% accuracy rate equates to one potential lawsuit every week. Most of these errors may cause no harm to the patient. In most cases, the physician or a caregiver may discover the error before the drug is taken. Each time an error is discovered before the patient ingests any of the drug, a patient is saved from injury and the pharmacy is saved from a lawsuit, but its reputation is probably damaged and its business is likely to suffer. The pharmacy may not only lose the future business of the patient who was given the misfilled prescription, but potentially also the business of everyone who hears of the incident. Perhaps the most telling measure of errors made by pharmacists is from pharmacists themselves. In 1996, Drug Topics Magazine reported on a survey of 1000 community pharmacists. According to this survey, more than half of the pharmacists interviewed said they had made at least one error on a prescription in the previous sixty days. 5 Approximately eight percent of these pharmacists believed they had made more than six in this time frame. Most of these were either wrong dose or wrong drug. The Drug Topics survey indicated it was not only high volume that caused errors. Several of the pharmacists reported that they had made errors in the last couple of months on days when they filled less than 100 prescriptions. A large number of all of the errors referred to in the survey, in some cases up to 60%, were caught by the patient or a family member. The most serious of these errors are commonly referred to as mechanical errors, because they involved a purely mechanical misstep. These usually do not involve professional judgments or decisions, but are simple human mistakes. As typically defined, mechanical errors are (1) wrong drug dispensed; (2) wrong strength of the drug dispensed; and (3) wrong directions placed on the label. According to the Pharmacists Mutual Insurance Company Claims Study 6 of claims against pharmacies, pharmacists or pharmacy technicians, mechanical errors represent more than eighty percent of all claims reported to the insurance company over the past two decades. See Figure 1, Pharmacists Mutual Claims Study 1989 through The significance of the Pharmacists Mutual Study is that it represents a subset of errors ones that are most likely to result in professional liability claims and lawsuits. If the pharmacy makes a mechanical error, it is more likely to result in harm to the patient and, therefore, more likely that the patient will make a claim or file a suit. These are the errors that are most dangerous to the patient and the ones that are thus the most important to avoid. Every pharmacist s greatest nightmare is filling a prescription with the wrong medication or the wrong strength of the drug. Failing to warn that a tranquilizer may cause drowsiness could result in injury, but providing a child with an anti-diabetic medication instead of the attention deficit disorder drug called for in the prescription can be disastrous. In one case, a South Carolina jury found that such a mistake led to brain damage in the child patient. 7 """#$%&'($%#$)*! +,-%!=!

3 The patient is not the only one to suffer. The cost of one error to the pharmacy can be staggering. While most verdicts for a pharmacy malpractice suit are paid by the pharmacy s insurance company, some damages are not covered by insurance, leaving the pharmacy to pay what may be large amounts. In 2000, the Iowa Supreme Court approved a jury verdict against a pharmacy 8 for an additional $150,000 in punitive damages, a type of verdict excluded by most insurance policies. This extra award was above that given by the jury as compensation for the injuries suffered by the patient. The Iowa high court found that punitive damages in this case were reasonable because the pharmacy failed to take steps to protect its patient after an error was made, discovered and reported. 9 Earlier, the Alabama Supreme Court 10 found punitive damages could be assessed against a pharmacy based upon the pharmacy s failure to institute sufficient quality assurance measures to reduce the risk of medication errors. In the brain damaged child case referred to above 11, an appellate court in South Carolina let a ten million dollar punitive damages verdict stand partly because of what the Court found to be the pharmacy s lack of controls to protect against errors. The cost is not just in money. Every time a patient receives a prescription that contains a mistake, the pharmacy s reputation suffers. Above all else, patients expect their pharmacy to fill their prescription accurately. In a survey of pharmacy customers, when asked what services from a pharmacy they thought most important, 99% of those surveyed said it was an accurately filled prescription. 12 There are no surveys showing the number of customers lost because they have lost faith in their pharmacy, but the common wisdom is it is less expensive to keep ten customers than to replace one. """#$%&'($%#$)*! +,-%!>!

4 =94"#/%&(>+%"(*+"#(,+" Ask pharmacists why they make mistakes and they will give a variety of reasons. In a survey of pharmacists, the most frequent factors cited were workload related, including telephone and customer interruptions. Pharmacists said they were generally overworked. 13 Research, however, suggests that mistakes occur not just during hectic times, but also during less busy periods. 14 Additional factors such as lack of sleep, poor concentration and not enough staff help are blamed. Regardless of the reason, most pharmacists that were asked admitted to making errors within the past couple of months. 15 First, do no harm is the premier lesson taught to every student in all of the health care professions. For the pharmacist this means fill each prescription accurately, with the correct drug in the correct strength. It is the overriding demand of every patient 16 and the reason for most professional liability claims filed against the pharmacy profession. 17 There is now a system that can be introduced into the prescription filling and delivery workflow that can verify the accuracy of almost all prescriptions before they are dispensed to the patient.!"?+@/+a"$."&9+"-!''"?b C" '4%&+:" PASS Rx is a pharmaceutical authentication sensor system that scans and tests filled prescriptions before the medication is delivered to the patient and alerts the pharmacist of any discrepancy or question of accuracy. While doing so, the PASS Rx verifier shows a picture on the unit s LCD screen of what the product should look like, allowing the pharmacist to also visually identify the medication in the prescription bottle. Through its use of overlapping systems, PASS Rx can verify virtually all prescriptions dispensed in the typical pharmacy. PASS Rx can be used by the technician as part of the filling process or by the pharmacist at the final quality check station, or both. Just as each person has a unique fingerprint that can be used to identify that one person out of the entire population, each pharmaceutical drug has a unique spectral fingerprint. In seconds, PASS Rx analyzes spectral and physical characteristics of the drug being dispensed, compares the findings against the thousands of medications in its database and returns its finding to the pharmacist """#$%&'($%#$)*! +,-%!?!

5 Using the vast amounts of information stored in its memory, in addition to checking the spectral signature of the drug, for the majority of solid dosage forms, PASS Rx also checks the size, color and shape of the drug in the vial. What is even more amazing, all of this is done in approximately eight seconds. Most times the LCD monitor verifies to the pharmacist that the prescription is correct, that the prescription passed every one of the multiple verification steps. Occasionally, however, PASS Rx finds an error or recommends additional steps that must be taken before the prescription can be released for patient use. It is at these times that PASS Rx becomes most appreciated. Not only will PASS Rx verify the accuracy of the prescription, it also records the information in a manner that allows the pharmacy to verify what was dispensed one, two, or three months later if a question should arise. Actually, the information can be kept as long as the pharmacy decides to store it. In the past, if a patient accused the pharmacy of misfilling a prescription, there was no way to prove that the correct medication was dispensed. Now the pharmacy can view a report that shows the date and time the prescription was filled, along with the NDC number and a stock picture of the drug scanned from the label. In addition, there can be on file an actual picture of the medication in the prescription bottle at the time of scanning. If there was an error, the pharmacist can see what was given, allowing appropriate corrective measures to be taken. On the other hand, if there was not an error, irrefutable proof that the pharmacy filled the prescription correctly has been preserved. Often in the past, pharmacists had little choice but to accept a patient s statement that Last month you gave me a different tablet. With Pass Rx, the pharmacist has the capability of verifying what indeed was given. Having a reporting system that can verify the accuracy of a prescription can be valuable, but the PASS Rx system goes beyond that. The pharmacy can receive a workflow summary and a performance summary of every prescription filled and verified for the last month, quarter, or year, depending on how the pharmacy requests the information. The performance summary provides a statistical accuracy versus error report for the period of time specified by the pharmacy. This performance summary compares the number of prescriptions filled and analyzed with the number of prescriptions verified and the number that failed verification. Using this information, the pharmacy can identify areas of vulnerability within its quality system and correct errors before they occur. 18 There can be many uses of the workflow summary. An important one is that it can provide information on the consistency of the staff s use of the PASS Rx system itself. PASS Rx is most effective when it is used with every appropriate prescription. With every quality system, there will be times the pharmacist or technician may be tempted to bypass the use of available tools. Usually this occurs when the pharmacist or technician becomes overconfident. Just as quality must become a habit to be effective, skipping steps can also become a habit. The key to avoiding such a bad habit is to know how often it occurs. Such knowledge allows for proper training and leads to consistency in the verification process. """#$%&'($%#$)*! +,-%!@!

6 With most quality products, there is no way to determine when or how often a step is omitted. The PASS Rx workflow summary provides statistical information showing how often it was used compared to how often it should have been used and was not. In most pharmacies, virtually every prescription should be PASS Rx verified. The workflow summary provides the pharmacist in charge with a percentage calculated readout of prescriptions that were actually verified. The importance of this is that it allows the pharmacy to determine how well staff is using the system and when additional positive reinforcement may be warranted. The workflow summary provides the manager or the pharmacist in charge with a valuable teaching tool. Making staff aware of this percentage, along with a message stressing the need for quality verification for every prescription, reinforces the habit of regular checking necessary for reaching the goal of total quality. There could be few things more disconcerting than believing a prescription had been filled correctly only to discover that the one in question was not passed through PASS Rx verification, so the proof that the pharmacy was right is not available. Since PASS Rx will normally be used as part of the pharmacist s final quality check station, 19 the performance summary and workflow reports can give a statistical picture of the accuracy of every part of the quality system. As such, it provides a valuable report card that can be used by every pharmacist and pharmacy technician in the pharmacy. It is also an analytical tool that should be a part of regular quality training and continuous quality improvement (CQI). Staff meetings may be an effective part of a CQI program. Each month or quarter, as the pharmacy chooses, an all staff quality meeting could be organized and held. The purpose of the meeting would be to improve the pharmacy s quality program. The goal of every CQI program is perfection no errors. The only acceptable number of mistakes reaching the patient is ZERO. This will, of course, never be reached, but will always remain the goal. In striving to reach the goal, each period of time should show improvement over the last. Each meeting should therefore concentrate on two questions How are we doing? and How can we improve? To this meeting, the leader brings the tools for continuous improvement. These tools are information that the group can analyze and use in answering these questions. In addition to a list of errors discovered since the last meeting, these tools could include a report of near-misses showing where and what mistakes were made during the last period; the PASS Rx workflow summary; and the PASS Rx performance summary. Using these tools, the leader can assist the """#$%&'($%#$)*! +,-%!A!

7 group to reach a consensus to select one or two best practices on which staff can concentrate in the period before the next meeting. These best practices will be ones that the staff believes could if used consistently, correct the most striking vulnerabilities revealed in the reports. One hundred percent verification, using PASS Rx should be a part of each new plan for the coming period. It is important that each quality report and all information used in analyzing and improving the CQI system, including reports, minutes, and summaries of the meeting itself, be protected from discovery by lawyers and others who would use the information against the pharmacy and or any individuals. The pharmacy and everyone involved in the analysis should feel that they can discuss all issues and offer opinions concerning improving quality in confidence and that their comments will be held in confidence. Members of the pharmacy staff should not have to worry about information regarding quality and mistakes being used against them or the pharmacy at some future time. '3::(*4" In pharmacies today, medication errors happen. According to a study by the Auburn University College of Pharmacy, for every one thousand prescriptions dispensed, a pharmacy in the United States will dispense one prescription that contains an error with, at least, the potential to cause serious injury or death. The most dangerous of these are mechanical errors, that is, (1) wrong drug dispensed, (2) wrong strength of the drug dispensed, and (3) wrong directions placed on the label. A new device, the PASS Rx pharmaceutical authentication sensor system, has been designed and is currently being sold to identify these errors by the use of patented sensor and machine vision technology billion prescriptions filled by community pharmacies in the United States, according to the Kaiser Family Foundation report in June See, By some calculations, the figure has been quoted as high as 3.8 billion in Flynn, EA, Barker, KN, Carnahan, BJ, National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies, J Am Pharm Assoc. 2003;43: , March/April (Referred to hereafter as the Auburn Study). 3 Flynn, Auburn Study, supra billions prescriptions dispensed (See, Auburn Study) times 0.1% yields over 3! million potentially serious or deadly errors a year. See, New York Times, January 15, 2004, referring to the Auburn Study. 5 Ukens C. Deadly Dispensing. Drug Topics, 1997;141: ; Also see, Gianutsos, G, Identifying Factors That Cause Pharmacy Errors, USPharmacist.com, 1/29/ Pharmacists Mutual Insurance Company has published its study of professional liability claims received since The latest study can be found on the company s web site at 7 See for example, Hundley v. Rite Aid of S.C., Inc., 339 S.C. 285, 529 S.E.2d 45 (Ct. App. 2000) 8 McClure v. Walgreen, 613 NW 2d 225, Supreme Court of Iowa. (July 6, 2000) 9 McClure v Walgreens, supra. 10 Harco Drugs, Inc. v. Holloway, 7669 S. 2d 878 (Ala 1995) """#$%&'($%#$)*! +,-%!B!

8 11 Hundley v. Rite Aid of S.C., Inc., 339 S.C. 285, 529 S.E.2d 45 (Ct. App. 2000) 12 Wilson Rx 2008, Pharmacy Satisfaction Digest; See, 13 Gianutsos, G, Identifying Factors That Cause Pharmacy Errors, US Pharmacist 2009, Peterson GM, Wu MSH, Bergin JK, Pharmacists attitudes towards dispensing errors: their causes and prevention. 1999; 24:57-71; Massachusetts Board of Registration in Pharmacy. Medication Error Study. Massachusetts Office of Health and Human Services. Accessed October 1, Grasha AF. Psychosocial factors, workload, and risk of medication errors. US Pharm. 2002;27(4):HS32-HS52. ISMP Newsletter, Vol 3, Issue 4, US Pharmacist, December 2008: ID 16 Wilson Rx 2008, Pharmacy Satisfaction Digest. 17 See Pharmacists Mutual Claims Study, supra. 18 The PASS Rx system s performance summary can be used in conjunction with a report that collects information on near-misses. 19 PASS Rx can also be used by the technician as part of the filling part of the prescription process. """#$%&'($%#$)*! +,-%!C!