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Each issue will include an editorial on a topic that is important for the profession of pharmacy, as well as a review of a new drug that includes a comparison of the new drug with previously marketed drugs that are most similar in activity, and a New Drug Comparison Rating (NDCR) for the new drug. Read on for this month's issue.
May 2007 Issue
New Drug Review
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Pharmacy Errors: Part 2 "More Prescriptions Faster" Policies of Some Chain Pharmacies Increase the Risk of Errors
Part 1 of this two-part series of editorials addressed the televised 20/20 report on pharmacy errors (The Pharmacist Activist, April 2007). The report described very harmful consequences that resulted from errors in two prescriptions dispensed in Walgreens pharmacies. Attorneys representing the patients made allegations regarding the large number of prescriptions pharmacists were expected to dispense on their shift and the level of professional staffing in Walgreens pharmacies. A retired Walgreens pharmacist who was interviewed voiced concerns about receiving evaluations that he was "too slow." This editorial addresses some policies and workplace issues in some chain pharmacies that I believe increase the risk of errors.
Shortage of pharmacists
Although there is a shortage of pharmacists in many areas of the country, there are some chain pharmacies that have a very low turnover rate and waiting lists of pharmacists who wish to work for them. In contrast, there are some other chain pharmacies that have a high turnover rate and continuing shortages. To a large extent, the shortage of pharmacists these chains experience is self-inflicted, primarily as a result of policies that do not respect or encourage the professional role of pharmacists, stressful working conditions, and low job satisfaction that result in a high turnover rate.
A recent situation provides a clear, but unfortunate, example of differences that exist among some of the chains with respect to policies and management styles. Walgreens purchased Happy Harry's, a regional chain of approximately 70 pharmacies (most in Delaware) that has enjoyed a positive reputation among its pharmacists and in its communities. It can be expected that there will be challenges during any transition of this type, but the new policies and systems, and the manner in which they have been implemented, have been described by one pharmacist as "chaotic and impersonal" and have been criticized by many other pharmacists, as well as patients. Many pharmacists, some with many years of experience at Happy Harry's, have left to take positions at other pharmacies. One individual who worked at Happy Harry's for more than 10 years told me that the change would result in a significant loss of vacation and other benefits associated with seniority, but that working under the new management was extremely frustrating and no longer acceptable. Another individual made a specific point of identifying certain strengths that Walgreens had, such as more advanced computer systems and other technologies, but he left because of his concerns about the emphasis on speed and the number of prescriptions expected to be dispensed, as well a substantial reduction in the opportunities to speak with patients. He noted that it was very clear that Walgreens' focus was on profit, and not on patients. Other Walgreens/Happy Harry's employees have told me of their concerns about the increased number of dispensing errors since the transition began. The scramble to hire full-time and part-time pharmacists, including bringing some out of retirement, to replace the ones who have left adds further to the difficulty that is being experienced.
A former CVS pharmacist informed me of the following experience. He and another pharmacist shared the manager responsibilities in a CVS pharmacy in Pennsylvania, but CVS offered the other pharmacist a bonus to go to a CVS pharmacy in another state in which the need for pharmacists was more acute than it was in Pennsylvania. A replacement pharmacist manager could not be quickly identified so pharmacists designated as "floaters" were rotated in as staff pharmacists. This arrangement placed additional demands on the responsibilities and schedule of the pharmacist manager, and he made repeated requests of his district manager that another pharmacist be designated as his manager partner. After months of frustration with the "interim" staffing arrangements the pharmacist voiced his concerns once again. He was told that, during the time he had been without a second pharmacist manager, CVS had only opened 57 new pharmacies in the whole country. The pharmacist responded that that meant that CVS had to hire 114 pharmacists to operate these new pharmacies but they wouldn't identify just one pharmacist to meet his need. Not much later, this pharmacist resigned from CVS and is now happily employed in another community pharmacy.
Circumstances such as these are very important reasons for which some chains are experiencing a shortage of pharmacists. Their difficulty in retaining pharmacists and the resultant high turnover rate results in a self-inflicted "shortage" that can only be blamed on themselves rather than an insufficient number of pharmacists in the workforce. In actuality, chain pharmacies are in the best position of all employers of pharmacists to recruit new graduates of colleges of pharmacy. They offer the highest salaries and they employ more pharmacy students than anyone else, thereby already having direct communication with the very individuals whom they will want to recruit as full-time pharmacists when they graduate. However, the unfortunate reality is that the experience of many students in certain of these chain pharmacies is so negative that they decide they will not consider community pharmacy as a career option.
CVS and Walgreens are the chains that have the highest number of pharmacies. Both of these companies are in a rapid growth mode and extol their plans to open 400-500 new pharmacies over the next year. However, this rate of growth is stimulated by competitive factors, not by a need for new pharmacies, many of which are opened across the street or in similar close proximity to existing pharmacies. One of the attorneys interviewed in the 20/20 report decried what appears to be an exclusive focus on profit and challenged why Walgreens was opening up so many new pharmacies when their existing pharmacies appeared to be understaffed.
Prescription "quotas" and fast dispensing
Although they are unwilling to disclose specifics, many chain pharmacies have policies that include "quotas" regarding the number of prescriptions that must be dispensed during a certain period of time before additional pharmacist and/or technician staffing will be provided. Many factors influence the time it takes to dispense prescriptions including the skills, thoroughness, and accuracy of pharmacists. Given the nature and number of the variables, it is very difficult to identify a specific number of prescriptions that can be dispensed appropriately in a designated period of time. However, the action of some chains to push or exceed what would seem to be reasonable boundaries that would justify additional staffing, mandates attention to this issue. Although there are some pharmacists who thrive on a very fast pace of activity, others voice concern that when they leave a stressful workplace environment at the end of a long day, the patients, prescriptions, and other responsibilities are all a blur.
In addition to "quotas" regarding the number of prescriptions dispensed, Walgreens and some other chain pharmacies have developed policies/systems using green, yellow, and/or red lights to apprise the pharmacist as to whether the prescription is being prepared in the period of time that is considered appropriate. Pharmacists who are "not fast enough" may receive negative evaluations.
CVS has a policy that I consider particularly egregious. Patients who are waiting for a prescription are to be given a wait time of less than 15 minutes for their prescription to be ready. The only exceptions are when a patient has seven or more prescriptions or there are already 10 or more people in line. Therefore, a patient who has six prescriptions would be told they would be ready within 15 minutes. Policies such as this have just one purpose - dispense prescriptions as fast as possible (translation - increase profits) regardless of how many previous prescriptions or other responsibilities are currently pending, or how many of the new prescriptions have a potential for interaction, require prior authorization, or need other special attention. Policies that encourage speed, combined with prescription quotas, send a very clear message of "more prescriptions faster" that ignores safety implications and communication with patients. A larger number of errors is an inevitable consequence, and such policies should be abandoned.
When pharmacy errors occur, the highest priority must be given to the welfare of the patient. Some errors may be so serious that irreversible harm or death may result. When an error or negligence occurs and a patient is harmed, a lawsuit is often initiated. If there is not an out-of-court settlement (which usually occurs), and the litigation goes to trial, it is my expectation that the patient/family will almost always win, with the primary question being the amount of money awarded in the judgment. An important factor in many of these court decisions has been the attorney’s discovery of "quota and speed" policies like those described, and the use of these policies to persuade a judge/jury that inadequate time and attention was given to safety in dispensing the prescription.
I would like to think that every pharmacy would do everything possible to avoid errors. Regrettably, it would appear that some chain pharmacies view errors and litigation as just a cost of doing business, much of which may be covered by insurance. In some situations, not even an apology is provided to the patient that has been harmed.
What should pharmacists do?
I hope that you never make an error that results in the disability or death of a patient. But what if you did make such an error? How would you feel? How could you face the patient or the family? It is a difficult thing to even think about, isn't it? However, such errors are made, sometimes by pharmacists who are every bit as attentive and caring as we consider ourselves to be.
We must consider every prescription to have a potential for serious error. We must not allow ourselves to be inattentive or distracted to the point that accuracy and judgment are compromised. We must never allow ourselves to be so rushed or otherwise pressured in our responsibilities that the safety of our patients is jeopardized.
Pharmacists should strongly oppose the development and implementation of policies that monitor the speed of dispensing prescriptions, or have excessive expectations regarding the number of prescriptions pharmacists are expected to dispense in a certain period of time. If such policies are already in place, pharmacists should urge that they be rescinded. If there is an unwillingness to rescind such policies, the pharmacist should seek an opportunity in another pharmacy that provides policies and workplace conditions that are supportive of the professional role of the pharmacist and reflect a commitment to patient safety. If it is not feasible to pursue another employment arrangement, the pharmacist must not be intimidated by policies but must commit the time necessary to feel confident that everything possible is being done to help and protect the patient. Reminders may be helpful. One approach would be to place a sign behind the prescription counter that has the message that we have seen on highway signs – SPEED KILLS.
Daniel A. Hussar
New Drug Review
Retapamulin (Altabax – GlaxoSmithKline)
New Drug Comparison Rating (NDCR) = 4
in a scale of 1 to 5, with 5 being the highest rating
For use in adults and pediatric patients aged 9 months and older for the topical
treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body
surface area in pediatric patients aged 9 months or older) caused by
Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.
Most important risks/adverse events:
Unlikely to occur.
Most common adverse events
Adults – application site irritation (2%), headache (2%);
pediatric patients – application site pruritus (2%), pruritus (2%),
diarrhea (2%), nasopharyngitis (2%).
A thin layer of ointment should be applied to the affected area twice a day for
five days; the treated area may be covered with a sterile bandage or gauze dressing.
Ointment – 10 mg/gram (1%) in 5 gram, 10 gram, and 15 gram tubes.
Mupirocin (e.g., Bactroban).
Less frequent administration (twice a day compared with three times a day);
Shorter course of treatment (five days compared with at least eight days);
First of a new class of antibacterial agents (pleuromutilins);
Unique mechanisms of action, and cross-resistance with other antibacterial
agents has not been reported.
Has not been directly compared with mupirocin;
Clinical effectiveness against methicillin-resistant isolates of S. aureus has not been established;
Indications are more limited (certain formulations of mupirocin are also
indicated for the treatment of secondarily infected traumatic skin lesions,
and for intranasal administration for the eradication of nasal colonization
with methicillin-resistant S. aureus in adult patients and healthcare workers);
Effectiveness and safety have been established in children as young as 9
months of age (compared with 2 months of age for mupirocin).
Retapamulin is the first of a new class of antibacterial agents designated as pleuromutilins. It is active against S. aureus and S. pyogenes, the bacteria that are most often responsible for causing impetigo, a highly contagious skin infection. The new drug inhibits bacterial protein synthesis through multiple mechanisms that differ from those of other antibacterial agents, including interacting at a site on the 50S subunit of the bacterial ribosome. Cross-resistance with other antibacterial agents has not been reported, but efficacy studies have not been done to determine its activity against strains of bacteria that are resistant to other antibacterial agents.
The effectiveness of retapamulin in the treatment of impetigo was demonstrated in a placebo-controlled study in which its clinical success rate was 86%. It has not been directly compared with mupirocin ointment. Although in vitro studies of retapamulin did not identify differences in susceptibility between methicillin-susceptible and methicillin-resistant isolates of S. aureus, the susceptibility did not correlate with clinical success rates in patients with methicillin-resistant S. aureus, and its indication for impetigo caused by S. aureus is limited to infection caused by methicillin-susceptible isolates.
Like mupirocin, retapamulin is well tolerated and adverse events are infrequent and, rarely, serious. Following application, the treated area may be covered with a sterile bandage or gauze dressing to protect the area and avoid accidental transfer of ointment to the eyes or other areas.
The application of retapamulin twice a day for five days is more convenient than the regimen for mupirocin ointment that is usually applied three times a day for at least eight days, and this represents an advantage of the new drug for some patients.
Daniel A. Hussar