On Tuesday, November 1, 2011, Drake University College of Pharmacy and Health Sciences students and faculty were privileged to attend the Herb and Karen Baum lecture series discussing ethics, this one specifically directed over pharmacy. Entitled “Pharmacy Workplace Issues and Patient Safety,” this symposium was sponsored by Rho Chi in collaboration with the Baum Chair of Ethics and the Professions. As the Baum Endowed Chair, Dr. Garry Frank prefaced before the panel, pharmacy is consistently ranked among the top fields for honesty and ethics in Gallup polls. “According to that poll, approximately three-fourths of Americans rated pharmacists as being very trustworthy, honest, and ethical.” Dr. Frank continued to stress how pharmacists must continue to retain that belief in the future.

Included on the panel was Joseph Clamon, a health care attorney with Iowa Health System, Jane Dewitt, an associate professor in Social and Administrative Sciences at Drake University, Mike Case-Haub, a pharmacy manager and diabetes educator for Hy-Vee pharmacy, Greg Johansen, president of GRx Holdings, Candace Jordan, a clinical pharmacist and residency director at the Veteran Affairs of Central Iowa, Lloyd Jensen, Executive Director of the Iowa Board of Pharmacy, and Deann Wedemeyer-Olson, Iowa Board of Pharmacy member and director of pharmacy at Guthrie County Hospital. Moderators included Andrea Kjos and Michael Andreski, both assistant professors of Social and Administrative Pharmacy at Drake University.

The format of the evening involved the reading of a case, followed by opinions of the panel, and then the floor was opened to students and faculty to comment or further question the panel for additional thoughts on the issue. While fictional, the cases are based on common issues that can occur in pharmacy settings. 

Case 1

S.S. is a pharmacist in an inner city area. Due to a recent spate of burglaries, S.S. is no longer willing to stock Schedule II narcotics, but will obtain them for “regular” customers as needed. Discuss the ethical concerns related to this situation.

The discussion began with Dewitt asking if this is the right course of action, considering the patients who legitimately require the narcotics. It becomes, as Johansen explained, an issue of patient access. Can a pharmacist deny patients with chronic pain the medications they need because of the actions of a few? It was also pointed out that there are other options that could be considered, including security systems. Case-Haub added that he once worked in a similar setting, and the presence of a full-time police officer worked to deter burglaries. Hardening security would allow the pharmacy to maintain patient access. A student from the audience also noted that it’s difficult to define a “regular” customer. It can be considered a commitment of the profession to provide these products to all patients with legitimate need.

Case 2

G.B. is a pharmacist at Local Medical Center.  One of G.B.s duties is to assist the hospitals clinical pharmacy manager in the preparation of medications monographs for review at the hospitals’ Pharmacy and Therapeutics Committee, where decisions on the formulary status of medications is decided. G.B. recently completed an MBA degree, where she met O.M. in several classes. While they were not close friends through school, they did know each other fairly well. After she completed her MBA, O.M. was hired by a pharmaceutical company as a sales representative.  Over the past year, O.M. has visited G.B. at work several times, and often they have had lunch together in the hospital cafeteria where O.M. would pick up the check for the meal, waving it off as “I have a great expense account and we are friends.” O.M. scheduled a meeting with G.B. last week where G.B. was offered a container of Tennis Balls and a Visor from the US Open that O.M. had recently attended. Being a tennis player and fan, G.B. accepted them thinking they were a considerate gift from a friend. Today, however, O.M. has left a message on G.B.s’ voice mail, asking for a meeting to discuss how O.M. can get her companies new drug “on the formulary as quickly as possible”. What are some of the ethical issues presented in this situation? In addition, discuss the ethical issue of gifts from vendors to pharmacy professionals.

The discussion opened with Jordan relating the case to personal examples she experienced while working for the VA. She explained that any time she attends or gives a presentation in which she is representing the VA, she does not feel it is ethical to accept any form of monetary compensation, including free meals. Case-Haub agreed, stating, “there’s no such thing as a free lunch.” Drug representatives can be a great resource for medical information and patient education, but care must be taken in working with them, especially when it comes to accepting gifts. Wedemeyer-Olson added that in her practice, drug representatives are not allowed to approach employees; they can only leave contact information. Clamon brought up the point that financial involvement has become an ethical issue at all levels of the profession. It is important to recognize not only if conflict of interest exists, but if there is the appearance of a conflict. As soon as this conflict becomes even the smallest factor in a decision, the decision is no longer autonomous. He finished by stating that it’s also an issue of disclosure. Full disclosure is required to make autonomous, informed decisions.

Case 3

A.P.  has been a pharmacist for over 15 years with DrugCo pharmacy. Recently she had been working the midnight shift where on an average work shift she has been filling 60 to 100 refill prescriptions, 20 to 40 new prescriptions, preparing 5 compounded prescriptions, answering 20 to 30 questions on OTC products, and updating the C-II inventory for the previous day. In addition to these tasks, the management of DrugCo is now requiring A.P. to become certified and to provide immunizations. A.P. refused to comply with this requirement, stating that she felt that there was inadequate time to add this to her already hectic workload. DrugCo terminated A.P.s employee on grounds of insubordination. Has DrugCo acted in an ethical manner? Has A.P. acted in an ethical manner?  Discuss the ethical implications of increasing workload in an already busy practice environment.

Jensen began by commenting that this is an issue in workload vs. patient safety. He argued that pharmacists like A.P. need to be able to exercise professional judgment on what they can or cannot do in a workday. Wedemeyer-Olson added that this is an issue frequently seen by the Iowa Board of Pharmacy. In her opinion, A.P. knows what’s reasonable and is, therefore, not at fault. The problem was not that she didn’t want to offer immunizations, but that she was concerned she did not have time to devote to it. This is not being insubordinate, and it was the responsibility of DrugCo to respond to her assertion that the workload was too high. Dewitt related this case to a personal example of a pharmacist who didn’t feel she could safely perform immunizations due to limited function in her hand. Management, however, made her get certified, despite the fact that she doesn’t feel she can do it well.

Johansen brought up the importance of needing to view this case from the view of the employer. We can’t pass judgment without knowing if there had been any prior conversation on this issue. It is also important to note that a pharmacy’s workload differs from day to day. Case-Haub agreed with this stance, reiterating that DrugCo may not be at fault. He explained that they may not see it as adding to the workload and may consider an immunization simply one more prescription to fill. With this viewpoint, A.P.’s refusal could easily be seen as insubordination. A student in the audience commented that with only one pharmacist working, the rest of the pharmacy may be neglected while A.P. provides immunizations. It is important to recognize that they require the pharmacist to leave the central pharmacy area and spend time monitoring the patient’s reaction. This process could compromise the safety of another patient. Dean Rospond summarized these points by stating that it is an issue of professional ethics vs. obligations to employers. In this economy, many pharmacists are concerned about keeping their jobs, a need which may overpower the desire to defend ethics. Wedemeyer-Olson concluded the discussion, asserting that the problem stems from the fact that sometimes the people making these decisions are not pharmacists and, therefore, do not have the same professional obligations.

Case 4

H.P is a pharmacy manager for a large hospital, and her primary responsibilities include inventory management.  Recently H.P. has been keeping informed about shortages of critical medications, including injectable electrolytes and cancer chemotherapy drugs. H.P. has just received a call from Gray Drug Company, a medication wholesaler. Gray has just heard that a medication used to treat cardiac failure has been recalled due to poor manufacturing practices, but they have a large supply of non-recalled lots of the medication. H.P. knows that the hospital uses a significant amount of the medication, and she doesn’t want to be responsible for it not being available for patients. However, Gray Drug is offering to supply 2 months’ worth of the medication, but at 3 times the usual price. What ethical issues does the use of “gray market” wholesalers pose to H.P? What ethical issues would NOT using these wholesalers pose? Discuss the ethical concerns associated with shortages and high markup wholesalers.

Wedemeyer-Olson began by commenting that this is an extremely common situation for hospital pharmacies, especially with the drug shortages of today. She asked the room how many knew that pharmacies hire individuals to manage these shortages, stating, “It’s really a perfect example of a time that pharmacists can rise to the occasion and show leadership.” She continued by explaining that H.P. needs to consider all alternatives and ask whether or not they are acceptable. Clamon added that the ethical concern arises from deciding whether it is more important to do what is best for the largest number of people, even if some are harmed, or to do what’s best for the patient currently in need, regardless of how that action might effect other patients. He explained that this is an issue of competing interests, worsened by the fact that there are a finite number of resources. A student in the audience brought up the point that using Gray Drug might encourage them to keep stockpiling the medications and maintain the high rates. Dewitt agreed, stating that it also might encourage counterfeiting. It is, therefore, important to first make sure Gray Drug is licensed as a wholesaler. Wedemeyer-Olson concluded by summarizing, “we’ve all had to use wholesalers, but it is important to look for other options. If you continue to utilize them, they will thrive.”

Case 5

J.L. is a pharmacist in rural Iowa. He prides himself on how much he knows his patients and on the care he provides them. Y.M. is a 22 year old male who has recently moved to the town to work in the local agricultural industry. Y.M. tends to be a bit “scruffy” looking but has never been the cause of any issues in the pharmacy. Recently Y.M. presented a prescription for 30 Acetaminophen with Codeine #3 for treatment of a broken arm, with the directions “Take one tablet every 4 to 6 hours as needed for pain.”  The prescription is being paid for through the agricultural plants workers compensation program. The physician has authorized one refill. Three days after filling this prescription, Y.M. has entered the prescription into the pharmacy’s automated refill line. When J.L. went to check the prescription bottle that had been filled by the technician, he noted that the supply should have been adequate for at least five days. J.L. is not sure what he will do at this point. In evaluating the situation, what are some of the ethical and possible legal, implications of J.L. dispensing or NOT dispensing this prescription? Discuss the ethical implications of dispensing of controlled substances when the patient is not well known.

Case-Haub opened the discussion, asserting that it doesn’t matter how long J.L. has known Y.M., he should need clarification on why the refill is needed early. Case-Haub explained that there could be various reasons; for example, the physician could have instructed him to take more if needed or the patient could be going out of town. Johansen commented that in this type of situation, he would call the patient back and discuss it with him directly. It is important, he explained, to ask and go from there. Nothing can be assumed based on appearance or familiarity with a patient. Y.M. could have simply been under-dosed. Wedemeyer-Olson added that it is important to document conversations had with both the patient and the prescriber, so that when these situations arise, it is easy to see if it’s occurred in the past. Clamon countered by asserting that histories can sometimes hurt more than help. Patients make mistakes, and assumptions can’t be made about a patient because of them. An audience member added to the discussion by pointing out how often pharmacy employees tell patients to call their refills in ahead of time. Day 3 of 5 is not extreme. Pharmacy professionals often assume abuse in these types of situations, but that should be the very last thing considered. It is instead, more important to ask why the medication didn’t last the patient as long as it should have. It is likely that he isn’t getting adequate pain control, and that should be our first priority.

Case 6

M.A is a pharmacist at Rural Memorial Hospital, which is the only hospital within a 50 mile radius of its location. Rural Memorial is a critical access hospital, but has limited financial strength due to stagnant economic conditions leading to a slowly decreasing population base. Rural Memorial has contracted with a surgeon who will fly in to perform surgeries in trauma situations, addressing a critical access need due to the nature of the industry in the area and the local interstate highway.  Recently the surgeon has approached you and requested that the pharmacy stock a clotting factor that may be used in certain situations. You’ve investigated the medication and found that the cost for a usual course of therapy of the medication is $31,000. Further investigation also finds that the drug is not returnable once purchased.  Most patients treated at Rural Memorial are covered by Medicare, Medicaid, or capitated private insurances, so mostly likely the added expense would not be covered by insurance. What ethical issues arise from either stocking or not stocking the medication? Discuss balancing the costs of treatment of patients versus the ability to keep a critical access hospital financially viable.

Case-Haub started the discussion by first asking if there are any alternative medications that could be used. He explained the importance of first using clinical knowledge to look for other options, as well as considering how frequently this type of situation occurs and acknowledging what motives the physician might have for asking them to carry it. Is he getting a kickback? Clamon added that this situation could be approached both from the perspective of need and the perspective of resources. What’s right for an individual patient might not be right for the population the hospital serves.

Jordan took an opposite standpoint, asking what the ethical implications would be if the patient were terminal and those medications could give him another month. Clamon countered by stating that it shouldn’t necessarily matter whom the patient is: “Does it matter if they contributed to society? Does it matter if they are at the end of their life? Does it matter if it’s a surgeon, or the patient is unemployed? Do we care at all about who we are giving it to?” Wedemeyer-Olson added that spending that much on a drug that might expire without use is not realistic. Critical access hospitals, she explained, exist to take care of routine procedures and stabilize patients for transfer. She asserted that she could not ethically justify stocking the medication when the money could be used for other things. Case-Haub brought up the point that the rural setting should not determine the kind of care a patient gets. To this, a student in the audience originally from a rural area agreed, saying that residents are often aware of the limited resources and lack of access to specialists.

Case 7

P.M. is a pharmacist in a pharmacy located in a grocery store. In the tight economy, the grocery store is looking for ways to increase prescription volume in order to remain profitable. In the monthly meeting with the company’s non-pharmacist district manager, P.M. was told that a decision had been made where the pharmacy will guarantee new prescriptions will be ready for pick up in 15 minutes or less. The justification for this timing is that studies in the stores had shown the average shopping trip to the store lasted less than 10 minutes, and the comment was made that a 10 minute guarantee had been discussed, so P.M. should consider himself lucky that the target was 15 minutes and not 10 minutes. Discuss the ethical implications of such a guarantee.

Discussion opened with Jensen relating this case to several situations that have recently been brought to the Board of Pharmacy’s attention. He pointed out that this has been an ongoing conversation on the national level, as well, because many professionals feel passionately about this issue. Johansen asserted that there is a limit to the amount anyone can do in a workday. He added that it is important to note, however, that this case does not specify what the penalty would be for failing to meet the guarantee. There is a difference between the pharmacist or pharmacy being penalized and the customer being given a $2 coupon for groceries. Johansen went on to say that this guarantee could be sending the wrong message, as patients might not understand the importance of the process if they are being assured that it can be completed in under 10 minutes. Case-Haub agreed with this point, stating that the public must be better educated on everything that goes on behind the counter of a pharmacy. Many are ignorant of the work that goes into processing a single prescription. A couple students in the audience added to the discussion by pointing out that rushing pharmacists to fill prescriptions can compromise patient safety, and an incident in safety would be even worse for business than slower operations. This issue addresses the need to increase the public’s respect for the profession. Wedemeyer-Olson concluded the conversation by adding that many corporations monitor how quickly the DUR process is completed or how many prescriptions are filled, but they rarely observe the quality of counseling. This demonstrates the need for a shift in priorities.

The November Ethics Symposium was the first of a series of ethics seminars that will occur at Drake University. The inaugural event allowed students, faculty, and other professionals to come together and discuss emerging issues in the field of pharmacy. Moderator Kjos commented: “Overall, I thought the symposium was a unique opportunity for students to hear and participate in discussion on tough ethical issues in a safe environment. The panel provided a multitude of perspectives for students to learn about. Ethics is not a ‘black or white topic,’ and I believe that it is sometimes tough for a scientifically minded people (like us) to wrap our heads around it. Therefore, having open and real discussions on ethical issues we face in pharmacy and health care is something we need to practice. This forum provided exactly such an opportunity.”