stated that while some Indian companies meet U.S. quality stan - dards, others are challenged by them (Palmer, 2017). Another quality issue regarding active drug ingredient contami - nation may provide some useful perspective. In September 2019 FDA learned that some ranitidine medications contain low levels of a cancer-causing nitrosamine impurity called N-nitrosodime - thylamine (NDMA). FDA did not state if this contamination was limited to generic drug products, or if it impacted both brand and Case study: Tina Pharmacist Timothy is the proud third generation owner and op- erator of Thomas’ Uptown Pharmacy. Over the years, Thomas has earned the trust of the community. As a result, many people from the neighborhood come to the pharmacy to get friendly, but sol- id, well-founded advice. One day as Timothy was preparing to close the pharmacy for the evening, a new customer that he was not familiar with entered the store. Timothy greeted her as was his practice. Rather than approach him right away, the lady browsed aimlessly, as if she had no clear objective. Timothy suspected that this was not the case, rather from her behavior, he sensed that she had something on her mind to discuss. He stepped out from behind the counter and approached her slowly, introducing him- self and asking if there was anything that he could do to help. She hesitated a bit, seeming to be gathering her courage. Although Timothy was anxious to close the pharmacy and go home, he re- alized that he had a new patient in need. He tried to get her to warm to him by introducing himself using his first name and iden - tifying himself as the pharmacist. This approach seemed to work. The lady became a bit more ani - mated, and told Timothy that her name was Tina, and she had a problem that she needed help with. Timothy invited her to have a seat in the patient counseling area. She sat down and appeared to become more at ease. She stated that she had recently been laid from her job and had to move in with her daughter. Timothy did not interrupt her as she went on explaining the financial hard - ships that she was experiencing. Every now and then, Timothy would nod or verbally validate her problems. This non-threaten - ing and accepting interplay seemed to be working. Tina was now ready to discuss the problem at hand. Although they were the only two people in the store, she drew her head closer to his, and whispered “I have epilepsy and need brand-name Lamictal to keep from having seizures.” She then went on to state that she has been reading for years about how important it is to stick with the brand-name product, since the generic versions cause seizures. She acknowledged that although her insurance co-payment was higher than for the generic, she was certain that it was worth it and was willing to pay the differ- ence. The problem now is that not only does she not have insur - ance, even if she did, she could not afford to pay the additional money. She was almost out of both medication and money. This was not a challenging issue for Thomas. He prides himself in keeping current in the research as it relates to the practice of pharmacy. He was well aware of the controversy surrounding the generic substitution of medications for epilepsy and had plenty of experience comforting his patients regarding the bad publicity for these generic products. He was relieved when he learned that AES had changed their position on generics for epilepsy. In short, he was well-equipped to help Tina. He first acknowledged that there were concerns beginning approximately 20 years ago. Then he went on to explain how the FDA had worked with the experts to fully understand the issue. He summarized by stating that they concluded that generic drugs are not always the best for every patient, but they are often a good choice for preventing seizures. Further to that, the substitution of generics for Lamictal had been specifically addressed and given the stamp of approval of AES.
generic formulations. It is critical to note that although NDMA is classified as a probable human carcinogen, it is a known envi - ronmental contaminant sometimes found in water and commonly consumed foods. The amount of NMDA found in ranitidine barely exceeded the amounts found in foods. As such, FDA stated that the benefits of taking these medications currently outweigh the risks of consuming the contaminant (FDA, 2019b). Tina’s face brightened a bit, but then reminded him that she no longer had insurance and was afraid that she might not even be able to afford the generic product. Timothy walked over to the counter and tore a coupon off a pad. Handing it to her, he said “this is a coupon that you can use to bring the cost down on your medication. I could not tell you how these work but one of my patients used one today to lower their cost of lamotrigine, the generic version of Lamictal. Not sure exactly what it came to, but for a month’s supply of 100 mg tablets, I think that it was about six dollars. Could that work for you?” Tina was beside herself. She jumped up, pulled a ragged prescription from her purse, and gave Timothy a hug. “Thank you, thank you thank you!” Self-Assessment Quiz Question #9 Pharmacist Timothy appears to be skilled at building patient rapport that is useful for communicating with patients. Provide an example from the case study that illustrates how he used this skill to help Tina. a. Timothy ignored Tina when she entered the store, providing her with the privacy that she needed. b. Timothy appeared to observe Tina’s behavior in an effort to surmise her general needs. Self-Assessment Quiz Question #10 Regarding the generic substitution of epilepsy medications, which of the following false statements did Pharmacist Timothy dispel? a. Timothy proved that there was never controversy regarding the use of generic seizure medications. b. AES and other professional associations have been consistently in favor of reducing patient costs through the use of generic drug products useful for the treatment of epilepsy. c. FDA worked to show that generic substitution of epilepsy medications is often appropriate. d. While some generic epilepsy products have been shown to be safe and effective, no data on the efficacy of lamotrigine is available. Healthcare Professional Consideration: Litigating each of the arguments for and against generic substitution is well beyond the scope of this educational program. Nonetheless, it is likely fair to conclude that while in some cases, this exercise is not warranted, in many, if not most, this practice is critical to deliv- ering safe and effective pharmaceutical care. It is incumbent on all healthcare professionals to understand the issues at hand so that they are in a position to help their patients make the best choices to suit their individual needs. c. He put Tina at ease by actively confronting her. d. Timothy practiced efficiency with Tina’s time by immediately asking her what her problem was.
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