Concentration Accuracy of Mitomycin C for Ophthalmic Surgery

Patients with glaucoma may undergo trabeculectomy surgery. This surgery is an operation that reduces pressure in the eye through a small hole in the sclera which allows the aqueous humor to drain out slowly. After this procedure, there is a potential risk of scarring. To prevent scarring, surgeons will use mitomycin C (MMC) during the procedure. At the right concentration, this medication can have a very beneficial effect on healing after surgery. The concentration of MMC used for each patient is different and dependent on the age of the patient, ethnicity/race, and if they have had past operations or conditions of concern. The normal concentration range of the drug is 0.20 – 0.40 mg/mL.

This particular study wanted to show the accuracy in the concentrations being compounded. Is the concentration they are expecting to compound accurate with the actual concentration of the final product? There were 60 samples taken from a few different pharmacy settings: academic/community hospitals and an independent pharmacy compounding accreditation board. These settings were to use normal procedure when compounding and storing MMC at a 0.4 mg/mL dose. Typically, MMC is refrigerated, frozen, or made as a dry powder for compounding. To test the samples, high accuracy (92-100%) C18 reversed-phase high-performance liquid chromatography and a calibration curve were used. The samples concentrations were surprising. The average measured concentration for the samples was 0.35 mg/mL; this is 12.5% lower than the expected concentration of 0.4 mg/mL. Among the 60 samples, the range of concentrations was 0.26 – 0.46 mg/mL. A range this large with an average concentration of 12.5% less than anticipated concentration could be caused by a number of reasons such as compounding techniques or degradation of the drug. The study concluded that this is one of the reasons glaucoma surgeries could be inconsistent. Attempting to predict the scarring risk of a patient is almost worthless if the compounded product is not accurate.

It is scary to think that many invasive procedures can be so inconsistent. It’s one thing to have inconsistency based on a patient’s genetics or personal ability to handle a drug or surgery, but another to be dispensing the incorrect concentration of a medication. Patients put their health on the line by trusting healthcare professionals to be accurate and precise. One small mistake or inconsistency could greatly affect a patient. For example, a compounding pharmacy may be mixing a suspension and add the wrong amount of water. This could severely affect a patient’s health and there are not many checks and balances set in place to catch these small mistakes. How do you think errors in compounding should be handled or minimized?

Kinast R, Akula K, Mansberger S, et al. Concentration Accuracy of Compounded Mitomycin C for Ophthalmic Surgery. JAMA Ophthalmol. 2016;134(2):191-195.

http://archopht.jamanetwork.com/article.aspx?articleid=2475038

Oral Fluoroquinolones and the Risk of Uveitis

This study was conducted due to findings in a previous study that had come about in the literature. Further investigation was conducted to determine the truth behind the previous studies. These studies had begun to speculate a correlation between the use of oral fluoroquinolones and the development of uveitis or uveitis-associated diseases. Uveitis is inflammation of the eye that can be indicated by redness, pain, and blurred vision. The inflammation is usually in the middle layer of the eye’s wall. Since fluoroquinolones are used the most in outpatient facilities, it is very important to know if the previous findings were true and to what extent are they correlated.

This particular study set out to find some truth in the previous findings. Using a medical claims database and data from ambulatory care centers in the US, a large number of patients were found and participated in the study. The total sample size was 4,387,651 samples. These patients had either been prescribed an oral fluoroquinolone or a β-lactam antibiotic and data prior to the prescription date was known for a period of 24 months. Patients with previous diagnoses of uveitis or associated diseases were not considered for the study. 843,854 patients received a fluoroquinolone while the remaining 3,543,797 patients received the β-lactam. At days 30, 60, or 90, observations concluded there was no hazard risk for developing the associated diseases or uveitis. There was a small increase in this risk for fluoroquinolone uses after 1 year. There was a larger risk for developing the associated diseases at the 365-day mark. The conclusions of this study determined there was not necessarily a correlation between oral fluoroquinolone use and risk of uveitis. However, there does seem to be some possible correlation between fluoroquinolone use and the risk of the associated diseases. More studies would need to be conducted in order to prove a definite correlation between these diseases and the antibiotic use.

I think that this study is interesting because it demonstrates the checks and balances in the research fields of pharmacy. We are learning in class to look up multiple sources for information to make sure all of the information we relay to others is accurate and reliable. The researches involved in this study saw other research being conducted and were interested in the results. To confirm them or refute them, they decided to conduct the study themselves and come to their own conclusion. Do you think this is a good example of obtaining reliable and accurate information?

Sandhu HS, Brucker AJ, Ma L, et al. Oral Fluoroquinolones and the Risk of Uveitis. JAMA Ophthalmol. 2016;134(1):38-43.

http://archopht.jamanetwork.com/article.aspx?articleid=2465311

Characteristics of FDA drug recalls: A 30-month analysis

This article describes the Food and Drug Administration (FDA) recalls for a period of 30 months (June 20,2012 – December 31, 2014). The FDA is in charge of regulating many types of drugs including prescription, nonprescription, dietary supplements, and biological products. The analysis of the recalls were based on the following data: product type, recalling firm, country, voluntary/involuntary recall, how the recall was communicated, FDA classification, product availability, reason of recall, recall initiation, and recall report date. There were 21,120 products recalled during the time frame and only 14.4% of them were analyzed based on meeting the inclusion criteria. The main reasons for recalled drugs were due to contamination, adverse reaction, incorrect potency, defective product, and mislabeling. There was a total of 348 manufactures involved in the recalls, and the top 5 manufactures accounted for 1,014 out of the 3,045 recalled drugs (33.3%). The majority of the contamination occurred at compounding firms rather than non-compounding firms.

I believe that these results are not entirely surprising. It makes sense that more contamination would occur at compounding firms because they deal with physically making the products they dispense rather than dispensing medication that is already ready to be dispensed. What is surprising is that 33.3% of the drugs that were recalled came from only 5 manufactures out of the 348 manufactures. In my opinion, there should be specific regulations regarding how many drugs can be recalled from the companies. If there is a high recall rate from a specific company, there is probably an error in their processing. Intense monitoring should be implemented in order to minimize the risk of contamination and mistakes during production. It is almost scary that 5 companies were responsible for so many recalls. If a patient took a medication that was not formulated correctly, it could seriously affect a patient’s health. What types of regulations do you think could be implemented to ensure the minimization of risks?

Hall K, Stewart T, Chang J, et al. Characteristics of FDA drug recalls: A 30-month analysis. Am J Health Syst Pharm. 2016;73(4)235-240.

http://www.ajhp.org/content/73/4/235.abstract

Hospital pharmacies cope with surge in drug prices

Every year, the price of drugs increases. Valeant Pharmaceuticals International, Inc. is just one company that seems to have taken advantage of their resources by purchasing the right to available drugs and raising their prices. This article speaks of one situation at Baystate Health in Massachusetts where the dramatic price increases caused them to remove a drug from their formulary—a drug that had been used successfully for many years. It started with the increased price of nitroprusside and isoproterenol and after many meetings with the pharmacy and therapeutics committee, nitroprusside was taken off the formulary and replaced by other cheaper alternatives. By taking an older popular drug off the formulary, physicians are forced to change their patient care techniques. Therefore, when making the decision to remove the drug, physicians’ opinions were also considered. Cost-effective methods are very important to the success of a hospital, physicians, and pharmacists; by taking this drug off the formulary, treatment costs would decrease by a factor of 8 to 60.

The increased cost of nitroprusside was not a large problem due to the small amount that was dispensed each year. The hospital does dispense a large amount of isoproterenol and could not afford to lose the therapeutic benefits by removing it from the formulary. Instead, other measures were taken in the hospital pharmacy to ensure minimal wastes. For example, instead of keeping the chemicals mixed beforehand, the pharmacy would only mix the solution when it was time to use it. This is only when the doctor had specifically ordered it. The pharmacists also work with the physicians to discuss other cost-effective therapies to ensure they only use the expensive drugs when it is absolutely necessary. The management of these drug therapies and the cost associated with their use is important to manage every day, not something that can be ignored.

I believe that companies that buy out older drugs just to increase their prices are unethical. We live in a capitalist society where everything is based on how much money an individual or company can make. Being a pharmacist or other health care provider should be about taking care of the patient. If drugs that have a higher rate of therapeutic benefits with an ability to be priced at a lower cost, there is no reason the prices should be increased just to make more money. A profit is a profit and maximizing profit at the expense of a patient’s health is not what health care is about. Do you think drug companies should be able to increase prices with no real reason other than to make money?

Traynor K. Hospital pharmacies cope with surge in drug prices. Am J Health Syst Pharm. 2016;73(4):182-184.

http://www.ajhp.org/content/73/4/182.1.full

Participant satisfaction with a community-based medication synchronization program

In a metropolitan area in Kansas City, a grocery store chain pharmacy decided to assess patient satisfaction with a new program they were offering. They called this program Time My Meds. Time My Meds was designed for patients taking 3 or more chronic medications to sync them to all fill on one day each month. The patients that were enrolled were asked to take a survey 3 months later to assess their satisfaction with the program. The survey collected demographic information and satisfaction based on the 5-point Likert scale. A total of 48 surveys were considered with no differences in trends based on age, education, income, or number of medications. Overall satisfaction was ranked very high with each question receiving a median score of 5 out of 5 on the scale.

This program was designed to benefit the patient. First, it helps reduce noncompliance. Three out of four Americans report not taking their medications as prescribed with long-term adherence rate at 50%. This can severely reduce the quality of life for an individual with an uncontrolled chronic disease. The results of the Time My Meds program showed patients had 3.4 to 6.1 times greater odds of adherence than unenrolled patients. This helps adherence because a patient is more like to come to the pharmacy if they only have to come once a month rather than once a week. Second, the study showed that pharmacy workflow would be improved because they could fill everything at once for a single pick-up date and reduce the unplanned and sporadic fills. By reducing these unnecessary fills, there will be more time for pharmacy staff to assist the patient.

From a patient’s perspective, this plan may be a great idea. It is extremely convenient to only make one trip to the pharmacy, easier to remember what medications are needed, and reduces the likelihood of noncompliance/nonadherence which improves the patient’s health. From a pharmacy technician/interns perspective, the program has many flaws. For example, some patients cannot afford to pick up all of their medications at once. Others like to manage their own medications and call them in when they are needed. The program may also take a few weeks to fully synchronize the “acceptable” medications, which can confuse an older adult that does not fully understand the program. Also, the only medications that can be enrolled in the program are those that are deemed “acceptable.” Patients may be on medications that are not deemed “acceptable” and would therefore, still need to manage some medications by themselves. Again, for an older adult, this may cause confusion as they would be expecting to pick up certain medications that may not actually be included in the synchronization. Overall, the idea of the program is great. I still believe there are kinks that need to be worked out to make the program the best it can be. Do you feel like a program like this would be easy to implement in a community pharmacy?

Butler K, Ruisinger J, Bates J, et al. Participant satisfaction with a community-based medication synchronization program. J Am Pharm Assoc(2003). 2015; 55(5):534-539.

http://www.japha.org/article/S1544-3191(15)30114-X/fulltext

Age-Related Sex-Specific Changes in Brain Metabolism and Morphology

This study, published in the Journal of Nuclear Medicine, was conducted to determine the age-related, sex-specific changes in brain metabolism and morphology which indicates how the brain changes over a period of time. Their main goal was to analyze the differences between men and women. The study was conducted on 963 cognitively healthy adults aged 30-40 years old (with a comparison difference of 5 years) where each individual took a medical questionnaire, the mini-mental state exam, underwent an MRI and whole-body 18F-FDG PET. The images were analyzed in a 3-dimensional surface projection which allowed the changes in the brain to be seen more clearly. For each age group, the sex-specific differences were analyzed and compared. Even though atrophy of the brain for both males and females was seen in the lateral frontal and parietal regions, there were still differences in the extent of the condition. Men were more likely to experience morphology and metabolism changes in the parietal region of the brain which would ultimately affect their visuospatial ability. Women were more likely to experience morphology and metabolism changes in the ventrolateral prefrontal regions which would affect the Broca area needed for processing speech. The study also showed that the sex-related differences were insignificant once over the age of 66.

I think that the technology that has developed in the field of nuclear pharmacy is extremely interesting. Being able to see 3-dimensional images of the brain, the most functionally complex organ in the body, is a great way of analyzing how it works and is a step in understanding why people are the way they are. If the age-related and sex-specific differences in individuals is known and studied, new drugs that specifically target these differences can be developed and studied. Similar to the studies in genetic variability between people, there could also be other differences that could affect the way people are dosed.

Kakimoto A, Ito S, Okada H, et al. Age-Related Sex-Specific Changes in Brain Metabolism and Morphology. J Nucl Med. 2016;57(2):221-225.

http://jnm.snmjournals.org/content/57/2/221.abstract

Kentucky Pharmacists’ opinons of the potential reclassification of pseudoephedrine as a legend drug

This research study surveyed Kentucky pharmacists during the months of June-October in 2012. The survey was initiated due to concerns of pseudoephedrine accessibly and the abuse of methamphetamine. It was mailed to pharmacists to analyze their opinions on 3 different aspects: effectiveness of current methamphetamine precursor control, propose legislation to make pseudoephedrine a legend drug, and to analyze the potential impact of such legislation on pharmacy practice and patients. 431 community pharmacists were surveyed and the results were as follows: 77% believed that making pseudoephedrine available via prescription only would reduce methamphetamine abuse and lab-related incidents, and 56.2% of pharmacists surveyed supported this legislation. Some of the factors that influenced the support for the legislation were whether they were independent or chain pharmacies, where they practiced, time commitment for new activities involving pseudoephedrine, profit, abuse, and lab-related incidents. Those practicing in an independent pharmacy seemed to be less supportive of the legislation, and those in regions of higher abuse reports were more in favor of the legislation.

I believe these results are to be expected based on how people think in a business, but not with the general well-being of the community in mind. For example, methamphetamine abuse can be a problem in all parts of the United States. However, it is the pharmacists that see it more frequently that agree with making a change to improve the health of these individuals. Pharmacists in regions of low methamphetamine abuse do not see the problem often (if ever), and therefore, they may not feel it is worth the time and effort to make pseudoephedrine a legend drug. The same is true for an independent pharmacy. Since they may not have as much time and money to spend on the new legislative program, it may not be cost effective for them to support it. As pharmacists, I believe we need to do what we can to protect the health of the community. If methamphetamine abuse is still an issue in the United States, then more intensive measures should be taken in order to minimize the abuse further. Do you think it would be beneficial to make pseudoephedrine a legend drug?

Monson K, Freeman P, Goodin A, et al. Kentucky pharmacists’ opinions of the potential reclassification of pseudoephedrine as a legend drug. J Am Pharm Assoc (2003). 2014;54:397-405.

http://japha.org/article.aspx?articleid=1892312

Public Perception of Pharmacists: Film and TV Portrayals 1970-2013

This was a study that was conducted to identify the public perception of pharmacists as seen in media. The investigators viewed and analyzed 214 different works – television shows and movies – where 231 pharmacist roles were analyzed. In some cases, the pharmacists had multiple reoccurrences, so there were only 160 people being analyzed. They were analyzed with definitions for villains, victims, and heroes in mind. The results showed that 145 out of the 231 roles were considered to be negative. Only 30 of the 231 roles were positive, and the remaining 56 were neutral. This means that 62.7% of pharmacists displayed in television shows and movies are considered to be negative. Many people watch these shows, and their emotions and values are influenced by them. If the majority of the public considers pharmacists to be a negative presence in health care, then the values pharmacists strive to live by are not useful. The purpose of this study was to provide evidence for current and upcoming healthcare professionals about the public perception of the pharmacist role in their health. Pharmacists and student pharmacists should work hard to advocate the positive impact they can have on an individual’s health care and work to build trust with patients and physicians.

I chose this article because I was interested to see how the public views pharmacists in the media. When you watch medical shows or movies, the pharmacist does not usually play a significant role. However, in class we are learning the opposite. Pharmacists have a direct impact on a patient’s health as counselors, advisers, and advocates. Pharmacists are also starting to play a bigger role in physician relationships via collaborative practice agreements and immunizing in the community setting. We as student pharmacists should work hard to advocate for our own profession and break the negativity portrayed in media. Why do you think pharmacists are portrayed negatively in television and films?

Yanicak A, Mohorn P, Monterroyo P, et al.  Public perception of pharmacists: Film and television portrayals from 1970 to 2013. J Am Pharm Assoc (2003). 2015;55:578-586.

http://japha.org/article.aspx?articleid=2462035