Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

As Ebola virus disease (EVD) was at it’s peak, World Health organization brought up a list of drugs that could potentially be researched to treat Ebola. This research was originally set-up as a randomised trial, but due to high mortality rate, it was found to be unethical for many reasons. The main reason this research was made to be randomized was to avoid any implications that could arise from patients not recieveing treatment drug when they need to as it could lead to less people believing in the healthcare system. So, this research was randomized in which 99 patient’s data was represented in this study.

The study was done using Favipiravir, an antiviral that is used to treat severe influenza, to research it’s efficacy on patients with EVD. All of the patients were given either standard therapy treatment or treatment with experimental drug to see it’s efficacy. During this study of being non-randomized, it was seen that the patient’s with Ct count of less than 20 had high mortality rate than patients with Ct count of over 20. The data extracted from these patients was sufficient to consider whether this drug was efficacious for patients to use in the future, as this study was non-randomized and the the mortality of the patient was as predicted.

This study had no real results, but showed some potential of setting up a clinic for EVD patients. Knowing the ethical implications along with the clinical aspects of treating ebola is what this paper was implying. Although there was not any presentable data that could help with treatment of EVD, this paper helps understand some of the important aspects that a researcher will face if Ebola patients were used in a study. Would you use Ebola patients for your study? How can you justify if a person gets the treatment dose or not having randomized trial?

 

Sissoko D, Laouenan C, Folkesson E. (2016).Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea. 2016 Mar 1;13(3):e1001967.

Published online first.

 

Differential Impact of Selective Serotonin Reuptake Inhibitors on Platelet Response to Clopidogrel: A Randomized, Double-Blind, Crossover Trial

SSRIs and other antidepressant medications constitute one of the most commonly prescribed drug classes that pharmacists will see in the community setting. When taken alone, any one of these medications can be a good treatment option for patients experiencing depression; however, these drugs can cause a patient who is taking multiple drugs  to experience significant interactions with his/her other medications. For this reason, it is crucial to know how the effects of other medications can be altered through this therapy.  This study analyzed the effects of two SSRIs (citalopram and fluvoxamine) on the blood thinning medication clopidogrel. These medications all work on the same CYP enzyme (CYP2C19)  and have opposing effects. Researches tested these medications on healthy individuals and found that fluvoxamine was the only drug that caused significant inhibition of clopidogrel action.

I think this is important to note because these medications are commonly utilized by patients and thus there is a high likelihood that they may be taken together. As pharmacists, we should be able to provide adequate care in response to possible drug-drug interactions. To do this, we have to be able to recognize when there could potentially be a problem in medication therapy. By taking the proper precautions when these situations arise, pharmacists will be more likely to help patients avoid adverse medical events associated to drug therapy methods.

Association between guideline recommended drugs and death in older adults with multiple chronic conditions: population based cohort study

When prescribing medications for the initiation of  a new therapy in patients with multiple chronic diseases, physicians often look to guidelines to determine their recommended treatment option.  While this is considered good practice, it is important to not look at the disease state as a singular entity when choosing a therapy for the patient to follow due to the effects that certain conditions have on one another. This study looked to analyze the association between guideline recommended drugs and death in older adults with multiple chronic disease states. To do this, 8578 adults aged 65 and older were monitored though three years of treatment. Patients involved in the study had a variety of disease states including but not limited to atrial fibrillation, chronic kidney disease, depression, diabetes,  and hyperlipidemia. Results from the study showed that over 50% of the participants received guideline recommended drugs without the consideration of other disease states. Although 15% of the patients died during the course of the study, researchers were able to determine that cardiovascular medications were associated with a decrease in mortality. Other guideline medications analyzed in the study did not show an association with reduced mortality. Overall, it was determined that choosing medication therapy for patients should only be done after fully analyzing the patients other conditions.

I believe this study is important due to the fact that guideline recommended medications are commonly dispensed in the pharmacy setting. It is thus important for us to understand how guideline drugs interact with each other to protect a patient at the point of treatment initiation. By doing this, we will be able to avoid adverse drug effects that can result due to medication interactions. I believe that this is one of the most important roles of a pharmacist because it helps promote patient well-being and increases the likelihood of medication regiment adherence. The goal of our profession is to protect patients and advise them on how to find ways to live a healthy lifestyle. The easiest way to do this is by starting at the roots of the solution.

Tinoetti M, McAvay G, Trentalange M, et al. Association between guideline recommended drugs and death in older adults with multiple chronic conditions: population based cohort study. BMJ 2015; 351: h4984

Computerized Decision Support Improves Medication Review Effectiveness: An Experiment Evaluating the STRIP Assistant’s Usability

When physicians prescribe medications to patients with certain disease states, there is no way of determining whether the medication that is being prescribed will work for the patient. For example, obtaining adequate control of chronic disease states may involve a process of testing different medications on a patient until one can be deemed as an appropriate treatment option. There are different programs that have been established in the past to provide aid to physicians looking to initiate therapy options on a patient; however, they have not been proven to cause changes in care that lead to clinically significant improvement. For this reason, a new tool referred to as STRIP (Systemic Tool to Reduce Inappropriate prescribing) has been developed to optimize the prescribing process by conducting medication reviews in the primary care setting. This program is a computer-based technology that allows physicians to analyze patients medication histories and preferences to determine the best form of therapy.

In this study, 42 physicians were asked to optimize medical records of patients utilizing multiple medications by both the traditional manner and by the STRIP analysis. Utilization of the STRIP assistance program was linked to an increase in the number of appropriate medication decisions (to 76% from 58% without). Along with this, physicians on average spent more time meeting with patients and discussing treatment options using the program. The only major negative result gathered from the study was the fact that it received a below-average score by physicians examining the usability of the system. Therefore, the STRIP assistance program was determined to be an effective tool for providing medication reviews.

I believe this study is important because it shows how one of the main roles of a pharmacist (providing medication reviews) benefits the overall experience that a patient will have with their medication. I believe having systems like this in place to aid physicians in the process of decision making will allow pharmacists to eventually become more active in the process of prescribing medications. This is something that I think is important due to the amount of knowledge that pharmacists have about medications. Optimization of prescribing methods will not only benefit the health of the individual receiving the medication, but it will also ensure that we are limiting the cost that adverse effects from drugs have on the health care system. I believe that the role of a pharmacist will only continue to expand over the next couple of decades, and as a result, the profession will be more respected by the public.

Evaluating the Effects of an Interdisciplinary Practice Model with Pharmacist Collaboration on HIV Patient Co-Morbidities

HIV patients are likely to have certain medical co-morbidities at a higher prevalence than members of their age group and are more vulnerable to adverse events related to these problems. For this reason, monitoring of patients with this condition is highly utilized through primary care clinics that specialize in the treatment of the infection in association with chronic disease states. The disease states common among HIV patients over the age of 60 include hypertension (45% of people), diabetes (21% of people), and vascular disease (23% of people). Interdisciplinary practice models used in treatment of patients with this condition have been effective in managing these chronic disease states. Because pharmacists play a crucial role in how HIV patients adhere to medications and treatment guidelines, this study focused on determining if there is a benefit to adding pharmacists to this inter professional team.

This study found that pharmacists were able to help in the management of  lipid levels and the cessation of smoking. Along with this, pharmacists were found to significantly decrease the amount of money these patients spend management of their individual chronic co-morbidities (with average savings of $3,000). For this reason, pharmacists involvement in the primary care of patients with HIV should expand past the provision of medications to include counseling and other services.

I think this study is important due to the fact that it represents how the role of a pharmacist within the health system is constantly changing. We are not only trusted sources of information for medications and proper treatment techniques, but we are also crucial in providing adequate counseling to patients. This is something that I believe has been a major focus throughout our studies in pharmacy school over the course of the year, and as a result, a feel I will be well prepared to fill this role in my future profession. This article makes me want to learn specific ways that I can help patients from this population manage their condition.

Cope R, Berkowitz L, Arcebido R, et al. Evaluating the effects of an interdisciplinary practice model with pharmacist collaboration on HIV patient co-morbidities. AIDS Patient Care and STDs. 2015, 29(8): 445-453

Antidepressant Use and Risk of Recurrent Stroke: A Population-Based Nested Case-Control Study

Approximately 30% of individuals that have had a stroke are also diagnosed with depression, and although antidepressant therapy is recommended in patients with post-stroke depression, there are no guidelines for choosing therapy options. For this reason, a study was conducted to determine the relationship between the use of various classes of antidepressant medications and the recurrence of stokes. This longitudinal study analyzed health insurance database information of adults over the age of 18 who had a stroke and were readmitted with this condition. Around 10,000 patient cases were included in the study results (6,679 controls; 3,536 cases).  The study found that there was not an increased risk of stroke recurrence in patients taking SSRIs for depression; however, a correlation was found in patients being treated with TCAs (1.41 times increase). The risk for stroke recurrence in patients taking TCAs did not show much differentiation when analyzing dose and treatment duration variations. As a result, the study highly recommends using alternative methods of treatment for depression symptoms in patients who have experienced a stroke.

I believe this article is important to the understanding of pharmaceutical care due to the fact that antidepressants are one of the most commonly prescribed classes of medications. As healthcare professional that prioritize on the safety of treatment methods, we should be aware of medication contraindications so that we can provide the best patient care. Although all healthcare professionals look out for the best interests of the patient, pharmacists specialize on medications and thus will have the best knowledge on the potential dangers associated with treatment methods. This study makes me want to learn more about specific medication contraindications so that I will no how to protect patients health after graduation from pharmacy school.

 

 

Improving Patients Primary Medication Adherence

Pharmacists across the globe face a key issue in their ability to provide patients with the tools that enable them to adhere to medication regimens. Increasing adherence to prescribed treatment options will help to improve the overall health outcomes of the patients that pharmacist’s are serving.  For this reason, research into the causes for non-adherence and its resulting issues is and will continue to be an area of high importance. The interest that I have in improving medication adherence led me to the article entitled improving Patients Primary Medication Adherence.

This article is focused around a study completed in a French hospital during the months of November 2010 to June 2011. The study, which included patients over the age of 18 that were admitted into the ITD (Infectious and Topical Disease) and the general medicine unit, was developed to determine if incorporating clinical pharmacy activities into the discharge process would decrease the amount of post-discharge adverse effects.  To assess the results of this study, medication adherence was determined by contacting the patients’ community pharmacists 7 days after discharge.  The study did not find a correlation between the rate of re-admittance and/or visits to emergency rooms, but patients who received extra counseling during discharge were more likely to be adherent to newly prescribed medications.  For this reason, the study supported the idea that adherence can be increased by providing discharge counseling sessions to patients.

I feel like this is an important study for us to consider as pharmacists because managing patient adherence to medication regimens is the most important role we play in improving health outcomes.  By improving adherence, we have the ability to lower the risk for serious adverse drug events which can lead to hospitalization.  For this reason, I believe that pharmacists should implement all activities that are proven to increase adherence to maximize the results of treatment options.  This article has left me wondering how similar programs to increase medication adherence can be implemented in community pharmacy settings.

Leguelinel-Blache G, Dubois F, Bouvet S, et al. Improving patient’s primary medication adherence: the value of pharmaceutical counseling. Med. 2015;94(41)

 

Seasonal Affective Disorder and Methods for Treatment

In an article by Sherri Melrose, it is explained that seasonal affective disorder (SAD) is a recurrent form of depression during the fall and winter seasons. Common signs that someone is dealing with SAD includes sad mood, low energy, irritability, crying frequently, lethargy, abnormal sleep, decreased physical activity, carbohydrate craving, and withdrawal from social activity. Severity of symptoms is different in each patient and can include violent behavior. Women are more affected by SAD than men, and SAD begins to occur between 18 and 30 years of age.

Currently there are multiple ways to help those with SAD, including antidepressants, light therapy, vitamin D, and counseling. Antidepressants prevent the reuptake of serotonin and light therapy is a way to mimic the light that is produced from the sun. Vitamin D supplementation is important because the body is not as capable of producing vitamin D without light exposure. Counseling is another method for helping those with SAD because of the help and support that it can provide to the patient. It is helpful to limit sugar intake, increase exercise, manage stress, and avoid social withdrawal when symptoms are not sever. It is also helpful to patients to provide instruction about mindfulness, and enjoyable activities.

SAD is a serious problem that most people do not realize is the reason for a change in mood over the fall and winter seasons. It’s interesting how it is caused by small changes in the body, but it is very important for people to take care of themselves when onset occurs. I can understand how it can be difficult to diagnose, and it can be very difficult for the patient to understand what is happening. Treatment is important to start and continue throughout the darker months.

Melrose S. Seasonal Affective Disorder: An Overview of Assessment and Treatment Approaches. Depress Res Treat. 2015.

http://www-ncbi-nlm-nih-gov.pitt.idm.oclc.org/pmc/articles/PMC4673349/

Novel Drug Therapy for Treatment of Relapsed Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia (CLL) is the most prevalent leukemia among adults. It is also one of the most commonly relapsing types of cancer. While chemotherapy and traditional forms of cancer treatment do prolong remission and overall survival rates, relapse occurs in practically all patients. The commonality of relapse in patients with CLL has prompted the discovery of novel drug targets in hopes of stopping the proliferation of leukemia cells in the body. Bruton’s tyrosine kinase (BTK) is a downstream signal proliferator in several pathways that are relevant to both tumor-cell survival and the ability for the tumor-cells to adhere to one another.

However, the inhibition of BTK results in the loss of immunoglobulins in blood serum which results in an increased risk of infection for those affected by BTK inhibitors. In addition, because the structure of BTK is vastly different from other tyrosine kinases it is a perfect therapeutic target. Ibrutinib is a first-in-class, small molecule drug that covalently binds to and inhibits the action of BTK, specifically its cysteine (C481) site. Ibrutinib is, however, not a very selective inhibitor as it also inhibits the action of many other protein kinases and causes severe side-effects. Second generation BTK inhibitor, acalabrutinib, is highly selective to BTK C481 and therefore has a lower side-effect profile than ibrutinib.

The response to acalabrutinib in early clinical testing was overwhelming with 98% of patients having reduction in lymphadenopathy (swollen lymph nodes) and 61% having concomitant lymphocytosis (elevation in blood-lymphocytes). Additionally, most adverses effects of the medication were not considered dangerous or life-threatening with most being mild headaches and diarrhea. Only two events of progression were reported in the study. All in all, acalabrutinib shows major steps in the reduction of relapses for CLL patients, and a new string of hope for those diagnosed with CLL.

Do you think this drug has the potential to become a first like treatment for leukemias? Could drugs like this lead to the end of chemotherapy?

 Article Link

Citation:

Byrd JC, Harrington B, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374:323-332