In a paper published by Research in Pharmaceutical Science, new formulations of loratadine (Claritin (R)) were tested to determine whether or not formulating loratadine as a nasal gel could increase the drug’s bioavailability in the body and therefore its effectiveness. It was found that creating a gel-like nasal spray with the loratadine compound is feasible. The compound could be created using a mixture of hydroxypropyl methylcellulose and xanthan gum and still be stable enough to used intranasally. The compounds created contained over 95% the active loratadine compound. Additionally it was found that the compounded gel formulation was even stable six months after preparation enhancing its real-life usefulness.
Overall, the study was seen as a success as the compound was able to adhere to mucus dense membranes for several hours. In fact, the exposure to the drug to the drug was up to 10 hours of exposure depending on the specific excipient:active compound ratio. The study also overcame a large problem with loratadine, the fact that it really does not have a very large bioavailability in the body in its current formulations (tablet and capsule). This new formulation would allow the active ingredient to overcome first-pass metabolism in the body and expose the body to more consistent levels of the anti-allergen. The new nasal formulation also acts where it is needed quicker than other formulations. In fact, was shown to be effective in under 30 minutes. Additionally, the nasal formulation means that the drug is absorbed easily because of the large amounts of capillaries present in the nasal cavity, is not degraded by GI enzymes, and it results in fewer total-body side effects because the whole body is not exposed to the drug compound.
This is a convenient new formulation for a commonly used seasonal allergy medication, do you think other drugs should be evaluated for formulation changes? If so, what drugs do you think would be good candidates for such formulation changes? Do you think a pharmacist should have the right to change a formulation based on a patient’s need?
Sherafudeen SP, Vasantha P. Development and Evaluation of in situ Nasal Gel Formulations of Loratadine. Res Pharm Sci. 2015;10(6):466-476
A study recently conducted by the Society of Public Health assessed whether or not rural mothers receiving text messages with healthcare advise would lead to better health outcomes for both herself and her children. Of the rural community 85% of people own a cell phone (many less have broadband internet) and 76% of the people who own cell phones in rural communities use them to send and receive text messages. The study sent out weekly messages regarding healthcare topics that could receive immediate action by the recipient. The topics covered in the rather short health tips ranged from diet/exercise to health insurance enrollment tips.
The overall outcomes of the study were positive. A majority of the participants reported acting on the messages. Many kept the messages for later review, but most importantly most participants read the messages right away. While action varied on topic (only 19% acted on the health insurance advice) there was still acknowledgement and possible future action on most of the topics as expressed by participants. Over 70% of all participants said they would share the information they received through the study to friends and family – this could be one of the most impactful outcomes of the study.
Text messages were reported by the participants as a very convenient way to receive healthcare information. They claimed that because it was a message they did not feel pressured to act right away, they felt they could go back and access the information later, and lastly texts were reported as an easy method to read because the messages are required to be so short. Do you think this concept should be more generally applied to healthcare? This method is already used to try and enhance patient adherance at retail pharmacies with limited success, how can we improve outcomes?
Aldoory L, Yaros RA, Prado AA, Roberts E, et. al. Piloting Health Text Messages For Rural Low-Income Mothers: Effects of Source Similarity and Simples Action Steps. Health Promot Pract. 2016;pii:91-97
In an article published by the American Journal of Health-System Pharmacy it was examined whether or not pharmacist-driven medication management for patients on warfarin regimens improved outcomes for these patients. In the study three hundred twenty-seven charts were reviewed by clinical pharmacists and then recommendations were made by the pharmacist about the medication regimen.
INRs within therapeutic range increased from 27.8% of patients to 38.5% after the chart review and counseling by a pharmacist. There was also a drop in subtherapeutic INRs going from 55.3% of the patient population to 39% of patients examined. The pharmacist intervention also lowered the average time to achieving therapeutic INR levels by 0.5 days. This clearly shows one of the obvious benefits that clinical pharmacists can play on an interprofessional team.
Do you think the pharmacists should have had a greater impact on these numbers? Or do you believe that any positive outcome is good? Should pharmacists be required members of rounding teams at hospitals in order to reduce the complications faced with medications?
Downing A, Mortimer M, Hiers J. Impact of a pharmacist-driven warfarin management protocol on achieving therapeutic International Normalized Ratios. Am J Health-Syst Pharm. 2016;73:S69-S73
In a study published in the Journal of the American Medical Association the guidelines for determining whether a patient in a hospital setting is brain dead or not was examined among top hospitals in the United States. Brain death is classified as an “irreversible cessation of all functions of the entire brain, including the brain stem” as specified by the American Academy of Neurology (AAN). The object of this study was to determine whether or not top US hospitals were performing all of the necessary steps in determining whether or not a patient was brain dead or not according to the updated guidelines of the 2010 AAN practice parameters.
The guidelines provide step by step instructions for specific staff members to follow in order to pronounce a patient as ‘brain dead’ a short version of the tests that need to be performed are as follows: determination performance (who was qualified to determine brain death), prerequisites for testing, details of clinical examination, details of apnea testing, and details of ancillary testing. These are also the 5 categories the study used to determine whether or not hospitals were correctly following brain death determination standards.
The results of the study were rather disheartening. Only 28% of hospitals required a pupillary reflex to be conducted, 13% of hospitals only required one exam to determine brain death (85% required two or more examinations), only 33.1% of hospital policies required that the physician determining brain death had expertise in neurology or neurosurgery, and 30% had no specific requirements for the staff member making the determination. Since it is impossible to record a “false-positive” determination of brain death the study states that most hospitals do not feel the need to update their protocols for determining brain death. Acknowledgement of the AANPP guidelines would help make the determination of brain death 100% accurate 100% of the time.
Do you think this is a rather scary thought to imagine about our hospitals? Do you think a pharmacist should be consulted when determining brain death because of possible drugs that interfere with brain activity?
Greer D, Wang H, Robinson J, Varelas P, et al. Variability of Brain Death Policies in the United States. JAMA Neurol. 2016;73(2):213-218
This study was conducted using students at a university student health center. Two types of counseling were used for those students diagnosed with depressive symptoms. One group was asked to attend group counseling meetings with fellow students and the other group was asked to sit down with a specially trained pharmacist one on one. It was found that both groups of students improved physically with outside symptoms of depression but only those who met individually with a pharmacist improved their score of mental health.
The prevalence of depressive students among this population increased with higher GPA and depended on program of attendance. About 13.7% of students encountered were considered of depressed mood. The study found that of these patients those who received advice and counseling from a specially trained pharmacist improved their mental health status from a CES-D (mental health scoring exam) of 37.9 to 43.1 where as those in group counseling did not see a vastly significant change in mental health scoring.
The study also found that medical and public health students had the highest prevalence of depressive symptoms whereas nursing and pharmacy students had lower prevalence. The study concluded with the recommendation that community pharmacists be considered as first-line depression screeners.
Do you think a depression screening course should become part of curriculum at pharmacy schools? Do you think community pharmacists should practice regular depression screenings with patients while conducting CMRs? Do you think people will take the advice of a pharmacist when it comes to this matter seriously?
Phinmarn W,Kaewphila P, Suttajit S, et al. Depression Screening and Advisory Service Provided by Community Pharmacist for Depressive Students in University. SpringerPlus. 2015;4:470-82
One study from the Journal of the American Medical Association found that having a certain allele and being of a low socioeconomic status makes one more likely to eat fatty foods and become at risk for being overweight. In contrast, the study also found that having a certain allele (DRD47) and being of a high socioeconomic status made one less likely to eat fatty foods and be at risk of obesity. The study was conducted using 190 children who kept food journals and were weighed on a daily basis. The study found that children who were carriers of the so called ‘obesity-risk’ alleles and who came from a low socioeconomic background were more likely to eat fatty foods and become obese than non-carriers from low socioeconomic backgrounds.
Interestingly, the ‘obesity-risk’ allele does not function the same way in children of higher socioeconomic status. Those who were carriers of the allele were found to eat less fatty foods than those without it when coming from a higher socioeconomic status. This led the researchers to speculate that the allele may not control cravings themselves but rather the openness of the person to accept what is given to them and what people around them do. For instance, if one lives in a poorer community and is surrounded by people who eat poorly, carriers may be more easily persuaded to eat poorly as well and vice versa for the higher socioeconomic classes.
This study implies that possibly obesity is not entirely related to decision making of the individual but rather the genetics of his/her decision making. Should people be screened for alleles like this and be treated differently by healthcare professionals or institutions like schools? Could it become okay for people to use genetics as a defense for unhealthy eating?
Silveria P, Gaudreau H, Atkinson L, et el. Genetic Differential Susceptibility to Socioeconomic Status and Childhood Obesogenic Behavior. JAMA Pediatr. 2016;E17:1-6
In a study called “Economic Evaluation of the Impact of Medication Errors Reported by U.S. Clinical Pharmacists” it was found that medication errors are quite common and cost an average of $89 per error per patient. The study was conduced over two weeks with 52 clinical pharmacists reporting data to the study coordinators. Unlike most studies conducted on the subject in the past this study asked the clinical pharmacists involved to report all medication errors occurring in the hospital, no just those that caused direct patient harm. A total of 779 medication errors were reported over the 2 week course of the study. That number corresponds to about one error reported per clinical pharmacist per day.
The study produced a “tree” of medication errors to help determine the cost associated with each type of error. The errors ranged from “error did not reach patient, patient was not contacted, patient medication was unchanged” to “error did reach patient, patient was harmed by error, patient had permanent harm from error, patient died as a result from error.” Each step of the medication error “tree” was positioned at a certain value from repercussions of the error ranging from $10 for a change in dosing or regimen to $100,000 or more for patient harm/death. The study points out that further research is needed on different patient settings (as this study was inpatient) to determine actual financial repercussions. The study ends with the thought that it is important to find cost-effective ways to reduce medication errors.
Since this study was only conducted at inpatient settings with clinical pharmacists who caught the errors do you think the hospitals without many clinical pharmacists have higher costs associated with each error? Do you think clinical pharmacists reduce costs to hospitals enough to make themselves cost-effective? Can you think of other ways to catch medication errors to reduce their cost burden?
Samp J, Touchette D, Marinac J, and Kuo G, et al. Economic Evaluation of the Impact of Medication Errors Reported by U.S. Clinical Pharmacists. The Journal of Human Pharmacology and Drug Therapy. 2013;34:350-357
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?
Byrd JC, Harrington B, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374:323-332