The Efficacy of High-Dose vs. Standard-Dose Influenza Vaccinations for Older Adults

Older adults are known to suffer from more severe complications caused by the flu. 90% of deaths due to influenza are experienced by adults aged 65 and older. In 2009, the FDA licensed the high-dose influenza vaccination with 4 times more influenza haemagglutinin than the standard-dose. It was passed according to accelerated approval regulations. However, more research needs to be conducted to gather additional data beyond what was done prior to the high-dose vaccination’s approval to assess the effectiveness of the high-dose.

This article discusses a retrospective cohort analysis that studies the effectiveness of the high-dose versus the standard-dose influenza vaccinations in adults aged 65 and older. Influenza vaccination and infection rates were gathered from the US Medicare Program. The participants were thus enrolled in Medicare and had a Healthcare Common Procedure Coding System or Current Procedural Terminology code for either the high-dose or low-dose influenza vaccines between August 2012 and January 2013. The vaccinations were received in community pharmacy settings. If a participant had influenza before receiving the vaccination or received both the high-dose and standard-dose, he or she was excluded from the study.

Of the 12.5 million Medicare beneficiaries received influenza vaccinations within the set time frame, 19% received high-dose vaccinations and 81% received standard-dose vaccinations. The participants were said to be similar in age and medical condition. The high-dose vaccination was more effective in participants between the ages of 65 to 85 years old. There was a 22% reduction in influenza diagnosis in the group that received the high-dose vaccine. The high-dose vaccine was also more effective in preventing hospital and community setting influenza-related outcomes.

 

 

Lancet Infect Dis. 2015; 15(3): 293-300.

 

Because pharmacists have recently been given the responsibility of providing immunizations, the next step is to ensure that the most effective vaccines are being distributed to the population. At my Community Health site, almost all the older adults tell me that they have received their ‘flu shot’ at their community pharmacy. The results found in this study include evidence that can potentially lead to preventing the flu in these older adults who now come to the pharmacy for their influenza vaccination. Do you agree that pharmacists’ roles go beyond striving for positive health outcomes from medications to now including positive health outcomes from vaccinations?

Alcohol Consumption and Its Effect on Cardiovascular Diseases, Alcohol-Related Cancers, Injury, Admission to the Hospital, and Mortality

Alcohol consumption obviously has an effect on one’s health. However, that effect is determined by what a person drinks and the person’s drinking pattern. This article discusses information found in the Prospective Urban Rural Epidemiological (PURE) study. The PURE study was used to seek out a relationship between alcohol consumption, cardiovascular disease, cancer, injury, admission to the hospital, and mortality.

The PURE study included participants between 35 and 70 years of age from 12 different countries. The participating countries were grouped according to the World Bank classification. High income and upper-middle income countries were grouped together and low income and lower-middle income countries together. Participants were excluded if they were from a country in which 95% of the population did not consume alcohol due to the possibility of interference from religious beliefs. 114, 970 of the participants were included in the statistical analysis based on having a baseline history of heart disease, stroke, and cancer.

The participants were asked to report their alcohol intake at baseline along with types of alcohol consumes, number of drinks, and frequency of drinks. “Never drinking” fell under the category of “abstinence.” “Formally drinking” fell under the category of “ceased alcohol consumption for 1 year or more.” Intake was recorded based on how many drinks a person consumed per week and was then categorized as low, moderate, or high. The outcomes analyzed were mortality, cardiovascular disease, alcohol-related cancer, injury, and admission to the hospital. Cardiovascular diseases included myocardial infarctions, strokes, and other incidents. Cancers known to be linked to alcohol consumption and were included were mouth, esophagus, stomach, liver, as well as others.

65% of the participants were never drinkers, 4% were former drinkers, and 31% were current drinkers. 72% of the current drinkers has low intake and 17% had moderate alcohol intake. Male current drinkers had higher blood pressure than male never drinkers. The frequency of drinking varied according to geographical location and income classification. In all areas, drinking was more commonly seen by men. In the follow-up of the study, of the 31% of drinkers, a positive relationship was seen with alcohol-related cancers and injury. Yet, the drinkers saw reduced myocardial infarction occurrence. High intake was seen to increase mortality. Differences in risk were seen across the board according to income classification. The article concludes that different health results are seen in drinkers according to their type of alcohol consumption (what they drink, how much, how often, etc.) as well as income classification, which was confirmed by the results.

 

The Lancet. 2015; 386(10007): 1945-54.

 

Pharmacists play a huge role in influencing lifestyle modifications in patients. This article provides evidence of a relationship between alcohol consumption and health, although that relationship can sometimes be tricky to identify. This type of research can have an impact on those patients already at risk for cardiovascular diseases, certain cancers, etc. who also drink and can hopefully serve as evidence to support their pharmacists who are counseling them to quit drinking. I know that drinking is already known to have negative effects on health, however I feel that it is important to continue performing research in this field to continue finding evidence to help influence patients in which their drinking can do much damage.

Use of Sildenafil in term and premature infants for pulmonary hypertension

Sildenafil is more commonly being used to treat pulmonary hypertension in term and premature infants. However, the FDA has only approved this use in adults. Controlled trials that studied the efficacy of sildenafil use in term and premature infants with hypertension as well as premature infants at risk for developing bronchopulmonary dysplasia (BPD) were reviewed in a review article.

The researchers from the review article designed their study to answer two main questions: Does sildenafil use improve in-hospital mortality in term infants with pulmonary hypertension or premature infants with BPD-associated pulmonary hypertension compared with placebo or inhaled nitric oxide? Does sildenafil use in premature infants prevent or treat BPD as defined by oxygen requirement at 36 weeks’ corrected gestational age (GA)? Primary studies were found using a literature search of MEDLINE, PubMed, EMBASE, Cochrane Library, and International Pharmaceutical Abstracts databases. Studies with a focus on these questions were selected if they included term or near-term infants with pulmonary hypertension and previous exposure to sildenafil or premature infants at risk for BPD or who had BPD-associate pulmonary hypertension. Also, studies that compared efficacy of sildenafil to a placebo or inhaled nitric oxide, but not other therapies, were analyzed. The selected studies were reviewed by two people who assessed the quality of the study, research design, analysis, and results.

Of 4 articles and 1abstract reviewed, 3 articles and the abstract looked at the use of sildenafil for term or near-term infants. The other article studied sildenafil use in premature infants. Sildenafil was dosed in a range of 1mg/kg every 8 hours to 3mg/kg every 6 hours in all the trials. The results of all the trials recorded oxygen index and death. Oxygen index was seen to improve 6-8 hours after sildenafil administration whereas little to no improvement was seen after placebo administration. Combing participants from 3 of the trials, 3 of 51 infants taking sildenafil died before hospital discharge. In contrast, 16 of 37 infants receiving placebo died. In conclusion, term infants exposed to sildenafil had a relatively low mortality risk. However, although sildenafil improved oxygen index in the trials, there are still no guidelines available for dosing sildenafil in term and premature infants.

 

Clin Ther. 2015;37(11):2598-2607.

Link to Article

 

This article made me think back to pediatric calculations with Dr. Howrie in PDA. Although this review article finds evidence to suggest that sildenafil is effective and potentially safe in infants, its use should still be utilized carefully. Dosing must dramatically be reduced for infants who have yet to develop complete organ function, especially for premature infants. While reading this article, a question about dosage form in infants came to my mind. Do you think IV is the best dosage form compared to oral or inhaled therapies to use to treat infants nfants because of their inadequate organ function?

The Effect of Anesthesia on Neurodevelopment in Infants

Researchers set out to see if anesthesia has an effect on children’s neurodevelopment. The study was performed as an observer-blind, randomized-controlled trial. It was an international study and conducted at 28 hospitals both in the U.S. and outside.

The researchers wanted to analyze toddlers at the age of 2 who had previously had anesthesia. Thus, they chose to include infants up to 60 weeks postmenstrual age (gestational age plus chronological age). Infants were chosen from operating room schedules or at preadmission clinics. The babies had to be scheduled for unilateral or bilateral hernia repair, and strict exclusion criteria was set. After recruitment, 722 infants were set to participate in the trial.

The infants were split into two groups: the awake-regional group and the general anesthesia group. For the awake-regional group, anesthetic techniques used included: awake-spinal anesthetic, awake-caudal anesthetic, and combined spinal-caudal anesthetic. Isobaric bupivacaine was the drug used unless it was unavailable at a particular site. Back-up plans were put into place incase the set dose of bupivacaine was insufficient to settle the baby or keep the baby asleep during the operation. The general anesthesia group was given sevoflurane for approximately an hour.

Of the 722 infants recruited, 587 were discussed in the results. 292 infants from the awake-regional group and 295 from the general anesthesia group took part in a cognitive scale. Cognitive, language, motor, social-emotional, and adaptive behavior scores were recorded. Results showed that both groups of infants scored similarly for cognitive ability. The researchers also found that both group scored nearly the same for motor, language, and adaptive behavior scores. At 2 years, small numbers of the infants who participated in the study were diagnosed with cerebral palsy, had a hearing or visual impairment, or had a specific behavioral diagnoses (i.e. autism). However, the researchers felt no comparative analysis could be made due to the low appearance. Because of the similar scores in both groups, the study determined that 1 hour of general anesthesia shows no evidence of increased risk of poor neurodevelopment at age 2.

 

The Lancet. 2016;387(10015);239-50.
Link to Article

 

I feel that this study is of extreme importance. Unfortunately, infants face situations where they need anesthesia. Because of their still-developing brain and other organs, it seems likely that anesthesia could affect their development. Although this study found no evidence of an increased risk of neurodevelopmental damage post-anesthesia exposure, I am not yet convinced. Besides the issue of neurodevelopmental damage, I am concerned about dosing anesthesia in infants. If we barely know how to dose anesthesia for adults, how can we be sure it is even safe for babies?

Incorporating Peer Teaching by Physical Therapy Students into Pharmacy School Curriculum

This study analyzed the effect of interprofessional peer-teaching being added to pharmacy school curriculums. In this study, second year physical therapy graduate program students taught third year pharmacy students about 3 ambulatory devices- canes, crutches, and walkers. This took place at the University of Alberta in Canada.

The course was designed as a laboratory activity. The physical therapy and pharmacy faculties decided to incorporate this activity into the pharmacy students’ bone and joint course. The goal of the activity was to teach the pharmacy students how to properly select and fit canes, crutches, and walkers and also how to educate patients on using these devices safely. As for the physical therapy students, this peer teaching opportunity was added to their curriculum to allow for practicing professional behavior and interaction with other health professionals.

The first year that the session was held, a group of 10-12 pharmacy students were taught by either a physical therapy or an occupational therapy student. All the material covered was never taught to the pharmacy students before in their curriculum. The physical therapy or occupational therapy students volunteered to teach and underwent a training session to ensure the materials were covered the same way in different settings. The classes were laid out as follows: 20 minutes for demonstration; 20 minutes for instruction; 20 minutes for practice on canes, crutches, and walkers; and 15 minutes for pre- and post-examinations.

The second year of the study was structured a little differently. The peer learning experience became a required part of the physical therapy students’ curriculum. This change was so that more physical therapy students would get to have this experience. The groups of pharmacy students were downsized to 3-4 students, and the groups were taught by 2-3 physical therapy students. The physical therapy students developed a teaching plan and handout before the lab activity which was reviewed by one of the course instructors. The instructors decided on one teaching plan, and all the physical therapy students used that one to teach so that the content was standardized.

110 pharmacy students received instruction from the physical therapy students via the student peer learning group method. Another 110 students were taught be instructors for comparison purposes. The success of the study was determined based off the students’ post-activity examination scores. The results showed that the pharmacy students answered all questions about referrals to physical therapists correctly. However, questions about how to use and size a cane were often answered incorrectly. 8.2% of students in the peer learning group received perfect post-test scores. 99% of pharmacy students answered that pharmacists need to be involved in helping patients with canes, crutches, and walkers. In regards to talking to patients about ambulatory devices, the pharmacy students went from an average confidence level of 1.8/7 to 3.5/7 after the activity.

AJPE. 2015;79(10).

Link to Article

 

I feel that incorporating interprofessional peer teaching into different healthcare professional curricula can influence how these professionals interact after graduation and beyond. As of now, the only interprofessional interaction we have had was the interprofessional forum last semester (unless some of us had interprofessional encounters at our Community Health sites). By having different healthcare professional students teach others, this helps develop respect amongst the different professions. I think it would be pretty cool if we had the opportunity to teach as well. For example, have P3 or P4 pharmacy students lead an activity to nursing students about medication education prior to patient discharge.

Palliative Care Consultations Effect on Health Care Costs

This review article discusses a study that looked at how palliative care consultations can reduce costs for advanced cancer patients and other diseases. The researchers analyzed the cost-savings of patients with cancer located at six different hospitals.

The results showed that those who received palliative care consultations went on to have lower health costs. Patients who received the consultations had health costs 20% less than those who did not. Furthermore, patients with multiple chronic conditions saved an average of 32%. The earlier the palliative care consultations took place, the more effect this had on reducing health costs. Besides cost-savings, patients appeared to benefit in other ways. The consultations often influenced patients to decline painful end-of-life treatments and get them out of the hospital sooner.

This study is important because patients with multiple chronic conditions currently pay a huge chunk of the total health care spending. In fact, two-thirds of Medicare beneficiaries have comorbidities, according to the article. It is anticipated that patients in these categories will be spending even more within the next few years. The lead author of the study, Sean Morrison, MD, made a statement that the team’s research highlights the relationship between health care cost and the number of comorbidities.

Going along with how the palliative care consultations benefitted patients in other ways than just financially, it seems that using harsh treatment is not even what the patients want. This actually leads to worse quality of life which is why the researchers feel that palliative care should be more easily accessible.

 

JCP. 2016; 1.

Link to Article

 

I liked this article because palliative care is a subject with which I have just became familiar. Pharmacists play a crucial role on the palliative care consultation team. Sometimes pharmacists actually have to make the decision to NOT use drugs. Pharmacists have the best knowledge to make that judgement. However, much of a pharmacist’s work revolves around feeding off what the patients wants. Yet, in palliative care situations, it may not be possible to communicate with the patient. Because of this, I feel that it would take a lot of time and experience to become an expert in the field of palliative care.

Genotype Screening for Dosing Nortriptyline and Venlafaxine

This journal article discusses a study currently in progress. It is designed to screen elderly patients for the CYP2D6 gene to determine the dosage of two depression medications, nortriptyline and venlafaxine. Furthermore, the study will determine if screening is cost-effective as well.

According to the journal article, the randomized controlled trial is underway in the Netherlands at several different psychiatry and geriatric mental health care institutions. The participants who are being recruited are 60 years or older and diagnosed with depression. There will be two parts to the study. The first part, which is occurring now, involves asking patients who are starting either of the medications in question for a genotype via a finger prick. If the patients have an appropriate genotype, they moved on to the second part of the study which is the actual trial. Several outcomes are being recorded during the study, according to the article. The primary outcome is the time needed to reach certain blood levels of either drug. Also, adverse drug reactions, quality of life, productivity, and cost of health care use will also be monitored and measured. Depression has to be monitored carefully to distinguish between side effects of depression versus from the medications.

The researchers say that the results of this study will assess whether genotype test can achieve the most effective dose faster while also avoiding adverse drug reactions. Usually, it takes approximately 4 weeks for a patient to reach desired drug levels. However, the researchers estimated this time can be cut in half if prescribers have access to the patients’ genotype information. However, limitations are present. Firstly, the genotype information gets in the hands of the prescribers after therapy has begun. This can be overcome due to the fact that prescribers tend to initiate a low starting dose. Secondly, the group of participants are very different. It would be difficult to limit the inclusion principles to depression patients without other physical or psychiatric disorders. In spite of this, the mixed participant group better represents real-life practice situations. The researchers feel the study will be strong because the participants are randomly allocated and significant differences in response have a better chance of being detected.

Although this trial will focus on CYP2D6’s ability to metabolize nortriptyline and venlafaxine, there are many other drugs that are metabolized by this enzyme. The article states that if this trial is successful, it could lead into regular genotype screening when initiating drug therapy.

 

Trials. 2015;16:37.

Link to Article

 

We have discussed pharmacogenetics several times thus far in our short pharmacy school careers. Next week, we will even be offered the opportunity to have our own genomes sequenced. It seems that in the next few years that genotype screening will be a regular occurrence for all patients. It already seems to be finding its way into practice for drugs like warfarin (Coumadin®). Yet, before this can happen for more drugs, trials like the one discussed in this article need to be performed and find positive results to support the effectiveness of this prescribing and dosing procedure.

This article caught my attention because the researchers began looking for participants in 2013 and were expected to search until spring of this year. I think this ties in well with what we are doing in our Drug Development course. In order to get the most accurate and diverse results, researchers must design trials that encompass different types of patients over the long term. But, what do you guys think? Do you think 3 years was a little too long to extend this trial? Why did the researchers not just publish the results from the participants during two years of the study instead?

Investigation of rivastigmine’s ability to manage gait in patients with Parkinson’s Disease

This article discussed a phase 2 trial that was conducted that studied rivastigmine’s ability to stabilize gait in individuals who have Parkinson’s disease. Before explaining the components and results of the trial, the article explained that Parkinson’s disease leads to gait variability (i.e. reductions in step length, loss of gait automaticity, etc.). Consequently, individuals with Parkinson’s disease and have developed gait are at a higher risk of falls. According to the article, gait characteristics are attributed to a loss of cholinergic function. The researchers therefore determined an acetylcholinesterase inhibitor would prevent falls by improving gait in patients with Parkinson’s disease.

The trial was performed at a hospital in the UK. Participants included those with moderate Parkinson’s disease and were stable on some type of antiparkinsonian treatment for at least 2 weeks prior to the study. They also had to be capable of walking a set distance without assistance and to have experienced at least one fall in the previous year. Patients who had already taken an acetylcholinesterase inhibitor were excluded. The trial was a 32-week long randomized placebo-controlled, double-blind, parallel-arm study. A total of 130 patients were either given rivastigmine or a placebo capsule. Participants were initially dosed at 3mg per day and eventually reached a maximum daily dose of 12 mg. Gait, balance, cognition, and mood were compared pre- and post-trial. Records of falls were also kept throughout by the patients.

The article says there was significant improvement in gait speed and controlled leaning balance in the rivastigmine group. However, fall risk, fear of falling, cognition, mood, disease severity, and quality of life measures were similar between the two groups. 23 of 65 participants stopped taking rivastigmine due to experienced adverse events. However, many of these were concluded to have not been due to rivastigmine treatment. The study found that rivastigmine participants reported more vomiting.

A discussion to conclude the article states that phase 3 trials need to be carried out in order to conclude that rivastigmine should be used to prevent falls in patients with Parkinson’s disease. The study confirmed improvement of gait in participants taking rivastigmine. However, considering the drug did not improve cognitive function in the participants, further research needs to be conducted to study if the treatment has cognitive benefit on non-cognitive impaired patients.

 

 

The Lancet Neurology. 2016;0: 1-9.

http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(15)00389-0/fulltext

The point that was made in the closing discussion about rivastigmine’s potential for improved cognitive function in individuals without decreased cognitive function was something that had come to mind when I read that the researchers were analyzing cognition in participants. If one already has adequate acetylcholine levels, can an acetylcholinesterase inhibitor really provide any benefit?