Relative bioavailability of diclofenac potassium from softgel capsule vs. powder for oral solution and immediate-release formulation

Diclofenac potassium is a type of NSAID that is used to treat mild to moderate pain.  The people who take this medication want it to act as fast as possible, so their pain will subside.  This study has determined which formulation, soft gel, powder for oral solution, or tablet, would provide the fastest results.

The softgel is a newer formulation, combining the benefits of a tablet form and an oral solution.  It gives the medication as a solution in a solid dosage form.  The investigators wanted to see if this would effectively treat pain as quickly as the other two formations.

The patients were given one of the three dosage forms in a 50 mg strength.  They fasted for 10 hours before receiving the dose as well as for 4 hours after receiving the dose. Each subject had to give 17 blood samples over the course of 24 hours.

The study came to a few conclusions.  They determined that taking the oral solution formulation led to the highest mean peak plasma concentrations of the drug.  The amount of time that it took for the softgel formulation to reach its maximum effect was 0.5 hours, which was right between the oral solution (0.25 hours) and the tablet (0.75 hours).  Overall, the study concluded that the effectiveness of the softgel formulation of diclofenac potassium was comparable to that of the oral solution and tablet.  Patient compliance was increased when they had the opportunity to take the softgel.

 

Link to article

Bende, G., Biswal, S., Bhad, P., Chen, Y., Salunke, A., Winter, S., Wagner, R. and Sunkara, G. Relative bioavailability of diclofenac potassium from softgel capsule versus powder for oral solution and immediate-release tablet formulation. Clinical Pharmacology in Drug Development, 2016; 5: 76–82.

The Obesity Paradox in Type 2 Diabetes Mellitus: Relationship of Body Mass Index to Prognosis: A Cohort Study

The study focused on the issue of type 2 diabetes and the relationship between body mass index. During the study 10,568 patients were followed for an average of 10 years. The study was a prospective cohort and showed very unique trends. It showed that being overweight was associated with a lower mortality and obese patients had similar to that of a normal weight individual. It should be noted that these individuals were all diagnosed with type 2 diabetes. The study found that patients with type 2 diabetes who were overweight or obese were more likely to be hospitalized for cardiovascular reasons. I think it is interesting that those who are considered overweight have a lower mortality and is something that further research could expand upon.

As pharmacists I believe we are on the front lines of treating and identifying patients with type 2 diabetes. While pharmacists cannot prescribe diabetic medications they are often very knowledgeable on how to treat type 2 diabetes and the necessary lifestyle changes that need to be made. They also know the many health issues that often accompany type 2 diabetes. I think shows that diabetes is a spreading epidemic and needs to be confronted head on. Through collaborative care agreements patients would be better to able manage their diabetes since the pharmacist can adjust dosing of diabetic medications that best fit the patients needs. Pharmacist are also great in helping those taking injectable insulin feel more comfortable taking the medication. Pharmacists are also the most accessible healthcare professional and can offer immediate information and help in the treatment of diabetes.

 

http://annals.org.pitt.idm.oclc.org/article.aspx?articleid=2288519

 

Costanzo P, Cleland JG, Pellicori P, Clark AL, Hepburn D, Kilpatrick ES, et al. The Obesity Paradox in Type 2 Diabetes Mellitus: Relationship of Body Mass Index to Prognosis: A Cohort Study. Ann Intern Med. 2015;162:610-618. doi:10.7326/M14-1551

Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation

Considering how accessible pharmacists are and how well suited they are to interact with patients obtaining smoking cessation medications, pharmacists can be instrumental in delivering programs to patients and hopefully improve quit rates for smokers. This study explored the idea of utilizing a pharmacist team (a licensed clinical pharmacist and APPE students) in order to deliver a smoking cessation program face-to-face. The researchers compared outcomes from this approach with that of a method that involved brief telephone assistance to patients aiming to quit smoking. Outcomes were measured through the 7-day point prevalence quit rates, Fagerstrom Test for Nicotine Dependence scale, Perceived Stress Scale, and Center for Epidemiological Studies Short Depression Scale, as well as questionnaires regarding self-efficacy, motivation to quit smoking, and withdrawal symptoms. Biological measures of smoking, including cotinine levels, were also assessed. In addition to the two interventions, participants had a choice to receive either bupropion IR (Zyban®) tablets or nicotine patches.

The group receiving face-to-face treatment from the pharmacist team had a quit rate of 28% confirmed by the 7-day point prevalence and cotinine levels, while the standard care group receiving phone calls had a quit rate of 11.8%. Pharmacist-delivered face-to-face care seems to be beneficial in improving outcomes for those wanting to quit smoking. Perhaps collaborative practice agreements that allow pharmacists to prescribe smoking cessation medications can be developed to help improve quit rates. Pharmacists can be uniquely suited to this approach as they are so accessible and can help patients through all the aspects of taking smoking cessation medications– dispensing, counseling, and monitoring for efficacy, safety, and adherence.

 

Dent LA, Harris KJ, Noonan CW. Randomized trial assessing the effectiveness of a pharmacist-delivered program for smoking cessation. Ann Pharmacother. 2009; 43:193-201.

Nonpharmacologic Versus Pharmacologic Treatment of Adult Patients With Major Depressive Disorder: A Clinical Practice Guideline From the American College of Physicians

This study analyzed nonpharmacological versus pharmacologic treatment of adults with major depressive disorder. More specifically the study compared how treatments such as acupuncture, exercise, yoga, St.John’s wort etc.. worked compared to that of second generation antidepressants. Depressive disorders are a growing concern in the health community since it affects a broad range of patients. In recent years more has been done to try to educate others on depression and possible treatments. The study was done by collecting randomized controlled trials through the years of 1990 through September 2015. The study utilized several databases to find appropriate studies that fit into the desired criteria. After comparing multiple studies, the data concluded that clinicians should choose between cognitive behavioral therapy or second generation antidepressants. The major point was made that the therapy should be picked based on the patient’s lifestyle, desires, and needs.

 

After reading the study and the conclusion of the data I found it refreshing that there are ways to manage Major Depressive Disorder without the use of medications. While as pharmacist our whole business is drugs, but this doesn’t mean we push unnecessary drugs onto our patients. As pharmacists we are obligated to provide the best possible information to patients in order to help them lead healthier lives. I think the big take away point it which therapy is more beneficial and which therapy is a patient more likely to stick with. If a patient is often considered with the possible side effects of antidepressants and doesn’t like the idea of taking a medication. Then if cognitive behavioral therapy has been shown to replicate the same outcomes as a medication then that would be the best course of action for them since they are more likely to stick with it. Overall, I think it’s important to remember that there are other options for certain disease states that require life style changes and may offer the same benefits as a medication.

 

http://annals.org.pitt.idm.oclc.org/article.aspx?articleid=2490527

 

Qaseem A, Barry MJ, Kansagara D, for the Clinical Guidelines Committee of the American College of Physicians. Nonpharmacologic Versus Pharmacologic Treatment of Adult Patients With Major Depressive Disorder: A Clinical Practice

Unfettered Access to Reliable Contraception: Pharmacist Prescription Derails a Definitive Solution

In this article, the author describes the importance of access to birth control and other forms of contraceptives. In the article it makes the argument that often women are bared from obtaining birth control due to the need of prescription or the cost of the medication itself. It talks about how having birth control over the counter would help thousands have better access to birth control. They also argue that monitoring and screening for birth control can be done by the patient alone. It argues that while there is a risk for thrombosis, that risk is relatively low and should not be of concern for women. It also talked about how as study was done that showed women are able to accurately self-screen their own birth control.  The article only referenced one study that showed this which does not confirm this statement for me personally. It then describes how pharmacists in Oregon and California are able to prescribe and dispense contraceptive. It talked about how this was praised as a step in the right direction but the article criticizes the notion stating it was replacing one barrier with another one.

 

While I found the article interesting, and it offered a new perspective I highly disagree with most of the statements made. To begin with I think it is necessary the patients be counseled on birth control and possible side effects they may experience. Also, if a patient could simply purchase birth control over-the-counter there would be no indication in their profile at a pharmacy that indicates they were taking birth control. This creates a risk of pharmacists not being able to properly notify patients that certain medications such as antibiotics, anticonvulsants, mood stabilizers, and antipsychotics decrease the effectiveness of birth control. Which is important information a patient should be alerted to, since their chances of becoming pregnant would increase. The other statement made in the article that having a pharmacist prescribe adds another barrier is another point in which I disagree with. Pharmacists are the most accessible health care professional. Most people live within a few miles of a pharmacy. Meanwhile getting an appointment with your doctor may take weeks or months. Pharmacists can provide direct care for things like birth control in a faster more efficient matter. The article was written by a practicing medical doctor and while I think the authors perspective is important, I think it further shows how many doctors are still uniformed about the benefits that pharmacist can provide.

 

http://annals.org.pitt.idm.oclc.org/article.aspx?articleid=2498494

 

Lawrence HC. Unfettered Access to Reliable Contraception: Pharmacist Prescription Derails a Definitive Solution. Ann Intern Med. [Epub ahead of print 1 March 2016] doi:10.7326/M15-3003

FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder

Flibanserin is a medication for women experiencing Hypoactive Sexual Desire Disorder or HSDD. After rejecting the medication twice, the FDA finally decided to approve this medication. In the New England Journal of Medicine, the reasons for initial rejection and ultimately the approval of Flibanserin.

After hearing testimonies of the emotional distress caused by the disorder, researchers determined many patients could see a benefit from the medication. In the first two phase 3 trials, the medication was rejected, because women did not experience daily increase in sexual desire, although sexual events were more satisfying. The FDA then reevaluated the medication based on the side effects. Flibanserin may cause hypotension, CNS depression, and syncope. These adverse effects may be worsened in combination with alcohol. The FDA stood by this decision based on the stance that safety versus efficacy was a primary concern.

Many women felt that the FDA’s decision to do so was sexist, considering the numerous male sexual dysfunction medications. The FDA defended their rejection of Flibanserin, but decided to reevaluate new clinical trial data.They ultimately determined that although there was not significant treatment effect and the safety profile was somewhat concerning, there was an unmet need for this type of drug for women. 10% of patients saw a clinically meaningful improvement. A REMS requirement was added to the medication based on the safety profile.

I support the approval of this medication by the FDA, because even if only some women saw a meaningful improvement, the medication treats a condition in women that is currently untreated for most. The potential adverse effects are concerning but adding the REMS requirement and ensuring patients are educated on the therapeutic effects and averse effects eliminates some of that concern. I hope to see the development of future medications like Flibanserin that may better treat HSDD.

N Engl J Med. 2016: 374: 101-104.

http://www.nejm.org/doi/full/10.1056/NEJMp1513686

RxPATROL: A Web-based tool for combating pharmacy theft

Pharmacists are not only health care providers, but also gateway keepers to prevention of drug abuse. In some isntances, these cannot be helped when another party has malicious intent. Some of this intent results in pharmacy products becoming a supply for the black market. Within the products, controlled substances are most desired. In a study performed by a Risk Management & Health Policy group, theft data was gathered between 2005 and 2006. Points of data that were collected were incident type, date, and location; type of weapon involved; point of entry; and the pharmacies security features. Although this features security breaches, fraud was 46.4% of the total incidents that occurd, followed by forgery at 22.7%

Most of this occurred in the north eastern coast of the United States, near the Ohio-Kentucky border. All of this is a threat to the controlled substance supply of pharmacies in addition to the wrong hands it can enter through the black market. Communities perform these studies in order to better their future security.

What suggestions would you make in order to prevent medication from leaving the pharmacy with wrongful intents? Are there ideas that you have viewed from other pharmacies that were found to be effective?

Smith M, Graham J, Steffey A. RxPATROL: a web-based tool for combating pharmacy theft. J Am Pharm Assoc. 2009;49(5):599-603.

http://www.japha.org/article/S1544-3191(15)31048-7/fulltext

Needle-free Vaccines: Inactivated poliovirus type 2 vaccine delivered to rat skin via high density microprojection array elicits potent neutralising antibody responses

This study conducted by Muller and colleagues tested a needle-free vaccination delivery system on rats. The 4 mm x 4 mm patches were coated with a modified inactivated polio vaccine (IPV) and applied to the rat’s ear for 2 minutes. Each nanopatch is covered in 10,000 microprojections per square cm which deliver the vaccine 230 mcm under the skin. In previous studies, this novel method of delivery was shown to have a dose-sparing effect, meaning that a lower dose (approximately 1/40th the standard dose) was needed to elicit an effect compared to the traditional method. Equivalent doses of the vaccine, adjusted for the patches’ dose-sparing effect, were administered via nanopatch and IM injection. 100% of rats receiving the nanopatch exhibited positive antibody titres, compared to 20% of IM administrations.

Poliovirus is close to eradication, but still persists in Afghanistan and Pakistan. The vaccine exists in IPV and OPV (oral polio vaccine). IPV is more effective than OPV and only requires a single administration to provide the patient with immunity. The WHO faces several barriers to complete eradication due to the higher cost, chronic shortages, and storage/refrigeration requirements associated with IPV. Additionally, there is also a constant need of health professionals to deliver the vaccines in both countries. Because the nanopatch requires much smaller dose of vaccine for efficacy, this method is a promising way to more efficiently use global vaccine inventory. It also can be administered by less trained healthcare workers and does not require refrigeration. The nanopatch is a very promising tool to be used in the eradication of polio, and hopefully other diseases with more research.

What can the widespread use of this technology mean for the role of pharmacists in immunization campaigns? What other applications does the nanopatch have?

Scientific Reports, 2016, article number 22094.

Use of Selective Serotonin Reuptake Inhibitors during Pregnancy and Risk of Autism

Autism and its causes have been a heavily discussed issue.  This study specifically concerns the issue of the use of antidepressants during pregnancy and increased risk of autism spectrum disorders.  The study was conducted in Denmark and looked at live births from 1996 to 2005.  It looked at the use of SSRIs by the mother before and during pregnancy, autism spectrum disorders that were diagnosed and any other potential confounders.

The results of the study showed that there was no increased risk of autism spectrum disorders associated with use of SSRIs during pregnancy when compared to no SSRI use both before and during pregnancy.  While no significant association could be found, based on the upper boundary of the confidence interval relative risk of up to 1.61 could exist.  Therefore, the study concluded that more research had to be conducted to determine a conclusive answer.

I found this article interesting because of how much attention is being paid to autism and its potential causes.  I think it is extremely important to always do your research before making a claim or even sharing an article on Facebook.  So many people are willing to accept inaccurate information, especially if its explains something in their life that was previously unexplainable.

Hviid A, Melbye M, and Pasternak B. Use of Selective Serotonin Reuptake Inhibitors during Pregnancy and Risk of Autism. N Engl J Med. 2013;369(25): 2406-415.

http://www.nejm.org/doi/full/10.1056/NEJMoa1301449

How to Get Better Care with Lower Costs? See the Person, Not the Patient

This article discusses the importance of interacting with individuals as “people” not “patients” in order to provide a more all-inclusive type of care. This is especially important for older adults, who experience chronic health problems, functional limitations, physical challenges, and a deeper reliance on social support. Programs such as disease state management fail to recognize a person as a whole, with many other factors affecting their health and outcomes than just one specific disease itself.

The process of a person-centered care program means putting people in charge of their own health. It involves taking time to identify their personal needs, preferences, and values, consulting familial support if needed. When this information is combined with a health and functioning assessment, the person is able to shape their own personal goals rather than those based simply on medically-defined clinical outcomes. This process allows for the development of a care plan and implementation strategy individual for each person. By allowing each person to identify their own personal goals, and providing the needed support for it to happen, they will be much more motivated and successful in striving for those goals. This process has been developed with and supported by the American Geriatrics Society (AGS).

Three critical indicators of quality person-centered care for older adults are high functional quality of life with minimal intervention, healthcare providers acting in an efficient, convenient manner, and ability to easily navigate the care system as needed. The degree or extent of each of these indicators will vary for each person based on individual functional abilities, family support, and more.

There are several models that embrace this paradigm. They have been able to demonstrate that there is an opportunity for better care for high-need older adults at lower costs. These cost savings may not seem favorable initially when considered on a short-term small scale. This is the case with remote mail-order pharmacies for prescription refills rather than direct pharmacy interaction. However, Washington University’s care management program under the CMS Medicare Coordinated Care Demonstration Pilot is working on proving the long-term benefit of face-to-face interaction over mail-order pharmacy experience for individuals in the older adult population. Considering the points made in this article and the person-centered care approach that is outlined, do you think the emphasis we are seeing currently in mail-order pharmacy for many Medicare patients will be short-lived

Westphal, E., Alkema, G., Seidel, R., Chernof, B. How to get better care with lower costs? See the person, not the patient. J Am Geriatr Soc. 2016; 64:19-21. Doi: 10.1111/jgs.13867