Tuesday, September 17, 2013

Background

To begin this blog, I wanted to give my readers some background on me and my interest in pharmacy as it pertains to women's health. My name is Alexis Ireland and I am currently a P3 at the University of Iowa College of Pharmacy. I have four children, ages 17, 5, 3, and 1. They always keep me busy!

I have always been fascinated with the female body and how it works. I am in awe of the thought that two tiny cells can come together and create human life. My first pharmaceutical passion was on fertility drugs. If the human body impressed me enough in its ability to make life, the fact that drugs can alter a person's body to change this ability was amazing to me. It is impressive that pharmacists have developed drugs that can help the heart beat right when it stops working, or drugs that can stop the production of cholesterol to lower the chances of a heart attack, or stop a runny nose during allergy season, but it is near incomprehensible that a drug can indirectly produce life.

There are not many pharmacists that focus solely on this topic. It is an emerging science, and there is not yet enough work to be done for a hospital or facility to have a pharmacist dedicated solely to this topic. For this reason, I began to look deeper to see if there was anything else related that I was interested in. Pregnancy was what brought me to my interest in fertility, so I began to study pregnancy. I am probably in the minority when I say that I loved being pregnant. At times it was uncomfortable, but the knowledge of what my body was accomplishing was enough to override any negative thoughts about the state in which my body was. Pregnancy is a very complicated topic when it comes to systemic drugs. The baby's and the mother's bodies are so intricately intertwined that it actually changes the structure and function of the mother's entire body. This is the only thing that can so drastically change the body's physical sense of meaning. It is incredible.

High risk OB was an area that caught my interest. There are certain medications that cannot be stopped during pregnancy for the sake of the mother's health, such as transplant medications and antiepileptics. If the mother would stop these medications, she would die, along with her baby. It is necessary to keep patients on these treatments but monitor them closely so that the baby is harmed in the least way possible. This is a very interesting concept in pharmacy. Which life is valued more, the mother's or the baby's? There is never an answer to that questions. Our job as health care professionals is to attempt to save both. 

The last area of interest I found that will be featured in this blog is medication during lactation. Breastfeeding is yet another unique change in the human body that cannot be replicated. The mother's body still has the purpose of taking care of the baby even after it has left the uterus. The production of milk is still not completely understood, and it is very difficult to test for the presence of drugs in the milk. Even after the presence of drug is found in the milk, it's "back to the drawing board" with the pharmacokinetics. How much of this chemical will get to the baby's circulation? How will it effect the baby? What do the other nutrients in the breast milk do to the stability of the chemical? Is it's mechanism different when it is suspended in breast milk than when it is in tablet form? These are all perplexing questions that would need to be answered in order to tell if medications are safe during breastfeeding. 

My favorite example is duloxetine (Cymbalta). Duloxetine is inactivated by the low pH of the stomach, so it is manufactured in a capsule that can withstand the hostile environment and pass into the intestines. In this higher pH, the capsule dissolves and the drug is released. It is then absorbed into the systemic circulation, where it can diffuse into the breast milk of a lactating woman. However, when the milk that contains the duloxetine reaches the stomach of a term infant with a mature digestive system, the drug is inactivated before it is able to be absorbed into the circulation. I am specific in describing the infant because a preterm neonate with an immature digestive tract houses a much higher stomach pH than other babies. It is not known if duloxetine tainted breast milk would be harmless in these infants. The topic is entertaining, however, there is not much data. It is hard to get test subjects for a study when the premise is, "We're not sure if this will harm your baby not." Most mothers will refuse. 

With these topics in mind, I began speaking with other pharmacists and doctors on their opinions on how a pharmacist would be able to help. Across the board, everyone agrees that having an expert on medications would be an excellent addition to the team. Unfortunately, life is not that easy. That are not any studies published on how a pharmacist would impact the clinic in this area. Research and studies need to be done to see how a pharmacist in the Women's Health Clinic would be able to reduce costs, reduce hospitalizations, improve patient safety and outcomes, and improve patient satisfactions. My goal is to conduct this study and become the first pharmacist dedicated clinically to an ambulatory care Women's Health Clinic. 

In this blog, I aim to educate myself as well as my readers on pharmacists that already practice at least part time in the areas stated above, any new and relevant research done on the topics listed above, and to analyze the material available to the general public on the world wide web. I hope that through this blog, I will become a more able pharmacist in this area, and my readers will be more properly and credibly educated on the topics of interest here.

Thank you for your time. Look forward to a blog in the next couple weeks on my research on human milk banks in North America and their policies on accepting milk from donor mothers who routinely take medications.
Alexis Ireland, PharmD Candidate 2014

Friday, June 28, 2013

Review of short term outcomes after in utero exposure to serotonin reuptake inhibitors

Short-Term Neonatal Outcome among Term Infants after in utero Exposure to Serotonin Reuptake Inhibitors
Neonatology 2013;104:65-70
Alexis Ireland, PharmD Candidate 2014

Background
·         Usage of antidepressant medications has increased in entire population, especially in pregnant women
·         SRI medications have been considered safe in pregnancy due to large therapeutic range and fewer side effects when compared to other antidepressants
·         Little research has been done on effect on fetus/neonate and extent of observation and follow-up required
·         Some risks found include premature delivery, low birth weight, meconium-stained amniotic fluid, low Apgar score, respiratory distress, pulmonary hypertension, hypoglycemia, convulsions, neonatal abstinence syndrome (central nervous system, gastrointestinal system, and autonomic nervous system), and NICU admission
·         Symptoms present in 28-30% of exposed infants in referenced studies
·         Intense monitoring of newborn deprives mother and baby of bonding time and may be unnecessary

Objectives
·         Evaluate short-term neonatal symptoms related to in utero exposure to SRI medications to determine level of monitoring and observation necessary due to symptom severity and duration

Study Design & Methods
·         Retrospective review of medical charts of term infants born to mothers who self-reported SRI use during pregnancy up to delivery
·         Matched control born at same gestational age and born closest in time to study infants
·         Sheba Medical Center in Israel from Jan 2007-Dec 2011
·         Infants taken to secondary-level care unit for 48 hours after birth
·         Nurses monitored vital signs, temperature, capillary glucose, NAS scores, and symptoms every 8 hours
·         Symptoms charted included convulsions, jitteriness, sleepiness, restlessness, tachycardia, bradycardia, tachypnea, cyanotic events, feeding difficulties, regurgitations, and vomiting
·         Significant symptoms included respiratory distress lasting longer than 6 hours, convulsions, cyanotic events, or fever 38°C as well as combination of two mild symptoms (sleepiness/restlessness, jitteriness, feeding difficulties)
·         Exclusion criteria: preterm infants, in utero exposure to psychiatric medications, B-blockers, alcohol, or illicit drugs
·         Maternal data collected: diseases (hypothyroidism, hypertension, gestational diabetes), GBS status, prolonged rupture of membranes, meconium-stained amniotic fluid, delivery mode, and type/dose SRI used
·         High dose: fluoxetine/paroxetine/citalopram dose 40 mg/day or higher; sertraline/fluvoxamine/ venlafaxine dose 150 mg/day or higher
·         Infant data collected: gestational age, birth weight, weight for gestational age, length, head circumference, gender, Apgar at 1 and 5, congenital malformations, respiratory distress syndrome, usage/duration of oxygen, antibiotic use, cardiac anomalies, hypoglycemia, length of stay
·         Same demographic and clinical data collected for control infants but vital signs and glucose monitoring was only as indicated by postnatal course

Statistical Analyses
·         Continuous variables were compared using analysis of variance
·         Categorical variables were compared using Pearson’s x2 test or Fisher’s exact test
·         P value of <0.05 considered significant
·         Analyses performed using SPSS version 15 software

Results
·         38,036 term infants born, 452 infants exposed to SRI in utero, 401 infants included in study group
·         More infants in study group were born to diabetic mothers (p=0.028), shorter in length (p=0.023), low Apgar score <7 at 1 minute (p=0.002), meconium-stained amniotic fluid (p<0.001), and respiratory distress syndrome (0.026)
·         After excluding respiratory distress syndrome, onset of symptoms was 29 hrs (5-48 hrs)

Symptom
Number
Percent
One symptom
165
41%
RDS
19
5%
Jitteriness
53
13%
Restlessness
33
8%
Feeding Difficulties
17
4%
Regurgitations
79
20%
Fever
2
0.5%
Short Cyanotic Event
3
0.75%
Convulsions
1
0.25%


Significant Symptom
Study
Control
One significant symptom
46 (11%)
10 (2.5%)
RDS longer than 6 hours
12 (3%)
7 (2%)
Convulsions
1 (0.25%)
1 (0.25%)
Short Cyanotic Events
3 (0.75%)
2 (0.5%)
Fever
2 (0.5%)
Not reported
Two mild symptoms
24 (6%)
Not reported
Three mild symptoms
4 (1%)
Not reported











·         Study group: NICU admissions due to low Apgar, malrotation, and exchange transfusion
·         Control group: NICU admissions due to respiratory distress, convulsions, and exchange transfusion
·         High-SRI dose: MSAF (p<0.001), low Apgar at 1 (p=0.007), regurgitation (p=0.043)
·         Comparison between subgroups of medications limited due to high variance of use

Author’s Conclusions
·         High rate of symptoms recorded could be due to close observation of infants (all minor clinical manifestations reported)
·         Most infants presented with mild symptoms, all with non-life-threatening symptoms, which could be monitored in rooming-in setting with subsequent admission to secondary-level care unit if warranted
·         Monitoring by parents or care staff should continue for 48 hours after birth
·         NICU admissions were not likely related to SRI exposure and were similar to admissions in the control group
·         Possible intrauterine fetal stress with SRI exposure depressing HPA axis leading to relaxation of anal sphincter and meconium excretion which results in meconium-stained amniotic fluid and low Apgar at 1 minute. No meconium aspiration noted in study or control group. Stress was mild because all Apgar’s were normal at 5 minutes.
·         Higher incidence of respiratory distress but similar use of oxygen at 6 hours when compared to controls. No NICU admissions due to respiratory distress.
·         Conclusion: Infants exposed to SRI in utero do not obligate monitoring involving separation from parents. Parents and clinical staff should be educated on signs to look for and follow-up regarding feeding difficulties and restlessness.

References
Kallen, B. Neonate characteristics after maternal use of antidepressants in late pregnancy. Arch Pediatr Adolesc Med 2004;158:312-316.
Koren G, Nordeng G. Antidepressant use during pregnancy: the benefit-risk ratio. Am J Obstet Gynecol 2012;207:157-163.
Kulin NA, Pastuszak A, et al. Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study. JAMA 1998;279:609-610.
Chambers CD, Johnson KA, et al. Birth outcomes in pregnant women taking fluoxetine. N Engl J Med 1996;335:1010-1015.
Oberlander TF, Warburton W, et al. Neonatal outcomes after prenatal exposure to selective serotonin reuptake inhibitor antidepressants and maternal depression using population-based linked health data. Arch Gen Psychiatry 2006;63:898-906.
Lund N, Pederson LH, Henriksen TB. Selective serotonin reuptake inhibitor exposure in utero and pregnancy outcomes. Arch Pediatr Adolesc Med 2009;163:949-954.
Levison-Castiel R, Merlob P, et al. Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants. Arch Pediatr Adolesc Med 2006;160:173-176.
Zeskind PS, Stephens LE. Maternal selective serotonin reuptake inhibitor use during pregnancy and newborn neurobehavior. Pediatrics 2004;113:368-375.
Moses-Kolko EL, Bogen D, et al. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA 2005;292:2372-2383.
Jordan AE, Jackson GL, et al. Serotonin reuptake inhibitor use in pregnancy and the neonatal behavioral syndrome. J Matern Fetal Neonatal Med 2008;21:745-751.
Stahl MM, Lindquist M, et al. Withdrawal reactions with selective serotonin re-uptake inhibitors as reported to the WHO system. Eur J Clin Pharmacol 1997;53:163-169.
Sie SD, Wennink JM, et al. Maternal use of SSRIs, SNRIs, and NaSAs: practical recommendations during pregnancy and lactation. Arch Dis Child Fetal Neonatal Ed 2012;97:F472-F476.
Pawluski JL, Brain UM, et al. Prenatal SSRI exposure alters neonatal corticosteroid binding globulin, infant cortisol levels, and emerging HPA function. Psychoneuroendocrinology 2012;37:1019-1028.

Wednesday, May 8, 2013

Example of noncredible website: NaturalNews.com


                Today’s blog is a follow up from last week. I was introduced to what I think is the worst article and natural website I have ever encountered. The original article is linked below. The website is called NaturalNews.com and the article is entitled “Alzheimer’s is really just ‘type-3’ diabetes, new research shows.”
                First, we will analyze the website using the tips I suggested in an earlier blog post on how to check the credibility of an internet site.  On the home page of the site, there is a recording, which is also linked below, talking about the man who runs NaturalNews and the website’s mission. I must say that I was extremely appalled by the allegations that he makes in this recording. However, I am going to evaluate the information without emotion because science is based on facts and evidence, not on opinions and emotions.
                NaturalNews is a website designed to offer people information on non-medicinal therapies and cures for different diseases as well as encouraging a natural, healthy lifestyle in general. Mike Adams is the editor of the website, and he claims that until eleven years ago, he was in very poor health but has since turned that all around and is completely healthy. He claims to be able to cure diabetes in 4 days, which we know in the medical field is impossible. He claims to be able to cure cancer with herbs and sunlight, which we also know to be impossible. The most crushing allegation that he makes in this post is about the Susan G. Komen foundation for breast cancer research. If someone had a cure for cancer, they would share it, right? No. He says that 99% of the money the Komen foundation raises is to conduct mammograms, which emit radiation and actually cause cancer in the women they screen, only causing them to be able to collect more money. This is a very painful statement. (Adams)
According to this man, the FDA is trying to ruin our health by passing safety bills, and the government is trying to take away health freedom by passing health care reforms.  Pasteurization and irradiation can kill people, and we shouldn’t do it, he claims. However, there are many harmful bacteria present in raw milk that cause diseases such as dysentery and cholera that are eliminated by pasteurization. (CDC) He claims to expose the true agenda of the USDA, FDA, DEA, and the government “which does not want you to be healthy.” This way, they can make money! He claims that medications and vaccinations are poison that the government gives us to shorten the longevity of our population because the elderly cost the government money and don’t pay taxes. However, the human life expectancy in the United States, when compared to third world countries that do not vaccinate and compared with the United States a hundred years ago, is much longer.  (Adams)
                His final statement exemplifies the incredibility of his site. “You don’t have to agree with 100% of what is posted, no one agrees 100% on everything.” (Adams) The problem is that everyone agrees 100% with truth – facts that are evidence based and can be proven and replicated. This statement shows that not all that he posts is true scientific fact. He posts subjective opinions, which contribute to the lowest strength recommendation that doctors use. Doctors rely on evidence and proof to treat their patients, not opinion.  (Andre)
                The next check for credibility also fails. The website is .com and there is no HONcode or URAC accreditation listed. There are incredible advertisements that overtake most of the page on each page of the site. When in an article, it’s hard to tell the advertisements from the content of the article because they are so prevalent. One of the ads is for making colloidal silver in your home, to ingest and treat all of your ailments. Colloidal silver was banned from OTC products in 1996 due to serious adverse effects from consumers taking it to treat certain conditions. Dietary supplements were still allowed, provided that no health claims were made for its use. (Barrett) I am not going to trust this site.
                Let’s move on to the article. The author is listed as well as the references. When I see references, I expect to see primary literature, which consists of studies that have proven information. The resources for this article are a hospital’s webpage and a news website. The news website was a mirror image of NaturalNews.com and was also summarizing the hospital webpage. The hospital webpage was summarizing the original study. So the article posted on NaturalNews.com could be considered a tertiary source, which is much less reliable than the original information. However, the article does seem to summarize the hospital’s webpage correctly.
                Of course, they follow this up with their own recommendations which are not validated by references at all, and are complete advertisements as they link to other pages on the website and products that are advertised on the side of the page. The second part of the article is entitled “Eating more healthy saturated fats like coconut oil can help prevent, cure Alzheimer’s.” The original study says nothing about this and absolutely does not validate this statement. This part of the article is the author’s opinion. If it is backed up by scientific evidence, he did not cite is reference and therefore cannot be checked by readers.
                This is a perfect example of a website that cannot be trusted. Although some of the information is true and credible, is too much to ask to have to sort through everything to find what is right and what is not. Please refer to the previous blog post about credible sources for information, including NaturalStandard.com which provides true, complete information about natural products.
Alexis Ireland, PharmD Candidate 2014

References
Adams, Mike. “Welcome to NaturalNews!” NaturalNews. Mp3.
Andre, FE, et. al. “Vaccination greatly reduces disease, disability, death and inequity worldwide.” Bulletin of the World Health Organization. 86:2. Feb 2008.
Barrett, Stephen MD. “Colloidal Silver: Risk Without Benefit.” Quackwatch. 17 Aug. 2005.
Benson, Jonathan. "Alzheimer's Is Really Just 'type-3' Diabetes, New Research Shows."NaturalNews.  6 Aug. 2012.
“Raw (Unpasteurized) Milk.” CDC. 25 Feb. 2013.

Friday, May 3, 2013

Natural and Herbal Products


                Today’s blog is going to focus on natural medicine. This is a topic that I find very important, but I don’t think that the general population is educated enough about it. I hear from many patients that they are taking something herbal for their memory, energy level, or fertility. Their rationalization is that it’s natural, so it can’t be bad for them. Arsenic is natural. Just because something is a natural product or herb doesn’t mean that it’s safe and good for you. This blog will go over how to get information on natural and herbal products that is credible, accurate, and complete.
                Natural products and herbs are not regulated by the FDA. This is what makes selecting a product so hard. You might notice that on the back of the box or bottle of a natural product, it states what it is intended to do. “Promotes heart health” or “increases energy” are common statements. However, each of these statements is always followed by an asterisk, which correlates to a statement near the bottom of the box in small print that says “These claims have not been substantiated by the FDA.” Companies that make natural products are allowed to state that their product “supports the structure and function of the body, but can’t claim to diagnose, treat, cure, or prevent any disease. Their manufacturing plants also aren’t regulated, so it’s hard to tell if they use good manufacturing processes or if they monitor how much of the natural product goes into each dosage form. Some companies choose to go through a process to gain certification from the USP Dietary Supplement Verification Program. This is voluntary, but it ensures the quality of the product. USP Verified products contain the ingredients listed on the label in the listed strength, do not contain levels of contaminants that could be harmful, and are made according to the FDA’s good manufacturing processes. These products have a stamp on them to show that they are quality. See the end of the blog for a sample stamp.
                The biggest issues with natural products are of quality, safety, and efficacy. The composition of the products can vary between different manufacturers, and even between different lots from the same manufacturer. It’s also hard to tell if what’s in the bottle is what it says it is. Contaminants are another concern. Are there pesticides, metals, or other organisms in the product? Side effects and interactions aren’t written on the bottle, and people seldom ask a pharmacist if it is safe to take with their medications. There aren’t many studies on these products, and use of these can sometimes delay important medical procedures.
                So where does one look for information on natural products? Usually it’s a family member, a friend, or Google. Getting information from a family member can be dangerous because they might not have all the important information about the product. Also, the things that were used routinely when grandma was younger but aren’t used anymore aren’t used for a reason. We found them unsafe, ineffective, or less effective than another treatment that is used now. Information coming from a friend is often going to be one-sided and biased, because your friend has an opinion on the product. Whether he/she thinks it’s a great product or an awful product, it’s based on experience and subjective information, not on evidence. Google is full of even more old, biased, opinionated “facts” on herbal and natural products, so it can’t be any more trusted than the first two sources. There are, however, good sources to find information.
                Natural Standard is a company that was founded to provide accurate and complete evidence-based information for health care practitioners and patients. It is a very comprehensive source for all natural products and alternative medicine therapies. The information included is peer-reviewed and evidence-based. They have different monographs for different levels of information. There are monographs for professionals that include all the information in scientific terms, and then there are monographs in easier-to-understand language that also include all the information. This allows patients to get information they can understand and know that they have all the information available. The monographs include information on effectiveness, side effects, drug interactions, dosing, use in pregnancy and breastfeeding, historic background, and safety. This encompasses all of the information you would need to know.
                Natural Standard has five different databases to help search for information: Herbs & Supplements, Condition Center, Alternative Modalities, Dictionary, and Patient Information. In Patient Information, the database includes background, evidence, usage, dosing, safety, and interactions, as well as the monographs listed above. You can search by condition if there is something you are looking to treat, and the site offers all therapy options ranging from pharmaceutical to natural products to alternative medicine such as acupuncture. This site is definitely comprehensive in including all necessary information.
                If you are using or planning to use natural products, it is essential for you to get all of the information on the specific product you are considering. It is also important to ask your pharmacist if you can take it while you are on your other medications, even if the other medicines you take are not prescriptions. To get more information, there are databases online that can help provide complete and accurate information for patients. Naturalstandard.com is one of those sites. Please be safe when selecting therapies and always do your research!
Alexis Ireland, PharmD Candidate 2014


References 
FDA. www.fda.gov/Food/DietarySupplements.
Mani, Nandita MLIS. Natural Standard. J Med Libr Assoc. 2005 October; 93(4): 507–509.
Natural Standard. www.naturalstandard.com
U.S. Pharmacopeia. www.usp.org/USPVerified.

Wednesday, April 24, 2013

How to assess credibility of health care information on the internet


                Following up from last week, I wanted to go more in depth on the importance of getting health information from credible sources. According to a recent study, 80% of people reporting to b internet users used the internet to research a disease or treatment. 82% of Pharmacists surveyed were asked a question by a patient about information they obtained on the internet. This shows how important the internet is to people when it comes to finding information about their health care.
                In the usual course, a patient is given a medication or treatment, diagnosed with a disease, or recommended something by their doctor. The patient types this subject into a google search, and clicks on the first 1-5 links that come up. Undoubtedly, Wikipedia is one of those first five links. However, Wikipedia content has been found to be inaccurate and incomplete when compared to other more credible sources of information. What was even more alarming to me than patients looking up health information on Wikipedia was the amount of healthcare providers that have admittedly used Wikipedia as a source. Convenience and ease of use is important, but it doesn’t always reflect the content of the website.
                Grossman and Zerilli wrote an article on how to discern a credible source from a not credible source on the web. The first recommendation is to consider the website on which the article is found. What is the purpose of the site? Is the information objective? Who runs the site? If the site is run by a commercial company about a certain drug, this is different from a blog run by an individual or a government-funded health library. What is the url? Url’s that end in .edu, .org, or .gov are more likely to have quality information when compared to .com sites which can be geared toward promoting a certain product or treatment. Are there advertisements on the website? Can you easily differentiate the advertisement from the content of the article? This is important because advertisements are notorious for being misleading. Websites that are intended for advertisement or promotion of a certain product must be carefully scrutinized for credibility, as it is not infrequent for manufacturers or a certain product to inflate the greatness of their product.
                Next, evaluate the article details before reading the article. Is the author listed? If an author is listed, especially if correspondence is provided so that questions may be asked, the site is likely more credible than an article that was written anonymously. Are references noted? It is very important to decide where the information found in the article came from. If the author has listed several primary literature sources and trials, the information is likely to be complete. When was the article written? If it was written in 1985, it might be helpful to find more recent information, as health care is a field that is constantly evolving.
                To make things easier, there are two organizations that rate websites or articles based on their content so that users can be more assured that the content is credible. These ratings are not concrete, and the organizations do not guarantee credibility, but it is a helpful step. The Utilization Review Accreditation Commission and the Health on the Net Foundation are these two organizations. Internet users can be more at ease with the content of an article if the HONcode or URAC-accredited stamp is on the article or website.  Sample seals are included at the bottom of this post.
                It is important that if you as a patient are looking for credible information on the internet, speak with your doctor about websites or articles that he/she recommends. Most health care providers understand patients’ desire to learn more about their conditions, and they try to make information available that will be easy for the patient to understand. I mentioned in the last post that regarding fertility, the majority of patients are very highly educated on their condition and their treatment or therapy. As patients understand their treatment at a certain level, they need information that is more challenging and informing. It is important for doctors to be able to provide “the next level” of information for their patients. Fortunately, there are several credible health care sites that offer different levels of information on different disease states.
                Ask your doctor or pharmacist about credible health information websites, or come back for a future post on individual reviews of credible websites.
Alexis Ireland, PharmD Candidate 2014




References
Grossman S, Zerilli T. Health and medication information resources on the world wide web. Journal of Pharmacy Practice. 2013 April 01;26(2):85-94.