Abigail M. Yancey

The Use of Galactogogues in the Breastfeeding Mother

Objective: To review data regarding the efficacy of galactogogues available in the US to increase breast milk production in postpartum mothers. Data Sources: Literature was sought using PubMed (1966-June 2012) and EMBASE (1973-June 2012). Search terms included breastfeeding, breast milk, Lactation, galactogogue, motoctopramide, oxytocin, fenugreek, milk thistle, Silymarin, growth hormone, thyroid releasing hormone, medroxyprogesterone, domperidono. goats rue, beer, Asparagus racemosus, shatavari, Medicago sativa, alfalfa. Onicus bonedictus. blessed thistle, Galoga officinalis, brewers yeast, and herbals. Study Selection and Data Extraction: All studies including humans and published in English with data assessing the efficacy of galactogogues for increasing breast milk production were evaluated. Data Synthesis: Breast milk is considered the optimal food source for newborns through 1 year of age. Many factors influence overall maternal production, including maternal pain, illness, balance of time when returning to work, anxiety, or emotional stress. Although a variety of herbal and pharmaceutical options have anecdotal evidence of their ability to improve breast milk production, peer-reviewed studies proving their efficacy are lacking. Metoclopramide, oxytocin, fenugreek, and milk thistle have shown mixed results in improving milk production; however, the trials were small and had a variety of limitations. Conclusions: Nonpharmacologic recommendations should be exhausted before adding therapy. Although anecdotal evidence encourages the use of metoclopramide, fenugreek, asparagus, and milk thistle for their galactogogue properties, efficacy and safety data in the literature are lacking. Oxytocin and domperidono are potentially available for compounding purposes, but safety data are limited. More studies are needed to evaluate the effects of available galactogogues on breast milk production.

Safety of the HPV Bivalent and Quadrivalent Vaccines During Pregnancy

OBJECTIVE: To evaluate the safety of the human papillomavirus (HPV) bivalent and quadrivalent vaccines in pregnancy. DATA SOURCE: PubMed (1966-August 2010) was searched using the terms human papillomavirus, human papillomavirus vaccine, and pregnancy. References were reviewed for relevant information. STUDY SELECTION AND DATA EXTRACTION: All studies including humans that were published in English with data describing HPV vaccine administration in pregnancy were evaluated. DATA SYNTHESIS: Two combined analyses of 7 Phase 3 efficacy trials have retrospectively evaluated the safety of unintentional administration of either the bivalent (n = 1786) or quadrivalent (n = 2085) HPV vaccine during pregnancy. In addition, postmarketing pregnancy registry surveillance data (prospective, n = 787; retrospective, n = 76) for the quadrivalent HPV vaccine have been published. However, only 279 pregnancies from the studies and 90 pregnancies from the registry occurred within 30 days of receiving the vaccination. Overall, the vaccine does not appear to be associated with an increased risk of spontaneous abortion, fetal malformations, or adverse pregnancy outcomes beyond that found in the general population. Although the data are limited, neither HPV vaccine appears to be associated with an increased risk of adverse pregnancy outcomes. However, limitations of the data include small patient populations, minimal to no adjustments for factors known to influence pregnancy outcomes or malformations, and the majority of the available pregnancy data are from retrospective analysis of Phase 3 efficacy trials. CONCLUSIONS: Neither HPV vaccine should be routinely administered during pregnancy. If a pregnancy occurs midseries, the remaining vaccines should be given after pregnancy completion. Further studies are required to determine actual risk.

The Prophylactic Role for the Human Papillomavirus Quadrivalent Vaccine in Males

Objective: To determine the role of human papillomavirus (HPV) quadrivalent vaccine in males. Data Source: PubMed (1966–March 2010) was searched using the terms human papillomavirus, human papillomavirus vaccine, quadrivalent, males, cancer, and genital warts. Reference citations were reviewed for relevant information. Study Selection and Data Extraction: All studies including humans and published in English with data describing HPV quadrivalent vaccine administration in males were evaluated. Data Synthesis: The HPV quadrivalent vaccine is currently recommended in females, but its role in males is still being defined. Three clinical trials evaluated the immunogenicity and tolerability of the vaccine in more than 1100 males 9–26 years of age. Greater than 99.5% of males seroconverted for HPV 6, 11, 16, and 18 at 1 month post-completion and titers were found to be numerically higher than those in females 16–26 years old. One study found that immune response persisted in >92.5% of males at 1 year. The results show high efficacy against detection of new anogenital lesions in males 29 months after receiving the quadrivalent HPV vaccine. In addition, the quadrivalent HPV vaccine appears to be well tolerated, with the most common adverse effects being syncope, fever, local site reactions, dizziness, nausea, and headache. Conclusions: The HPV quadrivalent vaccine appears to be safe and induces an effective immune response in males. It may also decrease the incidence of anogenital and penile cancer, although current data are limited in number and duration of follow-up. Further analysis of the long-term immunogenicity and effects on HPV-associated complications is needed.

Buprenorphine Versus Methadone for Opioid Dependence in Pregnancy.

Objective: To evaluate maternal and neonatal safety outcomes for methadone and buprenorphine in the obstetric population. Data Sources: A literature search of PubMed (1966 to March 2016) and EMBASE (1973 to March 2016) was completed using the search terms buprenorphine, methadone, pregnancy, opioid, and neonatal abstinence syndrome. Priority was given to randomized controlled trials and trials directly comparing buprenorphine and methadone during pregnancy. The bibliographies were reviewed for other relevant articles. Study Selection and Data Extraction: All human studies published in English, that compared methadone and buprenorphine use in pregnancy were evaluated. Because of the limited number of obstetric studies, only 5 critical studies were found. Data Synthesis: Buprenorphine significantly improved or had similar outcomes to methadone for development of neonatal abstinence syndrome (NAS), percentage of infants requiring treatment for NAS (20%-47% vs 45.5%-57%, respectively), total amount of morphine used to treat NAS (0.472-3.4 vs 1.862-10.4 mg, respectively), duration of NAS (4.1-5.6 vs 5.3-9.9 days, respectively), peak NAS (3.9-11 vs 4.9-12.8 score, respectively), infant hospital stay (6.8-10.6 vs 8.1-17.5 days, respectively), and gestational age at delivery (38.8-39.7 vs 37.9-38.8 weeks, respectively). No difference was found with other neonatal or maternal outcomes. Conclusions: Both methadone and buprenorphine are effective agents, with improved safety compared with continued nonmedical opioid use during pregnancy. There is evidence to suggest that buprenorphine should be considered as an equivalent option to methadone for use in pregnancy; however, larger studies are still needed to fully evaluate buprenorphine safety and advantages over methadone in the obstetric population.

Ospemifene in the Treatment of Vulvovaginal Atrophy

Objective: To review the pharmacology, efficacy, and safety of ospemifene in the management of dyspareunia. Data Sources: Literature was sought using PubMed (1966-January 2014) and EMBASE (1973-January 2014). Search terms included ospemifene, FC-1271a, dyspareunia, vulvovaginal atrophy, and vaginal atrophy. Study Selection and Data Extraction: All studies, including studies on humans, published in English with data assessing the efficacy and safety of ospemifene in the management of dyspareunia were evaluated. Data Synthesis: Ospemifene is a new oral estrogen receptor agonist/antagonist indicated for moderate to severe dyspareunia. Clinical trials evaluating efficacy have shown a significant improvement in superficial cells, parabasal cells, vaginal pH, vaginal dryness, and dyspareunia. The most frequently reported adverse drug reactions in the clinical trials included hot flashes, vaginal discharge, muscle spasms, and hyperhidrosis. Similar to systemic estrogen, boxed warnings with ospemifene include risk for thromboembolism and cerebrovascular disease. Additionally, patients with a uterus still need to use a progestogen with ospemifene to reduce the risk of hyperplasia. Conclusions: Ospemifene has been effective in improving symptoms of vulvovaginal atrophy when compared with placebo; however, no studies comparing ospemifene with estrogen products exist. Additional clinical trials are needed to evaluate the efficacy and safety in specialty populations, and long-term safety data are needed to assess the potential for serious adverse events. With the risks being similar to that for systemic estrogen therapy, ospemifene appears to be an alternative agent to estrogen therapy but does not have any advantages over estrogen.

Pneumococcal vaccination process improvement in an acute care setting

Background and objective Despite the availability of the pneumococcal vaccine since 1977, the vaccine is greatly underutilised. Centers for Medicare and Medicaid Services, The Joint Commission and Healthy People 2010 have all listed the administration of the pneumococcal vaccine before hospital discharge as a standard of care and a quality initiative in the 21st century. SSM St Marys Health Center chartered a multidisciplinary team to address a disappointing pneumococcal vaccination rate of 34.7% in the first quarter of 2005. Methods The team utilised the improvement model of Plan–Do–Study–Act to implement and monitor process changes. Changes were made to four key steps in the pneumococcal vaccination process: assessment, ordering, obtaining and administering. The team also implemented a concurrent review process. The team tracked the hospitals pneumococcal vaccination rate per the published Centers for Medicare and Medicaid Services and The Joint Commission guidelines. Results Over a 2-year period, the vaccination rate of pneumonia patients has improved incrementally from 34.7% and is now consistently greater than 90%. Conclusion Utilising Plan–Do–Study–Act allows for continual improvement of the vaccination process. Multiple cycles are necessary to achieve standardisation and optimal process flow.

Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice:

Objective: To provide guidance for clinicians on risk assessment of medication use during pregnancy and lactation. Data Sources: Authors completed PubMed searches to identify articles focused on the use of medications in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Study Selection and Data Extraction: Articles were reviewed to provide overall guidance to medication selection during pregnancy. The following information was reviewed: medication use in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Data Synthesis: This article will provide an overview of medication safety considerations during pregnancy and lactation. Information was interpreted to help clinicians predict the potential risk and benefit in each patient to make an evidence-based decision. The article concludes with guidance on risk assessment and how pharmacists may support fellow health care providers and their patients when considering medication use. Conclusions: Information about the effects of medication use during reproductive periods is limited. With the removal of the Food and Drug Administration pregnancy categories, clinicians will be relying on pharmacists to aid in the appropriate selection of therapies for patients. It is critical that pharmacists keep abreast of resources available and be able to assess data to help prescribers and their patients.

Impact of Clinical Pharmacy on Asthma in Pregnancy in a Maternal-Fetal Care Clinic A Pilot Study

Background: Asthma complicates 4% to 8% of pregnancies. The impact of clinical pharmacists providing asthma management and education to obstetric patients is unknown. Objective: Evaluate the impact of and patient satisfaction with clinical pharmacy services on asthma in pregnancy. Methods: This prospective quasi-experimental study enrolled 30 pregnant patients with asthma and assessed perceived asthma understanding, control, and inhaler technique before and after a clinical pharmacist visit and education. The primary outcome was change in pre- and postsurvey scores. Items were rated on a 5-point Likert-type scale; higher scores represented higher perceived knowledge or satisfaction. Secondary outcomes included inhaler technique scores, asthma control, correlating patient-specific factors with the primary outcome, and level of patient satisfaction with clinical pharmacy services. Results: Perceived knowledge of asthma in pregnancy median score (maximum score 50) significantly increased with clinical pharmacy education (37.5 pre vs 49 post, P = .001). Prior to clinical pharmacy services, patients highly rated their perceived knowledge of asthma in pregnancy with median scores on 7 of 10 items between 4 and 5. Despite this, significant changes were observed on 9 items. The proportion of patients with controlled asthma significantly increased after the pharmacist visit (33.3% vs 90%, P < .001). Satisfaction with clinical pharmacy services was overwhelmingly positive with average scores on all items 4.5 to 5. Inhaler technique scores significantly increased from baseline to follow-up (4 vs 7, P = .001). Conclusions: Pharmacists significantly improved patient perceived knowledge about asthma, asthma control, and inhaler technique. Patients were overwhelmingly satisfied with the care provided by the pharmacist.

Sofosbuvir, a New Nucleotide Analogue, for the Treatment of Chronic Hepatitis C Infection

Objective: To evaluate the clinical role of sofosbuvir (Solvadi) in the treatment of hepatitis C virus (HCV). Data Sources: A MEDLINE, EMBASE, and Cochrane search indexed from January 2000 to July 2014 was performed using the search terms GS-7977 and sofosbuvir. Study Selection and Data Extraction: Studies including humans subjects, published in English, and assessing efficacy and safety of sofosbuvir in management of chronic HCV were evaluated. Data Synthesis: Sofosbuvir, a nucleotide analogue NS5B polymerase inhibitor, competes with nucleotides within the hepatocytes resulting in chain termination and inhibition of RNA replication. Trials evaluating the efficacy of sofosbuvir combination therapy have demonstrated significant advantage in sustained virologic response (SVR) over previous therapies. Genotype 1, 4, 5, and 6 patients treated with peginterferon-α, ribavirin, and sofosbuvir for 12 weeks achieved SVR rates of 90%. Twelve-week peginterferon-free regimens have resulted in SVR rates of 90% in genotype 2 patients, whereas genotype 3 patients required 24 weeks of therapy to achieve similar results. Favorable SVR rates were also seen in previously difficult-to-treat patient populations including cirrhosis, HIV coinfection, and treatment-experienced. Sofosbuvir appears to be well tolerated and relatively safe, avoiding severe adverse drug reactions, laboratory abnormalities, and resistance issues associated with traditional HCV therapies. The biggest limitation of sofosbuvir is the high cost associated with therapy. Conclusions: Sofosbuvir is a safe and effective treatment option for patients infected with genotypes 1 to 6 HCV including previously difficult-to-treat populations. The shorter duration, oral route, minimal side effects, and decreased resistance potential makes it a welcome addition to the treatment of chronic HCV.

Evaluation of the impact of body mass index on warfarin requirements in hospitalized patients

Background: Despite well established empiric dose adjustments for drug and disease-state interactions, the impact of body mass index (BM) on warfarin remains unclear. The objective of this study is to evaluate warfarin requirements in hospitalized patients, stratified by BMI. Methods: This retrospective review included two cohorts of patients: cohort A (patients admitted with a therapeutic international normalized ratio (INR)) and cohort B (newly initiated on warfarin during hospitalization). Exclusion criteria included: age under 18 years, pregnancy, INR (goal 2.5–3.5), and warfarin thromboprophylaxis post orthopedic surgery. The primary outcome was mean total weekly dose (TWD) of warfarin based on weight classification: underweight (BMI <18 kg/m2), normal/overweight (BMI 18–29.9 kg/m2), obese (BMI 30–39.9 kg/m2), and morbidly obese (BMI ⩾ 40 kg/m2). Data were extracted from two community hospitals in reverse chronologic order during July 2015–June 2013 until both study institutions evaluated 100 patients per cohort in each BMI classification or until all patients had been evaluated within the prespecified timeframe. Results: A total of 585 patients were included in cohort A (26 underweight, 200 normal/overweight, 200 obese, 159 morbidly obese). There was a statistically significant difference in TWD as determined by one-way analysis of variance (p < 0.05). A Tukey post hoc test revealed a statistically significantly higher TWD in morbidly obese (41.5 mg) compared with underweight (25.6 mg, p < 0.05), normal/overweight (28.8 mg, p < 0.05) and obese patients (32.4 mg, p < 0.05). In cohort B, 379 patients were evaluated (9 underweight, 166 normal/overweight, 152 obese, 52 morbidly obese). Overall, 191 patients had a therapeutic INR on discharge (88.9% underweight, 52.4% normal/overweight, 44.1% obese, 55.8% morbidly obese, p = 0.035). Of those, there was a statistically significant difference in TWD (p = 0.021) with a higher TWD in the morbidly obese (41 mg) compared with underweight patients (24.4 mg, p = 0.017). Conclusions: Based on the results of this study, morbidly obese patients may require higher TWD to obtain and maintain a therapeutic INR.