Jamie M. Pitlick

Nicotine Replacement Therapy Effect on Pregnancy Outcomes

Objective: To review data assessing the effects of nicotine replacement therapy (NRT) during pregnancy on fetal, neonatal, and maternal outcomes. Data Sources: A literature search of PubMed (1966-Jufy 2010) was performed using the terms smoking, smoking cessation, pregnancy, and nicotine replacement therapy. Bibliographies and the Cochrane Database were reviewed to identify additional relevant articles. Study Selection and Data Extraction: All studies including humans and published in English with data describing NRT effects on pregnancy outcomes or malformations as a primary or secondary outcome were evaluated. Data Synthesis: Currently, behavior modification therapy is recommended for smoking cessation in pregnancy as first-line treatment, but NRT should be offered to patients who are not successful. NRT is currently a pregnancy category D medication. Pregnancy outcomes and malformation rates for NRT in pregnancy were evaluated as either primary or secondary outcomes in several trials. Four studies examined pregnancy outcomes after a full course of nicotine gum or patch therapy. NRT use significantly decreased the risk of preterm delivery and low birth weight compared to that of smokers. Only 1 study evaluated the risk of malformations after exposure to the NRT patch during the first trimester. In a retrospective analysis, NRT users had an increased risk for any fetal malformation but not for major or musculoskeletal ones. However, no adjustments were made for many known factors associated with malformations. Conclusions: Behavior modification therapy should always be the first method tried for smoking cessation in the pregnant population. If behavior modification therapy is attempted without success, NRT should be offered because of decreased risk for low birth weight and preterm delivery compared to continued smoking. Additionally, NRT does not appear to increase the risk for malformations.

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.

Bevacizumab for the Treatment of Neovascular Age-Related Macular Degeneration

Objective: To review data regarding the efficacy and safety of bevacizumab for the treatment of neovascular age-related macular degeneration (nARMD). Data Sources: Literature was searched using MEDLINE (1976-September 2011) and EMBASE (1973-September 2011). Search terms included bevacizumab. Avastin, neovascular macular degeneration, age-related macular degeneration, vascular endothelial growth factor, intravitreal, and safety. Reference citations were reviewed for relevant information. Study Selection and Data Extraction: All randomized clinical trials published in English with data assessing the safety and efficacy of bevacizumab for nARMD were evaluated. Data Synthesis: The only Food and Drug Administration-approved treatments for nARMD are photodynamic therapy (PDT) with verteporfin, intravitreal pegaptanib, and ranibizumab. However, bevacizumab has gained attention as a potential agent in treating nARMD and is now widely used in practice. PDT with verteporfin and pegaptanib has shown only stabilization of visual acuity (VA). When the efficacy of bevacizumab was compared to these therapies, bevacizumab clinically and statistically improved VA outcomes. When compared to ranibizumab, which has also been shown to improve VA, bevacizumab showed no significant difference in VA outcomes and was associated with a decrease in average annual cost of

Thrombolytic Therapy in Wake-Up Stroke Patients.

22,605. Conclusions: Bevacizumab administered intravitreally is appropriate for prevention of vision loss and recovery of VA in patients with nARMD. Although further analysis of long-term effects of bevacizumab on VA and safety is needed, it is potentially a more cost-effective option than ranibizumab for the treatment of nARMD.

Conception of a Personalized Medication Adherence Discharge Kit for Rivaroxaban

Objective The aim of the study is to review existing and ongoing trial data on wake-up stroke (WUS) patients for thrombolytic therapy. Methods A literature search was conducted in PubMed (conception–October 2016) using the terms wake-up stroke, acute ischemic stroke, wake-up thrombolysis, computed tomography imaging in wake-up stroke, and magnetic resonance imaging in wake-up stroke. Ongoing trials were found using the ClinicalTrials.gov website. Results The search yielded 61 articles in PubMed and 7 ongoing trials. After removing duplicate/irrelevant articles, 33 articles and relevant references were reviewed; of these, 6 articles and 3 ongoing trials were included. Two retrospective studies evaluating the characteristics between WUS and known-onset stroke were identified; the only significant difference between groups was the ability to receive treatment with tissue plasminogen activator (tPA). One study suggested that perfusion brain imaging may be useful to identify patients that may benefit from tPA. In addition, 3 studies have evaluated WUS treatment; all used different methods to identify potential patients. Two of 3 studies showed that treatment with tPA is associated with better outcomes when controlling for baseline National Institutes of Health Stroke Scale. No difference in safety outcomes was seen between groups for all 3 studies. Conclusions Available data suggest promising strategies to identify WUS patients who may benefit from thrombolysis. Once on-going trials are complete, there may be sufficient information to redefine tPA eligibility for previously excluded patients.

PCSK9 Inhibitors An Emerging Class of Medications

Purpose Due to a lack of necessary monitoring with rivaroxaban, patients have fewer opportunities for education, adherence reinforcement, and follow-up. If rivaroxaban is taken incorrectly, patients are at increased risk for adverse events. The objective was to create personalized rivaroxaban patient adherence kits (R-PAKs) to enhance successful transition from 15 mg twice daily to 20 mg once daily on day 22 of venous thromboembolism (VTE) treatment. Summary A review of rivaroxaban drug information and existing medication adherence tools was completed to increase understanding of ways to improve adherence. Clinical pharmacists identified several concerns the R-PAK should address, including patient understanding of correct dose, administration timing, serious adverse effects, and importance of compliance, along with loss to follow-up by a health care provider. In the pilot phase, 100 R-PAKs were created. Each kit includes an educational handout describing adverse effects, administration, and monitoring; a reminder card with dosing information, date to transition, and emergency contact information; and a personalized 28-day pill organizer containing customized dividers to correlate with the first 21 days of treatment. Color-coded stickers denote the first day of starting twice-daily therapy upon discharge and the day of transition to once-daily dosing. The items were distributed in tote bags at discharge along with pharmacist education. Conclusion The R-PAKs are being used at a community teaching hospital for patients newly diagnosed with VTE who are discharged on rivaroxaban. The concept of a personalized medication box could be modified for any medication that requires high compliance or dose transitions.

Individualization of resident orientation for nontraditional pharmacy residents.

Objective: To evaluate the safety and efficacy of 2 human monoclonal antibodies, alirocumab and evolocumab, on reduction of low-density lipoprotein cholesterol (LDL-C), cardiovascular benefits, and their place in current practice. Data Sources: A search of MEDLINE and Scopus databases (1966 to May 2016) with search terms “alirocumab,” “evolocumab,” “LDL,” and “PCSK9.” Study Selection and Data Extraction: The search identified phase 3 randomized control trials in English language in the past 10 years that studied LDL-C reduction of alirocumab or evolocumab. The studies were assessed for all efficacy and safety endpoints. Data Synthesis: Twelve total studies were identified evaluating alirocumab or evolocumab. These monoclonal antibodies have been shown to significantly decrease LDL-C as monotherapy and in combination with statins in phase 3 clinical trials in patients with primary hypercholesterolemia as well as familial hypercholesterolemia by inhibiting PCSK9. Alirocumab significantly reduced LDL-C by up to 61%, while evolocumab significantly reduced LDL-C by up to 66%. Adverse effects of these medications have been low and overall well tolerated. Conclusion: Although these monoclonal antibodies have shown to significantly reduce LDL-C, their effect on cardiovascular outcomes has not yet been determined. Further studies are being conducted to assess the cardiovascular benefit of both alirocumab and evolocumab. Until these studies demonstrate a reduction in atherosclerotic cardiovascular disease risk, statins should remain first-line therapy for most patients. However, alirocumab and evolocumab can be used as an effective adjunctive therapy option to lower LDL-C or in patients who are statin intolerant.

Development of assessments for use on advanced pharmacy practice experiences

The ASHP accreditation standards for postgraduate year 1 (PGY1) pharmacy residency programs indicate that residents must be oriented to the residency program.[1][1] This orientation provides the foundation for a successful first year of residency training. Successful orientation often includes an