Brooke L. Griffin

A Review of Antibiotic Use in Pregnancy

During pregnancy, untreated sexually transmitted or urinary tract infections are associated with significant morbidity, including low birth weight, preterm birth, and spontaneous abortion. Approximately one in four women will be prescribed an antibiotic during pregnancy, accounting for nearly 80% of prescription medications in pregnant women. Antibiotic exposures during pregnancy have been associated with both short‐term (e.g., congenital abnormalities) and long‐term effects (e.g., changes in gut microbiome, asthma, atopic dermatitis) in the newborn. However, it is estimated that only 10% of medications have sufficient data related to safe and effective use in pregnancy. Antibiotics such as beta‐lactams, vancomycin, nitrofurantoin, metronidazole, clindamycin, and fosfomycin are generally considered safe and effective in pregnancy. Fluoroquinolones and tetracyclines are generally avoided in pregnancy. Physiologic changes in pregnancy lead to an increase in glomerular filtration rate, increase in total body volume, and enhanced cardiac output. These changes may lead to pharmacokinetic alterations in antibiotics that require dose adjustment or careful monitoring and assessment.

International Normalized Ratio values in group versus individual appointments in a pharmacist-managed anticoagulation clinic

PURPOSE The clinical effectiveness of a group-visit model versus individual point-of-care visits is compared by International Normalized Ratio (INR) monitoring in a pharmacist-managed anticoagulation clinic. METHODS This study was a prospective, randomized, repeated-measures, two-group, intention-to-treat comparison and survey at a pharmacist-managed anticoagulation clinic in a managed-care ambulatory care setting. Patients were eligible for this study if they were taking warfarin therapy for at least 30 days, had a goal INR range, and provided consent. At a routine point-of-care visit, eligible patients were randomly invited to participate in group visits. The number of visits and INR values were documented prospectively for both groups during the 16-week study period. RESULTS Of the 45 patients who consented and enrolled in group visits, 28 patients participated for the 16-week study period. The control group included 108 patients seen by a pharmacist for individual anticoagulation appointments. No significant difference in the percentage of INR values within the therapeutic range was detected between patients in the group-visit model versus patients receiving individual visits (59% versus 56.6%, respectively; p = 0.536). Seventy-three percent of INR values for patients who attended group visits were within +/- 0.2 of the desired INR range compared with 71.9% of those in the control group ( p = 0.994). In addition, 79% of group-visit patients were within the therapeutic range at their last clinic visit compared with 67% of patients who attended individual appointments (p = 0.225). Group visits were preferred by 51% (n = 38) of patients who completed the satisfaction survey. Of the 92 patients who declined group-visit participation, 36% indicated that the time of day that group visits were offered was inconvenient. There were no thromboembolic or hemorrhagic events documented in either group during the study period. CONCLUSION Group visits in a pharmacist-managed anticoagulation clinic may provide a safe and effective alternative to individual appointments.

Roles of the Pharmacist in the Use of Safe and Highly Effective Long-Acting Reversible Contraception: An Opinion of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy

The U.S. population continues to experience an alarmingly high rate of unintended pregnancies that have an impact on individual families and society alike. Lack of effective contraception accounts for most unintended pregnancies, along with incorrect use of contraceptives. The most common reversible contraceptive method used in the United States is the oral contraceptive pill, which has significant failure and discontinuation rates. Use of long‐acting reversible contraceptive (LARC) methods has been increasing in recent years after efforts to educate providers and patients. Women are more likely to use LARC methods when barriers such as access and cost are removed. An uptake in the use of LARC methods would allow for markedly reduced contraception failure rates and higher user satisfaction and thus higher continuation rates than those seen with current contraception use. Promoting the use of LARC methods is an important strategy in improving both individual and public health outcomes by reducing unintended pregnancies. The pharmacists role in family planning is expanding and can contribute to these efforts. Although knowledge regarding LARC has not been studied among pharmacists, a knowledge deficit exists among health care professionals in general. Thus pharmacist education and training should include LARC methods along with other contraceptives. The American College of Clinical Pharmacy Womens Health Practice and Research Network advocates for the pharmacists role in the use of safe and highly effective LARC methods. These roles include educating patients, informing providers, facilitating access by providing referrals, and modifying institutional procedures to encourage provision of LARC methods.

Roles of the Pharmacist in the Use of Safe and Highly Effective Long-Acting Reversible Contraception

The U.S. population continues to experience an alarmingly high rate of unintended pregnancies that have an impact on individual families and society alike. Lack of effective contraception accounts for most unintended pregnancies, along with incorrect use of contraceptives. The most common reversible contraceptive method used in the United States is the oral contraceptive pill, which has significant failure and discontinuation rates. Use of long‐acting reversible contraceptive (LARC) methods has been increasing in recent years after efforts to educate providers and patients. Women are more likely to use LARC methods when barriers such as access and cost are removed. An uptake in the use of LARC methods would allow for markedly reduced contraception failure rates and higher user satisfaction and thus higher continuation rates than those seen with current contraception use. Promoting the use of LARC methods is an important strategy in improving both individual and public health outcomes by reducing unintended pregnancies. The pharmacists role in family planning is expanding and can contribute to these efforts. Although knowledge regarding LARC has not been studied among pharmacists, a knowledge deficit exists among health care professionals in general. Thus pharmacist education and training should include LARC methods along with other contraceptives. The American College of Clinical Pharmacy Womens Health Practice and Research Network advocates for the pharmacists role in the use of safe and highly effective LARC methods. These roles include educating patients, informing providers, facilitating access by providing referrals, and modifying institutional procedures to encourage provision of LARC methods.

Active-learning instruction on emergency contraception counseling.

Objective. To increase pharmacy students’ knowledge of and confidence in counseling patients regarding emergency contraception and to identify any barriers to counseling patients about emergency contraception. Design. Approximately 200 third-year pharmacy students participated in the Women’s Health Therapeutics workshop at Midwestern University Chicago College of Pharmacy. Students observed a 5-minute skit of a counseling session on emergency contraception and then were asked to pair up with a classmate and practice counseling each other regarding the use of emergency contraception following a checklist of key points. Assessment. One hundred eighty-nine students completed pre- and post-workshop survey instruments. Students’ knowledge scores increased from 86% to 93% (p<0.001). Approximately 25% of the students stated they were confident in counseling patients on emergency contraception before completing the active-learning exercise compared to 58.5% after (p<0.001). The most common barrier to counseling that students identified on the pre- and post-workshop survey was lack of knowledge. Conclusion. Participation in an active-learning exercise significantly increased pharmacy students’ knowledge of and confidence in counseling patients regarding emergency contraception and significantly reduced several barriers to counseling identified prior to participation.

Survey of bisphosphonate regimen preferences in an urban community health center.

OBJECTIVE to determine patient preference for bisphosphonate therapy based on dosage form and dosing schedule. DESIGN prospective telephone survey. SETTING urban community health center. PATIENTS, PARTICIPANTS all patients who were seen in the osteoporosis clinic during the 22-month time period were contacted. Patients were excluded if they could not complete the survey in English, had difficulty hearing, had cognitive impairment, or were unable to be reached by telephone. INTERVENTIONS patients were asked which route and frequency of bisphosphonate therapy was preferred, convenient, and easiest to remember. MAIN OUTCOME MEASURE(S) patient-reported preference for route and frequency of bisphosphonate administration. RESULTS ninety patients were included in the final analysis. Preference for bisphosphonate therapy illustrated that equal numbers of respondents preferred either once-monthly or once-yearly regimens (24.4% for each, n = 22). One-third of respondents (n = 30) indicated that a once-yearly infusion was the most convenient method of administration. The survey revealed no strong association of which regimen was easiest to remember. CONCLUSION the majority of patients preferred once-monthly or less frequent dosing schedules. Clinicians may consider discussing patient preferences during initiation and throughout therapy.

Methadone, Buprenorphine, and Naltrexone for the Treatment of Opioid Use Disorder in Pregnant Women

Pregnant women with opioid use disorder can be treated with methadone, buprenorphine, or naltrexone to reduce opioid use and improve retention to treatment. In this review, we compare the pregnancy outcomes of methadone, buprenorphine, and naltrexone in clinical trials and discuss the potential behavioral and developmental effects of these agents seen in offspring in animal studies. Important clinical considerations in the management of opioid use disorder in pregnant women and their infants are also discussed. Outside of pregnancy, buprenorphine is used in combination with naloxone to reduce opioid abuse and diversion. During pregnancy, however, the use of buprenorphine as a single agent is preferred to prevent prenatal naloxone exposure. Both methadone and buprenorphine are widely used to treat opioid use disorder; however, compared with methadone, buprenorphine is associated with shorter treatment duration, less medication needed to treat neonatal abstinence syndrome (NAS) symptoms, and shorter hospitalizations for neonates. Despite being the standard of care, medication‐assisted treatment with methadone or buprenorphine is still underused, making it apparent that more options are necessary. Naltrexone is not a first‐line treatment primarily because both detoxification and an opioid‐free period are required. More research is needed to determine naltrexone safety and benefits in pregnant women. Animal studies suggest that changes in pain sensitivity, developmental processes, and behavioral responses may occur in children born to mothers receiving methadone, buprenorphine, or naltrexone and is an area that warrants future studies.

Assessment of a simulated contraceptive prescribing activity for pharmacy students.

BACKGROUND AND PURPOSE The role of the pharmacist has been shifting rapidly. One example of change is the passage of legislation allowing pharmacists to independently initiate self-administered hormonal contraceptives in several states. There is no evidence of this specific topic being covered in pharmacy school curricula, and many states are requiring additional post-graduate training. This activity was designed to determine the utility of a contraceptive prescribing simulation activity for pharmacy students. EDUCATIONAL ACTIVITY AND SETTING Pharmacy students enrolled in a womens health elective learned about relevant state legislation and attended a clinical skills center simulation activity where they utilized an available prescribing algorithm. Students completed two scenarios and received grades based on their clinical decision-making and patient interaction skills. An electronic survey was distributed post-activity to assess student satisfaction and confidence when prescribing contraceptives. Responses and grades on the assignment were analyzed to determine the activitys utility. FINDINGS Students finished with median scores of 15, 14.8, and 14.5 out of 15 possible points for the three scenarios. Students reported overall satisfaction with the activity, with general agreement that the activity was realistic and made them feel like they were prepared to prescribe contraceptives. SUMMARY Independently initiating contraceptives is a novel practice area for pharmacists. This activity introduced students to the process of prescribing using realistic forms and scenarios. The utility of the activity was twofold - it introduced students to the changing environment of pharmacy practice and allowed students to apply their knowledge of contraceptives and womens health. Students performed well on the activity and reported high levels of satisfaction.

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.

Doses, durations, and gender predict vancomycin-induced kidney injury in pre-clinical studies

BACKGROUND Although the exposure-dependent efficacy thresholds of vancomycin have been probed, less is known about acute kidney injury (AKI) thresholds for this drug. Sensitive urinary biomarkers, such as kidney injury molecule 1 (KIM-1), have shown high sensitivity and specificity for vancomycin-associated AKI. The aims of the study were to determine if there were dose-response curves with urinary KIM-1, and to evaluate the impact of therapy duration and sex on observed relationships. METHODS A systematic review was conducted via PubMed/MEDLINE. Data were compiled from preclinical studies that reported individual subject data for urinary KIM-1 concentrations, vancomycin dose (mg/kg), duration of treatment, and sex. Sigmoidal Hill-type models were fit to the individual dose-response data. RESULTS A total of 15 studies were identified, 6 of which reported vancomycin dose and KIM-1 data. Of these, three included individual animal-level data suitable for analysis. For all pooled rats, increasing total daily vancomycin doses displayed a dose-response curve with urinary KIM-1 concentrations (50% maximal toxic response=130.4 mg/kg/day). Dose-response curves were shifted left for females vs. males (P = 0.05) and for long (i.e. ≥7 days) vs. short (i.e. <4 days) duration of vancomycin therapy (P=0.02). CONCLUSIONS The collective findings demonstrate a clear dose-response relationship between vancomycin dose and AKI. As these analyses focused exclusively on dose-response relationships, additional preclinical data are needed to more clearly define vancomycin exposures that predict the onset of AKI.