Sally Rafie

Cethromycin: A Promising New Ketolide Antibiotic for Respiratory Infections

Community‐acquired pneumonia remains the primary infectious cause of death in the United States. At current levels of antimicrobial resistance, conventional agents are at risk of becoming less effective, and the need for new agents is pressing. Cethromycin is a new ketolide antibiotic being investigated for use in respiratory tract infections. To review its pharmacology, in vitro susceptibilities, pharmacokinetics, efficacy, safety, and drug interactions, we conducted a MEDLINE search restricted to English‐language articles citing cethromycin or ABT‐773 (its original designation) from 1990‐May 2009. Additional data sources were identified from the references of selected articles. All published trials and available poster data citing cethromycin were selected for review. In vitro, cethromycin displays more potent antibacterial effects than its predecessor telithromycin. Cethromycin exhibits potent inhibition of both gram‐positive and gram‐negative respiratory pathogens. A new drug application for cethromycin was submitted to the United States Food and Drug Administration in 2008 for the treatment of community‐acquired pneumonia. Clinical trial data in the treatment of respiratory tract infections support cethromycins efficacy. The limited safety data have not included any reports of hepatotoxicity. If cethromycin proves to be safe with regard to hepatotoxicity, it has great promise as an alternative to current standard therapy for community‐acquired respiratory infections, especially pneumonia. Given current resistance levels, cethromycin could provide more reliable coverage against common respiratory pathogens than traditional agents in the β‐lactam and macrolide classes.

Changing oral contraceptives from prescription to over-the-counter status: an opinion statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy.

Addressing the issue of unintended pregnancy is a national priority. One proposed strategy to reduce unintended pregnancy is to improve access to oral contraceptives by changing them to over‐the‐counter (OTC) status. Existing data indicate that oral contraceptives meet safety criteria required of OTC products. Available literature demonstrates that women can self‐screen for contraindications to oral contraceptives and can do this as well as clinicians, and experience with OTC emergency contraception suggests that OTC oral contraceptives would not increase sexual risk‐taking behavior. Women support OTC access to oral contraceptives, but express an interest in accessing pharmacist counseling. On the basis of these data, the Womens Health Practice and Research Network of the American College of Clinical Pharmacy supports changing oral contraceptives to OTC status under two conditions: that they are sold where a pharmacist is on duty and that there are mechanisms in place to cover OTC contraceptives through Medicaid. Future research should address the issues of out‐of‐pocket costs to individuals, label‐comprehension studies, and models for pharmacist reimbursement for time spent counseling on contraception.

Updates in Hormonal Emergency Contraception

In recent years, there have been many updates in hormonal emergency contraception. Levonorgestrel emergency contraception has been available for several years to prevent pregnancy when used within 72 hours after unprotected intercourse or contraceptive failure, and it was recently approved for nonprescription status for patients aged 17 years or older. Current research suggests that the primary mechanism of action is delaying ovulation. Ulipristal is the newest emergency contraception, available by prescription only, approved for use up to 120 hours after unprotected intercourse or contraceptive failure. The primary mechanism of action is delaying ovulation. When compared with levonorgestrel emergency contraception, ulipristal was proven noninferior in preventing pregnancy. Evidence suggests that ulipristal does not lose efficacy from 72–120 hours; however, more studies are warranted to support this claim. Many misconceptions and controversies about hormonal emergency contraception still exist. Research does not support that increased access to emergency contraception increases sexual risk‐taking behavior. Several studies suggest that health care providers, including pharmacists, could benefit from increased education about emergency contraception. It is important for pharmacists to remain up‐to‐date on the most recent hormonal emergency contraception products and information, as pharmacists remain a major point of access to emergency contraception.

Over-the-counter access to emergency contraception without age restriction: an opinion of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy.

Family planning remains a high priority area for the United States, with goals to increase the proportion of pregnancies that are intended, reduce pregnancy rates among adolescents, and increase contraceptive use prioritized in the Healthy People 2020 objectives. Contraception intended for use after unprotected intercourse, known as emergency contraception, remains underutilized. Levonorgestrel is one method of oral emergency contraception, which prevents fertilization and does not disrupt an already established pregnancy; thus, timing of administration is critical. Despite data demonstrating safety and efficacy, evidence‐based decision making has been overshadowed by politically charged actions involving levonorgestrel emergency contraception for over a decade. The Womens Health Practice and Research Network of the American College of Clinical Pharmacy supports expanded access to levonorgestrel emergency contraception and removal of barriers such as age restrictions on the nonprescription drug product. Pharmacists remain a key provider of emergency contraceptive services and can help ensure timely access. In states where direct pharmacy access to emergency contraception is available, pharmacists are encouraged to participate. Education, research, and advocacy are other important responsibilities for pharmacists in this arena.

Direct pharmacy access to hormonal contraception: California physician and advanced practice clinician views

BACKGROUND The United States has high rates of unintended pregnancy, and many women report difficulties in obtaining contraception. Pharmacy access would expand access to hormonal contraception. STUDY DESIGN A qualitative study using a structured interview guide was conducted with 20 reproductive health practitioners including physicians and advanced practice clinicians in California in 2008-2009. RESULTS Most respondents considered the current prescription-only model of access to hormonal contraception to be too restrictive. Some reported a preference for a pharmacy access model where women could obtain contraceptives directly from a pharmacist, bypassing the clinic visit. Many providers believed that method continuation and compliance would improve with pharmacy access to contraception. The most common concern reported was pharmacist refusal to provide services. CONCLUSIONS Overall, providers viewed increased access to hormonal contraception as an important public health service and supported pharmacy access. They thought that pharmacy access can be accomplished through pharmacist education and training. Additional research is needed to test the hypothesis generated by this qualitative study that physicians and advanced practice clinicians would welcome an enhanced role of pharmacists in the provision of hormonal contraception.

Contraceptive use in female recipients of a solid-organ transplant.

Context Women of reproductive age account for more than one-third of all solid-organ transplant recipients and are advised against becoming pregnant for 1 to 2 years after their surgeries. The risks posed to the woman, the transplanted organ, and the fetus underscore the importance of systems to ensure that patients receive counseling on family planning, including return to fertility, contraceptive use, and when pregnancy can be safely considered, and highly effective methods of contraception. Objective To investigate use of contraceptives among women after solid-organ transplant and to identify opportunities to improve care. Design A cross-sectional survey study. Setting An urban academic medical center. Patients Women 18 to 50 years old who have received a kidney, pancreas, and/or liver transplant within the past 1 to 24 months. Intervention Participants completed self-administered questionnaires regarding their menstrual pattern, pregnancy history, contraceptive use before and after transplant, and counseling on family planning issues. Main Outcome Measures Contraceptive use. Results The most common contraceptive method used in both the year preceding transplant and the year after transplant was condoms. Participants desired more counseling on highly effective contraceptive methods, such as intrauterine devices. Participants would like to receive contraceptive counseling from an obstetrician/gynecologist or transplant care team provider. Conclusion Female recipients of solid-organ transplants want more counseling on highly effective methods of contraception.

Over-the-Counter Access to Emergency Contraception without Age Restriction

Family planning remains a high priority area for the United States, with goals to increase the proportion of pregnancies that are intended, reduce pregnancy rates among adolescents, and increase contraceptive use prioritized in the Healthy People 2020 objectives. Contraception intended for use after unprotected intercourse, known as emergency contraception, remains underutilized. Levonorgestrel is one method of oral emergency contraception, which prevents fertilization and does not disrupt an already established pregnancy; thus, timing of administration is critical. Despite data demonstrating safety and efficacy, evidence‐based decision making has been overshadowed by politically charged actions involving levonorgestrel emergency contraception for over a decade. The Womens Health Practice and Research Network of the American College of Clinical Pharmacy supports expanded access to levonorgestrel emergency contraception and removal of barriers such as age restrictions on the nonprescription drug product. Pharmacists remain a key provider of emergency contraceptive services and can help ensure timely access. In states where direct pharmacy access to emergency contraception is available, pharmacists are encouraged to participate. Education, research, and advocacy are other important responsibilities for pharmacists in this arena.

Novel oral contraceptive for heavy menstrual bleeding: estradiol valerate and dienogest

Abnormal uterine bleeding (AUB) is associated with significant direct medical costs and impacts both society and the quality of life for individual women. Heavy menstrual bleeding, a subset of AUB, also referred to as menorrhagia, is defined as menstrual blood loss greater than 80 mL or the patient’s perception of excessive blood loss. The newest treatment option available is a novel combination oral contraceptive product containing estradiol valerate (E2V) and dienogest (DNG). As with other combination oral contraceptives, E2V/DNG works primarily by preventing ovulation. However, in contrast with other combination oral contraceptives, it is the progestin component of E2V/DNG that is responsible for endometrial stabilization. Use of E2V/DNG for six months has led to significant reductions in heavy menstrual bleeding with an average 65% reduction in mean blood loss. Approximately half of the women with heavy menstrual bleeding who received E2V/DNG for six months demonstrated an 80% reduction in mean blood loss. Additionally, significant improvements in hematologic indicators (ie, ferritin, hemoglobin, and hematocrit) have been shown. Based on its chemical properties, E2V/DNG may have fewer adverse effects on lipid and glucose metabolism and reduced risk of thromboembolic complications compared with other combination oral contraceptives. This has not yet been shown in clinical trials and until then it should be assumed that E2V/DNG has a safety profile similar to other combination oral contraceptives containing 35 μg or less of ethinyl estradiol. E2V/DNG has been compared with another combination oral contraceptive in healthy women without heavy menstrual bleeding and demonstrated improved bleeding patterns. E2V/DNG has not been compared with the levonorgestrel intrauterine device or other treatments for heavy menstrual bleeding. When compared with some other treatment options for AUB, E2V/DNG provides the added advantage of effective contraception.

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.