Texas community pharmacists' willingness to participate in pharmacist-initiated emergency contraception.

OBJECTIVES: To determine Texas community pharmacists' knowledge about and experience with emergency contraception (EC), their perceptions about and willingness to participate in pharmacist-initiated emergency contraception (PIEC), and whether their willingness is influenced by their background characteristics or experience with EC. DESIGN: Cross-sectional study. SETTING: Texas in November through December 2004. PARTICIPANTS: 300 community pharmacists. INTERVENTIONS: Mailed questionnaire consisting of 40 questions divided into three SECTIONS: experience with EC, perceptions about PIEC, and background information. MAIN OUTCOME MEASURES: Pharmacists' perceptions and behaviors regarding EC and PIEC, and their willingness to participate in PIEC. Bivariate analysis to assess background characteristics and experience with EC in relation to willingness to participate in PIEC; multiple regression to identify predictors of willingness to participate in PIEC. RESULTS: With a usable response rate of 51%, results indicate that most pharmacists (91.2%) had heard of EC, while 45.2% kept EC in stock. More than one half (57.8%) had dispensed EC, and 95.5% were aware that EC is most effective when taken within 72 hours. Some 27.4% were opposed to dispensing EC, primarily because of religious (86.1%) and moral (80.6%) beliefs. Most (57.7%) believed that there should be a minimum age (mean +/- SD, 17.25 +/- 1.93 years) for patients receiving EC. Less than one half (46.7%) had heard of PIEC. Although pharmacists agreed (3.42 +/- 1.38) that PIEC would enhance the role of community pharmacists, they were unwilling (2.71 +/- 1.54) to participate in PIEC. Significant predictors of willingness to participate in PIEC included background characteristics, experience with EC, as well as benefits and barriers associated with PIEC. A regression analysis indicated that these significant predictors accounted for 58.6% of the total variance in willingness to participate in PIEC. CONCLUSION: A majority of Texas community pharmacists were quite knowledgeable about and aware of EC, but fewer had actually dispensed EC. Most had not heard of PIEC before study participation, and their perceptions relating to PIEC were generally unfavorable. Potential barriers to PIEC outnumbered potential benefits for most pharmacists. Findings indicate that Texas community pharmacists were not willing to become involved in PIEC at the time of this study.     

Hormonal emergency contraception.

In the 1960s, high-dose estrogen was identified as a highly effective emergency contraceptive but was associated with a high frequency of nausea and vomiting. The combination of low-dose estrogen and a progestin (the Yuzpe regimen) is highly effective and much better tolerated. Recently, a progestin-only regimen containing levonorgestrel was found to be more effective than the Yuzpe regimen and caused significantly less nausea and vomiting. Danazol, an antigonadotropin, is well tolerated but has questionable efficacy Mifepristone has several pharmacologic actions that make it highly effective with an adverse-effect profile similar to that of the Yuzpe regimen. Progress has been made in the last 3 years toward increasing the number of emergency contraceptives that are accessible to women in the United States, and several highly effective options are available. The most effective and well-tolerated regimen available is levonorgestrel. However, the barriers to access and low patient and provider awareness limit the impact of emergency contraception on the rate of unintended pregnancies.     

Documentation of pharmacists' interventions in an emergency department and associated cost avoidance.

PURPOSE: An analysis was conducted of pharmacist interventions and resuscitation experiences, including pharmacist participation in a hospital emergency department (ED), and the potential cost avoidance associated with the interventions made by the pharmacists. METHODS: All pharmacists working in the ED prospectively documented the pharmacist interventions that were accepted by physicians and nursing staff and entered into a spreadsheet on a weekly basis, between September 1, 2003, and December 31, 2003. Intervention categories included the provision of drug information; recommendations for dosage adjustment, formulary interchange, initiation of medications, alternative drug therapy, discontinuation of drug therapy, changes in medication therapy due to allergy notification, drug therapy duplication prevention, or changes in the route of drug administration; questions from nursing staff; order clarifications; drug compatibility issues; patient information; toxicology; and drug interaction identification. Intervention data were analyzed and the likelihood of harm was scored; interventions were classified and analyzed by calculating average cost, probability of harm, and potential cost avoidance. RESULTS: During the study, 2150 pharmacist interventions were documented. Pharmacists participated in the care of 1042 patients triaged to the resuscitation area of the ED. Cost avoidance during the study was determined to be 1,029,776 dollars. CONCLUSION: The most commonly documented interventions made by pharmacists involved in the care of patients visiting the ED included provision of drug information, dosage adjustment recommendations, responses to questions from nursing staff, formulary interchanges, and suggestions regarding initiation of drug therapy. The potential cost avoidance attributable to the pharmacist interventions during the study period was over 1 million dollars.     

Levonorgestrel emergency contraception and bodyweight

Objectives: Emergency contraception (EC) provides an opportunity to avoid an unwanted pregnancy following unprotected sexual intercourse (UPSI), failure of a regular contraceptive method, or after sexual assault. Two main methods are currently available: oral pills or the copper-T intrauterine device. In recent years there has been some debate regarding the efficacy of oral therapy in obese women. In this brief commentary we review new evidence, published after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) referral of 2014, relating to the effect of obesity on the pharmacokinetics and clinical efficacy of levonorgestrel EC in light of some of the concerns that have been raised.

Methods: A PubMed literature search (“levonorgestrel” and “emergency contraception”) was conducted between 1 January 2005 to 31 March 2018; results from the main clinical trials are discussed. Additional literature known to the authors and identified from the reference lists of cited publications was included.

Results: Overall, it should be noted that, in studies which determined pregnancy rates across different weight or BMI categories, the overall pregnancy rate was low (1–2%) and there was no direct evidence that lower levonorgestrel plasma levels contributed to an increased pregnancy rate in obese women. This conclusion was reached by the EMA referral in 2014 and they concluded that emergency contraceptive pills (ECPs) could be taken regardless of body weight or BMI, as soon as possible after UPSI. Since the EMA review, additional evidence has been published regarding this topic. This includes PK data (which can neither support, nor deny the previously submitted meta-analyses during the Article 31 Referral procedure), or re-analyses of the previously submitted data.

Conclusions: Evidence published since the EMA referral in 2014 does not change the original conclusions of the agency, which recommended that ECPs could be taken regardless of body weight or BMI, as soon as possible after UPSI.     

Levonelle-2 for emergency contraception

About 190,000 therapeutic terminations of pregnancy occur in the UK each year. Many of these could be prevented by the use of emergency contraception. We have previously discussed the use of combined hormonal emergency contraception. Now, a progestogen-only emergency contraceptive, levonorgestrel in the form of [symbol: see text]Levonelle-2 (Schering Health), has been licensed in the UK. The manufacturer claims that the treatment offers "unsurpassed efficacy in oral emergency contraception" with "significantly less nausea and vomiting than combined oral emergency contraception". We investigate these claims and discuss whether Levonelle-2 is an advance in emergency contraception.     

Levonorgestrel-only dosing strategies for emergency contraception

The United States Food and Drug Administration-approved progestin-only dosing strategy for emergency contraception is levonorgestrel 0.75 mg taken as soon as possible within 72 hours of unprotected intercourse, with a second 0.75-mg dose taken 12 hours later. However, different dosing strategies have been studied and promoted by various organizations. The American College of Obstetricians and Gynecologists recommends a single dose of levonorgestrel 1.5 mg for emergency contraception as one option. As another option, they recommend two doses of levonorgestrel 0.75 mg may be effective when taken 12-24 hours apart. We performed a search of MEDLINE and International Pharmaceutical Abstracts from 1967-2006 to evaluate and describe the existing pharmacokinetic and patient outcome data regarding administration of levonorgestrel as a 1.5-mg single dose or two 0.75-mg doses taken 12 or 24 hours apart. Additional studies were identified from the bibliographies of the selected literature. Several pertinent articles were identified. All of the studies demonstrated that emergency contraception effectively prevented pregnancy. In addition, evidence supports the safety and efficacy of a single dose of levonorgestrel 1.5 mg for emergency contraception. Furthermore, when two doses of levonorgestrel 0.75 mg are administered, the second dose can confidently be taken 12-24 hours after the first without compromising efficacy. Understanding the evidence that supports the different emergency contraception dosing strategies is critical for clinicians, and especially pharmacists, who have interactive roles in dispensing emergency contraception.     

How safe is emergency contraception?

Emergency contraception is used to prevent pregnancy after unprotected sex but before pregnancy begins. Currently, women can use emergency contraception by taking higher doses of the active ingredients found in ordinary oral contraceptive pills [either combined estrogen-progestogen (progestin) or progestogen-only formulations], or by having providers insert copper-bearing intrauterine devices (IUDs). The antiprogestogen mifepristone also has an excellent efficacy and safety profile as emergency contraception, but it is currently available for this indication only in China. Many studies have documented providers' and women's fears about the individual and public health safety risks of emergency contraception. Some of these concerns include potentially increased risks of cardiovascular events (including arterial and venous disease), worries about possible effects on future fertility, feared teratogenic consequences following method failure or inadvertent use during pregnancy, exaggerated or extreme fears of adverse tolerability, and concerns about drug interactions with other medications. Wider public health questions include feared reductions in the use of ongoing, more effective contraception, possible 'abuse' of emergency contraception through overly frequent use, and potential increases in risky sexual encounters (owing to the existence of a back-up, postcoital method) and therefore in rates of sexually transmitted infections, including HIV/AIDS. These fears can each be generally allayed. Direct and indirect investigations of emergency contraception in the biomedical and social science literature, the extensively documented safety profile of ordinary oral contraceptives, and more than 30 years of clinical experience since hormonal emergency contraception was first described, give strong evidence for its safety. This review confirms declarations by the World Health Organization and the US Food and Drug Administration, and shows that emergency contraception has an excellent safety profile in nearly all women. Finally, emergency contraception allows women a second chance to avoid unwanted pregnancies. Whether pregnancy is carried to term or terminated, the condition has inherent risks that are greater than any posed by emergency contraception.     

不同剂量国产米非司酮用于紧急避孕的临床研究

目的 探讨不同剂量国产米非司酮用于紧急避孕的临床疗效。谅圻内对４００余名要求紧急避孕者，分别给予不同剂量的米非司酮片１００ｍｇ、５０ｍｇ、４０ｍｇ、２０ｍｇ、１０ｍｇ，观察紧急避孕效果，药物副反应，月经复潮情况。结果 避孕有效率为９５％可信区间分别为１００ｍｇ组８４．１１％～９６．９５％，５０ｍｇ组９３％～１００％，４０ｍｇ、２０ｍｇ、１０ｍｇ组均为８８％～１００％。药物副反应发生率分别为２４％、     

不同剂量米非斯酮用于紧急避孕的临床观察

目的比较米非斯酮10 mg和25 mg用于紧急避孕的有效性,副反应及可接受性.方法将无保护性交后72 h内的198例健康育龄妇女随机分为2组.Ⅰ组198例,口服米非斯酮10 mg;Ⅱ组100例,口服25 mg.于预期下次月经日期的第7天随访,了解避孕效果、副反应及月经的变化.结果 2组紧急避孕的有效率分别为89.28%和89.04%,无统计学差异(P＞0.05);各种副反应发生率较低,均在10%以内,2组相近;2组月经延迟5天以上者的比率分别为8.16%和12%,差异有显著性(P＜0.05).结论 10 mg米非斯酮用于紧急避孕优于25 mg米非斯酮.     

An assessment of community pharmacists' responses to hypothetical medical emergency situations

Objective To investigate community pharmacists' proposed actions in hypothetical medical emergency situations in South‐East Queensland, Australia. Method A survey was posted to 151 Gold Coast and Toowoomba community pharmacies in October 2009. Pharmacists were asked to document their opinions regarding the pharmacist's role in medical emergencies and to respond to statements associated with two hypothetical medical emergency situations: an anaphylaxis and an asthma attack. Key findings Forty‐five pharmacists responded to the survey (29.8%). In response to a hypothetical situation involving an asthma attack, 41 pharmacists (91.1%) agreed that they would assist the asthmatic person to administer salbutamol through a spacer, with 28 pharmacists (62.2%) confident in treating an asthma attack in the pharmacy. In comparison, only 21 pharmacists (21/38; 55.3%) agreed to administer an adrenaline auto‐injector (Epi‐Pen) for a child experiencing an anaphylaxis, with nine respondents (9/38; 23.7%) indicating that they would ask the mother for directions in a situation where they were unsure how to administer it. There were comments questioning whether indemnity insurance covers pharmacists for medicine administration, and 12 pharmacists (12/38; 31.6%) indicated that if they were unsure about insurance cover they would ask the mother to administer the adrenaline. Conclusion Pharmacists' responses to administering medications in hypothetical medical emergencies were variable. The cause of this variation is multi‐factorial and likely to include familiarity with the medication, its safety profile and uncertainty about the pharmacist's role and responsibilities in these situations. Further clarification, training and guidelines are needed in order to address this.