Introduction

The use of combined oral contraceptives (COC) is the most common reversible method of birth control in developed and developing countries. Nearly 100 million women worldwide use this method. COCs contain a combination of synthetic estrogen and a steroid with progestational activity; appropriate use of COCs can yield contraceptive efficacy greater than 99% [1]. Besides prevention of pregnancy, there are several other non-contraceptive benefits associated with the use of COC, such as reduction in the risk of ovarian and endometrial cancers and improved regulation of menstruation [2,3].

Despite the contraceptive and non-contraceptive benefits, COCs are associated with a high self-reported 12-month discontinuation rate (approximately 50%). COC discontinuation has been reported to lead to unintended pregnancies in more than 50% of cases [1,4]. Unintended pregnancies carry a huge humanistic and economic burden to the individuals and to society, with an estimated cost of $11.1 billion each year in the United States [5]. Access to COCs in a majority of countries is by prescription only, making it necessary to contact a physician to have access to these pills. This form of access poses some difficulties for many women who wish to acquire COCs, and is reported as one of the most common reasons for not using COCs, or introducing gaps in the use of COCs [4,6,7]. Other frequently reported barriers to COC adherence is a lack of patients’ knowledge of COC contraceptive and non-contraceptive benefits, suggesting that health care professionals need to provide adequate evidence-based contraceptive counseling [4,8]. These results suggest a need for developing practices that improve long-term COC adherence.

Currently, there is a debate about whether over-the-counter (OTC) access to COCs should be allowed, with an attempt to improve COC access and use [9,10]. However, no drug or intervention is completely without risk of adverse effects for the patient. Women presenting with specific pre-existing conditions are at an increased risk of developing myocardial infarction, stroke, thromboembolism (DVT)/pulmonary embolism (PE), and other health problems associated with the use of COCs [11,12]. These pre-existing conditions included age > 35 years, smoking of >15 cigarettes/day, elevated blood pressure levels (systolic > 160 mmHg or diastolic > 100 mmHg), diabetes with nephropathy/retinopathy/neuropathy or other vascular disease, diabetes a duration of >20 years, migraine with aura, presence or history of DVT or PE, history of ischemic heart disease, history of cerebrovascular accident, complicated valvular heart disease, and less than <21 days after childbirth (with or without other risk factors for venous thromboembolism). It is recommended that health professionals conduct a screening for safe use before the patient begins using COCs. This screening should involve evaluation of the patient’s medical history, family history and blood pressure before the patient begins using COCs, with periodic evaluation thereafter [13,14].

Previous pharmacoepidemiological studies have reinforced the importance of conducting a screening to insure the safe use of COCs, given the significant number of women in whom these agents are contraindicated. For example, one study using data from the National Health and Nutrition Examination Survey (NHANES) found that approximately 16% of women of reproductive age in the U.S. had at least one contraindication for COC use [15]. A study carried out in the U.S. city of El Paso found that approximately 39% of women of reproductive age had at least one contraindication for COC, noting that migraine with aura (17%) and hypertension (blood pressure of 140/90 mmHg or higher; 14%) were amongst the most common contraindications [16]. Of the conditions in which COCs were contraindicated in an estimated 18% women of reproductive age in areas along the U.S.-Mexico border, hypertension (8%) was the most common condition, followed by smoking at age 35 or older (5%), and migraine with aura (4%) [17].

The results of previous studies [16,18] verified that women could perform self-screening for contraindications as well as physicians, but some practical considerations must be addressed in reference to these studies. First, women in these studies reviewed COC contraindications by using a checklist developed by specialists, an option not offered at practitioner’s offices and an activity that would be difficult to implement on a large scale in clinical practice. This is particularly difficult to implement in developing countries with few economic resources invested in health policies and high rates of health illiteracy. Second, the patients recruited for these studies had a higher mean level of education, which did not represent the educational profile of women in many developing countries and can have direct effects on the self-screening process. For example, the findings of a study carried out in areas along the U.S.-Mexico border supported the hypothesis that women who obtain COCs OTC in a real-life situation are more likely to experience adverse effects than patients who obtain COCs with a medical prescription [17]. These results highlight the need to adopt strategies that are better adapted to the reality of developing countries, and the real-life situations of women in these countries.

Community pharmacists (CPs) could play a vital role in the access to COCs (OTC or prescription), since they are in a strategic position to help screen patients for contraindications and counsel patients during the dispensing process on the correct use of COCs. Prior to drug consumption, the process of drug dispensation (either OTC or prescription) is the patient’s last point of contact with a health professional, an action performed and/or supervised by a CP in the majority of countries. Pharmacy-based screening for safe use of COCs, and counseling regarding the correct use, benefits, and adverse effects of COCs can improve patient adherence and safety [19]. Based on the results of previous studies indicating the potential and ability of CPs to provide effective clinical services in the community setting, the American College of Clinical Pharmacy (ACCP) supports the change of COCs to OTC with the condition that they are sold where a pharmacist is on duty [20]. The ACCP also states that there is a need to evaluate how COCs are actually dispensed, in order to identify the CPs’ role in COC access [20]. However, to the best of our knowledge, there are few studies evaluating the COC dispensing practices of CPs either OTC or with a prescription.

Although many women use COCs, very little is known about COC dispensing practices compared to what is known about the dispensing practice of emergency contraception pills (ECPs) [21-24]. Previous studies verified that the practice of dispensing ECPs is not carefully undertaken, with infrequent collection of patient history and limited engagement in patient counseling [21-24]. Differences in indication, drug dosage, and contraindications comparing ECPs and COCs also make it difficult to extrapolate predictions for COCs from published data.

Additionally, most of the earlier studies administered self-reported questionnaires to CPs, or conducted patient interviews to evaluate dispensing practices [25-27], which could have led to an overestimation of the rate of effective COC dispensing practices. For example, in methods such as self-reported questionnaires and interviews, the CPs and/or the patients know that a test is being conducted. This can alter the testee’s performance, yielding results that do not express what actually happens in the pharmacy practice setting [28]. In this respect, the simulated patient (SP) method has been shown to help overcome the methodological problems of other quantitative methods like self-reported questionnaires and interviews, and has become a useful and objective tool for evaluating professional performance [29]. The SP method focuses on actual behaviors rather than proxy measures [30]. A SP is an individual who is trained to visit a pharmacy and enact a scenario previously developed by researchers that tests a specific behavior of the pharmacist or pharmacy staff member. The professionals who are being audited are unaware that the SP is not a genuine patient and that they are being evaluated [30]. The aim of this study was to evaluate the COC dispensing practice of CPs by using the SP method.

Methods

Results

Discussion

To our knowledge, this is the first study to use the SP method to evaluate the COC dispensing practices of CPs in a large number of cities in a developing country. Awareness of gaps in the COC dispensing practice could help in the development of interventions to address this public health problem. The results demonstrate that most CPs did not perform screening for the safe use of COCs (92.7%) neither did they provide counseling on COCs (85.4%). The professionals who attempted to perform screening and provide counseling did so inadequately. Efforts to improve the COC dispensing practice must be addressed in order to guarantee the rational use of COC as an OTC or as a prescription-only drug.

Previous studies indicated that women desire active participation of the CPs in the process of accessing COCs. In a study by Landau et al [45], women stated that they believe that CPs should provide information on instructional methods (75%), provide screening and counseling regarding the method (46%), and be available to answer questions (24%). In this study, women also reported that they were more comfortable assessing COCs as OTC if CPs participated in this process [45]. Almost every woman who participated in the Direct Access Study was satisfied or very satisfied with the CP services focused on the provision of COCs. They indicated a willingness to recommend this service to a friend, and were also willing to pay for this kind of service [19]. These results suggested that women wish to be screened for contraindications and counseled by CPs regarding the use of COC.

However, similar to the findings reported by previous studies, we found that many CPs did not ask the women any questions neither did they measure their blood pressure when dispensing COCs. In Mexico City, only 31% of pharmacy workers reported having asked women any questions before selling drugs to them [25]. Chirdan and Zoakah found that 32.7% of pharmacy and chemist shop workers self-indicated that did not ask any questions of women who bought oral contraceptives [26]. Ratanajamit and Chongsuvivatwong found that COCs were sold with little or no history-taking in the city of Hat Yai, Thailand [46]. In a study carried out in Jamaica evaluating OTC access to COCs, the majority of CPs denied COC access to SPs presenting contraindications to COC use and recommended that these women consult a doctor to find out whether the pill would be safe for them before attempting to use the method [47]. In this study the SPs gave appropriate cues of the presence of contraindications to the CPs (for example, the SPs informed the CPs that they were smokers and had hypertension) [47]. However, on a daily basis, how many women will understand the significance of and inform the CPs about the existence of possible COC contraindications? Therefore, we strongly support the approach whereby CPs must actively engage patients in order to identify these contraindications, even in situations where appropriate cues are provided, similar to the scenario of our study.

The lack of screening for the safe use of COCs by CPs could present some risks for women, because in some conditions, unacceptable health risks are associated with concurrent use of COCs, and in other conditions, the theoretical or proven risks usually outweigh the advantages of using a COC [13,14]. For example, one meta-analyses established that the relationship between COC users with hypertension and risk of acute myocardial infarction (AMI) was 2.48 times (95% CI, 1.91–3.22) higher than that among nonusers without hypertension [48]. The likelihood of developing an ischemic stroke in COC users with a history of migraine was approximately eightfold higher than that in women without migraine (relative risk, 8.72; 95% CI, 5.05–15.05) [49] The prevalence of such risk factors for COC use is significant in women of reproductive age (range, 16–39%) [15-17].

Taking patients’ medical and family history and measuring the patients’ blood pressure systematically (for example, when the patient starts using COCs and subsequently at specific time intervals such as 4 months) during dispensation could help identify the presence of these dangerous conditions. For example, in a systematic review, Curtis et al. verified that the odds ratios for AMI were generally higher among COC users who had not had their blood pressure checked (OR, 2.76–9.47; 95% CI, 1.36–24.1) than among COC users who had (OR, 1.07–3.48; 95% CI, 0.66–8.70) [50]. CPs are in a strategic position to provide these clinical services to women, and could reduce the occurrence of negative outcomes associated with the use of COCs. Future studies evaluating the effect of screening by CPs for safe use on the negative outcomes of COCs use are needed.

In our study, every question asked by the CPs was closed-ended. Closed-ended questions reduce the patient’s degree of openness (the patient will answer as either “yes” or “no,” or in a few words at the most) and cause the patient to become more passive during the interview process [51], which may result in the loss of important information. Open-ended questions are more difficult to formulate but allow patients to become more involved in the communication process by allowing them to present information in their own words. Open-ended questions are also more effective for gathering information [51,52]. CPs must be aware of the importance of asking open-ended questions when interacting with patients.

Few CPs provided counseling when dispensing COCs, and the counseling provided by these few CPs was inadequate. Ratanajamit and Chongsuvivatwong found that COCs were sold with little or no counseling in the city of Hat Yai, Thailand [46]. The counsel provided by Jamaicans CPs to COC users was also inadequate, with a negligible number of CPs providing counseling regarding the best time to take the pill, steps to be taken on missing a pill or pills, the appropriate time to use backup methods, and the adverse effects of COCs [47]. A study carried out in Kuwait revealed that few CPs counseled women regarding COC use, with 17.4% and 13.0% providing counseling on their use and their adverse effects, respectively [27]. Previous studies found that a lack of counseling is a leading cause for incorrect use of COCs (for example, discontinuation and wrong attitude when missing pills) [1,5,53]. It is known that thorough patient counseling by pharmacists may improve adherence to pharmacotherapy, clinical outcomes, and patient satisfaction with pharmacy care [54-56]. It is therefore important that CPs provide counseling while dispensing COCs, to improve the quality of COC use.

Several guidelines have been published by professional organizations regarding the content, conditions, and circumstances for patient counseling [41-44]. Most of these guidelines suggest that the following information may be provided: name and description of the drug, indications, route of administration, dose and dosage form, directions for use, duration of therapy, special directions, precautions, adverse effects, and contraindications. These guidelines state that pharmacists need to individually tailor their counseling based on the patients’ understanding, culture, feelings, and cognitive abilities [41-44]. However, in our study, the CPs only provided counseling regarding dosage and a few adverse effects. Furthermore, the CPs who were studied also did not try to individualize counseling according to patient needs. Efforts are needed to improve counseling in COC dispensing practice.

This lack of screening for safe use and counseling regarding COC use could be attributed to several factors. For example, one third of the CPs of our sample have administrative functions in community pharmacies, including activities related to the acquisition and inventory control of drugs, leading to limited time and manpower to perform clinical activity directed toward the patient. Another factor underlying this kind of behavior is the CP’s focus on the product instead of the patient. Thus, assessment of the patient’s information needs is based on their medicines instead of posing questions to the patients. Furthermore, CPs may assume that patients who request a specific medicine are already knowledgeable about its use, and that asking questions and giving additional advice would be patronizing and could lead to a negative patient reaction [57,58]. Additionally, while U.S. pharmacy graduate programs have curricular requirements encompassing the various aspects of hormonal contraceptive service provision, including screening, prescribing, and monitoring [20], Brazilian pharmacy graduate programs are deficient in this respect.

Conclusion

Our results indicated that most CPs did not perform screening for safe use of COCs neither did they counsel the patients during drug dispensation. The few CPs that attempted to perform screening for safe use and counsel the patients, did so inadequately. These practice patterns may affect the occurrence of negative therapeutic outcomes such as adverse effects and treatment failure. Efforts are needed to improve COC dispensing practice in these Brazilian microregions to promote the rational use of COCs.

Supporting Information

Acknowledgments

The authors would like to thank the community pharmacists and simulated patients who participated of the study.