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Evaluation of Patient Assessment and Counseling of Over-the-counter Oral Contraceptives by Community Pharmacists in South Korea: A Mystery Shopper Study
Yakhak Hoeji 2020;64(4):250-256
Published online August 31, 2020
© 2020 The Pharmaceutical Society of Korea.

Bo Hee Lee and Yun Jeong Lee#

College of Pharmacy, Dankook University
Correspondence to: #Yun Jeong Lee, College of Pharmacy, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam 31116, South Korea
Tel.: +82-41-550-1445
Fax: +82-41-559-7899
E-mail: yunlee@dankook.ac.kr
Received April 13, 2020; Revised May 20, 2020; Accepted May 25, 2020.
Abstract
Oral contraceptives (OCs) are readily available without a prescription in South Korea. We aimed to evaluate the quality of patient assessment and medication counseling of over-the-counter (OTC) OCs by community pharmacists in South Korea. This was a cross-sectional mystery shopper study, where trained mystery shoppers visited pharmacies and asked for an oral contraceptive for contraception purposes. A total of 54 pharmacies were visited. Majority of pharmacists (75.9%) conducted counseling of OTC OCs during the visit. Of the 24 evaluated medication counseling and patient assessment items, median of 3 (IQR 0.3 to 5) points were achieved and median counseling time lasted 22 (IQR 3.0 to 42.3) sec. Pharmacists spent more time on counseling of administration instructions and basic counseling points of the OC, but more detailed patient assessments, such as the presence of concurrent medications or drug allergies were conducted less often. Pharmacists in their 30s and 40s provided more information than those who were in their 50s and older, while no difference was observed when analyzed by pharmacists’ gender. There are room for improvements in patient assessment and counseling of OTC OCs by the community pharmacists and such improvements is imperative to ensure safe and efficacious use of OCs.
Keywords : Oral contraceptives, birth control, pharmacy, pharmacist, counseling, mystery shopper
Introduction

Oral contraceptives (OCs) are the second most commonly used reversible contraceptive method in the world, used by 8.8% of women worldwide.1) While the combined OCs consisting of estrogen and progestin are very effective with failure rate of 0.3% with perfect use and 9% with typical use,2) they are associated with adverse events such as headache, nausea, dizziness, breast tenderness, and irregular bleeding, as well as more serious adverse events such as thromboembolism.3) In addition, there are certain conditions in which OCs are contraindicated in, such as smoking in those aged ≥35 years, uncontrolled hypertension, and migraine with aura,4) and adequate patient assessment and counseling by the pharmacists can help decrease the use of OCs in women with contraindications.5)

In South Korea, combined OCs are available in the pharmacy without a prescription, with the exception of fourth generation progestin-containing OCs which are prescription-only drugs. While over-the-counter (OTC) OCs contain product labeling within the packaging, it has been reported that OTC product labeling is not always comprehensible by an adult user and selfscreening of contraindications or understanding of potential adverse drug events could be challenging.6) Therefore, pharmacists’ role in patient assessment and medication counseling is critical to ensure efficacious and safe use of OCs.

To date, there has been lack of studies that evaluated the realworld status of OTC OC counseling conducted by community pharmacists. Most previous mystery shopper method studies have focused on counseling of emergency contraceptives.7-12) While there have been few studies that evaluated the counseling conducted on OCs in the pharmacy,13-16) they were either on prescription OCs,13) described encounters mostly with pharmacy sales assistants,14) or had limited in number of participating pharmacies.15) Additionally, these studies generally focused on whether counseling was conducted and put less focus on contents of the counseling.

Interestingly, several previous studies evaluated the potential differences of OC counseling encounters based on the gender of the pharmacists. In a simulated patient study, female pharmacists were observed to be more empathic to emergency contraceptive users during counseling sessions,9) and another study reported that pharmacists perceived OC users as welcoming female pharmacists’ counseling more than that of male pharmacists.17) While gender differences of the pharmacists did not translate into differences in counseling quality in these studies, it is possible that gender of the pharmacist may result in differences in some aspects of OC counseling encounters.

In this study, we aimed to evaluate the quality of patient assessment and medication counseling of OTC OCs provided by community pharmacists in South Korea using the mystery shopper method. We also aimed to evaluate differences in the quality of patient assessment and counseling based on the demographics of the pharmacists. Through this study, we intended to suggest areas of improvement in medication counseling of pharmacists to enable safe and effective use of OCs in women.

Research Methods

This was a prospective, cross-sectional mystery shopper study conducted in Cheonan-si, Chungcheongnam-do between July to August, 2017. Mystery shopper is a type of a research method utilized to monitor the quality of processes and procedures used in the delivery of a service while mystery shoppers act as potential customers.18) It has advantages in that information from real-life situations can be collected to evaluate the quality of services from the perspectives of customers and it has been suggested to be a useful tool in health service evaluations.19,20) This study was approved by the Institutional Review Board (IRB) at Dankook University (IRB approval no. 2017-05-024). Before undertaking the study, we informed the purpose and expected dates of the study to pharmacies in the Cheonan-si area through Cheonan Pharmaceutical Association.

Sample size

As we hypothesized that gender of the pharmacist may affect some aspects of patient assessment and medication counseling, we conducted a pilot study amongst six (three male and three female) pharmacists to determine the adequate sample size for the study. During the pilot study, the response rate was determined to be 4.5 points out of 24 evaluated items, and the effect size was calculated to be 2.25 when predicted differences between male and female pharmacists were 3 points. Therefore, the standard size derived from the calculation was 14.5 and each group was calculated to be 15. Accounting for dropouts and losses during the study, the minimum number for each gender group of pharmacists was determined to be 20, amounting to a minimum of 40 pharmacists.

Scenario

The profile of the mystery shopper was set for a female who is planning to take OCs for the first time to prevent pregnancy. The mystery shopper is to walk into the pharmacy and request for an OC (i.e. “Hi, I would like to purchase an oral contraceptive.). The mystery shopper will not mention the purpose of taking the OC unless inquired and will not request for a specific brand name OC product. It was predetermined that the shopper did not have any underlying disease or surgical history. However, shoppers would respond that they are smokers when inquired. In order to collect data under the same conditions, mystery shoppers were trained not to deviate from the scenario and were not allowed to ask questions spontaneously during the pharmacy visit.

Mystery shoppers

Four female pharmacy students in their 20s volunteered to be mystery shoppers. Prior to initiation of the study, shoppers were educated on the background knowledge and methods of the study, including the study scenario. After comprehension of the mystery shopper study scenario, they received additional training through role playing sessions with research personnel who are licensed pharmacists. Four mystery shoppers had the same scenario, and the list of pharmacies to visit were divided evenly among them.

Data collection and statistical analysis

List of pharmacies in Cheonan-si was provided by the Cheonan Pharmaceutical Association. The list was divided into geographical zones and targeted pharmacies were chosen at random prior to the visits. Pharmacy visits were voice recorded, and after making a visit to a pharmacy, the following items were recorded immediately: pharmacists’ age estimated by the mystery shopper, time of the day visited, and length of medication counseling time, defined as the time between inquiry on OCs to the end of the counseling session. Study personnel scored the content of the medication counseling through the voice recording based on 24 evaluated items (1 point for each counseled points, for a total of 24 points). Observational items utilized in this study were created with reference to the Standard Procedures Algorithm for Oregon RPh Prescribing of Contraceptives and Hormonal Contraceptive Self- Screening Questionnaire by the Oregon Health Authority.21,22) Oregon was the first state in the United States to pass a legislation to allow pharmacists to prescribe hormonal contraceptives to women, and the Standard Procedures Algorithm is an algorithm used by the pharmacists in Oregon to evaluate the patient and guide appropriate care.23) The observational items in this study consisted of 4 categories: patient assessment (8 items), basic counseling (4 items), medication administration counseling (6 items), and adverse drug events counseling (6 items). The numerical data was used to calculate the median and interquartile ranges using Microsoft Excel 2013. Statistical values were calculated by Mann-Whitney Rank Sum Test or one-way ANOVA (ANOVA on Ranks) analysis using Sigmaplot 13.0.

Results

Four mystery shoppers visited a total of 54 pharmacies in Cheonan area. Demographic information of the pharmacists and pharmacies are shown in Table 1. Of the 54 pharmacists encountered, 23 (42.6%) of them were female. The most commonly encountered estimated age group of the pharmacists was those in their 40s, followed by those in their 60s. Most (72.2%) of the visited pharmacies were located near general (non-obstetrics and gynecology) clinics.

Basic demographics of visited pharmacies (N=54)

Pharmacist gender N (%)

Male 31 (57.4)
Female 23 (42.6)
Estimated age of the pharmacist N (%)

20s 4 (7.4)
30s 12 (22.2)
40s 18 (33.3)
50s 4 (7.4)
60s 14 (26.0)
70s 2 (3.7)
Location of pharmacy* N (%)

Near general hospitals 4 (7.4)
Near clinics 39 (72.2)
Near obstetrics and gynecology clinics 7 (13.0)
None of the above 4 (7.4)

*Based on presence of the hospitals/clinics within 30 m of the pharmacy. If more than one applies, order of priority is general hospitals > obstetrics and gynecology clinics > clinics



Assessment of medication counseling

A total of 75.9% of the visited pharmacies conducted medication counseling, while in 24.1% of cases, medication counseling was not conducted. Of the 24 observational items, the median number of items counseled on was 3 points (IQR 0.3 to 5 points) (Table 2). A total of 31 pharmacists (57.4%) scored between 1 to 5 points, and 10 pharmacists (18.5%) scored between 5 to 10 points, with the 9 points being the highest score recorded. The total length of time for medication counseling lasted for a median of 22 sec (IQR 3.0 to 42.3 sec). When analyzed by gender, there was no significant difference in both the mean score (male 2.8±2.8 points, female 3.6±2.5 points, p=0.209) and the length of counseling (male 28.6±40.5, female 35.2±30.5, p=0.137) (Fig. 1). However, when analyzed by the pharmacists’ estimated age, significant difference in the mean score and the length of the counseling was observed; pharmacists in their 30s and 40s provided more counseling points (30s 4.6±2.4 points, 40s 4.6±2.6 points) and spent the most time conducting the counseling (30s 54.3±42.1 points, 40s 41.2±40.1 points), while pharmacists in their 50s and older provided less counseling points (1.3±1.9 points, overall by age group p≤0.001) and spent less amount of time (8.5±14.5, overall by age group p=0.001) (Fig. 1). No significant difference in counseling score or length of time was observed when analyzed by the pharmacy location category or time of the day visited (data not shown). When medication counseling was further divided into categories, it was observed that pharmacists most frequently counseled on providing medication administration instructions (2.1±1.8 out of 6 items, 34.6%), followed by basic counseling (0.6±0.8 out of 4 items, 14.6%). The category with least points obtained was on patient assessment (0.1±0.4 out of 8 items, 1.4%) (Table 2).

Performance of patient assessment and counseling performed to mystery shoppers

Medication counseling performed N (%)

Yes 41 (75.9)
No 13 (24.1)
Medication counseling category (total items) Mean±SD Percent total (%)

Patient assessment (8) 0.1±0.4 1.4
Basic counseling (4) 0.6±0.8 14.6
Medication administration counseling (6) 2.1±1.8 34.6
Adverse drug events counseling (6) 0.3 ± 0.6 4.6
Total (24) 3.1 ± 2.7 13.1



Fig. 1. Observed counseling scores (out of 24 points) by gender (A) and estimated age of the pharmacists (B) and counseling time (in sec) by gender (C) and estimated age of the pharmacists (D). Box-whisker plot showing median (horizontal line), interquartile range (box) and 95% CI (whiskers)

Within the medication administration category, the most counseled item was on taking the medication same time every day (51.9%), followed by taking medication once a day (44.4%), instructions on 7-day placebo pills (42.6%), and initiation instructions (38.9%) (Table 3). For the basic counseling category, pharmacists most commonly inquired on the purpose of the oral contraception (44.4%), followed by discussion on the possibility of contraceptive failure (18.5%). Some of the adverse drug events for OCs were discussed, with nausea or abdominal pain being the most common (16.7%), followed by headache (5.6%) and venous thromboembolism (5.6%). While patient assessment information was least collected during the counseling sessions, most commonly collected data was smoking status (9.3%). There were multiple observation items that none of the mystery shoppers were assessed on (i.e. first day of last menstrual period, recent delivery or possibility of pregnancy, breastfeeding status, underlying diseases or past surgery) or counseled on (i.e. possibility of weight gain, breast pain or tenderness, depression or mood swings) (Table 3).

Frequencies of patient assessment and medication counseling performed by observational items

Category Observation Items N (%)
Patient assessment Smoking status 5 (9.3)
Current medications 1 (1.9)
Drug allergies 1 (1.9)
First day of last menstrual period 0
Recent delivery or possibility of pregnancy 0
Breastfeeding status 0
Underlying disease(s) 0
Prior surgery 0

Basic counseling Inquiry on the purpose of oral contraception 24 (44.4)
Discussion on possibility of contraception failure 10 (18.5)
Coping strategies for adverse drug events 2 (3.7)
Invitation of patient to a private area 0

Medication administration counseling Take medication at the same time every day 28 (51.9)
Once daily dosing 24 (44.4)
7 day placebo after taking medications for 21 days 23 (42.6)
Initiation instructions 21 (38.9)
Strategies for missed doses 13 (24.1)
Presence of bleeding during placebo 5 (9.3)

Adverse drug events counseling Nausea or abdominal pain 9 (16.7)
Headache 3 (5.6)
Venous thromboembolism 3 (5.6)
Weight gain 0
Breast pain or tenderness 0
Depression or mood swings 0

Discussion

We evaluated the quality of patient assessment and medication counseling of OCs at community pharmacies in a nonmetropolitan city in South Korea using the mystery shopper method. In general, the quality of counseling on OCs were less than optimal. While the medication counseling was conducted in majority of cases (75.9%), some were not conducted at all, and when counseling was conducted, median of 3 out of 24 observational items (12.5%) were conducted. This finding is not dramatically different from previous studies, where 21.7% of the mystery shoppers did not receive information for OTC OCs in Mexico,13) and 85.4% of the mystery shoppers did not receive any counseling for prescription OCs in Brazil.15) However, such finding is still alarming as South Korea is a developed nation with high healthcare quality and access, ranking in the second highest decile among 195 countries.16)

Unlike previous studies, this study evaluated detailed contents of the patient assessment and medication counseling of OCs in the community pharmacy setting. In this study, pharmacists spent most of the time counseling on medication administration directions, purpose of the OC, 7-day placebo pills, and initiation instructions. Inquiring on the purpose of the OCs is important as more women in South Korea take OCs to delay periods (60.8%), than for contraception purposes (47.1%, multiple answers allowed),24) and administration instructions are different between the two usages. On the other hand, counseling on adverse drug events were not performed frequently and detailed patient assessments, such as presence of concurrent medications, drug allergies, first day of last menstrual period were least performed. Observations in this study indicated that pharmacists put more emphasis on the efficacy and less on safety of OC use during patient counseling.

While gender of the pharmacists did not appear to have an impact on the time and contents of medication counseling, it was interesting that the age of the pharmacists influenced the time and contents of medication counseling. Pharmacists in their 30s and 40s were more likely to provide longer, more detailed medication counseling, which was consistent with a previous finding that younger pharmacists are likely to provide more information during medication counseling.25) It is possible that pharmacists in their 30s and 40s may be able to relate and understand the importance of family planning and proper use of oral contraceptives more than other age groups. However, all pharmacists regardless of their age should make efforts to ensure safe and efficacious use of oral contraceptives, as pharmacists may be the only healthcare providers that women come in contact with for getting access to OTC OCs.

In the United States, OCs are classified as prescription-only drugs. However, 10 jurisdictions have statutes or regulations that allow pharmacists to prescribe contraceptives.26) In these jurisdictions, pharmacists assess the appropriateness of contraception use of the patient, determine the appropriate contraception method, provide adequate education on the use of the contraception, and provide access to the contraception by furnishing or prescribing a contraceptive. Through these statutes and regulations, patient accessibility to contraceptives is enhanced, and patient safety and efficacy of contraceptive use can be ensured through patient evaluation and medication counseling by the pharmacists. As OCs are available without a prescription in South Korea, pharmacists are in an optimal position to take on the responsibility to properly assess and counsel patients.

A previous study found that while most pharmacists are interested in providing direct access and services to hormonal contraceptives, barriers included lack of payment for services and lack of time.27) It is possible that pharmacists in the present study had similar barriers. Currently, pharmacists are not compensated for patient assessment and counseling of OTC products and limited time for pharmacist-patient encounter may only allow time for a quick counseling of OCs. A previous study in South Korea reported that patients prefer to obtain more detailed information while receiving counseling on OCs.24) It should be kept in mind that during counseling, pharmacists should always make efforts to ensure patient understanding and avoid medical jargon, as it has been reported that the level of patient understanding of medical terms during medication counseling are low, especially with written materials.28) After pharmacists make proactive efforts for patient evaluation and counseling of OCs, adequate compensation for the level of service provided can be addressed afterwards.

There are several limitations in this study. First, this study was limited to one region in South Korea. It would be interesting to conduct a larger scale study in multiple regions and compare variations in the counseling provided based on the size of the cities or socio-economical differences. Second, the study was limited to only one mystery shopper scenario. Having multiple scenarios with different patient situations could depict a more comprehensive picture of the status of OC counseling.

Conclusion

In conclusion, current status of patient assessment and counseling of OTC OCs by pharmacists in South Korea is less than optimal and pharmacists’ medication counseling was focused more on efficacy than safety. Pharmacists in their 30s and 40s were most active in providing counseling compared to other age groups, while gender was not a factor in determining the quality or quantity of OC assessment and counseling. Improvements in medication counseling quality of OTC OCs -especially in the area of patient assessment and counseling of adverse events- is imperative in to ensure safe and efficacious use of OCs.

Acknowledgment

This work was supported by the National Research Foundation of Korea (no. NRF-2017R1C1B1003141). The authors would like to thank the four pharmacy students-Minah Park, Sinyeong Park, Jungeon Park, and Jieon Oh- who have volunteered as mystery shoppers in this study.

Conflict of Interest

The authors have no conflict of interest to declare.

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