key: cord-0273343-644xyb9q authors: Barakat, M.; Al-Qudah, R.; Akour, A.; Abu-Asal, M.; Thiab, S.; Dallal Bashi, Y. title: The Use/Abuse of Oral Contraceptive Pills Among Males: A Mixed-Method Explanatory Sequential Study Over Jordanian Community Pharmacists date: 2021-03-12 journal: nan DOI: 10.1101/2021.03.11.21253403 sha: f87bce5f048b335f0498015896fb6ee7e7fd45d0 doc_id: 273343 cord_uid: 644xyb9q Background: Oral contraceptive pills (OCPs) are considered one of the most important birth control methods in the world. However, these pills were designed for female administration rather than males. This study was designed to investigate patterns of OCPs use and abuse among Jordanian males, according to the community pharmacists' observations. Method: A mixed-method explanatory sequential study was conducted using an online self-administered survey and semi-structured in-depth interviews for community pharmacists. The interviews were utilized using a conceptual framework. Inductive thematic analysis and descriptive/regression analyses were completed using Nvivo and SPSS, respectively. Results: A total of 158 questionnaire responses and 22 interviews were included in our analysis. Around half (48.4%) of the questionnaire responses confirmed that males could use OCPs for hair growth enhancement, muscle gain and acne treatment 12.7%, 31.7% and 4.4%, respectively. Through the interviews, the majority of the pharmacists highlighted that most of the males use OCPs for bodybuilding purposes, according to recommendations by their coaches at the gym. The most abused OCPs containing estrogen (Ethinyl estradiol) and progestins (Drospirenone or Levonorgestrel). Conclusion: This study provided insight into unexpected uses of OCPs by males in Jordan. Community pharmacists have a crucial role in the management of OCPs use and abuse, However, restricted regulations and monitoring must be released and implemented on the community to limit such practices. The non-therapeutic consumption of medications, in terms of abuse and misuse, is recently on the 70 rise. Medication abuse is defined as the usage of drugs for non-medical purposes [1] . The most 71 common medications which are prone to abuse are products containing opioids, stimulants and 72 laxatives [2] [3] [4] . However, the abuse of oral contraceptive pills (OCPs) has not been fully examined In Jordan, it was reported that OCPs are the second most common birth control method [9, 10] , 86 and OCPs are sold over the counter [9] . Such unsupervised practice could be associated with 87 inappropriate administration of many medications [11] including OCPs, as reported by the 88 Jordanian community pharmacist in a previous study [12] . In that study, pharmacists stated that 89 both genders are prone to OCPs improper usage, such as topical application of OCPs for hair 90 growth enhancement and OCPs were used to give a false negative result for an addictive drug 91 The first draft of the survey was appraised by 20 independent academic staff members who have 117 decent experience in oral contraceptives research studies; as well a statistician was consulted at 118 this stage of validation. The final version of the survey was refined according to the provided 119 comments and feedback, translated from English into Arabic and then was back-translated by two 120 specialized academics. The questions were free from medical jargon or difficult terminologies. 121 The final validation stage was the piloting step, which involved 25 academic and 25 non-academic 122 participants. This stage of the study was conducted to enhance clarity, readability, 123 understandability, and confirm the study applicability in the Jordanian community pharmacists. Internal consistency reliability was tested by the Cronbach's alpha coefficient (=0.82). The study survey included three parts. The first part (Part A) comprised nine questions including and practice towards OCPs usage by males; which consisted of ten multiple-choice questions. Based on Tabachnick and Fidell recommendation for sample size calculation in linear regression 132 analysis, 5-20 subjects per predictor are suggested to be preferable [14] . Based on the number of 133 independent variables levels used in this study (n = 9) and using the number of 10 subjects per 134 predictor level, a minimum sample size of 90 or higher was considered suitable for the purpose of 135 this study. In this study, the recruited sample was 162 community pharmacists who met the inclusion criteria. The eligibility criteria for participation are being Jordanian pharmacists and trainees (who were 138 working/training in community pharmacy). Sample-sized recruitment was conducted using a 139 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The qualitative study was conducted using semi-structured in-depth interviews for community 153 pharmacists. The sample was recruited purposively then maximum variation sampling was 154 conducted, to reach sample saturation (22 community pharmacists). Purposeful sampling directed 155 the researcher to find community pharmacists with pure experiences regarding OCPs usage among 156 males. In this regard, introductory pilot interviews were employed to find the pharmacists who 157 provide fruitful and detailed responses then the selected pharmacists participated in in-depth 158 interviews. A series of questions regarding the use of OCPs among males were asked and answered freely by 160 the participants. This research instrument was reviewed by a group of leading clinical pharmacy 161 researchers to ensure the suitability of the measurement tool. The interview included three probing 162 questions. The first was "From your experience, please describe how could males use the OCPs", 163 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted March 12, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 and the second was "What is the best way to limit the abuse of OCPs among males?", each 164 interview lasted for 25 minutes. The participants were informed that all the data will be treated 165 confidentially and signed electronic informed consents. The interviews were recorded and 166 transcribed verbatim. Transcripts were written in Arabic (the native language of Jordan), translated 167 into English, checked for clarity and accuracy, uploaded to NVivo12 (qualitative data analysis 168 software; QSR International Pty Ltd. Version 12) for coding and then analyzed using inductive 169 thematic analysis using conceptual framework methods [15] . The inter-rater reliability was About half of the pharmacists (n=75, 47.5%) have been working in community pharmacies for 184 more than 10 years, which is located in the capital of Jordan "Amman" (n=115, 72.3%). Around 185 74% (n=117) of the pharmacy's customers were classified as middle social class, from the 186 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted March 12, 2021. ; https://doi.org/10.1101/2021.03.11.21253403 doi: medRxiv preprint pharmacists' perception. It is worth noting that 44.7% (n=71) of the pharmacies were adjacent to 187 sports gyms (Table 1) . 188 The sociodemographic data of the qualitative phase was representing the maximum variation 189 sample. A total of 22 pharmacists were involved in the study. Females percentage was slightly 190 predominant over males (n=12, 54.5%), less than one third were 41-55 years old (n=7, 31.8%) and 191 (n=17, 77.3%) were holding a bachelor's degree ( Sixty-two percent of the participating pharmacists acknowledged that they dispense OCPs without 203 prescription, and around 58% of them were dispensing OCPs for males for their personal use. In 204 particular, for muscle gain (36.5%) and hair growth enhancement (20.8%). Some of the 205 participating pharmacists also indicated that most males who used to use OCPs were stranger 206 customers (n=43, 27.7%) and most commonly aged 20-35 (n=114, 71.7%). Study participants 207 stated that the males' OCPs users either directly ask and admit their need for these pills or are 208 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted March 12, 2021. ; https://doi.org/10.1101/2021.03.11.21253403 doi: medRxiv preprint recognized by their facial expression and body language, 21.5% and 27.2%, respectively (Table 209 3). Multivariate logistic regression results exhibited a positive significant correlation (p< 0.05) 211 between the pharmacist exposure to males OCPs abuse cases and the following variables: age of 212 the pharmacist, female gender, the length of pharmacist experience (in years), the relatively low 213 social class distribution of the pharmacy customers, Table 4 . Thirty percent of the participating pharmacists said some of the customers came to their pharmacy 228 asking for OCPs for drug-addiction-related issues. Participant 5 stated, "most commonly, cocaine 229 abusers came to ask for OCPs approximately five hours before their annual urine test of illicit 230 drugs in order to give a negative result". Participant 7 also mentioned that "some customers 231 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted March 12, 2021. ; https://doi.org/10.1101/2021.03.11.21253403 doi: medRxiv preprint usually asking for eye drops containing Naphazoline HCl and Chlorpheniramine Maleate to 232 manage their eye symptoms due to addiction". 233 On the other hand, the pharmacists indicated that males use OCPs for hair growth purposes. Participant 10 said, "As the men's beauty centers recommend males to grind OCPs and mix them 235 with shampoo for topical application to improve their hair growth". Participant 13 acknowledged 236 "Such practice is more common in the presence of beauty centers around the pharmacy". As well, 237 fifty percent of the participants stated that beauty centers also recommend topical application of 238 OCPs (grinded pills mixed with topical products) for acne treatment. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. pharmacists were able to identify and report unanticipated patterns of OCPs use among Jordanian 261 males, which provides an insight into the pharmacists' role in patient education to limit medication 262 abuse. Half of the pharmacists participating in this study were aware of the possibility of OCPs use by 264 males for body appearance enhancing purposes such as muscle augmenting, hair growth as well 265 as an acne treatment. They were also knowledgeable about the side effects of OCPS in males, such 266 as gynecomastia, mood changes, altered libido, and weight gain. These side effects were actually 267 similar to those reported in a recent study that evaluated hormonal contraception for men [20] . Most males buying OCPs were young (25-35 year old), and this was comparable to other studies 269 that evaluated the abuse of androgenic steroids by male athletes in Jordan which found that the 270 mean age of the abusers was 28.1 years [21] . Tahtamouni [21] showed that in 42.9% of the abuse 271 cases, gym coaches were responsible for recommending medication use/abuse. Similar to our 272 study, participants also confirmed that the presence of a gym facility around the pharmacy 273 increases the potential to observe such cases. The accessibility and affordability of OCPs make 274 them more prone to misuse/abuse [22] . Although our findings demonstrated that around forty percent of the pharmacists refused to 276 dispense OCPs in cases of suspected improper use, yet the rest of them would agree to do so. 277 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. showed that these practices can be attributed to the pressure on the community pharmacists to sell 281 the medication, due to financial considerations of the pharmacy owners, or the continuous push showed that those pharmacists who refused to dispense emphasized that pharmacists should report 288 the abuse or misuse cases to the policymakers such as the JPA and pharmacovigilance committee 289 in the JFDA to monitor such practice. Remarkably, most of the documented cases of the improper use of OCPs in this study have been 291 rarely recognized in previous studies. Our qualitative analysis showed that OCPs were abused to 292 mask the results of addiction to drug urine tests. It was shown that several adulterants could be 293 added to urine in order to give a false-negative drug test, which could deter the ability to monitor 294 illicit drug use [29] . These can include oxidizing chemicals, such as nitrite or peroxide, as well as suggests there is a need to stop misusing these medications. However, such practices are still 300 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted March 12, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 available according to our study findings, which should highlight the need for further future studies 301 to better understand this issue and devise suitable recommendations for policymakers. A few participants reported the use of clomiphene to manage the side effects of OCPs. While this 303 was never reported in the literature, one case report showed that a young man admitted suffering 304 from severe depression and libido due to steroid abuse and was using clomiphene to alleviate these 305 adverse effects [31] . Clomiphene is used in females to induce ovulation, and also has an off-label 306 use for the treatment of hypogonadism [32, 33] . It has both estrogenic and antiestrogenic properties 307 and initiates a series of endocrinologic events that eventually lead increase in steroidogenesis [33] . Still, the mechanism by which clomiphene can alleviate the adverse effects of OCPs is yet unclear. In this study, the reporting of OCPs abuse cases by males was correlated to many factors according In Jordan, the policymakers and stakeholders (JFDA) emphasized that birth control pills should be 319 handled under prescription, and till the time of writing this study it is not allowed to handle such 320 medication as over-the-counter medications [36] . Nevertheless, a lack of surveillance and strict 321 control opens the chance to abuse the OCPs and make them accessible to the abusers, which could 322 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted March 12, 2021. ; https://doi.org/10.1101/2021.03.11.21253403 doi: medRxiv preprint ultimately lead to an increase of side effects and complications [37] . However, there is limited 323 documentation on cases of the use and abuse cases of OCPs among males. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted March 12, 2021. ; (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted March 12, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 Abuse (drug, alcohol, chemical, substance or psychoactive substance) Stimulant abuse: pharmacology, cocaine, methamphetamine, treatment, attempts 353 at pharmacotherapy. Primary Care: Clinics in Office Practice Chapter 18 -Substance Abuse Laxative abuse Current contraceptive status among women aged Oral contraceptive pills Non-contraceptive benefits of oral hormonal contraceptives What if a man takes birth control pills? Current knowledge, attitude, and patterns of oral 367 contraceptives utilization among women in Jordan Jordanian married Muslim women's intentions to use oral contraceptives Abuse and misuse of 371 prescription and nonprescription drugs sold in community pharmacies in Jordan Unforeseen uses of oral 373 contraceptive pills: Exploratory study in Jordanian community pharmacies Selecting, designing, and developing your questionnaire Using multivariate statistics Social scientific theories of drug use, abuse, and addiction Illicit use of androgens and other hormones: recent advances Androgen abuse epidemiology. Current opinion in endocrinology, diabetes, 383 and obesity 385 Endocrinology of the Testis and Male Reproduction The Community Pharmacist: Perceived Barriers and Patient-435 Centered Care Communication Social determinants of drug use: National Drug and List of Non-prescription medications A case report of oral contraceptive misuse induced cerebral venous 441 sinus thrombosis and dural arteriovenous fistula Severe acute respiratory syndrome coronavirus 2 444 (SARS-CoV-2) and corona virus disease-2019 (COVID-19): the epidemic and the challenges This study was not funded by any institution. 346 9. Availability of data and materials 347 The data will be made available by the corresponding author upon request. All rights reserved. No reuse allowed without permission.(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.