Legal and ethical dilemmas in the process of providing information to users of hormonal contraceptives

Authors

DOI:

https://doi.org/10.24959/sphhcj.23.305

Keywords:

hormonal contraceptives; consumers; ethical standards; information support; pharmacists.

Abstract

Aim. To elucidate legal and ethical dilemmas in the process of providing information to consumers of hormonal contraceptives (HC) at the pharmaceutical market of Ukraine and search for ways to solve them.

Materials and methods. The method of logical and content formulation of the problem, systematic and statistical methods, desk and field methods of marketing research, such as analysis of patient information leaflets for HC, the content analysis of publications in scientific and practically-oriented medical and pharmaceutical publications, the questionnaire survey method, tabular and graphic means of visual presentation of the data obtained were used in the work.

Results. The problem of preserving the reproductive health of women using hormonal agents associated with the possible abortive effect of modern HC has been highlighted. The role of pharmacists in providing consultations when dispensing prescription medicines, in particular HC, has been determined. According to the results of the research, it has been found that there are gaps in the assessment of the quality of information work of pharmacists when dispensing HC from pharmacies. Directions for improving the information support of HC consumers taking into account regulatory and ethical aspects have been proposed. The expediency of expanding the data in patient information leaflets regarding the pharmacodynamics of drugs has been substantiated; it will minimize the psychological consequences of the use of contraceptives under the condition of a non-exclusive abortive effect.

Conclusions. The paper highlights the legal and ethical dilemmas associated with dispensing modern HC without a doctor’s prescription and the possible abortive effect of the study group of drugs. Taking into account the social significance of regulating the information support of HC consumers, as well as legal and ethical norms, there is a need to develop and implement additional instructional and informational materials on the rational purpose and application of HC.

References

Aleksandrova, O. Yu. (2017). Demografichna bezpeka Ukrayiny : otsinka stanu, aktsenti derzhavnogo regulyuvannya. Agrosvit, 18, 69–75.

Unifikovanij klinichnij protokol pervinnoyi, vtorinnoyi (specializovanoyi), tretinnoyi (visokospecializovanoyi) medichnoyi dopomogi “Planuvannya sim’yi”. Zatverdzheno Nakazom MOZ Ukrayiny vid 21 sichnya 2014 roku No. 59. Available at: https://www.dec.gov.ua/wp-content/uploads/2019/11/2014_59_ykpmd.pdf.

Butko, A. (2022). Pharmaceutical aspects of women’s reproductive health. Trends and prospects of scientific thought in medicine : collective monograph. Boston : Primedia eLaunch.

Agulles Simo, P. (2015). Abortifacient effect of hormonal contraceptives: a review. Cuad. Bioet., 26 (86), 69–109.

Larimore, W. L., Stanford J. B. (2000). Postfertilization effects of oral contraceptives and their relationship to informed consent. Archives of family medicine, 9 (2), 126–133.

Chekman, I. S., Vojtenko, G. N., Vojtenko, A. G., Nagornaya, T. I. (2017). Eticheskie aspekty primeneniya gormonalnyh kontraceptivov. Recept, 20 (2), 181–186.

Dye, H. M., Stanford, J. B., Alder, S. C., Kim, H. S., Murphy, P. A. (2005). Women and postfertilization effects of birth control: consistency of beliefs, intentions and reported use. BMC women’s health, 5, 11.

Gala, L. O. (2015). Poshirennya dostovirnoyi informatsiyi pro likarski zasobi – vimoga nalezhnoyi aptechnoyi praktiki. Farmacevtichnyi chasopys,3, 57–62.

Vetiutneva, N. A., Ubohov, S. H., Budnykova, T. M., Pylypchuk, L. B., Todorova, V. I., Fedorova, L. A., Radchenko, A. P., Marusenko, N. A. (2014). Normativno-pravovi ta metodichni zasadi organizatsiyi farmacevtichnoyi prosviti naselennya v umovah vprovadzhennya nalezhnoyi aptechnoyi praktiki. Farmacevtichnyi zhurnal, 2, 20–26.

Konstitutsiya Ukrayiny. (Vidomosti Verhovnoyi Radi Ukrayiny (VVR), 1996, No. 30, st. 141). Available at: https://zakon.rada.gov.ua/laws/show/254%D0%BA/96-%D0%B2%D1%80#Text.

Pro informatsiyu : Zakon Ukrayiny (Vidomosti Verhovnoyi Radi Ukrayiny (VVR), 1992, No. 48, st. 650). Available at: https://zakon.rada.gov.ua/laws/show/2657-12#Text.

Pinyazhko, O. B., Zaliska, O. M., Got, N. R., Gnatishak, L. I. (2013). Analiz farmacevtichnogo zabezpechennya pri ginekologichnih zahvoryuvannyah v Ukrayinі ta sviti. Farmacevtichnyi chasopys, 4, 109–115.

Maganova, T. V., Tkachenko, N. O. (2020). Analiz rinku protizaplidnih likarskih zasobiv u konteksti farmacevtichnoyi bezpeki. Aktualni pitannya farmacevtichnoyi i medichnoyi nauki ta praktiki, 13 (1), 128–136.

Romanenko, T. G., Dovbnya, T. V. (2017). Gormonalna kontraceptsiya (Klinichna lektsiya). Zdorovye zhenshiny, 10 (126), 10–18.

Ethical criteria for medicinal drug promotion / World Health Organization. (1988). Available at: http://apps.who.int/iris/bitstream/handle/10665/38125/ 924154239X_eng.pdf?sequence=1.

Skaritanov, E., Wilkie, G., Kovell, L. C. (2022). Selection, Effectiveness, and Adverse Effects of Contraception. JAMA, 327 (15). 1504. Available at: https://doi.org/10.1001/jama.2022.2854.

Pravila nalezhnoyi promotsiyi farmacevtichnimi kompaniyami likarskih zasobiv profesionalam ohoroni zdorov’ya. Available at: http://aipm.org.ua/wp-content/uploads/2015/06/rules.pdf.

Medical eligibility criteria for contraceptive use. 5th ed. Geneva: WHO, 2015. 267 p.

Bogatta L., Buhling K.J., Rybowski S. (2016). A multicenter, open-label, randomized phase III study comparing a new levonorgestrel intrauterine contraceptive system (LNG-IUS 8) with combine doral contraception in young women of reproductive age. Eur. J. Conracept. Reprod. Health Care, 21 (5), 372–379.

Kayisli U.A., Basar M., Guzeloglu-Kayisli O. (2016). Long-acting progestin-only contraceptives impair endometrial vasculature by inhibiting uterine vascular smooth muscle cell survival. Proc. Natl.Acad. Sci. USA, 112 (16), 5153–5158.

Zhang, J., Cheng, L., Zhao, W. H. (2015). Association between levonorgestrel emergency contraception and the risk of ectopic pregnancy: a multicenter case-control study. Sci. Rep., 5, 8487.

Pro osnovi zakonodavstva Ukrayiny pro ohoronu zdorov’ya : Zakon Ukrayiny (Vidomosti Verhovnoyi Rady Ukrayiny (VVR), 1993, No. 4, st.19). Available at: https://zakon.rada.gov.ua/laws/show/2801-12#Text.

Pro likarski zasobi : Zakon Ukrayini (Vidomosti Verhovnoyi Radi Ukrayini (VVR), 1996, No. 22, st. 86). Available at: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text.

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Published

2023-11-17

Issue

Vol. 9 No. 4 (2023)

Section

Social medicine and pharmacy: past, present and development prospects

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