The effects of gender-affirming hormone therapy and mastectomy on psychopathology, body image, and quality of life in adults with gender dysphoria who were assigned female at birth.

PURPOSE: Individuals with gender dysphoria (GD) may request hormone therapy and various surgical operations to change their physical characteristics. The present study aimed to investigate the effects of two treatments, mastectomy and gender-affirming hormone therapy (GAHT), on adults with GD who were assigned female at birth (GD AFAB). METHODS: In this cross-sectional study, we gathered data from a total of 269 individuals in three groups: (a) untreated group (n = 121), (b) GAHT group (n = 84) who had been receiving treatment for at least 6 months, and (c) GAHT-MAST group (n = 64) who had been using GAHT for at least 6 months and had undergone mastectomy at least 3 months prior. All participants were asked to complete the Symptom Checklist-90-Revised (SCL-90-R), the Body Uneasiness Test (BUT), and the World Health Organization's Quality of Life Questionnaire- Brief Form, Turkish Version (WHOQOL-BREF-Tr). RESULTS: We found that individuals in the untreated group had higher psychopathological symptoms and body uneasiness scores, and lower quality of life scores compared to both GAHT and GAHT-MAST groups. There was no difference in psychopathology between the GAHT-MAST group and the GAHT group, but body uneasiness scores were lower, and quality of life scores were higher in the GAHT-MAST group. CONCLUSION: Our study suggests that individuals receiving GAHT improved mental health, body satisfaction, and overall quality of life. Combining mastectomy with GAHT may further enhance these benefits.

Methylphenidate-Induced Menorrhagia in Twin Girls.

Objective: Methylphenidate, a psychostimulant agent, is used in first-line psychopharmacological treatment in children and adolescents with attention-deficit/hyperactivity disorder. Common side effects associated with methylphenidate use in children and adolescents are insomnia, anorexia, headache, and nausea. Thrombocytopenia, nasal bleeding and menstrual bleeding disorders are very rarely reported during methylphenidate use. One of the least expected side effects during methylphenidate usage is menorrhagia. Method : In this article, we report methylphenidate monotherapy-induced menorrhagia in two adolescent identical twins. To our knowledge, this is the first report of menorrhagia associated with methylphenidate use in children and adolescents. Results: In both cases, menorrhagia has started after methylphenidate monotherapy and stopped after discontinuation. Other possible etiologies have excluded with clinical and laboratory evaluations. Naranjo Adverse Drug Reaction Probability Score was found 7, indicates probable side effect. Conclusion: Menorrhagia is a rare adverse effect of methylphenidate use and clinicians should be aware of this phenomenon.

Evaluation of the Performance of the Turkish Regulatory Agency: Recommendations for Improved Patients' Access to Medicines.

BACKGROUND: This study was to evaluate the Turkish regulatory review process and timelines between 2016 and 2018 with a view to assess the changes that had taken place since the previous study, which evaluated the Turkish review processes and timelines 2013 to 2015. METHODS: Data related to the Turkish Medicines and Medical Devices Agency (TITCK) organizational structure and general information were collected from publicly available sources. A standard questionnaire was then used to collect data with the aim of identifying the TITCK's review practices and key milestones for the marketing authorization process. Subsequently, a comparison with the previous study was conducted to identify the key changes and developments that had taken place from 2015- 2018. RESULTS: The TITCK has made considerable efforts to improve its regulatory capacity since 2016, which has contributed to the overall decrease in the agency review times. The overall median approval time for new active substances; however, increased from 529 calendar days (2016) to 663 calendar days (2018), with the review time in the agency decreasing from 408 calendar days to 326 calendar days, while the company time increased from 137 to 268 calendar days, respectively, over this period. CONCLUSIONS: For the TITCK to become an international reference agency, they will need to fully implement good review practices and a structured framework for benefit-risk assessment and decision making; consider implementing verification and abridged reviews based on a reliance model and expedite the PIC/S mutual recognition process as well as become a full member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore.

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other authorities, thus avoiding the delays by the current process; removing the requirement for prior approval or CPP; introducing shared or joint reviews with other similar regulatory authorities; formally implementing and monitoring GRevP; defining target timing for each review milestone; redefining the pricing process; and improving transparency by developing publicly available summaries for the basis of approval.