Increasing Care for Women
Mylan’s Women’s Health portfolio spans oncology, hypothyroidism, diabetes and menopause, among other health concerns predominant in women. As part of our commitment to the U.N.’s Every Woman Every Child initiative, Mylan pledged to register our contraceptives portfolio in 80% of Family Planning 2020 target countries (among the poorest countries in the world) by 2020, which we achieved this year. An additional goal is to provide contraceptives to 25 million women and girls in FP2020 countries. Our receipt in 2018 of the first World Health Organization (WHO) Prequalification for Medroxyprogesterone Acetate, 150 mg (IM DMPA), a generic injectable for Depo-Provera® that provides three months of birth control protection, should help further that effort.
Serialization is fueled by myriad government regulations that require Mylan to track our products along the supply chain and verify their authenticity.
We comply with the U.S. Drug Supply Chain Security Act and the European Union Falsified Medicine Directive. We employ serialization technology such as a 2D matrix on all products. Work also includes the gathering of data from the matrices so that we can identify and manage procedures associated with individual units regarding product picking, packing, shipping, sampling, returns and destructions.
Our Pharmacovigilance (PV) program, coupled with a global policy on product safety, guides Mylan’s approach to ensuring patient care and safety in relation to the use of our marketed products. In line with applicable global legislation, we have a cross-functional team of medical and scientific professionals that support a global pharmacovigilance system that reports our risk/benefit assessments to global health authorities.
Our Product Safety and Risk Management (PSRM) department is a key component of our program and is responsible for conducting internal and external audits along with ensuring that the personal health information of those participating in our clinical trials is carefully safeguarded. It is subject to external audits and inspections from health authorities around the globe.
Mylan’s Corporate Product Safety Committee provides a forum for the periodic and ad hoc evaluation of newly emerging safety information regarding our products. Potential safety signals are assessed and evaluated through our corporate safety governance structure and new information is communicated in a timely manner to healthcare professionals, patients and health authorities. Mylan currently has more than 300 risk management plans and associated interventional measures designed to ensure all of Mylan’s products are used safely and effectively.
We conduct training that complements Mylan’s policy on Pharmacovigilance Training Standards which defines training curriculum, frequency, effectiveness measurements and documentation and other requirements. PSRM employees are assigned professional development training courses based on individual experience. In 2018, we completed 25 PV audits and submitted more than 1,600 safety reports.