{"id":11548,"date":"2012-06-01T20:43:40","date_gmt":"2012-06-01T20:43:40","guid":{"rendered":"https:\/\/patients.org.ua\/?p=11548"},"modified":"2024-04-17T13:38:37","modified_gmt":"2024-04-17T13:38:37","slug":"mandatory-international-drug-manufacturing-standards-will-be-implemented-in-ukraine","status":"publish","type":"post","link":"https:\/\/patients.org.ua\/en\/news\/mandatory-international-drug-manufacturing-standards-will-be-implemented-in-ukraine\/","title":{"rendered":"Mandatory International Drug Manufacturing Standards Will be Implemented in Ukraine"},"content":{"rendered":"<p><img decoding=\"async\" class=\"alignleft\" src=\"https:\/\/patients.org.ua\/wp-content\/uploads\/2024\/02\/resolution.jpg\" alt=\"resolution\" \/>Starting from 2015, there will be\u00a0mandatory International Drug Manufacturing Standards approved by\u00a0the World Health Organization introduced in\u00a0Ukraine to\u00a0protect patients from poor quality drug use. This agreement was reached by\u00a0patients and the Ministry of\u00a0Health during the round-table discussion on\u00a0May\u00a031, 2012.<\/p>\n<p>According to\u00a0the document signed by\u00a0the Ministry of\u00a0Health, pharmaceutical companies and patients, WHO prequalification will be\u00a0introduced in\u00a0Ukraine for drugs purchased for state budget funds for patients with\u00a0TB and HIV. Years 2013-2014 will be\u00a0considered a\u00a0transitional period, when manufacturing companies will have time to\u00a0undergo certification.<\/p>\n<p><em>\u00abWHO prequalification procedure is\u00a0free of\u00a0charge for the manufacturers. It\u00a0was developed by\u00a0the international experts, and its main goal is\u00a0to\u00a0protect patients. Today, these standards have already been introduced globally, even in\u00a0African countries\u00bb<\/em>\u00a0\u2014 says <strong>Bogdana Scherbak-Verlan, representative of\u00a0WHO Country Office in\u00a0Ukraine.<\/strong><\/p>\n<p>Today, in\u00a0Ukraine all drugs purchased for money of\u00a0the Global Fund to\u00a0Fight AIDS, Tuberculosis and Malaria, in\u00a0other words for money provided to\u00a0Ukraine by\u00a0other countries to\u00a0control epidemics, are routinely prequalified by\u00a0WHO and meet all international quality standards. But this assistance constitutes only\u00a015% of\u00a0all the drugs that come to\u00a0Ukrainian hospitals and\u00a0TB clinics today.\u00a085% of\u00a0them is\u00a0purchased by\u00a0the state, and the state currently does not require international standards of\u00a0quality to\u00a0be\u00a0observed by\u00a0the manufacturers.<\/p>\n<p><em>\u00abToday poor quality drugs purchased through the state budget to\u00a0save money lead to\u00a0severe complications and adverse effects in\u00a0patients\u00bb<\/em>, states <strong>Dmytro Sherembey, Chairman of\u00a0Ukrainian Community Advisory Board.<\/strong> <em>\u00abThe drugs that we\u00a0are talking today about are very specific and toxic. They require strict dosages and have to\u00a0be\u00a0of\u00a0high quality. Even the smallest errors in\u00a0dosages of\u00a0some substances might lead to\u00a0permanent changes in\u00a0a\u00a0patient\u2019s body. Moreover, these drugs have to\u00a0be\u00a0taken on\u00a0a\u00a0day-to-day basis, and that definitely affects patient\u2019s health. That is\u00a0why international standards of\u00a0manufacturing these drugs are of\u00a0paramount importance.\u00bb<\/em><\/p>\n<p><em>\u00abMinistry of\u00a0Health supports the application of\u00a0up-to-date requirements to\u00a0drug manufacturing confirmed by\u00a0the inspection certificate PIC\/S and WHO prequalification toward the process of\u00a0drugs purchase for state budget money. This requirement will be\u00a0enacted starting 2015, so\u00a0we\u00a0give time to\u00a0pharmaceutical manufacturers to\u00a0undergo all the required procedures or\u00a0to\u00a0receive confirmation from PIC\/S and WHO\u00bb<\/em>, says <strong>Dmitro Pidturkin, Advisor to\u00a0the Minister of\u00a0Health.<\/strong><\/p>\n<p><em>\u00abYulia, my\u00a0niece, have been taking such drugs for 2\u00a0years already<\/em>, said <strong>a\u00a0guardian of\u00a0a\u00a013-year old HIV-positive girl<\/strong>. \u2014\u00a0<em>Every day the kid experiences severe side effects due to\u00a0the drugs: starting from nausea to\u00a0severe vomiting. Earlier, when she was taking other drugs, she didn\u2019t experience that. She lost a\u00a0lot of\u00a0weight, looks drawn and haggard. We\u00a0stopped taking drugs for some time, that, off course, tremendously affects Yulia\u2019s health. We\u00a0are hopeful that mandatory observance of\u00a0international standards for pharmaceutical manufacturing in\u00a0Ukraine will help increase their quality and resolve the problem that we\u00a0face. Meanwhile, we\u00a0are going to\u00a0look for other drugs for our child and wait.\u00bb<\/em><\/p>\n<p>Today over 600 thousand of\u00a0Ukrainians live with diagnoses of\u00a0TB and HIV. Mandatory WHO prequalification for drugs these people take on\u00a0a\u00a0daily basis is\u00a0aimed in\u00a0the first place at\u00a0expanding their access to\u00a0essential drugs that meet the necessary WHO recommended quality norms and standards.<\/p>\n<p>Currently, out of\u00a0333 drugs in\u00a0Ukraine available for treatment of\u00a0TB and HIV 77\u00a0are prequalified by\u00a0the World Health Organization.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Starting from 2015, there will be\u00a0mandatory International Drug Manufacturing Standards approved by\u00a0the World Health Organization introduced in\u00a0Ukraine to\u00a0protect patients from poor quality drug use. This agreement was reached by\u00a0patients and the Ministry of\u00a0Health during the round-table discussion on\u00a0May\u00a031, 2012. According to\u00a0the document signed by\u00a0the Ministry of\u00a0Health, pharmaceutical companies and patients, WHO prequalification will be\u00a0introduced in\u00a0Ukraine [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","_seopress_analysis_target_kw":"","footnotes":""},"categories":[140],"tags":[],"class_list":["post-11548","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/posts\/11548","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/comments?post=11548"}],"version-history":[{"count":2,"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/posts\/11548\/revisions"}],"predecessor-version":[{"id":11552,"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/posts\/11548\/revisions\/11552"}],"wp:attachment":[{"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/media?parent=11548"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/categories?post=11548"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patients.org.ua\/en\/wp-json\/wp\/v2\/tags?post=11548"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}