{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,3]],"date-time":"2025-10-03T09:01:27Z","timestamp":1759482087119},"reference-count":27,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2016,10,17]],"date-time":"2016-10-17T00:00:00Z","timestamp":1476662400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Tropical Med Int Health"],"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the impact of mandatory offer of generic substitution, introduced in South Africa in May 2003, on private sector sales of generic and originator medicines for chronic diseases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Private sector sales data (June 2001 to May 2005) were obtained from <jats:styled-content style=\"fixed-case\">IMS<\/jats:styled-content> Health for proton pump inhibitors (<jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>s; <jats:styled-content style=\"fixed-case\">ATC<\/jats:styled-content> code A02<jats:styled-content style=\"fixed-case\">BC<\/jats:styled-content>), <jats:styled-content style=\"fixed-case\">HMG<\/jats:styled-content>\u2010CoA reductase inhibitors (statins; C10<jats:styled-content style=\"fixed-case\">AA<\/jats:styled-content>), dihydropyridine calcium antagonists (C08<jats:styled-content style=\"fixed-case\">CA<\/jats:styled-content>), angiotensin\u2010converting enzyme inhibitors (<jats:styled-content style=\"fixed-case\">ACE<\/jats:styled-content>\u2010I; C09<jats:styled-content style=\"fixed-case\">AA<\/jats:styled-content>) and selective serotonin reuptake inhibitors (<jats:styled-content style=\"fixed-case\">SSRI<\/jats:styled-content>s; N06<jats:styled-content style=\"fixed-case\">AB<\/jats:styled-content>). Monthly sales were expressed as defined daily doses per 1000 insured population per month (<jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>). Interrupted time\u2010series models were used to estimate the changes in slope and level of medicines use after the policy change. <jats:styled-content style=\"fixed-case\">ARIMA<\/jats:styled-content> models were used to correct for autocorrelation and stationarity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Only the <jats:styled-content style=\"fixed-case\">SSRI<\/jats:styled-content>s saw a significant rise in level of generic utilisation (0.2 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>;<jats:italic> P<\/jats:italic> &lt; 0.001) and a fall in originator usage (\u22120.1 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>;<jats:italic> P<\/jats:italic> &lt; 0.001) after the policy change. Utilisation of generic <jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>s fell (level 0.06 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>,<jats:italic> P<\/jats:italic> = 0.048; slope 0.01 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>,<jats:italic> P<\/jats:italic> = 0.043), but utilisation of originator products also grew (level 0.05 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>,<jats:italic> P<\/jats:italic> &lt; 0.001; slope 0.003, <jats:italic>P<\/jats:italic> = 0.001). Generic calcium antagonists and <jats:styled-content style=\"fixed-case\">ACE<\/jats:styled-content>\u2010I showed an increase in slope (0.01 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>,<jats:italic> P<\/jats:italic> = 0.016; 0.02 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>,<jats:italic> P<\/jats:italic> &lt; 0.001), while the originators showed a decrease in slope (\u20100.003 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>,<jats:italic> P<\/jats:italic> = 0.046; \u22120.01 <jats:styled-content style=\"fixed-case\">DDD<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIM<\/jats:styled-content>,<jats:italic> P<\/jats:italic> &lt; 0.001). There were insufficient data on generic statin use before the policy change to allow for analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The mandatory offer of generic substitution appeared to have had a quantifiable effect on utilisation patterns in the 2 years after May 2003. Managed care interventions that were already in place before the intervention may have blunted the extent of the changes seen in this period. Generic policies are an important enabling provision for cost\u2010containment efforts. However, decisions taken outside of official policy may anticipate or differ from that policy, with important consequences.<\/jats:p><\/jats:sec>","DOI":"10.1111\/tmi.12785","type":"journal-article","created":{"date-parts":[[2016,9,27]],"date-time":"2016-09-27T09:18:18Z","timestamp":1474967898000},"page":"1504-1512","source":"Crossref","is-referenced-by-count":4,"title":["Impact of the introduction of mandatory generic substitution in South Africa: private sector sales of generic and originator medicines for chronic diseases"],"prefix":"10.1111","volume":"21","author":[{"given":"Andrew Lofts","family":"Gray","sequence":"first","affiliation":[{"name":"University of KwaZulu Natal Durban South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yared","family":"Santa\u2010Ana\u2010Tellez","sequence":"additional","affiliation":[{"name":"WHO Collaborating Centre for Pharmaceutical Policy and Regulation Utrecht Institute for Pharmaceutical Sciences Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronika","family":"J Wirtz","sequence":"additional","affiliation":[{"name":"Department of Global Health Boston University Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,10,17]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"Minister of Health.White Paper on National Health Insurance in South Africa. 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