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For Peer Review Only - Page 1 of 27 BMJ Open BMJ Open BMJ Open: first published as 10.1136/bmjopen-2015-010387 on 4 April 2016. Downloaded from FALSIFIED MEDICINES IN PERU: A Retrospective Review (1997-2014). ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2015-010387 Article Type: Research Date Submitted by the Author: 27-Oct-2015 Complete List of Authors: Medina, Edwin; University of Barcelona - Faculty of Pharmacy, Department of Pharmacy and Pharmaceutical Technology Bel, Elvira; University of Barcelona - Faculty of Pharmacy, Department of Pharmacy and Pharmaceutical Technology Suñé, Josep María; University of Barcelona - Faculty of Pharmacy, Department of Pharmacy and Pharmaceutical Technology <b>Primary Subject Public health Heading</b>: Secondary Subject Heading: Global health, Epidemiology, Health policy, Health services research Keywords: Safety, Falsified, Medicines, Alerts, counterfeit, Drugs http://bmjopen.bmj.com/ on September 24, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 27 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2015-010387 on 4 April 2016. Downloaded from 1 2 3 FALSIFIED MEDICINES IN PERU: A Retrospective Review (1997-2014). 4 5 6 7 Authors: Edwin Medina1, Elvira Bel1, Josep María Suñé1 8 9 10 11 12 Affiliations: 13 14 15 1. DepartmentFor of peerPharmacy and review Pharmaceutical onlyTechnology, Faculty of 16 Pharmacy, University of Barcelona, Spain 17 18 19 20 Corresponding author: 21 22 Edwin Salvador Medina Vargas 23 24 Department of Pharmacy and Pharmaceutical Technology 25 Faculty of Pharmacy 26 University of Barcelona 27 Joan XXIII, s/n, 08028 Barcelona 28 29 Spain 30 Email: [email protected] 31 32 33 http://bmjopen.bmj.com/ 34 Keywords: Safety, Falsified, Medicines, Alerts, counterfeit, Drugs 35 36 37 38 39 Word Count 40 41 Abstract: 298 on September 24, 2021 by guest. Protected copyright. 42 Main text: 3440 43 Figures: 4 44 Tables: 2 45 Supplementary: 1 46 References: 56 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 27 BMJ Open: first published as 10.1136/bmjopen-2015-010387 on 4 April 2016. Downloaded from 1 2 3 ABSTRACT 4 5 6 7 Objective: To show the extent of the problem of falsified medicines in Peru. 8 9 10 Design: A retrospective review of drug alerts. 11 12 Setting: The General Directorate of Medicines, Supplies and Drugs (DIGEMID - 13 Ministry of Health of Peru) website search for drug alerts issued between 1997 14 and 2014. 15 For peer review only 16 Eligibility criteria: Drug alerts related to falsified medicines. 17 18 19 Results: A total of 669 Digemid Alerts were issued during the study period, 354 20 (52.91%) of which refer to a total of 1738 cases of falsified medicines (many 21 alerts deal with several cases at a time). Regarding the type of establishment 22 involved in the possession or sale of falsified medicines, 1010 cases (58.11%) 23 involved pharmaceutical establishments; 349 cases (20.08%) involved non- 24 pharmaceutical commercial outlets); in 126 cases (7.23%) the medicines were 25 seized in unauthorized trade (without any marketing authorization), and in 253 26 cases (14.56%) the type of establishment or business related with the seized 27 product is not identified. 28 29 30 The finding of 626 duplicate products/batches in the study period highlights the 31 persistence of falsified medicines on the market, and suggests that the impact 32 of the alert system needs to be revised. 33 http://bmjopen.bmj.com/ 34 Conclusions: In light of the results, there is no doubt that falsified medicines 35 represent a serious public health problem in Peru. A review of the data alone is 36 not enough to conclude whether falsified medicines in Peru have increased 37 38 during the study period, or if the monitoring action of different government 39 health agencies has brought the magnitude of the problem more to the surface 40 by providing more evidence. The problem is clearly structural, since the majority 41 of cases (58.11% of the total) were detected in legitimate supply chains. Most on September 24, 2021 by guest. Protected copyright. 42 falsified medicines involve staple pharmaceutical products and common dosage 43 forms. 44 45 Considerable work remains to be done to control the serious problem of falsified 46 medicines in Peru. 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 27 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2015-010387 on 4 April 2016. Downloaded from 1 2 3 INTRODUCTION 4 5 The WHO has been receiving reports of falsified medicines since 1982. [1] The 6 phenomenon was first referred to as a problem at the WHO Conference of 7 Experts on the Rational Use of Drugs in Nairobi, Kenya, in 1985. Since then, 8 public awareness of falsified medicines has grown, [2] and it has become a 9 10 major public health issue, as reflected by government initiatives worldwide in 11 response to the problem. 12 13 The issue of falsified medicines is so complex that, for example, even today 14 different definitions are used, or a falsified medicine is confused with one of 15 poor qualityFor (substandard), peer a serious review mistake that hampersonly the exchange of 16 information between countries, and makes it difficult to grasp the true scale of a 17 global problem. The WHO defines falsified medicines as those whose labels 18 19 include, intentionally and fraudulently, false information about their identity and 20 origin. Falsification can affect both branded and generic products, and may 21 include products with the correct or wrong ingredients, without active [2] 22 ingredients, with insufficient active ingredients or with fake packaging. 23 24 According to the WHO, the highest rates of medicine falsification in the world 25 occur in regions with the weakest regulatory and control systems, such as many 26 African, Asian, and Latin American nations and countries in transition. In most 27 industrialized nations, regulatory systems and market control are effective and 28 29 thus the incidence of spurious/falsely-labeled/falsified/counterfeit medicines is low, estimated to be less than 1% of the market value. [3] Medicine falsification 30 [4] 31 involves manufacturing and distribution networks related to organized crime, [5-6] 32 with annual turnovers between 75 and 200 billion dollars and has a [7] 33 significant impact even in large economies like the US. http://bmjopen.bmj.com/ 34 35 In general, the deregulation of any trade or business and the existence of 36 uninformed potential customers constitute a breeding ground for unscrupulous 37 criminal activities, whose sole purpose is to obtain illegitimate profits at the 38 39 expense of harming consumers and, in this case, the health system. In short, 40 this is what has happened with medicines in Peru (according to the World Bank, 41 a country of upper-middle income with a gross national income per capita of $ on September 24, 2021 by guest. Protected copyright. [8] 42 4126 - 12,745). A staple product (medicine) was subjected to the free market 43 by a political decision in the early 1990s without the slightest preliminary 44 analysis of the possible consequences, which have proved disastrous. Attempts 45 to amend certain irregularities have not achieved convincing results so far, as 46 evidenced by this study, despite the efforts and resources invested over the last 47 few years. 48 49 50 The consequences of this illegal phenomenon represent a serious public health [9] 51 problem, including treatment failure, possible cases of added contaminants, 52 and even death. It has also resulted in the deployment and disbursement of 53 often scarce resources, a loss of faith in health systems, distrust of medications 54 and even the failure of major global health policies such as the fight against 55 malaria. [10] 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 27 BMJ Open: first published as 10.1136/bmjopen-2015-010387 on 4 April 2016. Downloaded from 1 2 3 The regulatory authority for medicines in Peru is the General Directorate of 4 Medicines, Supplies and Drugs (DIGEMID), created by the Legislative Decree 5 No. 584 of 16 April 1990, [11] as a linear agency of the Ministry of Health of Peru. 6 In May 1998, the work instigated by the Directorial Resolution No. 367-98-DG- 7 DIGEMID in 1997 was normalized, and the Alerts Committee was created to 8 evaluate and define the actions to take regarding alerts or communications 9 [12] 10 about safety and/or efficacy of pharmaceuticals and related products. 11 12 13 14 OBJECTIVE 15 For peer review only 16 This work seeks to consolidate and assess information on falsified medicines in 17 pharmaceutical alerts issued by the Peruvian medicine agency in a period of 18 18 19 years (1997-2014) of health monitoring and enforcement. The ultimate aim is to 20 draw attention to the situation of falsified medicines in Peru and highlight the 21 efforts of various state institutions headed by DIGEMID. 22 23 24 25 METHOD 26 27 To develop this work, a retrospective and systematic review was carried out of 28 each Digemid alert about falsified medicines, published on the official DIGEMID 29 [13] 30 website from 1997 to December 2014. 31 32 Data from each of the aforementioned Digemid alerts were collected and 33 organized in Microsoft Excel spreadsheets, considering, extracting, and filling in http://bmjopen.bmj.com/ 34 the following information: 35 36 Alerts ordered by year.
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