Letters to the Editor The journal publishes both invited and unsolicited letters. DEPENDENCE ON PRESCRIBED MEDICINES: CAN WE MOVE PAST AWARENESS TO ACTION IN EUROPE? The Addiction readership may be interested in the developing discussion on the pressing need to respond to the challenge of dependence on prescribed medicines in Europe, as elsewhere. Dependence is a risk with medicines containing narcotic and psychotrophic substances, many of which are controlled by international, European and domestic provisions. A growing body of evidence on the impact in health and economic terms of misuse of and dependence on such medicines led the United Nations Office of Drugs and Crime (UNODC) to refer to it as ‘a global health concern’ [1]. Later, in 2011, the Executive Office of the President of the USA referred to prescription drug abuse as an ‘epidemic’ [2]. European data showed that in 2012, in 17 European Union (EU) countries, more than 10% of first-time treatment entrants were misusing an opioid other than heroin as their primary drug [3]. The need to address systematically dependence on prescribed medicines is referenced in the European Drugs Strategy 2013–2020 [4] and the EU Action Plan on Drugs 2013–2016 [5], as a result of which policy bodies at the European level have begun to discuss their role in framing the response. Such a discussion has been brought about gradually. Addressing dependence on medicines raises a different set of challenges from dependence on illicitly obtained drugs, challenges to which most European policy bodies are only beginning to be exposed. Traditionally, criminal justice bodies were called upon to manage the increasing supply of illicit drugs through the black market and that affected the understanding of, and response to, dependence ensuing from them. Conversely, dependence on controlled medicines, available on prescription in health-care settings from physicians and other prescribers, brings a need to base a response within health-care institutions which are better equipped to manage it. Additionally, policy bodies are faced with a lack of solid data on the extent and characteristics of dependence on prescribed medicines. Such data as exist up to now point to a heterogeneity across Europe in terms of the types of medicines involved and in how dependence on them is understood. Lack of harmonized data across countries confuses the picture further and contributes to the gap in the understanding of which medicines are misused, how these © 2015 Society for the Study of Addiction
are misused, by whom, why and how such a dependence can be addressed systematically. Drug dependence monitoring systems have not been able to address such questions: to date, they have tended to focus only on the diversion of methadone and buprenorphine prescribed as treatment for dependence, ‘allowing’ people dependent on prescribed opioids who do not use illicit drugs to fall through the cracks. European health-care systems are in need of an accurate picture of dependence on prescribed medicines that is based on consistent, harmonized data, produced by prescription monitoring systems, including pharmacoepidemiology, pharmacovigilance and illicit drug monitoring systems, and reported against shared indicators. This need is pressing; otherwise, there will continue to be a lack of shared, comparable indicators to inform detection, validation, evaluation, prioritization and evidence-based responses to growing signals of dependence on prescribed medicines. It is essential that in Europe, as elsewhere, a framework for monitoring misuse of medicines and any ensuing dependence is defined in cooperation with competent bodies in the fields of pharmaceutical use, misuse and dependence. This framework will help to ensure that policy and service delivery responses are appropriate and this will, in turn, support prescribers and policymakers in their task of ensuring the safe delivery of effective health care to all in need. Declaration of interests G.F., C.G., T.G., J.McC. and E.S. have no conflicts of interest; M.L.K. is a member of the Advisory Board and Speaker for Reckitt Benckiser and a member of the Advisory Board and Speaker for BioDelivery Systems International. Keywords Common indicators, monitoring, policy responses, prescription painkillers dependence, reporting. 1
2
GUIDO FANELLI ,CHRISTINA GOLNA , 3
4
5
TANIA GRISKIENE , MARK L. KRAUS , JOHN MCCRACKEN , 6
& ELISABETTA SIMEONI Department of Surgical Science, University of Parma, Anesthesia Intensive Care Service Azienda Ospedaliera Universitaria Parma, 1 Parma, Italy, Public Policy Consultant, Scientific Director, 2 Hepatitis B and C Public Policy Association Maroussi, Greece, 3 National Drug Coordinator Lithuania, Vilnius, Lithuania, Assistant Clinical Professor of Medicine, Yale University School of Medicine, Diplomate of the American Board of Addiction Medicine, Franklin Medical Group, Chief Medical Officer Connecticut 4 Counseling Centers, New Haven, CT, USA, Drugs Programme 5 Manager, Department of Health, London, UK Head of National Observatory and International Relations, Presidency of the Council 6 of Ministers, Department for Anti-Drug Policies, Rome, Italy E-mail: [email protected] Addiction, 110, 712–714
Letters to the Editor References 1. United Nations Office on Drugs and Crime (UNODC). The nonmedical use of prescription drugs: policy direction issues. 2011. Available at: http://www.unodc.org/documents/drug-prevention-and-treatment/nonmedical-use-prescription-drugs.pdf (accessed September 2014). 2. Executive Office of the President of the United States. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. 2011. Available at: http://www.whitehouse.gov/sites/default/files/ ondcp/issues-content/prescription-drugs/rx_abuse_plan.pdf (accessed May 2014). 3. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). European Drug Report, Trends and Developments. 2014. Available at: http://www.emcdda.europa.eu/edr2014 (accessed June 2014). 4. European Union (EU) Council. EU Drugs Strategy 2013–2020 (2012/C 402/01). 2012. Available at: http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:402:0001:0010: en:PDF%20 (accessed June 2013). 5. European Union (EU) Council. EU Action Plan on Drugs 2013– 2016 (2013/C 351/01). 2013. Available at: http://eur-lex. europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:351:0001: 0023:en:PDF (accessed 2014 May).
IS THE RECENT BAN ON ANIMAL TESTING OF LEGAL HIGH PRODUCTS A FATAL BLOW TO THE DEVELOPMENT OF A LEGAL MARKET FOR ‘LOW-RISK’ PSYCHOACTIVE PRODUCTS IN NEW ZEALAND? In July 2013, New Zealand established the world’s first regulated legal market for new psychoactive substances (NPS) (i.e. ‘legal highs’) with the passing of the Psychoactive Substances Act (PSA) [1,2]. This approach has received considerable international attention as a possible solution to the ongoing problems with NPS which could be adopted in other countries [3-8]. The UK NPS Expert Panel recently called on the UK Government to monitor the New Zealand regime, including its public health impacts and the mechanisms used to identify ‘low-risk’ psychoactive products [9]. Implementation of the PSA has proved to be controversial. The transitory interim regime, which allowed a limited number of existing products continue to be sold subject to new retail restrictions (i.e. R18, no sales from convenience stores, limited advertising) [10], was brought to an abrupt end by the passage of the Psychoactive Substances Amendment Act (PSAA) [11] on 7 May 2014, following reports of adverse effects from products [12]. While the ending of the interim regime was viewed widely as a set-back, a potentially more fatal impact of the PSAA was the decision to prohibit the use of animal tests (including tests conducted overseas [13,14]) to demonstrate that products are ‘low-risk’ and thus able to be © 2015 Society for the Study of Addiction
713
approved for legal sale [15,16]. The animal testing ban followed public protests against the harming of animals for the purpose of testing products with no therapeutic effect [12,14]. The Psychoactive Substances Regulatory Authority (PSRA) has gone so far as to state that: ‘it is unlikely that a product can be shown to pose no more than a low risk of harm without the use of animal testing’, suggesting that the PSA was now unworkable [13]. Other commentators have expressed greater optimism. The legal high industry lobby group predicted recently that there is an ‘over 80% chance’ that an approved psychoactive product will be available for sale by the end of 2015 [17]. Our reading of the PSAA and engagement with key stakeholders suggests four possible ways forward: (1) modify the animal testing ban (e.g. allow testing on select species); (2) wait until validated non-animal models are available to assess all aspects of product safety crucial to demonstrate low risk; (3) challenge the rejection of product applications in court by questioning whether the animal testing ban is consistent with the stated purpose of the PSA to create a regulated NPS market; and (4) ‘creatively comply’ with the law by providing required evidence of low risk without direct reference to animal tests. This may involve supporting a product application with data from human clinical trials following animal tests (completed overseas) without directly referencing the animal testing, and may entail application for approval of a pharmaceutical product with psychoactive effects which already has extensive safety data (i.e. a ‘failed medicine’). The PSRA has signalled that regulations for the full regime will be finalized by mid-2015, so there is growing urgency for a political, regulatory or judicial solution to the impasse. We are continuing to investigate and assess the feasibility of the above options. What is clear from the short-lived interim regime is that the financial returns of a legal market are considerable (estimated $140 million annual retail sale [12]), and this may focus decisionmakers’ minds.
Declaration of interests None. Keywords Animal testing ban, legal highs, new psychoactive substances (NPS), Psychoactive Substances Act 2013, Psychoactive Substances Amendment Act 2014, regulated market. MARTA RYCHERT & CHRIS WILKINS
Social and Health Outcomes Research and Evaluation (SHORE), SHORE and Whariki Research Centre, College of Health, Massey University, Auckland, New Zealand E-mail: [email protected] Addiction, 110, 712–714
This document is a scanned copy of a printed document. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material.
are misused, by whom, why and how such a dependence can be addressed systematically. Drug dependence monitoring systems have not been able to address such questions: to date, they have tended to focus only on the diversion of methadone and buprenorphine prescribed as treatment for dependence, ‘allowing’ people dependent on prescribed opioids who do not use illicit drugs to fall through the cracks. European health-care systems are in need of an accurate picture of dependence on prescribed medicines that is based on consistent, harmonized data, produced by prescription monitoring systems, including pharmacoepidemiology, pharmacovigilance and illicit drug monitoring systems, and reported against shared indicators. This need is pressing; otherwise, there will continue to be a lack of shared, comparable indicators to inform detection, validation, evaluation, prioritization and evidence-based responses to growing signals of dependence on prescribed medicines. It is essential that in Europe, as elsewhere, a framework for monitoring misuse of medicines and any ensuing dependence is defined in cooperation with competent bodies in the fields of pharmaceutical use, misuse and dependence. This framework will help to ensure that policy and service delivery responses are appropriate and this will, in turn, support prescribers and policymakers in their task of ensuring the safe delivery of effective health care to all in need. Declaration of interests G.F., C.G., T.G., J.McC. and E.S. have no conflicts of interest; M.L.K. is a member of the Advisory Board and Speaker for Reckitt Benckiser and a member of the Advisory Board and Speaker for BioDelivery Systems International. Keywords Common indicators, monitoring, policy responses, prescription painkillers dependence, reporting. 1
2
GUIDO FANELLI ,CHRISTINA GOLNA , 3
4
5
TANIA GRISKIENE , MARK L. KRAUS , JOHN MCCRACKEN , 6
& ELISABETTA SIMEONI Department of Surgical Science, University of Parma, Anesthesia Intensive Care Service Azienda Ospedaliera Universitaria Parma, 1 Parma, Italy, Public Policy Consultant, Scientific Director, 2 Hepatitis B and C Public Policy Association Maroussi, Greece, 3 National Drug Coordinator Lithuania, Vilnius, Lithuania, Assistant Clinical Professor of Medicine, Yale University School of Medicine, Diplomate of the American Board of Addiction Medicine, Franklin Medical Group, Chief Medical Officer Connecticut 4 Counseling Centers, New Haven, CT, USA, Drugs Programme 5 Manager, Department of Health, London, UK Head of National Observatory and International Relations, Presidency of the Council 6 of Ministers, Department for Anti-Drug Policies, Rome, Italy E-mail: [email protected] Addiction, 110, 712–714
Letters to the Editor References 1. United Nations Office on Drugs and Crime (UNODC). The nonmedical use of prescription drugs: policy direction issues. 2011. Available at: http://www.unodc.org/documents/drug-prevention-and-treatment/nonmedical-use-prescription-drugs.pdf (accessed September 2014). 2. Executive Office of the President of the United States. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. 2011. Available at: http://www.whitehouse.gov/sites/default/files/ ondcp/issues-content/prescription-drugs/rx_abuse_plan.pdf (accessed May 2014). 3. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). European Drug Report, Trends and Developments. 2014. Available at: http://www.emcdda.europa.eu/edr2014 (accessed June 2014). 4. European Union (EU) Council. EU Drugs Strategy 2013–2020 (2012/C 402/01). 2012. Available at: http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:402:0001:0010: en:PDF%20 (accessed June 2013). 5. European Union (EU) Council. EU Action Plan on Drugs 2013– 2016 (2013/C 351/01). 2013. Available at: http://eur-lex. europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:351:0001: 0023:en:PDF (accessed 2014 May).
IS THE RECENT BAN ON ANIMAL TESTING OF LEGAL HIGH PRODUCTS A FATAL BLOW TO THE DEVELOPMENT OF A LEGAL MARKET FOR ‘LOW-RISK’ PSYCHOACTIVE PRODUCTS IN NEW ZEALAND? In July 2013, New Zealand established the world’s first regulated legal market for new psychoactive substances (NPS) (i.e. ‘legal highs’) with the passing of the Psychoactive Substances Act (PSA) [1,2]. This approach has received considerable international attention as a possible solution to the ongoing problems with NPS which could be adopted in other countries [3-8]. The UK NPS Expert Panel recently called on the UK Government to monitor the New Zealand regime, including its public health impacts and the mechanisms used to identify ‘low-risk’ psychoactive products [9]. Implementation of the PSA has proved to be controversial. The transitory interim regime, which allowed a limited number of existing products continue to be sold subject to new retail restrictions (i.e. R18, no sales from convenience stores, limited advertising) [10], was brought to an abrupt end by the passage of the Psychoactive Substances Amendment Act (PSAA) [11] on 7 May 2014, following reports of adverse effects from products [12]. While the ending of the interim regime was viewed widely as a set-back, a potentially more fatal impact of the PSAA was the decision to prohibit the use of animal tests (including tests conducted overseas [13,14]) to demonstrate that products are ‘low-risk’ and thus able to be © 2015 Society for the Study of Addiction
713
approved for legal sale [15,16]. The animal testing ban followed public protests against the harming of animals for the purpose of testing products with no therapeutic effect [12,14]. The Psychoactive Substances Regulatory Authority (PSRA) has gone so far as to state that: ‘it is unlikely that a product can be shown to pose no more than a low risk of harm without the use of animal testing’, suggesting that the PSA was now unworkable [13]. Other commentators have expressed greater optimism. The legal high industry lobby group predicted recently that there is an ‘over 80% chance’ that an approved psychoactive product will be available for sale by the end of 2015 [17]. Our reading of the PSAA and engagement with key stakeholders suggests four possible ways forward: (1) modify the animal testing ban (e.g. allow testing on select species); (2) wait until validated non-animal models are available to assess all aspects of product safety crucial to demonstrate low risk; (3) challenge the rejection of product applications in court by questioning whether the animal testing ban is consistent with the stated purpose of the PSA to create a regulated NPS market; and (4) ‘creatively comply’ with the law by providing required evidence of low risk without direct reference to animal tests. This may involve supporting a product application with data from human clinical trials following animal tests (completed overseas) without directly referencing the animal testing, and may entail application for approval of a pharmaceutical product with psychoactive effects which already has extensive safety data (i.e. a ‘failed medicine’). The PSRA has signalled that regulations for the full regime will be finalized by mid-2015, so there is growing urgency for a political, regulatory or judicial solution to the impasse. We are continuing to investigate and assess the feasibility of the above options. What is clear from the short-lived interim regime is that the financial returns of a legal market are considerable (estimated $140 million annual retail sale [12]), and this may focus decisionmakers’ minds.
Declaration of interests None. Keywords Animal testing ban, legal highs, new psychoactive substances (NPS), Psychoactive Substances Act 2013, Psychoactive Substances Amendment Act 2014, regulated market. MARTA RYCHERT & CHRIS WILKINS
Social and Health Outcomes Research and Evaluation (SHORE), SHORE and Whariki Research Centre, College of Health, Massey University, Auckland, New Zealand E-mail: [email protected] Addiction, 110, 712–714
This document is a scanned copy of a printed document. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material.
