In addition to requiring authors to register their clinical trials in a publicly accessible database, Addiction now requires authors to report and justify any discrepancies between the trial protocol and the study itself in the methods section of the submitted paper. A full list of registers can be found via the WHO International Clinical Trials Registry Platform (ICTRP).
We welcome suggestions and contributions from our readers. Send your material to John Witton, News and Notes Editor, Addiction, National Addiction Centre PO48, 4 Windsor Walk, London SE5 8AF. Fax +44 (0)20 7848 5966;
The Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2014 came into effect in India on April 1, following the Indian health ministry’s notification on September 24, 2015 of its plan to implement the rules. The new rules stipulate that tobacco products should have pictorial health warnings covering 85% of the packaging space. In March a parliamentary committee had recommended that the warnings should be just 50% on both sides of the principal display area “as it will be too harsh and result in the flooding of illicit cigarettes in the country.” Immediately following the introduction of the new rules the major Indian tobacco and bidi companies decided to shut all their factories and stop production, citing an “ambiguity” in the new policy. In response a senior health ministry official said: “We want to clarify that there is no ambiguity. This is a bogey raised by the tobacco industry. The case is crystal clear. We had issued the notification in September last year. If they had found an ambiguity, why did they send their letter in March, 2016?”
Data from the Coroners Court of Victoria (Australia) have shown that overdose deaths in the state have increased by nearly 23 per cent since 2010, with 420 overdose deaths recorded for 2015. In 2015 almost twice as many overdose deaths involved legal prescription medication, compared with illicit drugs. The data were released with coronial findings into the death of Frank Edward Frood, a 47-year-old man who died from bronchopneumonia "in a background of methadone and benzodiazepine use." The coroner wrote that the death "reinforces the immediate need for a real-time prescription monitoring system to assist doctors in their clinical decision-making around drug prescribing... to tackle the ever-increasing toll of pharmaceutical drug related deaths in the state." The Age reports that the Victorian Alcohol and Drug Association executive officer Sam Biondo said there had been calls for prescription monitoring going back 20 years: "If you add up this sort of death level and multiply it over 20 years, how many thousands of people have died deaths that were preventable and who is responsible for that?" A health ministry spokesperson said that the Victorian government has committed $300,000 to start work on a prescription monitoring system.
The Texas Tribune reports that the Texas Supreme Court has overruled a lower court decision and determined that state regulators could impose a special tax on cigarette makers that were not part of a multibillion-dollar settlement reached with the major tobacco companies in the late 1990s. A 2013 state law placed a 55-cent-per-pack fee on cigarettes not manufactured by the major tobacco companies that settled lawsuits filed by Texas and other states over allegations of deceptive advertising and marketing to children. The tax had been imposed to recover smoking-related health care costs from all manufacturers and to remove a marketing advantage that allowed smaller tobacco companies to sell cheaper products, making them more attractive to younger people. The tax also was intended to protect state funding as the market share continued to fall for the six large tobacco companies that pay Texas about $500 million per year under the settlement. State Attorney General Ken Paxton welcomed the ruling and said: “Tobacco producers who have not taken responsibility for the ill-health effects of their products must not enjoy a competitive advantage over producers who do.”
Following a review by Canada’s Federal Health Department, naloxone is now available in Canada without a prescription. In announcing the review, Health Canada said: "The large increase in opioid overdose episodes has prompted the provinces to design programs to provide greater access to naloxone at the site of the overdose, either through first responders or ‘take-home programs’. These programs are hindered by the prescription status of naloxone. The provinces and territories have collectively asked Health Canada to re-evaluate the status of naloxone." From March naloxone is exempt from prescription status for the emergency use of naloxone outside hospital settings for opioid overdose. The exemption became effective immediately, without the usual six-month delayed implementation period.
The California legislature passed six anti-tobacco bills in March that included a bill to raise the tobacco smoking age from 18 to 21. California would become the second US state after Hawaii to adopt the higher age limit statewide. Governor Jerry Brown must sign the legislation before it can become law. Speaking to KPBS, Assemblyman Jim Wood said: “We are not criminalizing smoking in California. We are just making it harder for young people to buy cigarettes.” Another bill in the package would also restrict electronic cigarettes by classifying them as tobacco products. “With California having such a huge population, it’s going to be very impactful nationwide,” said Cathy Callaway, associate director of state and local campaigns for the American Cancer Society.
The New York Times reports that the US Supreme Court declined to hear a lawsuit challenging Colorado’s legalization of recreational cannabis. Nebraska and Oklahoma, two states neighbouring Colorado, had argued that cannabis grown and processed in Colorado was being trafficked into their states and was causing crime and other problems. The states asked the Supreme Court justices to allow them to file a lawsuit directly in the Supreme Court. The US Constitution gives the court such “original jurisdiction” to hear disputes between states, but this process is only rarely used. Oklahoma and Nebraska’s lawsuit had no data to support it and in urging the justices to reject the lawsuit the US Solicitor General Donald B. Verrilli wrote: “Nebraska and Oklahoma essentially contend that Colorado’s authorization of licensed intrastate marijuana production and distribution increases the likelihood that third parties will commit criminal offenses in Nebraska and Oklahoma by bringing marijuana purchased from licensed entities in Colorado into those states. But they do not allege that Colorado has directed or authorized any individual to transport marijuana into their territories in violation of their laws.”
The second EU Drug Markets Report estimates that the EU retail drug market is worth at least 24 billion euros a year. While the cannabis market is the largest at 38% of the total, the report says that there are recent signs of an increasing availability of heroin in Europe. In 2015, 100 new psychoactive substances were detected for the first time, bringing the total number of new substances monitored in Europe to more than 560. The report suggests that: “It is unlikely that any regulatory system can be designed to sufficiently limit the stream of new substances being manufactured without resorting to a ban on a huge range of chemicals.”
In March U.S. Health and Human Services (HHS) Secretary Sylvia M. Burwell announced a targeted initiative aimed at reducing prescription opioid- and heroin- related overdose, death and dependence. The HHS plans to develop bipartisan work across the federal government and through strategic partnerships with states and private industry. To support this initiative, the Centers for Disease Control and Prevention (CDC) have issued the Guideline for Prescribing Opioids for Chronic Pain. The guideline provides recommendations for managing chronic pain in primary care settings and information about the benefits and risks of opioid use for patients and doctors. The guidance can help doctors to determine if and when to start opioids to treat chronic pain, and provides information on medication selection, dosage, and duration of treatment.
The British government’s blanket ban on “legal highs” due to come into effect on 6 April was postponed. The announcement followed claims that the current definition of a psychoactive substance in the Psychoactive Substances Act is not enforceable by the police. The same difficulty has hindered prosecutions in Ireland, which introduced similar legislation in 2010. “We need to ensure the readiness of all the activity necessary to enable the smooth implementation of the legislation across the UK and to support law enforcement in their ability to drive forward the legislation on commencement,” a government spokesperson said. The legislation aims to ban any substance intended for human consumption that is capable of producing a psychoactive effect. Exemptions from the act include alcohol, nicotine and caffeine. Alkyl nitrites, poppers, were excluded from the act at a very late stage following advice from the Advisory Council on the Misuse of Drugs that alkyl nitrites are not psychoactive in the context of the act and were also not seen to be capable of “having harmful effects sufficient to constitute a social problem.”
A report from the European Monitoring Centre on Drugs and Drug Abuse (EMCDDA) draws on an EMCDDA study that examined internet drug markets and the contributions of a wide range of experts attending an EMCDDA meeting on the topic in 2015. The report describes how internet markets work, the technology that enables them to work, and how these markets work in relation to the more traditional drug markets. Academics, journalists, law enforcement practitioners, treatment service workers and drug users all contributed to the report, which provides an up-to-date conspectus of practical experience and research. The report also covers the sale of psychoactive medicines via online pharmacies and/or other virtual platforms and explores their potential role as a source for the illicit drug market. A final chapter observes that the size and scale of online markets is unclear but experienced drug users report choosing to use online drug markets for their easy accessibility, availability of their drugs of choice and good quality of products. The report suggests that the next generation of darknet markets are likely to be decentralised, peer-to-peer networks. Judith Aldridge, one of the report’s co-authors, said “Despite the growth and popularity of these markets, they tend to be short-lived, and their success substantially hampered by the growth of mistrust amongst market participants due to scams and, to a more limited extent, law enforcement activities.”
The Centre for the Integrated Management of Addiction in Dakar (CEPIAD) opened in Senegal in December 2014. The centre is the first publicly supported opioid substitution treatment (OST) to open in West Africa and received support from the World Health Organization and the United Nations Office on Drugs and Crime. The centre also offers a needle exchange programme, skills training, anti-retroviral therapy and counselling as well as a pilot methadone service. While there are similar services in Sub-Saharan Africa, based in Kenya, Tanzania and Mauritius, other countries such as Burkina Faso and South Africa only have private OST services.
The Guardian reports that ambassadors from all the 28 European Union (EU) member states have agreed to instruct the European Commission to devise plans by 2017 to reclassify e-cigarettes as tobacco products for tax purposes. The ambassadors said it was aimed to reduce "legal uncertainty, hamper substitution by borderline products and avoid possible different approaches in member states.” The plans will be put forward for public consultation. This follows a warning from the Commission in December 2015 that a failure to harmonise excise duties for e-cigarettes could have “significant long term budgetary implications” for countries, which could lead to national taxes being levied that could threaten the EU’s internal market.” “There is an argument that it would be quite good to do something like minimum levels of excise duty for e-cigarettes. Member states could then decide whether to raise them higher or not,” one EU official said. “At present they don’t fall under excise duties like cigarettes, so maybe we would set a minimum threshold.” Deborah Arnott, Chief Executive of Action on Smoking and Health (ASH), said "If the EU were to require member states to tax electronic cigarettes like tobacco products it would be seriously detrimental to public health. It would lead to increased prices and discourage smokers from switching." After EU finance ministers also called for a rise in taxes, a Commission spokeswoman said "It would be extremely unlikely that we would propose to apply the same taxation levels on e-cigarettes as those applied to cigarettes."
The BBC reports that courts across all of London will be able to issue "sobriety tags" for offenders whose crimes were influenced by alcohol. The move follows the results of an initial pilot scheme in four boroughs in South London that found 92% of the 113 people issued with tags did not drink. The pilot will be extended to the rest of London and offenders in the scheme will be banned from drinking any alcohol for up to 120 days and monitored constantly using a sobriety ankle bracelet. The ankle bracelets detect alcohol levels in the wearer's sweat and alert a probation officer when someone has breached an abstinence order. Michael Gove, the Justice Secretary, said “By giving courts this new power and making the latest technology available, we are helping offenders understand the detrimental impact drinking alcohol can have on their behaviour.”
The Australian Department of Health has published a Post-Implementation Review (PIR) for the Tobacco Plain Packaging Act 2011(TPP).The review reported that it was unable to provide a precise monetary value for the benefits of the legislation but concluded that tobacco plain packaging is having a positive impact on the mechanisms for reducing smoking levels and exposure to tobacco.
The Independent reports that after successful trials in Bergen and Oslo, Norway’s narkotikaprogrammet (narcotics programme) is being introduced nationwide. Justice Minister Anders Andundsen said “We’re rolling out a program that has been tested since 2006, in which addicts have been sentenced to treatment with concrete follow-up." “The goal is that more addicts will rid themselves of their drug dependency and fewer will return to crime,” Anundsen added. “But if the terms of the programme are violated, the convicts must serve an ordinary prison term.” Arild Knutsen of the Association for Humane Drug Policy in Norway said “Drug courts constitute a form of forced treatment where the primary symptom of addiction, relapse, is punished with prison. Only one in three people successfully complete the programme.”
A new set of guiding drug policy principles for both the national and international levels is proposed in a major report, After the Drug Wars. Written by the London School of Economics and Political Science Expert Group on the Economics of Drug Policy, the report advocates replacing prohibitionist drug policy goals with the Sustainable Development Goals (SDGs) that aim to end poverty, protect the planet, and ensure prosperity for all. Second, public health approaches, including harm reduction services, should be expanded. Third, the principles of harm reduction should be applied to supply-side policies and management of illicit markets. Fourth, inherent flexibilities within the international drug conventions should be used to foster social scientific policy experimentation.
The World Health Organization (WHO) has published The Health and Social Effects of Nonmedical Cannabis Use, an update of the WHO’s major 1997 report on the drug. Based on background papers discussed at an international expert group meeting held in 2015, the report presents the latest evidence on the impact of cannabis on health and health system responses to cannabis-related problems. The report concludes that there is less knowledge about the health and social effects of nonmedical cannabis use than about the use of alcohol and tobacco and outlines a research agenda.
On 1 February, naloxone became available as an over-the-counter (OTC) medicine in Australia. The move follows a decision by the Therapeutic Goods Administration (TGA) in Australia in November 2015 to place “naloxone when used for the treatment of opioid overdose” on Schedule 3, which allows OTC purchase. Naloxone would still retain its original listing under Schedule 4 (requiring prescription) so that the drug will be government-subsidised, but only when on prescription. The TGA said that “the benefits of increasing availability of Naloxone outweigh the risks.” The TGA suggested that full and clear instructions understandable by lay people should accompany OTC naloxone and emphasised that naloxone does not replace other resuscitation treatments.
CNN reports that on 27 February the Australian parliament passed a measure legalizing the medical use of cannabis, permitting the licensed production and distribution of cannabis to qualified patients. The measure amends the Narcotic Drugs Act of 1967 to allow "for the cultivation and production of cannabis and cannabis resin for medicinal and scientific purposes," and to authorize "a state or territory government agency to undertake [in the] cultivation and production of cannabis and [in the] manufacture of medicinal cannabis products.” Regulations for the new programme still need to be developed and approved by the government before any production licences can be issued. “This is an historic day for Australia and the many advocates who have fought long and hard to challenge the stigma around medicinal cannabis products so genuine patients are no longer treated as criminals,” Minister for Health Sussan Ley said in a statement, adding “This is the missing piece in a patient’s treatment journey and will now see seamless access to locally-produced medicinal cannabis products from farm to pharmacy.”
Belgium is to reverse its 2007 ban on e-cigarettes. New legislation that will legalise electronic cigarettes in Belgium is to receive royal assent. The move follows the publication of a risk assessment report from Belgium’s Superior Health Council that supported the use of e-cigarettes for smoking cessation. Under the new legislation, e-cigarettes will have to comply with all the conditions set for tobacco products including advertising restrictions and health warnings on cigarette packets. E-cigarettes will be available from newsagents, online sales are banned and there will be a minimum age of 16 to purchase them.
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