Even in experienced hands buy tadacip paypal impotence pills for men, this type American Thoracic Society Documents 393 of surgery is associated with a relatively high morbidity 20 mg tadacip amex erectile dysfunction doctors rochester ny. Third, with bronchiectasis include autogenic drainage, oscillating posi- these data likely represent very highly selected patient popula- tive expiratory pressure devices, and high-frequency chest com- tions, and the results from these reports may not reflect the pression devices. These modalities offer additional mucus clear- likely more variable clinical and microbiologic results expected ance advantages to patients, and should be considered in in patients with complex, advanced disease. A special circum- individuals with significant mucus production and clearance stance that merits discussion is the surgical removal of a solitary problems. Other potentially important considerations include nu- directly assessing this problem, expert consensus is that, in the trition and weight gain, and exercise and cardiovascular fitness. There are few centers with extensive experience with my- female predominance, and nearly all reported cases are in whites cobacterial surgery. For children with recurrent disease, a second surgical pro- Considerations in delaying or withholding treatment. An alternative for recurrent disease tinction between colonization and invasive disease is not rele- or for children in whom surgical risk is high (e. Consideration should excisional surgery (or surgical debridement) and chemotherapy also be given to the use of adjunctive therapies, in addition to is usually performed. Clearly, these measures may be estimated 37,000 cases in the United States in 1994 (17). Rifabutin cannot be used with certain of these drugs and underlying immunosuppression. Routine monitoring is not indicated unless the tise or consultation with experts in this field. Although monotherapy with T-cell count of over 100 cells/ l for at least 12 months (312). Ethambutol is considered as the second drug to be used, with Most of the reports of treatment of M. O nthebasis a dose of 450 mg/day did appear to offer modest clinical benefit of both efficacy and ease of use, azithromycin—given as 1,200 mg when used as a third drug (313). For patients with macrolide-resistant strains, treatment regimens are far less Treatment successful. Drugs that should be considered for inclusion are Clarithromycin 500 mg orally twice daily Azithromycin 500 mg daily aminoglycosides, such as amikacin, and a quinolone, such as Ethambutol 15 mg/kg orally daily Ethambutol 15 mg/kg daily moxifloxicin. Combinations of clarithromycin and rifabutin may result Rifabutin†300 mg orallydaily in high serum levels of rifabutin and have been associated with * For evidence quality, see Table 1. American Thoracic Society Documents 395 once weekly—is the preferred agent (Table 6) (320). Therefore, routine screening of respiratory or gastroin- (341, 344, 345, 347–350). Four-month sputum con- with the same phage type as those isolated from patients have version rates with rifampin-containing regimens were 100% in been recovered from drinking-water distribution systems in the 180 patients from three studies (344, 345, 347). Two patients Netherlands and environmental isolates of the same genotype failed therapy after initial sputum conversion and both failures as clinical isolates have been identified in France (325, 327). Long-term relapse rates with rifampin-containing regi- subspecies or types are present among both environmental and mens were very low, with only one relapse recorded among human isolates (328–333). Because of the excellent outcomes with type responsible for human infection (328–336). A second group of 14 patients were treated with is the second most common nontuberculous mycobacterium that the same regimen but for a total of 18 months. The treatment regimen for disseminated disease no disease relapses after 46 months of follow-up (95). There is successfully with a regimen that consists of high-dose daily isoni- no recommended prophylaxis or suppressive regimen for dissem- azid (900 mg), pyridoxine (50 mg daily), high-dose ethambutol inated M. The southeastern United States from Florida to cin or amikacin for a total of 6 months (342). The excellent in vitro activity accidental trauma or surgery in a variety of clinical settings (173). However, several studies of post- mycin or azithromycin), moxifloxacin, and at least one other injection abscesses in which no therapy was given revealed dis- agent based on in vitro susceptibilities, such as ethambutol or ease that persisted in most patients for 8 to 12 months before sulfamethoxazole, are likely to be effective for treatment of a spontaneously resolving. The largest group of patients with this lung disease are white, female nonsmokers, and older than 60 years, with no 1. Patients should receive a daily regimen including rifampin predisposing conditions or previously recognized lung disease. The distinguishing feature of patients with three-drug regimen is recommended based on in vitro suscep- a recognized underlying lung disease is that their M. Removal of foreign 50 years, and almost all patients younger than 40 years have one bodies, such as breast implants or percutaneous catheters, is of the predisposing disorders (32). Approximately 15% of patients with culture positivity, short of conversion to negative culture, are M. The natural history of this disease depends outlined above) with amikacin plus cefoxitin or imipenem for 2 primarily on the presence or absence of underlying disorders. For some patients, symptoms can be a study published in 1993, death occurred as a consequence of controlled with intermittent periods of therapy with clarithro- M. Because of vari- can be realistically administered to control the symptoms and able in vitro drug susceptibilities to some drugs, antibiotic suscep- progression of M. Because side effects tibility testing of all clinically significant isolates is recommended. For patients with underlying esophageal or other swallowing For serious skin, soft tissue, and bone infections caused by disorders, treatment of the underlying condition can result in M. The macrolides are the only oral include three newer classes of drugs, the oxazolidinones, the agents reliably active in vitro against M. The lower dose (10 mg/kg) should been treated with linezolid and a companion drug, usually a be used in patients older than 50 years and/or in patients in macrolide, with mixed results. The three- usually recommended antibacterial doses (600 mg twice daily) times-weekly amikacin dosing at 25 mg/kg is also reasonable, is often associated with severe side effects, such as anemia, pe- but may be difficult to tolerate over periods longer than 3 months ripheral neuropathy, nausea, and vomiting. The amikacin combined with high-dose cefoxitin (up to 12 g/d given intravenously in divided doses) is recommended mg/day, is associated with fewer gastrointestinal and hematologic for initial therapy (minimum, 2 wk) until clinical improvement side effects and may still have significant antimycobacterial activ- is evident. The tetracycline derivatives, glycylcyclines, especially choice of an alternative agent such as imipenem (500 mg two tigecycline, also have in vitro activity against M. This to four times daily), which is a reasonable alternative to cefoxitin drug must be given intravenously and it is known to cause nausea (175, 359, 360). For serious disease, a minimum of 4 months of and anorexia in some patients when given long term for myco- therapy is necessary to provide a high likelihood of cure. Telithromycin, a ketolide, in limited testing bone infections, 6 months of therapy is recommended (354). At present, there is no reliable or dependable antibiotic The optimal therapy for M. Recently, additional species, including cefoxitin, or imipenem) or a combination of parenteral M. Skin, bone, and soft tissue disease are the most important clinical manifestations of M. Isolates are susceptible to amikacin (100%), (l00%), linezolid (90%), imipenem (60%), amikacin (50%), clo- ciprofloxacin and ofloxacin (100%), sulfonamides (100%), cefox- fazimine, doxycycline (25%), and ciprofloxacin (20%).

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Legal production of both does take place but buy tadacip 20mg line free erectile dysfunction drugs, compared to the legal production of opium cheap tadacip 20 mg fast delivery erectile dysfunction doctor prescription, it is on a much smaller scale and there is much less publicly available information— indeed the whole process is somewhat shrouded in secrecy. Coca leaves as a favouring agent The 1961 Convention specifcally allows for de-cocainised coca leaves to 154 be used as a favouring agent. In the case of Coca-Cola, coca leaves are purchased from South American suppliers by the American conglom- erate, Stepan Chemicals Company. Separation of the cocaine and favouring involves a fairly elab- orate process in which the leaf is ‘ground up, mixed with sawdust, soaked in bicarbonate of soda, percolated with toluene, steam blasted, mixed with 155 powdered Kola nuts, and then pasteurized’. A number of smaller product brands also use coca favouring, many (unlike Coca-Cola) specifcally building their marketing around the 156 coca leaf being an ingredient, despite their drinks having no active coca-derived content. Cocaine-based pharmaceuticals There is relatively little information in the public domain about the production and use of pharmaceutical cocaine for medical use. No fgures are available regarding the balance of global production (from the de-cocainised leaf based favourings process), or demand, or whether there is any leakage into the illicit market at any point during the coca/ cocaine production process. In practice, cocaine now has relatively few mainstream medical 155 ‘The Legal Importation of Coca Leaf’, University of Illinois, Class module 9. Its former role in anaesthesia has been progressively displaced by newer, more effective synthetically derived alternatives including Novocaine, Lidocaine and Xylocaine. Under the 1961 Single Convention, countries that legally produce coca and cocaine are expected to have established an agency to control and oversee the cultivation of coca and production of cocaine. Peru also manufactures a small amount of raw cocaine to 162 be exported to other countries for the production of medical cocaine. This statement understandably caused outrage in Bolivia and Peru where coca leaf chewing is a long established tradition amongst 159 The use of various coca preparations in South America as a traditional medicine in various forms remains widespread. The traditional use of coca leaf has increasingly become a political fashpoint in the international arena, as such long established cultural and traditional indigenous practices have collided with the prerogatives of Western governments determined to stamp out the source of illicit cocaine production that exists in parallel with sources for traditional use. To date, this report has never been offcially published although the relevant sections have subsequently 165 been leaked and made available online. Currently four countries (Bolivia, Peru, Argentina and Colombia) main- tain legislation permitting some form of protection of traditional use, to different extents. Bolivia and Peru allow the growing of the leaves for this use, limiting this to a certain amount of hectares. Argentina allows people to carry leaves for traditional chewing, as does Colombia and Chile for their indigenous peoples. Signifcant problems exist for the legal and quasi-legal markets in coca- based products in that they struggle to compete with the illegal coca production that supplies the illegal cocaine trade. Discussion Legal coca production for use in its raw leaf form, lightly processed products, or pharmaceutical cocaine does not present any signifcant problems in and of itself. Low potency coca products (leaf and tea) do not require any more controls than equivalent products such as coffee, whilst the processing of coca into pharmaceutical cocaine would take place at an industrial level for which any security and product regulation issues would operate within well established models. The key problems in any such system are the ones already seen in coca producing regions: the potentially destabilising economic tensions and pressures created by any remaining parallel illicit market. Regulating legal production of coca leaf in line with the established fair trade guidelines—price guarantees along with a range other social and environmental protections (for growers of coffee, cocoa, sugar, etc. Furthermore, in a similar fashion to opium and cannabis, such problems would progressively diminish with the shrinking demand for illicit supply, as the global market shifted towards legal regulation of production and supply. These include legal regulation of cannabis production for a range of purposes (primarily for various medical uses and preparations, but also, to a lesser extent regulation of industrial hemp production and some sacra- mental/religious uses) in a number of different countries over a number of decades. The challenges and issues raised by these existing models provide a clear indication of how licensed models for cannabis produc- tion for non-medical use can evolve as and when the political and legislative environment allows it. Cannabis holds a unique place within contemporary drug culture and politics, being the most widely used illegal drug globally by an 170 171 enormous margin, as well as being a plant based drug that can be consumed in its raw herbal form without requiring the signifcant levels of processing associated with, for example, heroin or cocaine. Regulatory control issues are also complicated by the fact that the plant itself is uncommonly simple to cultivate in a wide range of environ- mental conditions. The combination of these factors with the enormous and growing demand for the drug (expanding steadily in the West over the past four decades but now showing signs of having fattened off or 172 even falling ) means that regulation of cannabis production, supply, and use has presented an impossible challenge from the perspective of prohibition’s enforcers; illicit production, supply and availability having more than kept pace with demand. Legal cannabis production for medical use The most useful contemporary model for production of cannabis is for its medical uses, in both processed and herbal form. These licences allow the company to research and develop cannabinoid prescription medications such as Sativex. A 2007 case documented street cannabis being bulked up (by weight) with lead particulates leading to a signifcant number of serious lead poisonings, in the New England Journal of Medicine, ‘Lead Poisoning Due to Adulterated Marijuana’, April 10, 2008. It is interesting to note that there are currently two other prescription drugs based on compounds found in the cannabis plant. They notably found that ‘Dronabinol is the main active principle of cannabis and has similar effects on mood, perception and the 178 cardiovascular system’. Gettman—this move was ‘in response to a petition fled by the manufacturer on February 3, 1995’: www. It remains controversial in the medical world because, unlike almost all other licensed drugs, it is consumed in its raw herbal form (seen as a ‘messy’ cocktail of active substances), because it is frequently smoked (although it can be used with a vaporiser or eaten in variety of preparations), and because it has not been through the stan- dardised rigours of other potential prescription drugs. There are also ethical issues around potential side effects, not least plea- surable ones, and concerns about diversion to non-medical use. None the less, provision of medical herbal cannabis does exist in various forms and provides some useful indications for how potential non-med- ical production models may operate in the future. John’s Wort as an anti-depressant, that lacks any parallel non-med- ical/recreational uses), as the issue has become inexorably entwined with the wider political and cultural discourse about non-medical cannabis use and legislation. None the less, the widely reported eff- cacy of herbal cannabis relative to standard prescribed drugs for a large number of individuals with chronic illnesses, who do not ft the bill as stereotyped drug users, has forced the issue. Thirteen states now allow the use of medical cannabis—they are Alaska, California, Colorado, Hawaii, Maine, Maryland, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont, and Washington. As a result, there have been a series of unpleasant enforcement incidents, with federal police closing down medical production and dispensaries that were offcially sanctioned by state governments. These patients have been provided with medical cannabis for between 11 and 27 years. Material is shipped to the Research Triangle Institute in North Carolina where it is chopped and rolled on modifed tobacco cigarette machines, then stored partially dehydrated and frozen. Legal cannabis production in Canada A similar scenario has played out in Canada where, in 2001, medical use of cannabis was legalised in restricted circumstances through the 180 Canadian Department of Health’s Medical Marihuana Access Division. According to their Marihuana Medical Access Regulations, individuals can get licences to produce their own supply of cannabis, or a licence can be given to another designated individual to grow on their behalf. In 2000 Canada’s department of health, Health Canada, contracted Prairie Plant Systems, on behalf of the federal government, to grow cannabis in an underground mine at Flin Flon Manitoba for research purposes, and in 2003 to distribute to the expanding number of medical users in the 180 Health Canada website: 210 www. Along with the estimated 600 users of the Prairie Plant Systems 183 cannabis there are over 11,000 users of ‘compassion clubs’ in Canada. These clubs act as medical cannabis dispensaries, supplying cannabis for therapeutic use upon a valid recommendation or confrmation of 184 diagnosis from a licensed health care practitioner. Whilst the Senate 185 Special Committee on Illegal Drugs and other government bodies have recommended that these organisations be licensed and legally recogn- ised, currently they are operating without legal sanction. They set clearly defned standards, including demands that a variety of strains be offered 181 Health Canada’s Medical Marihuana Access Division website: www. Report of the Senate Special Committee on Illegal Drugs’, Summary Report, September 2002, page 20. Cultivators must also protect the cannabis from yeasts, moulds, mildews and fungi.

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Table 9 – Pharmaceutical market growth by region Region Market growth Market growth projections 2013 (%) 2012–2017 (%) North America -2 order tadacip 20mg with mastercard causes of erectile dysfunction in 40 year old. Low- and middle-income countries often have a small but wealthy high- income population that is of interest to the industry because it can afford to pay for high-priced medicines order tadacip without prescription erectile dysfunction only with partner. However, for companies to have a social license to operate in developing country markets they will have to develop strategies to serve the needs of the entire population, in the interests of public health. This section describes the access policies of a selection of pharmaceutical companies that have important cancer drug portfolios or cancer drug development projects. The information for this section was collected through research on companies’ websites and other publicly available sources. Pharmaceutical companies have a responsibility to make their products available to those in need. Growing demand for cancer care in low- and middle-income countries requires companies with cancer drug portfolios to develop access strategies. Roche’s strategy with regards to access to medicines in the developing world is set out in the document ‘Access to Healthcare –Roche’s global commitment’. According to this document, the aim of the company ‘is for every person who needs our products to be able to access and benefit from them’. The paper goes on to say that ‘Roche shares a joint responsibility with governments, international organizations and the rest of our industry to tackle the challenges of improving access to quality healthcare. Roche lists the following approaches for improving affordability:  securing reimbursement through commercial arrangements and/or differential pricing;  assisting patients who pay out-of-pocket through patient assistance programmes;  contributing to the development of private health insurance coverage. Roche is in the process of establishing differential pricing programmes for their therapies, including anti-cancer drugs, in low- and middle-income countries. In the Philippines, Roche is experimenting with a tiered pricing scheme for Herceptin that is linked to the individual patient’s ability to pay, as assessed by a third party. There is no information publicly available about the price levels that have been set, nor the outcome of the programme. However, based on information from a blogger/journalist in the Philippines writing about 31 Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication. Roche points out that there are many challenges with implementing differential pricing, identifying the use of international reference pricing as a concern. Roche calls for global solidarity to ensure that lower prices granted to low- and middle-income countries are not taken advantage of by high-income countries. They want to see inter- governmental action to ensure that reference pricing and parallel trade are not used outside groups of countries of the same economic development level. Another approach to differential pricing is through ‘second brands’ which means that the same product has a different brand name and packaging from the original Roche product. Examples of a cancer drug second brand includes Herclon, a renamed and repackaged brand of trastuzumab (Herceptin) provided by Emcure in India, following an agreement with Roche. In 2003 the New York Times criticized Novartis for using the programme to prevent generic supply by threatening to stop its donations when generic versions of the medicines are made available, and to enlist patients to lobby 106 for reimbursement of the drug. In the case of cancer medicines they use direct-to-patient donations, which involve case-by-case management. Drug donations can never provide a sustainable answer to the current cancer care crisis in low- and middle-income countries. Differential pricing is only practised in the case of the antimalarial drug Coartem – which is a second brand of the antimalarial drug artemeter/lumefantrine sold under the brand Riamet for travellers from high- income countries. Novartis is open to 107 licensing of their patents for neglected tropical diseases research only. Sanofi’s central approach to affordability is through ‘a differentiated pricing policy to help ensure medicines are affordable for all’. And to ‘Adapt our commercial offering based on the economic conditions in the countries we seek to help’. Cancer is mentioned in the context of support programmes for prevention, diagnosis and follow-up, for chronic diseases (e. But the website does not list a programme or outlines an approach to provide access to Sanofi’s cancer medicines. Genzyme, a Sanofi biotech company, works with Project Hope and the National Cancer Coalition to donate medicines. It provides the following information about access to its products in developing countries: Outside the United States, medical care is often managed and funded by national governments. In such countries, Genzyme works closely with governments to help facilitate approval of our treatments and ensure that they are accessible to citizens covered by national health services (Genzyme. In developing countries, we help physicians and local authorities build sustainable health care systems that can pay for critical treatment. Where such systems do not yet exist, we provide free treatment to patients in the interim until longer-term, sustainable solutions can be established locally. Bristol-Myers Squibb Bristol-Myers Squibb, according to its own website, is a global BioPharma company that is producing medicine to help patients in their fight against major diseases, including cancer. On access to medicine in the developing world, the company claims to work closely with government health authorities and other payers in seeking marketing authorization and reimbursement for therapies, while also relying on a number of companywide policies, programmes, and innovative initiatives to guide their efforts. Bristol-Myers Squibb stresses ‘with particular importance, the pressing need for medications produced by this company in low-and middle-income countries in the developing world. Since 1999 the foundation has allocated $150m in grants for medical research and care and community support. The three areas ‘pricing and assistance’, ‘access management’, and ‘patent, licensing and technology transfer’ are most relevant to this report. The area ‘pricing and assistance’ lists the following with regards to access to cancer medication. Through the ‘Bridging Cancer Care’ programme of the Bristol-Myers Squibb Foundation, seven initiatives to improve cancer care in Russia are supported by Foundation grants. The grants, totalling $1m, focus on improving the capabilities of nurses in cancer care. The website does not provide information about the number of patients that have been able to benefit from access to cancer treatment under the listed activities. Bayer Bayer has patient assistance programmes for kidney cancer and liver cancer patients in countries of South and Southeast Asia, in Brazil, and several countries in South Eastern Europe. In 2008, Bayer implemented a Patient Assistance Programme in India along with the market launch of sorafenib (Nexavar) in the Indian market. According to the Bayer website, the programme reduces the cost of the monthly treatment of the patented Bayer drug therapy for qualified patients enrolled, to about 10 percent of the regular 110 pharmacy price for the complete duration of treatment. Conclusion Drug companies’ policies for access to cancer drugs do not seem to be well developed. Companies’ access approaches for cancer lean heavily on traditional drug donations/charitable approaches and are often on a case-by-case basis. For example, none of the websites mention licensing approaches for cancer 35 Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication.

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Some efforts to untangle drug use harms from drug policy harms have been made purchase genuine tadacip on line lipo 6 impotence, although this is an area that warrants more detailed consid- eration and analysis generic tadacip 20mg with mastercard erectile dysfunction hormones. Correspondingly, the Transform report then makes a distinc- tion between the aims of the drug policy reform movement—to reduce or eliminate the harms specifcally created or exacerbated by prohibi- tion and illicit markets—and the more conventional aims of an effective drug policy—to reduce or eliminate the range of direct and indirect harms associated with drug use and misuse. A more comprehensive ‘taxonomy of drug-related harms’ has been 32 constructed by MacCoun and Reuter who break down forty six iden- tifed drug-related harms into four general categories: ‘health’, ‘social and economic functioning’, ‘safety and public order’, and ‘criminal justice’. Whilst these systems have some functionality, they are frequently both inconsistent and oversimplifed. On a practical level, they are built on generalisations, they (confusingly) fail to include legal drugs, and both confate and fail to fully acknowledge multiple harms; this has substantially reduced their utility, both as policy making tools, and as aids to individual users seeking to make informed decisions about personal drug use. Before discussing these issues and their policy implications in more detail it is worth trying to deconstruct the main vectors of harm associ- ated with drug use specifcally (as distinct from harms related to drug policy) that policy makers must consider. The level of risk associated with a given drug’s toxicity and propensity to cause dependence is then moderated by a series of behavioural variables, and by the predispositions of the individual user. A drug’s acute toxicity relates to the size of the margin between an active threshold, the dose at which the drugs effect (or desired effect) is achieved by the user, and the dose at which a specifed toxic reaction, or overdose, occurs. Such a toxic reaction could involve merely unpleasant temporary side effects, such as vomiting, dizziness, fainting, distress, etc. The comparable terminology for medical drugs is the ‘therapeutic index’, which is the ratio of the therapeutic dose to the toxic dose. With non-med- ical drugs acute toxicity of a given drug is often measured by assessing the ratio of lethal dose to the usual or active dose. The smaller this gap between active and toxic dosage, the more toxic a drug is deemed to be. Other methods for measuring toxicity, such as sub-lethal toxic effects, also exist; all are clear and relatively simple. When ranking drugs, however, issues of acute drug toxicity are compli- cated by a number of behavioural variables, most obviously including mode of drug administration, and poly-drug use. It is especially hard to establish individual effect causality in the context of a range of lifestyle variables, and use of multiple drugs. Even when credible esti- mates or measurements can be made of long term effects, the problem arises that rankings of drugs by acute and chronic toxic effects do not necessarily match up. For example, it is diffcult to compare tobacco smoking, which involves low acute risk but high chronic risk, with opiate use, which has high acute risk but lower chronic risks. Drug addiction, or drug dependence as it is generally now described, is a diffcult concept to precisely defne, or to achieve consensus on. However, more agreement does exist on the physiological components of drug dependence, described in terms of brain chemistry (neurotransmitters, receptors, etc. These physiolog- ical components have been well described in the medical literature of the last century (for established drugs at least, if not perhaps so well for more recently emerging ones), and are now well understood. An additional physiological aspect of drug action that impacts on dependence is its half life, which measures how long the drug effect lasts. The qualita- tive nature of the initial onset of the intoxication experience, or ‘rush’, and the post-rush experience—the subjective pleasure associated with using the drug—are also important variables. They are, however, harder to objectively quantify, and also dependent to a signifcant extent on drug preparation, dosage and mode of administration. However, while the physiological elements of drug action as it relates to dependence can be assessed and potentially ranked, dependency issues are dramatically complicated by the individual user, and the range of psycho-social factors that interface with physiological processes. This interaction produces dependency-related behaviours, which may require the attention of policy makers and service providers. The psycho-social infuences upon, or components of dependency relating to, a given drug are far harder to quantify and rank, and far more contentious in the literature. For example, psychological dependence— ‘addiction’—is now also associated with sex, shopping, gambling, the 34 internet and so on. These psycho-social components are, however, arguably no less important in terms of determining behaviours. Some drugs that have relatively moderate or low physiological dependency effects are none the less frequently associated with powerful psychological depen- dency, cocaine being an obvious example. Whether physiological and psychological dependence should be pooled together in rank- ings remains a moot point—as does the question of whether ‘addiction’ remains a useful term, as opposed to dysfunctional, problematic or dependent use. Alexander, ‘The Globalisation of Addiction: A Study in Poverty of the Spirit’, Oxford University Press, 2008. In particular, risk assessment is made more diffcult by the wide variation in physiological and psychological makeup of individual drug users. Key variables include general phys- ical and mental health, and age (young and old are more vulnerable). Specifc physical and mental health conditions can have a major impact on individual risk, and pharmacogenetic factors can also cause vulner- abilities to certain drug harms in certain individuals. This is largely unaccounted for by broadly generalised drug harm categories and rankings. Clearly, a small amount of a Class A or Schedule 1 drug will be less risky than a large dose of a drug from a lower schedule. However, in a regu- lated market, with standardised products and packaging information, the specifc risks of unknown potency (and in particular, of unexpectedly high potency) will largely be removed. The issue of relative potency- related risk has probably been overstated as users, if possessed of the requisite dosage information, will rationally dose control to regulate their own risk exposure—or auto-titrate, to achieve the level of intoxica- tion they are seeking. The nature of the drug preparation, how the drug is administered, and the physical and social/peer environment in which consumption takes place are also crucially important linked variables in determining risk. This is usefully illustrated with the example of coca based drugs—from 76 4 5 6 Making a regulated system happen Regulated drug markets in practice Appendices chewed coca leaf, through coca drinks, snorted cocaine powder, to smoked crack cocaine (see: page 120). It is worth noting that the risk of lung damage can be signifcantly reduced if the drug can be inhaled in a vaporised form,36 rather than as smoke from a burning process. By contrast to the seconds associated with injection, this is lower intensity and gives some degree of control over dosage. Some drugs, including tobacco and coca leaf are held in the mouth and absorbed through the gums. The reform position is substantially predicated on the observation that both health and secondary social drug risks/harms are increased in the context of illicitly controlled production and supply, and illicit using environments. Whilst there is a great deal of complexity in teasing out these relative risks/harms, the broader point is simply illustrated with a real world example. Compare two injecting heroin users; the frst is committing high volumes of property crime and street sex work to fund their illicit habit. They are using ‘street’ heroin (of unknown strength and purity) with dirty, often shared needles in unsafe environments. Their supplies are purchased from a criminal dealing/traffcking infrastructure that can be traced back to illicit production in Afghanistan.

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