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By C. Milok. Indiana University Northwest. 2019.

Detoxification A controlled process of providing symptomatic relief to assist patients to complete withdrawal from a Drug order zofran 4mg on line, while minimising the associated adverse effects generic zofran 8 mg free shipping. In the context of Illicit drug use, the aim of detoxification is to reverse or reduce Dependence on and Tolerance to a Psychoactive drug. Diversion From a medical perspective, diversion is the inappropriate use of a Drug by those for whom it has been prescribed, or use by a person for whom the medication was not prescribed. The term may be used to describe diversion of a shipment of drugs out of legal channels at wholesale level or, for example, to describe the sale of prescription methadone to, and use by, an individual for whom it was not prescribed. The term diversion is also used in a criminal justice context to refer to measures that take an arrestee out of the criminal justice system and into education, medical management or another type of intervention. In medicine, it refers to any substance with the potential to prevent or cure disease or enhance physical or mental welfare, and in pharmacology it refers to any chemical agent that alters the biochemical or physiological processes of tissues or organisms. In common usage, the term often refers specifically to Psychoactive drugs, and often, even more specifically, to Illicit drugs, of which there is non-medical use in addition to any medical use. Professional formulations (eg ‘alcohol and other drugs’) often seek to make the point that caffeine, tobacco, alcohol and other substances in common non-medical use are also drugs in the sense of being taken, at least in part, for their psychoactive effects. In other contexts, abuse has referred to non-medical or unsanctioned patterns of use, irrespective of consequences. Drug control The regulation, by a system of laws and agencies, of the production, distribution, sale and use of specific Psychoactive drugs (Controlled substances) locally, nationally or internationally. Drug misuse Use of a substance for a purpose that is not consistent with legal or medical guidelines, as in the non-medical use of prescription medications. This term is often preferred to Drug abuse, as it is perceived to be less judgemental. Drug poisoning A state of major disturbance of consciousness level, vital functions, and behaviour following the administration in excessive dosage (deliberately or accidentally) of a Psychoactive substance. In the field of toxicology, the term poisoning is used more broadly to denote a state resulting from the administration of excessive amounts of any pharmacological agent, psychoactive or not. In the context of Illicit drug use, poisoning may occur as a result of adulterants in the drug. Drug policy In the context of Psychoactive drugs, the aggregate of policies designed to affect the supply and/or demand for Illicit drugs, locally or nationally, including education, treatment, control and other programmes and polices to reduce the harms related to illicit drug use. In this context, ‘drug policy’ often does not include pharmaceutical policy (except with regard to diversion to non-medical use), or tobacco or alcohol policy. Drug-related problem Any of the range of adverse accompaniments of Drug use, particularly Illicit drug use. The term was coined by analogy with alcohol-related problems but is less used, since it is Drug use itself, rather than the consequence, that tends to be defined as the problem. This term has been used throughout this book rather than Drug abuse or Drug misuse, as it is non-judgemental. Gateway drug An Illicit or Licit drug, use of which is regarded as opening the way to the use of another drug, usually one that is viewed as more problematic. Harmful use A pattern of Psychoactive Substance use that is causing damage to health. The damage may be physical (eg hepatitis following injection of drugs) or mental (eg depressive episodes secondary to heroin use). Harmful use commonly, but not invariably, has adverse social consequences but social consequences are not necessary to justify a diagnosis of harmful use.

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One of the more recent publications in this thera- peutic compound class buy cheap zofran 8mg on-line, involving studies using both in vitro and patient dosing cheap 8 mg zofran with amex, has described the use of the bronchodilatory drug salbutamol 11. Whether this will indeed prove to be the case remains to be seen following appropriately designed long-term studies. Encouraging results have been reported in various animal studies, although no clinical evaluation has yet taken place in human patients. While only limited data has been published to date,246,247 Phase 3 clinical trials with valproic acid and carnitine co-dosing at least appear to be planned. Furthermore, the use of agents originally designed for oncology indications in a potentially chronically dosed paediatric indi- cation seems optimistic, and will in all likelihood require more selective compounds with a signicantly cleaner toxicological prole than that seen with compounds thus far. Interestingly, despite the presence of reactive electrophilic functional groups such as the triepoxide and butenolide motifs, no apparent toxicity was noted. Initially, researchers designed a reporter-based screening assay to identify compounds such as the anthracycline aclarubicin (11. No details of the criteria which qualied these six classes as preferable for further evaluation were described. Although both series were felt to represent viable start points for medicinal chemistry optimisation, only work on the latter series appears to have been undertaken. Optimisation of the 2,4-diaminoquinazoline analogues has been pub- lished recently, and described the structure–activity studies which led to the discovery of lead candidate D156844 (11. Most notably, and (so far) uniquely for this disease, other key compound data were described including pharmacokinetic parameters, and systemic and central plasma and tissue compound levels, all of which were found to be extremely encouraging. Illustrating a typical challenge faced during a drug discovery programme, the off-target pharmacology of compounds was also assessed, and examples of the 2,4-diaminoquinazoline View Online 316 Chapter 11 Figure 11. Of particular note was the additional publication of exposure and efficacy data for several analogues in the series. This compound has been described as having a similar chemical structure to quinazoline 11. Repligen has very recently announced that it has signed a licensing agreement with Pzer to further develop the programme. Because a molecular target for the compound has now been identied and crystal structures are available, it could reasonably be anticipated that development of next-generation View Online Drug Discovery Approaches for Rare Neuromuscular Diseases 317 compounds using both screening and computational drug discovery plat- forms will follow. In contrast, the groups previously reported assay measured increases based on splicing alone. Using this novel assay a collection of 115 000 compounds were screened, which resulted in the identication of 462 hits. Conrmatory screening removed a signicant proportion of hit molecules, leaving 294 compounds which fell into 19 structural classes. In order to assess the specicity of the mode of action of the various compounds (i. The authors proposed that these results indicated differing mechanisms of action were in play for the different structural classes, with 11. For any future studies it would be useful to investigate these in more detail, particularly whether they translate to non-genetically modied cells such as patient-derived broblasts as there are important implications for future progression of compounds, for example they may act in an additive manner and offer possible co-treatment options. Secondly the effect on ‘gem’ formation (localisation of protein to nuclear bodies) at lower compound concentration was assessed. Because it had been hypothesised that the compound classes may have differing modes of action, a novel experiment undertaken in these studies was an evaluation of combination effects. Evidence of improved efficacy was View Online Drug Discovery Approaches for Rare Neuromuscular Diseases 319 seen with several combinations of 11.

An emphasis on the public health risks of illegitimate drugs is central to framing this problem; protecting drug companies’ proprietary interests is not zofran 4mg with mastercard. In the past generic zofran 8 mg with visa, disagreements about the overlap between public health protection and intellectual property guarantees have crippled international discussion on drug safety. Any global governance process will need to focus on public health, a goal all parties can support and come to consensus around. Global governance includes hard law, such as treaties, and soft law, such as resolutions, declarations, memorandums of understanding, and codes of practice (Gostin, 2013). If countries or regions wish to negoti- ate a treaty on falsifed and substandard drugs, then they should do so, but international soft law may be a more practical short-term solution to the problem. A soft-law solution could encourage international momentum for drug regulation, surveillance, and law enforcement. It would also build trust among stakeholders and pave the way for a future hard-law solution if necessary. Two treaty processes already under way relate to the problem of substandard and falsifed medicines. The Council of Europe’s Medicrime Convention (offcially, “the Convention on the counterfeiting1 of medical products2 and similar crimes involving threats to public health”) is a multi- lateral treaty intended to prevent the public health threats of illegitimate medicines (Council of Europe, 2011). The convention aims to make crimes of drug adulteration and of the intentional manufacture, supply, or trade in illegitimate medicines or ingredients, and their accessories (Council of Europe, 2011). Other criminal offenses under Medicrime include tamper- ing with the drug pedigree or making false drug documents; putting an unauthorized drug on the market; and intentionally aiding or abetting a criminal in one of the named offenses (Council of Europe, 2011). Med- icrime also gives terms for protecting victims, including victim’s rights to compensation from perpetrators, and for international cooperation in investigation, extradition, and mutual legal assistance (Council of Europe, 2011). By December 2012, 22 countries had signed the convention, but only Ukraine had ratifed it (Council of Europe, 2012). Medicrime will not come into force until fve countries ratify it, including three Council of Europe members (Council of Europe, 2011). Critics of the convention see in Medicrime an attempt to treat routine 1 The Medicrime Convention defnes a counterfeit as a false representation of identity or source (Council of Europe, 2011). And, though Susanne Keitel, the director of the European Directorate for the Quality of Medicines, explained to the committee in March that the Medicrime Con- vention does not cover infringement of intellectual property rights, some see hostility to generics companies in the treaty (Attaran and Bate, 2010). As Chapter 1 explains, this report is not concerned with intellectual property rights. The committee believes that the real or perceived mixing of public health and intellectual property concerns only holds back action on the problem of falsifed and substandard drugs. In her opening remarks, Director-General Margaret Chan reiterated the organization’s commitment to working against harmful products in the drug supply and promoting the availability of good-quality medicines around the world (Chan, 2012). Because the problem has legal dimensions, it will also be crucial to include experts in law enforcement, criminal justice, and customs. Contributing to the law enforcement and criminal justice sections of an international code on falsifed and substandard medi- cines would draw on the agency’s strengths and complement the goals set out in its 3-year strategy. National customs offces are under pressure to facilitate international trade and to monitor the safety of products enter- ing the country; they have a unique understanding of the circumstances through which illegitimate medicines enter commerce. Monitoring the trade in illegitimate medicines and enforcing laws against them depend on customs bureaus, however. Failing to include them in the development of the code would risk its being unacceptable or impractical for customs offcers, one of the main groups that would need to adhere to it. Unicef continues to work with legislators and lawyers to implement maternity protection laws in more countries (Unicef, 2012). Recommendation 7-1: The World Health Assembly, in partnership with the United Nations Offce on Drugs and Crime and the World Customs Organization, and in consultation with major stakeholders, should institute an inclusive, transparent process for developing a code of practice on the global problem of falsifed and substandard medicines. The code should include guidelines on surveillance, regulation, and law enforcement, empowering states and the international community to prevent and respond to drug quality problems.

Pharmacopeia National governments have long created offcially recognized lists of le- gal drugs purchase zofran 8 mg line. Starting in the 16th and 17th centuries order zofran 4mg on-line, city-based pharmacopeia attempted to standardize the apothecaries’ products (Brockbank, 1964). The strength of regulation by pharmacopeial standards depends on the regulatory agency to enforce the standards. Pharmacopeia standards as offcial and to be enforced by the Bureau of Chemistry in the U. Terra silligata, medicinal clay from the Greek island of Lemnos (left), was stamped with a seal of authenticity (right), an early example of a drug trademark. In China and India, national pharmacopeial standards and organiza- tions have developed rapidly in the last two decades. The government of India began enforcing pharmaceutical standards more systematically after the Drugs and Cosmetics Act of 1940 (Gothoskar, 1983). Only in 2009, however, did the Indian Pharmacopoeia Commission became an indepen- dent agency under the Ministry of Health, separate from the drug regula- tory authority (Indian Pharmacopoeia Commission, 2011). The Indian government also maintains a pharmacopeia on ayurvedic medicines, frst published in a single volume in 1978 (Pharmacopoeial Laboratory for In- dian Medicine, 2011). Registration Agencies and National Pharmaceutical Authorities National regulatory authorities are responsible for approving new drugs, also known as drug registration or medicines licensing (Rägo and Santoso, 2008). These agencies conduct the premarket safety and eff- Copyright © National Academy of Sciences. This agency enforced drug quality and antiadulteration standards in accordance with the Pure Food and Drugs Act of 1906. In 1927 it became a separate agency in the Department of Agriculture (Swann, 2009). Thalidomide was a sedative and antiemetic developed in Ger- many, used widely throughout Australia, Europe, and Japan in the late 1950s (Kim and Scialli, 2011). It was effective against morning sickness and commonly prescribed to pregnant women (Bren, 2001; Kim and Scialli, 2011). By 1961, however, thalidomide was identifed as the cause of severe birth defects in more than 10,000 children. Birth defects included abnor- mally short limbs, toes sprouting directly from the hips, fipper-like arms, or no limbs at all; eye and ear defects; and congenital heart disease (Bren, 2001; Kim and Scialli, 2011). After the tragedy, governments worldwide revamped their drug regula- tion systems. Hence, although thalidomide was not a problem of Copyright © National Academy of Sciences. Good manufacturing practices and bioequivalence standards, in addi- tion to traditional pharmacopeial standards, are two of the most important conceptual instruments of modern drug quality regulation. They are applied to traditional medicines as well as to allopathic drugs (Carpenter, 2010). The rise of generic drugs in the 20th century raised new questions about bioequivalence. From the 1950s to the late 1970s, bioequivalence standards, which required measuring metabolites in urine and blood, re- placed older standards of chemical equivalence, which required only labora- tory and dissolution tests (Carpenter and Tobbell, 2011). These rules, coupled with the Hatch- Waxman Act of 1984, cemented a new generic drug approval process and bioequivalence regulations (Carpenter and Tobbell, 2011). Countering the Problem of Falsified and Substandard Drugs 34 Copyright © National Academy of Sciences.

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