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Complementary and alternative medicine is an increasingly popular form of health intervention used by millions of people in the UK each year. The demand for such therapies has seen their use grow and many have been adopted by district nurses as a supplement to the treatment and care they provide their patients. The use of complementary and alternative medicine is largely unregulated and this has led to increasing call for more effective regulation to ensure patient safety. Of particular concern recently has been the need to regulate the use of herbal medicines. This article considers the proposals for the reform of herbal medicines and professional and legal implications for district nurses who use complementary and alternative medicine in their practice.

Drug Policy and the Public Good was written by an international group of scientists from the fields of addiction, public health, criminology and policy studies to improve the linkages between drug research and drug policy. The book provides a conceptual basis for evidence-informed drug policy and describes epidemiological data on the global dimensions of drug misuse. The core of the book is a critical review of the cumulative scientific evidence in five general areas of drug policy: primary prevention programmes in schools and other settings; health and social services for drug users; attempts to control the supply of drugs, including the international treaty system; law enforcement and ventures into decriminalization; and control of the psychotropic substance market through prescription drug regimes. The final chapters discuss the current state of drug policies in different parts of the world and describe the need for future approaches to drug policy that are coordinated and informed by evidence.

Objective: Middle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage., Methods: We selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA., Results: All countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation., Conclusions: The study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies., (Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.)

Aim: To present the activities of the Agency for Medicinal Products and Medical Devices in the first 5 years of its existence and to define its future challenges., Methods: Main activities within the scope of the Agency as a regulatory authority were retrospectively analyzed for the period from 2004-2008. Data were collected from the Agency's database and analyzed by descriptive statistics., Results: The number of issued medicine authorizations rose from 240 in 2004 to 580 in 2008. The greatest number of new chemical and biological entities was approved in 2005. The greatest number of regular quality controls (n=5833) and special quality controls was performed in 2008 (n=589), while the greatest number of off-shelf quality controls (n=132) was performed in 2007. The greatest number of medicine labeling irregularities was found in 2007 (n=19) and of quality irregularities in 2004 (n=9). The greatest number of adverse reactions was reported in 2008 (n=1393). The number of registered medical devices rose from 213 in 2004 to 565 in 2008., Conclusion: Over its 5 years of existence, the Agency has successfully coped with the constant increase in workload. In the future, as Croatia enters the European Union, the Agency will have to face the challenge of joining the integrated European regulatory framework.

Background: Generic drugs play an important role in the delivery of healthcare services in Kenya because of their affordability and availability. The Pharmacy and Poisons Board (PPB) is the body mandated to regulate the manufacture and supply of all drugs in Kenya. Approximately 90% of all applications for registration of drugs in Kenya are for generic drugs; however, there are concerns about the quality of generic drugs supplied to patients in Kenya., Objective: The study aimed to investigate the perceptions and views of the regulatory pharmacists on the registration system for generic drugs in Kenya, and the role of the National Quality Control Laboratory (NQCL)., Design: A cross-sectional survey was designed to collect the views and perceptions of regulatory pharmacists on the system for the registration of generic drugs for human use in Kenya., Setting: The survey was conducted in the capital city of Kenya, Nairobi from January to February 2007. Nairobi was selected because it has a high concentration of pharmaceutical manufacturers and distributors involved in drug registration., Participants: The sample included regulatory pharmacists working in the registration departments of pharmaceutical companies dealing in generic drugs for human use. A sample of 40 participants was recruited for the survey and a response rate of 60% was targeted., Results: Over half (55.6%) of the respondents reported satisfaction with the drug registration system while 33.3% were unsatisfied. The level of satisfaction did not seem to be associated with the length of time it takes to register a generic drug (p-value=0.74) or the gender of the respondent (p-value=0.94). The respondents had confidence in the analytical procedures carried out by NQCL but were less satisfied with its role in generic drug registration process. The respondents made a number of recommendations towards better drug registration mechanisms for generic drugs in Kenya., Conclusion: The study suggests that although the drug registration procedures appear to be working, there is need for improvement. One area in which the registration of generic drugs in Kenya can benefit is in the observation of the operation of what other countries have done to streamline their drug registration systems.

In light of debates about the relationship between interests and scientific expert judgments, and the potential for declarations of conflict of interest (COI) to minimize corporate bias, we reviewed the approach to COI in 3 European drug regulatory bodies. These bodies were the Irish Medicines Board, the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency in the European Union. Official statements about COI laws and codes of practice in the 3 contexts suggest that COIs are prohibited. In practice, the approaches to COI in the 3 drug regulatory agencies presuppose and promote the ideas that COIs cannot and need not be eliminated as the risk of bias can be managed. Because the evidence about if and how COI affects micro-level decision-making in drug regulatory authorities is neither complete nor comprehensive, we advocate a precautionary principle model. Under this model COI would be prohibited on the grounds that it might influence the outcome of regulatory decisions., (2009 Elsevier Ltd. All rights reserved.)

Objectives: This study aims to provide baseline data to support the implementation of generic substitution policy in Malaysia by evaluating the community pharmacists' perceptions and opinions on generic substitution and current substitution practices., Methods: A cross-sectional descriptive study involving the entire population of Malaysian community pharmacies (n=1419) was undertaken using a self-completed anonymous mail questionnaire., Results: A total of 219 responses were received for a response rate of 15.4%. Majority of the respondents (93.6%) agreed that pharmacists should have generic substitution rights. Almost all pharmacists (96.8%) viewed Poison Class C (pharmacist only medicine) as most suitable class of controlled medicines for substitution. About half (51.6%) of the pharmacists preferred a policy which allowed substitution on any prescription. The pharmacists prefer to consult the physician when substituting narrow therapeutic index medicines (88.1%) and prescription only medicines (51.3%). Less than 25.0% of the pharmacists routinely keep the medication records and follow-up the patients who received substitution. Monitoring the efficacy (79.2%) and patient's satisfaction with the generic medicines (74.9%) were the main reasons for following-up the patient if substitution occurs., Conclusions: Malaysian community pharmacists are generally in favour of generic substitution policy implementation.

Background: Abuse of prescribed controlled substance has become a serious social as well as health care issue over the past decade. A particularly alarming trend exists among patients aged 12 to 17. Common abuse behaviors include doctor shopping, drug theft, feigned pain symptoms to gain health care access, drug sharing, prescription forgery, and improper prescription practices. In response to this epidemic of abuse, many states have adopted prescription monitoring programs (PMPs). Such programs first originated in the early twentieth century. As of 2006, 38 states had such programs, many of which are supported by federal grants. As PMPs become more widespread, they have also increased in sophistication. By keeping a record of the prescription and dispensing of narcotics, these programs are able to build a comprehensive data network for tracking prescription medications. These databases aid law enforcement agencies in investigations of narcotic trafficking; they also help state regulatory boards to monitor improper prescription practices., Objective: This manuscript examines the basic structure of a PMP, including the way the data are collected and the way these data are stored and used. It also looks at the organizational differences amongst state programs. NASPER and Harold Rogers are two federal programs that provide funding to the state PMPs, and the current study examines the differences as well as similarities between these 2 programs. This study also compares the results of 2 reports: the U.S. General Accounting Office Study and the Twillman study.& Both studies have evaluated the efficiency of the PMPs., Discussion: The U.S. General Accounting Office Study showed that while considerable differences exist among the state PMPs, these programs not only reduce the time and effort for law enforcement agencies to conduct investigations, but also cut the supply of prescription medications. However, the Twillman report suggests that prescription programs caused a shift in prescription practice, while the actual rate of abuse may not have been reduced. These 2 studies both point to the challenges the PMPs face. However, more recent data suggest that proactive use of the PMPs results in the decreased growth of prescription medication sales. Finally, a number of states have also begun to objectively evaluate the efficiencies of the system., Conclusion: Many states have developed PMPs to help regulatory agencies as well as physicians detect prescription drug abuse. Limited data so far suggest that such programs reduce abuse practices. In addition, proactive usage of the data further prevents abuse.

What Is Already Known About This Subject: Increasing numbers of people are accessing medicines from the internet. This online market is poorly regulated and represents a potential threat to the health of patients and members of the public., What This Study Adds: Prescription-only analgesics, including controlled opioids, are readily available to the UK public through internet pharmacies that are easily identified by popular search engines. The majority of websites do not require the customer to possess a valid prescription for the drug. Less than half provide an online health screen to assess suitability for supply. The majority have no registered geographical location. Analgesic medicines are usually purchased at prices significantly above British National Formulary prices and are often supplied in large quantities. These findings are of particular relevance to pain-management specialists who are trying to improve the rational use of analgesic drugs., Aims: To explore the availability to the UK population of prescription-only analgesics from the internet., Methods: Websites were identified by using several keywords in the most popular internet search engines. From 2000 websites, details of 96 were entered into a database., Results: Forty-six (48%) websites sold prescription analgesics, including seven opioids, two non-opioids and 18 nonsteroidal anti-inflammatory drugs. Thirty-five (76%) of these did not require the customer to possess a valid prescription., Conclusion: Prescription-only analgesics, including controlled opioids, are readily available from internet websites, often without a valid prescription.

Drug diversion has become a $100 billion a year problem for the healthcare industry. By far the leading source of such diversion is the obtaining of prescription drugs by bogus patients from ER staff, the author claims. Solving the problem will not be easy, he says, because drug seekers are experts in avoiding detection or in persuading health providers to supply them with the pharmaceuticals they want. But, he adds, a program for reducing such diversion in your health facility can be successful if a multi-disciplinary approach is taken. Such a program is described in this article.

Objectives: To review the global implications associated with the use of substandard and or counterfeit drugs in developing and may be developed countries. The focus of this review is particularly on antiretroviral (ARVs), antimalarials and other drugs., Methods: Review of various literatures through Pub-Med, Medline, Google and Internet search to retrieve and download published materials was done by the author of this review paper., Results: When patients receive a counterfeit medicines, they are subjected to multiple risks. They often suffer more than just an inconvenience; as they become victims of fraud medicines and are all put at risk of adverse effects from unprescribed medicines or substandard ingredients. Additionally, patients may lose confidence in health care professionals including their physician and pharmacist, and potentially modern medicine or the pharmaceutical industry in general. Counterfeit or substandard (poor quality) drugs pose threats to society; not only to the individual in terms of the health side effects experienced, but also to the public in terms of trade relations, economic implications, and the effects on global pandemics. It is vital for suppliers, providers, and patients to be aware of current trends in counterfeiting in order to best prepare for encounters with suspicious products. Furthermore, this is an issue that needs to be continually dealt with on national and international policy levels. Developing countries should try their level best to establish good laboratories for monitoring and checking quality of all pharmaceuticals manufactured locally and those imported or donated to these countries. The Ministries of Health and all stakeholders involved in this issue must ensure that all drugs meet the set or established international standards and national standards. Failure to do so will be to misuse the hard earned forex that is normally borrowed from banks for the procurement and distribution of drugs to its people. Indeed sub-standard medications do more harm than good to people's health and it is unethical to give such drugs to people. Of course, in any market, some corruption and fraud always exist, but there are few commercial markets where fraud can have such drastic impact on global health and welfare. It is essential, therefore, that a multi-faceted approach be used to control this problem which affects the international community and continuously threatens the health of millions of people especially in developing countries., Conclusion: Developing countries should try their best at all costs establish good laboratories for monitoring or checking for quality control for all pharmaceuticals locally manufactured and those imported (entering) or donated to countries to make sure that they meet the set or established international or national standards. Short of that countries will be wasting a lot of money using forex which has been borrowed in a form a loans procuring and distributing to its people sub-standard medications which will do more harm than good to its indigenous people and this is unethical per se to give people drugs not meeting required set international standards.

Certain useful pharmaceutical agents carry a high risk of embryopathy. The US Food and Drug Administration (FDA), in cooperation with drug manufacturers, has established pregnancy prevention programs (PPPs) to reduce the incidence of birth defects for thalidomide (STEPS [System for Thalidomide Education and Prescribing Safety]) and isotretinoin (iPLEDGE) but not for other teratogenic drugs in clinical use. These programs are complex and raise important concerns regarding privacy, the clinician-patient relationship, and convenience of medical care. Furthermore, pregnancies continued to occur in isotretinoin-exposed females during the first full year of the iPLEDGE program. We review the design and application of STEPS and iPLEDGE and consider the ethical issues raised by the introduction of these programs. The goal is to eliminate birth defects caused by teratogenic agents, without making procedures so onerous that they result in restricted access to useful agents. Confidentiality must be maintained, and the rights of disadvantaged populations and individuals with special religious concerns must be protected. Informed consent must be complete and include all risks of treatment, including risks of contraceptive methods. All teratogenic agents should be covered by PPPs, which then must be no more burdensome than requirements that have existed for many years for other controlled substances.

Background: There is increasing interest in whether methamphetamine is an emerging recreational drug in the UK., Aim: To determine what evidence is there that methamphetamine use is an emerging drug in the UK compared to established recreational drugs such as MDMA., Design and Methods: We undertook a retrospective study collating data on the number of enquiries to both our poisons centre and the UK National Poisons Information Service (NPIS) relating to all recreational drugs, methamphetamine and MDMA; presentations to our Emergency Department (ED) with acute methamphetamine toxicity and the frequency of positive urine tests for methamphetamine and MDMA in workplace drug screening programmes., Results: There was a small increase in the number of methamphetamine-related calls to our poisons centre, but it remained uncommon (0.1% of all recreational drugs cases in 2000 to 1.23% in 2006) compared to MDMA (17.3-42.7% of all recreational drugs cases). The number of 2005/6 enquiries to the UK NPIS for methamphetamine was 12, compared to 455 MDMA enquiries (0.014 and 0.52% of all enquiries, respectively). There were five presentations to our ED relating to methamphetamine over a 15-month period compared to 171 for MDMA. Of the 254 440 urine samples screened for the presence of drugs in the workplace (2000-06), three were positive for methamphetamine and 147 for MDMA., Conclusion: There is no evidence of increasing use of methamphetamine or that acute methamphetamine poisoning is a significant clinical problem compared to established recreational drugs such as MDMA. In our opinion, healthcare, educational and law enforcement resources should be proportionally directed towards tackling drugs that pose an immediate and continuing healthcare risk to the population rather than emerging recreational drugs.

The National Drug Policy (NDP), 1982, of Bangladesh was expected to make available essential, good quality drugs at affordable prices. This article gives an overview of the situation today, more than two decades after the Drugs (Control) Ordinance, 1982, was promulgated to implement the NDP. While there have been some successes, many of the goals of this initiative are yet to be achieved. Inadequate supply of essential drugs, substandard quality, uncontrolled drug prices and inappropriate uses of drugs are major problems in Bangladesh.

According to a hospital pharmacy's procedures, one pharmacy employee is responsible for wasting expired or unused medications and for recording all waste transactions on a standardized form. Once a quarter, this employee accesses the area of the controlled substance vault where drugs intended for wasting are stored. The employee senses that the hospital does not regularly compare the waste transaction forms with the drugs stored in the vault, and periodically, the employee will take three boxes of expired fentanyl ampoules and will not record these boxes on the forms.

There are well-defined legal requirements for the safe storage, handling and disposal of controlled drugs (CDs): The Misuse of Drugs Act 1971, and Safer Management of Controlled Drugs (Department of Health, 2007). Clinical staff involved in the prescription and administration of CDs to patients are responsible and accountable for the appropriate disposal of these drugs because of the risk of substance abuse. A review of current practice, as followed by staff involved in the use and disposal of CDs, has been evaluated in a multi-centre audit. This audit showed that a wide variation in attitude towards disposal of CDs exists among medical and non-medical staff, and that the sample hospitals are falling short of meeting proposed standards.

In 2003 the Thai government announced a radical shift in drug policy with the implementation of a War on Drugs. Although consequences of this controversial measure (e.g. drug dealer deaths) have received widespread attention relatively little work has evaluated changes in substance use. We used two anonymous representative samples of secondary school students to compare drug use in Northeast Thailand before (1998; n=4217) and after (2004/5; n=3489) the War on Drugs. Results indicate that reported levels of current illicit drug use reduced significantly between 1998 and 2004/5 (for methamphetamine from 4.2% to 0.9%). By examining trends in year of first methamphetamine use we identify that observed reductions in drug initiation are temporally consistent with the War on Drugs. However, while prevalence of alcohol use has also fallen, there was a three-fold increase in daily alcohol use. We suggest that this rise, combined with other negative impacts of 'wars' on drugs, means drug control requires a public health perspective that sees eliminating drug use as part of a wider strategy that has improvement in population health, not just drug prevention, as its core objective.

Sales of consumer products over the Internet have grown rapidly, including sales of pharmaceutical products. Online pharmacies mimic mail order pharmacies. To operate legally online, pharmacies must be licensed in every state in which sales occur. Although online pharmacies provide benefits to consumers, when compared with traditional pharmacies patients' safety may be compromised. Purchasing prescription drugs online may pose a risk to consumers because they cannot tell whether the site is offering drugs of the same quality offered by a retail pharmacy. There is also a possibility that prescription drugs purchased online may be counterfeit, illegal, or unapproved. A U.S. General Accounting Office study conducted in June 2004 showed that most counterfeit and unapproved drugs sold online are from non-U.S. pharmacies. The Food and Drug Administration and other government agencies have worked to enforce laws on drug sales over the Internet. The biggest challenge in regulating non-U.S. pharmacies is due to their off-shore location. Unfortunately, given the widespread anonymous and ever-changing nature of the Internet, it is very difficult to close down illegal websites.

Australia has a National Medicines Policy with aims that include quality use of medicines, but policy stakeholders failed to protect Australia from the COX-2 (cyclo-oxygenase-2) inhibitor disaster. Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures on COX-2 inhibitors. Drug companies ran intense and misleading promotional campaigns on COX-2 inhibitors without adequate controls. Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising. Core elements of the National Medicines Policy--in particular the drug approval process, the post-marketing surveillance system, the control of drug promotion, and the quality of independent drug information--require major reappraisal if we want to avoid similar disasters in the future.

A century ago, the Chinese opium epidemic spurred international action on drug control as policymakers realized that the problem was too complex for any one country to tackle in isolation. Starting with the International Opium Commission (Shanghai, 1909), Governments over time established an international consensus on the need for the regulation of psychoactive substances. Moreover, a set of normative instruments and multilateral bodies and systems were developed to help States implement and adjudicate such regulation. As a result, the three main drug control conventions, which form the foundation of the international drug control system, today enjoy near universal adherence, with more than 180 States parties. This volume presents an outline of the historical development of the modern drug control system: why and how it arose, its impact on drug production and consumption and its legacy for present and future international drug control efforts.