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The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication., (Copyright © 2018. Published by Elsevier B.V.)

Purpose: Reducing global disease burden requires improving access to medicines, thus the need for efficient and effective supply chain management for medicines. The Nigerian government came up with new policies on Mega Drug Distribution Centres and National Drug Distribution Guidelines to improve access to quality medicines with pharmacists having a key role to play. However, pharmacists in Nigeria seem not to be aware and adequately equipped to handle the medicines supply chain. This article aimed at assessing the awareness and readiness of Nigerian pharmacists on supply chain management practices for improving access to medicines., Methods: Pharmacists in Nigeria's Capital were randomly sampled. Semi-structured questionnaires were administered. Descriptive statistics was used in data analysis. P values less than 0.05 were considered to be significant., Results: 29.3%, 20.7% and 53.7% were not aware of supply chain management, National Drug Distribution Guidelines and Mega Drug Distribution Centres, respectively. 85.46% do not have a copy of the National Drug Distribution Guidelines. 78% were not aware that Mega Drug Distribution Centres are already operational. 35.4% have never been involved in any supply chain management practice. 69.5% often experience stock out of vital and essential medicines, of which 85.2% were in hospitals. 15.9% were successful in managing their facility's supply chains. 84.1% opined that pharmacists in Nigeria are not yet ready to handle the medicines supply chain., Conclusions: Findings showed limited awareness and readiness on supply chain management of medicines. This may be due to inadequate supply chain management skills and infrastructure, poor financing, lack of accountability and poor management. Tackling these as well as pharmacists showing more interest in the country's health policies and obtaining necessary postgraduate certifications will lead to improvements. This will improve access to quality medicines and thus help in the fight to reduce disease burden both locally and globally., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The history of Fixed Dose Combination (FDC) oral drug products has been tumultuous over its history. Some FDCs were prepared for marketing purposes and others for clinical improvements. Often, the products prepared for marketing advantage ended up causing negative outcomes. However, in recent years, there has been a resurgence of FDCs as clinicians have found them adventitious for treatment of AIDS/HIV and for oral contraceptives, just to name two examples. International regulatory Agencies and most major drug regulatory agencies have established guidelines along with regulations concerning preparation, labeling and marketing for FDCs. The advantages of FDCs are said to be in the clinical realm where simplified therapy regimens are thought to enhance patient's medication taking compliance. On the financial side, health insurers and other payers normally save money from a decreased number of dispensing fees, the use of fewer bottles, labels, etc., and from the possible situation where the price of the FDC is less than the medication price of the two separate ingredients dispensed individually. Overall, there is a great deal of evidence in favor of appropriate FDCs.

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.

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.

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.

The study set out to identify the strategies for public drug supply in Nigeria, assess its functionality, and recommend appropriate means to ensure regular availability of safe, efficacious, good quality and affordable essential drugs at public health facilities. The investigation was carried out at the Directorate of Pharmaceutical services, Federal Ministry of Health (F.M.O.H) Abuja and Federal Medical Stores, Oshodi, Lagos. Semi-structured interview was conducted with key informants at the Department of Food & Drugs, Drug procurement unit and Central Medical store using structured questionnaires and direct informants answers. Our study shows that public drug supply in Nigeria is governed by a National Drug Policy (NDP) which was introduced in 1990 and it is yet to be reviewed after ten years. We also identified the Central Medical Store (CMS) system as the current public drug supply strategy in Nigeria. Public drug supply is mainly financed by governments and this is inadequate to ensure sustained availability of essential drugs. The major procurement methods in use are open tender and direct procurement. These methods as presently operated suffer from late order placement, delay in payment and poor supplier lead-time mainly attributable to lateness in payment for previous drug supplies. These have contributed to stock out of essential drugs at public health facilities. Major losses due to expiration and spoilage are recorded at both central and peripheral storage points despite adequacy of storage facilities and personnel. Road transportation was the major mode of drug distribution from central to peripheral storage points and shortage of vehicle was a key factor affecting drug distribution. There was an apparent lack of a functioning drug management information system to effectively coordinate public drug supply and there are no definite systems that monitor and evaluate staff performance. The CMS strategy currently used for public drug supply in Nigeria has not ensured regular availability of essential drugs at public health facilities. Our study suggests that this is more of an administrative failure. Public drug supply in Nigeria is therefore in need of urgent reforms and this could be achieved through the use of an autonomous drug supply agency to assure efficiency and sustainability.

The paper describes the situation of drugs and drug sources found available at the village level in Thailand. It concludes, from village-survey data (N = 195) and village case studies (N = 15), that drugs are available in abundance. A vast variety of drugs, including prescription drugs, are available at various sources, of which the most common ones are grocery stores. The situation reflects the failure of the drug regulation system as well as the influence of commercial pharmaceutical sector in drug provision. This situation hampers attempts to rationalize drug use by consumers.

Member States of the Association of South-East Asian Nations (ASEAN) have decided to concert their efforts in order to overcome drug-related problems and illicit trafficking, which are recognized as a threat to their national security, stability and resilience. The activities and significant achievement of each member State show the important role that has been played by each country in combating illicit drug traffic. Member States of ASEAN realize the importance of mutual co-operation between themselves as essential in the effective fight against illicit drug traffic.

In a returned-medicines campaign lasting 3 weeks 362000 tablets and capsules were returned in 11400 containers from a population of 1.05 million. This yield was considered low. A comparison of hospital admission figures for childhood poisoning before, during, and immediately after the campaign suggests that the publicity and the destruction of unwanted medicines had little preventive value. The quantities of different medicines returned were roughly proportional to the quantities prescribed.

The States Parties to the South American Agreement on Narcotic Drugs and Psychotropic Substances (ASEP), which entered into force on 26 March 1976, decided to co-ordinate measures to achieve close co-operation and the efficient exchange of information between States Parties to the Agreement in the fight against drug abuse and illicit drug traffic. To this end, ASEP organizes regional and international training courses, seminars and conferences on the subject of illicit drug trafficking; facilitates permanent exchange of information between the States Parties to the Agreement regarding drug law enforcement techniques and the methods resorted to by illicit traffickers; and maintains close technical co-operation with the International Criminal Police Organization (Interpol), the United Nations and other international agencies concerned with drug control. In addition, ASEP is involved in a number of activities that indirectly contribute to the suppression of illicit drug trafficking such as: the establishment of national drug control co-ordinating bodies; co-operation between States in the area of legislative measures conducive to drug control; and the operation of a computerized system designed to facilitate contacts between the various drug law enforcement agencies of the States Parties to ASEP.

The Drug Advisory Programme (DAP) of the Colombo Plan Bureau assists member States in organizing national and regional seminars, workshops, conferences and discussions on various aspects of drug abuse prevention and control and publishes reports on proceedings of such meetings. The DAP advises and assists member States in updating drug legislation and promoting the drug law enforcement action. The DAP operates fellowship and training programmes for narcotics officials, provides grants to participants from member States in various meetings on drug abuse control and supports research in this area of activity. It also provides assistance in the form of consultancy programmes for the least developed countries in the region. DAP disseminates information on regional and world-wide problems related to drug abuse, illicit drug traffic, modus operandi of illicit drug traffickers and counter-measures to deal with such problems. The Colombo Plan encourages and supports voluntary non-governmental organizations in their efforts to prevent and control drug abuse and, in co-operation with other organizations and member States, organizes international conferences whose aims are to promote the involvement of non-governmental organizations in the prevention and control of drug abuse.

The Pompidou Group, a co-operation group to combat drug abuse and illicit trafficking in drugs, has functioned at the Council of Europe since 1980 as a section of the Directorate of Economic and Social Affairs. Owing to its specific features, it is the only organization of its kind in Europe that deals with all areas of drug control, including the work of police and customs authorities, as well as work on prevention, treatment, rehabilitation, epidemiology and research. It also deals with fellowship programmes. The political and technical activities of the Pompidou Group are described in this article, illustrating how it operates in the area of combating drug abuse at the international level.

The International Criminal Police Organization (ICPO/Interpol), whose main aim is the prevention and suppression of ordinary crime, has 135 member countries. The Government of each of these countries has designated an Interpol National Central Bureau to co-operate and liaise within the framework of Interpol. The Drugs Sub-Division of Interpol's General Secretariat monitors and responds to incoming communications on drug enforcement matters, conducts intelligence analysis of information and produces tactical and strategic intelligence reports as well as statistical and other specialized reports. It received 33,181 and dispatched 6,741 drug-enforcement-related communications in 1982, which was over 60 per cent of the entire communications of the General Secretariat. The Drugs Sub-Division participates in drug training and drug strategy seminars world-wide. Interpol also carries out drug liaison officer programmes in five regions of the world.

The profits of illicit drug trafficking have attracted world-wide attention. In 1980, a decision of the House of Lords in the United Kingdom ruled that the English criminal courts had no power to forfeit such profits even though earned by convicted defendants. This lacuna in the law aroused considerable criticism and the Howard League of Penal Reform established an independent committee to propose reforms. Its report will be published shortly. This article discusses some of the issues which the Committee faced, particularly the delicate balance between the interest of the State in ensuring that crime does not pay and a commitment to due process before financial punishments are imposed.

Drug trafficking is controlled by well-organized international criminal syndicates, whose only motives for becoming involved are to make profits and secure influence, which in turn help perpetuate illicit drug distribution networks. For example, one producer of illicit opium receives approximately $Can 650 for 10 kilograms of opium, from which one kilogram of heroin is produced and sold to end-users for up to $Can 12 million. The risks involved for those at the highest level of international criminal syndicates is extremely low since they are financiers who may never come in direct contact with illicit drugs or the law enforcement authorities. The proceeds of drug crimes are laundered through sophisticated international transactions often covered by legitimate operations. Current legislative provisions at both national and international levels are inadequate to support effective action to trace, freeze, seize and secure the forfeiture of the proceeds of crimes and to prosecute individuals who knowingly possess such proceeds. In pursuance of recent resolutions of the Commission on Narcotic Drugs, the Division of Narcotic Drugs of the United Nations Secretariat convened two expert group meetings, one in 1983 and the other in 1984, to consider ways and means of dealing with this problem. The meetings recommended the establishment of machinery that would facilitate, at both national and international levels, concerted action to deprive drug traffickers of the proceeds of their crimes. The annex to this article contains provisions recommended by the second expert group meeting for inclusion in an international instrument to supplement existing provisions of the international drug control treaties in order to deal more effectively with the profits of drug crimes.