Adulterated Medicines Research Articles

Experiences of Consumers on the Health Effects of Fake and Adulterated Medicines in Nigeria

Medicines are used to cure and treat ailments, relieve or eliminate disease symptoms, and slow down the disease process. Any attempt to disrupt this natural medicine process, using falsified medications, spells doom to a consumer of such medication. The challenge of fake medicines is a global one and affects developing and developed nations and currently assumes great significance as a result of globalization challenges, which have flattened the entire world, hence removing barriers to the movement of products and services. The cross-sectional survey was conducted, using six local government areas of Anambra State in South-East Nigeria, namely Awka, Nnewi, Onitsha, Aguata, Ogbaru, and Anaocha, among adults aged 18 years and above. A minimum sample size of 500 was calculated and stratified sampling was employed to select respondents in order to ensure that various population groups, the upper class, middle class, and lower class were represented. This research has shown that falsified medicine is an evil wind that blows nobody any good. It negatively affects every aspect of the citizen’s livelihood, ranging from their health, which manifests as treatment failures, deformities, loss of life to death, to loss of confidence in the healthcare providers, revenue losses to individuals, healthcare providers, manufacturers, and finally corruption of the genuine medicines supply chain with fake and adulterated medicines. The study has clearly shown the experiences of residents of Anambra State, South-East Nigeria with fake and adulterated medicines and also services as a wake-up call to medicines regulators like NAFDAC, PCN, the PSN, and Federal Ministry of Health to declare a state of emergency on the fight against fake and adulterated medicines and make enabling laws that are punitive enough towards the fight against this scourge, so that the healthcare and well-being of Nigerians would be assured at all times.

A Review on Application of DNA Barcoding Technology for Rapid Molecular Diagnostics of Adulterants in Herbal Medicine.

The rapid molecular diagnostics of adulterants in herbal medicine using DNA barcoding forms the core of this meticulously detailed review, based on two decades of data. With 80% of the world's population using some form of herbal medicine, authentication, quality control, and detection of adulterants warrant DNA barcoding. A combined group of keywords were used for literature review using the PubMed, the ISI Web of Knowledge, Web of Science (WoS), and Google Scholar databases. All the papers (N=210) returned by the search engines were downloaded and systematically analyzed. Detailed analysis of conventional DNA barcodes were based on retrieved sequences for internal transcribed spacer (ITS) (412,189), rbcL (251,598), matK (210,835), and trnH-psbA (141,846). The utility of databases such as The Barcode of Life Data System (BOLD), NCBI, GenBank, and Medicinal Materials DNA Barcode Database (MMDBD) has been critically examined for the identification of unknown species from known databases. The current review gives an overview of the ratio of adulterated to authentic drugs for some countries along with the state of the art technology currently being used in the identification of adulterated medicines. In this review, efforts were made to systematically analyze and arrange the research and reviews on the basis of technical progress. The review concludes with the future of DNA-based herbal medicine adulteration detection, forecasting the reliance on the metabarcoding technology. DNA barcoding technology for differentiating adulterated herbal medicine.

Current Threats to Maintaining a Secure Pharmaceutical Supply Chain in an Online World.

Background: Maintaining integrity of the pharmaceutical supply chain is critical to providing medications that are free from adulteration (counterfeit, substandard or unapproved medications), making them safe for patient use. Purchasing pharmaceuticals through the Internet can be associated with a risk of receiving adulterated medicines. Objective: The objective of this study was to review the current threats to maintaining a secure pharmaceutical supply chain, specifically focused on Internet-based procurement of medications. Methods: A review of the literature was conducted along with collating important up to date resources and other publications that provide foundational information to understanding the risks and prevention strategies for online purchasing of pharmaceuticals. Conclusion: The information provided in this article helps to properly inform pharmacy leaders to the resources available to protect against the risks of on-line purchasing of pharmaceuticals.

An LDI-MSI approach for targeted and untargeted differentiation and assessment of pharmaceutical formulations

Falsified, counterfeit and adulterated medicines are an endemic problem worldwide that results in both monetary and health-related losses. Developing fast and reliable methods that are able to present a timely result based on the drug's spectral profile is an effort that is sure to benefit those involved in the whole distribution chain. We propose herein a Laser Desorption/Ionization imaging-based method that provides simple and minimal sample preparation; this method is capable of providing specific markers that characterize adulterations, using as proof of concept one of the most adulterated drug products for oral use, sildenafil. Our approach is able to provide quality markers, which can be applied in the fast screening of any product within the same molecular class. This same strategy may be a useful alternative to provide accurate measurements with high specificity for unraveling contaminants and/or byproducts in virtually any given pharmaceutical product.

Adulterated Pharmaceutical Product Detection Using Statistical Process Control

Drugs manufactured in pharmaceutical companies - that do not comply to current Good Manufacturing Practice (cGMP) - are considered by Food and Drug Administration (FDA) as "adulterated medicines", even if they did not impose any health or quality risk to the final consumers. Non compliance to cGMP has adverse effects on both customers and companies with think again escalating legal penalties may be issued. In the current study, newly established pharmaceutical plant launched film coated tablet for treatment of common cold symptoms. The local regulatory agency in collaboration with quality team of a well-established pharmaceutical company in the area has conducted large survey that covered new firms to elucidate the compliance of the facilities of those newly emerging companies to cGMP, partially using statistical process control (SPC). The generated results for the product by quality control (QC) and in-process control (IPC) were processed using statistical software packages. Trending of data brought the focus on hardness test which later highlight the need to investigate dissolution pattern of the three active components of the dosage form. Time series plot of hardness for 195 batches manufactured during 2016 showed non consistency and stability of the process which can be segmented chronologically into three distinct segments. A significant negative correlation (-0.64 by Spearman correlation) was found between the hardness and the dissolution of one the active pharmaceutical ingredient (API) viz, Pseudoephedrine Hydrochloride. Inconsistent operation during hardness as IPC test was reflected in the dissolution QC test. Effect on other properties should be investigated.Bangladesh Pharmaceutical Journal 21(1): 7-15, 2018

“Good Enough for America”:

In the mid-nineteenth century, the term “good enough for America” was used to identify adulterated medicines destined for the American market.³ Adulterated and counterfeit drugs were pouring into the United States. Providing poor medicines was a growing business and the market was growing with the rapid expansion of the country itself. There seemed to be little that could be done to slow or stop it. The sophistication of the adulterations was superior to available tests, standards were lacking, and there were few trained pharmacists or physicians who could apply them. There were no laws that would prohibit the importation of these products nor limit their sale once ashore. This was the situation in the late 1840s when a small group of New York pharmacists took it upon themselves to convince other health professionals and legislators that there was a problem; they devised a solution that would establish patient safety as the core value of the emerging profession of pharmacy.

“Good Enough for America”: Adulterated Drugs and the 1848 Drug Import Act

In the mid-nineteenth century, the term “good enough for America” was used to identify adulterated medicines destined for the American market.³ Adulterated and counterfeit drugs were pouring into the United States. Providing poor medicines was a growing business and the market was growing with the rapid expansion of the country itself. There seemed to be little that could be done to slow or stop it. The sophistication of the adulterations was superior to available tests, standards were lacking, and there were few trained pharmacists or physicians who could apply them. There were no laws that would prohibit the importation of these products nor limit their sale once ashore. This was the situation in the late 1840s when a small group of New York pharmacists took it upon themselves to convince other health professionals and legislators that there was a problem; they devised a solution that would establish patient safety as the core value of the emerging profession of pharmacy.

Development of standard operating procedure and standardization of Habb-e-Banafsha Qawi-A Unani polyherbal formulation.

Introduction:Herbals drugs became a boon for mankind since ancient times and still are used worldwide for the treatment of various human ailments. The safety of alternative medicinal preparations has been questioned due to reports of unwanted side effects. To maintain the quality and efficacy of these drugs, it is essential to standardize them in order to avoid the use of substandard or adulterated medicines in the market. Unani system of medicine mainly focuses on the treatment by natural drugs. Habb-e-Banafsha Qawi is useful in a cough, catarrah, and coryza.Materials and Methods:Physiochemical constants of Habb-e-Banafsha Qawi were determined through organoleptic characters, macro- and micro-scopic characters, ash value, solubility, pH values. Chromatographic fingerprints were developed using thin layer chromatography method. Aflatoxin (AF) contamination, heavy metal, and pesticide residues were also evaluated by standard methods.Objectives:In the present study, an attempt has been made to develop standard operating procedure and physiochemical parameters to monitor the quality of a Unani poly-herbal formulation, Habb-e-Banafsha Qawi.Results:The tablets tasted sweetish bitter with a pleasant odor, water soluble and acidic in nature. Rf values were almost same in all the extracts. No AF, heavy metal, and pesticide residues were observed.Conclusions:It may be concluded that the values and chromatographic fingerprints obtained can be used for quality evaluation and to set new pharmacopoeial standards for the preparation of Habb-e-Banafsha Qawi.

Authentication of Cassia angustifolia and Cassia acutifolia in Herbal Medicines Employing SCAR Markers

According to the World Health Organization (WHO) estimates, herbal drugs are still the mainstay of 75 – 80% of the world population, mainly in the developing countries for the treatment of diseases, especially chronic ones due to their better compatibility with the human body and lesser side effects. Twelve percent of the population worldwide are affected with constipation and treated with herbal medicine prepared from either the pods and leaves of Cassia angustifolia and Cassia acutifolia or with their pharmacologically active ingredients i.e. Sennosoides. The therapeutic efficacy of these medicines, however, totally depends on the presence of authentic plant components in the formulation. Further, these medicines are often found to be adulterated with other species of Cassia i.e. C. sophera and C. tora. Various conventional taxonomic methods including macroscopy, microscopy and chemoprofiling are being used to determine the presence of genuine herbal components of C. angustifolia and C. acutifolia in herbal medicines, but these methods have limitations to distinguish genuine components from their adulterants. Thus, the therapeutic potential of adulterated medicines is either reduced or these medicines become ineffective due to adulteration. The aim of present work was, therefore, to develop SCAR markers for the genuine herbs, C. angustifolia and C. acutifolia and their adulterants, C. sophera and C. tora that can be used for the authentication of genuine herbal components in crude and processed drugs samples. In the development of SCAR markers, RAPD analysis was done first to identify and select putative species-specific amplicons in the genus of C. angustifolia and C. acutifolia as well as C. sophera and C. tora, which were then sequenced to design sequence specific internal pair of primers. These primer sets were referred as SCAR primers and able to amplify 829bp, 398bp, 589bp and 700bp fragments from the genomes of C. angustifolia, C. acutifolia, C. sophera and C. tora, respectively. These SCAR markers were finally used to authenticate market samples of the herbal medicines containing Cassia sp. The results showed that more than 50% of the market samples were adulterated and these markers were also to detect even 10% of the adulterant in the market samples of the medicines. The SCAR markers developed in this study, hence, could be employed by pharmaceutical companies and public agencies to monitor the quality of these herbal medicines. Acknowledgements: The financial support from Department of AYUSH, Ministry of Health and Family Welfare, Government of India for this work is greatly acknowledged. The research facilities developed from UGC-SAP (DRS-1) grant sanctioned to the Department of Biotechnology and used in this study are also thankfully acknowledged.

Providing safe medicines for children in Nigeria: The impediments and remedies

Promoting safety of medicines for children is a global concern which has prompted the World Health Organization (WHO) to launch a campaign of "Making Medicines Child Size". Children in Nigeria were once victims of unethical clinical medicine trials and repeated victims of use of fake and adulterated medicines. Considering the magnitude of harms children had suffered in Nigeria from the use of medicines, there is a need for literature review to identify the factors preventing children from accessing safe medicines and to suggest remedies to the problems. Lack of access to up- to- date medicine information, lack of training and research in pediatric clinical pharmacology, deficiencies in undergraduate and postgraduate teaching of medicine risk management and clinical pharmacology and therapeutics, irrational medicine use due to lack of pediatric focus on essential medicine list and inappropriate home storage of medicines by parents, lack of evidence- based medicine (EBM) practice, lack of national adverse drug reaction surveillance among children, and weak national drug policies were the major problems identified. It is to be hoped that development and provision of a pediatric national drug formulary for health professionals in Nigeria, creating a comprehensive national pediatric drug research network in collaborations with developed countries, reviewing the undergraduate and postgraduate curriculum in pediatrics to include teaching of basic elements of rational prescribing, drug dose calculations, adverse drug reactions and pharmacovigilance, increasing access to essential medicines for children, postgraduate teaching of EBM, and strengthening of the national drug policies would improve children's access to safe medicines in Nigeria.

Counterfeit medicines as global treat

As early as the fourth century BC people were warned about the dangers of adulterated medicines, and despite all the advances made over the years this concern has not disappeared. In the recent past the unregulated proliferation of pharmaceutical industries and products has brought with it many problems. Counterfeiting is just one example. In recent years, the problem of counterfeit medicines was first addressed at the international level in 1985 at the Conference of Experts on the Rational Use of Drugs in Nairobi. The meeting recommended that WHO should study the feasibility of setting up a clearing house to collect data and to inform governments about the nature and extent of counterfeiting. In 1988 the World Health Assembly adopted resolution which requested to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, counterfeited or substandard pharmaceutical preparations. Given the rapid spread of counterfeit drugs in many national distribution channels, the World Health Assembly in 1994 adopted complementary resolution. Medicine is considered counterfeit if it has been deliberately and fraudulently mislabelled with respect to its identity and/or source. Both branded and generic products can be counterfeited, and these products could include one or more of the following: incorrect ingredients; wrong ingredients; inactive ingredients; insufficient active ingredients; fake packaging. Increasing international trade of pharmaceuticals and sales via the internet has further facilitated the entry of counterfeit products into the supply chain. In 2006 this led to WHO’s launch of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT*) which has been the main conduit for WHO’s work against counterfeits since. The falsification of medicines is a global problem, requiring effective and enhanced international coordination and cooperation in order to ensure that anti-falsification strategies are more effective.

Continuing Equivalence: Is There an End to the Story?

For many active pharmaceutical ingredients and their corresponding drug products, the possibility of a single global system of harmonised bioequivalence and pharmaceutical equivalence requirements for first-entry and interchangeable multi-source drug products may be considered. The topic should be of interest to all manufacturers, to practitioners and patients as well, and to government policy-makers. In an era when substandard, counterfeit, and adulterated medicines are increasingly available, the topic requires careful consideration.