Amongst the mandates of United Nations, health of mankind is the thrust area of UN through World Health Organization (WHO). Planning and execution of policies for mainstreaming of traditional medicines (TRM) of respective countries along with conventional system of medicine (allopathy), first in the country of origin followed by the international arena, is the priority agenda of operations of WHO. Within Indian context, WHO accorded prime focus to Ayurveda in its activities related to TRM.Sponsorship and encouragement of studies substantiating parameters of standardization, safety and efficacy of herbal medicines of Ayurveda are under chief consideration of WHO. In this review, several guidelines of WHO are summarized. Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), Central Council of Research in Ayurveda and Siddha and numerous other collaborative centers of WHO in India are assigned with several Appraisal Project Work (APW) and Direct Financial Cooperation (DFC) projects that will strengthen Ayurveda as evidence-based medicine for its global acceptance. Implementation of pharmacovigilance program in Ayurveda, publication of documents for rational use and initiatives to prepare consumer guidelines for appropriate use of Ayurvedic medicines are some other contributions of WHO toward advancement of Ayurveda at national as well as global level. Here, we suggest further exploration, interaction and interpretation of traditional knowledge in the light of contemporary core sciences and biomedical sciences that can pave the way for accreditation of Ayurveda worldwide as an established system of medicine.
Ayurveda; efficacy; standardization; safety; traditional medicine
The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting.
In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use.
We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way.
Pharmacovigilance; Safety reporting; Public sector; Non-commercial; Service set-up
Allopathic practitioners in India are outnumbered by practitioners of traditional Indian medicine and homeopathy (TIMH), which is used by up to two-thirds of its population to help meet primary health care needs, particularly in rural areas. India has an estimated 2.5 million HIV infected persons. However, little is known about TIMH use, safety or efficacy in HIV/AIDS management in India, which has one of the largest indigenous medical systems in the world. The purpose of this review was to assess the quality of peer-reviewed, published literature on TIMH for HIV/AIDS care and treatment.
Of 206 original articles reviewed, 21 laboratory studies, 17 clinical studies, and 6 previous reviews of the literature were identified that covered at least one system of TIMH, which includes Ayurveda, Unani medicine, Siddha medicine, homeopathy, yoga and naturopathy. Most studies examined either Ayurvedic or homeopathic treatments. Only 4 of these studies were randomized controlled trials, and only 10 were published in MEDLINE-indexed journals. Overall, the studies reported positive effects and even "cure" and reversal of HIV infection, but frequent methodological flaws call into question their internal and external validity. Common reasons for poor quality included small sample sizes, high drop-out rates, design flaws such as selection of inappropriate or weak outcome measures, flaws in statistical analysis, and reporting flaws such as lack of details on products and their standardization, poor or no description of randomization, and incomplete reporting of study results.
This review exposes a broad gap between the widespread use of TIMH therapies for HIV/AIDS, and the dearth of high-quality data supporting their effectiveness and safety. In light of the suboptimal effectiveness of vaccines, barrier methods and behavior change strategies for prevention of HIV infection and the cost and side effects of antiretroviral therapy (ART) for its treatment, it is both important and urgent to develop and implement a rigorous research agenda to investigate the potential risks and benefits of TIMH and to identify its role in the management of HIV/AIDS and associated illnesses in India.
Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.
Drug safety; erice declaration; pharmacovigilance
Pharmacovigilance is the outcome of a natural and implied willingness of a physician to ensure safety to his patient. This is a discipline in medicine which pragmatises the principle of first do no harm towards a wider and systematic application in clinical practice. It is however important to understand that despite of its huge potential in ensuring a safe practice of medicine through knowledge of avoidable causes of adversities, its path has never been easy. Applying principles of pharmacovigilance into the realm of traditional medicine particularly to Ayurveda is even more difficult for the issues of why and how of pharmacovigilance in light of historical practice and anecdotal evidences of safety in Ayurveda. Application of pharmacovigilance in Ayurveda thereby demands a careful and thoughtful observation of its needs and its methods of application in order to to maximize its impacts to ensure the patient safety to every extent possible.
Adverse drug reaction; drug safety; pharmacovigilance
Currently, India recognizes five different healthcare systems, collectively known as AYUSH (Ayurveda, Yoga, Unani, Siddha, Homeopathy), along with the conventional biomedicine. These systems have their own institutionalized structure for monitoring medical education and practice. However, because of the ‘parallel’ kind of policy model that is followed in India, there is no formal provision for any cross-talk between the professionals belonging to these different streams. This situation has not only given rise to mutual misgivings among these professionals regarding the strengths and weaknesses of each other, but also has led to a poor appreciation of the historical and socio-cultural connections these streams share with the community at large. To tackle these issues and to promote adequate participation of biomedicine experts in AYUSH-related research projects, ‘introduction of an AYUSH module in the current curriculum of MBBS (Bachelor of Medicine and Bachelor of Surgery) program’ has been proposed in this communication along with a possible roadmap for its implementation. It is also suggested that the experts in biomedicine be engaged for training AYUSH graduates in their respective specialties so that quality AYUSH education may be ensured.
AYUSH; biomedicine; cross-talk; medical education
Objective: To assess the pharmacovigilance awareness among the healthcare professionals in a teaching hospital in Northern India.
Material and Methods: A questionnaire which was suitable for assessing the basic Knowledge, Attitude and the Practice (KAP) of pharmacovigilance was designed and distributed among 100 doctors of the Punjab Institute of Medical Sciences (PIMS) Hospital, Jalandhar, Punjab, India.
Results: Among the 100 doctors, 61 responded. The data was analyzed by using the SPSS statistical software. Although 77% of the subjects knew the term ‘pharmacovigilance’, only 59% were aware of the existence of the National Pharmacovigilance Program. 23% volunteered to reports Adverse Drug Reactions (ADRs), but more than 60% doctors did not know how and where to report the ADRs.
Conclusion: There is a need for a regular training and the reenforcement for the ADR reporting among the health care personnel. The perception of the reporting process being tedious, the lack of time, a poor knowledge on the reporting mechanism and inadequate expertise seemed to be the main reasons for not reporting the ADRs. A majority of the respondents suggested regular training sessions on a priority basis for the success of the pharmacovigilance program and for the better clinical management of the patients in general.
Pharmacovigilance; Knowledge; Attitude; Practice; Adverse drug reactions
A centralized hemovigilance program to assure patient safety and to promote public health has been launched for the first time in India on Dec 10, 2012 in 60 medical colleges in the first phase along with a well-structured program for monitoring adverse reactions associated with blood transfusion and blood product administration. National Institute of Biologicals (NIB) will be the National Coordinating Centre for Hemovigilance. This program will be implemented under overall ambit of Pharmacovigilance Program of India (PvPI), which is being coordinated by Indian Pharmacopoeia Commission (IPC). All medical colleges of the country will be enrolled in this program by the year 2016 in order to have a National Centre of Excellence for Hemovigilance at NIB, which will act as a global knowledge platform.
Hemovigilance; India; Medical colleges; Transfusion Reaction Reporting Form
The potential of Ayurvedic philosophy and medicines needs to be recognized and converted into real life treatment paradigm. This article describes a comprehensive therapeutic approach used in Ayurveda and modern medicine to treat arthritis. We present concise summary of various controlled drug trials carried out by us to validate standardized Ayurvedic drugs using modern medicine protocol to treat Rheumatoid Arthritis and Osteoarthritis knees. Several of the latter are published. The trials consistently demonstrate excellent safety of Ayurvedic medicines but often fail to unequivocally show superior efficacy. Some key findings of a recently unpublished trial in OA knees are also presented to show equivalence between Ayurvedic medicine and celecoxib and glucosamine, and we speculate that equivalence trials may be a way forward. The data from the trials also supports the Ayurvedic ‘Rasayana’ concept of immune-modulation and healing. We need to interpret logic of Ayurveda when, adopting modern science tools in drug development and validation and much research is required. Validation of Ayurvedic medicines using the latter approach may lead to an evidence based Ayurveda – Modern Medicine interface. Also, in pursuit of finding better treatment solutions, we ought to step beyond the realm of only drugs and attempt validation of comprehensive specific treatment package as per classical Ayurveda. Finally, validation of a combined (Ayurveda and modern medicine) therapeutic approach with superior efficacy and safety is likely to be a major leap in overcoming some of the current frustrations to treat difficult disorders like arthritis using only modern medicines.
Ayurveda; rheumatoid arthritis; osteoarthritis; clinical trials; Rasayana
By 2020, it is predicted that non-communicable diseases will be causing seven out of every 10 deaths in developing countries. Indian traditional medicine system with the concept of personalized therapy in Ayurveda has the potential to offer remedies to these challenging health issues. Integration of Ayurveda, Siddha and Unani, the three Indian systems of medicine (ISM), along with homoeopathic and allopathic systems of medicine to ensure health for all citizens across the country is the new Mantra of the Union health ministry. To tap the potentials of our indigenous medicine systems and other popular systems of medicine it is important to assess the awareness among people and make efforts to popularize them. The present study was therefore carried out to assess the awareness among 200 respondents with the help of a multiple choice questionnaire by the interview method. Convenience sampling technique was employed. The awareness about lifestyle, diet, oil consumption needs more vigorous attention as observed in this study. The most popular choice was found to be groundnut oil. Around 4% of the participants used more than one medium of cooking. Forty-two percent of the participants observed fast regularly. Twenty-three percent of the participants did not include any form of exercise in their daily routine while walking was the most popular form of exercise performed by 43%. By using multiple comparisons it was observed that the difference between i) Allopathy- Homeopathy, ii) Allopathy – Ayurvedic and iii) Ayurvedic- Homeopathy as 15.5263, 7.1053 and 8.4211, respectively, are significant at α = 0.05. A larger sample size encompassing various economic strata could be a better index of popularity of various alternative medicine systems existing in different sections of our society.
Alternative and complementary medicine; health awareness; Indian system of medicine; popularity of Ayurveda
Herbal drugs constitute a major share of all the officially recognised systems of health in India viz. Ayurveda, Yoga, Unani, Siddha, Homeopathy and Naturopathy, except Allopathy. More than 70% of India’s 1.1 billion population still use these non-allopathic systems of medicine. Currently, there is no separate category of herbal drugs or dietary supplements, as per the Indian Drugs Act. However, there is a vast experiential-evidence base for many of the natural drugs. This offers immense opportunities for Observational Therapeutics and Reverse Pharmacology. Evidence-based herbals are widely used in the diverse systems and manufactured, as per the pharmacopoeial guidelines, by a well-organised industry. Significant basic and clinical research has been carried out on the medicinal plants and their formulations, with the state-of-the-art methods in a number of Institutes/Universities. There are some good examples. Indian medicinal plants also provide a rich source for antioxidants that are known to prevent/delay different diseased states. The antioxidant protection is observed at different levels. The medicinal plants also contain other beneficial compounds like ingredients for functional foods. Hence, the global knowledge about Ayurveda and Indian herbals will hopefully be enhanced by information on the evidence-base of these plants. This will yield rich dividends in the coming years.
Ayurveda; Indian medicinal plants; reverse pharmacology; observational therapeutics; antioxidant
To review the status of pharmacovigilance system among surgeons and in surgical wards with recommendations. Literature search using MEDLINE, cross-reference of published data and review of World Health Organization—Pharmacovigilance transcripts. Pharmacovigilance system is still in its infancy among surgeons and in surgical wards. No major studies have been published addressing this issue, till date. Surgeons are professionals least likely to report adverse drug reactions. Moreover widespread and irrational antibiotic use is contributing towards high incidence of adverse events apart from multidrug resistance. Lack of interest, funding and knowledge pose challenges in effective post marketing drug surveillance in surgery. A three tier proactive pharmacovigilance system in surgical wards is suggested along with specific recommendations. The pros and cons of adverse drug reporting among the surgeons are discussed. With growing awareness of pharmacovigilance in various fields of medicine, surgery can no longer remain an exception. In the transition from medical school to surgery clinic a subtle shift must occur from emphasizing pharmacokinetics to appreciating pharmacodynamics. This change in philosophy will occur at the level of instruction when the surgeons of tomorrow are motivated through regulatory and institutional means at school level to adopt pharmacovigilance in their clinical practices along with the practicing surgeons.
Pharmacovigilance; Pharmacodynamics; Adverse drug reactions; Surgery
Ayurveda, the traditional medical system of India, is understudied in western contexts. Using data gathered from an Ayurvedic treatment program, this study examined the role of psychosocial factors in the process of behavior change and the salutogenic process. This observational study examined associations with participation in the 5-day Ayurvedic cleansing retreat program, Panchakarma. Quality of life, psychosocial, and behavior change measurements were measured longitudinally on 20 female participants. Measurements were taken before the start of the program, immediately after the program, and 3 months postprogram. The program did not significantly improve quality of life. Significant improvements were found in self-efficacy towards using Ayurveda to improve health and reported positive health behaviors. In addition, perceived social support and depression showed significant improvements 3 months postprogram after the subjects had returned to their home context. As a program of behavior change, our preliminary results suggest that the complex intervention Panchakarma may be effective in assisting one’s expected and reported adherence to new and healthier behavior patterns.
Ayurveda; health behavior change; complex medical system
To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL) administered as first-line treatment for uncomplicated malaria in rural Tanzania.
Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS). Three distinct channels for identification of adverse events (AEs) and serious adverse events (SAEs) were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact) study (conducted only in March-April 2008).
Training was provided for 40 healthcare providers (with refresher training 18 months later) and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence.
Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges.
Experience gained in this setting could help to improve spontaneous reporting of AEs and SAEs to health authorities or marketing authorization holders.
Community pharmacies in Nepal serve both rural and urban populations and are an integral part of the Nepalese healthcare system. These community pharmacies are run by non-pharmacist professionals with orientation training on pharmacology and drug dispensing. Graduate pharmacists’ involvement in community pharmacy will help with patient counselling, dispensing of medication and promotion of safe and appropriate medicine use. Nepal has an organised pharmacovigilance system which incorporates adverse drug reaction (ADRs) from hospitals and tertiary care centres but not from the community. Involvement of pharmacists in community pharmacy will help in ADR reporting and, monitoring at community level and will help in promoting medication safety in the community. This article describes the community pharmacovigilance program in Nepal and the prospects for community pharmacists.
Community Pharmacy; Adverse Drug Reaction; Pharmacist; Nepal
Change of first-line treatment of uncomplicated malaria to artemisinin-combination therapy (ACT) is widespread in Africa. To expand knowledge of safety profiles of ACT, pharmacovigilance activities are included in the implementation process of therapy changes. Ghana implemented first-line therapy of artesunate-amodiaquine in 2005. Drug utilization data is an important component of determining drug safety, and this paper describes how anti-malarials were prescribed within a prospective pharmacovigilance study in Ghana following anti-malarial treatment policy change.
Patients with diagnosis of uncomplicated malaria were recruited from pharmacies of health facilities throughout Accra in a cohort-event monitoring study. The main drug utilization outcomes were the relation of patient age, gender, type of facility attended, mode of diagnosis and concomitant treatments to the anti-malarial regimen prescribed. Logistic regression was used to predict prescription of nationally recommended first-line therapy and concomitant prescription of antibiotics.
The cohort comprised 2,831 patients. Curative regimens containing an artemisinin derivative were given to 90.8% (n = 2,574) of patients, although 33% (n = 936) of patients received an artemisinin-based monotherapy. Predictors of first-line therapy were laboratory-confirmed diagnosis, age >5 years, and attending a government facility. Analgesics and antibiotics were the most commonly prescribed concomitant medications, with a median of two co-prescriptions per patient (range 1–9). Patients above 12 years were significantly less likely to have antibiotics co-prescribed than patients under five years; those prescribed non-artemisinin monotherapies were more likely to receive antibiotics. A dihydroartemisinin-amodiaquine combination was the most used therapy for children under five years of age (29.0%, n = 177).
This study shows that though first-line therapy recommendations may change, clinical practice may still be affected by factors other than the decision or ability to diagnose malaria. Age, diagnostic confirmation and suspected concurrent conditions lead to benefit:risk assessments for individual patients by clinicians as to which anti-malarial treatment to prescribe. This has implications for adherence to policy changes aiming to implement effective use of ACT. These results should inform education of health professionals and rational drug use policies to reduce poly-pharmacy, and also suggest a potential positive impact of increased access to testing for malaria both within health facilities and in homes.
Of all the countries in the world, why did you choose Taiwan to pursue your study? It is a question that I (comments of the first author) have answered a thousand times. My first visit to a laboratory at National Taiwan University opened my eyes to the possibilities of herbal medicine research, especially in the area of veterinary medicine. It became my ambition to link the knowledge of Traditional Chinese Medicine (TCM) and Ayurveda from the Indian subcontinent and their integration with other systems of medicine, including Western medicine (WM), to achieve the concept of Sustainable Medicine, firstly for animals and then for humans. The Ministry of Economic Affairs (MOEA) has implemented a technology development program to quickly establish the key technologies, and this is a moment of opportunity for Taiwan's traditional herbal medicine industry to upgrade and transform itself. This paper, initially intended to be a student's narration, has evolved into a multi-author treatise on the present state and likely future scenario of herbal medicine research in Taiwan.
herbal medicine; research; Taiwan
Herbal formulations being widely accepted therapeutic agents as antidiabetics, antiarthritics, hepatoprotectives, cough remedies, memory enhancers, and adaptogens. The commonest myth regarding herbal medicines is that these medicines are completely safe, and can therefore be safely consumed by the patient on his/her own, without a physician's prescription. This belief has led to large-scale self-medication by people all over the world, often leading to disappointing end-results, side-effects, or unwanted after-effects. There is an increasing awareness at several levels of the need to develop pharmacovigilance practices for herbal medicines. The current model of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs, and applying these methods to monitoring the safety of herbal medicines presents unique challenges in addition to those described for conventional medicines. Several problems relate to the ways in which herbal medicines are named, perceived, sourced, and utilized. This may be because of differences in the use of nonorthodox drugs (e.g., herbal remedies) which may pose special toxicological problems, when used alone or in combination with other drugs. The purpose of pharmacovigilance is to detect, assess, and understand, and to prevent the adverse effects or any other possible drug-related problems, related to herbal, traditional, and complementary medicines.
Adverse reaction; herbal medicines; pharmacovigilance
Adverse drug reactions (ADR) are ranked as some of the major causes of patient morbidity and mortality. Spontaneous reporting of ADRs has remained the cornerstone of pharmacovigilance and is important in maintaining patient safety. This study was conducted to assess the nurses’ knowledge and attitude towards pharmacovigilance, reasons for not reporting ADRs, and their pharmacovigilance practice.
Materials and Methods:
A questionnaire was prepared to investigate knowledge, attitude and practice (KAP) of nurses regarding ADR reporting. In November 2009, the questionnaires were given to 500 nurses of a teaching hospital in Tehran.
Knowledge and practice of participants were not satisfying; however, their attitude towards pharmacovigilance was at a high level. About 91% of the nurses had never reported an ADR. Most nurses liked to report the ADRs to the physicians (87.1%) and pharmacists in hospital's ADR center (1.8%) rather than the ADR National Center. The main cause of under-reporting of the suspected ADRs was unawareness about the existence of such a national center. Among nurses who had reported ADR for at least once, the majority preferred using phone (10 out of 50) or Yellow Cards (7 out of 50). Only 1 person out of 50 preferred using internet for submitting the reports
Since the nurses in this study had little knowledge and poor practice regarding the pharmacovigilance and spontaneous reporting system, interventions such as holding pharmacovigilance workshops in the hospitals focusing on the aims of pharmacovigilance, completing the Yellow Card and clarifying the reporting criteria are strongly recommended.
Knowledge; attitude; practice; nurse; adverse drug reaction; pharmacovigilance; Iran
Over the past 20 years the Fundacion Salud de Ayurved Prema Argentina has spread the knowledge of Ayurveda throughout Latin America. The Fundacion is based in Buenos Aires in the Argentine Republic, where it now runs courses in two of the country’s major medical schools - at the School of Medicine of the University of Buenos Aires, and the National University of Cordoba’s School of Medicine. Based on an MoU with Gujarat Ayurveda University, at Jamnagar, Gujarat, the Fundacion has been accredited as a Collaborating Center for teaching, assistance and research in the field of Ayurvedic Medicine in Argentina. This has led to successful missions to other countries in the region where the Fundacion and its associates have been able to start dialogues with governments, and in places hold sizeable courses. The knowledge of Ayurveda is now spreading throughout South and Central America and hardly a country remains untouched by it.
Ayurveda; Argentina; Latin America; education; local medicinal plants
Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals. In light of this recommendation and the rapid scale-up of ACT worldwide, an analysis of Global Fund Round 8 proposals and the President's Malaria Initiative (PMI) 2009 Malaria Operational Plans was conducted to assess if and how pharmacovigilance has been incorporated into countries' national malaria plans and donor budget requests.
The Global Fund - Malaria Round 8 proposals for the 26 countries and the PMI Malaria Operational Plans (MOPs) for fiscal year 2009 for the 15 countries that were approved and received funding from either the Global Fund - Malaria Round 8 or PMI were accessed through the programme websites. The analysis consisted of conducting word counts and key word in context analyses of each proposal and plan.
Twelve out of 26 (46%) of the Global Fund proposals mentioned that established pharmacovigilance systems were present in their countries. Four of the fifteen PMI MOPs (27%) mentioned that established pharmacovigilance systems were present in their countries. Only seven of the 26 (27%) Global Fund proposals included a request for funding for new or current pharmacovigilance activities. Seven of 15 (47%) MOPs included a request for funding for pharmacovigilance activities.
There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The findings stress the need for more active direction to strengthen active surveillance and passive adverse event reporting systems to augment the issuance of guidance documents.
Standardization of a compound Ayurvedic formulation is a critical and essential issue to be considered in assuring the therapeutic efficacy and safety and to rationalize their use in the health care. Sitopaladi churna is a reputed polyherbal formulation of Ayurveda. It is prescribed for the treatment of pleurodynia, intercostal neuralgia, cold, cough associated with bronchitis, pneumonia, tuberculosis, viral respiratory infection, and in pharyngeal and chest congestion.
The present study aimed at physico-chemical standardization of in-house and two marketed brands of Sitopaladi churna.
Materials and Methods:
In our investigation, in-house churna and two commercial brands of Sitopaladi churna were standardized based on powder microscopy, physico-chemical evaluations, thin layer chromatography (TLC) and high performance thin layer chromatography (HPTLC) finger printing as per standard procedures.
The set parameters were sufficient to evaluate the churna based on various physico-chemical parameters.
The data evolved can be adopted for laying down the standards for the manufacturing units of Sitopaladi churna.
High performance thin layer chromatography; physico-chemical; Sitopaladi churna; standardization
Pharmacovigilance plays an important role in the rational use of medicines by providing information about adverse drug reactions (ADRs) in the general population. Knowledge of ADRs caused by drugs is important for effective treatment. KIST Medical College has recently joined the national pharmacovigilance program as a regional center. Clinicians, pharmacists, house officers, nurses and other staff are encouraged to report ADRs to the center. The center started functioning from mid‐July 2008. The objective of this study was to report the various ADRs presented to the center in its first seven months of operation. Doctors and other health care professionals were briefed regarding the ADR reporting system. An ADR reporting form was designed and circulated to all the departments in the hospital. The reported reactions were analyzed for causality, severity and preventability using different scales. To date, thirty six ADRs have been reported. The majority of the reports (23) were from the Department of Medicine. Other departments like Pediatrics, Obstetrics‐Gynecology and Radiology have also reported ADRs. As per the causality assessment, 21 (58.3%) reports were found to be “possible” and 15 (41.6%) were found to be probably associated with the named medication. With respect to severity, 17 (47.2%) reports were mild and 19 (52.7%) were moderate. As per the preventability scale, 8 (22.2%) ADRs were definitely preventable while 28 (77.7%) were not preventable. The ADRs are reported to the Uppsala Monitoring Center through Vigiflow via the Department of Drug Administration.
Ayurveda is getting its due recognition as a rationale system of medicine worldwide despite the fact that medical and scientific fraternity of the globe has very strong opposite opinion regarding safety and efficacy of Ayurvedic medicines. Meanwhile, provisions of Intellectual Property Rights under World Intellectual Property Organization (WIPO) and Patents have attracted many individuals and organizations to explore possibilities of commercial benefits with Ayurvedic traditional knowledge. Although rules are not favoring to grant a patent on prior published knowledge, biopiracy managed grant of Patent on knowledge of Ayurvedic medicinal plants which has been successfully checked with references of data base of Traditional Knowledge Digital Library (TKDL). Current provisions of the Patent law of India are obstructive in nature for getting patent on Ayurvedic medicines. If we have to invite researchers from basic science to ensure quality, safety and efficacy of Ayurvedic medicines, there is an urgent need to amend laws of patent with pragmatic promotional policies. This will encourage more patents on numerous pharmaceutical, nutraceutical and cosmaceutical products based on Ayurveda. As every action of today's world is based on economic criteria so why stakeholders of Ayurveda should be deprived of it. New inventions would drive acceptance of Ayurveda as a global system of medicine.
Ayurvedic pharmaceuticals; cosmaceuticals; IPR; nutraceuticals; product patent; TKDL
Monitoring and evaluation of malaria control in pregnancy is essential for assessing the efficacy and effectiveness of health interventions aimed at reducing the major burden of this disease on women living in endemic areas. Yet there is no currently integrated strategic approach on how this should be achieved. Malaria control in pregnancy is formulated in relation to epidemiological patterns of exposure. Current emphasis is on intermittent preventive treatment (IPTp) during pregnancy with sulphadoxine-pyrimethamine in higher transmission areas, combined with insecticide treated bed nets (ITNs) and case management. Emphasis in lower transmission areas is primarily on case management. This paper discusses a rational basis for monitoring and evaluation based on: assessments of therapeutic and prophylactic drug efficacy; proportional reductions in parasite prevalence; seasonal effects; rapid assessment methodologies; birthweight and/or anaemia nomograms; case-coverage methods; maternal mortality indices; operational and programmatic indicators; and safety and pharmacovigilance of antimalarials in pregnancy. These approaches should be incorporated more effectively within National Programmes in order to facilitate surveillance and improve identification of high-risk women. Systems for utilizing routinely collected data should be strengthened, with greater attention to safety and pharmacovigilance with the advent of artemisinin combination therapies, and prospects of inadvertent exposures to artemisinins in the first trimester. Integrating monitoring activities within malaria control, reproductive health and adolescent-friendly services will be critical for implementation. Large-scale operational research is required to further evaluate the validity of currently proposed indicators, and in order to clarify the breadth and scale of implementation to be deployed.