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
India has a population of 1.21 billion people and there is a high degree of socio-cultural, linguistic, and demographic heterogeneity. There is a limited number of health care professionals, especially doctors, per head of population. The National Rural Health Mission has decided to mainstream the Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy (AYUSH) system of indigenous medicine to help meet the challenge of this shortage of health care professionals and to strengthen the delivery system of the health care service. Multiple interventions have been implemented to ensure a systematic merger; however, the anticipated results have not been achieved as a result of multiple challenges and barriers. To ensure the accessibility and availability of health care services to all, policy-makers need to implement strategies to facilitate the mainstreaming of the AYUSH system and to support this system with stringent monitoring mechanisms.
Ayurvedic medicine; homeopathy; indigenous medicine; India; public health
Shankha Vati, a classical Ayurvedic formulation that is widely used by the practitioners of Ayurveda, contains a heavy metal i.e. Parada (mercury) and a poisonous herbal drug i.e. Vatsanabha (Aconitum chasmantum Staff.ex.Holmes) along with other ingredients. There are certain apprehensions on this formulation, mainly due to the presence of its ingredient Vatsanabha. Shankha Vati (Bhaishajya Ratnavali 10/186 – 187, also in Ayurvedic Formulary of India Part1), is one of the formulations in which Vatsanabha is used without its usual coingredient and antidote Tankana (borax). With an hypothesis that classical combination of Shankha Vati is not completely safe and there could be some adverse effects due to the presence of poisonous ingredient Vatsanabha in it, and any possible adverse effects of Shankha Vati due to the presence of Vatsanabha will be nullified by the addition of Tankana to the formulation, another modified formulation with the addition of purified Tankana equal to the quantity of Vatsanabha in the classical Shankha Vati, was also taken up for the study.
Acute toxicity study as per OECD Guideline 425, and Chronic toxicity study (90 days with the recovery period of 30 days) as per AYUSH170 guideline (Guidelines for preclinical safety evaluation for Ayurveda, Siddha and Unani drugs and other traditional medicines in India) were carried out. Biochemical and haematological investigations were carried out on 30th, 60th, 90th and 120th days. Histopathological study of acute chronic toxicity study were carried out.
Histopathological study of both acute and chronic toxicity study were also carried out. There were no toxicity related changes found in the animals treated classical Shankha Vati as well as modified Shankha Vati in both acute and chronic toxicity study. Similarly biochemical and haematological investigations also did not toxicity related changes.
Classical formulation of Shankha Vati is completely safe and there is no need to modify the composition to make it safer.
Sharing of public health knowledge and skills by professionals in allopathic system of medicine with Ayurveda, Yoga, and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) professionals in India has always been considered as part of integrating the health system in India. But till date, a curriculum has not been framed for follow-up.
Materials and Methods:
A training course was developed for AYUSH professionals in India on the public health principles for the prevention and control of non-communicable diseases (NCDs). Three course chairs interacted with international and national public health and AYUSH experts, and the curriculum for a 3-month course was developed.
The curriculum comprised interactive lectures, problem-based exercise, field visits, and research protocol development. A total of four participants, nominated by the World Health Organization, India, were trained during the course, with significant (P = 0.00) improvement in knowledge from 53.2 to 80.0 points.
A novel and feasible public health course for complementary and alternative medicine professionals on the public health principles for NCDs’ prevention and control is needed to bridge the demand gap for public health professionals in India.
AYUSH course; non-communicable disease; public health
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
To achieve the goal of good rural health the need of incorporation of Ayurveda was realized and Ayurveda Gram Yojna was implemented in Govt. Ayurveda Dispensary of Chhattisgarh. Aims were to achieve good public health in rural area, maintain lifestyle according to Ayurvedic regimen, promote cultivation and use of medicinal plants, control and prevent endemic diseases, make national health program successful in those villages.
A comparative study was done before and after implementation of AGY from 2009 to 2012 in Govt. Ayurveda dispensary, Gorpar village. Data was collected from the available reports and the records at the Govt Ayurvedic dispensary regarding the operational mechanism and utilisation of the services and their benefits under the AGY. All the data collected were critically analysed and expressed in means.
In Gorpar village AGY was implemented since 2009. Increase in number of patients visiting the dispensary old 147 to 301, Female 1126 to 1745, male 1365 to 2091 before and after respectively. Health camps done 0 and 11 (no. of patients 1156), Yoga camps done 0 and 2, school health camps done 0 and 11 (no of students treated 825), Ayurveda awareness camp done 0 and 3, Plantation of medicinal plant in village 0 and 128, training program for Mitanin 0 and 3 before and after respectively. Before implementation of this yojna there were endemic disease like diarrhea but after implementation there was no any endemic reported. After this yojna dispensary took part in national program like family control program, malaria and T.B. control program, leprosy eradication program.
Upgrowing trend shows that Ayurveda gram yojna is effective program for improvement of rural heath through Ayurveda. Beside few shortcomings at the quality, quantity and adequacy of the system strength of the services through it, it has a large and positive impact on the rural health.
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.
The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern.
adverse drug reactions; Africa; medicines safety; pharmacovigilance
India is among the important megabiodiversity centers of the world with nearly 45,000 known plant species. This diversity coupled with a rich heritage of traditional knowledge has made India a home to several important time-honored systems of health care such as Ayurveda, Siddha and Unani. Herbal medicines, however, are associated with a number of shortcomings including uniform efficacy and lack of appropriate quality control measures at various stages of product development. The review intends to outline the importance of fostering quality parameters towards standardization and manufacturing of botanicals for India to emerge as a leader in global market of herbal products. Literature survey was carried out on important parameters for processing and manufacturing of botanicals. The review highlights that there have been constant efforts for developing state of the art technologies in the field of herbal research. It also reflects that Government authorities have also taken a number of initiatives to formulate appropriate guidelines from standardization of raw materials to obtaining botanical products. However, in the Indian context, there exist certain lacunae in the current regulatory mechanisms which need to be strengthened and stringently implemented to ensure safety, purity and efficacy of herbal medicines. Towards this the approaches being developed globally can be adopted. Based on the literature reviewed, in our opinion, four areas viz., benefit sharing, investment by industry, standardization and national/international networking structure need immediate attention for strengthening Traditional Systems of Medicine in India.
India; quality control; regulations; standardization; traditional medicine
The use of biotechnology-derived medicines has significantly increased in recent decades. Although biosimilars undergo rigorous characterization as well as clinical studies to document their safety and effectiveness, they are highly complex molecules and small changes in the purification and production process of a biosimilar can have major implications in its safety and effectiveness profile. In Latin America, regulatory authorities have begun to establish well-described and standardized pathways that permit a biosimilar to gain commercial licensure. In order to be certain that a biosimilar reaches its potential in ordinary clinical use, an intensive post-licensing monitoring system must be established since it is the only means to ascertain the true similarity between the original biologic and its biosimilar. Pharmacovigilance allows national authorities to determine a drug’s performance in the marketplace. An effective tracking and pharmacovigilance system for biological medicines has many steps and processes. To aid policy makers in Latin American in addressing the many issues surrounding the establishment of an effective pharmacovigilance system, the Americas Health Foundation convened a group of experts to discuss the topic and develop recommendations for implementation. The group discussed current challenges and gaps in pharmacovigilance in Latin America, paying close attention to the major issues associated with traceability and pharmacovigilance of biosimilars following their approval. The recommendations developed should enable countries to accurately document the safety and performance of a biosimilar as experienced by patients under real-life conditions and have a significant impact on the successful implementation of pharmacovigilance of biosimilars throughout the region.
Biosimilars; Naming; Pharmacovigilance; Surveillance; Traceability
Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010.
This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists’ participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates.
Materials and Methods:
A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.). The study was conducted, over a period of 3 months from May 2012 to July 2012.
Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients.
The Indian pharmacists have poor knowledge, attitude, and practice (KAP) towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists working in different sectors can become part of ADR reporting system.
Adverse drug reaction; adverse drug reaction reporting; knowledge; attitude; and practice; national pharmacovigilance program; pharmacists
Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report misinterpretation; this generates the negative impact on system. Although, Ayurveda which is holistic system of medicine from India has elaborated the causes and methods of drug-induced consequences along with preventive measures the available data in classical texts is scattered. The compilation and analysis along with modern concept drug safety is need of the hour. Present literature review was conducted from various compendium of Ayurveda and electronic data base with search terms of ‘Vyapad’, ‘Viruddha’, ‘Ahita’, ‘herb–herb interaction’, ‘idiosyncrasy’, ‘Prakritiviruddha’ etc. The reported information was analysed for the possible correlation on concept of ADR and Pharmacovigilance of current science. Overall review demonstrated that drug interaction, iatrogenic, over dose, administration of unsuitable drugs, reprehensive drug administration with respect to disease, complication from five procedural therapies (Panchakarma) and reprehensible preparation of mineral drug are nearer to the modern causes of ADR. Thus, concept of drug safety and ADR is not new to the Ayurveda. The concept “Drug which is not appropriate to be used as medicine”(Abheshaja) of Ayurveda sounds similar as that of modern pharmacovigilance.
Pharmacovigilance; ADR; Ayurveda; Drug safety; Abheshaja
Malaria is one of the dreaded global killer diseases especially in the poor, forested, hilly, remote regions with little medical facilities. About 2 million malaria cases are estimated to occur in India annually as per the National malaria research institute study, but many more unreported cases also occur. Each leads to treatment cost of Rs. 1,000/ (one thousand) on average. This implies Rs. 2 billion drug market. Considering that the proposed local medicinal plants based drug will cut the treatment cost by at least 50% , the business potential with 100% replacement would be Rs. 1 billion at least. The formula is basically clinically found successful by Bombay Hospital scientists. The pharmaceutical companies do not invest in the market “at the bottom of the pyramid” due to thin margins/ loss risk. Thus, of the patented malaria medicine developed by National Research Development Council (NRDC) named “Ayush 64” (www.nrdcindia.com/pages/ayush64.htm), hardly any companies bought marketing rights or did many sales. There is huge market in N. E. India/ Africa/ S. America! Ayurveda has proven medicines to treat malaria viz. Mahasudarshan Churna, Tribhuvan kirti & Parijat vati, who treat “Visham jwara” its Ayurvedic indication. However, these are unknown, unavailable, costly & unused in the tribal areas so not popularized. Folk medicines reported, but rarely, to treat malaria include Neem, Kalmegh & Harsingar, where in a clinical study in Mumbai on 120 Malaria patients, 77% showed complete parasite eradication within 7 days of treatment with the leaf paste, and is also found safe. We also found it effective in our work in Balangir in 2011, besides also by the other NGOs in Orissa viz. Sambandh & FRLHT (www.iaim.edu.in), mainly as a prophylactic. About 30% of the family expenses today spent on Malaria treatment will be cut by about 50%, saving about Rs.2,500/ annually to spend on food, health & education. About 10% productivity will also grow, taking total benefit to Rs.4, 000/ annually, as each person per family spend lying on bed about 10 15 days in Malaria fever. This will be at a cost of just Rs. 500/ making the output: input ratio 1.5, than the total loss now! Also, local & common plants sources, simple technology ensure continued availability & low cost unlike Artemissin drug.
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
Spontaneous adverse drugs reaction (ADRs) reporting represents a precious resource for control and information about the drug's safety and pharmacovigilance. The current reporting system is mainly based on handwritten forms and later manually loaded into a national electronic database by few local pharmacovigilance centers. This reporting system is complicated for both reporters and pharmacovigilance centers which often avoid reporting ADRs for several reasons such as the lack of data on the report. The reporting system might be implemented by improving online platform for ADRs upload; this could allow inspecting all ADRs loaded. Currently, the database is only accessible by the Italian Medicine Agency (AIFA) and local pharmacovigilance centers; neither reporters nor other healthcare professionals can access the database. Finally, it would be right to implement pharmacovigilance centers with specific professional figures qualified in the pharmacovigilance to support both citizens and reporters on various aspects of ADRs reporting.
ADRs; AIFA; database; drugs; Italy
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
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.
Pharmacovigilance has not progressed well in India and the concept is still
in its infancy. India rates below 1% in pharmacovigilance as against the
world rate of 5%.
The aim of our study was to evaluate the knowledge, perception and practice
of pharmacovigilance among registered community pharmacists in Hyderabad,
This was a prospective study to find out the knowledge, perception and
practice of adverse drug reaction reporting among community pharmacists. It
was conducted by a face to face questionnaire and the convenience factor of
the pharmacist was taken into consideration.
From the 650 questionnaire administered to community pharmacists, 347 (53.3%)
were returned completely filled questionnaires. A number of 120 (34.6%)
pharmacists could define the term ‘pharmacovigilance’ to an acceptable
extent and 119 (34.3%) knew about the National Pharmacovigilance Programme
in India. 96 (27.7%) had good knowledge, 36(10.4%) had fair knowledge and
215(61.9%) had poor knowledge about pharmacovigilance. We have found that
196 (56.5%) had good perception, 94(27.1%) had fair perception and 57(16.4%)
had poor perception. Only 41(11.8%) pharmacists ever reported an ADR and the
other never reported ADR. The majority of pharmacists 223(64.3%) felt that
the AE is very simple and non-serious and hence did not report. Pharmacists
have poor knowledge, good perception and negligibly low reporting rates.
Incorporation of ADR reporting concepts in education curriculum, training of
pharmacists and voluntary participation of pharmacists in ADR reporting is
very crucial in achieving the safety goals and safeguarding public
Adverse Drug Reaction Reporting Systems; Pharmacists; Professional Practice; Attitude of Health Personnel; India
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
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
Most of India population resides in rural and are not that economically sufficient to attend to rich healthcare bills of costly medicine, therapies and laboratory tests. The government is surely upto create more health centres and aid in future, as such this is a time taking project. On the other hand, an easy and effective way is following Ayurvedic life style and measures, moreover rural India is more closer to nature and the science of life, and it is more favourable to implement the ways mentioned in Ayurveda at core level. A study to verify the ways that can be advocated, from the basics of Ayurveda was projected.
Simple methods like following of dinacharya, ritucharya, sad vyavahar, plantation of home remedial medicinal plants along with the prime occupation of agriculture farming, using or organic fertilizer, following the medicinal ethics in rituals, protecting off from modern disorder causatives like sedentary lifestyle, junk canned foods, synthetic fertilizers, pollutants, etc. living in close with the nature, precisely Ayurvedic living seen to be very efficient.
The cost of healthcare expenses and maintainence was nullified, except the genetic and traumatic disorders most of them were very well handled or controlled before attaining full-blown condition. The concept of swasthavritta, nidaan parivarjan and samprapti vighatan could control most of the diseases. Health and happiness is a gift of life, was truly experienced. Implementing simple ways, which are in chorus with the lifestyle of rural, is not a complex issue. The results are highly benefitting and puts up a golden example for other to follow. It is in tune with enriching of public health through Ayurveda.
Rural population is the core of our country. Health to them in an economical and easy way Ayurveda will result a comprehensive progress to the whole country, and set an example for the world to follow.
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
Detecting medication errors needs collaboration between various organizations, such as patient safety institutions, pharmacovigilance centres, and poison control centres. In order to evaluate the input of pharmacovigilance centres and poison control centres in detecting and evaluating medication errors a pilot project was initiated by the World Alliance for Patient Safety in collaboration with the Uppsala Monitoring Centre; the Moroccan pharmacovigilance centre acted as project coordinator. As part of this project, a questionnaire on detecting medication errors was circulated to pharmacovigilance centres and poison control centres around the world, in order to assess their ability to detect and analyse medication errors.The results showed that through their databases pharmacovigilance centres can detect, identify, analyse, and classify medication errors and carry out root cause analysis, which is an important tool in preventing medication errors.The duties of pharmacovigilance centres in preventing medication errors include informing health-care professionals about the importance of reporting such errors and creating a culture of patient safety. Pharmacovigilance centres aim to prevent medication errors in collaboration with poison control centres. Such collaboration allows improved detection and improved preventive strategies. In addition, collaboration with regulatory authorities is important in finalizing decisions.Collaboration between pharmacovigilance centres and poison control centres should be strengthened and bridges need to be built linking pharmacovigilance centres, poison control centres, and organizations dedicated to patient safety, in order to avoid duplication of workload.
detection; medication errors; pharmacovigilance centres; poison control centres; prevention; root cause analysis
Spontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world. The dissemination of pharmacovigilance knowledge among Italian healthcare professionals, and the new pharmacovigilance regulations may promote the early detection and reporting of ADRs. This review examines the legislative framework concerning the pharmacovigilance in Italy.
Materials and Methods:
The information was collected from scientific articles and the websites of the Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA).
The pharmacovigilance system, both in Italy and Europe, has undergone profound changes. European legislation on pharmacovigilance has been changed in 2010 according to the EU Regulation 1235/2010 and Directive 2010/84/EU. Basically, the changes tend to increase the efficiency, speed and transparency of pharmacovigilance activities. The new Regulation (1235/2010) and the Directive (2010/84/EU) aim to strengthen the system of pharmacovigilance, establish more precisely who is obliged to do what, and allow faster and easier circulation and retrieval of information about ADRs.
A greater knowledge on what is the Italian pharmacovigilance legislation will be useful to improve the status of ADRs reporting and spread the culture of spontaneous reporting.
ADRs; AIFA; Italian; legislation; monitoring
Ayurveda is most commonly practiced form of complementary and alternative medicine (CAM) in India. There are very few studies showing the knowledge, attitude, and practices (KAP) of allopathic doctors about Ayurvedic drugs and its use.
The study was initiated to assess KAP toward Ayurvedic medicine use among allopathic resident doctors.
Settings and Design:
Cross-sectional and prospective study.
Materials and Methods:
After obtaining permission from the Institutional Ethics Committee, allopathic resident doctors from clinical departments were approached personally. They were given pre-formed validated questionnaire to assess KAP toward Ayurvedic medicine use.
Statistical Analysis Used:
Allopathic residents had little knowledge about basic concepts of Ayurveda, that is, ‘panchakarma’ and ‘tridosha’. Majority residents (99%) had no opportunity to learn basics of Ayurveda, but 67% residents prescribed Ayurvedic medicines to patients. However, many residents (76%) mentioned that cross practice should not be allowed due to lack of knowledge. One resident knew that cross-practice was not allowed by law. The commonly prescribed proprietary Ayurvedic medicines were Liv-52 (39%), Shatavari (13%), Cystone (12%) and common ailments for which these medicines prescribed were liver disorders (34%), arthritis (18%), cough and cold (13%), kidney stones (11%), and piles (10%). Nearly 76% residents felt incorporation of Ayurveda with modern medicine would attract more patients and at the same time most residents (92%) agreed that Ayurvedic medicines need scientific testing before use. Though 50% of the residents agreed for voluntary training in Ayurveda, 80% denied compulsory training. Nearly 63% residents recommended Ayurveda among all CAMs. Most of residents heard of Ayurveda from their colleagues.
This study reveals that allopathic resident doctors had little knowledge about Ayurveda and Ayurvedic medicine use but engaged in prescription of Ayurvedic medicines. So some interventions should be taken to increase the knowledge and awareness of allopathic resident doctors about Ayurvedic medicine use.
Allopathy; Ayurveda; cross-practice; knowledge; attitude; and practices study; residents