INTRODUCTION:

Pharmacovigilance is a concept from French that describes recognizing a drug's side effects, treating them, recording them, reporting them, and making regulatory decisions based on them.

The pharmaceutical science of pharmacovigilance is anxious with the identification, evaluation, comprehension, and avoidance of negative effects or other drug-related issues, especially those involving the long- and short-term side effects of medications.^1,2 It is the science of gathering, observing, investigating, analysing, and evaluating data from medical professionals and patients regarding the side effects of prescription drugs, biological products, and complementary and alternative therapies. Any drug's two main concerns are safety and efficacy. It is quickly becoming recognized as a crucial strategy for the early identification of pharmacological side effects and the taking of essential regulatory action to guarantee the safer use of drugs.^3,4

Pharmacovigilance is a concept from French that describes recognizing a drug's side effects, treating them, recording them, reporting them, and making regulatory decisions based on them. The pharmaceutical science of pharmacovigilance is anxious with the identification, evaluation, comprehension, and avoidance of negative effects or other drug-related issues, especially those involving the long- and short-term side effects of medications.^1,2 It is the science of gathering, observing, investigating, analysing, and evaluating data from medical professionals and patients regarding the side effects of prescription drugs, biological products, and complementary and alternative therapies. Any drug's two main concerns are safety and efficacy. It is quickly becoming recognized as a crucial strategy for the early identification of pharmacological side effects and the taking of essential regulatory action to guarantee the safer use of drugs.^3,4

OBJECTIVES OF PHARMACOVIGILANCE:

The major objectives of pharmacovigilance are:^5,6

· To enhance public safety and health with regard to the usage of herbal remedies.

· To enhance patient safety and care with respect to the utilization of herbal remedies and any other medical and paramedical procedures

· Participate in the review of the advantages, disadvantages, dangers, and effectiveness of pharmaceuticals to promote their safe, suitable, and effective use.

· Increase public knowledge, education, and clinical training in pharmacovigilance and its dissemination.

NEED OF PHARMACOVIGILANCE:

Pharmacovigilance aims to identify, evaluate, comprehend, and prevent side effects as well as any other potential issues connected to herbal remedies or drugs. It is a helpful tool for post-marketing surveillance to find, assess, and address adverse drug reactions (ADRs) and safety concerns related to pharmaceuticals. After being introduced to the market, novel and medically developing treatments must be closely observed for efficacy and safety in everyday situations. Under the framework of the WHO International Drug Monitoring Program, the WHO has stepped up efforts to support herbal safety monitoring.⁷

WHO International Drug Monitoring Programme:

Various monitoring committees we have in the system of pharmacovigilance are mainly includes, the WHO international drug monitoring programme and national pharmacovigilance canters selected by the appropriate health authorities. These programs are helps to detect, collect process and evaluate the case reports of suspected adverse reactions or effects which are mainly provided or supplied by health care professionals of different medicine systems connected to the administration of prescription drugs. The above two programme has reported in two publications mainly safety monitoring of medicinal products which are discussing the necessity of pharmacovigilance, which is concerned with the safety monitoring of pharmaceutical preparations, as well as the rules for establishing and managing a pharmacovigilance centre. The Programme composed of more than seventy national pharmacovigilance centre’s which operate independently.^8,9

Functions of National Pharmacovigilance Centers: Various functions of Pharmacovigilance system are listed as below:

· The national pharmacovigilance centers continuously collect the suspected adverse reactions or adverse effects and case reports for marketed medicinal preparations.¹⁰

· The national pharmacovigilance centers assess the adverse reactions and case reports with respect to its quality documentation.

· The national pharmacovigilance centers helps for the assessment and coding to international standards with the help of suitable medicine classification such as adverse reaction classification, anatomical therapeutic-chemical, using the medical dictionary for quality testing, clinical relevance, and drug regulatory operations.¹¹

· They help to investigate various risk factors and pharmacological mechanisms involved in adverse event or reaction.

· They help to provide the feedback to reporters.

· They help to advice or guide the health care professionals at different levels and consumers or patients on drug safety issues

· They educate and train the persons who are involved in the activities of pharmacovigilance.¹²

Functions of Pharmacovigilance:

There is a lengthy history of using traditional medicine. worldwide, helping people maintain their health and well-being through curative and preventative uses. Traditional medicine is outlined by the World Health Organization (WHO) as a range of health practices, methods, knowledge, and beliefs that include manual, spiritual, and exercise therapies that can be used to treat, diagnose, or cure diseases in addition to maintaining good health. Many different people use herbal treatments for both acute and long-term ailments. Many people buy herbal medicines to maintain their overall health and well-being as well as to prevent and treat common, mild illnesses. In addition to the herbal remedies recommended by conventional medical professionals, many people use herbs or other herbal items in place of allopathic prescription drugs since they have fewer side effects and higher efficacy levels. While conventional medicine and herbal remedies have traditionally been seen to be safer than modern pharmaceuticals, hazards and side effects may not always be entirely avoided. One of the biggest global problems is the underreporting of adverse medication reactions, which might be linked to a lack of time and report forms.¹³ The World Health Organization (WHO) is known to have started a program to record any adverse drug reactions that occur. The profession and science of pharmacovigilance which is the study of identifying, evaluating, comprehending, and averting unfavourable consequences or any other potential drug-related issues emerged as a result of increased knowledge about adverse drug reactions. It is commonly acknowledged that before a medication is commercially released, it must first pass several stages of clinical trials to demonstrate its safety and effectiveness. The science of monitoring and evaluating adverse effects of pharmaceuticals, has traditionally focused on synthetic drugs. However, In the most recent years, there has been an increasing fascination with extending this surveillance to herbal products due to their widespread use and perceived safety. Herbal products, often regarded as natural and harmless, are subject to the same regulatory scrutiny as conventional drugs. The goal of this paper is to present a thorough examination of pharmacovigilance procedures pertaining to herbal products. It looks at current approaches, problems, and legal frameworks in an attempt to clarify the difficulties involved in keeping an eye on the safety profile of herbal treatments. In a time when the use of herbal products is becoming more and more common, it is crucial to comprehend the pharmacovigilance landscape of these products in order to ensure public health and safety.¹⁴

Plants and its importance:

India is home to 15,000 medicinal plants and 45,000 distinct plant species. 7000 plants are utilized in Ayurveda, 700 in Unani, 600 in Siddha, and 30 in modern medicine. At the 56th World Health Assembly in Geneva in March 2003, it was claimed that 65% of India's rural population relies on Ayurveda and medicinal plants to assist them meet their basic needs. They are rich in vitamins, minerals, and antioxidants, herbs support general health and may help stave off chronic illnesses. Herbs are essential to holistic, medical, and culinary activities that promote mental and physical health.^15,16

Adverse drug reactions:

ADRs are defined by the World Health Organization (WHO) as an adverse drug reaction that happens at levels that are typical for human usage and is unpleasant, unexpected, and unintentional.¹⁷ Herbal medications are not completely devoid of adverse pharmacological responses. For example, ginkgo biloba can induce bleeding, capsicum annuum can cause cardiac rhythms, myocardial infraction, ephedra can cause anxiety, and so on. Misidentification is the primary cause of adverse pharmacological reactions to herbal medications. These ADRs exhibit as fever, vomiting, rashes, and nausea, among other symptoms. Poor quality herbal remedies, especially unprocessed plant material and incorrect plant species identification, are a major cause of unfavourable outcomes.^18,19

Drug Interactions:

It is best to prevent patients from using herbal remedies if they are taking medications with a narrow therapeutic index, such as phenytoin, warfarin, cyclosporine, etc. Any medication having a limited when used with herbal products, the therapeutic index may result in an increased risk of side effects or a decrease in effectiveness. Individuals should avoid using herbal remedies interchangeably with contemporary medications as this may lead to drug interactions and a higher chance of negative drug reactions.^20,21Table 1 represents common drug interaction effects.

Table 1: Common Drug Interaction

Category of drugs	Effects
Amino glycosides	Hearing problem, kidney problem
Warfarin	Increased risk of bleeding
Lithium	Hypothermia
Benzodiazepines	Sedation and Respiratory suppression
Miconazole	Severe hypoglycaemia
Theophylline	Insomnia, seizures, restlessness
Barbiturates	Muscle weakness, Reduced consciousness, coma
Methotrexate	Bone marrow suppression

Challenges in monitoring the safety of herbals:

The pharmacovigilance of herbal medicines presents unique difficulties since these preparations are often sold through a variety of outlets without the presence of a healthcare professional, with the majority of sales occurring in an OTC (over-the-counter) setting. Safety concerns also result from subpar and intrinsically hazardous products, which are set against a backdrop of lax regulatory policy for herbal therapeutic items. It is imperative to keep an eye on the safety of herbal medications. Research on the effectiveness of recommendations made by physicians, nurses, and other healthcare professionals about herbal remedies is lacking. It is often recognized that people who take herbal medications seldom tell medical experts that they use them, and that medical professionals also seldom inquire about their usage of these items. Even with the provision of usage information, the majority of medical professionals lack sufficient knowledge about these items since they do not have access to trustworthy sources of information that can be updated.²²

a) Regulation:

The registration and national regulations pertaining to herbal medicines differ among nations. Herbal remedies may be categorized as over-the-counter or prescription, medications in states where they are subject to regulations. Products made from herbs can be classified in ways other than as medications. Furthermore, a given herbal product's regulatory status may vary among nations. Typically, the national regulatory framework also covers qualified distributors and providers of the relevant substances. Consequently, the regulatory status dictates how these products are distributed or can be accessed.^23,24,25

b) Quality Assurance and Control:

Good manufacturing practices (GMP) for herbal medicines, national quality specifications and standards for herbal materials, labelling, and licensing programs for imports, manufacturing, and marketing are examples of quality assurance and control measures that should be in place in any nation that regulates herbal medicines. To ensure the efficacy and safety of herbal medications, several precautions are essential. Poor monitoring and quality control measures can lead to a high rate of unfavourable reactions linked to subpar herbal medication, specifically when strong ingredients are hidden or tainted with potentially dangerous compounds and residues. Compared to conventional pharmaceuticals, the standards and procedures for quality control of finished herbal products are significantly more complicated, especially when it comes to mixed herbal products. The Caliber of the raw material employed affects the caliber of these items. Thus, it is crucial to follow proper farming and gathering procedures for medicinal plants, which include careful plant selection and cultivation. Since most herbal products are unregistered, quality control of ethno traditional medicines is distinct and raises concerns about public health.^26,27

c) Safety monitoring:

In wealthy nations, the use of complementary and alternative therapies is rising quickly. Concerns regarding the security, caliber, accessibility, preservation, standardization, and future growth of this health care system are shared by policy makers, medical experts, and the general public worldwide. Most nations have developed a pharmacovigilance system as a result of various concerns over the safety of traditional herbal medications. Studies on side effects and drug interactions are most frequently found in clinical trials and unplanned reports. Providers of herbal remedies who are not doctors, dentists, pharmacists, or nurses are often left out of reporting systems. In order to get sufficient coverage of herbal medicines, national reporting schemes pertaining to traditional, complementary, and alternative medicine providers as well as herbal medicine prescribers and dispensers should be created, taking into account national specifics. Customers' participation in the use of herbal goods and medications in healthcare, as well as their worry about potential side effects, should be highly recognized. Customer reports of negative reactions ought to be acknowledged as a valuable informational resource that can aid in the detection of indicators for unidentified effects of herbal remedies.^28,29

WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems:

According to the WHO safety play principal role in the provision of phytomedicines for health care and it is the one of the critical cares of quality evaluation of phytomedicines. The WHO guidelines have given the practical guidance for the monitoring safety of phytomedicines. The observation of herbal medicine safety is currently controlled by WHO international drug monitoring programme. The WHO have included the phytomedicines in the system of pharmacovigilance and promoted the growing use of herbal preparations and phytomedicines worldwide. We have worldwide the large consumption of phytomedicines and hence it is essential to identify and report the risks related with use of phytomedicines. Many phytomedicines are administered along with other modern medicines and hence it is required to study the interaction and the consequences of such administrations and monitor for the cause of any adverse effects.^30,31

The main objectives of WHO guidelines are ³²:

· To assist member states in strengthening national pharmacovigilance and ensuring efficient safety monitoring of phytomedicines within the framework of the worldwide drug monitoring program.

· To encourage safe use and marketing of phytomedicines.

· To promote the establishment of system for national drug safety monitoring in phytomedicines.

· To give standard definitions and terminologies related to pharmacovigilance, adverse effects and safety monitoring of phytomedicines.

· To support and strengthen the exchange of information and information on the different member states' pharmacovigilance and safety monitoring programs for phytomedicines.

· To give in detail technical support on the principles for good pharmacovigilance.

Pharmacovigilance and WHO International Drug Monitoring Programme:

The scientific process and activities connected to the discovery, assessment, understanding, and prevention of adverse events or any other potential problems associated to medications are known as pharmacovigilance. Pharmacovigilance's primary objectives are:³³

· To enhance patient safety and care, particularly with regard to drug usage and related medical and paramedical procedures.

· To enhance the safety of medications and public health in relation to their use.

· To encourage the safe, sensible, and efficient use of pharmaceuticals and medicines as well as to assist and contribute to the evaluation of their efficacy, risk, and benefit.

· To advance public awareness of pharmacovigilance, education about it, clinical training in this area, and the efficient dissemination of information to consumers and the general public.

The science of pharmacovigilance is mainly deals with following:

· Adverse effects or reactions

· Medication errors or related problems

· Lack of efficacy reports on drugs

· Substandard medicines or medicinal products

· Reports of both acute and persistent poisoning cases.

· Evaluation of medicines related mortality

· Abuse and misuse of drugs

· Use of drugs or medicinal products for indications which are not approved

· Adverse interactions of drugs with chemicals,

· Adverse interactions of one medicine with other medicines

· Adverse interactions of drugs with food.

The science of pharmacovigilance is applicable to mainly following:

· Drugs or medicines of any origin

· Traditional or complementary medicines

· Herbals

· Vaccines.

· Blood products

· Biological products

· Medical devices

Herbvigilance:

Is the pharmacovigilance of herbal medicines. The assessment of adverse effect and its reporting caused by phytomedicines is very much essential. In order to generate the pharmacovigilance data the information provided by patients and other healthcare systems play great role. The company who are involved in the manufacturing of phytomedicines and herbals should carry out a comprehensive pharmacovigilance and safety audit to evaluate the compliance products with regulations, guidance and worldwide laws.³⁴

Pharmacovigilance of Phytomedicines in India:

The use of herbs or plants as medicines for treatment and prevention of disease or disorders began over 4000 years ago. Plants are used in traditional medical systems and are crucial to the healing process. The correct administration of dose of a drug also very important in traditional system of medicines as the adverse effect of medicinal preparations may occurs due to the misuse and incorrect administration of wrong species of herbs, errors in the use of phytomedicines, interactions with other medicines and administration of medicines contaminated with impurities or hazardous components such as agrochemical residues, toxins, metals and pathogens.³⁵ The use of traditional systems of medicine is expanding continuously across the world. Many drugs and formulations originated from ASU systems of medicine are consumed as well as prescribed as over the counter medicines. They are selling the Ayurveda and related systems of medicine at different levels of health sector. Hence the need of rationalization is a great requirement for assessing and monitoring the safety of such medicines along with its efficacy. The traditional systems of medicine are considered to be safest but few adverse reactions were reported in literatures which are arising may be due to the improper use, use without proper prescription, continues use of preparation without need. Hence there is great demand of providing database for the safe use of traditional preparations in modern world. The adverse events of herbal medicines have been reported due to the improper administration, poor quality control of preparations, internet sales of medicines, number of uncontrolled distribution channels and deficiency or inadequate regulatory measures or lack of control on manufacturing of phytomedicines. The efficacious and safe use of traditional preparations is mainly based on the quality of raw materials used, method of preparations, quality control and standardization methods. Hence during manufacturing of herbal preparations proper care should be taken by following various related guidelines on its manufacturing. Good dispensing practices should be followed or ensures the effective form of the medicines and drugs are delivered to the right consumer in proper dose along with proper and clear instructions. Critical observations made on marketing of traditional systems of medicine indicates that the container or package of medicine do not contain the required or necessary mandatory information. The clinical effectiveness of drug is mainly based on proper and correct administration of medicine and hence it should be mentioned in the package or containers or leaflets. When it comes to Ayurvedic medications, each medication should be taken according to precise instructions that are sent to the patients through the systems. It is also mandatory that the practitioner or physician having proper and concrete knowledge of theory, principles and adequate practices or experiences of his or her own systems of medicine prescribe the related medicines.³⁶

Need of Pharmacovigilance in Phytomedicines:

Pharmacovigilance play very important and essential role in the phytomedicines. Reporting of adverse reactions of herbs and phytomedicines is grateful task. In order to provide consistency in reporting the adverse reactions the WHO has recommended the centre for international drug monitoring. They use the proper scientific binomial names for plants used in medicine. Systematic reporting of adverse reactions helps to ensure and compare the reports submitted by various international pharmacovigilance databases. Pharmacovigilance helps the researchers to recognize the particular product, the dosage used, the manufacturer's information, and the exact component.³⁷

Adverse Effects in Phytomedicines:

Adverse effects can be defined as the unintended and noxious response to a marketed medicinal preparation or product of any origin which may occurs at the normal dose during use of it for the treatment, prevention or diagnosis of diseases or disorders.³⁸ It was observed that adverse effects are found to be more in the synthetic medicines as compare to the medicines from natural origin. But in the traditional practice many ASU drugs are found to be observed that they are prescribed along with or taken by patient in combination with other modern medicines and this may leads to adverse drug reaction. Natural source especially medicinal plants have very essential and great role in the development of modern medicines. The use of plant medicines along with other modern medicine may generate some adverse effects as the plant products are found to possess many phytoconstituents which may interact with other modern drugs when used in combination. The database of WHO confirmed and reported more than 16000 suspected adverse effects and case reports are mainly related to use of phytomedicines. Safety of phytomedicines is very important as many of such preparations may causes severe adverse effects or reactions. Many herbal preparations with their continues use may leads to kidney damage. Misidentification of species or plant materials and its consumption for therapeutic use may show some other adverse effects. Some herbal products were reported to possess corticosteroid like effects due to the presence of Betamethasone.³⁹ The administration of phytomedicines with interferons leads to severe or sometime interstitial pneumonia. The administration or use of Ginkgo biloba reported to cause of prolonged coagulation time and also subcutaneous hematomas and intracranial haemorrhage. The investigation of adverse reaction of phytomedicines after its post marketing is also very much essential for pharmacovigilance of herbal drugs. Hence it is very much essential to identify and report the various adverse effects or reactions which are mainly related to the use of phytomedicines for its modernization and safety use in worldwide. It is unique and great challenge for all the practitioners, physicians, researchers, health care workers and regulators to identify and report the adverse effects of phytomedicines.⁴⁰

Reporting of Adverse Effects:

Reporting adverse reactions or adverse effects is very important and submitting proper and correct information helps regulators to prepare and analyse the database. WHO collaborating centre for international drug monitoring has suggested that the use of suitable scientific binomial names for plants used in medicine in the coding of reports of adverse reactions. The WHO guidelines help to ensure the comparable difference between reports from different international databases of pharmacovigilance system.⁴¹ The quality of reporting the adverse reactions or adverse effects depends on reporters and also what types of data are going to report for assessment. It is also necessary to maintain order and consistency in the naming of plants in reporting of adverse effects.⁴² The authors who are publishing data of adverse effects of specific product in case reports he should be very careful about identity of product, manufacturer information, label and specific component, and dose of medicine. Published case reports of phytomedicine toxicity have identified misidentification of plants as a possible source of confusion. In order to document the adverse reactions various pharmacovigilance centers has been set up throughout country which include: National Pharmacovigilance Centre (NPC), Regional Pharmacovigilance Centers (RPC) and Peripheral Pharmacovigilance Centers (PPC).⁴³

Reporting Adverse Effects of Herbal Medicines in India:

In India adverse reactions or adverse events of Indian systems of medicine were reported through the programme known as national pharmacovigilance programme. By considering the value and importance of drug safety, the department of AYUSH, Ministry of Health and Family Welfare has launched this programme.⁴⁴ The protocol for reporting adverse reactions related to drugs has been developed through National Pharmacovigilance Programme for ASU (NPP-ASU) drugs and published by the department of AYUSH. They have collaborated with WHO in the development and publication of protocol.⁴⁵

The main objectives of this programme are:⁴⁶

· To achieve proper documentation of adverse reaction

· To regulate the activities of pharmacovigilance

· To monitor and control various activities of pharmacovigilance.

The national pharmacovigilance resource center for India is the Institute for Post Graduate Teaching and Research in Ayurveda at Gujarat Ayurved University in Jamnagar. Poor quality assessment of traditional medicines and formulations, incorrect use, and inadequate regulations on manufacturing procedures account for the bulk of adverse reactions recorded under the national pharmacovigilance program for pharmaceuticals derived from Siddha, Unani, and Ayurveda.⁴⁷

Table 2: Adverse Effects of Some Herbals

Plant Name	Adverse Effects
Alfalfa	Induces systemic lupus erythromatosus and related syndromes.
Aloe vera	Long term use causes potassium deficiency.
Ephedra	Restlessness, irritability, hypertension and arrhythmias.
Ginkgo biloba	Long term use leads to increase in bleeding time, hemorrhage.
Ginseng	Hypertension, mastalgia and blood clotting.
Ispaghula	Asthma, bronchospasm.
Liquorice	Edema, hypertension.
Senna	Long term use leads to problems of heart, grand mal seizures and hypertension.
Sassafras	Long term use leads to liver toxicity.
Aconite	Cardiac complications, neuralgia.

Role of Pharmacists in Identification and Reporting of Adverse Effects of Phytomedicines:

Pharmacists have a very essential role in identification and reporting adverse effects of phytomedicines as they are literally experts on drugs of synthetic, semisynthetic and natural origin.⁴⁸ Pharmacists are working in various fields and levels which include community pharmacy environments, hospitals, industry, research and academia, and regulation and hence they are exposing themselves to various aspects about phytomedicines which helps them to identify adverse effects and report the same.⁴⁹ Many pharmacists are working in hospitals and hence they can face events related to adverse drug reactions or other phytomedicines related problems. Pharmacists also going through an extensive education, literatures, practices and facts associated with phytomedicines and he or she can easily identify the adverse effects of phytomedicines. Many phytomedicines and their constituents may interact with other drugs and leads to adverse events which can be identified at level of pharmacists at different levels. Many patients found to have insufficient knowledge about administrations of drugs including phytomedicines which may leads to generation of adverse effects which can be identified by pharmacist by effective communication. WHO has prepared in detail guidelines on monitoring of phytomedicines in the pharmacovigilance systems which can be studied by pharmacist to identify such events related to phytomedicines.⁵⁰

Safety Monitoring of Phytomedicines

Sources of Information on Adverse Effects:

The common sources of data on adverse effects related to drugs are:⁵¹

· Physicians or practitioners

· Clinical trial

· Spontaneous reports (Mainly by voluntary and unsolicited communications on marketed preparations)

· Patients or consumers

· Manufacturers of medicinal products

· National poisonous centers

· Drug information centers

· Clinical trials centers

· Clinical research organizations.

In order to collect the information on safety of phytomedicines national reporting scheme should be developed to include both dispensers and prescribers. The quality reporting of adverse effects at international level is depends on the post marketing safety survey which is again depends on voluntary reporting of events by various health care practioners and other workers. The pharmacist working at community level and also nurses play essential role in the monitoring the safety issues related to non-prescription drugs.⁵²

The information provided by consumers regarding adverse events is considered and valued positively and also consumer reports on the adverse events should be accepted as one of the serious sources which may help for identification of signal for the unknown effects of phytomedicines. The consumer source play great role in the identification of adverse events associated with nonprescription herbal products as consumer is only one source of reporting adverse events in this case. Manufacturers of particular herbal medicinal product are one more source for collecting information on adverse effects of their own products. National poisons centres play essential role in pharmacovigilance and safety monitoring of phytomedicines.⁵³

The drug information centres can also offer helpful details about the side effects of medications. The national pharmacovigilance centres must to maintain effective communication with other pharmacovigilance and drug safety monitoring centres. One excellent source of information on adverse reports or case reports of pharmaceutical preparations is clinical organizations' trials and research. A herbal product's pharmacovigilance studies should take into account its classifications⁵⁴

Reporting of Suspected Adverse Reactions:

The national pharmacovigilance center mainly consists of a network of regional and national centers to collect information on adverse effects. The reports should be sent to the respective centers in the proper format in accordance with particular national reporting scheme. Various health professionals, providers of phytomedicines, pharmacists, doctors and nurses should be responsible for reporting of adverse events to the national pharmacovigilance centre. In general, consumers should report to their practitioners first.⁵⁵ From there, they can report directly to manufacturers, consumer organizations, or the national pharmacovigilance center. Producers should notify the national regulatory body or the national pharmacovigilance center directly if they become aware of any adverse effects.

Following information normally reported or provided while reporting adverse reactions:^56,57

· Patient's age, gender, and medical history

· Details of suspected medicine.

· Administration details including dose and quantity administered, formulation and route of administration

· Indication for its use

· Adverse reaction data including:

§ Date of onset

§ Duration from first administration to onset of effect

§ Signs and Symptoms

§ Medicines used along with administration details.

§ Seriousness,

§ Results of clinical investigations and tests

§ Severity

§ Risk factors

§ Name and address of reporter.

It is acceptable to use the electronic or standard printed report form to report the adverse effects to various centers. The adverse reports also can be accepted by telephone, letters and e-mails. If possible the sample of phytomedicines along with its packaging information should be submitted with report to the pharmacovigilance centers. If reporter has no or lack of knowledge regarding how to report adverse events then it is advisable for him or her to design the form in any way. The coding and recording the identity of phytomedicines should be done by using standard classification and coding systems. The reporting of adverse effects of herbal products should be complete and accurate. The identity of patient and the reporter should be remains kept confidential.⁵⁸

Challenges in Monitoring the Safety of Phytomedicines

The various challenges associated with monitoring the safety of phytomedicines include:^59,60

· The registration of phytomedicines is different from country to country.

· Lack of regulation on the phytomedicines categorized other medicines and foods and also weak quality control processes and loose distribution or marketing channels.⁶¹

· National regulatory authorities do not receive all regulatory information on phytomedicines, and neither do national regulatory authorities and national safety monitoring or pharmacovigilance centers.

· Lack of post-marketing safety survey on phytomedicines.⁶²

· Poor regulation on the quality assurance and quality control of phytomedicines

· Lack of quality standards and specification for phytomedicines, labeling and licensing for manufacturing, good manufacturing practices for herbal products, imports and market of herbal products.⁶³

Future Prospective in Pharmacovigilance of Herbals and Phytomedicines.

The science of pharmacovigilance is very much essential and needed in the Indian systems of traditional medicine to ensure patients safety. The practice of pharmacovigilance should be followed in following areas and components:⁶⁴

· Need to explore the practice of pharmacovigilance in ASU systems of medicine.

· There is need of increasing and strengthening the education, training and publicity mainly related to pharmacovigilance of medicines.⁶⁵

· There is need and scope in communicating and disseminating the safety information on phytomedicines to identify the nature of adverse drug reactions.

· There is need of preparing the international database for adverse reactions in future.

· Need to support and motivates the pharmaceutical and herbal drug manufacturers for the post marketing surveillance and risk management of ASU drugs.

· There is need of promoting the rational use of ASU drugs. ⁶⁶

In order to guarantee patient safety in traditional Indian medical systems, the science of pharmacovigilance is very necessary. The following domains and elements should adhere to the Pharmacovigilance practice.

Research on pharmacovigilance in ASU medical systems is necessary.⁶⁷

· Education, training, and publicity pertaining primarily to medication pharmacovigilance need to be expanded and reinforced.

· To determine the type of adverse drug reactions, there is a need and opportunity for sharing safety information about herbal remedies.

· The global database needs to be ready for potential negative responses.

· It's important to encourage the judicious use of ASU medications.⁶⁸

CONCLUSION:

In order to maintain the advantages of conventional therapeutic methods while ensuring public safety, the subject of pharmacovigilance for herbal medicines is crucial and becoming more complex. This review emphasizes the need for strict and customized pharmacovigilance approaches by highlighting the particular difficulties brought about by the inherent unpredictability and lack of standardization in herbal products.

Strong regulatory frameworks, interdisciplinary cooperation, and the integration of traditional knowledge with contemporary scientific methods are necessary components of efficient pharmacovigilance systems for herbal products. In order to be successful in this attempt, healthcare personnel must actively participate in identifying and reporting adverse occurrences, and public awareness must be raised. Pharmacovigilance efforts will be much more reliable if extensive databases are established, data collection and interpretation methods are improved, and a safety monitoring culture is promoted.

We can conclude that the advantages of herbal medications are maximized while limiting hazards by addressing the difficulties and utilizing our collective expertise. In this way, we can protect public health in a world where natural remedies are becoming more and more popular.

CONFLICT OF INTEREST:

The authors declare that they have no conflict of interest.

ACKNOWLEDGMENT:

The authors thank Principal, KLE College of Pharmacy Belagavi, for all the support to complete this review.

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Received on 21.10.2024 Revised on 15.11.2024

Accepted on 30.11.2024 Published on 10.12.2024

Available online on December 17, 2024

Asian J. Res. Pharm. Sci. 2024; 14(4):407-417.

DOI: 10.52711/2231-5659.2024.00064

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