INTRODUCTION:

Adverse drug reactions (ADRs) are one of the major problems associated with drug. effectiveness and success of any pharmacovigilance program relies heavily on the participation of all health professionals. The World Health Organization (WHO) defined ADR as any response to a medicine that's noxious and unintended, and that occurs at boluses used in humans for prophylaxis, opinion, or remedy, banning failure to negotiate the intended purpose.

ADRs are responsible for a significant number of sanitarium admissions ranging from 0.3 to 11^1-2. It's imperative to cover ADRs in order to minimize or help detriment to cases arising from their medicines, to descry ADRs before they're clinically manifested, and to gain much further knowledge to insure safe operation of medicines. Pharmacovigilance is a part of patient care and patient safety that ensures the stylish use of drugs for the treatment or forestallment of adverse medicine responses³. According to WHO pharmacovigilance is the wisdom and conditioning relating to the discovery, assessment, understanding and forestallment of adverse goods or any other medicine- related problem^4-5. Numerous checks are conducted to estimate the mindfulness and understanding of adverse drug reaction (ADR) reporting by druggists.

The significance of reporting serious ADRs was rated advanced than for mild ADRs voluntary reporting of suspected adverse drug reactions is honored worldwide as an important means of covering medicine safety, immaculately furnishing signals for relating problems not detected during clinical trial⁶. Adverse Drug Reaction can be define as “an appreciably dangerous or unpleasing response, performing from an intervention related to the use of a medicinal product, which predicts hazard from unborn administration and clearances forestallment or specific treatment, or revision of the dosage authority, or pullout of the product” Adverse drug reactions are classified into six types (with mnemonics) cure- related (stoked), non-dose-related (crazy), cure- related and time- related (habitual), time- related (Delayed), pullout (End of use), and failure of remedy (Failure). operation includes pullout of the medicine if possible and specific treatment of its goods. Suspected adverse medicine responses should be reported. Surveillance styles can descry responses and prove associations⁷.

Pharmacovigilance is a practice aimed to cover medicinal safety in real life conditions and captive adverse drug effect during the post marketing phase of drug’s life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. As per available scientific literature, the major impediments to ADR reporting are inadequate knowledge and observation among health professionals, clinicians, perceptions towards reporting, problems with establishing reporting systems in hospitals and shy training to fete ADR’s. There are certain Measures to enhance the situation include advanced involvement of nursers, druggists as well as consumers in the reporting of ADRs, making the process simpler and faster through electronic means, introducing educational interventions and training programs for health care providers and spreading knowledge about the reporting system amongst caregivers and receivers likewise. Giving a boost to the pharmacovigilance system and guaranteeing a robust reporting process is a challenge but proper planning, attainable results and concentrated sweats can help bring about the change assuring patient safety – the ultimate ambition of pharmacovigilance⁸. Adverse drug reaction (ADR) rates in clinical trials constantly understate those in trial.

Post-marketing surveillance is employed to help overcome the limitations in ADR identification in clinical trials. These arise from multitudinous factors including in respectable sample size, limited trial duration, limited range of assessed issues, and relative rejection of precisely those cases most likely to witness adverse goods, analogous as the elderly and those with poly drugstore -morbidities. Because of analogous factors," the challenge of early discovery (of ADRS) has largely shifted to post marketing systems," which seek to capture' real- world' ADR geste and are a major medium undergirding drug recessions. Post marketing surveillance" provides vital information of clinical significance," it may lead to the identification of new ADRS, and may modify knowledge about known ADR’s. ADRs are a pervasive global problem and a significant contributing factor to morbidity and mortality responding in preventable medical centres admissions and gratuitous medical costs.

Administration of ADRs is essential to patient safety and healthcare quality. In the United States (US), ADRs have been associated with as multitudinous as, deaths per time and are the seventh most common cause of death in Sweden. Attestation from a organized review of ADRs in an acute care setting showed that one in ten medical centre’s admissions in the elderly were due to ADRs. A regular review and meta- analysis of 39 US predicated prospective studies reported that hospitalizations due to serious ADRs ranged from1.0 to16.8, while another review of 22 experimental studies reported that ADR- related hospitalizations in European countries ranged from0.5 to 12.8⁹. Adverse drug reactions (ADRs), will continue to pose a trouble to public health as long as specifics are being used to treat varied affections. Prompt ADR reporting is critical in assuring medicinal safety. The thing of this narrative research was to emphasize the part of druggists in pharmacovigilance and to identify walls and facilitators toward ADR reporting proved in the literature. The perspective of drugstore scholars on pharmacovigilance and ADR reporting has also been bandied with an idea to emphasize the need to enhance content related to ADR reporting and pharmacovigilance in undergraduate drugstore class.

Generally, although the part of druggists within public pharmacovigilance systems varies, it's actually well fete. In general, pharmacists admit that ADR reporting is part of their professional responsibility and have a positive station toward reporting ADRs. Still, current disquisition evidence suggests that there are still critical knowledge gaps with regard to ADR reporting among druggists, especially in countries where the part of pharmacists within the health care system is limited. These knowledge gaps can be fulfilled through continuous professional development programs and supporting theoretical and practical knowledge in undergraduate drugstore institutes. Without adequately relating and fulfilling training conditions of chemists and other health care professionals, the effectiveness of public pharmacovigilance systems is doubtful to enhance which may compromise case safety¹⁰.

ADRs reporting methods:

Currently, there are mainly two methods through which ADRs are collected and processed further after due scrutiny of a particular ADR. These are passive and active surveillance methods. The brief descriptions about these methods with subcategories are discussed below¹¹.

1 Passive surveillance:

1.1 Spontaneous reporting: - Spontaneous reporting method is a voluntary reporting of suspected ADRs by the healthcare professionals or an individual to the ADR monitoring Centre, company, regulatory authority or other organization. It plays a significant role in the identification of safety signals after the launch of medicines in the market¹².

1.2 Cohort Event Monitoring (CEM): - It is complementing to the spontaneous reporting method which is known as prospective, observational, cohort study of ADEs associated with single medicine or group of medicines. It is an interview-based method where patients are interviewed before and after the treatment procedure thus providing early warning signs of the medicines used in the clinical testing¹³.

1.3 Targeted Spontaneous Reporting (TSR):- The targeted spontaneous reporting methodology proposed by WHO in 2010 that builds on the principles of spontaneous reporting system. Health professionals manage a well-defined group of patients in this methodology system. The main aim of TSR is increase reporting rate by targeting, training and mentoring the ADRs reporters especially nurses, pharmacists, and patients as well¹⁴.

1.4. Stimulated reporting: - The aim of a stimulated reporting system is to inspire and accelerate the healthcare professionals to report ADRs in specific circumstances. It encourages on-line reporting of and methodical motivation of ADRs reporting according to the pre-designed method. It is helpful in generating and preparing spontaneous reports of adverse drug events identified at an early stage of post-marketing phase¹⁵.

1.5 Case series: It is a theoretical methodology which provides a relationship between a medicine and an adverse drug related event. It is profoundly valuable in developing theories without providing strong evidence about post-marketing medicine exposure and its result¹⁶.

2 Active surveillance method:-

2.1 Sentinel site: - In the active surveillance method, an observation is done to get data of ADR from medical records patients and practitioners. This method gives specific data from specific groups and sub-groups of patient, drug abuse etc. which is in passive surveillance a little bit difficult. It is carried out at institutions, nursing homes and hospitals etc. for patients who are taking orphan drugs. This method is useful for observation of adverse drug events¹⁷.

2.2 Drug Event Monitoring: It is the procedure of active surveillance where electronic prescription data or health insurance claims are used to identify the patients. Further, demographic information of the patients, treatment details such as indication for treatment, duration of treatment, dosage, clinical manifestations, and reasons of discontinuation, if any, are collected through questionnaires sent to physicians and patients at specified intervals¹⁸.

2.3 Cohort study: In cohort study patients are monitored over the time to record the occurrence of the disease or event in a population who are at risk for the disease or event. Information on exposure status of medicine is accessible during the follow- up for each patient and each time span. At the same time the population exposure of medicine during follow-up is acknowledged and incidence rates can be calculated. A cohort of interest (special population) is selected on the basis of concerning medicine exposure and monitored over time, in many cohort studies. These studies are useful when it is required to know the prevalence rates of adverse events with relative risks and many ADRs can also be examined utilizing the same data source under the study¹⁹.

ADR REPORTING PROCEDURE:

· Who can report?

· What to report

· How to report

· Whom to report

· Where to report

· Who can Report?

· All healthcare professionals (clinicians, Dentist, Pharmacist, Nurses, Physicians, etc)

· All non-healthcare professionals including consumers/patients etc. can report ADR’s.

· What to Report?

· All types of suspected adverse reactions

· Known or unknown

· Serious or Non-serious and

· Frequent or rare

· Reactions from all types of pharmaceutical products

· Allopathy

· Ayurvedic

· Vaccines

· Medical devices

· How and Whom to Report?

· Use the 'Suspected Adverse Drug Reaction Reporting Form/ Medicine side effect Reporting form which are available on the official website of IPC (www.ipc.gov.in) to report any ADR

· Filled ADR form submitted to nearest ADR Monitoring Centers (AMCS) or directly to the NCC-PvPI.

· A reporter can also email the Suspected ADR form at pvpi@ipcindia.net or pvpi.ipcindia@gmail.com.

METHODOLOGY:

A cross sectional study was conducted in which a validated self-administered questionnaire which was made with the help of Professor from our college and some article and was distributed to 20 pharmacists in the Amravati. This cross-sectional questionnaire based observational survey contained 25 questions. The questionnaires were filled by the respondents and returned back to us within the next 10 min. Data obtained from filled questionnaires were thereby analysed.

Design of the study is as:

1. Questionnaire was prepared based on the topics such as Pharmacovigilance, basic ADR knowledge, process of reporting an ADR and some related to personal views of the pharmacists on ADRs

2. Questionnaire survey forms were finalized and printed.

3. All the medical stores were physically visited by us and the views of the pharmacists were collected on the survey forms.

4. The response was collected in the type of YES or NO or MAY BE responses.

5. The collected data was evaluated.

The parameters for the preparation of the questionnaire are as follows:

1. Pharmacovigilance perspective:

• Whether the pharmacist is aware of the basic information of pharmacovigilance and about

• Pharmacovigilance and its purposes

• National Pharmacovigilance Programme in India

2. Adverse Drug Reactions basic knowledge:

• About ADR’s and Adverse Events

• New techniques used in finding ADRs

• Helpline No of ADR reporting office

3. Awareness about ADR reporting:

• Whether the pharmacist is trained to report an ADR.

• Whether, how to identify an ADR.

• Whether ADR reporting should be made mandatory in Pharmacist profession.

• Most common type of ADR.

4. ADR reporting practice in the profession:

• Pharmacist is one of the most important health care professionals to report ADRs.

• Whether training is needed to report an ADR.

• Whether involved in treatment decisions.

Field Work:

A questionnaire was made by us containing 25 questions to carry out a survey of Adverse Drug Reactions awareness among the pharmacists. Here the questionnaire provided to the community pharmacist is as follows.

Questions:

1. Do you know about pharmacovigilance and its purpose?

2. Do you know the existence of a National Pharmacovigilance Programme in India?

3. Do you know about Adverse drug reaction?

4. Do you know about Adverse events?

5. Do you know the difference between Adverse drug reaction and Adverse Event?

6. Do you know how to identify Adverse drug reaction?

7. Do you know which new techniques are used in finding Adverse Drug Reaction?

8. Do you know how and where to report an Adverse drug reaction to an authorized person or in ADR center?

9. Do you know about help line number of ADR office or where it located?

10. Do you have been trained how to report an ADR?

11. Do you keep a written record of patient feedback about ADR’s they came across?

12. Do you think there is a lack of time to fill-in an ADR report?

13. Do you experienced adverse drug reaction during your professional practice?

14. Do you believe all drugs available in market are safe?

15. Whether all suspected ADR’s are associated with drug - drug interactions?

16. Were you involved in the treatment decisions?

17. According to you the most common type of ADR are reported?

18. Do you think training is needed in reporting an ADR?

19. Do you think it is necessary to confirm that an ADR is related to a particular drug before reporting it?

20. Do you think that it is necessary to report only serious and unexpected ADR?

21. All serious ADRs are well-documented before marketing?

22. Pharmacist is one of the most important health care professionals to report ADRs?

23. Do you think ADR reporting should be made mandatory in my profession?

24. With your present knowledge, you are very well prepared to report any ADR’s report in my future practice?

25. Is suspected ADR Reporting form was found to be simple and clear to you?

RESULT AND DISCUSSION:

This is the first study conducted by us to evaluate and compare Information and Vision regarding awareness of pharmacovigilance and ADR reporting among community Pharmacists in Amravati District. In the current study, a total response rate of 100% was recorded. From the results, it was noted that overall in our research, Knowledge and Opinion was better among the Young Pharmacists compared to the elderly ones. As they were students of Pharmacy once, this is not surprising as pharmacy students are exposed to all the basics features of pharmacovigilance in their syllabus during the academic years. It was also evident in the knowledge-based research question to the community pharmacist and they were found to know more about pharmacovigilance and basic common ADR's reporting a reaction. This is because they are taught about identification, testing, understanding and preventing drug reactions to some degree in their syllabus.

The survey was questionnaire based in which questions is divided into five phases viz: Basic Knowledge about Pharmacovigilance Basic knowledge of Adverse Drug Reaction, Reporting of ADR's Awareness based, Pharmacists personal views.

Total 20 medical stores were included in the survey and visited personally for the one-to-one interaction with the respective Pharmacist. The form was filled signed by the Pharmacist and then only collected .This survey gave an idea of the knowledge of the Pharmacist regarding Adverse Drug Reactions (ADR's) and Pharmacovigilance During the survey it was found that some Pharmacist were unaware and lack of basic information regarding the reporting of an ADR, while some of them were found to be aware and knew the process of reporting an ADR and were found to be cooperative in nature and willing to share their views and information according to their experience. The Pharmacist who were unaware were provided the basic information about ADR reporting and tried to encourage them to report an ADR. During the survey we also came across some barriers with the Pharmacists, they were as follows:

· Non-cooperative nature of the pharmacists.

· Feeling hesitation due to lack of knowledge.

· Not willing to expose the identity.

· Giving excuses such as lack of time.

Figure 1: Pharmacist Awareness about Pharmacovigilance

Figure 2: Pharmacist Awareness about ADR

Figure 3: Pharmacist perspective

Figure 4: Pharmacist Awareness among pharmacist about Pharmacovigilance, ADRs and Reporting in Amravati District

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Received on 19.04.2023 Modified on 16.07.2023

Asian J. Pharm. Res. 2024; 14(1):39-44.

DOI: 10.52711/2231-5691.2024.00006