|Year : 2023 | Volume
| Issue : 1 | Page : 64-79
Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals: A Step towards Patient Safety
Vandana Roy1, Vandana Tayal1, Ijasul Haque1, Jamshed Ahmad2, Kavita Verma2, Virendra Singh2
1 Department of Pharmacology, Maulana Azad Medical College, New Delhi, India
2 ADR Monitoring Center, Department of Pharmacology, Maulana Azad Medical College, New Delhi, India
|Date of Submission||04-Aug-2022|
|Date of Decision||20-Dec-2022|
|Date of Acceptance||05-Mar-2023|
|Date of Web Publication||28-Apr-2023|
Head, Department of Pharmacology, Maulana Azad Medical College, New Delhi 110002
Source of Support: None, Conflict of Interest: None
Introduction: Pharmacovigilance plays an important role in patient safety and rationalizing the use of medicines. It helps in identifying the frequency of adverse drug reactions (ADRs), their causes, and the associated risk factors. Pharmacovigilance activities are facilitated through adverse drug reactions monitoring centers (AMCs) in most of the institutions. Aim: The objective of this paper is to provide an overview to the health care professionals regarding ADRs reported from the associated hospitals of Maulana Azad Medical College (MAMC) and the pharmacovigilance activities undertaken. Observations: Maulana Azad Medical College, Department of Pharmacology was recognized as an AMC in 2014 under the Pharmacovigilance Program of India (PvPI). The AMC established a way for reporting ADRs both by spontaneously and through active monitoring of ADRs from different wards. The causality assessment of all ADR reports collected is done. The program was informed by a college pharmacovigilance committee, emails, and by putting posters in the hospital nursing stations. Fourteen training workshops for doctors and pharmacists and two training workshops exclusively for nurses have been conducted so far on pharmacovigilance. In 2017, a program to sensitize doctors working in the Delhi government hospital was started. A total of 854 healthcare workers have been sensitized. The center has reported a total of 2572 ADRs to the National Coordination Centre (NCC) at Indian Pharmacopoeia Commission until December 2021. ADRs reported were highest in the age group of 20 to 59 years. Most of the reports were from the department of T.B. and Chest (n = 589, 23.8%). The most common class of medicines implicated in causing ADRs was antimicrobials (n = 1100, 44%). Among the ADRs reported, the majority were mild (n = 1451, 81.1%) with 346 (18.8%) reported as serious. Conclusion: A system for reporting ADRs on campus has been established. The pattern of ADRs reported to this ADR monitoring center is comparable to the national and global data. Hospital-based ADR monitoring and reporting programs are very crucial to identify and quantify the risks associated with the use of medicines. The pharmacovigilance program at MAMC is a commitment and a small step towards patient safety.
Keywords: Adverse drug reactions, patient safety, pharmacovigilance
|How to cite this article:|
Roy V, Tayal V, Haque I, Ahmad J, Verma K, Singh V. Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals: A Step towards Patient Safety. MAMC J Med Sci 2023;9:64-79
|How to cite this URL:|
Roy V, Tayal V, Haque I, Ahmad J, Verma K, Singh V. Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals: A Step towards Patient Safety. MAMC J Med Sci [serial online] 2023 [cited 2023 Jun 6];9:64-79. Available from: https://www.mamcjms.in/text.asp?2023/9/1/64/375333
| Introduction|| |
Medicines are used to help patients get cured and improve their health. Notwithstanding this, it is a fact that adverse events resulting from medicines themselves can cause morbidity and mortality. They are among the top four causes of mortality. Adverse drug reactions (ADRs) are a cause of hospital admissions, prolonged hospital stays, and deaths. Inpatient hospitalizations due to ADRs have ranged from 4.8% in Germany, 6.5% in UK to 7.3% in USA. Up to 6.5% of all admissions in a United Kingdom hospital were related to ADRs with an overall fatality of 0.15%. Studies have predicted that 2.4% to 30% of hospitalized patients may experience an ADR during their hospital stay., In a recent meta-analysis, the prevalence of fatal ADR varied from 0% to 5.2%., Loss of economic resources and adverse effects on quality of life are other consequences of ADRs.,
Studies conducted in India have estimated the incidence of suspected ADRs to be nearly 2% to 3% among hospitalized patients. A systematic review estimated the median incidence of ADRs that led to hospitalizations and those that developed during hospitalization as 2.85% and 6.34%, respectively.
Depending upon the size of health care facilities, the annual costs of adverse drug events have been estimated to be up to $5.6 million per hospital. The total cost of management of drug related events in a tertiary care public sector hospital was INR 17,37,339 (Euro 30,215) and the projected cost of management in a private sector hospital was estimated to be INR 63,63,872 (Euro 1,01,676).
Studies have indicated that more than half of ADRs are preventable.,
Public sector hospitals have huge patient loads with disproportionate doctor patient ratios. The focus and attention of the healthcare provider are on the patients getting well. Other issues related to medicines and “Patient Safety” may not get the attention they deserve.
Pharmacovigilance is defined as the science and activities related to the detection, evaluation, understanding, and prevention of ADRs or any other drug related problems. Pharmacovigilance plays a crucial role in the surveillance of ADRs. The main objective of ADR monitoring is to assess the quality and frequency of ADRs and identify the risk factors that can cause the adverse reactions. Because many ADRs are preventable, therefore these data can be used for improving patient safety in hospitals.
The World Health Organization (WHO) initiated an international program for drug monitoring in 1968. Currently, 139 countries, including India, are members of this international program.
Pharmacovigilance program of India
The Pharmacovigilance programme of India (PvPI) was approved by the Ministry of Health and Family Welfare, Government of India, under the Central Drugs Standard Control Organization (CDSCO) in July 2010 with the primary objective of creating a nation-wide system for promoting safe use of medicines. The PvPI is coordinated by the National Coordination Centre (NCC) at the Indian Pharmacopoeia Commission (IPC), Ghaziabad. ADRs are reported from all over the country to the NCC-PvPI, which also works in collaboration with the WHO International Drug Monitoring Centre-“Uppsala Monitoring Centre” (WHO-UMC) in Sweden to contribute to the global ADRs data base [Figure 1]. NCC-PvPI monitors the ADRs among the Indian population and helps the regulatory authority of India (CDSCO) in taking decisions for the safe use of medicines.
|Figure 1 Pharmacovigilance program of India. CDSCO, Central Drugs standard Control Organization (India); WHO, World Health Organization.|
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There are 505 functioning Adverse Drug Reaction Monitoring Centers (AMCs) present in all states and Union Territories throughout India (in medical colleges, public hospitals, and corporate hospitals) as part of PvPI.
The AMC analyzes all ADRs for causality before sending them to the NCC via a web-based system called ”Vigiflow.” Data received from AMCs are assessed at the NCC for quality of data, and if found valid are sent via VigiFlow to WHO-UMC in Sweden. This information about ADR is analyzed by the Indian drug regulator at Central Drugs Standard Control Organization (CDSCO). The drug regulator uses the information to decide whether to withdraw the drug or make changes to the label information. Till date, 11 signals, 133 drug safety alerts, and 54 packet insert changes have happened.
Under the National PvPI, Maulana Azad Medical College (MAMC), Department of Pharmacology was recognized as an Adverse Drug Reaction Monitoring Centre (AMC) in the year 2014.
We report here the progress made by the AMC in trying to make a patient-safe environment in relation to medicine use on the MAMC campus.
Report of pharmacovigilance activities done in MAMC and associated hospitals
MAMC as a pharmacovigilance center
At the beginning, an assessment was done to see if there was for any existing information and data on any pharmacovigilance activities and ADRs on campus. There was none. The goal and aims of the program on campus were defined.
To create a “safe use of medicine environment for all” by increasing awareness, training, and monitoring of ADRs and medicine-related problems, thereby promoting safe and rational use of medicines and enabling practice of patient safety.
Aims of the center
The objectives of the center are the following:
- To increase awareness about pharmacovigilance (PV) and ADRs among healthcare providers on the campus.
- To train healthcare providers about importance of PV, identifying ADRs, and reporting them.
- To establish a system for reporting of ADRs.
- To promote spontaneous and active reporting of ADRs among health care professionals.
- To review the ADRs and report to the national coordination center.
- To identify the risk factors for ADRs.
- Use the data to improve patient safety.
- Increase awareness about hemovigilance and materiovigilance among healthcare providers on the campus.
- Increase awareness of patients and public about need for appropriate use and monitoring of medicines.
- Expand the program to other health facilities under Govt. of NCT Delhi.
Health facilities under the program
All hospitals associated with Maulana Azad Medical College (MAMC), that is, Lok Nayak Hospital, GB Pant Institute of Medical Education and Research (GIPMER), Guru Nanak Eye Centre (GNEC), and Maulana Azad Institute of Dental Sciences (MAIDS) were brought under the ambit of this program. Lok Nayak Hospital is a 2800 bedded hospital with approximately 1,03,091 inpatients and 10 lakh outpatients in a year. GIPMER has 714 beds and caters to approximately 15,000 inpatients and 3 lakh outpatients in a year, GNEC has more than 212 beds, and MAIDS has 350 beds.
Structural organization of the program
To initiate the program on the campus, a College Pharmacovigilance Committee was formed in 2014. The Medical Council of India (MCI) and now the National Medical Commission (NMC) mandate every medical college to have its own pharmacovigilance committee. The purpose of the committee is to supervise and monitor pharmacovigilance activities in the Medical College with the aim to increase awareness of pharmacovigilance among all medical doctors, nurses, pharmacists, and students and also help in the reporting of ADRs. The committee comprises of heads of the institutions as well as the heads of all the clinical departments of MAMC and its associated hospitals. The coordinator chairperson of this committee is the Head, Department of Pharmacology and is responsible for the smooth and effective functioning of the AMC. A Member Secretary, who is one of the faculty members of the department of Pharmacology and a Pharmacovigilance associate appointed by the NCC are also members of this committee. Subsequently, the need to include nursing superintendents, chief pharmacist, blood bank officer, and casualty medical officer in the committee was realized and a revision was done to include them in the MAMC pharmacovigilance committee. A sub-committee comprising of nominated doctors from the clinical departments and nurses representing different wards was also formed to improve the effectiveness and reporting of ADRs and events in the hospital.
This committee has been regularly updated (2016, 2018, 2020, 2021, and 2022). The committee meets once a year. The details of all activities done under the program, the ADRs collected, and the steps needed to be taken to further improve the reporting are discussed.
Department pharmacovigilance committee
A committee in the department of Pharmacology, MAMC has been constituted to plan activities related to increasing awareness and developing training programs about pharmacovigilance. Weekly meetings of this committee are held to assess the causality of ADR reports collected from the hospital. The resident doctors in the department contribute to this program by collecting and reporting ADRs from the clinical departments.
Establishing the pharmacovigilance center
A dedicated room in the department of Pharmacology (room number 176), with a phone, computer, and internet facilities, has been set up.
To facilitate the process of reporting of ADRs by doctors, nurses, and pharmacists, a separate mobile number (9560605612), an email id ([email protected]), a WhatsApp group, and a simple 1-minute form (the “pink slip”) for easy reporting of ADRs have been created [Figure 2]. The pink slip is kept on the nursing stations in the hospital. It requires the health care providers (HCP) to put in the patient number and ADR on it. The residents from the department go and get the details regarding the ADRs.
Activities of the center
Increasing awareness within the college and hospitals about the need for pharmacovigilance has been one of the main activities of the center. For the same, posters about the program were put all over the boards in college [Figure 3]a and b and hospital, in all wards, and nursing stations. Initially posters given by the NCC were put up in all nursing stations in the hospitals [Figure 4]a. Subsequently, posters were designed by the department [Figure 4]b and c.
|Figure 4 (a) Posters to increase awareness about pharmacovigilance amongst health care professionals. (b, c) Posters designed by AMC, Pharmacology Department, MAMC.|
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Training programs for health care providers
- Regular workshops are held (twice in a year) to sensitize HCP, including doctors, pharmacists, and nurses. CME workshops involving doctors, nurses, and pharmacists of MAMC and associated hospitals were conducted.
- In 2016, a separate workshop for doctors working in Delhi government hospitals was started, with representation from one to two doctors from each hospital. Till date, 854 health care providers, including doctors, nurses, and pharmacists from LNH, GIPMER, GNEC, MAIDS, and other Delhi government hospitals have been sensitized [Table 1].
|Table 1 Training and sensitization programs on pharmacovigilance for health care workers|
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- Realizing that nurses play a significant role in the delivery of healthcare in hospitals, it was decided that a separate workshop would be held for them. Continuing Nurses Education (CNE) on pharmacovigilance was started. Two such workshops have been organized, in which 212 nurses were trained [Table 1]. It has been planned that all nurses working in the hospitals would be sensitized.
- The MBBS, BDS, and postgraduate students are being sensitized about pharmacovigilance regularly. The topic has been included in their curriculum. A total of 1875 MBBS and BDS students have been sensitized till date. They are taught and encouraged how to fill up ADR forms and report the same to the Center. To further engage the students in pharmacovigilance activities, logo designing and quiz competitions on the same theme have been organized. It is hoped that they will carry forward this sensitization as they start practicing independently as doctors.
Collecting and reporting of ADRs
Presently, two approaches, spontaneous reporting and active monitoring of ADRs, are being used to collect ADR reports from different wards. Spontaneous reporting is done by HCP, who sends the report to AMC in the department of Pharmacology. These reports are sent on the “suspected adverse drug reaction reporting form” for HCP, as prescribed by IPC. The residents from the department go regularly to the wards to collect ADR reports. These reports are discussed, and causality assessment is done according to WHO Uppsala Monitoring Centre (UMC) causality assessment criteria by the PV committee in the department of Pharmacology [BOX 1]. The same is then sent via vigiflow and collated by the NCC-PvPI. Standard operating procedures are followed. The final assessment is performed by the NCC.
Since its inception in the year 2014 till December 2021, the AMC has reported a total of 2572 suspected ADR reports to the NCC [Figure 5]. The ADRs reported have gradually increased over the years. Interruptions in ADR reporting have happened due to a lack of staff and the leaving of PV associates (2016, 2019) as well as the COVID pandemic 2020–2021. Reporting of ADRs was affected as all services and doctors were diverted for the care of COVID patients only.
|Figure 5 ADRs reported from ADR monitoring center (September 2014–December 2021).|
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As an offshoot of the activities, case reports are being published. Other departments are now giving thesis topics related to the assessment of the prevalence of ADRs in specific patient groups to postgraduates.
Pattern of ADR reporting from Lok Nayak and its associated hospitals
In terms of the patient demographics, ADRs reported were highest in the age group of 20 to 59 years, with similar frequency in both males and females. More than half were in the probable category [Table 2].
|Table 2 Patient demographics and causality assessment of reported adverse drug reactions (September 2014–December 2021)|
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The majority of the reports were from the department of T.B. and Chest (589, 23.8%) followed by the department of Medicine (403, 16.3%), anti-retrovirus therapy (ART) clinic (339, 13.7%), and radiotherapy (312, 12.6%) [Figure 6].
|Figure 6 Adverse drug reactions reported from different departments (September 2014–December 2021).|
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The most common class of drugs implicated in causing ADRs was antimicrobials (1100, 44%) belonging to the antitubercular and beta lactam groups followed by anticancer drugs (602, 24%) like paclitaxel [Figure 7]. In the causality assessment, most of the ADRs belonged to the “Probable” category (1607, 62.48%) [Table 2]. The details of ADRs reported with individual medicines are shown in [Table 3]. The ADRs belonged to all systems.
|Figure 7 Pharmacological classes of drugs implicated in adverse drug reactions (September 2014–December 2021). ART, anti-retroviral therapy; CNS, central nervous system; CVS, cardiovascular; GIT, gastrointestinal; NSAIDS, non-steroidal anti-inflammatory drugs|
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|Table 3 Drugs and the associated adverse drug reactions (ADRs) involving different organ systems|
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Among the ADRs reported, the majority were mild (1451, 81.1%) according to the Common Terminology Criteria for Adverse Events (CTCAE) with 346 (13.5%) reports as serious [Table 4], BOX 2].
| Discussion|| |
Patient safety has been defined as the absence of preventable harm to a patient during the process of health care and the reduction of the risk of unnecessary harm associated with health care to an acceptable minimum. Monitoring medicine use is an important aspect of patient safety. Establishing a PV program for a hospital is one of the first step in promoting the safe use of medicines.
The PV center at MAMC started with well-defined aims and structure. The creation of a college PV committee with representatives of doctors, nurses, and pharmacists from the associated hospitals of MAMC to review the work done was a first step. Putting up posters on all nursing stations, designing simple ADR reporting forms as the “pink slip,” and organizing a room dedicated to PV in the Department of Pharmacology were other steps. Increasing awareness about PV has been an important part of the college program. Doctors, nurses, and pharmacists are regularly being trained in interactive hands-on workshops.
Despite so many training programs, speaking personally to doctors, meetings with nurses, and the reporting of ADRs by health care workers have been low. This has also been noted in other studies, in which it was found that even after active surveillance and constant reinforcement for reporting, there was less reporting of ADRs from the clinical departments. Reasons cited for this include lack of time, not considering the reporting of ADRs as important, and lack of awareness that a problem or a symptom a patient reports could actually be an ADR. Likewise, studies have shown that ADR under-reporting is directly linked to the knowledge, attitude and practice of healthcare professionals, and the availability of ADR reporting systems. Under-reporting of ADRs has been the main challenge of pharmacovigilance globally, as evidenced by several studies.,,,,,,, A study conducted among medical doctors in India reported that the spontaneous reporting rate was very low (19.1%). The studies also cited lack of clarity of information on the ADR reporting form, lethargy, and insufficient training to identify ADRs as important factors for underreporting of ADRs., A study done in Kuwait showed that 74.6% medical doctors had identified ADRs during their daily practice while only 34.2% had ever reported ADRs.
Usually, there is a lot of enthusiasm about the program during the training but nearly no response after the training is done. An important reason for the same could be that the concept of patient safety requires more emphasis in the health care system. To ensure successful implementation of strategies for patient safety, clear policies, data to drive safety improvements, and continuous involvement of health care professionals and patients in their care, are all needed. It requires a systemic approach and has to be inbuilt into the hospital’s working system. It requires a dedicated team, time, and communication resources to implement and continuously monitor the same. The system at present is not asking for it, and resources for same are also not sufficient. Hence, a health care professional overloaded with work and not having sufficient systems to support them while taking care of patients may consider it of lesser importance to report ADRs.
The pattern of ADRs observed at our AMC was very similar to observations from other settings.,,,,,, The published data shows that the most common age group affected by ADRs was 21 to 60 years, with almost equal involvement of the male and female genders.,, Similarly, a study analyzing the global patterns of ADRs over a decade, reported to the WHO-ADR database, revealed that ADR reports were less frequently reported for patients in the 5 to 19 years age group. However, there are few studies that have shown higher prevalence of ADRs in females compared to males.,,
The drugs most commonly suspected of causing ADRs belong to antimicrobial agents, which is also in agreement with several other studies., A study found that nearly 78% of ADRs were due to antimicrobial agents, which was the highest among all other groups of drugs. This could also indicate that antimicrobial agents are among the most common group of drugs used in hospital setting, which could be another reason for rationalizing the use of antimicrobials.
The causality assessment of most of the ADR reports was probable, as has also been reported in other studies also.,,,, Establishing the causality of ADR as certain requires re-administration or re-challenge of the patient with the same drug. This is usually not done due to ethical considerations.
The majority of ADRs were mild and non-serious, again similar to other studies,, and 18% were serious. Global patterns of ADRs reported over a decade revealed that overall, 16% of reports were found to be serious. In all the serious reactions, the culprit drug was withdrawn and appropriate management for the same was instituted.
Thus, overall the study pattern of ADRs reported to this ADR monitoring center is comparable to the studies done in other parts of the country and globally.
The reporting of ADRs has been increasing slowly, with interruptions whenever a dedicated PV associate leaves and recently due to the COVID pandemic. These ADR reports are a drop in the ocean. In a tertiary care hospital with 1 lakh inpatients and 10 lakh outpatients a year (if we only consider LNH and not the other three hospitals on campus), the number of ADRs is bound to be much higher. What we have observed is not even the tip of the iceberg. Hospital-based ADR monitoring and reporting programs are very crucial to identify and quantify the risks associated with the use of medicines. This information would be useful in identifying and minimizing preventable ADRs and enhancing the knowledge of the prescribers to deal with ADRs more efficiently.
The pharmacovigilance program that has been established is helping by sensitizing health care providers and increasing awareness about drug safety. By reporting ADRs to the National PV program, the center is contributing to the National ADR database.
| Conclusion|| |
The pharmacovigilance program has been established at Maulana Azad Medical College (MAMC) and its associated hospitals. Even though the adverse drug reactions (ADR) reported in MAMC are comparable to Indian and global data, there is under reporting of ADRs when considering the total number of expected ADRs. Increasing awareness, encouraging spontaneous reporting of ADRs, continuous training, and disseminating data to all health care professionals may help to improve the reporting. The spontaneous reporting of ADRs is considered as the foundation of post-marketing surveillance for medicine safety. Thus, effective ADR monitoring programs are vital to reduce the harmful effects of therapeutic products. The pharmacovigilance program at MAMC is a commitment and a small step towards patient safety.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
[Table 1], [Table 2], [Table 3], [Table 4]