• Users Online: 474
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 


 
 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 11  |  Issue : 2  |  Page : 181-187

Adverse drug reaction: Knowledge, attitude and practice amongst paediatric dentists in India: An electronic survey


Department of Pediatric and Preventive Dentistry, K. M. Shah Dental College and Hospital, Sumandeep Vidyapeeth, Vadodara, Gujarat, India

Date of Submission25-Sep-2020
Date of Acceptance05-Mar-2021
Date of Web Publication14-May-2021

Correspondence Address:
Bhavna H Dave
Department of Pediatric and Preventive Dentistry, K. M. Shah Dental College and Hospital, Sumandeep Vidyapeeth, Vadodara - 391 760, Gujarat
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/aihb.aihb_107_20

Rights and Permissions
  Abstract 


Background: In India, though pharmacovigilance programme had been introduced way back in 2003, still there are very less cases reported regarding adverse drug reaction (ADR), especially by dental professionals. This led to the necessity to find out the knowledge regarding ADR amongst the dentists and the reasons for underreporting. Moreover, as ADRs are more common and severe amongst paediatric population when compared to adults, this electronic survey was carried out to assess the knowledge, attitude and practices amongst the students pursuing masters in paediatric dentistry. Methods: A questionnaire survey was conducted amongst post-graduate students registered with Indian Society of Pedodontics and Preventive Dentistry. A Google Form with covering letter which included specified instruction format, informed consent, covering letter with clear description of the purpose of the study and questions in different categories were mailed. Descriptive statistics were used to analyse responses. The association of knowledge and attitude with respect to position of paediatric dentists was analysed with Chi-square test. Results: The questionnaire was completed by 274 participants. Ninety per cent of participants were aware that ADR can be caused by the drugs available in the market and such drugs can be banned post availability in the market. Only 20% of the participants were aware of PvPI app but 75% participants opted for online reporting of ADR. Nearly 81% of participants believed that ADR should be reported the moment it is observed and this reporting is basically for the safety of the patients. Nearly 90% of participants agreed that dental materials can cause ADR due to either lack of knowledge to identify ADR and the procedure of reporting or the fear of legal issues. Almost only 4% of the participants have ever attended an ADR workshop. Conclusion: The general knowledge of ADR is prevalent amongst the participants, but there is strong evidence of underreporting and lack of reporting system information.

Keywords: Adverse drug reaction underreporting, adverse drug reaction, dental materials adverse reactions, latex allergy, materiovigilance, Pharmacovigilance, pink form


How to cite this article:
Chari DN, Dave BH, Bargale SS, Deshpande AN, Shah SS, Shah PS. Adverse drug reaction: Knowledge, attitude and practice amongst paediatric dentists in India: An electronic survey. Adv Hum Biol 2021;11:181-7

How to cite this URL:
Chari DN, Dave BH, Bargale SS, Deshpande AN, Shah SS, Shah PS. Adverse drug reaction: Knowledge, attitude and practice amongst paediatric dentists in India: An electronic survey. Adv Hum Biol [serial online] 2021 [cited 2023 Feb 7];11:181-7. Available from: https://www.aihbonline.com/text.asp?2021/11/2/181/315949




  Introduction Top


Dr. W. Mc Bride who pioneered the link between fetal deformities and thalidomide laid the foundation of Pharmacovigilance (PV) in December 1961. In 1963, World Health Organization (WHO) introduced 'Programme for International Drug Monitoring - with the motive of detecting the earliest possible PV signals.[1],[2] PV is geared at monitoring drug safety under actual-life conditions and capturing detrimental drug events during the life cycle post-marketing stage of the pharmaceutical.[3]

India had started the clinical trials globally since 1986 with 12 regional centres.[4] India joined WHO - adverse drug reactions (ADR) monitoring programme based on Uppasala, Sweden in 1997. 2005 marked India's breakthrough year with Pharmacovigilance Program of India (PvPI) initiation.[5]

PV focuses on research and practices related to analysis, assessment, perception and protection of deleterious effects or any other drug issues.[6] ADR is referred to as a harmful and accidental response to a medication at doses typically used for the beings for maintenance therapy, prognosis, therapeutic or alteration of biological function. ADR is ranked amongst top ten leading causes for death and illness.[7]

Children are considered at greater risk compared with adults. When used in paediatric patients, pharmaceuticals' safety and effectiveness is influenced by a host of biological, developmental and behavioural factors. Differences in body proportions and age coupled with body composition distinguish newborns, infants and children from adults.[8] Drug therapy is like double-sided coin – the drug which can cure an individual can cause ADR in another individual.[9]

Lack of information regarding pharmacokinetics data or dose finding studies in the paediatric population has led to under- or over-dosing in some age groups. Children often cannot verbally express their own drug therapy experiences.[10] Hence, children are considered to be at an increased risk of therapeutic failure thus are known as 'Therapeutic Orphans'.[8] ADRs affect both children and adults with varying magnitudes, causing both morbidity and mortality.[11]

Antibiotics and analgesics, the major causes of ADRs, are amongst the common prescription by any dentist. There have been case reports on ADR caused by the mouthwashes, toothpastes and topical anaesthesia usually prescribed by a dentist.[12]

The materials used by a dentist can also be a means of ADR, and the practice monitoring the ADR due to materials is known as materiovigilence. The rubber dam isolation used can cause latex allergy in few patients.[13] Fatal anaphylactic shock has been reported by the usage of impression material – alginate. The most basic preventive measure – the fissure sealant – has been reported to cause asthma and urticarial.[14] The most common metal amalgam was found to be three times more frequent in causing ADR when compared to resins.[15] There have been various case reports that have documented the ADR by the root canal sealers and obturating materials.[16]

One hundred and thirty-four patients in a study where tested for contact reactions due to allergens. Inflammatory rash on lips and on the skin around the mouth were found to be amongst the most common manifestations which was nearly 25.6% followed by burning mouth syndrome which was 15.7%, lichenoid reaction which was 14% and orofacial granulomatosis which was 10.7%. The specific allergens to contact were 14% by sodium thiosulfate, 13.2% by nickel sulphate, 9.9% by mercury, 7.4% palladium chloride and 5.8% by 2-hydroxyethyl methacrylate.[17]

ADR can be even evident amongst the practitioners such as Type I allergic reaction due to the presence of powder present in the latex gloves.[18],[19] As dentistry is a wet work with frequent handwashing, there is high prevalence of hand eczema amongst dentists. The frequent encounter with the chemical substances also has been the leading causes for allergic contact dermatitis.[20] The prevalence for occupational-related dermatitis was more by dental products than by the usage of latex gloves.[18] Respiratory ADR has also been found by the presence of volatile methacrylates amongst dental practitioners and the patients.[21],[22]

Based on the risk of ADRs in the dental setup, the role of a dentist in spontaneous reporting is crucial and not to be underestimated. Around 6%–10% of all the ADRs have been found to be reported by any dentist and such lack of ADR reporting has resulted in delayed detection of serious ADRs which has been proven to be threat to the public health.[23],[24] The 'seven deadly sins' for underreporting of ADR as suggested by Inman and Weber were ADR-citing complacency, fear of litigation, shame, desire to publish before reporting, humiliation, lack of respect and distrust.

Other factors that also have an important role include the severity of reaction, the period the product has been in the market, age and experience of the reporter, location of practice and publicity of the media.[25]

In order to improve the participation of health professionals in spontaneous reporting, it might be necessary to design strategies that modify both the intrinsic (knowledge, attitude and practices [KAPs]) and extrinsic (relationship between health professionals and their patients, the health system and the regulators) factors. The intrinsic factors can be known and the reasons for underreporting can be understood by conducting a KAP analysis.

This questionnaire survey amongst post-graduate (PG) paediatric dentists was carried out with an aim to assess their level of understanding, their reasons for not using it and their potential training needs in this area.


  Methods Top


An electronic cross-sectional (national wide) study was conducted amongst PG student members registered with the Indian Society of Pedodontics and Preventive Dentistry (ISPPD) in 2018 following the Ethical Approval of the Committee on Institutional Ethics (SVIEC/ON/DENT/SRP/18103). ISPPD directly engages and focuses on improving children's oral health at national level.

Twenty-four multiple-choice question questionnaire was carefully curated to assess the KAP amongst ISPPD student members regarding ADR. Two types of validation were carried out – content validation and concurrent validation: (1) The content validation of the questionnaire was validated by professors, readers and senior lecturers of the Department of Paediatric and Preventive Dentistry and the Department of PV and suggested recommendations have been incorporated in the questionnaire. (2) A concurrent validation of the same questionnaire was done on a sample of ten registered PG students of paediatric and preventive dentists.

The Google link questionnaire was then e-mailed to the student members of the ISPPD along with a covering letter briefing the study need and type and their role in the study.

The e-mail addresses of the students were collected from the ISPPD head office. A recall mail was sent twice to those members who failed to respond within 15 days. A response was awaited for a period of 3 months.

Ten responses were rejected as were not completely filled and those responses which were submitted after the timeline of 3 months were not included in the study. Hence, the first 274 responses from the participants who were student members of ISPPD and who completely filled the questionnaire within the timeline specified were included in the study.

Using the SPSS(Statistical Package for Social Sciences)®, version 18.0 (SPSS Inc, Chicago IL) software, data collected were entered into a computer and analysed. Descriptive and inferential statistical analyses were carried out in our study. Continuous measurement results were presented on average SD and categorical measurement results were presented in number (%). The degree of significance was set at P = 0.05, and any value below or equal to 0.05 was regarded statistically significant.

Chi-square analysis was used to determine the significance on categorical scale of study parameters. Two tailed, independent student t-tests were conducted to determine the significance of study parameters on a continuous scale on metric parameters for analysis of intergroups.


  Results Top


The study was performed on a total of 274 PG student members of ISPPD across India. Amongst them, 170 were females and 104 were males. There was no statistically significant difference found in the replies amongst the male and female participants of the study.

First 274 participants of three different years were selected for the study. Year-wise distribution was as follows: 91 participants from I MDS, 92 participants from II MDS and 91 participants from III MDS. It could be observed that the I MDS participants almost matched with the II MDS and III MDS participants regarding the knowledge about ADR. However, it was noticed that on the grounds of attitude and practice regarding ADR, the response from I MDS participants was less when compared to II MDS and III MDS but with no statistically significant difference [Graph 1]. This slight difference may be attributed to the knowledge gained all through the clinical exposure from the educators and fellow students [Graph 1].



Knowledge regarding adverse drug reactions

Eight out of the total 24 questions were framed to evaluate the knowledge regarding ADR amongst the participants.

261 (95%) participants from the total of 274 were aware of the full form of ADR and 249 (91%) participants knew the full form of AMC-ADR Monitoring Centre. 232 (85%) participants were aware that ADR forms were known as PINK form in India, but only 10 (4%) participants were aware that there is an ADR PvPi app through which clinicians can easily report an ADR. Around 227 (83%) participants were aware of the National Coordination Center (NCC) centre located at Ghaziabad, while 257 (94%) had no idea about nearby AMC centres. 248 (90%) participants agreed that not all drugs in the market were safe and 251 (92%) participants believed that medicines can be banned due to ADRs after clinical trial once available in the market [Table 1].
Table 1: Responses of participants in general regarding the knowledge related to adverse drug reaction

Click here to view


Attitude regarding adverse drug reactions

Six out of 24 questions were framed for the evaluation of the attitude amongst the participants regarding ADR.

All the 274 participants were aware of the fact that is necessary to report an ADR and dentists are eligible to report an ADR. One hundred and fifty-eight (75%) participants preferred online method of reporting an ADR against telephonic, post- and direct methods. 257 (94%) participants believed that main purpose behind reporting an ADR is for the safety of the patients. Two hundred and twenty-one (81%) participants agreed that ADR should be reported immediately once it is noticed [Graph 2] and main reasons for ADR underreporting were both fear of ADR-related legal issues and lack of knowledge/perception as opted by 239 (87%) [Graph 2].



Practice regarding adverse drug reaction

Seven out of 24 questions were framed in accordance with the practice pertaining to a paediatric dentist.

Two hundred and fifty-five (93%) participants agreed that ADRs can occur in paediatric patients, but 246 (90%) participants have never experienced any ADR during their dental practice. Two hundred and fifty-four (93%) participants were aware that penicillin was considered to have allergic reactions amongst paediatric patients when compared to amoxicillin which was favoured by 20 (7%) participants. Two hundred and forty-nine (91%) participants had basic knowledge regarding haemovigilence and 250 (91%) participants knew about materiovigilence. Two hundred and sixty (95%) participants agreed to the fact that dental materials can cause ADRs [Table 2].
Table 2: Practice related response of the participants regarding adverse drug reaction

Click here to view


Awareness regarding adverse drug reaction

Only those who had attended any ADR workshop were directed to the last two questions.

Only 11 (4%) of the participants had attended workshops on ADR and were aware of the term 'signal' and the location of the worldwide centre. A positive attitude rounded off in this study was that almost 249 (91%) participants considered that ADR training amongst paediatric dentists should be made compulsory, while only 13 (5%) considered it optional while 12 (4%) amongst them thought such workshops were not necessary [Table 3].
Table 3: Awareness regarding adverse drug reaction amongst the participants

Click here to view



  Discussion Top


ADR monitoring is an area of pharmaceutical care that concerns with the detection, management and reporting of the ADRs.[26] This requires the health professionals worldwide to report ADRs when encountered.[27] The present survey-based study in the questionnaire format was conducted amongst the student members of the ISPPD who are currently enrolled pursuing their PG studies in 2018. The motto of this electronic survey is to find out the awareness regarding ADR KAP amongst those students pursuing masters in paediatric and preventive dentistry.

The study was conducted with 274 participants including 170 female candidates, and the remaining 104 were male applicants. 91 (I MDS), 92 (II MDS) and 91 (III MDS) ISPPD students members participated in this cross-sectional study.

Participants had greater knowledge of general details related to ADR such as the abbreviation of ADR which is Adverse Drug Reaction and that of AMC which is Adverse Drug Reaction Monitoring Center, which was 95% and 91%, respectively. The information regarding the ADR form which is also called as Pink form in India was well-known amongst almost 85% of the participants. According to a study done by Singh and Bhatt,[28] the structured ADR reporting format consists of 58 necessary elements that are essential for an authentic assessor of casualty by evaluating ADR forms of 13 different countries. For further convenience for reporting, the ADR forms in India are made available in ten different languages (Assamese, Bengali, Gujarati, Hindi, Kannada, Marathi, Malayalam, Oriya, Tamil and Telugu) and the PvPI helpline number is also available to be contacted on weekdays for reporting any ADR.[29] The awareness regarding the new technology – ADR PvPI app was not known to 96% of participants. Unawareness regarding the same may be one of the reasons for underreporting as the app can be an easy and cumbersome method to submit the ADR.[30]

When observed, ADR should be reported to nearby AMC centre. There are currently 250 such AMC centrers. The ADR reported to the regional centres will be entered into Vigiflow and sent to the NCC which was shifted from New Delhi to Ghaziabad (started in the year 2011) known to 83% of the participants. This centre connects all the AMC centres and then sends signals to the global Uppsala Monitoring centre located at Sweden. Nearly 150 countries are members of the WHO International Drug Monitoring System, of which India is member since 1998.[31]

Ninety per cent of participants accepted that all products on the market were not safe and 92% claimed that products should be banned due to ADRs which contrasted with the findings of the study conducted by Wysowski and Swartz,[32] where approximately 33.8% were unaware of the possibility of severe ADRs wit newly marketed drugs. Many extreme and rare ADRs are only detected post the marketing clearance and after its availability to the general public.[33]

All participants were aware of the need to report an ADR, and dental professional are qualified for reporting the ADR can be compared to a study conducted in the UK where only 74.5% of dental practitioners were aware of the ADR reporting method.[17] Similar types of the study showed 77.5%, 79.5% and 84.4% of medical and dental doctors were encouraged to report serious ADRs.[34]

Lack of knowledge regarding the method of reporting an ADR and the fear of getting involved in legal issues were the main reasons amongst participants (almost 87%) preventing them from reporting the ADR which can be supported by the study done by Inman and weber[25] who mentioned 'seven deadly sins of underreporting'. Similar factors were identified by studies conducted by Torwane et al.[35] Gupta et al.[36] and Showande and Oyelola.[37]

The awareness regarding ADR to occur in a dental clinic and particularly paediatric setup was amongst 93% of the participants but only 10% seemed to have encountered ADR. Misconception and lack of confidence in diagnosis of ADR could be the reasons for very low percentage of ADRs that have been reported.[38]

India's Haemovigilance System initiated in 2012 with the goal of tracking transfusion blood quality and blood products, analyses and works to improve the quality and health of blood products, as well as the transfusion cycle for patient safety.[39],[40]

In 2015, India's Materiovigilance System was launched to track and record ADRs. Dental materials right from latex, impression materials, local anaesthetic agents, composites endodontic materials and metals can cause allergy to both the practitioners and the patients. The basic knowledge regarding what haemovigilance, materiovigillance mean and whether the dental materials can cause ADRs amongst the participants was 91%, 91% and 95%. However, to put the knowledge into practice can be difficult due to a lack of awareness regarding the allergies documented regarding known materials.[41] A study stated that dental patients exhibit symptoms mainly on the oral mucosa and dental staffs usually have hand dermatitis.[17]

The need to report an ADR as soon as the ADR is noticed is the most important information that almost 81% of the participants agreed to reflecting their attitude toward the seriousness and importance of ADR reporting system along with 94% of participants agreeing to the fact that ADR reporting is for patient safety.

Just 4% had attended ADR workshop which is very negligible. This could be one of the major reasons for underreporting. There was a strong link between PV preparation and ADR reporting by health-care practitioners.[35]

Limitations

Since this research was performed amongst the PG students of the branch of Pediatric and Preventive Dentistry only, the sample size does not reflect the awareness regarding ADR among the actual dental fraternity. Hence, it is advisable to conduct studies that could include the dental practitioners, PG students of all the branches of dentistry and also undergraduate dental students. Carrying out such study will give us idea about the knowledge – the dental students hold regarding ADR and further steps for the improvement can be undertaken.

Suggestions

  • Addition of syllabus regarding ADR and in particular designing a course for dental students at undergraduate level
  • Organizing ADR orientation programme specifically for the PG students of all branches for imparting knowledge pertaining to specialised branches
  • Organising workshop for teaching the practitioners as to how to fill the ADR form and submit it by offline and online methods
  • Each dental college should be affiliated with pharmacology department for spontaneous reporting of such cases for timely intervention.



  Conclusion Top


  • The general knowledge of ADR is prevalent amongst the participants, but there is a strong evidence of underreporting and lack of reporting system information. Organising orientation programme and creating awareness about ADR reporting may aid in improving the spontaneous reporting
  • The purpose of the article is not only to assess the understanding of ADR amongst Paediatric and Preventive Dentistry PG students but also to provide some essential and useful information that could help practitioners deal positively with ADR in the future. This may aid in attaining the ultimate goal of safety of the patients which indirectly will lead to safety of the clinician.


Acknowledgement

We express gratitude towards Dr. Bhagya Sattigeri, Head, Department of Pharmacology, Sumandeep Vidyapeeth deemed to Be University and to Dr. Jayant Patharkar, Assistant Professor, Department of Pharmacology, Sumandeep Vidyapeeth deemed to Be University for helping us to improve our knowledge regarding ADR and for validating the questionnaire. We are thankful to all Indian Society of Pedodontics and Preventive Dentistry student members who helped us with the research by filling up the questionnaire.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
McBride WG. Thalidomide and congenital abnormalities. Lancet J 1961;278:1358.  Back to cited text no. 1
    
2.
Bégaud B, Chaslerie A, Haramburu F. Organization and results of drug vigilance in France. Rev Epidemiol Sante Publique 1994;42:416-23.  Back to cited text no. 2
    
3.
Mulchandani R, Kakkar AK. Reporting of adverse drug reactions in India: A review of the current scenario, obstacles and possible solutions. Int J Risk Saf Med 2019;30:33-44.  Back to cited text no. 3
    
4.
Kulkarni RD. Reporting systems for rare side effects of non-narcotic analgesics in India. Problems and opportunities. Med Toxicol 1986;1 Suppl 1:110-3.  Back to cited text no. 4
    
5.
Sandeep B, Sunil K. Protocol for National Pharmacovigilance Program. Indian pediatrics 2006;43:27-32.  Back to cited text no. 5
    
6.
World Health Organisation Collaborating Centre for International Drug Monitoring. The Importance of Pharmacovigilance; 2007. Available from: http://www.who-umc.org. [Last accessed on 2020 Dec 18].  Back to cited text no. 6
    
7.
Smyth RM, Gargon E, Kirkham J, Cresswell L, Golder S, Smyth R, et al. Adverse drug reactions in children – A systematic review. PLoS One 2012;7:e24061.  Back to cited text no. 7
    
8.
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998;279:1200-5.  Back to cited text no. 8
    
9.
Elzagallaai AA, Greff M, Rieder MJ. Adverse drug reactions in children: The double-edged sword of therapeutics. Clin Pharmacol Ther 2017;101:725-35.  Back to cited text no. 9
    
10.
Napoleone E. Children and ADRs (adverse drug reactions). Ital J Pediatr 2010;36:4.  Back to cited text no. 10
    
11.
Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:14.  Back to cited text no. 11
    
12.
Moghadam BK, Drisko CL, Gier RE. Chlorhexidine mouthwash-induced fixed drug eruption. Case report and review of the literature. Oral Surg Oral Med Oral Pathol 1991;71:431-4.  Back to cited text no. 12
    
13.
Chin SM, Ferguson JW, Bajurnows T. Latex allergy in dentistry. Review and report of case presenting as a serious reaction to latex dental dam. Aust Dent J 2004;49:146-8.  Back to cited text no. 13
    
14.
Hallström U. Adverse reaction to a fissure sealant: Report of case. ASDC J Dent Child 1993;60:143-6.  Back to cited text no. 14
    
15.
van Noort R, Gjerdet NR, Schedle A, Björkman L, Berglund A. An overview of the current status of national reporting systems for adverse reactions to dental materials. J Dent 2004;32:351-8.  Back to cited text no. 15
    
16.
Braun JJ, Zana H, Purohit A, Valfrey J, Scherer P, Haïkel Y, et al. Anaphylactic reactions to formaldehyde in root canal sealant after endodontic treatment: Four cases of anaphylactic shock and three of generalized urticaria. Allergy 2003;58:1210-5.  Back to cited text no. 16
    
17.
Khamaysi Z, Bergman R, Weltfriend S. Positive patch test reactions to allergens of the dental series and the relation to the clinical presentations. Contact Dermatitis 2006;55:216-8.  Back to cited text no. 17
    
18.
Hamann CP, DePaola LG, Rodgers PA. Occupation-related allergies in dentistry. J Am Dent Assoc 2005;136:500-10.  Back to cited text no. 18
    
19.
Leggat PA, Kedjarune U. Toxicity of methyl methacrylate in dentistry. Int Dent J 2003;53:126-31.  Back to cited text no. 19
    
20.
Wallenhammar LM, Ortengren U, Andreasson H, Barregård L, Björkner B, Karlsson S, et al. Contact allergy and hand eczema in Swedish dentists. Contact Dermatitis 2000;43:192-9.  Back to cited text no. 20
    
21.
Lönnroth EC, Shahnavaz H. Hand dermatitis and symptoms from the fingers among Swedish dental personnel. Swed Dent J 1998;22:23-32.  Back to cited text no. 21
    
22.
Andreasson H, Ortengren U, Barregård L, Karlsson S. Work-related skin and airway symptoms among Swedish dentists rarely cause sick leave or change of professional career. Acta Odontol Scand 2001;59:267-72.  Back to cited text no. 22
    
23.
Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJ, Aronson JK, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol 1996;42:423-9.  Back to cited text no. 23
    
24.
Feely J, Moriarty S, O'Connor P. Stimulating reporting of adverse drug reactions by using a fee. BMJ 1990;300:22-3.  Back to cited text no. 24
    
25.
Inman WH. Attitudes to adverse drug-reaction reporting. Br J Clin Pharmacol 1996;41:433-5.  Back to cited text no. 25
    
26.
Abubakar AR, Simbak NB, Haque M. A systematic review of knowledge, attitude and practice on adverse drug reactions and pharmacovigilance among doctors. J Appl Pharma Sci 2014;4:117-27.  Back to cited text no. 26
    
27.
Kamal NN, Kamel EG, Mahfouz EM. Adverse drug reactions reporting, knowledge, attitude and practice of physicians towards it in El Minia University Hospitals. Int Public Health Forum 2014;1:13-7.  Back to cited text no. 27
    
28.
Singh A, Bhatt P. Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form. J Pharmacol Pharmacother 2012;3:228-32.  Back to cited text no. 28
[PUBMED]  [Full text]  
29.
Kalaiselvan V, Kumar P, Mishra P, Singh GN. System of adverse drug reactions reporting: What, where, how, and whom to report? Indian J Crit Care Med 2015;19:564-6.  Back to cited text no. 29
[PUBMED]  [Full text]  
30.
Dhamija P, Kalra S, Sharma PK, Kalaiselvan V, Muruganathan A, Balhara YPS, et al. Indian college of physicians (ICP) Position statement on pharmacovigilance. J Assoc Physicians India 2017;65:63-6.  Back to cited text no. 30
    
31.
Gupta YK. Pharmacovigilance Programme for India. Available from: http://www.pharmabiz.com/PrintArticle.aspx?aid=57406&sid=9.. [Last accessed on 2020 Jun 17].  Back to cited text no. 31
    
32.
Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 19692002: The importance of reporting suspected reactions. Arch Intern Med 2005;165:1363-9.  Back to cited text no. 32
    
33.
Shaji J, Lodha S. Regulatory status of banned drugs in India, 2010. Indian J Pharm Educ Res 2010;86-94.  Back to cited text no. 33
    
34.
Praveen S, Jai Prakash R, Manjunath GN, Gautam MS, Kumar N. Adverse drug reaction reporting among medical and dental practioners: A KAP study. Indian J Med Special 2013;4:10-5.  Back to cited text no. 34
    
35.
Torwane NA, Hongal S, Gouraha A, Saxena E, Chavan K. Awareness related to reporting of adverse drug reactions among health caregivers: A cross-sectional questionnaire survey. J Natl Accredit Board Hosp Healthc Provid 2015;2:1, 23-9.  Back to cited text no. 35
    
36.
Gupta SK, Nayak RP, Shivaranjani R, Vidyarthi SK. A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India. Perspect Clin Res 2015;6:45-52.  Back to cited text no. 36
[PUBMED]  [Full text]  
37.
Showande JS, Oyelola FT. The concept of adverse drug reaction reporting: Awareness among pharmacy students in a Nigerian University. Internet J Med Update 2013;8:24-30.  Back to cited text no. 37
    
38.
Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in-patients: A prospective analysis of 3695 patient-episodes. PLoS One 2009;4:e4439.  Back to cited text no. 38
    
39.
Mukherjee S, Maiti R. Haemovigilance: A current update in Indian perspective. J Clin Diagn Res 2016;10:EE05-9.  Back to cited text no. 39
    
40.
Kumar P, Thapliyal R, Coshic P, Chatterjee K. Retrospective evaluation of adverse transfusion reactions following blood product transfusion from a tertiary care hospital: A preliminary step towards hemovigilance. Asian J Transfus Sci 2013;7:109-15.  Back to cited text no. 40
[PUBMED]  [Full text]  
41.
Syed M, Chopra R, Sachdev V. Allergic reactions to dental materials A systematic review. J Clin Diagn Res 2015;9:ZE04-9.  Back to cited text no. 41
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

Top
 
 
  Search
 
Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
Access Statistics
Email Alert *
Add to My List *
* Registration required (free)

 
  In this article
Abstract
Introduction
Methods
Results
Discussion
Conclusion
References
Article Tables

 Article Access Statistics
    Viewed2036    
    Printed45    
    Emailed0    
    PDF Downloaded392    
    Comments [Add]    

Recommend this journal


[TAG2]
[TAG3]
[TAG4]