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Table of Content-Volume 2 Issue 2 May 2017
Pharmacovigilance in dental practice: A study to evaluate knowledge, attitude and practices (KAP) of reporting of adverse drug reactions (ADR) among dental practitioner in a city of central region of Maharashtra, India
Ajinath Jadhav1*, Ajay Chandrikapure2, Pooja Tarte (Jadhav)3
1Assistant Professor, 2Associate Professor, 3Junior Residence, Department of Dentistry, IIMSR Medical college, Warudi, Tq. Badnapur, Dist. Jalna, Maharashtra, INDIA. Email: dr.ajinathjadhav@gmail.com
Abstract Background: Adverse drug reaction (ADR) is defined as a response of a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of a disease or for the modification of physiological function. These adverse drug reactions are an imperative public health crisis striking a substantial fiscal burden on the society and healthcare system. ADR leads to the number of medical and economic consequences like prolonged hospital stay, increased cost of treatment and risk of death also increases. Hence detection, recording and reporting of adverse drug reactions become vital. For this purpose the concept of pharmacovigilance has been formed. As a large number of dentist are using various drugs during treatment of dental problems. But various KAP studies performed on dentist shows that there is negligible role of dentist in pharmacovigilance programme. Material and Method: This was a cross sectional questionnaire-based study in which 106 private dental practitioners were involved who answered predesigned questionnaire prepared based on previous studies on knowledge, attitude and practices of pharmacovigilance. Result: The results were calculated by using MS-Excel spreadsheet and expressed in terms of percentage of observations. Conclusion: We conclude that 106 dentists in our study have poor knowledge about pharmacovigilance. They have good attitude towards practice of reporting ADR. But unable to report ADR due to lack of knowledge, lack of training of ADR reporting, non-remuneration of reporting, difficult to decide whether ADR has occurred or not. Key Words: Pharmacovigilance, dental practioner, adverse drug reaction.
INTRODUCTION WHO (World Health Organisation) defines pharmaco-vigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine related problems.”1 Adverse drug reaction (ADR) was defined by WHO as “a response of a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of a disease or for the modification of physiological function.”2 According to Barkar there are three possible actions of a drug: the one you want, the one you don’t want and third that you don’t know about.3 Use of any drug for diagnostic, prophylactic or therapeutic purpose is rationalised on the basis of its efficacy and safety. Efficacy of a drug can be quantified with relative ease the same cannot be said about the safety. Although these adverse may vary from mild to moderate severity sometimes they are very serious.4 Adverse drug reactions are an imperative public health crisis striking a substantial fiscal burden on the society and health care system. It is one of the significant basis of hospitalisation varying from 5- 20 percent.5,6 adverse drug reaction leads to the number of medical and economical consequences like prolonged hospital stay, increased cost of treatment and risk of death also increases. Around 3.7 percent of patients had fatal adverse drug action.7 Hence detection, recording and reporting of adverse drug reaction has become vital and health expert should be encouraged to execute this opportunity to ensure safer use of medication. For this purpose the concept of pharmacovigilance has been formed. Though pharmacovigilance program started in India in 1982 its contribution to Uppsala Monitoring Centre (UMC, WHO, Sweden) is very little7. According to UMC which maintains international database of the adverse drug reaction reports, only 6- 10 percent of all the adverse drug reactions are reported.8 This is because of lack of knowledge and awareness regarding detection, communication and spontaneous monitoring of adverse drug reactions among health care professionals including physician, surgeon, dentist, pharmacist and nurses.9 It is important for health care professionals to know how to report and where to report an adverse drug reaction. The active participation of health care professionals in the pharmacovigilance program can improve the adverse drug reaction reporting.10 Many studies about knowledge, attitude and practice about pharmacovigilance are carried among medical professionals but very few among dental professionals. Hence the present study was carried out to asses knowledge, attitude and practices of pharmacovigilance among dentists.
MATERIALS AND METHODS Study design This was a cross sectional study, questionnaire-based study which was conducted in Aurangabad city located in central region of Maharashtra. Study population In this study 106 private dental practitioners were involved who answered predesigned questionnaire prepared based on previous studies. The details of questionnaires is as follows
RESULTS The results were calculated by using MS-Excel spreadsheet and expressed in terms of percentage of observations.
Table 1: Showing questionnaire and answers with Results.
*is a most probable answer RESULT It was noticed that knowledge and awareness about pharmacovigilance was very poor and adverse drug reaction reporting was almost close to nil.
DISCUSSION Dentists use various medications for diagnosis and treatment of different oral, dental and maxillofacial pathologies. Commonly used drugs include non steroidal anti-inflammatory drugs, opiod analgesics, antibiotics and antacids. Sometimes drugs like steroids, multivitamins, anti-oxidants and anti-epileptics like carbamazepine are also used. Injectable drugs like lignocain with or without adrenaline for local anaesthesia, sodium tetradecyl for treatment of small arteriovenous malformations etc. These drugs have documented evidence of different adverse drug reactions starting from headache, tinnitus to severe form of anaphylactic shock and teratogenic nature. Though rare they are very serious and found to be fatal in 3.67 percent of cases7. Hence reporting of these unwanted adverse drug reactions become very important not only for future references and development of better medicines but also to avoid unnecessary burden on health care system and morbidity or mortality of patients. This resulted into development of concept of pharmacovigilance. After invention of a drug most of the things are known about its therapeutic activity but rather less about its safety because clinical trials are conducted in a controlled condition with few number of subjects. Later drug is marketed and prescribed by hundreds of doctors to thousands of patients. The scenario is complicated when there are ethnic variations, presence of comorbid conditions, and concomitant medications. This is the phase where unusual and rare adverse drug reactins can be encountered. Thus adverse drug reaction reporting is of prime importance in pharmacovigilance program.12 Thus pharmacovigilance is an integral and essential part of patient care. However underreporting of adverse drug reaction is one of the major problems associated with pharmacovigilance program. Even in countries like United Kingdom where pharmacovigilance programs are well established, a high level of underreporting is documented. Various factors related with the knowledge and attitude of doctors are attributed to underreporting of adverse drug reactions11. Many studies have tried to find out these factors among medical professionals and very few studies are documented among dental professionals alone in India. Most of knowledge, attitude and practice studies on adverse drug reporting are carried among medical health professionals and very few among dental professionals. Sarfaraz et al13 performed a study among dental professionals and concluded that lack of knowledge and problems in attitude of dental doctors as causative factor in underreporting of adverse drug reaction. These factors include lack of awareness about adverse drug reaction reporting system, inadequate training to recognize adverse drug reaction, fear factors, lethargy and lack of professional obligations.13 In our study 87 percent of dentists know about side effects and adverse drug reactions but 98 percent were unaware of pharmacovigilance program. According to Torawane et al 28.57 percent of healthcare professionals knew that in India the Central Drug Standard Control Organisation (CDSCO) is a regulatory body responsible for monitoring and reporting of ADR. But according to our study only 10.37 percent of dentists were aware of CDSCO which far low as compared to studies among medical professionals. According to Sarfaraz et al 65.5 percent of dentists found difficulty to recognise whether ADR has occurred or not13 and according Gupta et al 80.9 percent of medical professionals were concerned about non remuneration of report and 81.8 percent were in condition of difficult to decide whether ADR has occurred or not14. In our study 22.64 percent dentists were concerned about non remuneration for reporting, and 60.45 percent of dentist found it difficult decide whether ADR has occurred or not. These finding are in accordance with above studies. According to Gupta et al and Torawane et al 75.51 percent of healthcare provider (including medical professionals, dentists, nurses and pharmacist.) accepted that ADR reporting is essential.12, 14 in another study 31.8 percent of doctors including dentists could not realise the significance of reporting one ADR, while 84.10 percent were obliged to report ADR.15 in our study 88.67 percent accepted the necessity of ADR reporting, while 11.32 percent were thinking that ADR reporting is not necessary. Most of the studies found that the main reason for not reporting ADR is lack of knowledge and training of reporting ADR. In our study almost everyone suggested that every healthcare provider should be trained in pharmacovigilance and it should be included in undergraduate curriculum to create awareness among the budding doctors. A survey conducted in UAE revealed that only 5.5 percent of doctors received training on ADR reporting.16 But Torawane et al in his KAP study found that none of dentist received training on ADR reporting. This finding is almost similar in our study where 99.6 percent of dentists were never trained in ADR reporting. This finding was very discouraging for us as the role of dentists is very negligible in ADR reporting in spite of huge number of dentist practicing all over the India. Sarfaraz et al further noticed that, despite high rate of ADR in ambulatory patient, 34.4 percent of dentists revealed that they have never seen an ADR. This closely resembles to our study, where we found that 65.09 percent dentist came across ADR but never ever thought of reporting13. Torawane et al observed that there was a huge gap between ADR experienced (52.29%) and ADR reported (6.12%) by the health care professionals.12 Our study confirms this finding of huge gap between ADR experienced(65.09%) and ADR reported (0%). This indicates a serious issue of concern and immediate measure should be taken regarding this., as dentists are an integral part of health care system. Interestingly 92.45 percent of dentist in this study, are willing to report ADR. But certain factors have been noticed in our study, which are responsible for underreporting of ADR. These factors are lack of knowledge about pharmacovigilance, difficult to decide whether ADR has occurred or not, non remuneration of reporting, lack of training of reporting ADR. These factors are reconfirmed in our study among dental practitioners alone as compared to previous studies which are combinely carried among health care providers including medical professionals, dentists, nurses and pharmacist. We also observed that almost every dentist in our study willing to participate in training program about paharmacovigilance. Many Indian studies have stated that there is gradual increase in the knowledge and the attitude of the health care professionals towards pharmacovigilence18,19. Further it has been reemphasised that there is a positive correlation between training of pharmacovigilance and ADR reporting.20 Thus we recommend conduction of pharmacovigilance related continued dental education (CDE) programs for private dental practitioners by Indian Dental Association at state, district and dental college level. The limitation of study was being a localised study with limited number of dentists so it may not be generalised and we recommend a multi centric study that may provide deep insight about knowledge, attitude and practice of reporting ADR among dentists.
CONCLUSION We conclude that 106 dentists in our study have satisfactory knowledge about adverse drug reaction but poor knowledge about pharmacovigilance. They have good attitude towards practice of reporting ADR. But unable to report ADR due to lack of knowledge, lack of training of ADR reporting, non-remuneration of reporting, difficult to decide whether ADR has occurred or not. But almost every dentist was willing to participate in pharmacovigilance program.
REFERENCES
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