Abstract

Background: Given the imperative for dental practitioners to be familiar with the existing ethical principles and laws governing their practice, this study aimed to evaluate awareness and practice of the dentists (code of ethics) regulations 2014 and consumer protection act 2019 among dental practitioners in Andhra Pradesh state, India.

Methods: A cross sectional study was conducted among 384 dental practitioners in Andhra Pradesh state, India. A questionnaire consisting of 25 items was used to assess awareness and practice of the dentists (code of ethics) regulations and consumer protection act. The data collected were analysed using IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.

Results: Only 53(13.8%) dental practitioners in the study were aware that the dentists (code of ethics) regulations had been revised in 2014. About 190 (49.5%) practitioners were aware of the precise period for mandatory preservation of patient records. Most dental practitioners (278, 72.4%) accepted commissions in the form of gifts or cash from laboratories, radiologists, or pharmacists and 306 (79.7%) dental practitioners used unregistered dental lab technicians as employees in their practice. Furthermore, 297 (77.3%) practitioners were found to provide or sell drugs to patients in their clinic/office. The new regulations under consumer protection act 2019 were unknown to 194 (50.5%) dental practitioners.

Conclusions: The present study indicates that the awareness of dental practitioners towards the dentists (code of ethics) regulations 2014 and consumer protection act 2019 is inadequate. It highlights the need for training programmes and curriculum changes with a focus on ethical and legal issues in clinical dental practice.

Keywords: code of ethics, consent, consumer protection act, dental practice, medicolegal issues.

Introduction

Dental practitioners are governed by an ethics code and a set of regulations [1]. Dental ethics are the moral duties and obligations of dental practitioners towards their patients, professional colleagues, and society [2, 3]. The Dental Council of India (DCI) is the statutory body regulating the profession of dentistry and dental practice, laid down the Dentists (Code of Ethics) regulations in 1976 [3]. Due to the steady increase in the number of cases of negligence in dentistry during the last two decades [4], the DCI revised its Dentists (Code of Ethics) Regulations in 2014 (hereinafter referred to as dentists regulations 2014) [3]. The changes incorporated included details on the duties and obligation of dentists in general, duties of dental practitioners to their patients, duties of dental surgeons and specialists in consultations, responsibilities of dental surgeons to one another etc [5]. The DCI requires dentists to read, understand and abide by these regulations [1, 2, 3].

Dental jurisprudence is a set of regulations related to the practice of dentistry. Among the laws affecting dental practitioners in specific situations [6] is the Consumer Protection Act (COPRA) which came into force in 1986 to safeguard the interests of consumers [7, 8, 9]. COPRA was revised in 2019, including amendments on the jurisdiction for complaints, claims for compensation at various stages, the period for appeal against the district forum’s order, and the national level regulator dealing with matters relating to violation of consumers’ rights [10]. The rise in health literacy among patients has led to an increase in malpractice cases against dental practitioners [4]. Understanding medico legal issues would protect them against such litigation [6, 7, 8, 9].

Dentists receive little formal training in healthcare ethics during their education and must rely on their own experiences and those of their senior colleagues [1]. Sometimes ethical issues take a back seat as they struggle to succeed in a competitive field and make enough money to recover the expenses of their dental education loan and the even higher costs of setting up a clinical practice [11]. This has a significant impact on patients [1]. An understanding of ethical and legal concerns is the foundation of responsible dental practice; this requires becoming familiar with existing regulations [1, 12]. To our knowledge, the literature is scarce on dentists’ awareness and practice of the dentists regulations 2014 and COPRA 2019. We therefore undertook this study to evaluate dentists’ awareness and practice of the revised code of dental ethics and consumer protection act among dental practitioners in Andhra Pradesh state, India.

Methods

A cross sectional study was conducted to assess the awareness and practice of the dentists regulations 2014 and COPRA 2019 among dental practitioners in Andhra Pradesh. The institutional ethics committee of Vishnu Dental College approved the study protocol with reference number IECVDC/2021/F/PHD/Q/101. A non-probability sampling procedure was employed in selecting the study population. The study was conducted from April 2022 to September 2022. The sample size was calculated by considering the single proportion formula by assuming a 95% confidence interval, 1.96 standard normal variables (Z score) with a 5% margin of error, it was calculated that a minimum of 384 participants were required for the study. Participants were told about the nature and objectives of the study, and written informed consent was obtained from them before they started filling out the questionnaire.

A self-administered questionnaire was developed after a brainstorming session with two experienced dental researchers in three discrete review rounds. When there was a disagreement, expert opinion was sought to reach a consensus. The questionnaire was kept short and had only closed-ended questions to maximise participation. To determine the questionnaire’s reliability and validity, we conducted a pre-test with 75 dental practitioners, who were asked to rate the questionnaire’s clarity, writing style, question sequence, and internal consistency. Internal consistency was assessed using Cronbach’s alpha (α = 0.82) and was found to be good. The population of pre-testers included differences in age, gender, dental specialty, and experience. Pre-testers were precluded from the final analysis to avoid response bias. The questionnaire was designed to assure the anonymity of the participants with no declaration of personal identification data.

A questionnaire was developed based on the dentists regulations 2014 and COPRA 2019 [5, 10]. The first section of the questionnaire consisted of demographic details including age, sex, qualification, and years of clinical practice. The second section consisted of 25 questions related to awareness and practice of the dentists regulations 2014 and COPRA 2019. Statistical analysis was done using IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. Percentages were calculated for the responses given by dental practitioners.

Results

Table 1 shows the demographics of the study participants. Out of 384 dental practitioners, 195 (50.8%) were men and 189 (49.2%) were women. A significant portion of the participants (284, 74%) held master’s degrees. The age of the participants ranged from 25 to 65 years, with a mean age of 38.46 (standard deviation = ± 11.71) years. More than half of the dental practitioners (214, 55.7%) had less than 5 years of clinical practice.

Table 1: demographics of the study population (n=384)

Characteristics	Category	Number (%)
Gender	Men	195 (50.8%)
	Women	189 (49.2%)
Qualification	Bachelor of Dental  Surgery	100 (26%)
	Master of Dental Surgery	284 (74%)
Years of practice	0-5 years	214 (55.7%)
	6-10 years	109 (28.4%)
	>10  years	61 (15.9%)

Table 2 shows the awareness of dentists regulations 2014 among dental practitioners. Very few dental practitioners (53, 13.8%) were aware of the dentists regulations 2014 but the majority (265, 69%) knew that the regulations were made by the DCI. The majority (321, 83.6%) of dental practitioners understood the need for preserving patient records. However, nearly half of them (159, 49.5%) were aware of the precise period for mandatory preservation of patient records. Nearly half of dental practitioners (190, 49.5%) did not know that it was unethical to use abbreviations of memberships in associations or organisations as a suffix. A correct response to the question concerning regulations about free consultations for fellow dentists and their families was provided by 224 (58.3%) participants. When asked about the hiring of an agent, the majority of dental practitioners (267, 69.5%) thought it was unethical. One quarter of participants (97, 25.3%) held that dentists should be allowed to advertise, and offer discounts and financial benefits to patients. The majority (280, 72.9%) considered it unethical to mention their names on commercial products such as toothpaste and toothbrushes. When asked whether dentists were required to provide standard care to patients who have a cardiac episode, and whether they were supposed to have training in or basic life support, the majority of them (309, 80.5%) responded correctly, that this was required. Almost all dental practitioners (370, 96.4%) considered it unethical to refuse treatment to patients on grounds of their colour, caste, religion, nationality or because they had an infectious disease.

Table 2: Responses for questions related to awareness regarding the Revised Dentists (Code of Ethics) Regulations among dental practitioners.

S.No	Questions	Response  N(%)
1	The dentist (code of ethics) regulations first came into force in the  year?  a)  1948  b)  1958  c)  1976  d)  2022	275(71.6%)  39 (10.2%)  46(12%)  24 (6.2%)
2	The dentist (code of ethics) regulations were revised in the year?  a)  1948  b)  1958  c)  2014  d)  2022	7(1.8%)  26 (6.8%)  53(13.8%)  298(77.6%)
3	The dentist (code of ethics) regulations were given by  a)  Indian Council of Medical Research  b)  Indian Council of Dental Research  c)  Indian Dental Association  d)  Dental Council of India	0(0%)  41(10.7%)  78 (20.3%)  265 (69%)
4	According to the code of ethics, is preserving patient records  required?  a)  Yes  b)  No	321(83.6%)  63(16.4%)
5	If yes, what is the minimum period for the preservation of patient  records? (n=321)  a)  3  b)  4  c)  5  d)  6	159(49.5%)  55(17.1%)  64(20%)  43(13.4%)
6	Dentists are allowed suffix their names with abbreviations  indicating their membership in associations or organizations.  a)  Yes  b)  No	190(49.5%)  194(50.5%)
7	Is it mandatory to provide free consultations to other dentists and  their family members?  a)  Yes  b)  No	160(41.7%)  224(58.3%)
8	Dentists can use any agency or canvasser to attract patients in a  commercial manner  a)  Yes  b)  No	117(30.5%)  267(69.5%)
9	Dentists are allowed to advertise or disseminate press releases  about incentives, discounts, and benefits.  a)  Yes  b)  No	97(25.3%)  287(74.7%)
10	Dental surgeons’ names can be used to mark commercial  products like toothpaste, toothbrushes, and mouthwash.  a)  Yes  b)  No	104(27.1%)  280(72.9%)
11	Dental surgeons are required to provide standard care, such as  resuscitation in the event of cardiac events, and to possess  sufficient training in basic life support.  a)  Yes  b)  No	309(80.5%)  75(19.5%)
12	Dental surgeons have the right to deny treatment based on a  patient’s race, caste, religion, nationality, or the existence of  contagious diseases like HIV, HPV etc.  a)  Yes  b)  No	14(3.6%)  370(96.4%)

Table 3 shows the extent to which dental practitioners follow the code of ethics. Gifts or cash commissions from laboratories, radiologists, or pharmacists are accepted by 278 (72.4%) dental practitioners. More than half of the practitioners (206, 53.6%) had never provided patient case summaries when referring a patient to a specialist. A majority of dental practitioners (306, 79.7%) had unregistered dental lab technicians as employees. In addition, 297 (77.3%) practitioners either provided or sold drugs to patients in the clinic or office. The majority of dental practitioners (335, 87.2%) provided their patients with the necessary information regarding diagnosis, treatment, outcomes, costs, etc.

Table 3: Responses to questions related to the practice of Revised Dentists (Code of Ethics) Regulations 2014

S.No	Questions	Response (%)
1	Have you received any gifts/vouchers from a  lab/radiologist/chemist in exchange for referring your patients?  a) Yes  b) No	278(72.4%)  106(27.6%)
2	When sending a patient to a specialist for more complex care, do  you give them a case summary?  a) Yes  b) No	178(46.4%)  206(53.6%)
3	Is the lab technician a qualified and registered dental auxiliary  following the DCI norms?  a) Yes  b) No	78(20.3%)  306(79.7%)
4	While prescribing medicines to patients, do you explicitly state  the drug’s proprietary formula and generic name?  a) Yes  b) No	204(53.1%)  180(46.9%)
5	Before providing dental services to a patient, do you provide them  with necessary information related to  diagnosis/treatment/outcomes/costs, etc?  a) Yes  b) No	335(87.2%)  49(12.8%)
6	Do you supply or sell drugs to your patients in the clinic/office?  a) Yes  b) No	297(77.3%)  87(22.7%)

Dental practitioners’ awareness of the COPRA 2019 is shown in Table 4. Half (194, 50.5%) were unaware of the COPRA 2019 regulations. When asked about the compensation limit under the district forum, 150 (39.1%) participants responded correctly that it was up to Rs 1 crore. Only 156 (40.6%) were aware that health services were not excluded from the Act. The majority (238, 62%) were not aware of the deadline for appealing a district forum decision. About 196 (51%) were aware of professional indemnity insurance coverage as a protection against the financial consequences of legal liabilities. A very small percentage (57, 14.8%) were aware of the establishment of the Central Consumer Protection Authority as the regulator dealing with issues connected to consumer rights violations.

Table 4: Responses for questions related to awareness regarding the revised Consumer Protection Act 2019.

S.No	Questions	Response (%)
1	Are you aware of the new Consumer Protection Act of 2019?  a)  Yes  b)  No	190(49.5%)  194(50.5%)
2	The territorial jurisdiction to complain is  a)  Where the service provider has an office  b)  Where the complainant resides or works	237(61.7%)  147(38.3%)
3	As per COPRA 2019, the district forum can entertain a claim for  compensation up to?  a)  20 lakhs  b)  1 crore	234(60.9%)  150(39.1%)
4	Are health services excluded from the COPRA?  a)  Yes  b)  No	228(59.4%)  156(40.6%)
5	The period for appeal against the order of the district forum is  a)  30 days  b)  45 days	238(62%)  146(38%)
6	Are you aware of professional indemnity (repayment)  insurancecoverage?  a)  Yes  b)  No	196(51%)  188(49%)
7	What is the national-level regulator dealing with matters relating  to the violation of the rights of consumers, unfair trade practices,  and false or misleading advertisements?  a)  National Consumer Dispute Redressal Commission  b)  Central Consumer Protection Authority	327(85.2%)  57 (14.8%)

Discussion

To our knowledge, this is the first study to assess awareness and practice of the dentists regulations 2014 and COPRA 2019 among dental practitioners in Andhra Pradesh state, India. When addressing unethical behaviours, the recently introduced regulations discourage dentists from engaging in practices such as advertisements, solicitation, publicity, patent and copyright involvement, operating open chemist shops, offering rebates and commissions, promoting secret remedies, endorsing products, establishing connections with pharmaceutical companies, and accepting gifts etc. [5]. Despite the mandate for dental practitioners to comprehend and adhere to these ethical guidelines, nearly half of the dental practitioners were unaware of many aspects of the revised regulations. These findings were similar to studies conducted in Chennai [6], Delhi [13] , Pune [14], Bangalore [15] and Mathura [16]. In this context, dental ethics education should be an integral aspect of training dental professionals at the undergraduate level. Dental practitioners can also enrol in courses in dental ethics offered by continuing dental education programmes [17].

Dental practitioners reported awareness of some revised regulations such as the ban on refusal of treatment on grounds of race, colour, and presence of an infectious disease; the need to provide standard care in case of cardiac episodes, and the ban on permitting the use of one’s name on commercial products like toothpaste and toothbrushes. Similar findings were reported in a study conducted by Chopra [13] . These findings may be a result of dental practitioners’ knowledge, varying levels of training, and practice experiences. Another possible reason is that dental practitioners who had encountered ethical dilemmas may have explored other sources of knowledge, such as seminars or workshops for their improved awareness of it [18].

On the other hand, when asked about COPRA 2019, more than half of the dental practitioners in this study were unaware of the revised act and the various regulations under it. These findings were in sharp contrast to the study conducted in Ghaziabad [19], in which 84.8% of the respondents were aware of COPRA, 1984 regulations. A study conducted by Singh et al [20] revealed that awareness of medico-legal issues was higher among medical professionals compared to dental professionals. Similarly, low awareness was reported by dental professionals in Chennai [21], Pune [22] and Gujarat [23]. Because there is limited literature on the COPRA 2019, comparisons were made with awareness levels of the COPRA 1984 regulations and hence should be interpreted with caution. As consumer awareness is emerging, dental practitioners need to have updated and adequate knowledge about COPRA 2019, to provide quality care and prevent legal disputes [24, 25].

It is important to consider the limitations of the present study. There was no actual judgement of awareness and practices as the study was based on subjective assessment. The findings may not be generalisable since the study was restricted to dental practitioners in Andhra Pradesh state. Further, the study participants were not representative of dental practitioners in Andhra Pradesh because of the convenience sampling procedure. Another limitation was the possible “recall bias” of participants. Keeping in view the above limitations, a nationwide survey with a representative sample of dental practitioners is recommended to better understand the awareness and practice of the dentists regulations 2014 and COPRA 2019.

The present study concluded that participants had sparse knowledge about dentists (code of ethics) regulations 2014 and consumer protection act 2019. It underlines the need for specific programmes and training methods for dental practitioners to promote awareness of revised regulations of ethics and law. The curriculum for dental education at the undergraduate level must place more emphasis on ethical, legal, and judicial issues related to clinical practice. This would help in developing acceptable ethical and legal behaviour among dental practitioners while providing quality care to patients.

Conflict of interest: None to be declared

Funding: This research did not receive funding.