|Year : 2021 | Volume
| Issue : 2 | Page : 115-124
Questionnaire-based Pan-India survey for impact assessment of National Formulary of India
Sudhir Chandra Sarangi1, Bikash Medhi2, Ajay Prakash2, Jai Prakash3, Yogendra K Gupta4
1 Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India
2 Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
3 Indian Pharmacopoeia Commission, Government of India, Ghaziabad, Uttar Pradesh, India
4 All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India
|Date of Submission||03-May-2021|
|Date of Acceptance||08-May-2021|
|Date of Web Publication||26-May-2021|
Prof. Yogendra K Gupta
All India Institute of Medical Sciences, Bhopal, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
Objectives: The National Formulary of India (NFI), a ready reckoner for medicines among healthcare-professionals aims for promoting rational drug use. This needs periodic update based on evidence-based medicines and suggestions from end-users. This study assessed the level of awareness among health-care professionals and sought suggestions for enhancement of utility/content of NFI.
Materials And Methods: This pan-India cross-sectional, questionnaire-based survey was conducted between November-2020 and March-2021. A Google-doc-based validated questionnaire (20 questions) was circulated through E-mail/social media groups and to 311 medical institutes/hospitals/clinics across India through the adverse drug reaction monitoring centers under the Pharmacovigilance Program of India.
Results: A total of 461 participants (39-interns, 167-resident doctors, and the rest practicing physicians/doctors) affiliated to 224 institutes/hospitals/clinics had responded. About 46% respondents consulted NFI for drug-related information and 82.3% stated that NFI provides balanced unbiased information. About 95% respondents were aware of NFI's content and 76% mentioned usefulness of NFI in their clinical practice; however, 34.4% had misconceptions about NFI, 28.7% had a false belief that NFI is a legal document to safeguard health-care providers and 22.2% had never used it. Suggestions to enhance NFI's utility included digital accessibility, incorporation of information like drugs for basic medical emergencies (71.3%), disposal of expired-pharmaceutical products (38.7%), pharmaceutical price control policy (36.3%), and drug-procurement practices in hospitals (35.6%).
Conclusion: As per the survey findings, NFI is an effective tool for instant access to precise and unbiased drug-related information, and fostering rational use of drugs. Boosting its practical usefulness needs incorporation of suggested information, digital accessibility, and periodic update.
Keywords: Healthcare professionals, national formulary of India, pan-India survey, practical usefulness, rational use of drugs
|How to cite this article:|
Sarangi SC, Medhi B, Prakash A, Prakash J, Gupta YK. Questionnaire-based Pan-India survey for impact assessment of National Formulary of India. Indian J Pharmacol 2021;53:115-24
|How to cite this URL:|
Sarangi SC, Medhi B, Prakash A, Prakash J, Gupta YK. Questionnaire-based Pan-India survey for impact assessment of National Formulary of India. Indian J Pharmacol [serial online] 2021 [cited 2021 Jun 13];53:115-24. Available from: https://www.ijp-online.com/text.asp?2021/53/2/115/316949
| » Introduction|| |
The information retrieval phenomenon in the current era has achieved great importance with an almost limitless library. However, the lack of control and ease of publication signifies that a fair proportion of the information and its sources are not reliable. Similar is the case for information about medicines and the health-care system. Internet search is a close and user-friendly aid for finding medicine information; however, it often breaches the reliability of findings. The authenticity of medicine information has significant insinuations for the safety of the patient, betterment of health-care facility, roles of the state and drug regulators, established commercial and noncommercial medical institutions as well as socially committed health-care personnel who have a track record of professional achievements. This necessitates having the right tools to know genuine information about drugs.
When searching for any information, it is of utmost importance to know the source of this or who takes the responsibility for the available information. Another important factor to look for when searching for medical information is whether the information has been reviewed by an editorial board/expert committee. The sound policy requires to have a source of information that is regularly updated.
Thus, there is a need for a database/source of information that is credible and has wealth of information on a wide range of topics related to drugs/medications, including treatment strategies, medications available for a particular disease condition, their characteristics such as dose, strengths available, indications and contraindications, adverse effects, precautions, and storage conditions. It should be in a comprehensive language for advanced search options, easy to read, and friendly to search specific content. Everything on this source should be evidence-based, time tested, and following current treatment guidelines and drug regulatory status.
Drug formulary provides an imperative guidance on proper use of the medications. It acts as a foundation of right information on essential medicines for drug regulators, policy-makers, and physicians prescribing medicines. A formulary is a compilation of facts related to each medicine's clinical indications, dose, formulations, adverse effects, contraindications and precautions, guidance on choosing the proper medicine for specific conditions like hepatorenal dysfunction, pediatric, and pregnant women.
National Formulary of India (NFI) is a comprehensive document summarizing the therapeutic and pharmacological data about the listed drugs. Furthermore, this document has additional information about the handling of drugs from the manufacturer to the consumer level including storage, prescribing, and dispensing of drugs. The model of World Health Organization (WHO) formulary has been referenced while preparing and updating the content of NFI, especially keeping the prescribers, pharmacist, and consumers' role in India. Its main focus is on essential medicines. NFI has its first footprint in India in 1960 through the Ministry of Health, Government of India, followed by the 2nd and 3rd editions in 1966 and 1979. Since 2008, the responsibility of NFI is with the Indian Pharmacopoeia Commission (IPC), Ghaziabad. Subsequently, its 4th and 5th editions are published in 2011 and 2016. Currently, it is on the verge of revision for its 6th edition.
The principal objective of NFI is the promotion of rational use of medicines. Health professionals are supposed to refer this document during practice along with their professional experience, judgment, etc., while prescribing medicines or adopting treatment regimes. The references to statutory provisions/requirements, etc., in NFI are based on the status of such provisions at the time of compilation of this document. In the event of any dispute in any of the content of these documents and the statutes, the statutory provisions shall prevail.
The primary objective of NFI is to provide physicians a ready reckoner for medicines. It is also aimed to provide information about other medicines not commonly available from other sources. It also intends to promote the rational use of medicines. NFI contains comprehensive monographs of selected drugs with priority being assigned to the drugs mentioned in the National List of Essential Medicines (NLEM), National health programs, Indian Pharmacopoeia, and drugs recommended by a panel of experts. Harmonization with global standards is one of the objectives of NFI and for which its revision is corroborated through collaboration with other formularies available in the world. Revision of NFI along with its drug monographs is conducted periodically; the obsolete and undesirable drugs are excluded, the new drugs with sound evidence are included and information about existing drugs requiring up-gradation/revision are amended.
In spite of this broad mission and periodic update through expert committee, the NFI has assumed limited utility among health-care professionals. According to a previous study by Sharma et al. 2010, assessing attitude and opinion toward essential medicine formulary through a questionnaire-based survey, it has been found that 45% responded to the questionnaire and nearly 74% consulted formulary during clinical practice for obtaining medicine-related information. To fulfil the basic aim of NFI, i.e. updating medical practitioners and other health-care professionals, there is a need for introspection of the methods adopted for its proposed use and access. Programs related to information, education and communication, and research activities are needed for establishing and circulating the scope and utility of NFI-based drug information among stakeholders.
The stakeholders of NFI includes prescribers or interns (medical and dental), pharmacist or interns, nurses, and other health-care professionals, personnel involved in the supply chain management of medicaments (basic reference on drug information), and government and individual hospitals. Hence, this study assessed the level of awareness among prescribers/doctors, resident doctors, or interns (medical and dental) regarding the use of NFI, its practical information/content, and to seek suggestions to enhance practical usefulness/popularity of NFI through a questionnaire-based pan-India survey.
| » Materials and Methods|| |
This was a pan-India, cross-sectional, questionnaire-based survey among health-care professionals (prescribers or interns) (medical and dental) conducted between November 2020 and March 2021.
The study population consisted of health-care professionals (prescribers/doctors, resident doctors, or interns [medical and dental]) who can read, write, and understand the English language, has access to E-mail. The participants were recruited/contacted by E-mail. Prospective participants were identified for participation based on their location (North, North-central, Central, West, South, East, and North-east) and affiliation (government and private) from all over the country. The study was initiated after obtaining Ethical approval (IEC-1075/06-11-2020).
According to a previous study by Sharma et al., 2010 assessing attitude and opinion toward essential medicine formulary through a questionnaire-based survey, it has been found that 45% responded to the questionnaire and nearly 74% consulted formulary during clinical practice for obtaining medicine-related information. Considering the precision as 5% and the level of the confidence interval as 95%, sample size for this prevalence survey was estimated to be 296. Expecting 65% response (as compared to 45% of the previous study), the sample size for this survey was kept at 455.
The questionnaire was sent through E-mail as Google Doc. format explaining the purpose of the study to medical institutes across India through the adverse drug reaction monitoring centres enrolled under the Pharmacovigilance Programme of India (PvPI). It was also circulated through E-mail/social media groups individually by the investigators. The E-mail mentioned that it is voluntary to participate in this survey and there was no undue coercion or financial interest. The questionnaire had the initial page to fill up the name, designation, affiliation, and E-mail of the participant which served as the consent for participating in this study. The participants were given sufficient time (within 15 days) to answer the questions by striking out the most appropriate option(s) against each item and sent back the answered document by clicking submit button in the Google Doc. They were given the alternative to leave any question unanswered if desired. The collected responses in form of a filled questionnaire had undergone final analysis as Google doc. format. A completeness check and quality analysis of all the questionnaires received was carried out. The questionnaires received in an incomplete form, i.e. not having the designation, affiliation, or E-mail address of the participants were removed from the final analysis. About 10% of respondents to the questionnaires were randomly selected and contacted to check the authenticity of participation in the study.
This questionnaire-based survey used a standard and validated questionnaire. The questionnaire was developed by a group of experts and after detailed revision by the group, it was finalized. Initial validation was through its application in about 10 participants as a pilot survey. After the analysis of the pilot data, it was further modified. The final set comprised 20 questions (multiple choice type including 4 open-ended questions) about overall awareness/background regarding the use of the NFI, practical information/content of NFI, and the suggestions to enhance practical usefulness/popularity of NFI among general practitioners and the medical fraternity. The questionnaire was prepared by keeping in view the suggestions of Jayakaran, 2011.
All the questionnaires fulfilling the inclusion criteria were taken for the final analysis. The items not attempted by the respondents were removed from the final count. However, other marked items of that questionnaire were taken up in the final analysis. For the items, where multiple options are marked by the respondents against only one applicable option, all the chosen options were considered toward the final analysis. For analyzing item responses of the questionnaire, descriptive statistics were applied. The percentage of responses for each question was judged based upon the total number of responses for that question. The data were analyzed using Excel in Microsoft office and Statistical Package for the Social Sciences (SPSS, Chicago, Illinois, USA) version 23 for Windows. Data were presented as frequency (percentage).
| » Results|| |
The questionnaire has been circulated in Google-doc format to the doctors and interns in about 311 medical colleges and private hospitals/clinics. A total of 461 doctors/interns affiliated with more than 224 hospitals/institutes across the country (the affiliation of 39 respondents could not be localized) had completed the questionnaire. These include 39 interns, 167 resident doctors, and the rest as practicing physicians or doctors.
Out of the 461 respondents, 452 have mentioned consulting some database or book for ready information about medicines. Maximum (n = 251, 54.4%) have consulted Current Index of Medical Specialities alone or in combination with others while practicing for ready information about medicines. A significant number (n = 214, 46.4%) have mentioned regarding consultation of NFI alone (n = 55, 11.9%) or in combination with other resources for drug-related information [Question 1 and [Table 1]].
|Table 1: Participants' response to the questions in the survey regarding enhancement of utility of NFI|
Click here to view
Maximum respondents (n = 376, 82.3%) have opined that NFI provides balanced unbiased information about medicines, whereas 15.1% did not provide any comment. Similarly, 68.5% have opined that NFI promotes rational use of the drug, whereas 24.5% suggested that it needs to be assessed [Question 2] and [Question 3, [Table 1]].
Most of the respondents (92.9%) were aware that NFI is published by the IPC, Ghaziabad. Regarding access to NFI, there were varying opinions. About 56.6% opined for its free downloadable App and 45.5% preferred a printed version of NFI. Even practitioners are willing (20.5%) to subscribe to an upgradable version of the NFI app [Question 4 and 5 and [Table 1]].
About 76.7% have mentioned that NFI is useful (very useful or useful to some extent) in their clinical practice, though 22.2% have never used it [Question 6 and [Table 1]]. About 90.8% have information that NFI can be used as a reference document during practice for medical professionals. Although it is not under the purview of NFI, about 20.6%–33.3% have mentioned that it is a document with the chemical formula of drugs, treatment regimens for common diseases, and information about newly launched drugs in India. This is also noted down that 28.7% of respondents have a false belief that NFI is a legal document for safeguard of health care provider, whereas, actually it has no legal binding as mentioned in the NFI document [Question 7 and 8 and [Table 1]].
Most of the practitioners are aware of the content of NFI and rightly indicated that NFI contains monographs of the medicines (95.3%) and provides information regarding drugs commonly used and their indications (96%). Although 91.5% have marked that NFI has information about dose, dosage forms, and strengths, only 25.4% have rightly mentioned that NFI contains a combination of drug information such as clinical indications, dose, dosage forms and strengths, contraindications, and precautions. However, about 34.4% have given wrong reply that NFI contains information regarding brands of drugs available in the market [Question 13, 9, and 10 and [Table 1]].
The purpose of NFI has been rightly identified as rational use of drugs by 92.3%. A few participants (6.6%) have pointed that NFI promotes more popular drugs. Except for a few participants (2.4%), all others have the right information that medicines mentioned in NFI are aligned with the Essential Medicines List of WHO, NLEM of India, and Standard treatment workflow [Question 11 and 12 and [Table 1]].
Suggestions have been provided to include drugs for basic medical emergencies (71.3%), disposal of expired pharmaceutical products (38.7%), pharmaceutical price control policy (36.3%), and drug procurement practices in hospitals (35.6%) in NFI [Question 14 and [Table 1]].
To make NFI more useful about 446 of total 461 have suggested including one or other of the following: drugs used for doping (22.0%), common drug interactions (88.6%), normal values of electrolytes (17.5%), nomogram for drug titration in poor liver function test (LFT) and Karl Fischer titration (KFT) (58.1%), and drugs with potential teratogenicity (59%) [Question 15 and [Table 1]]. About 24.8% have suggested including the common brand name of drugs available in the market, 22.5% suggested for price range of available drug brands in the market, and 47% suggested both for increasing utility of drug monographs in NFI [Question 17 and [Table 1]]. Other topics suggested by more than one persons for inclusion are antidotes, nomogram/guidance for drug dosing in specific population i.e. pediatric, geriatric, pregnant, and lactating women, approximate cost and maximum price of drugs under National Pharmaceutical Pricing Authority, source/places of availability of generic medicines, off label use of drugs, biologics and biosimilars, nutraceuticals, and drugs with abusive potentials [Table 2].
|Table 2: Recommendations by the respondents regarding enhancement of utility of National formulary of India|
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About 63% are fully agreed and 30.1% agree to some extent that NFI would enrich the quality of care within a health-care facility in India, though 6.6% did not comment upon it [Question 16 and [Table 1]. The majority (97.3%) of the respondents were willing to recommend/suggest their colleagues use NFI in their clinical practice because it will promote the safe use of medicines. Similarly, about 90.2% of the practitioners/resident doctors/interns were willing to attend 1 day CME organized on NFI [Question 18 and 19 and [Table 1].
Regarding the last question in the questionnaire seeking any other comments, it has been found that the majority have mentioned it as a very useful document and need a soft copy (App based) for its use.
| » Discussion|| |
As per a recent decadal survey (2007–2017) by WHO, about a quarter of the world population (2 billion) lacks access to essential medicines leading to a cascade of health hazards including chronic pain, sustained illness, disabilities, and poor quality of life, increased morbidity and mortality. NLEM aims to improve medicine use rationally ensuring access, and availability of well-established and cost-effective medicines mentioned in this list.,
Despite the availability of NLEM, access to affordable medicines/devices is an unmet need in low- and middle-income countries including India. According to previous studies, the prevalence of potentially inappropriate medicines use worldwide ranges from 21% to 84% and some of the factors associated with this are prolonged illness, polypharmacy, gender bias i.e. female subjects, self-medication, and skewed access to the health-care facility. The high incidence of potentially inappropriate medicines not only potentiates inefficacy and safety concerns/adverse effects of medicines but also raises the health-care cost which emphasizes the need for actions to reduce their use.,
There has been considerable development toward rational use of medicines in India in recent years from government initiatives including PvPI, Free Drugs Service Initiative under National Health Mission, Pharma Jan Samadhan initiative under the aegis of Digital India program of Government of India, New Drugs and Clinical Trials Rules 2019, revised NLEM, India-2015, Pradhan Mantri Bhartiya Janaushadhi Pariyojana', Drugs (Prices Control) Order-2013, Pharmaceutical Promotion Development Scheme, Cluster Development Programme for Pharma Sector-2014, and NFI.
The drug formulary is a desk-reference manual describing the concise facts about clinical and pharmacological information of selected medicines. In addition, the information related to safe handling of medicines, storage, disposal, regulatory matters, and other facts concerned with prescribing and dispensing of drugs may also be included in this formulary. Aligning with NLEM, a national drug formulary focuses on the drugs which are required for the treatment of diseases prevalent in the country or satisfy the essentiality concept. Drug formularies can be prepared at different levels of the health system or can be at the level of individual institution/hospital/clinic specific; however, they should be aligned with NFI.
In India, the initial versions of NFI were available in 1960, 1966, and 1979 as the first, second, and third editions, respectively by the Ministry of Health, Government of India. In the later period, the responsibility of NFI publication was bestowed upon the IPC, Ghaziabad. Considering the huge expansion in the pharmaceutical sector and availability of marketed drugs in the last few decades, there is an immense need for frequent updating of this formulary. The NFI has adopted the fundamental principles of the WHO Model Formulary and being thoroughly updated keeping in view the Indian context for its content based on evidence. The recent version of NFI (5th edition, 2016) was published by IPC with 521 drug monographs and many value added Appendices. To make this formulary more user-friendly, the views of the end-users like physicians and other health-care professionals in India are of utmost importance.
The WHO has recognized Pharmaceutical and Therapeutics Committees (PTCs) in several countries for the promotion of rational use of medicines; these are also referred to as Drugs and Therapeutics Committees. One of the primary responsibilities of PTCs is formulary development and management. Enlisting medicines in formularies considers several key factors about clinical practice, ethical concerns, legal and social aspects, philosophical views, quality-of-life, safety, and economic perspectives. Decisions for inclusion and deletion of medicines should also focus on accessibility and procurement practice of drugs. Besides, periodic update of the formulary is indispensable which should consider the views of users, current changes in health-care practice, and the unmet need of the society about the use of drugs, although decisions should be based on scientific rationality.
This study was designed to congregate data regarding some of the above key influencing factors because of the forthcoming update of NFI. A questionnaire (Google-doc based) was circulated to doctors/interns across the country to learn about their practice experience and opinion toward the NFI. Among the representative sample of the doctor population, i.e., 461 participants, >95% have responded to all the questions of this questionnaire.
A significant number 46.4% have consulted NFI during clinical practice, which is one of the main objectives of NFI. As per a previous study, the survey regarding Delhi State Essential Medicines Formulary, 74% referred to this in their practice. In the current era, doctors prefer the digital version of the reference document like a mobile app or soft copy. Most of the responders are aware that NFI is published by IPC; about 56% have preferred the availability and access of NFI as a soft copy/downloadable application. This will improve the usability of NFI.
In the opinion of responders, NFI disseminates unbiased and useful information about medicines used in current health-care practice. More than 90% have opined that NFI is to promote rational use of drugs and considered it as a reference document during clinical practice. Most of them are aware of the contents of NFI, though about one-third (28.7%–34%) have the wrong information that NFI is a legal document for the safeguard of health-care workers and it contains brand name of drugs.
Several doctors have suggested that NFI should provide information about drugs for basic medical emergencies, disposal of expired pharmaceutical products, pharmaceutical price control policy, and drug procurement practices in hospitals. Similarly to enhance the utility of NFI, it has been suggested to include information such as drugs used for doping, common drug interactions, normal values of electrolytes, nomogram for drug titration in poor LFT and KFT, and drugs with potential teratogenicity. Consequently, this broad information will serve as a guide for the rational use of prescribed medicines. Commendation for prescribed medicines should only be based on evidence and simultaneously, there should be a rigorous process to optimize the use of available resources. However, limitations pertain to the ambit of recently approved medicines and recent advances of already marketed medicines for which substantial information on efficacy and safety are lacking.
The increasing health care cost vis-à-vis drug prices leads to an increment in the challenges to industry sustainability, consumers, and health-care providers, and this compels for options with value for money. Cost-effectiveness analysis is gradually evolving and will be more focused in future healthcare, especially for chronic diseases. The information of pharmaceutical pricing is a gray area for the doctor fraternity, and as per a previous study, doctors have expressed that cost information would improve their prescribing. These data favor the inclusion of pricing policy information, price range, and median value of the cost of marketed preparations of the concerned drug in the NFI, and some responders have opined in favor of this. However, it is far from feasibility to provide the price information of all medicine brands in the formulary since generic medicines are continuously being added to the market-leading to the dynamic nature of medicine brands' availability and their pricing, also the constraints of expected periodic revision of NFI. It will be worthy of providing the information about drugs price control policy, the median price with a range of commonly prescribed medicines with mention of the period of its assessment.
Although this questionnaire was circulated to most of the health-care facilities across the country including medical institutes, private hospitals, and clinics, only 461 practitioners/resident doctors/interns have responded. It may be because others were reluctant to contribute due to time constraints, work pressure, or not following the NFI which is available as hard copy in the current digital era.
| » Conclusion|| |
In terms of responses, the majority of respondents considered NFI an effective tool for instant access to drug-related information such as therapeutic indications, dosage and availability of formulations, strengths, and safety aspects of commonly prescribed medicines. The information provided in the NFI is considered precise, unbiased, and simple, making it reader-friendly and handy. Several key suggestions were assimilated for improvement and enhanced practical usefulness of the NFI. In general, the view was to make the NFI digitally accessible which will reduce the time spent in choosing medicine with optimal efficacy and safety. As this document is considered by the majority of respondents to be a key source of medicines information, so its periodic update, introspection, and collating users notions akin to this pan-India survey is vital for achieving the goal of NFI.
- To achieve the goal of promoting rational drug use, National formulary of India (NFI) needs periodic update and feed back from end-users like physicians and other health-care professionals.
- This pan-India questionnaire-based survey reflected that 95% respondents were aware of NFI's content and 46.4% used this in clinical practice
- Also there are misconceptions about NFI (34.4%) and even 22.2% had never used it
- Boosting its practical usefulness needs incorporation of suggested information, digital accessibility, periodic update, and creating more awareness among health professionals.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]