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 Table of Contents  
ORIGINAL ARTICLE
Year : 2023  |  Volume : 16  |  Issue : 1  |  Page : 137-141

Evaluating the validity of the National List of Essential Medicines 2015 for “anesthetic agents” in 2022: An observational cost analysis


Department of Medicine, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India

Date of Submission17-Jun-2022
Date of Acceptance25-Jul-2022
Date of Web Publication21-Jan-2023

Correspondence Address:
Mr. H Shafeeq Ahmed
Bangalore Medical College and Research Institute, K.R Road, Bangaluru - 560 002, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/kleuhsj.kleuhsj_464_22

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  Abstract 


BACKGROUND AND AIMS: The concept of essential medicines (EMs) was introduced in 1977 by the World Health Organization. The most recent National List of EMs (NLEM) is the NLEM 2015, comprising 376 drugs. The following study was undertaken due to the lack of similar studies conducted on anesthetic agents and aims at evaluating “Section 1 – anesthetic agents” of NLEM 2015 and the relevance of EMs in India.
MATERIALS AND METHODS: The study takes into account the drugs under Section 1 anesthetic agents. Data were collected from MedGuideIndia, a database of medicines marketed in India. Both cost ratio and percentage cost variations were calculated.
RESULTS: Under Section 1 – anesthetic agents, atropine 1 ml injection (0.6 mg/1 ml) at 654.72% and lignocaine + adrenaline 30 ml injection has the lowest percentage cost variation at 6.26%. It was identified in the current study that the average percentage cost variation and cost ratio of all the 24 variations of the drugs is 164.51% and 2.64%, respectively. 1.3 – preoperative medication and sedation for short-term procedures have the highest price variation drug, atropine and 1.2 – local anesthetics have the lowest price variation drug, lignocaine + adrenaline.
CONCLUSION: This study mainly discusses the large price variations comparing the lower versus the higher priced branded variants under Section 1 anesthetic agents. Appropriate physician education is required and newer pricing regulations require enforcement.

Keywords: Anesthesia, critical care, pain, pharmacoeconomics


How to cite this article:
Ahmed H S. Evaluating the validity of the National List of Essential Medicines 2015 for “anesthetic agents” in 2022: An observational cost analysis. Indian J Health Sci Biomed Res 2023;16:137-41

How to cite this URL:
Ahmed H S. Evaluating the validity of the National List of Essential Medicines 2015 for “anesthetic agents” in 2022: An observational cost analysis. Indian J Health Sci Biomed Res [serial online] 2023 [cited 2023 Jan 28];16:137-41. Available from: https://www.ijournalhs.org/text.asp?2023/16/1/137/368326




  Introduction Top


The concept of essential medicines (EMs) was introduced in 1977 by the World Health Organization.[1] EMs are those which satisfy the priority health-care needs of majority of the population. They are selected while keeping in mind the specific needs toward the public health relevance, emphasis on efficacy and safety, and comparative cost-effectiveness. EMs are intended to be available with the context of a functioning health-care system with having adequate amounts in the appropriate forms, strengths, and qualities at all times, with assured quality and at a price that the individual and the community can afford.[2]

With the development of the first list of EMs, the National Essential Drugs List in 1996, which was revised in 2003 as the National List of EMs (NLEM).[3] The most recent NLEM is the NLEM 2015, comprising 376 drugs.[4] The main aim of the NLEM 2015 is to ensure that the medicines in NLEM 2015 are available at affordable costs and with assured quality. The medicines used in the various National Health Programmes and emerging and reemerging infections should be addressed in the list.[5]

Acute and chronic pain control is a significant clinical challenge that has been largely unmet. Local anesthetics are widely used for the control of postoperative pain and in the therapy of acute and chronic pain. While a variety of approaches are currently used to prolong the duration of action of local anesthetics, an optimal strategy to achieve neural blockage for several hours to days with minimal toxicity has yet to be identified.[6] According to the NLEM 2015, Section 1 – anesthetic agents, there are three categories under this which are 1.1 – general anesthetics and oxygen, 1.2 – local anesthetics, and 1.3 – preoperative medication and sedation for short-term procedures.

Due to the lack of relevant studies conducted on the same, and with the focus on evaluating the relevance of EMs in India according to NLEM 2015, almost 7 years after its release, the current study was conducted.


  Materials and Methods Top


The study is of an analytical variety and does not use animals and/or human participants. The study takes into account the aforementioned Section 1 – anesthetic agents, under this which are three classes, 1.1 – general anesthetics and oxygen, 1.2 – local anesthetics, and 1.3 – preoperative medication and sedation for short-term procedures.

In the current study, all drugs that were in the NLEM 2015 in purely the inhalation form were excluded completely. Only quantifiable methods, which are oral and parenteral were included, as these can be calculated, but inhalation drugs are given based on individual patients' specifications.[7],[8],[9] All other drugs were included, other than any drug variant either in the form of dose or formulation which did not have a competing brand with or without a different price was excluded from the study. On the basis of the above, 1.1.1 halothane, 1.1.2 isoflurane, 1.1.4 nitrous oxide, 1.1.5 oxygen, and 1.1.7 sevoflurane were completely excluded from the study.

Data were collected from MedGuideIndia, a nonprofit online website which collects up-to-date information on various aspects of health care, drugs, and insurance.[10]

The cost in Indian Rupee (INR/₹) of the different branded generic drugs of the same formulations and combinations were collected and compared. The study conducted the cost ratio comparison using data from the abovementioned sources. Cost ratios are defined as the ratio of prices of the highest priced branded generic formulation and lowest priced branded generic formulation of a drug with the same formulation, dose, and dosage forms.[11] Cost ratios give us the data on the number of times more the most expensive formulation is priced in comparison to the cheapest formulation.

The cost ratio was calculated using the following formula:



The percentage cost variation was calculated using the formula:



Both cost ratio and percentage cost variation are taken to two decimal points.

Data obtained was then analyzed using descriptive statistics.


  Results Top


Data collected from the previously mentioned sources was analyzed, tabulated, and graphed. A total of 24 variations of the drugs were considered, seven under 1.1 – general anesthetics and oxygen, eight under 1.2 – local anesthetics, and nine under 1.3 – preoperative medication and sedation for short-term procedures. The cost ratios and percentage cost variations were then further analyzed and compared.

[Table 1] contains the drug generic names, dose, formulation, maximum and minimum branded generic prices, and the percentage cost variation, calculated using the formula mentioned.
Table 1: Drugs, dose, formulation, highest and lowest priced variants, and percentage cost variation of anesthetic agents in the National List of Essential Medicines 2015

Click here to view


Under 1.1 – general anesthetics and oxygen, ketamine 10 ml injection (10 mg/1 ml) has the highest percentage cost variation at 476%, followed by ketamine 10 ml injection (10 mg/1 ml) at 316.67%. Thiopentone 0.5 g 1 vial has the lowest percentage cost variation at 74%, followed by propofol 50 ml injection (10 mg/1 ml) at 80.91%. [Figure 1] represents the cost ratios of the drugs under 1.1 – general anesthetics and oxygen.
Figure 1: Cost ratios of medicines under Section 1.1 – general anesthetics and oxygen

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Under 1.2 – local anesthetics, bupivacaine 20 ml injection (0.5%) has the highest percentage cost variation at 418.79%, followed by lignocaine + glucose 4 ml injection at 340.59%. Lignocaine + adrenaline 30 ml injection has the lowest percentage cost variation at 6.26%, followed by prilocaine + lignocaine at 16.82%. [Figure 2] represents the cost ratios of the drugs under 1.2 – local anesthetics.
Figure 2: Cost ratios of medicines under Section 1.2 – local anesthetics

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Under 1.3 – preoperative medication and sedation for short-term procedures, atropine 1 ml injection (0.6 mg/1 ml) has the highest percentage cost variation at 654.72%, followed by glycopyrrolate 10 ml injection (0.2 mg/1 ml) at 175%. Morphine 1 ml injection (10 mg/1 ml) has the lowest percentage cost variation at 42.86%, followed by midazolam 10 ml injection (1 mg/1 ml) at 45.38%. [Figure 3] represents the cost ratios of the drugs under 1.3 – preoperative medication and sedation for short-term procedures.
Figure 3: Cost ratios of medicines under Section 1.3 – preoperative medication and sedation for short-term procedures

Click here to view



  Discussion Top


It is common knowledge that the NLEM 2015 has not been revised in almost 7 years, since 2015. The last revision was done after 2011 in 2015, on the basis of an order issued by the Supreme Court of India.[3] After the revision in 2015 after 2011, several drugs were added and removed yet, one needs to assess whether it has maintained its purpose in current times.

It was identified in the current study that the average percentage cost variation and cost ratio of all the 24 variations of the drugs is 164.51% and 2.64, respectively. This clearly shows that certain drugs are 2.5 times more expensive than the basic generic variations. Due to the expensive nature of anesthetics, one needs to question the affordability of these medications.[12],[13],[14]

The aforementioned cost variations are definitely a cause for concern as “comparative cost-effectiveness” is one of the core principles of EMs since 1977, and 45 years since, we need to assess if whether the NLEM 2015 is able to fulfill one of its core principles.

In India, studies evaluating the costs of the independent medications used for anesthesia, may it be generalized or local, are lacking. Moreover, since anesthesia is an important aspect of modern practice, both in medicine and especially in surgery, its evaluation is of utmost importance. For this reason, this study was undertaken to compare the cost of different brands of drugs under Section 1 of the NLEM 2015.

With the economical impact of the COVID-19 pandemic lasting more than 2 years, the financial issues attributed to patients have further increased.[15] Higher medication costs have been found to be a reason for medication nonadherence and have been found to be related to an increase in adverse health outcomes. Medication noncompliance can be one of the single most common reasons for treatment failure. Noncompliance of the drug therapy results in the progression of the disease which increases the overall medical care costs dramatically.[16],[17]

This study further necessitates the intervention by the appropriate pharmaceutical authorities, the Central Drugs Standard Control Organisation (CDSCO), and the National Pharmaceutical Pricing Authority (NPPA). The main goal of the NPPA is to be a “Regulator for pricing of drugs and to ensure availability and accessibility of medicines at affordable prices,” as stated by them.[18],[19]

The Drug Price Control Order (DPCO) is an order issued by the Government of India, to fix the prices of drugs in the Indian market. Drugs which come under the DPCO cannot be sold at a price higher than that which has been fixed by the government. In India, in 1979, 80%–85% of the drugs in the market were under price control, and in recent years, this number has slowly decreased, and by 2002, only 15%–20% of drugs were under price control.[20]

Appropriate physician education is also needed among anesthesiologists to ensure that expensive variants are not unnecessarily prescribed to patients while ensuring adequate evaluation of a patients' financial background while considering anesthetics. This article also gives scope for future larger-scale studies to be conducted and at the same time allows the potential for conducting an international study.

Another limitation of the NLEM 2015 is that several formulations, doses, and dosage forms available in the market were excluded from the list.[4] This is further worrying and needs appropriate rectification by the core committee responsible for drafting the NLEM. One of the advantages of the current study is that it explores a new approach toward analyzing the costs of anesthesia medications while using appropriate government documents. The only demerit in this study is the selectivity in the identification of medications, only using those in the NLEM 2015, and the exclusion of inhalation type general anesthetics.


  Conclusion Top


This study mainly discusses the large price variations comparing the lower versus the higher priced branded variants under Section 1 – anesthetic agents. Increased treatment adherence can be ensured by maintaining appropriate pricing regulations and requisite price caps. This study essentially reasons out the need for the CDSCO and NPPI to intervene and appropriately modify the NLEM 2015, and introduce stricter rules and regulations while ensuring that the appropriate price caps are both enforced and maintained for EMs.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Das M, Choudhury S, Maity S, Hazra A, Pradhan T, Pal A, et al. Generic versus branded medicines: An observational study among patients with chronic diseases attending a public hospital outpatient department. J Nat Sci Biol Med 2017;8:26-31.  Back to cited text no. 17
    
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