Pharmacy-based dispensing of antimicrobial agents without prescription in India: appropriateness and cost burden in the private sector

Antimicrobial drugs without prescription can be obtained with ease from over two-thirds of the randomly sampled pharmacies and drug stores in our city. Our study results indicate that antimicrobial dispensation takes place with scant consideration for possible adverse effects and drug interactions, and the dose and duration or both are frequently not addressed. The choice of antimicrobial is often inappropriate, and the use of irrational combination antimicrobials is rampant. Such an amalgam of potent factors can predispose profoundly to adverse public health issues such as increasing community antimicrobial resistance and escalating costs of healthcare. The urban healthcare market in India is characterized by a supply of drugs through a plethora of small businesses and private providers of health services; these drug shops and pharmacies are commonly found in all Indian communities down to town level where common practices prevail [16]. Owing to the similarities in market practice with reference to drug sales and prescribing practices, our findings may be applicable to other Indian urban and semi-urban areas.

Antimicrobial agents remain one of the most commonly purchased drugs globally. A systematic review showed that non-prescription use occurred worldwide and accounted for 19–100 % of antimicrobial use in countries other than those in northern Europe and North America [17]. The sale of antimicrobials is largely unregulated, without involvement of a licensed trained pharmacist, and is often without prescription [17]. Drug stores and pharmacies in India and other parts of Asia are fast becoming substitutes for primary healthcare providers in urban areas [18]. Studies from other parts of the world with poor regulation of drug-dispensing policies show variable rates of non-prescription antibiotic sales. A Greek study in 2001 showed that 71 % of pharmacies agreed to sell broad-spectrum antibiotics to patients with low-grade fever and rhinosinusitis [19]. Several other simulation studies conducted in Spain and Brazil have shown that antimicrobial agents could be easily obtained in spite of regulations prohibiting such practice [20, 21]. In Tanzania, oral antibiotics were given to 81 % and 95 % of those who presented with diarrhea and upper respiratory infection respectively [22]. Other Indian studies particularly indicate alarming prevalence of inappropriate antibiotic consumption [5, 23, 24]. Our study used simulated illnesses that were most likely viral in etiology, and therefore showed that antimicrobials obtained without prescription were often not appropriately dispensed. Other assessments have indicated dispensation at sub-optimal doses and durations [5, 25]. A study of non-prescription-based sales of antibiotics by pharmacists from Thailand discovered that the closer the drug stores were to major hospitals, the more appropriate was the nature of the dispensing from those stores [26]. Widespread consumption of antimicrobials is the main force driving selection of pressure resulting in antimicrobial resistance. Communities with frequent use of antimicrobials without prescription commonly also have high community antimicrobial resistance rates [27, 28]. A study in Spain correlated the pattern of antimicrobial resistance with the community antibiotic consumption trends and found a decline in resistance with decrease in the use of antibiotics in the community [29].

What determines antimicrobial prescribing and dispensing practices among healthcare workers, pharmacists and community members in low-and-middle income countries (LMICs)? A comprehensive review indicated that factors include lack of knowledge of healthcare workers, public beliefs, demand from patients, expensive or poorly available diagnostic tests, economic influences and marketing pressures [30]. Qualitative studies from India with focus group discussion among pharmacists, doctors and the public reveal similar factors including the pressure to sell antimicrobials nearing their expiry date [7, 23]. In a survey done in Nagpur India, majority of pharmacists reported that their prime source of continuing education was from sales representatives from pharmaceutical companies [5]. A focus group discussion study among retail pharmacists in Delhi showed that commercial interests constitute a major force in driving sales of inappropriate antibiotics [23]. A community-based survey from Mongolia revealed that self-medication of antibiotics was common, particularly for childhood illnesses, and was driven by widespread misperceptions that antibiotics can ‘cure’ viral illnesses [31]. The authors concluded that one of the reasons for antibiotic misuse may be its widespread availability and poor oversight by community pharmacies [31]. Market financial incentives where antibiotics may be more profitable than more rational treatment for diarrhea such as zinc or oral rehydration solution may be another reason for widespread antibiotic dispensing [32].

In India, antimicrobials command the largest share in the Indian pharmaceutical market (18 %) [33]. We have estimated that the community’s financial burden pertaining to unnecessary antimicrobials dispensed by pharmacies in India can be over $ 1 billion. Overuse of antimicrobials represents a considerable financial burden among the less economically advanced section of the society. Equally, inappropriate use through suboptimal dosing and poor adherence can pose a tremendous cost liability from an individual and public health standpoint. In an attempt to curb the rising threat posed by the irrational sale of antimicrobials, in 2011 the Government of India amended the Drugs and Cosmetics Rule of 1945 to include certain drugs under a new Schedule H1. Currently, 46 drugs are enlisted under this category of which 35 are antimicrobial agents. For any drug under this category to be dispensed, a valid prescription is mandatory. In addition the pharmacist will have to maintain a sales record in a register with additional details like name and contact of the prescribing doctor and the quantity of the drug dispensed. This amendment may have limited efficacy in curbing indiscriminate use of antimicrobials as drugs like beta-lactam agents, older fluoroquinolones including ciprofloxacin and ofloxacin, and macrolides such as azithromycin that are most likely to be dispensed without prescription, are not included under schedule H1 [34]. In addition, studies across the globe have shown that state regulations may not be sufficient to curb the practice of inappropriate antimicrobial dispensing [35]. Although regulating sale of antimicrobials is essential to promote appropriate use, it should be only a part of a more comprehensive strategy. Other important measures include increasing awareness of rational antimicrobial use and antimicrobial resistance, and involving pharmacists as partners for creating this awareness among communities. Reports from some LMICs suggest that multi-component interventions can be successful in reducing non-prescription sale of antimicrobials. In Chile, strict legislations with simultaneous public health campaigns had an immediate and significant impact on sale of antimicrobials, while little or no effect was seen in other places such as Mexico and Venezuela where enforcement was not combined with public awareness campaigns [36]. Interventions that include different degrees of regulation and education have been shown to be effective in reducing inappropriate antibiotic dispensing by drug sellers in Vietnam and Thailand [25, 37].

Regulation of antimicrobial sales in resource-limited countries should be balanced with the prevailing healthcare burdens. A major cause of child mortality in these countries is inadequately treated infections, particularly serious respiratory infections [38]. Antimicrobials have been life saving on a broad scale, and non-prescription use may have certainly enabled wide access in these settings. A prime challenge is ensuring that truly deserving populations receive the antimicrobials they need, while at the same time restricting rampant non-prescription antimicrobial use. Achieving this balance is the task of interdisciplinary cooperative forces from governments, scientific advisory committees, public health academicians, economists and activists from many of the concerned nations.

Our study did not distinguish whether the dispensing workforce in pharmacies were licensed and trained personnel. The study was also limited by the fact that simulated cases were presented to pharmacies, rather than actual case scenarios, although this procedure helped maintain uniformity in our data collection. Since the sample size was limited, and only pharmacies from one urban area in India were included, our study may be limited by non-inclusion of other practices in rural areas, where alternative systems of medicine may be more popular. This diversity of practices was however, considered during the costing analysis. Notwithstanding these limitations, our findings bring to light an important public health problem that need to be addressed with a multi-disciplinary approach. Possible solutions to address this complex conundrum include training of pharmacists and surveillance of antimicrobial drug dispensation on a nationwide scale. Improved regulation of antimicrobial dispensing practices, coupled with appropriate market financial incentives can also help curtail inappropriate antimicrobial dispensing practices.