Nonprescription sale of schedule H1 antibiotics in a city of South India.

CONTEXT: The acquisition of antibiotic without a prescription by the general population is a typical practice found in community pharmacies across India, which is a notable contributor of antimicrobial resistance. According to the present regulation in India, sale of certain antimicrobials included in schedule H1 without prescription is unlawful. In this contest, a program was organized by the Drug Control Administration, Government of Andhra Pradesh, to educate pharmacists regarding schedule H1. AIMS: The aim of our study is to assess the impact of the program on the rate of antibiotics dispensed at community pharmacies. SETTINGS AND
DESIGN: A cross-sectional study was designed to investigate the nonprescription sale of antibiotics, from September to December 2018 through 200 community pharmacies located in and around Guntur city located in the state of Andhra Pradesh in India. SUBJECTS AND METHODS: A simulated client methodology was used in this study. A total of 3 female actors including an author of this present study are prior trained to present a standardized simulation of clinical conditions (sore throat, urinary tract infection, cold, and fever) to the pharmacist at the community pharmacies. STATISTICAL ANALYSIS USED: Microsoft excel sheet was used for data analysis.
RESULTS: The simulated patients successfully obtained antibiotic from 78% pharmacies with the highest rate of urinary tract infection when compared to other conditions. Pharmacists who objected to dispense antibiotics (22%) are found in developed locations in the city and appeared well qualified.
CONCLUSIONS: The present study revealed that the antibiotics are continued to be sold without prescription even after the education program on schedule H1. The deregulation of the act is definitely the problem to be addressed by the government.

Introduction

Globally, antimicrobial resistance (AMR) to very common bacterial infections is exponentially high in both clinical and community settings.[1] The high rate of mortality across the world accounts from acute respiratory tract infections, diarrheal diseases, measles, acquired immune deficiency syndrome, malaria, and tuberculosis. Pathogens causing these diseases reported 0%–100% of resistance to their first-line antibiotics. One of the major causes for this incidence is inappropriate use of antimicrobial drugs, leading to therapeutic failure and increase in the threshold of AMR which affects not only the individual but also the entire society.[2] The potential for the spread of resistant pathogens and superinfections increases throughout the hospitals and the community. “Combat drug resistance: no action today, no cure tomorrow” is a theme developed by WHO for World Health Day 2011.[3] Globally, antibiotic consumption is continually rising, particularly in developing countries. Despite regulations in many countries, antibiotics can be easily procured from local community pharmacies without a prescription.[4]

India is a rapidly developing country in the world, both socially and economically. In this instance, people approach community pharmacies for simple clinical conditions, like fever and common cold and seek medication for quick relief from symptoms. The pharmacists to grab the attention, popularity, or to earn money, dispense multiple drugs, with antibiotics definitely included in them. The acquisition of antibiotic without a prescription is one of the major irrational practices of community pharmacies contributing to the increased burden of AMR. Self-medication is another contributing factor for AMR. In recent years, huge production and the decline in the cost of antibiotics in India made them easily available for the public.[56]

In connection to the present scenario, many action plans have been launched in India to combat AMR. Schedule H1 and red line on antibiotic packing are one among them. Schedule H1 notification is an amendment to Drugs and Cosmetics Rules, 1945 made by Government of India with the primary intention of bringing control over dispensing antibiotics without prescription. This amendment was made in August 30, 2013 and came into force from March 2014. Totally, 46 drugs are listed under this schedule, of which 34 are antibiotics, mainly comprising of third- and fourth-generation cephalosporins, carbapenems, newer, and first- and second-line antitubercular drugs.[3]

India in 2016 advanced in the fight against AMR by introducing red line campaign on antibiotics packing. The manufactures are instructed to print a vertical red line on the antibiotic packing, which indicates that these medicines should dispense only on prescription. However, there is a need for the development of awareness regarding this issue, in the society and among healthcare professionals.[7]

The Andhra Pradesh Pharmacy Council is a statutory body constituted by the Andhra Pradesh state government under the provisions of the pharmacy act of 1948. The objective of the council is to regulate profession of pharmacy practice across the state of Andhra Pradesh. In connection with the condition of AMR, an awareness program, “Revised National TB Control Program Government of Andhra Pradesh, drugs control administration” was conducted by Andhra Pradesh Pharmacy Council. Community pharmacists from different parts of the state and pharmacy students from various colleges were invited to attend the program. In this program, the drug controller educated the attendees with AMR, schedule H1, and drug-resistant tuberculosis. All the pharmacy professionals were distributed with the schedule H1 registers as shown in Figure 1 and were instructed to follow the regulations. The main objective of our present study is to investigate the percentage of community pharmacies selling antibiotics, particularly antimicrobials listed in schedule H1, without a valid prescription from a medical practitioner.[8]

Figure 1

Schedule H1 register

Subjects and Methods

Study design

A cross-sectional study carried out from September through December 2018 in community pharmacies across Guntur city. The Guntur city is located very close to the capital of Andhra Pradesh state in India. As per provisional reports of census India, the population of Guntur is 647,508, of which male and female are 320,720 and 326,788, respectively. There are approximately 900 private community pharmacies established in urban and rural areas of Guntur. List of all pharmacies with addresses are collected from Andhra Pradesh Pharmacy Council, and the list was stratified into five main areas (North, South, East, West, and Center) of the Guntur city.[9] Randomized samples of 200 pharmacies are selected from the 5 areas to conduct the study and were given numbers from 1 to 200 and noted in the excel sheet. A separate data collection forms bearing only the number were prepared for each pharmacy. The study maintains confidentiality of names and addresses of the pharmacies, to avoid any controversies. The pharmacies located within the hospitals are not selected for our study because majorities of them are run by professional pharmacists and are busy in serving the hospital prescriptions. Most of the community pharmacies are owned by private bodies in India; hence, private community pharmacies are selected for the study.

A simulated client methodology was used in this study. A total of 3 female actors including an author of this present study are trained to present a standardized simulation of infection at the community pharmacies. The infections include sore throat, urinary tract infection, cold, and fever. At each visit, the actors quoted one infection, and with a gap of 1 week, they visited the same pharmacy and presented the other case. All the studies took a period of 3 months to complete.

Actors were trained to make every attempt to purchase the antibiotics. In the scenarios, four levels of demand were used to obtain the antibiotics. In the first-level demand, the actor addressed to the pharmacist with symptoms of infection and requested for medicine which gives immediate relief. If the antibiotic was not given, then the actor used the second level of demand: “This medication is not very strong, can't you give me some stronger medicine?” If the actor still did not receive the antibiotic from the pharmacist, then the actor openly stated the third-level demand: “I would like to have an antibiotic.” If the pharmacist gives an antibiotic other than schedule H1 drugs, then the actors directly ask the specific antibiotic from schedule H1 claiming that: I have heard specific antibiotic (from the list of schedule H1) is best for this infection, which is considered as fourth-level demand. At the end of the simulated situation, the investigators ask for the bill and would tell that he/she have not enough money right now to buy the total medicines so would come back to pick it up later.

Three actors visited the same pharmacy with a gap of 1 or 2 day's time simulating the three selected infections over the period of time. After every attempt, data collected was noted on a spreadsheet which contained a pharmacy identification number, and no other information on visited pharmacy was reported to maintain confidentiality. After completion of data collection, all the data were transferred into the main excel sheet which contained correlating the pharmacy identification numbers.

Data were analyzed and represented as percentage/proportions of the pharmacists' responses to the simulated clinical conditions. The study was prior approved by the institutional review board and considered as minimal a risk study to the human subjects. Complete disclosure of investigator entity data was kept impersonal.

Results

The simulated patients successfully obtained antibiotic from 78% pharmacies (156/200). From the study, it was found that major irrational antibiotic dispensing was found in rural pharmacies 97% (n = 80) when compared to urban pharmacy practice 74% (n = 120). The pharmacies objected to dispensing antibiotics (22%) without prescription were found located in the developed parts of the city, set up with a team of professional pharmacy staff.

Urinary tract infection

Total 152 (79.7%) community pharmacists dispensed antibiotics to the simulated patients on presentation of symptoms related to urinary tract infection. This accounted the highest percentage of sales among the 3 scenarios analyzed in this study as showed in Figure 2. The actors obtained antibiotic in 68 instances under the first level of demand shown in Table 1. Among the antibiotics sold without a prescription, most frequently sold were norfloxacin (55; 36%) and metronidazole (34; 22.3%) [Figure 3]. 10% of pharmacies sold antifungal drugs shown in Table 2. A few pharmacists (52/200) gave time to address the simulated patients and tried to provide certain non pharmacological remedies like, ingestion of more fluids which can improve UTI condition. Most of the pharmacist explained the mode of antibiotic administration (123; 81%) and the duration of the complete course. Many pharmacists asked about any other symptoms (137; 90%) and few referred to the physician when they are insisted to give antibiotic (12; 0.8%). Very few asked about whether she is pregnant (10; 0.6%) as shown in Table 3.

Figure 2

Antibiotics dispensed on levels of demand

Table 1

Clinical case presentation and sale of antibiotics

Level of demand	Clinical case presented, number of visited pharmacies (n=200)
	Urinary tract infection	Sore throat	Cold and fever	Average
Antibiotic obtained
Demand 1	76	38	13	42.3±31.72
Demand 2	45	56	56	52.3±6.35
Demand 3	31	37	85	51±29.59
Total pharmacies-sold antibiotic	152	131	154	145.66±12.74
Antibiotic not obtained	48	69	46	54.3±12.74

Demand 1=Can you give me something to improve the symptoms of the infection?, Demand 2=Can’t you give me some stronger medicine?, Demand 3=I would like to have an antibiotic

Figure 3

The antibiotics given in simulated conditions

Table 2

Antibiotics obtained by actors with simulated conditions

Prescribed antibiotic	Urinary tract infection (n=152)	Sore throat (n=131)	Cold and fever (n=154)
Norfloxacin	55	-	-
Levofloxacin*	8
Metronidazole	34	-	-
Pipemidic acid	8	-	-
Amoxicillin	16	64	36
Co-amoxiclav	22	34	8
Azithromycin	33	23
Cefixime*	6	-	56
Ciprofloxacin	3	7	38

*Schedule H1 drugs

Table 3

Pharmacist answers to the questions asked by patient on antibiotic use

Pharmacist statement explained	Clinical cases presented, number of pharmacies providing antibiotic
	Urinary tract infection (n=152), n (%)	Sore throat (n=131), n (%)	Cold and fever (n=154), n (%)	Total (n=437), n (%)
1. Explained how often to take the antibiotic	123 (81)	125 (95.4)	143 (92.8)	418 (95.6)
2. Explained duration of antibiotic treatment	123 (81)	123 (93.8)	132 (85.7)	378 (86.4)
3. Nonpharmacological counseling	52 (34)	76 (58)
4. Asked patient about other symptoms	137 (90.1)	109 (83.2)	82 (53.2)	328 (75)
5. Asked patient about previous drug allergies	0	0	0	0
6. Asked patient whether she might be pregnant	10 (0.6)	0	0	10 (0.02)
7. Referred to see a physician if there is no improvement	12 (0.8)	0	0	12 (0.02)

Sore throat

A total of 131 (65.5%) sold antibiotics without prescription in case of sore throat. However, only 28 (21%) pharmacies gave antibiotic in first-level demand and the others on second and third demands as shown in Table 1 and Figure 2. It is also appreciable that 76 (58%) pharmacists suggested salt water gargle and 69 pharmacies rejected to dispense antibiotics for this condition. Most commonly prescribed antibiotic was amoxicillin (64; 49%), followed by co-amoxiclav (34; 25%) and azithromycin (33; 25%) as shown in Table 2 and Figure 3. Most of the pharmacists asked the simulated patients about the presence of any other symptoms (109; 83.2%) and counseled them the mode of drug administration (125; 95.4%) and duration of therapy (123; 93.8%) as shown in Table 3.

Cold and fever

This simulated case came up with a positive outcome. A total of 154 pharmacies sold antibiotic for the symptoms of cold and fever. Appreciably, only 13 (0.084%) pharmacies dispensed antibiotics on first-level demand where others on the next two levels as shown in Table 1 and Figure 2. It is a good thing that many pharmacies asked to approach them back if the fever does not subside. Most commonly prescribed antibiotic is cefixime (51; 33%), followed by amoxicillin (37; 24%) and ciprofloxacin (35; 22.7%) as shown in Table 2 and Figure 3. Most of the pharmacists asked the simulated patients about the presence of any other symptoms (82; 53.2%) and counseled them the mode of drug administration (143; 92.8%) and duration of therapy (132; 85.7%) as shown in Table 3.

Drugs dispensed from schedule H1 list

In the present study, when the actors approached the pharmacies with simulated cases, many pharmacies sold the antibiotic without prescription. However, it was being Observed from Figure 3 that overall, nine different antibiotics are given for different conditions and only 2 antibiotics, levofloxacin (8) and cefixime (51), are from schedule H1 list. The present situation may be the result of awareness of camping.

Pharmacists' dispensed antibiotic

Pharmacies who sold antibiotics for different clinical conditions explained how to take the medication, but the duration of antibiotic therapy was not explained in the majority of cases. However, the majority of pharmacists asked for any other symptoms, but no pharmacist asked the simulated patients about their past allergies. Only 10 (0.064%) pharmacies asked if the patient is pregnant before the antibiotic being sold. 12 (0.08%) pharmacies referred the patient to see a physician if the symptoms does not improve. Antibiotic dispensing without prescription was observed majorly in rural pharmacies than urban pharmacies as shown in Table 3.

Pharmacies objected to selling antibiotics

Among 46 pharmacies, who have not sold antibiotics, the simulated patient asked the pharmacist about the reason for not dispensing the antibiotics. All the pharmacists tried to convince the patient, referring the problem of selling an antibiotic without an authorized prescription from the physician. A reasoned response related to health or antibiotic resistance was provided on in 6 (0.13%) pharmacies. In 3 pharmacies, the pharmacists dispensed placebo saying that it is an antibiotic.

Discussion

This is the first systematic study conducted in Andhra Pradesh state in India, to observe the status of antibiotics' procurement in community pharmacies with neither prescription nor diagnosis from the physician. However, despite certain limitations in our studies, we ended up with positive results. The actors appeared as normal customers with no knowledge regarding drugs. The actors found many people working in the pharmacy stores, but not able to inquire about the professional qualification of the person dispensing antibiotics because, it may raise suspicion.

India is one of the Asian countries in which antibiotic use for the treatment is very high. In recent years with the rise of AMR, India has launched many regulations, action plans, and awareness campaigns across the country. ICMR guidelines, schedule H1, and red line camping are some among them. However, the real challenge lies in implementation across the country by convincing all healthcare streams. With the publication of national treatment guidelines for antimicrobial use in infectious diseases by the Ministry of Health and Family Welfare, Government of India, there has been observed a reduction in antimicrobials prescribed by primary care physicians.[10] However, it is being observed that the awareness of the present regulation and red line on the packaging is not up to the mark in local private community pharmacies across the country.

The pharmacist can contribute best in this scenario. Particularly, community pharmacists who are first-port-call to the public can not only control the irrational antimicrobial dispensing but also educate the patients regarding AMR. International Pharmaceutical Federation (FIP), WHO expert committee framed good pharmacy practice guidelines stating, “the mission of pharmacy practice is to contribute to health improvement and to help patients with health problems to make the best use of their medicines.” The FIP, a global federation of national associations of pharmacists and pharmaceutical scientists, framed certain activities to be performed by hospital and community pharmacists to combat AMR.[111213]

In connection to the world scenario, the pharmacy council of India has published Pharmacy Practice Regulations (2015), duties of pharmacists toward patients. Under the new regulation, community pharmacists are being enabled to take part in health awareness and promotional activities.[14]

Several studies on the nonprescription sale of antibiotic were conducted in different parts of the world but very few in India.[1516171819]

In our study, we came across many antibiotics packed with red line were being dispensed by the pharmacist without asking for any prescription. Antibiotics such as metronidazole, azithromycin, and amoxicillin are some drugs widely dispensed in local community pharmacies; they are not being included in the schedule H1 although they reported high resistance rates. The exact situation for the present condition is not clearly evident in the regulation printed by the government of India. Except for two, all the antibiotics obtained by the actors by the simulated clinical condition are not included in the schedule H1 of Drugs and Cosmetics Rules of 1945. However, all the drugs bear red line on their packing. There is a need for answers to many questions regarding these issues. The present study is a small attempt to test the impact of the changed regulation in the country. It is a short study with randomly picked pharmacies. However, further studies are required to test the complete sample population.

Conclusions

India is a rapidly developing country with development in various sectors including health care. This is evident by the latest regulations made by the Indian government in drug safety and stood in the path of global health care development and concerns.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.