Abstract

This study is the first of its type to evaluate sources, patterns and appropriateness of antibacterial drug consumption within the Jordanian population. It uses a structured random interview to customers arriving at community pharmacy stores seeking antibacterial medication for systemic infections. Dispensed antibacterial drugs belonged to eight different main classes of systemically used antibacterial drugs in accordance with the Anatomical Therapeutic Chemical (ATC) classification system. Just less than one-half of all dispensed antibacterial drugs were without a prescription (46%), either via self-medication (23.2%) or pharmacist recommendation (23.1%). Inappropriateness in use was seen in 29.9% and 34% of the prescribed and non-prescribed (over-the-counter) antibacterial drugs, respectively. No uniformity in the treatment profile of the different treated complaints was seen. Our study shows great misuse and abuse of antibacterial drugs and hence there is a need to force regulations to control community use of antibacterial drugs and to increase awareness of the consequences of their inappropriate and uncontrolled use.

Keywords: Jordan; Antibacterial; Self-medication; OTC; Community pharmacy stores; Surveillance

Article Outline

1. Introduction

2. Methods

2.1. Settings

2.2. Antibacterial drug use data

2.3. Data collection

2.4. Data analysis

3. Results

3.1. Dispensed antibacterial drugs: sources and rationale of use

3.2. Appropriateness of antibacterial use relative to the complaint

3.3. Antibacterial class and appropriateness of use

3.4. Factors affecting the selection of OTC antibacterial drugs

4. Discussion

4.1. OTC acquisition of antibacterial drugs: percentage and appropriateness

4.2. Prescribed antibacterial drugs: sociocultural and economic perspectives and inappropriateness

4.3. Antibacterial use guidelines: implementation, availability and prospective

4.4. Limitations of the study

5. Conclusion

Acknowledgements

References

1. Introduction

A high percentage of the world's antibiotics are used in the community [1]. Uncontrolled use of these important medications can lead to substantial and serious problems with the emergence and prevalence of resistant microbial strains [2], which is a worldwide problem [3] and [4]. Resistance to antimicrobial drugs has been linked to levels of consumption [5] and [6], with evidence of a cause–effect relationship [7]. Intervention measures resulting in reduction of antibiotic consumption were found to halt and reverse the rate of emergence of resistant microorganisms [8]. Accordingly, each country must define and implement an antibiotic use policy that aims to reduce inappropriate antibiotic use, reduce antibiotic resistance and improve patient health. Detailed knowledge of antibacterial use and the prevalence of resistant strains is necessary for the definition, development and implementation of such policies [9]. Published data on the volume of community antibacterial consumption, patterns and appropriateness in Jordan are not available. Published studies that address antimicrobial use are limited. Otoom et al. [10] reported the overprescription trend of antibiotics, and another study showed that there is misuse of prescribed antibiotics [11]. No study within the literature has addressed the community use of non-prescribed antimicrobial drugs in Jordan.

Parallel to the lack of data in this area, published studies have shown that many community-acquired infections in Jordan are caused by resistant microorganisms [12], [13] and [14]. This study sought to collect data to describe the community use of antibacterial drugs within the Jordanian population.

2. Methods

2.1. Settings

The study was carried out in Amman, the capital of Jordan, where ca. 900 community pharmacy stores cater for the city's estimated population of 2 085 100 people. Legally, antimicrobial drugs are designated as prescription only medicines, acquired from community pharmacies. Whilst it is not illegal for individuals to request antibiotics over-the-counter (OTC), the Jordanian Drug and Pharmacy Law establishes that the act of dispensing antimicrobial drugs of any formulation without a prescription is a criminal offence subject to a pecuniary fine.

2.2. Antibacterial drug use data

Data on antibacterial drug use were collected using a structured random interview conducted by study researchers and third- and fourth-year pharmacy students who had been briefed about the study's aims and methods. Consecutive customers arriving at community pharmacy stores seeking antibacterial medication for systemic infections were interviewed. The interview was based on a well-structured questionnaire (Table 1), which had been pre-tested on a small pilot scale and subsequently modified to ensure that the data would provide reliable information. The questionnaire is available for review from the corresponding author upon request.

2.3. Data collection

Data were collected over a 12-month period (September 2003 to September 2004) from 20 community pharmacy stores distributed in different parts of Amman.

2.4. Data analysis

This study included antibacterial drugs used for systemic infections; antivirals, antifungals, antiprotozoans and topical antimicrobial treatments were excluded. The trade names of the dispensed antibacterial drugs were converted to their equivalent generic names using the Middle East Medical Index [15]. Each generic name was classified according to the Anatomical Therapeutic Chemical (ATC) classification system [16], as shown in Table 2.

Dispensed antibacterial drugs were assessed as ‘appropriate treatment’ or ‘inappropriate treatment’ using the methodology described in Fig. 1. The suitability of the dispensed antibacterial drug for the customer's complaint was decided using the information available in the drug leaflet.

Frequencies and percentages of appropriately treated complaints, OTC use, classes of antibacterial drugs dispensed and their appropriateness were calculated and presented. All data were entered and analysed using the SPSS package for Windows release 11.0 (SPSS Inc., Chicago, IL).

3. Results

3.1. Dispensed antibacterial drugs: sources and rationale of use

Four hundred and eighty customers were interviewed. Between them, they were dispensed 510 antibacterial drugs that included the eight main classes used for systemic infections as classified by the ATC (J01) classification system (Table 2).

The drugs were dispensed according to prescriptions from general practitioners (GPs) or specialists (53.7%), through self-medication (23.2%) and following pharmacist recommendation (23.1%) (Fig. 2). Of the prescriptions, 55.5% were written by a specialist and 44.5% were written by a GP. Of the self-medicated antibacterial drugs, 60% were based on a recent prescription for the same signs and symptoms and 40% were based on advice from a friend and/or family member or other person.

The contribution of the source of the dispensed antibacterial drug to ‘inappropriate treatment’ was 29.9% for prescription and 34% for non-prescribed drugs (Fig. 3). Non-prescribed antibacterial drugs were either self-medication or a pharmacist recommendation and represent the OTC consumption of antibacterial drugs.

The percentage of ‘inappropriate treatment’ among prescriptions written by specialists was 33.9% and among prescriptions written by GPs was 25.8%.

3.2. Appropriateness of antibacterial use relative to the complaint

Using respiratory tract infection as an example, there was no uniformity or consensus in the antibacterial drugs used to manage these complaints (Table 3). This would be expected across the prescribed treatments, but drugs from 12 different antibacterial classes and subclasses were prescribed to treat such complaints.

The appropriateness of the dispensed antibacterial drugs to the complaint varied from 36.8% to 100% (Fig. 4). Only 36.8% of the oral and gastrointestinal tract complaints were treated appropriately. Excluding complaints with low frequency of dispensed drugs (N < 20) owing to a small sample size (cardiovascular, nervous system and sexually transmitted complaints) yielded an appropriateness range of 36.8–78.2%.

3.3. Antibacterial class and appropriateness of use

Although regulations set antibacterial drugs as prescription-only medicines, 46% of the dispensed antibacterial drugs were non-prescribed, i.e. OTC drugs. The extended-spectrum penicillins (N = 96) were most frequently dispensed, mainly as self-medication (40%). They were also the drugs most frequently dispensed following a pharmacist recommendation. The other antibacterial drugs were mainly dispensed according to prescription, in the following descending order: macrolides, first-generation cephalosporins and clindamycins, second-generation cephalosporins, penicillin combination with β-lactamase inhibitors, third-generation cephalosporins, fluoroquinolones, tetracyclines, sulphonamides and trimethoprim, metronidazole, β-lactamase-sensitive penicillins and aminoglycosides. The number of dispensed β-lactamase-sensitive penicillins was equal to the aminoglycosides but they were mainly dispensed based on pharmacist recommendation (Fig. 5). The appropriateness of these antibacterial drugs varied from 40% to 94% (Fig. 6). Forty percent of dispensed aminoglycosides were appropriate whilst 94% of the dispensed fluoroquinolones were appropriate. Excluding aminoglycosides, metronidazoles, β-lactamase-sensitive penicillins, and sulphonamides and trimethoprim since the frequency of dispensing is relatively low (N < 20), the appropriateness of these dispensed antibacterial drugs will be in the range 55.6–94%.

Percentages of prescribed and non-prescribed antibacterial drugs used to treat different complaints are presented in Fig. 7. It shows the high percentage of OTC acquisition of antibacterial drugs to treat upper respiratory tract, oral and gastrointestinal tract, skin and eye, lower respiratory tract, sexually transmitted and urinary tract infections, whilst there was no OTC acquisition for the treatment of cardiovascular and nervous system infections.

3.4. Factors affecting the selection of OTC antibacterial drugs

The major influential factor on the selection of non-prescribed (OTC) antibacterial drugs was the dosage form, where the patient demand for oral dosage form contributed to 49.5% of the factors. The price of the antibacterial drug affected its choice in 45.3% of the non-prescribed dispensed antibacterial drugs.

4. Discussion

The aim of this study was to collect data reflecting the state of antibacterial drug consumption within the Jordanian community. OTC acquisition of antibacterial drugs, prescriptions for antibacterial drugs and guidelines for antibacterial use have an impact on community antibacterial use.

4.1. OTC acquisition of antibacterial drugs: percentage and appropriateness

This study has revealed a high use of OTC antibacterial drugs (46%) originating from either self-medication or pharmacist recommendations. The OTC availability of antimicrobial drugs and the structure of the Jordanian pharmaceutical market, where the average retail price for some pharmaceutical antibacterial drugs is low and therefore tends to encourage people to use antimicrobial drugs whether needed or not, are major factors contributing to this high percentage.

The percentage of appropriateness of self-medicated antibacterial drugs was relatively high and could be explained by three major factors. First, a high percentage of the self-medicated antibacterial drugs (60%) was based on a recent prescription for the current signs and symptoms, i.e. physicians indirectly contributed to these self-medicated antibacterial drugs. Second, we should not neglect the assistance of the pharmacist in the guidance of customers on the appropriate use of these self-medicated antibacterial drugs. Third, people in countries with a high percentage of acquisition of non-prescribed antibiotics are often well informed about antibiotics [17] and acquire the skill of self-diagnosing and self-medicating. Nevertheless, our study has shown that many of the self-medicated antibacterial drugs were inappropriate and this cannot be ignored. Other problems with self-medication are that self-diagnosis and buying of antimicrobial drugs in subtherapeutic quantities tend to become cultural norms in countries with few regulations on the acquisition of non-prescribed antimicrobial drugs [18], which is an essential factor in the emergence of resistance by exerting selection pressure. Also, many of the self-diagnosed infections did not need antibacterial medication, for example most of the self-medicated upper respiratory tract infections probably did not need antibacterial drugs since most are viral infections.

Although extended-spectrum penicillins are effective against many bacterial infections and are relatively safe, this does not promote their uncontrolled use (highest class of non-prescribed antibacterial drugs) since prudent use of antimicrobial drugs promotes the use of narrow-spectrum targeted drugs when appropriate in order to decrease the chance of selecting drug-resistant microbial strains.

Better control of antimicrobial use is needed, whether by forcing the current regulations or by defining and applying new regulations that allow prudent and controlled use of certain antimicrobial drugs as OTC. If new regulations that allow OTC use of certain antimicrobial drugs are to be defined, they should be based on thorough studies taking into consideration the potential benefits and disadvantages of self-medication with antibacterial drugs, the characteristics of the antibacterial drug to be used for self-medication, possible indications for self-medication with antibacterial drugs, and persons for whom self-medication with an antibacterial drug might be suitable. Until that time, current regulations must be enforced more stringently.

4.2. Prescribed antibacterial drugs: sociocultural and economic perspectives and inappropriateness

Prescribing practices are affected by sociocultural perspectives [19] as well as the price of drugs, which, in our study, influenced selecting OTC antibacterial drugs.

A physician's decision to prescribe a particular drug may be influenced by pharmaceutical promotions, independent education, pharmaceutical price and patient demand. As a consequence, multifaceted interventions are required to improve inappropriate prescribing. Continuous education for health professionals is one approach that may encourage the prudent use of antimicrobial drugs.

4.3. Antibacterial use guidelines: implementation, availability and prospective

Preparation and implementation of guidelines for antimicrobial use are essential to any antimicrobial control policies. This study has shown that there is no uniformity in the treatment of complaints such as respiratory tract infections despite the availability of international guidelines for antibiotic use. International guidelines limit the use of amoxicillin, sulphonamides and trimethoprim, doxycycline, penicillin and erythromycin for acute upper respiratory tract infections [20]. However, in our study the aminoglycosides and fluoroquinolones were the only antibacterial classes not prescribed for these infections.

Various guidelines for infectious disease treatment are available in Jordan, but there is no consensus national guideline for infectious disease treatment. Accordingly, the development of national antimicrobial use guidelines should be a national health priority issue.

4.4. Limitations of the study

Although patient interviews are an acceptable tool in medical research, it is a subjective tool that might create biases due to misunderstandings and communication barriers.

Our findings give an overall picture regarding the community use of antibacterial drugs based on pharmacy stores in Amman and might not be generalisable to the whole country. However, OTC acquisition of many antimicrobial drugs is a common practice throughout Jordan.

5. Conclusion

This study reflects on the fact that antibacterial consumption in Jordan is uncontrolled and that there is a great extent of antibacterial drug misuse and abuse. This is in part due to the availability of antimicrobial drugs as OTC drugs despite the regulations that classify them as prescription-only medicines. Antibacterial misuse and abuse were not entirely due to self-medication but also due to prescribing and dispensing mistakes of health professionals.

We recommend the development of a national antimicrobial drug consumption and resistance continuous surveillance system, a continuous education programme for health professionals on the prudent use of antimicrobial drugs, and national antimicrobial use guidelines. These should aim to decrease the extent of antimicrobial misuse and abuse as well as the selection and prevalence of antimicrobial-resistant microorganisms.

Acknowledgments

This work was supported by the Deanship of Academic Research, University of Jordan grant number 167/2002–2003. We would like to thank the referee for insightful comments and enlightening suggestions, Dr H. MacLehose (UK) for proofreading and constructive comments, and the pharmacy students who helped in data collection.