THE SALE OF ANTIBIOTICS WITHOUTPRESCRIPTION IN COMMUNITY PHARMACIES INISRAEL

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FACULTY OF PHARMACY

DEPARTMENT OF DRUG TECHNOLOGY AND SOCIAL PHARMACY

EDEN ISHAKOV

THE SALE OF ANTIBIOTICS WITHOUT

PRESCRIPTION IN COMMUNITY PHARMACIES IN ISRAEL

Master‘s Thesis

Integrated study programme „Pharmacy“, state code 6011GX003 Study direction „Pharmacy“

Thesis Supervisor:

Assoc. Prof. Jurgita Dauksiene, PhD

KAUNAS‚ 2021

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LITHUANIAN UNIVERSITY OF HEALTH SCIENCES MEDICAL ACADEMY

FACULTY OF PHARMACY

DEPARTMENT OF DRUG TECHNOLOGY AND SOCIAL PHARMACY

APPROVED by

Dean of the faculty of Pharmacy Prof. Ramune Morkunienne

THE SALE OF ANTIBIOTICS WITHOUT PRESCRIPTION IN COMMUNITY PHARMACIES IN ISRAEL

Master Thesis

Thesis Supervisor

Assoc. Prof. Jurgita Dauksiene, PhD

Reviewer The thesis performed by

Name, Surname, signature Eden Ishakov

KAUNAS, 2021

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SUMMARY

Final master thesis by Eden Ishakov , supervisor PhD Jurgita Dauksiene; Department of Drug technology and social pharmacy at the Faculty of Pharmacy, Lithuanian University Of Health

Sciences- Kaunas.

Aim: To assess the sale of antibiotics without prescription in community pharmacies in Israel.

Background. Self -medication with antibiotics is defined as the acquisition of antibiotics and administrating them by own's decision in order to control and treat different infectious diseases. Incorrect antibiotic consumption has an important effect on microbial resistance. The World Health Organization (WHO) has labeled antimicrobial resistance as one of the three greatest concerns to human health.

Nationwide data on the comparative use of antibiotics in outpatient settings in Israel have only been partially collected and published. The aim of my study is to analyze the sale of antibiotics without prescription in community pharmacies in Israel.

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Methodology. In the first stage a simulated client methodology was used. A sample of 32 pharmacies were visited. Two cases of urinary tract infection were presented at pharmacies. Three levels of demand were used to convince the pharmacist to sell an antibiotic. In the second stage a qualitative interview was performed in order to assess the expertise of pharmaceutical professionals in self-medication counseling. A group of 20 pharmacists which are members of pharmaceutical society of Israel (PSI) were interviewed, the main topics which were discussed: the reasons for pharmacist refusal to dispense an antibiotic without prescription, the difficulties on counseling about self-medication and consultation of pharmaceutical specialists about self-medication

with antibiotics.

Results. Secret shopper study: It was revealed that the chances to obtain an antibiotic without prescription are low. However, the consultations which were provided by the pharmacists were collected and evaluated. The duration of pharmacist consultation was not more than 2 minutes in 50% of the total visited pharmacies.

More than half of the pharmacists have asked about allergies to any medications.

68.75% of the pharmacists, recommended the patient to buy a cranberries preparation as an alternative to the antibiotic treatment. More than 50% of the pharmacists recommended the patient to see a doctor in order to get an official prescription.

Majority of the pharmacists have inquired the patient if she felt any symptoms for the

infection and what was their duration.

Qualitative research: Pharmacist interviews have showed that the main reasons for pharmacist refusal to dispense a non-prescribed antibiotic were: to reduce the development of antimicrobial resistance, possible drug sensitivities, the prohibition to sell antibiotic without prescription and the exclusivity of the physician to give a prescription. The main difficulties during pharmaceutical consultations were lack of time and patient insistence to obtain the antibiotic.

Conclusion. The results of secret shopper research indicated that pharmacists have an important role in stopping and diminishing the development of the microbial resistance.

Overall the acquisition of antibiotics without prescription is rare in community pharmacies in Israel. The qualitative research of pharmacist interviews revealed that the pharmacists understand the importance of the regulations which stated by the ministry of health and also consulted about different alternatives.

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SANTRAUKA

E.Ishakov magistro baigiamasis darbas. Mokslinė vadovė Doc. Dr. Jurgita Daukšienė;

Lietuvos sveikatos mokslų universiteto Farmacijos fakulteto Vaistų technologijos ir socialinės farmacijos katedra – Kaunas.

Įvadas Savarankiškas gydymas antibiotikais apibrėžiamas kaip antibiotikų įsigijimas ir vartojimas jų pačių sprendimu siekiant kontroliuoti ir gydyti įvairias infekcines ligas. Neteisingas antibiotikų vartojimas turi svarbų poveikį mikrobų atsparumui.

Pasaulio sveikatos organizacija (PSO) atsparumą antimikrobinėms medžiagoms įvardijo kaip vieną iš trijų didžiausių rūpesčių žmonių sveikatai. Nėra gausu duomenų apie lyginamąjį antibiotikų vartojimą ambulatorinėse gydymo įstaigose Izraelyje ir vaistininkų svarbą antibiotikams atsparių bakterijų kultūrų formavimosi prevenciją Darbo tikslas: Įvertinti antibiotikų pardavimą be recepto Izraelio visuomenės vaistinėse.

Metodika: Tyrimas vyko 2 etapais. Pirmajame etape buvo naudojama imituota

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kliento metodika. Buvo aplankyta 32 vaistinių imtis. Vaistinėse buvo pateikti du šlapimo takų infekcijos atvejai. Įtikinant vaistininką parduoti antibiotiką, buvo naudojami trys paklausos lygiai. Antrajame etape buvo atliktas kokybinis interviu, siekiant įvertinti farmacijos specialistų kompetenciją konsultuojant savigydą. Buvo apklausta 20 farmacininkų, kurie yra Izraelio farmacijos visuomenės (PSI) nariai, grupė, aptartos pagrindinės temos: priežastys, dėl kurių vaistininkas atsisakė išleisti antibiotiką be recepto, sunkumai konsultuojant dėlsavigydos ir konsultacijos su vaistais

Rezultatai: Slaptas pirkėjų tyrima Aplankius 32 visuomenės vaistines nebuvo nevino antibiotikų be recepto išdavimo atvejo. : Vaistininkų teikiamos konsultacijos buvo ir įvertintos remianti vertinimo formos kriterijais. 50% visų aplankytų vaistinių vaistininkų konsultacijos trukmė buvo ne daugiau kaip 2 minutės. Daugiau nei pusė vaistininkų paklausė apie alergiją bet kokiems vaistams. 68,75% vaistininkų rekomendavo pacientui įsigyti spanguolių preparatą kaip alternatyvą gydymui antibiotikais. Daugiau nei 50% vaistininkų rekomendavo pacientui kreiptis į gydytoją, kad gautų oficialų receptą. Dauguma vaistininkų paklausė pacientės, ar ji pajuto infekcijos simptomus ir kokia buvo jų trukmė..

Kokybinis tyrimas: Vaistininkų interviu parodė, kad pagrindinės vaistininko atsisakymo išrašyti nereceptinį antibiotiką priežastys buvo: sumažinti atsparumo antimikrobinėms medžiagoms vystymąsi, galimą jautrumą vaistams, draudimą parduoti antibiotiką be recepto ir gydytojo išskirtinumą duoti receptą. Pagrindiniai sunkumai farmacijos konsultacijų metu buvo laiko stoka ir paciento reikalavimas

gauti antibiotiką.

Išvados. Tyrimų rezultatai parodė, kad vaistininkai vaidina svarbų vaidmenį stabdant ir mažinant antibiotikams atsparių bakterijų vystymąsi. Tyrimo metu nepavyko įsigyti antibiotikų be recepto visuomenės vaistinėse Izraelyje. Vaistininkai laikėsi Izraelio sveikatos ministerijos nuostatų. Kokybinio tyrimo rezultatai parodė, kad vaistininkai supranta šio įstatymo svarbą ir teorinius pagrindus.

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KEYWORDS

Over the counter - Over-the-counter means any drug that is sold without a

prescription [43

.[

Self- medication- It is the selection and use of non-prescription medicines by individuals’ own initiatives to treat self-recognized illnesses or symptoms [11].

Antibiotic- a chemical substance derivable from a mold or bacterium that can kill microorganisms and cure bacterial infections [43 .[

Secret shopper- Is an individual who is trained to visit a pharmacy or drug store to enact a scenario that checks a specific response of the pharmacist or pharmacy staff [47 .[

Pharmacist- A pharmacist is a one of the person in health care team, and he plays a key role in providing quality healthcare and pharmaceutical care to the public [37].

Pharmacy- Pharmacy is at the heart of the healthcare system, and it plays a very vital role in servicing the essential role in patient healthcare, education, counseling and

drug discovery[37

.[

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Antimicrobial resistance- the degree of unresponsiveness of a disease-causing microorganism to antibiotics [43 .[

ABBREVATION

UTI-urinary tract infection OTC-over the counter

SPSS- statistical Package for the Social Sciences CP-community pharmacy

CDC-center for Disease Control and Prevention LMIC-Low-to-Middle-Income Country

ABR-antibiotic resistance AMR- antimicrobial resistance WHO- World Health Organization

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INTRODUCTION

Self-medication with antibiotics is defined as the acquisition of antibiotics and self- administering them [or administering them to the children] with the aim of treating a perceived infection. This practice is a worldwide problem, not only in the developing countries but also in the developed countries [21]. The unnecessary use of antibiotics exposes the community to unwarranted medication and contributes to the development of antimicrobial resistance [2]. The World Health Organization (WHO) has labeled antimicrobial resistance as one of the three greatest concerns to human health [28]. Antimicrobial resistance poses a threat not only to health security but also to healthcare quality and population safety. There are some factors that might promote the development of microbial resistance like incorrect treatment indication, choice of agent, duration of antibiotic therapy and self-medication [18]. Health professionals like the pharmacists that are most accessible to the public might have an important role in preventing or minimizing the development and spread of microbial resistance by educating patients about the potential risks of irrational antibiotic use. They also may advice, distribute and supervise the patient's care plan, therefore they have an excellent opportunity for health promotion in the community [37]. Moreover, there are some actions that might be taken in order to reduce the prevalence of microbial resistance, these actions include improving international rules on the distribution,

quality and use ofantibiotics.

In this research, we have tried to assess the opportunity to obtain an antibiotic without prescription in community pharmacies in Israel. Moreover, pharmacist interviews were aimed to assess reasons for the pharmacist refusal to sell an antibiotic without prescription, the difficulties on counseling about self-medication and the experience of pharmacists in self-medication counseling. The results of this study will demonstrate weather there is a rational and safe dispensing of antibiotics in community pharmacies in Israel.

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AIM AND TASKS

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Aim: To assess the sale of antibiotics without prescription in community pharmacies

in Israel.

The research tasks:

1.To determine the chances to obtain an antibiotic without prescription.

2. To evaluate the consultations which are provided by the community pharmacists for patients that requested antibiotic.

3. To find out the reasons for pharmacist`s refusal to dispense antibiotics without prescription.

4. To assess the main difficulties while counselling about self-medication with antibiotics.

1. LITERATURE REVIEW

1.1Antimicrobial resistance

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Usually, antibiotics are considered prescription-only medicines and the acquisition of antibiotics in most developed countries requires a prescription. Nevertheless, a high percentage of antibiotics are used worldwide without prescriptions in the community pharmacies. Some developed countries have strict rules on antibiotic use, while in developing countries they are breeding grounds for drug-resistant bacteria because of poor supervision of antibiotic prescription [21,2].

Incorrect use of antibiotics is an important health problem. The inappropriate use of antibiotics exhibits the patients to unwarranted medication and contributes the development of antimicrobial resistance [2]. Over many years bacteria have been modified to resist the effect of natural antibacterial medications, and thus may be described as a natural phenomenon [5]. However, antimicrobial resistance was categorized by the World Health Organization (WHO) as one of the three biggest concerns to human health [28]. It was estimated that the annual fatality for infections caused by antibiotic-resistant bacteria summed to at least 50,000 in Europe and the USA alone and many more in other parts of the world [14]. More than 23,000 people died of Staphylococcus aureus and Escherichia coli bacteremia in Europe in 2007

alone [25].

Figure 1: Development and spread of antibiotic resistant bacteria [16]

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Figure 1 describes some ways of how resistant bacteria can be spread. The development of resistant bacteria might be increased when people are treated with antibiotics and the bacteria becomes resistant in the gut, unclean surfaces or toilets in the hospital, unclean hands of health care providers, and also if meat is not properly cooked.

One of the European countries-Lithuania has joined European Union surveillance programs on antibiotic resistance of clinically significant pathogens and started to perform monitoring programs on the antibiotic resistance of various infectious agents [27]. Moreover, a major reason which may lead to antibiotic resistance crisis is over- dosage and self-medication [16]. Another influential reason for the spread of antimicrobial resistance is a failure to implement infection control measures in hospitals [26]. Antibiotics that are prescribed inappropriately might contribute to the development of resistant bacteria. Studies have revealed that treatment indication, choice of drug, or duration of antibiotic therapy isn’t correct in 30% to 50% of cases [4]. The unnecessary high orders of broad-spectrum antibiotics in the hospital settings also promote extreme drug resistance development [29]. Furthermore, consecutive accumulation of multiple mutations can lead to the appearance of antibiotic resistance.

Bacteria can also obtain resistance by horizontal gene transfer or automatic mutations [15]. Antibiotic-resistant bacteria which are being hard to treat are becoming more and more common and are leading to a global health crisis, this problem might have been highly increased by self-medication [5]. Therefore, the prevalence and the risk factors associated with self-medication practices among the population should be investigated to ease the public health risks caused by incorrect practices of self- medication [11]. Improper antibiotic therapy might expose the patients to significant complications [4]. One of the EU agencies, the ECDC has the purpose of improving Europe’s defenses against infectious diseases. The European Antibiotic Awareness Day which was started by the ECDC has become a known yearly event on 18

November [45].

Figure 2 shows a growth in the number of beta-lactamase enzymes identified during the age of antibiotics. During the years 1970-1990 a steady state can be seen, in contrast, during the years 1990-2010, the number of enzymes were increased drastically. It might be presumed that the population of antibiotic-resistant strains was settled by the early 1960s in the United States where penicillin was available as over-

the-counter for 10 years[3].

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Figure 2: Numbers of unique beta-lactamase enzymes identified since the introduction of the first beta-lactam antibiotics [3

[

There are some actions that might be taken to minimize or prevent the prevalence of microbial resistance. First of all, health care professionals can play an important role in prevention by teaching people about the possible risks of antibiotic use [16].

Antimicrobial stewardship is another way to optimize the use of antimicrobials to avoid the development of resistance and enhance patient outcomes [29]. The Centers For Disease Control and Prevention (CDC) is one of the main international agencies, the CDC protects America from health, safety ,and security threats both foreign and in the U.S [44]. This agency also recommends few steps that health care providers can follow to diminish antibiotic resistance. For example: improving diagnosis, prescribing practices, therapeutic regimens ,and preventing infection transmission [4].

Also, health care professionals should be provided with tools to avoid the overuse of valuable resources, this will help to manage the growth of AMR [29]. The awareness concerning the problem of antimicrobial resistance (AMR) has been raised by the major international health groups, such as WHO and the European Centre For Disease Prevention and Control (ECDC .(

Antimicrobial resistance preset a threat to human health, health security, healthcare quality ,and population safety. The WHO has special objectives aimed at tackling antimicrobial resistance, which including enhancing international laws on the distribution, quality ,and use of antibiotics [13 .[

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Figure 3: Steps which are recommended by The Centers for Disease Control and Prevention (CDC) to reduce antibiotic resistance [44

[

Figure 3 presents us some steps which are recommended by the CDC to reduce antibiotic resistance .

1 . Preventing infections- avoiding infections would help to diminish the number of antibiotics that have to be used and reduces the probability that resistance will

develop during therapy

.

2 . Tracking- gathering data on antibiotic-resistant infections, causes of infections ,and whether there are special risk factors that caused some people to get a resistant

infection .

3 . Improving antibiotic prescribing- to change the way antibiotics are used, stopping the irrational and unnecessary use of antibiotics in people and animals would help

greatly in slowing down the spread of resistant bacteria .

4 . Developing new antibiotics- new antibiotics will be always needed to keep up with

resistant bacteria

.

5 . Improving diagnosis- new diagnostic tests to track the development of resistance .

As we can summarize there are no simple solutions to the problem of microbial Steps That

Are Taken To Minimize Antimicrobial

resistance

Preventing infections

Tracking

Improving antibiotic prescribin

g Improving

diagnosis Develpoing

new antibiotics

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resistance. However, pharmacists play an important role in educating patients about the rational and suitable use of antibiotics, their side effects, and encouraging them to stop the misuse of antibiotics. There is a necessity to discover newer antibiotics to resist drug-resistant pathogens and to decrease the death rate related to drug resistance 1.2 Self-medication with antibiotics and its risks

Self-medication is often defined as “the taking of medicines, herbal preparations or home medications on one’s initiative, or on the recommendation of another person, without consulting a physician" [6]. Self-medication can be classified as rational when taking any medication which was prescribed by a physician, and can be irrational when taking it without consulting a doctor. Antibiotics are classified as prescription- only medicines, thus self-medication with antibiotics is always irrational [8,11].

Self-medication with antibiotics is one of the most common causes for the promotion of human pathogen resistance to antibiotic medications [16]. There is a high prevalence of self-medication with antibiotics ranges from 24%-73.9% in Africa, 36.1% -45.8% in the Middle East, 29% in South America, 4% -75% in Asia as compared to developed countries where the lower frequency of self-medication with antibiotics was reported with 3% in northern Europe, 6% in central Europe, and 19%

in southern Europe. Usually, self-medication with antibiotics is found more in developing countries with weak regulatory systems [21]. Studies revealed that the prevalence of self-medication with antibiotics was 3% in Denmark, 11% in Spain, 19% in Malta, and 22% in Lithuania [46]. There are several potential risks of self- medication including improper self-diagnosis, failure to identify contraindications, risk of abuse ,and wrong selection of therapy [22].In addition, other risks are adverse drug reactions, incorrect manner of administration, incorrect dosage, masking of severe disease ,and storage in improper conditions or beyond the recommended shelf life [19]. Irrational use of antibiotics without medical supervision may also cause a greater probability of increased morbidity rate, failure to identify that the same active ingredient is already being used under a different name [6]. The poor health system and lack of professional control of pharmaceuticals in many developing countries impose people to self-medicate [8 .[

In other developing countries the health care services do not meet the standard criteria and are quite expensive, this might lead to self-medication is a simple and essential

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medical alternative [16]. Furthermore, other factors that might lead people to self- medicate include poverty, the existence and selling of medications outside pharmacies ,and extensive advertisement [23 .[

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Figure 4: Sources of information about medications [10]

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Figure 4 shows that the most common way of getting information about medication and advice was given by community drug dispensers followed by family members, friends ,and media. This study was performed by a sample of health science undergraduate students. The above data received from research conducted in Yemen,

2016 [10].

It was also suggested that many people which included in self-medication, tend to obtain knowledge and information of the practice from relatives, neighbors, medicine dealers, and sometimes media [8].In some cases, due to lack of awareness self- medication with antibiotics can cause hazardous effects such as antimicrobial resistance and health influences such as skin problems, hypersensitivity ,and allergy [6].Other consequences of self-medication can be wastage of financial resources and other health dangers which include prolonged diseases and adverse reactions [16].At the community level, incorrect self-medication might produce growth in drug-induced disease and in wasteful public expenditure [6]. Antibiotics resulted in 55.2% of all announced drug reactions from medication according to the report of the State Food and Drug Administration (SFDA) of China [21]. The community has to be always informed about the adverse effects of self-medication practices and steps to minimize should be taken [6].

Figure 5 shows the acquisition of drugs by the pharmacist or without the pharmacist.

There are various groups of OTC medications that are used by the population.

However, antibiotics are the most prevalent group which was taken without the consultation of the pharmacists. The above data was received from a study conducted in Pakistan, 2013.

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Figure5: Drugs used for self-medication[24]

Fig. 6: Reasons for self-medication [10]

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Common reasons for self-medication are presented in figure 6. The high cost of physician consultation was found to be the main reason followed by the case was not serious, and time-consuming. Additionally, several studies showed that the augmentation in self-medication occurred as a result of few factors. For example:

socioeconomic aspects, higher ability to deal with certain diseases by self-care, lifestyle, available access to medications ,and higher availability of drugs [9].

Dispensing of prescription medicines as OTC medicines which might be easily obtained from any pharmacy is another aspect that may contribute to the progress of self-medication in developing countries [16]. Other studies proved that there is an increase in self-medication practices ,especially among young patients. This can be related to socio-demographic and epidemiological factors, availability of healthcare and healthcare providers, law, society and exposure to advertisement, high level of education ,and professional state [11]. The practice of self-medication with antibiotics being reported more in developing and low-income countries where the laws and regulations are not implemented compared to developed countries [40].

As we can summarize, legislations have to be implemented by the governments to promote the rational and safe use of antimicrobials. Improved knowledge about self- medication will reduce the further development of microbial resistance and its side effects.

1.3 Role of the pharmacist in the provision of rational antibiotic use

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The pharmacist is “a person prepared to distribute and supply clinical information on medicines or drugs to doctors, nurses and patients.” Pharmacists are considered specialists in drugs and use their clinical expertise and pharmacological knowledge to assure the safe delivery and use of medicines by the patients. Moreover, pharmacists must ensure the quality of medications that are being provided to the patients [35].

Community pharmacies have an important role in the correct and safe use of antibiotics. For this purpose, a professionally qualified pharmacist should always be available in the pharmacy during working hours [37]. Pharmacists can have a positive contribution to the patient health-related with antibiotics use, including asking about possible drug-sensitivities or pregnancy, provide information about possible side effects or directing the patient to visit a doctor if it`s required and generally to increase the awareness of the public about the rational use of antimicrobials.

Furthermore, it is important to create health education programs for pharmacists which are explaining the potential risks of misusing antibiotics [32]. Community pharmacists also can play an important role in stopping the prevalence of antimicrobial resistance by supporting antimicrobial stewardship programs[41].

Community pharmacists should keep in mind that policies are defending the sale of antibiotics and there are punishments for the illegal dispensing of antimicrobials [40].

The pharmacists before dispensing the antibiotics must provide a verbal explanation on dosage or duration of treatment so that a safe and controlled antibiotic supply chain would be maintained [13]. The pharmacists as the main source of information to the consumers should provide knowledge regarding the advantages and disadvantages of self-medication with antibiotics [11]. Community pharmacies represent one of the main sources of antibiotics worldwide.

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Moreover, the attendance of a licensed pharmacist in a Chinese pharmacy was found to be a protective element for the irrational dispensing of antibiotics, which shows that the pharmacist has a highly important role in the prevention of self-medication with antibiotics. According to a study that was performed in China, it was found out main reasons for the pharmacists' refusal to dispense antibiotics without prescription were:

requesting a medical prescription, recommended referral to a physician [31].

Moreover, pharmacists are considered to be health educators rather than factors that can lead a patient to self-medicate with antibiotics. As well, the pharmacist needs to create good communication skills with the patient to provide a good pharmacy service [34]. Pharmacists could provide professional guidance and ask the customers about concomitant medicines which may expose the patients to potential risks, they are also a major source of information for the public and their functions have to be emphasized and tightly regulated and managed by health authorities [38, 10].

The pharmacist as a health care professional is the one who works on three major therapeutic elements in the community: Giving information, therapeutic counsel ,and education[6].

Figure 7 presents The concept of the “Seven-star pharmacist” was introduced by the World Health Organization (WHO) and include the following roles:

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Figure 7: World Health Organization concept of seven-star pharmacist [35]

1.Caregiver-Pharmacists have to supply caring services of the best quality, and must- see their work as integrated with other health-care providers.

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2.Decision-maker- The pharmacist must do correct decisions regarding appropriate, efficacious, safe, and cost-effective treatments.

3.Communicator- Pharmacists should have effective patient communication skills which may assist them to supply better pharmaceutical care to the patients.

4.Manager-Pharmacist should develop and maintain department policies and procedures, goals, objectives, quality assurance programs ,etc..

5.Teacher-it is important that the pharmacist will help with the education and training of future generations of pharmacists and the general population.

6.Leader-The pharmacist also has a leadership role in the healthcare system, making decisions ,and communicate with other healthcare providers.

7.Life-long-learner- Pharmacists should routinely maintain their pharmaceutical knowledge and skills in order to provide the best pharmaceutical service.

Moreover, the Royal Pharmaceutical Society of Great Britain noted that the promotion of healthy lifestyles is one of the five main roles of a pharmacist [17].

In the UK, there is an attempt to improve the role of pharmacists. Pharmacist’s role has been expanded to smoking cessation therapy, local health promotion, counseling to physicians and other healthcare providers, advice to nurses, health screening ,and diagnosis [20]. World Health Organization noted that the pharmacist is a counselor to the patients on everyday health care and is responsible to provide and deliver drugs to the consumer [12].

As we can summarizethe pharmacists as part of health professionals have a potential role in preventing the development and spread of antimicrobial resistance. The pharmacist in his daily practice has the possibility to educate his patients and give therapeutic advice about the suitable use of antibiotics. In addition, it is important to educate the pharmacists, for example: assessing the influence of training using simultaneous client pharmacy visits, and providing feedback to the pharmacists at their pharmacy based on the results of the simultaneous client visit.

To assess the chances of acquiring antibiotics without prescription, a systematic analysis of the results of studies in different countries was conducted.

Research results are given in table 1. The table shows us the acquisition of antibiotics without prescription by the general population in different countries. The highest opportunity to obtain an antibiotic without prescription was in Syria (87%) while in Spain we can see the lowest chances to get the antibiotic without prescription (45.2%).

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Table 1. Purchasing an antibiotic without prescription based on secret shopper methodology in other countries

[The table was created by the author based on [32, 38, 31,37,33,34,39,41,42]

Country Pharmacy sample

Year Scenarios Acquiring antibiotic %

Research authors

Syria 200 2011 1 87% Al-Faham Z. et al.

[32]

Saudi Arabia

327 2011 6 77.6% Abdulhak AA.et al.

[38]

China 256 2015 2 >50% Chang J. et al.[31]

Sri- Lanka

242 2017 4 61% Zawahir S. et al.

[37]

Spain 197 2010 3 45.2% Llor C. et al. [33]

Republi c of Srpska

131 2012 1 58% V. Marković‐

Peković et al.[34]

Jordan 202 2015 5 74.3% Almaaytah A.et al.

[39]

Ethiopia 100 2018 2 86% Erku DA.et al..[41]

Brazil 136 2005 1 58% Volpato DE.et al.

[42]

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As we can summarize, among other countries which have performed this study, Spain is more closely follow the prevailing legislation of not selling antibiotics to patients without a medical prescription.

2. MATERIAL AND METHODS

2.1 Research organization

The research was performed in 2 stages- secret shopper study and pharmacist interviews. The purpose of secret shopper research is to assess whether antibiotics can be obtained without prescription in community pharmacies in Israel. To achieve this goal a simulated client methodology was chosen. This research method allows also to assess the various responses of the pharmaceutical specialists and also to find out the reasons for pharmacist`s refusal to dispense antibiotics without prescription. A working scheme is presented in table 1. In the second part a qualitative interview was used in order to assess the expertise of pharmaceutical professionals in self- medication counseling .

Table 2. Working scheme

Parts which are done

Identifying the problem of relevance Literature research and analysis Methodology preparation Submission of

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documents to bioethics center Processing data of stage 1: secret shopper study Processing data of stage 2:

pharmacist interviews Discussion of results

Presentation of the research

*Participation in conference- "Science and practice" on November 2019.

Interviews methodology will allow to discover how the Israeli pharmacists feel when counseling to patients and what difficulties they might be encountered during the consultation. Ethics approval was granted by Bioethics Research Committee of Lithuanian University of Health Sciences. SPSS (version 26.0) was used for data analysis.

Table 3. Research summary

Stage I :Secret shopper study I I : Pharmacists interviews 2.2 Setting

and sample

This study was conducted during the year 2019 at selected community pharmacies located in Gush Dan area including Holon city.

The population of the locality and statistical area of Metropolitan Area (Gush Dan) according to latest official estimates includes 200,217 thousands in Holon.

This research was carried out during the year 2020. The pharmacists which were

interviewed working at a selected community pharmacies in Holon region, part of the metropolitan Gush-Dan area. In order to ensure the confidentiality of the

pharmacists their names are not mentioned.

The pharmacists which were participated in this interview need to:

1.Have more than 3 years experience working with patients 2.Agree to participate in this research

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The pharmacist who doesn`t had at least 3 years experience was excluded.

Continue of table 3: Research summary

Stage I: Secret shopper study I I :Pharmacists interviews 2.3Methodolo gy

Secret shopper study: a simulated client methodology was used to assess the possibility to obtain an antibiotic without prescription in community pharmacists in

A qualitative research involves few methods, I chose

interviews- this methodology allowed me to ask open

2.4 Data collection 2 clinical cases were presented, each case type was always presented by the same actor. In all cases, the actor who was stimulating patients was very polite and

The interview was composed of 5 questions, each interview was proceeded up to 15 minutes. The pharmacists were

2.5 Data analysis

Table 4: secret shopper study: the location of visited pharmacies (n=32) Location of the visited

pharmacy N (%)

In a shopping center 6 18.75

Near a medical clinic 11 34.38

In residential areas 15 46.88

Table 4 represents the locations of the pharmacies which were visited by the secret shopper. It shows that majority 15 (46.88%) of the visited pharmacies are located in residential areas, followed by 11 (34.38%) that are placed near a medical clinic.

only 6 (18.75%) of the visited pharmacies are placed in a shopping center.

Secret shopper study: Two scenarios were presented SCENARIO 1:

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The case:

The tourist stated that she is suffering from urinary tract infection and she lost the prescription from doctor.

SCENARIO 2:

The case:

The customer explained the pharmacist that she is suffering from urinary tract infection, she doesn`t has prescription and she has a flight a day after.

Figure 8: Secret shopper visit process

If the antibiotic was not given, the actor

used second level of demand

Observe the environment of pharmacy and make mental notes on the key indicators

The stimulated client presented the symptoms of the urinary tract infection

The pharmacist was asked if something could be given to alleviate the symptoms of the infection

(Demand Level 1 (

“ This medication is not very strong ,

can you give me something stronger

”?

) Demand Level 2 (

(32)

If the pharmacist still refuses to dispense the antibiotic

Table 5: Evaluation of pharmacists characteristics in qualitative research (n=20)

Item N (%)

Gender

Male 5 25%

Female 15 75%

Education level

Bachelor's degree (BPharm) 12 60%

Master of Pharmacy (MPharm)

5 25%

Doctor of Pharmacy (Pharm.D)

3 15%

Pharmacist spoke is Russian

Yes 10 50%

No 10 50%

Pharmacist was alone in the pharmacy

The actor openly stated: "I would like an antibiotic".

This was considered the 3^rd level of demand .

The end of the visit

Fill out the data collection form

(33)

Yes 3 15%

No 17 85%

As we can see in table 5, majority pf the pharmacists that participated in the interview are females and had bachelor`s degree. In most of the cases the pharmacist was not alone and other staff was found in the pharmacy. Half of the pharmacists that

participated in the interview spoke in Russian .

3. RESULTS

3.1 Secret shopper study results

In this research we have tried to assess the opportunity to get an antibiotic without prescription in community pharmacies in Israel. Among the 32 pharmacies which were visited by the secret shopper ANY pharmacist dispensed an antibiotic. However, the consultations which were provided by the pharmacists were collected and evaluated. In this section the patient had to evaluate his opinion and to choose one option out of 5, "Very much, "Somewhat", "Undecided", "Not really" and "Not at all".

First part will be demonstrated using a table, the second part using Bar graphs. The results of each question are illustrated by percentage.

Table 6: Patient`s evaluation on the pharmacy service Assessment of patient satisfaction with pharmacy services % The staff appear interested in helping me with my medical prolem -Very much

-Somewhat -Undecided -Not really

37.5 28.1 25.0 6.3

(34)

-Not at all 3.1 The staff were diligent during my visit

-Very much -Somewhat -Undecided -Not really -Not at all

21.9 43.8 9.4 21.9 3.0 The pharmacist offered me any alernatine instead of the antibiotic (example:cranberries preparation)

46.9 28.0 6.3 9.4 9.4 I am satisfied with the recieved serviece

46.9 34.4 6.3 9.4 3.1

Table 6 shows that 12 (37.5%) of the pharmacists's staff appeared to be interested in helping the secret shopper with her medical problem. Most of the pharmacists were diligent during the visit of the patient, 14 (43.8%) chose "somewhat" followed by 7 (21.9%) chose "very much". Majority of the pharmacists 15 (46.9%) have offered an alternative instead the antibiotic and mostly 15 (46.9%) the patient was satisfied with the general service that she received in the pharmacy. The table shows for us that mostly the patient was satisfied with the pharmaceutical service that was provided by

the pharmacist.

< 2 m i n 2 - 4 m i n

> 5 m i n

50.00%

40.63%

9.38%

(35)

Figure 9: The duration of pharmacist`s consultation

Figure 9 demonstrates the duration of the consultations which were provided by the counseling pharmacists. The duration of consultation was not more than 2 minutes in 50% of the total visited pharmacies, while in 13 (40.6%) pharmacies the duration was between 2-4 minutes. Only in 3 (9.4%) pharmacies the duration of the consultation was more than 5 minutes.

84.37%

15.63%

Yes No

Figure 10: The assessment of allergy or pregnancy risk

Figure 10 indicates that more than 50% of the counseling pharmacists asked from the patient whether there are some allergies to any medications or antibiotics, pregnancy was also asked.

No; 31.25%

Yes; 68.75%

No Yes

Figure 11: The provision of recommendation for cranberries preparation Figure 11 shows that 22 (69%) of the counseling pharmacists, recommended the patient to buy a cranberries preparation as an alternative to the antibiotic treatment.

(36)

Only 10 of the pharmacists did not recommended for it.

Yes No

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

68.75%

31.25%

Column1

Figure 12: Pharmacists inquires about possible symptoms and their duration

22 (68.75%) of the counseling pharmacists have asked the patient if she felt any signs for the infection and what were the symptoms and how long time she felt them, however 10 (31.25%) of the pharmacists did not asked if the patient experienced any symptoms and what were the signs.

(37)

Yes No 0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

81.25%

18.75%

Column1

Figure 13: The prevalence of pharmacists recommendation to see a doctor

Figure 13 shows that more than 50% of the pharmacists recommended the patient to see a doctor in order to get an official prescription while only 6 (18.8%) of the pharmacists did not recommended the patient to visit a doctor.

Table 7: Assessment of pharmaceutical service (n=32) What questions were

asked by the pharmacist N %

Who is the medicine for? 10 31.25%

What actions has already taken?

15 46.8%

Are you taking any other medications?

20 62.5%

Does medical and lifestyle history was taken?

7 21.8%

Table 7 demonstrates the interaction between the pharmacist and the simulated patient. It shows what questions were asked by the counseling pharmacist. More than half asked whether any other medications are taken, 31.25% asked for who the medicine is, 46.8% asked what actions has taken and only 21.8% took a medical and

lifestyle history.

(38)

Statistical reliability Std.

Deviation Mean

Attribute/characteristic

t=1.227 P>0.05 0.65828

1.6667 In a shopping

center/ Residential area

Location of pharmacy

0.67420 1.3636

Near a medical clinic

t=2.215 P<0.05 0.55251

1.9000 Young

Age group

0.66856 1.4167

Old

t=.890 P>0.05 0.74516

1.6500 chain

Type of

pharmacy Independent 1.4167 0.66856

t=0.933 P>0.05 0.84190

1.6429 Male

Gender Female 1.3889 0.69780

t=0.9792 P>0.05 0.85485

1.6923 Yes

Had to wait in the

pharmacy No 1.9474 0.62126

t= -.083 P>0.05 0.82327

1.7000 Yes

Pharmacist spoke in

Russian No 1.7273 0.88273

Table 8: Secret shopper study: satisfaction with pharmacy service

Table 8 presents the statistical analysis of the association between pharmacy/pharmacist characteristics and satisfaction with pharmacy service.

The results of the statistical analysis has showed that the satisfaction of pharmacy services was higher when the counseling pharmacist was young, P<0.05.

No significant association was found between locations of pharmacy, type of pharmacy, gender, weather the patient had to wait in the pharmacy or weather the pharmacist spoke in Russian and satisfaction level. Therefore, it may be assumed that if we had a bigger sample of pharmacies, the difference among groups could be statistically significant.

3.2 Pharmacist interviews results

After secret shopper study was performed, a qualitative analysis of pharmacist interviews was carried out in order to assess whether the pharmacists understand the

(39)

importance of rational antibiotic use/dispensing. 4 main topics were discussed during the interviews: consultations of pharmaceutical specialists about self -medication with antibiotics, the main reasons for the pharmacist refusal to sell an antibiotic without prescription, the difficulties on counseling about self-medication. Furthermore, the pharmacists were asked whether they would dispense an antibiotic without prescription.

A. The main reasons for the pharmacists' refusal to sell an antibiotic without prescription

During the research, the pharmacists were asked what would be the main considerations for their rejection to dispense the antibiotic without an official prescription. The analysis of the collected interviews identified few reasons: The pharmacists explained that he/she has responsibility as a health care provider to stop the spread of antimicrobial resistance, he also talked about the possibility of drug allergies or sensitivities which have to be clarified by the patient`s physician. In addition, the pharmacists referred to the prohibition of selling an antibiotic without an official prescription and that only the doctor has the legal right to give a prescription.

(40)

Fi

gure 14: The main reasons for the pharmacists' refusal to dispense an antibiotic without prescription

A.1. The reason for pharmacist rejection to dispense an antibiotic is antimicrobial resistance

The pharmacists explained that they have an important role in stopping and diminishing the development of the microbial resistance worldwide. They explained that by educating the patients for proper and rational use of antibiotics they will help to diminish it`s spread. Dispensing an antibiotic without an official prescription of the physician will promote and increase the prevalence of the resistance.

"Pharmacy student know that there is a worldwide problem of antimicrobial resistance, so I can`t let it grow" (FS.7,11)

"It is my duty as a health care professional to prevent the development of antibiotic

resistance, I will not let it increase"

(FS.3,15,18,20) .

"As a pharmacist I have the responsibility to educate people about those highly important things" (FS.6,8-12,19) As we can summarize, the pharmacists proved their pharmaceutical expertise.

This practice will help to reduce the prevalence of antimicrobial resistance in Israel.

A.2The reason for pharmacist rejection to dispense an antibiotic is due to possible drug sensitivities

1 Antimicrobi.

al resistance

2 . Possible drug sensitivities

3 Reffered to . the prohibition

of selling antibiotics

without prescription

4 . Only the physician has

the right to give a prescription

(41)

The pharmacists do not know whether the patient has any allergy or sensitivity to antibiotics or to other medications. They also explained that there is a possibility that the patients are taking any chronic medications, so the pharmacists can`t take the responsibility on them.

"I can`t take this responsibility on myself, maybe the patient is taking another medications-which might have an interaction with the antibiotic?"(FS.12,17,19)

"For instance: there are people which are allergic to penicillin, it is a well- known sensitivity. But sometimes the patient himself might even not know that he is allergic to penicillin". (FS.5,7-10).

As we can conclude, sometimes it is not known if the patient has any allergy to any medication so it must be clarified by the doctor.

A.3 The reason for pharmacist rejection to dispense an antibiotic is the prohibition of selling an antibiotic without an official prescription

The pharmacist explained that violation of the pharmacy laws or regulations will lead to the revocation of the pharmacist license by the ministry of health in Israel and the pharmacy will be closed. They talked about the illegal point of dispensing an antibiotic without a prescription from the doctor. Instead of the antibiotic they told they would suggest the patients other alternatives like OTC medications which might help for symptomatic relief or herbal preparations .

"

I would explain the patient that only the doctor is allowed to diagnose patients and write them prescriptions. I am a pharmacist, to diagnose patients? It is of course not the duty of the pharmacists." (FS.1-3,11,16 (

"

Sometimes I can suggest an OTC medication to help for short term treatment or a natural preparation based on plants."(FS.13,19 (

"the only way is to direct my patient to go to the doctor so he will diagnose him and write a prescription". (FS.1,10).

We see that the pharmacists behaved in a responsible way, tried to explain the situation to the patient. Moreover, some alternatives were suggested to the patient in

THE SALE OF ANTIBIOTICS WITHOUTPRESCRIPTION IN COMMUNITY PHARMACIES INISRAEL

THE SALE OF ANTIBIOTICS WITHOUT

PRESCRIPTION IN COMMUNITY PHARMACIES IN ISRAEL

TABLE OF CONTENTS

SUMMARY

SANTRAUKA

KEYWORDS

ABBREVATION

INTRODUCTION

AIM AND TASKS

1. LITERATURE REVIEW

2. MATERIAL AND METHODS

3. RESULTS