The Challenges of Ethical Behaviors for Drug Supply in the Iran Pharmacies by Deontological Approach

Background: Pharmacists as the trustee of pharmacy services must adhere to ethical principles and evaluate their professionalism. Pharmacists may sometimes show different unethical behaviors in their interactions, so it is essential to understand these behaviors. The present study aimed to determine the challenges of ethical behaviors based on a deontological approach in the area of drug supply in pharmacies. Methods: This qualitative content analysis study was conducted in Kerman in 2018. A range of key players in the field of medication supply were selected by snowball sampling to be interviewed. An effort was made to select samples with maximum variation. Exclusion criteria were; having less than 3 years of experience in pharmacy and supervision, not willing to participate in the interview, and canceling the interview for 3 times. The participants in this study consisted of pharmacy technicians (n=5), patients (n=6), pharmacists (n=8), inspectors of insurance companies (n = 4) and inspectors of food and drug administration (n = 3). Data were analyzed by MAXQDA- 10 software using guided content analysis. The principles of “Beauchamp and Childress Ethics” theory including autonomy, beneficence, non-maleficence, and justice were selected as the main principles. Results: Data analysis in this study revealed 8 main categories and 26 subcategories. The main categories included; patient privacy, patient independence, communication principles, patient-centered services, drug supplier, patient harm avoidance, supervision, and distributive, procedural and interactive justice. These categories also had some subcategories, including increasing patient awareness, culturizing prescription and rational drug use, confidentiality and privacy, and pharmacist-patient relationship/communication, which were the biggest ethical challenges in the area of drug supply at pharmacies.

Conclusions: According to the deontological approach, two principles of autonomy and beneficence had the greatest challenges. The emphasis of policymakers in health care system should be on patient independence, patient privacy, and patient-centered services. The results of this study can be used as a tool for introducing ethical challenges to policymakers and developing educational contents, charter of professional ethics in pharmacies, and measures of pharmacy accreditation.

Background
The function of health system is in many ways dependent on human resources and is influenced by their behavior and ethics. Today, due to the development of technology and the complexity of human behavior, the application of ethics in various professions is of great importance. However, service providers tend to unnecessarily increase the use of healthcare due to the profit gain motive, and the patient has no choice but to purchase the service because of the lack of information(1).
Among the professional occupations, pharmacy as a profession has both commercial and therapeutic dimensions (2,3). It also has some specific complexities (4). Ethical pharmacists in the delivery of pharmaceutical care are influenced by various factors, including physicians' decisions, rules and regulations, guidelines, and marketing drug supply in pharmacies. Many international studies have used a questionnaire containing ethical scenarios and respondents had to select an option (15). Some studies analyzed the frameworks of pharmaceutical ethics (13). W. Göttgens-Jansen in a study highlighted the awareness and insight into the ethical aspects of working in pharmacies and found 9 steps for analyzing ethical dilemmas and solving problems (16). However, many of these examples used in various studies are from American, British, Swedish and Australian pharmacists (13,17). Lowenthal conducted a study in the United States to examine the attitudes of pharmacy students toward ethical dilemmas and compare them with the pharmacists and found that, the main problem of pharmacy students was economic issues, and also ethical issues should be discussed in pharmacy curriculum (18).
In Iran, in order to support and guide work process and decision-making of those working in pharmaceutical profession, a comprehensive document of ethics in pharmaceutical system was approved and announced by the Ministry of Health (19). In 2015, a study examined the attitudes and experiences of pharmacists and faculty members of Shiraz school of pharmacy towards ethical challenges in pharmacies (20). In a study entitled: "Pathology of pharmacy ethics", Rasam emphasized on the importance of paying attention to ethics pathology in drug therapy process (9).
Thus, the present study was conducted to examine the perspectives and experiences of pharmaceutical technicians, patients, pharmacists, inspectors of insurance companies, and inspectors of food and drug administration about existing ethical behaviors in the area of drug delivery systems in pharmacies based on the Beauchamp and Childress theory. The results of this study are expected to provide an appropriate strategy for planning and improving ethical behaviors by identifying ethical challenges in the area of drug supply in pharmacy. 6 This qualitative content analysis study was conducted in Kerman in 2018. A range of key players in the field of medication supply were selected by snowball sampling to be interviewed. An effort was made to select samples with maximum variation. The purpose was to select people with a deep understanding of the subject under study. Exclusion criteria were; having less than 3 years of experience in pharmacy and supervision, not willing to participate in the interview, and canceling the interview for 3 times. General characteristics of the participants are shown in Table 1. The interviews continued until no new information was obtained from the interviews (data saturation). To ensure data saturation, two additional interviews were conducted. Semi-structured method was used in the interviews with an interview guide which was based on Childress's ethics framework, then a pilot interview was conducted with one person and all identified problems were corrected. Each interview took about 30-50 minutes and the average time of each interview was 37 minutes. Interviews were conducted at places agreed upon by the participants. The content of interviews was extracted immediately after each interview and used as a guide in subsequent interviews.

Methods
To ensure the trustworthiness of findings, Lincoln and Guba's method (21) was used, which is the equivalent of validity and reliability in quantitative research. Based on this method, four criteria of credibility, transferability, dependability, and confirmability were used for the evaluation. Sampling was carried out with the maximum variation to ensure that data are acceptable. Interviews were conducted over a 6-month timeframe, factors such as allocating sufficient time for data collection, good communication with research participants, and taking notes while recording data were considered during the study. In addition, the codes obtained from interviews were given to a number of participants to be reviewed by them and necessary modifications were made based on their comments. The codes were also reviewed by the research team members in numerous meetings and the inconsistencies were discussed until consensus was reached. Then, the codes were finalized.
To ensure transferability of results, all stages of the study along with the study environment and context were fully explained, so that future readers can repeat the study if they intend to do so. To ensure the reliability of findings, study process was presented to the research team who had experience in qualitative research and they confirmed the study results after reviewing the process. Given that, the three criteria of validity and reliability of qualitative research have been met in this study, it can be concluded that confirmability of results has also been ensured.
Guided content analysis was used to analyze the data. In this type of analysis, existing knowledge about the phenomenon is usually incomplete and requires further discussion.
The purpose of guided content analysis is to validate or develop a theoretical framework (22). The ethical principles of Beauchamp and Childress theory were chosen as the main principles. The sub-principles were also extracted from the interviews and tailored to the relevant core principles.

Results
In the present study, 8 main categories and 26 sub-categories were identified by guided content analysis to determine the challenges of drug supply. Human dignity should be respected in any circumstances, but a patient or a healthy person who has a health need deserves special attention and respect. Based on the findings, three main categories related to autotomy were identified in this study.

Category 1: Patient Independence
The ability to make informed or rational decisions and to act upon them is only made in caring situations. Patient independence is influenced by following factors and categories: Participating patient in decision-making was one of the codes of patient independence category. One participant in this regard stated: "…Lack of patient participations in decision-making on treatment is a moral challenge, and based on the principles of evidence-based medicine, the patient must be given the right to choose and it is wrong to use clinical power when prescribing a treatment…" (Pharmacist 5).
"…Lack of ethical decision-making models in pharmacies has caused them to not adhere to ethical principles and give, for example, calculus syrup to patient instead of prescribed calculus tablet regardless of patient's preferences..." (Insurance inspector 1) Giving patient the required information for decision-making was one of the codes of patient independence category. The participants in this regard stated: "…Presence of pharmacist in the pharmacy gives patient the right to receive information about drug treatment. Also, all information on how to use drugs in treatment process or other information should be given to patients according to their level of knowledge, literacy and health status, so that it would be understandable for them and their next of keens..." (Pharmacist 2) "…If the pharmacist does not give information to patient on how to use the drug and its side effects, the patient cannot get a favorable outcome from the treatment, so it is useless and dangerous to administer drug without providing information about its use.
This is why the pharmacist should be obliged to provide pharmaceutical information as the last treatment loop... "(Food and drug administration inspector 4)

Category 2: Patient Privacy
Preserving patient physical privacy was one of the codes found in this student. In this regard, some participants stated: "…Physical privacy is a place that surrounds a person's body and is actually a protective area for the person. The pharmacy's space should be such as to create an opportunity for respecting people's privacy…" (Patient 4) "…A pharmacy is an environment where patients have fewer facilities and more often their privacy is not respected and this is a moral challenge which inflicts harm…" (Pharmacist 2) "…Patients' privacy is not respected in pharmacy due to the lack of space physical which means that, there must be some private space between them and other clients when buying. One of our challenges is the crowded pharmacies and physical contact between ladies and gentlemen…"(Pharmacist 2) Privacy and confidentiality was another code which was found in this study. Participants in this regard stated: "…This issue is not specific to Iran, and countries such as the United States, Britain and Scotland also insist that pharmacists and pharmaceutical technicians should strive to respect the patient and protect their right to confidentiality..." (Pharmacist 1) "…Patients want their pharmaceutical information to be kept confidential by pharmacist.
The concern of some when visiting a pharmacy is that their colleagues, friends and neighbors will see or hear their pharmaceutical information..." (Patient 4) "…This is one of the most important ethical issues in the pharmacy environment and the need for serious and practical commitment of pharmacy's staff is evident. They are also obliged to adhere to this right by Sharia and law. But a problem that I have always seen in Kerman province is that patient's privacy and confidentiality is not important to pharmacist and pharmacy staff... "(Patient 1) Gender proportion or same-sex care delivery: The vast majority of participants believed that: "…People tend to get their medication and ask their questions from their same-sex peers, and adhering to the principles of same-sex care in the health sector will increase the morale of patients and reduce their stress when receiving a service..." (Pharmacist 7)

Category 3: Communication Principles
Proper communication is a win-win process for the pharmacist, the patient, the physician, and the healthcare system in general. This communication should be a two-way communication and have its own rules. This category had two subcategories as follow: Pharmacist-patient relationship/communication: The majority of participants believed that: "…The physician's family relationship with the pharmacist is one of the ethical challenges in this field, and the physician should prescribe medication based on patient's needs, but sometimes it is based on financial interest and other motivations. For instance: the daughter of a pharmacy owner is dermatology specialist who send her clients to her father's pharmacy, justifying it by saying that, this pharmacy reads the prescription better, is more skillful in making mixed medicines, and has a complete list of drugs without a deficit. " (Insurance Inspector 2) "…Occasionally, there is contract between physician and pharmacist in the way that, the pharmacist gives the list of its near-term medications and the physician prescripts these unrelated drugs to patients…." (Patient 5) Principle 2: Non-maleficent The pharmacy is permitted to take actions that their interests are greater than their risks.
In relation to this ethical principle, two main categories were extracted from the interviews, including patient harm avoidance and supervision.
Educational system in teaching the principles of pharmaceutical ethics: according to the participants' perspectives: "…There is no any related module/course for pharmacy students. After graduating, pharmacists are unaware of the principles of ethics in pharmacy and the rules that apply to their pharmaceutical activities. They think that pharmacy like the local supermarket is a place for selling drugs. This issue can cause irreparable damage to the country's health care system..".
Pharmacists' awareness of own professional commitment was one of the codes of this category. One participant in this regard stated that: "…The pharmacist must be aware of the requirements and principles within the pharmacy system and prevent any harm to patient and the pharmacy. Professional tasks should be done by the pharmacist and the pharmaceutical technicians should not be allowed to arbitrarily and unknowingly prescribe medication and by doing so affect the health system..." (Inspectorate of food and drug administration 1) Not letting pharmacy license: Participants believed that: "…Letting the pharmacy degree is one of the ethical challenges in Disposal of pharmaceutical waste: Based on the findings of this study, all participants believed that: "…Disposal of pharmaceutical waste is not done properly, and abandoning drugs in nature or household waste can cause many problems, including microbial resistance…" Principle 3: Beneficent The health system strives to maximize beneficence for individuals in line with its health goals. Beneficence means taking activities that benefit patients. Patient-centered services and drug use optimization were the two main categories identified in relation to beneficence.

Category 1: Patient-centered Services
Providing patient-centered service is influenced by the following known factors: Considering the patient's interest was one of the factors highlighted in this study. The participants believed that services provided to patient should be such that, the patient's benefit overrides the financial and economic benefit of the pharmacy.
"…When drug supply in the pharmacy is seen as a business, the patient's interest goes away and the profits from the sale take priority" (Pharmacist 4). Another interviewee stated that: "In pharmacy, financial gain is more important than serving patient, and when the basis is just money, patient will not be in priority. In such situation, the public view pharmacists as thieves..." (Food and drug administration inspector 2) Increasing patient awareness: This prepares people mentally and emotionally in facing disease-induced anxiety. Below are the interviewees' statements about patient awareness: "…The patient has the right to know how to take the medication. Not giving information or giving wrong information to patients breaks the treatment cycle. In such situation, the patient will not be treated and the treatment will not be effective. However, despite the importance of increasing patient awareness both legally and morally, this is not implemented for the sake of pharmacist benefit..." (Pharmacist 7) "…Putting similar drugs than those written in prescription without informing physician and patient is a moral challenge. The pharmacy has the right to consult, but has no right to change the prescription..." (Insurance inspector 1) "…We should inform patient about the near-expire drugs on the prescription. The patient could be an illiterate old man or woman who keeps the medication for few months without knowing that they will be expired soon. Acceptable quality of medication was another code related to patient-centered services. In this regard, the participants believed that: "…The production of low quality drugs is a waste of resources and sometimes a risk to people's health. The production of poor quality drugs is a problem..." (Pharmacist 5) "…The herbal medicines that are being distributed and the ointments and creams that are manufactured manually in the pharmacy may not have the required quality. For instance, the Zarband herbal company changes the expiry dates of its products and sends them to pharmacies to be sold to patients. Ointments and creams are also occasionally seen to be made by non-pharmacists..." (Pharmacist 8)

Category 2: Drug Supplier
The optimization of drug use is influenced by following factors: Standardization of the pharmacy in terms of space, temperature, humidity and shelving: According to most participants, this is important as it affects people's health, but it is less important in the pharmacy environment. Below are some of the participants' statements in "…Physician knows that if he writes a simple prescription for patient, he will not get a good response from the patient and sometimes, patient will not follow-up his treatment. It can also be a bad advertising for the physician. We have a cultural problem and the prescription and rational drug use is a problem in Iran..." (Pharmacist 6) "…One factor that causes irrational drug use is a faulty system of drug prescription and Interactive justice is about the ways by which customers who received a faulty service are treated.
Justice in protecting people's rights was one of the subcategories of interactive justice, which was highlighted in the present study. In this regard, the participants stated that: "… Interactive justice is felt when people's rights are being respected and unsatisfied customer is treated honestly, compassionately and politely. Pharmacies should treat patients as they would like to be treated by other pharmacies. …"

Discussion
The present study examined the challenges of ethical behaviors based on a deontological approach in the area of drug supply in pharmacy. According to Cooper RJ et al, many studies have been conducted on the ethics in health care, but ethical challenges in pharmacy have not been addressed (13). This qualitative study explored ethical behaviors based on four principles of bioethics and eliminated the suggestion made by the Cooper RJ. These four ethical principles are measured and judged in interaction with one another, and draw our attention to the extent and scope of their application, which is discussed below. The principle of autonomy gives patient the right to choose or refuse his or her treatment. The principle of beneficence refers to the fact that, healthcare providers must act in the patient's interest. The principle of non-maleficence emphasizes that patient should not be harmed. In regard to the distribution of health care resource and deciding who receives what treatment and medication, the principle of justice should be considered. According to the findings, the principles of autonomy and beneficence were most challenging among the rest, so these two principles will be further discussed.

Autonomy: Patient Independence
The principle of autonomy determines the rights of individuals in decision-making. This principle refers to having respect for each individual in the community and the ability to make informed decisions on own issues. The autonomy principle is discussed in three main categories: patient independence, patient privacy, and compliance with the principles of communication, most of which are related to patient autonomy and privacy.
In the study of Limond et al., patients' independence was defined in two areas: providing sufficient information to patients and allowing them to make therapeutic decisions (23). In this regard, the results of other studies reveal that health care providers do not respect patients' autonomy as they do not involve them in the decision-making process and do not provide them with information they need (24,25). In this regard, the Comprehensive

Document of Pharmaceutical System and the Patient Rights Charter in Iran and the Patient
Rights Charter of the American Hospitals Association (26) emphasize that comprehensible information must be given to patients and they must be involved in decision-making about any treatment or diagnostic process (19,27). Another study showed that nurses do not engage patients in clinical decision making, while patient participation is very valuable in decision making and improves the quality of services (28). Our study showed that, this issue is one of the ethical challenges in the field of medicine.

Autonomy: Patient Privacy
Studies show that due to crowded pharmacies and insufficient patient space in the pharmacy, patient privacy is not preserved in the pharmacies (29). In the study of Wereth et al., the lowest satisfaction level was related to patient privacy in the pharmacy (30).
Other health-related tudies emphasize on the privacy and confidentiality of patients (31).
Imaz's study showed that, the layout of pharmacy space is such that in about 50% of cases patients' physical privacy is not respected (32). The Patient Rights Charter also recognizes confidentiality and respect for patient privacy (27). According to the Code of Ethics of the American Pharmacy Association, pharmacists must strive to promote and protect patient privacy (33). People tend to get their medications and ask their questions from same-sex counterparts, while the UK Patient Rights Bill states that women should always have access to a female staff and people who perform examination and counselling must be the same -sex staff (34,35). The present qualitative study, while examining patient privacy, showed that non-compliance with this principle is one of the major challenges in pharmacies.

Autonomy: Communication Principles
A review of published studies of pharmacist-patient communication showed that pharmacist-patient communication is one-way and there is no interactive and collaborative process between them (36)(37)(38)(39) The results of other studies of pharmacistpatient relationship have shown that, the requests that are contrary to professional and ethical responsibility and demands of jobbers harm ethical communication (40). Failure to adhere to the principles of communication and non-presence of pharmacist in the pharmacy is one of the factors that lead to ineffective communication that endangers patient's interests and undermines community's trust (41)(42)(43). Studies in other areas, such as physician-pharmacy relationship, have shown that pharmacists' family relations with physicians, pharmacists' financial relationship with physicians (32) and self-referral are among ethical challenges of physician-pharmacist relationship that diminishes people's trust and confidence in them, increases health care costs and the commercialization of treatment and medication, which in turn promotes unethical relationship between physician and pharmacist (44). In the United States, to combat professional misconduct between a pharmacist and a physician, the Stark Low's law was established that says physicians do not have the right to refer patients to places that benefit them (45). The present study, while qualitatively examining this principle, showed that non-compliance with communication principles is one of the major challenges in pharmacies.

Non-maleficence: Patient Harm Avoidance
In principle, the most important thing for healthcare staff is not to harm patients and do their best with proper supervision. This is partly due to the fact that pharmacists believe they are doing well, without properly evaluating their performance and making sure it does not harm patient. The principle of non-maleficence will be discussed in two main categories, including patient harm avoidance and supervision.
Studies have shown that the weakness of educational system in teaching the principles of pharmaceutical ethics is one of the causes of harm to patient (33). Studies in other areas, such as teaching ethics to medical students, have shown that topics of medical ethics have been sporadically included in the pharmacy curriculum and many of the professional misconducts are due to the weakness of educational system in teaching ethics (46)(47)(48)(49).
Pharmacists about their professional obligations is one of the ethical challenges in this field. Studies show that pharmacists are professional people who should be aware of their professional obligations and know and adhere to drug and pharmacy standards, however pharmacists' lack of knowledge in social and behavioral sciences, as well as ethical concepts and values creates ethical challenges (50,51).

Non-maleficence: Supervision
One of the most important principles of professional ethics is the principle of nonmaleficence, which is closely related to the concept of supervision in the pharmacy. The results of studies, while emphasizing on the monitoring of drug storage in pharmacies, show that not only drug storage condition in the pharmacy is not supervised, but also there is not supervision in other areas of the health system, including diagnosis, prescription, distribution, and drug use, and this issue impose a heavy cost on the health system (52).
Studies have shown that lack of supervision over drug advertising causes financial gain to replace effectiveness and quality, and also prescribing brand medication to receive financial reward damages the professional responsibility of physicians and pharmacists (40). A study by Hosseini aimed at upholding consumer rights in advertising and marketing of pharmaceutical products found that, articles in the drug law that deal with advertising are vague, outdated and irrespective of world-wide developments and consumer rights (53). The present study showed that lack of supervision over drug advertising is one of the major challenges in the field of drug supply in the pharmacy. showed that failure to provide patient-centered services is one of the main challenges in the field of drug supply.

Beneficence: Optimization Of Drug Use
A study aimed at prioritizing the factors affecting the quality of pharmacy services showed that pharmacy standard in terms of space, temperature, humidity and shelving and overall suitability of physical environment lead to satisfaction of costumers and beneficence (53).
Also, international studies on the quality of pharmacy service reveal that tangible and physical factors such as standard of the pharmacy and suitability of physical environment affect the quality of pharmacy services and benefit both the patient and the pharmacy (26,50,57,58) These studies suggest that, pharmacies should be standardized in terms of space, temperature, humidity and shelving, which is consistent with the results of present qualitative study.

Justice: Distributive Justice
Justice means putting everything in its proper place, which is institutionalized within the

Justice: Procedural Justice And Interactive Justice
In this study, participants referred to procedural and distributive justice as ethical challenges of justice. Article 4 of the Code of Professional Ethics states that pharmacist must contribute to the promotion of community health in a fair and equitable manner (19).
A study that examined the outcomes of ethical values in an organization showed that ethical values affect procedural and interactive justice. When employees perceive procedures to be fair, they strive to undertake ethical behavior (56). These studies show that pharmacies should regulate their ethical behaviors based on justice, which is consistent with the results of present study.

Study limitations
One of the most important limitations of this study was the reluctance of some stakeholders to participate in the study. Also, the interviews were limited to the pharmacy stakeholders. It is suggested that future studies should conducted interview with the drug manufacturers, drug importers, and drug distribution companies.

Conclusions
The present study addressed the challenges of ethical behaviors in the supply of medications in pharmacies based on deontological approach. The results showed that most ethical challenges in drug supply were related to the aspect of autonomy with subscales of patient independence and privacy, and aspect of beneficence with the subscale of patient-centered services. In regard to the subscale of patient-centered services, attention should also be paid to increasing patient awareness, culturizing of prescription and rational drug use, confidentiality and privacy, and pharmacist-patient communication. This study can be used as a tool for introducing ethical challenges to policymakers.
It can also help to create a moral environment by reviewing drug supply policies. The Ministry of Health and other health and education authorities are suggested to dedicate ethical modules and seminars to pharmacy curriculum to reduce the ethical challenges of drug supply. Patients should participate in the decisions that are made for them and should also make decisions based on perceived information, this way we can respect patient's independence ethical commitment.
Institutionalizing ethics and ethical responsibility when prescribing medications based on effectiveness creates trust and increases productivity. Pharmacy environment should also be designed to facilitate patient communication with the pharmacist and protect patient privacy.
Using the results of present study, the Food and Drug Administration can develop an ethics charter communicate its codes to pharmacists and pharmacy technicians. It can also use measures like compliance with ethical codes in granting and extending pharmacy licenses.
Given that many approaches and theories have been presented in the field of ethical behavior and there is no ethical theory that covers all considerations of experts in the field of work ethics, it is therefore suggested to consider other ethical approaches.

Declarations
Ethics approval and consent to participate: The study was approved by the ethics committee of Kerman University of Medical Sciences (KUMS) with ID number IR.KMU.REC.1397.567 Ethical considerations were taken into account during data collection and analysis. Any questions asked about the study by the participant were discussed in full and the oral informed consent was obtained from the participants before recording the interviews. It was assured that confidentiality would be maintained, and that no personal information would be identified in any publications arising from the study. Participants were informed that participation was entirely voluntary and they could withdraw at any time. Respondent names were removed during analysis and other identifiers (i.e. Patient; Food and Drug Administration Inspector; Pharmacist, Insurance Inspector, and Pharmaceutical Technician) were replaced in the quotations used.
Consent for publication: Not applicable.
Availability of data and material: The transcribed interviews and open coding are available from the corresponding author on reasonable request. Of-course, it should be noted that all interviews were conducted, transcribed and are accessible into Persian language.