In the present study, 8 main categories and 26 subcategories were identified using directed content analysis to determine the challenges of drug supply. Therefore, the patient must decide independently.
Table 2: Challenges of drug supply at the pharmacy level
Principle
|
Category
|
Sub-category
|
Autonomy
|
Patient independence
|
Participating patient in decision-making
Giving patient the required information
|
Communication principles
|
Pharmacist-patient relationship/communication
Physician-pharmacy relationship/communication
|
Patient privacy
|
Preserving patient physical privacy
Privacy and confidentiality
Gender proportion or same-sex care delivery
|
Non-maleficence
|
Patient harm avoidance
|
Educational system
Pharmacists’ awareness of own professional commitment
Not letting pharmacy license
Lack of ignorance and not rushing to deliver drug to patient
|
Supervision
|
Pharmacist’s monitoring of drug storage condition in the pharmacy
Monitoring the import of foreign and smuggled drugs
Advertising drugs based on their effectiveness and not just paying attention to their brand
Disposal of pharmacological waste
|
Beneficence
|
Patient-centered services
|
Considering patient’s interests
Increasing patient’s awareness
Sense of responsibility in pharmacological system
Acceptable quality of medication
|
Drug supplier
|
Standardization of pharmacies in terms of space, temperature, humidity, and shelving
The criteria for entry or exit of drug to drug list
Culturizing prescription and rational drug use
Drug hoarding by distribution companies
|
Justice
|
Equitable distribution
|
Equitable distribution of drugs
Justice in the supply and distribution of medicines
Equitable distribution of responsibilities and interpersonal interests
|
Procedural justice
|
Justice in law enforcement
|
Interactive justice
|
Justice in protecting people’s rights
|
Principle 1: Autonomy
Human dignity should be respected in any circumstances, and patients or healthy persons as human beings choose the path of treatment and recovery consciously and autonomously, therefore, information is needed to make decisions. This flow of information takes place in the context of communication principles, and protecting the patients' privacy is effective in making this connection, and ultimately, making decisions. Therefore, according to the participants' opinions, for the concept of autonomy, three sub-categories including patient independence, communication principles, and patients' privacy were identified as follows.
Category 1: Patient independence
It is the ability to make informed or rational decisions and to act upon them, which are only made in caring situations. In this case, participants emphasized on the patients' participation in decision-making and giving patients the required information.
Patients participation in decision-making is one of the codes of the patient independence category. A participant in this regard stated that:
"…Lack of patient participations in decision-making on treatment is a moral challenge and based on the principles of evidence-based medicine, patients 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 tablet to the patient instead of prescribed calculus syrup regardless of patients' preferences..." (Insurance inspector 1)
Giving the patient the required information for decision-making was another code of patient independence category. The participants in this regard stated that:
"…The presence of a pharmacist in pharmacies gives patients 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 kin ..." (Pharmacist 2)
"…If pharmacists do not give information to patients on how to use the drug and its side effects, they 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 pharmacists should provide pharmaceutical information as the last treatment loop... "(Food and drug administration inspector 4)
Category 2: Communication principles
Proper communication is a win-win situation for pharmacists, patients, physicians, and generally, for the healthcare system. This communication should be a two-way communication with its own rules. According to the participants' opinions, this category had two subcategories as follow:
Pharmacist-patient relationship/communication: The majority of participants believed that:
"…The treatment environment should be so that patients realize staff are there because they are so valuable to them. Also, appropriate relationship and preserving patient dignity regardless of race, skin color, nationality, and income are fundamental to have an effective communication in clinical environment and its absence is a moral challenge... "
"…Sometimes pharmacists are faced with unethical and unprofessional request, for example, people want cosmetic drugs instead of prescription drugs, or want illegal documents for insurance without a prescription. Such issues are due to the unethical relationship between patients and pharmacists...” (Pharmacist 4)
"…The relationship between pharmacist and patient is a relationship between two people that should be based on respect and trust, but unfortunately, for a number of reasons, including self-interest, communication principles are not respected properly…" (Pharmacist 5)
Physician-pharmacy relationship/communication: Treatment process makes physicians to have a close relationship with pharmacists, but sometimes, the physician-pharmacy relationship presents an ethical challenge. Participants in this regard stated that:
"…The family relationship between physicians and pharmacists is one of the ethical challenges in this field, and physicians should prescribe medication based on patients' needs, but sometimes, it is based on the financial interests and other motives. For instance: the daughter of a pharmacy owner is a dermatologist who send her clients to her father’s pharmacy, justifying it by saying that, this pharmacy reads the prescription better, it is more skillful in making mixed medicines, and it has a complete list of drugs without a deficit. " (Insurance Inspector 2)
"…Occasionally, there is a contract between physicians and pharmacists in the way that, pharmacists give a list of its near-term medications and physicians prescribe these unrelated drugs to patients….” (Patient 5)
Category 3: Patient privacy
According to the participants' perspectives, one of the things that should be considered in autonomy and is a context for two subcategories of autonomy in decision making and having effective communication, is protecting patient's privacy, which refers to protecting the physical space privacy, confidentiality, and information privacy, as well as gender proportion.
Preserving patient physical privacy is one of the codes found in this study. In this regard, some participants stated that:
"…Physical privacy is a place that surrounds a person's body and is actually a protected area for the person. The pharmacies' space should be so that it creates 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 pharmacies due to the lack of physical space. Physical privacy means that there must be some private space between them and other clients when buying drugs. One of our challenges in the crowded pharmacies is physical contact between male and female clients…" (Pharmacist 2)
Privacy and confidentiality is another code related to the patient privacy. 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 patients and protect their right to confidentiality..." (Pharmacist 1)
"…Patients wish their pharmaceutical information to be kept confidential by pharmacists. The concern of some people 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, which indicates the need for serious and practical commitment of the pharmacy’s staff. 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 patients’ privacy and confidentiality is not important to pharmacists and pharmacy staff..." (Insurance inspector 1)
Gender proportion or same-sex care delivery: Participants believed that gender proportion is effective in the relationship between patients and pharmacists, in maintaining the patients' privacy, and reducing stress, and subsequently, in making patients autonomous, so that one of the participants stated:
"…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 patients' morale and reduce their stress when receiving a service..." (Pharmacist 7)
Principle 2: Non-maleficence
In any therapeutic action, it is a key principle to not inflict harm or injury on patients, and the pharmacy must take steps that their benefits outweigh the risks. According to the participants' opinions, avoiding harm to the patient, monitoring the conditions of pharmacies environment, and management of the pharmaceutical warehouse and its prescription by the providers were identified, which is discussed below.
Category 1: Patient harm avoidance
Participants also pointed out that in order to avoid harm to the patients, the education and learning system plays an important role in observing ethical principles in this regard, and pharmacists must be aware of their professional obligations and leave their pharmacy license to someone else and do not hurry and neglect the process of prescribing and delivering medicines to the patients.
Educational system: It has an important role in teaching the principles of pharmaceutical ethics, so that one of the participants stated that:
"…There is no related module/course for pharmacy students. After graduation, pharmacists start working in pharmacies while they are unaware of the principles of pharmaceutical ethics and the rules related to their pharmaceutical activities. They think that pharmacy like local supermarkets is a place for selling drugs. This issue can cause irreparable damage to the country's healthcare system..." (Pharmacist 5)
Pharmacists' awareness of own professional commitment is one of the codes of this category. One of the participants in this regard stated that:
"…The pharmacist must be aware of the requirements and principles within the pharmacy system and prevent any harm to patients and pharmacies. Professional tasks should be done by pharmacists, and pharmacy technician should not be allowed to arbitrarily and unknowingly prescribe medication, and subsequently, affect the health system..." (Inspectorate of food and drug administration 1)
Not lending pharmacy license: A participant believed that:
"…Lending pharmacy license is one of the ethical challenges in the pharmacy system in our country. Pharmacy graduates in the country lend their pharmacy license to investors at exorbitant prices. Pharmacists, who do not have 10 billion Rials to buy a property and medicines to establish a pharmacy, lend their license to an investor. Is it a pharmacy or a supermarket? The main issue is avoiding harm to patients." (Pharmacist 3)
Not neglecting or rushing to deliver drug to patients are effective measures to prevent harm to patients. One of the participant in this regard stated that:
"…Pharmacists should manage their pharmacy by giving priority to patients and avoiding patients' harm..." (Pharmaceutical Technician 3)
"…In a pharmacy, the manager rated technicians based on the number of prescriptions they prepared, which increased their carelessness and negligence. Patients’ life depends on medication and negligence puts patient’s life in danger, which its moral responsibility is on the pharmaceutical technicians..." (Deputy Inspector 1)
Category 2: Supervision
Supervision is one of the subcategories, which according to the participants' opinions, it can prevent harm to patients. Effective and efficient monitoring and control of drug storage conditions, the drug supply and distribution methods, especially smuggled drugs, and monitoring drug advertising are essential.
Pharmacist’s monitoring of drug storage conditions in the pharmacy: It is one of the important codes related to monitoring. As stated by one of the participants:
"…Due to the presence of reactive and supplementary substances in medicines, heat, cold, humidity, and light affect the nature of drugs..." (Pharmacist 1)
"…In the pharmacy evaluation guideline, which is issued every 3 months, the storage condition has 50 points out of 1000 evaluation points. Although this indicator is very important and affects the quality of drugs, its point is much less than other indicators…" (Food and drug administration’s inspectorate 1)
Monitoring the import of foreign and smuggled drugs: Insufficient monitoring of the import of foreign drugs may cause irreparable damages to patients. In this regard, one of the participants stated that:
"…Currently, the import of foreign complementary medicines into the country has increased, and while the country is facing the shortage of resources to meet drug needs, cost-effectiveness research should be conducted regarding the import of complementary drugs…" (Pharmacist 6)
"…A large number of drugs is currently imported and some of these drugs have national samples. Restrictions of pharmaceutical products import have created many challenges in the pharmaceutical field that need supervision…" (Pharmacist 2)
"…Iran's sanctions have led to the smuggling of a large volume of drugs in the country, and the types of supervision is one of the causes of this problem..." (Patient 4)
Advertising drugs based on their effectiveness and not just paying attention to their brand: According to the participants' statements, one of the current challenges in pharmacies is supplying drug based on their brand but not their effectiveness. In this regard, a participant stated that:
"…Many physicians, including dermatologists, prescribe branded medications advertised by drug salesmen without knowing their safety and effects on health..." (Insurance inspector 2)
"…Prescribing an effective drug ensures positive treatment outcome and now prescribing foreign drugs are being prohibited by the internal physicians under Section 6 of the Developmental Law. This is while the quality of national drugs is not the same as foreign ones and this paves the way for drug trafficking…" (Pharmacist 3)
Disposal of pharmaceutical waste, monitoring the process and doing it well are the issues that should be considered in this regard so that one of the participants stated that:
"…Disposal of pharmaceutical waste is not done properly, and disposal of drugs or household waste in nature can cause many problems, including microbial resistance…" (Pharmacist 5)
Principle 3: Beneficent
The health system strives to provide the highest levels of profitability and benefits for the society in line with public health goals. Profitability means doing things that benefit patients. According to the participants' opinions, the services should be patient-centered and the use of drugs should be optimal and rational, so the following two subcategories related to profitability were identified.
Category 1: Patient-centered services
Participants also stated that in providing services, patients' interests, informing patients about how to use drugs and their side effects, the sense of responsibility in the drug management cycle and also ensuring the quality of the drug should be considered; in other words, providing services should be patient-centered. According to the opinions, the following codes were extracted.
Considering the patient’s interest: It is one of the factors highlighted in this study. The participants believed that services provided to patients should be such that, the patients' benefits override the financial and economic benefits of the pharmacy.
"…When drug supply in the pharmacy is seen as a business, the patients' interests go away and the profits from the sale take priority" (Pharmacist 4).
Another interviewee stated that: "In pharmacy, financial gain is more important than serving patients, and when the basis is just money, patients will not be in priority. In such a situation, the public call pharmacists as thieves..." (Food and drug administration inspector 2)
Increasing patient awareness: This code creates psychological and emotional readiness in people facing with anxiety caused by disease. Based on the interviewees' statements about informing patients, the following cases should be considered:
"…The patients have the right to know how to take medications. Not giving information or giving wrong information to patients breaks the treatment cycle. In such a situation, patients will not be treated and the treatment will not be effective. However, despite the importance of increasing patients' awareness both legally and morally, this is not implemented for the sake of pharmacist benefits..." (Pharmacist 7)
"…Delivering similar drugs to patients without informing physician and patients is a moral challenge. Pharmacies have the right to consult, but have no right to change the prescription. For example, when a physician prescribed Madopar, pharmacies have no right to replace it with Levodopa..." (Insurance inspector 1)
"…We should inform patients about the near-expiry drugs on the prescription. Patients could be an illiterate old man or woman who keeps the medications for few months without knowing that they will be expired soon..." (Pharmaceutical technician 4)
Another interviewee in this regard stated that: "Patients should be aware of any mistake in insurance deductions created by physicians that could cause them to pay the full charge of drugs." (Patient 3)
According to the participants' comments, "Information on the technical fees, drug interactions, medication costs, adverse effects of the drug, and how to use the drug are among the issues that patients should be aware of ..."
Sense of responsibility in pharmaceutical system: It is another issue that was emerged in relation to patient-centered services. In this regard, the participants stated that:
"…Morality means a sense of responsibility that should be not only in the pharmacists but also in the pharmacy technicians. The technician should check the validity of prescription so that the pharmacy will not be fined..." (Pharmacist 6)
"Pharmacists must give clear and legible information to patients and this responsibility cannot be delegated to pharmacy technicians as this is the last thing that patients do before leaving pharmacies.'' (Insurance inspector 2)
"…Our challenge is the targeted sources of information, such as visitors of pharmaceutical companies, especially pharma-cosmetic companies that promote expensive, and in some cases, less-effective drugs for more profits. In such situations, nothing but a sense of responsibility and conscience of technical officer can prevent this problem..." (Insurance inspector 3)
Acceptable quality of medication is another code related to patient-centered services. In this regard, the participants believed that:
"…The production of poor-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 X 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
Optimizing drug supply environment is influenced by the following factors:
Standardization of pharmacies in terms of space, temperature, humidity, and shelving: According to the opinions of most participants, this is important as it affects people's health, but it is less important in the pharmacy environment.
"…In pharmacies, the condition of drug storage, cleanliness of the pharmacy environment, and the instructions of drug storage in order to achieve the optimal conditions should be monitored and supervised..." (Insurance inspector 1)
"…The physical standards of pharmaceutical care have been developed by the Food and Drug Administration in 8 articles and have been issued to pharmacies and drugstores. This regulation obliged pharmacies to comply with standards regarding temperature, humidity, light, and shelving, but it is not respected and it is not given more importance for many reasons..." (Food and drug administration inspector 4)
"…Sometimes pharmacies use lasers and lighting effects to make cosmetics products more luminous and noticeable, which can affect the chemical formulation of the products and medications and even make them ineffective..." (Pharmaceutical technician 5)
"…One ethical challenge that seems to be regular for pharmacy technicians is the use of cooler or heater for air conditioning. At one of my pharmacy inspections, I saw a KPTVA spray that was placed next to the heater with very high temperature and no one was concerned that the heat could decrease its effectiveness. Not controlling the temperature and humidity of pharmacies may cause financial loss and health risks...” (Food and drug administration inspector 4)
The criteria for entry or exit of drug to drug list is another code related to the optimization of drug supply, which has a significant effect on the patient's financial interests because insurance companies cover drugs listed on the drug list. In this regard, the participants stated that:
"…There are currently many drugs on the national drug list that cannot be prescribed at all. When the selection of drugs on the list is based on the proper and evidence-based criteria, the health indicators will also improve..." (Pharmacist 4)
"…Adding or removing drugs from the drug list and updating the drug list is in line with the Sixth Developmental Plan, but since the workgroup is novice, the criteria for drug entry into the drug list is not complete, which causes discontent and challenges among people and pharmacies…" (Pharmacist 5)
Culturizing prescription and rational drug use: Proper prescription and rational use of medicines is currently one of the most important factors in health care. The resources are seriously wasted in the field of medication. All participants, while emphasizing on the culturizing prescription and rational drug use, believed that:
"…Culturizing is a very important factor in prescribing and taking medication. If pharmacies send patients home with a large bag of drugs, the patient thinks that the physician is good and this is one of the causes of irrational prescription of drugs..." (Pharmacist 1)
"…Physicians know that if they write a simple prescription for patients, they will not get a good response from the patients, and sometimes, patients will not follow-up their treatment. It can also be a bad advertising for the physicians. We have a cultural problem and the prescription and rational drug use is a problem in Iran..." (Pharmacist 6)
"…The factor that causes irrational drug use is deficiency in the faulty system of drug prescription and distribution, which is caused by false propaganda and claims of some pharmaceutical companies and marketers that encourage physicians and pharmacists to use their products..." (Insurance inspector 2)
Drug hoarding by distribution companies: Drug hoarding or stoking and refusal to supply drug was another code related to the optimization of drug supply from the participants' point of view. For example, participants stated that:
"…The country has been sanctioned by some countries because of political issues. As a result, raw materials and technology are difficult to be imported into the country and this creates a suitable situation for drug trafficking and increasing price. The government must set policies to prevent hoarding…" (Insurance inspector 2)
"…Hoarding medicines that are directly linked to health and well-being may endanger the lives of thousands of innocent people, and the primary mission of pharmacists is to benefit society..." (Patient 5)
"…One of the factors that disrupt the optimum drug cycle is that, pharmacists and distribution companies stoke drugs in stores other than their pharmacies' store due to the shortage of medicines and become drug hoarders..." (Pharmacist 1)
Principle 4: Justice
The complexity of the issue of justice in the field of medical ethics and the health system is due to its great variety based on philosophy and different evaluation of the concept of ethics. Justice, fairness, and equality should be considered by the participants in issues related to the distribution of scarce health care resources, the process and procedure of decision making about who receives what treatment and how power interactions should be in different positions. Therefore, the codes extracted in this context, were categorized into three subcategories of distributive, procedural, and interactional justice.
Category 1: Equitable distribution
Participants stated that pharmacy licensing, capital distribution, as well as medicine distribution among pharmacies, labor division, and distribution of roles and responsibilities among individuals should be fair, so that the drug distribution system be equitable.
Equitable distribution of drugs: It was one of the codes highlighted in the present study. The participants believed that:
"…The transfer of pharmacies' capital is not fair and it is determined by the brokers according to the insurance-related license and the number of pharmacy sales, which is licensed by the Food and Drug Administration..." (Food and Drug Administration inspector 3)
Justice in the supply and distribution of medicines: It is another code that was considered in distributive justice and the participants stated that:
"…There is no justice in the distribution of medicines. Currently, there is the lack of some medicines in Kerman, and larger cities are always in preference for distribution of medicines..." (Patient 4)
"…Quota medicines are not distributed fairly, and we cannot track how many quota medications have been given to each pharmacy. Because top officials in the Food and Drug Administration have their own pharmacy, so it is the best interest of medicine distribution companies to make these powerful people happy…." (Pharmacist 3)
Equitable distribution of responsibilities and interpersonal interests: It is one of the subcategories of equitable distribution that was highlighted in the present study. In this regard, the participants stated that:
"…The distribution of responsibilities and interests in pharmacies must be based on the fairness and benefits of patients. Effective communication should also be established between individuals, and this will happen when the tasks are allocated correctly…."
Category 2: Procedural justice
Procedural justice is the extent to which the rules and procedures specified by the policies are followed uniformly in all cases. One of the codes extracted from the interviews is justice in law enforcement.
Justice in law enforcement: Seeing individuals equal in law enforcement can provide a good basis for achieving justice in the community. It also increases patients' trust in the pharmaceutical system. According to the interviewees' opinions:
"…People want the law and processes to be implemented equally for everyone. If there is no justice in law enforcement, mistrust is created. Mistrust is the most serious problem in our health system, and if it is the result of injustice in law enforcement, it cannot be corrected by guidelines and regulations".
Category 3: Interactive justice
Interactive justice is one of the main categories of justice. People are sensitive to the quality of their interpersonal interactions and tend to have relationships based on politeness, honesty, and respect, especially between patients and healthcare providers. Interactive justice is about the ways by which customers, who received an imperfect service, are treated.
Justice in protecting people’s rights: It is one of the subcategories of 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…"