While assessing determinants of patients’ financial accessibility, medicines availability, cultural acceptability, and geographical accessibility to facilities providing essential drugs among rural and urban populations, we were attentive to achieve stakeholder inclusiveness using a good and balanced choice.
The current study revealed that one-third of patients who did not get the prescribed drugs were unable to pay for the medicine. Donadel and his colleagues performed a study at PHC level in Tajikistan, 2016, where one-third of the interviewees who did not take in the prescribed drugs related it to their inability to pay. Their results are in the same direction as ours [13].
As regards medicine availability, the results of the present study goes in concordance with a study done in 36 developing and middle-income countries about medicine availability and concluded that the average public sector availability of medicines ranged from 29.4 to 54.4% [14]. Also, a study performed by Nascimento et al., 2017 showed that around 60% of patients said they pick up their needed medicines from PHC units [15].
However, a study conducted in PHC centers in Pakistan found that 90.9% of the prescribed drugs were dispensed [16]. Usually, the low percentage of actually dispensed drugs could be mainly attributed to inadequate drug stock. But also, essential drugs constrained availability is sometimes connected with budgetary restraints, fractional drug supply system, or indigent inventory management of the responsible staff [14, 15].
Concerning cultural acceptability, our observations effectuate the findings of many studies that investigated patients’ knowledge of generic medicines. They revealed that patients are inclined to branded medications as they think that medicine in private pharmacies is better than medicine in PHC facilities [17,18,19]. Patients felt that generic medicines were subsidiary and that herbal treatment is better. This could be attributed to their explanation that herbal treatments carry less chemicals and are less anticipated to bring adverse reactions [18].
The number of medicines per prescription (NMPP) is a prescribing indicator that is pertinent to the rational use of medicine (RUM). A high NMPP can stamp irrational use practices [19]. Regarding the percent of medicine prescribed from EDL, our results are analogous to a similar study, which found that the drug commanded from the EDL in urban PHC was above 90 % [16].
Our findings are consistent with a study by Gopalakrishnan et al., 2013, where it was found that nearly 71% of urban doctors were prescribing the drugs by generic names, but only 52% of the rural doctors did that [20]. Impairing access of poor citizens to health care occurs when patients buy expensive drugs instead of generics. Unfortunately, this happens when doctors prescribe brand names instead of International non-proprietary names (INN) [13].
Measuring physicians’ performances in terms of RUM does not only include contents of the prescriptions but also entails the cost of the prescribed medicines. In our study, most physicians mentioned that they put the cost of the drug into consideration. It was found that median expenses paid by patients to have the medicine in their visit to the PHC facility were significantly higher in the urban group than the rural group; this difference could be explained by the fact that patients in urban units often pay part of the cost of medicine.
This comes with the fact that nearly three quarters of Egypt’s health spending (72%) came directly from household out-of-pocket (OOP) payments [11]. Although the cost per prescription (CPP) prices of countries can yield foresight concerning pharmacoeconomic evaluations, yet it is impracticable to objectively compare the CPP prices of different countries because of the variations in purchasing power [19].
In similar studies, physicians reported that patient variables like clinical condition, compliance, financial situation, and ability to purchase had a powerful influence on their prescribing decisions. Meanwhile, the activities of pharmaceutical companies have little or no influence [21, 22]. In our study, physicians mentioned they did not respond to patient pressure to prescribe non-indicated drugs. On the contrary, another study denoted that patients and their families applied different kinds of direct and indirect pressures to affect physicians’ decisions as regards their prescription [22]. Physicians in the current study might have been reluctant to express their true opinions to the interviewer.
Sometimes nonessential drugs are prescribed to patients just to fulfill patients’ wrong awareness of health care. The enlightenment of common people and health professionals about the dangers of careless curative care is a distinct demand for modern times. Even in different countries, with the same level of health care expenditure, only diminution of clinical health care minimizes costs for the public health system and makes it more effective [20].
Research suggests that working constraints like time, infrastructure, and service management limit the provision of sound, user-oriented dispensing services. Sometimes the pharmaceutical practice actions are complex and the bad service level can result in impactful dispensing errors for the patients’ health [23]. Though there is a drug committee in the two studied PHC facilities for demonstrating the prescribing and dispensing policies, the system required to enforce these policies is still deficient. Duong et al. has suggested that in order to alleviate medicine shortages and to enable fair and equitable access to essential medicines, all committee members must clearly organize their decision-making priorities with procurement practices. Measures like prioritization of supply (number and diversity of product choices), storage space, ordering, transportation, budget decisions, and resilience planning in cases of unpredictable circumstances, such as expanded consumer demand, all secure sustainable patient care [24]. In order to improve drug committee function, there is a need to expand the roles of pharmacists and wholesaler/distributors in the committee decisions to improve the technique of medicines selection and procurement [25].
The current study revealed that Egypt’s reference price is the public one. This is consistent with a study performed by Kaló et al. on how external reference pricing (ERP) is extensively used in the Middle East. ERP rules are most strict in Egypt and Saudi Arabia; they dictate the least pharmaceutical price out of a basket containing more than 25 countries each. On the contrary, Kuwait and Qatar reference only the country of origin for new pharmaceuticals and they do not routinely use EPR for revision of prices after initial pricing decisions [26]. Egyptian MOHP, till 2012, adopted a cost-plus procedure to put the retail prices based on cost reports from producers when products were commenced to be sold in the Egyptian market. Once set, these prices were seldom re-evaluated to adjust for any alterations in cost from inflation or exchange rate oscillation. Hence, retail prices often persisted unvarying over several years and have been heeded very low by manufacturers [27].
In many Asian, African, and Latin American countries, certain strategies were used to contain pharmaceutical prices. The most commonly used pricing policy was mark-up regulation, followed by ERP, cost-plus, and finally generic promotion. The least used policy was the tax exemption [28]. ERP policy uses benchmarking against a basket of countries. Its evident limitation included that optimal ERP should be benchmarked against countries with an analogous economic position [26]. A study in Lebanon and Egypt where prices are benchmarked against developed and high-income countries (HICs) showed that this policy resulted in higher medicine prices for local clients, the requirement of proficient teams for policy design, implementation, and lack of transparency in results appraisal and decision-making [29]. In many low- and middle-income countries (LMICs), the reference price did not often become the actual national price due to the lack of precise analytical studies or monitoring reports. Moreover, companies responded by minimizing price transparency, resulting in the unevenness of the ERP mechanism [30].
Concerning pharmacovigilance (PV), our study demonstrated that there is a unit established in Egypt’s central administration of pharmaceutical affairs (CAPA). Of twenty-six sub-Saharan African countries, only eight countries collected reports on adverse events. Among them, only 3 programs were qualified to grant a sizeable number of PV reports [19]. Determining the performance of PV systems in a country requires membership of this country to the WHO—Program for International Drug Monitoring (PIDM). This membership requires a dedicated national PV center, an automatic adverse drug reaction (ADR) reporting system, and technical efficiency in managing individual case safety reports (ICSRs) [31].
A problem facing the National Medicine Regulatory Agency (NMRA) in most developing countries is the lack of human resources needed to conduct the inspection due to low salaries, insufficiency of pharmaceutical and training institutions [32]. Globally, the WHO rates that at least 30% of NMRA worldwide have confined the ability to accomplish the core regulatory functions [19]. The evaluation of bioequivalence data often presents a major challenge (technical and financial) for regulatory authorities in LMICs including Egypt to the extent that only some local manufacturers, not all of them can carry out bioequivalence studies [33, 34].
Concerning registration, our study findings are consistent with a South African study where registration timelines ranged between 1 and 3 years. Advancement of access to new medicines, through emboldening more companies to register medications in Africa could only be done through a proficient, foretold registration timeline [35]. Another study on marketing authorization (MA) demonstrated that market availability of the drugs is influenced by the time taken by an applicant to be granted an MA certificate [19]. Other causes of turning down were the potential conflicts of interest recorded in at least three African countries and the extra fees rushed upon for initial MA and provisions for its renewal certificate. Studies among both local and multinational pharmaceutical companies in Africa revealed that registration prices were among reasons for companies in making decisions not to provide medicines to specific countries [36].
Our findings are consistent with other study, which showed that the international community does not back up local pharmaceutical production in Africa. Certain African governments believe that investing in the local industry is a bad use of funds and that international procurement of expensive drugs is a more skillful option [32]. In the short run, importing instead of manufacturing appears like a faultless choice but it is a wrong notion in the long run as dependence on imports comes out with a contingent increase in prices [37].
In the Arab region, the local drug production builds up from 0% up to more than 90% of national drug outlets. The Egyptian marketplace in certain studies has been rated to be nearly US$ 1.7 billion. Formulations represent the most locally produced drugs. In some Arab countries, multinational companies give a production license to about 40% of drugs. The imported raw materials needed for local production reaches more than 90% [38].
The research and development activities in the drug industry are primarily quality control activities [37]. Initiation of the manufacturing of biotechnology products, especially vaccines is the focus of recent efforts in Egypt and other Arabic countries. Lack of funding, lack of experienced human resources in certain specialized areas, and lack of suitable environment represent the major challenges facing research and development [39]. Twelve percent of samples collected from Egypt, in a multi-country medicine quality survey, failed at minimum one medicine quality test and can be heeded substandard [40].
Limitations
Performing the study in a single governorate only was done owing to difficult administrative permissions. A second limitation was the inability to check the expiry date on tracer medicines as the PHC staff considered that as a sensitive issue. Difficulty in interviewing these various stakeholders and in taking appointments may have affected the quality of information given by the informants.
