Introduction  

Availability of and access to essential medicines, medical supplies, and other health technology products constitute an important part of an effective and efficient health system that contributes towards achieving health-related sustainable development goals for ensuring healthy lives and promoting wellness for all at all ages [1-3]. 

Iraq had suffered many crises in the last four decades including humanitarian and health-related ones. Internal as well as external efforts are being made to help the country overcome the consequences of these crises [4]. According to a report recently released by the Iraqi Ministry of Health and Environment (MoH), Iraq’s total gross domestic product (GDP) has exceeded 111 billion US dollars in 2019; however, only 4.5% (about 5 billion US dollars) of the GDP is allocated for the healthcare and environmental sectors [5]. This percentage (4.5%) is considered the lowest among all the countries in the region that have a comparable economy. The report also indicated that only about 1.24 million US dollars were allocated for procuring medicines, medical appliances, and supplies by the state company for marketing drugs and medical appliances (KIMADIA), a company described in more details later in this section.

The Iraqi National Regulatory Authority (NRA) includes several directorates and departments that are parts of the Iraqi MoH, mainly the directorate of technical affairs (DOTA) [6]. The main functions of the Iraqi NRA are associated with ensuring safe, effective, and affordable medicinal products available in Iraq. These functions include, but are not limited to, granting marketing authorization, estimation of medicines quantities needed to be procured for the Iraqi healthcare institutions, laboratory quality control testing and batch release of medicines, inspection duties, granting pharmaceutical manufacturing licenses, and pharmacovigilance.

The Iraqi NRA is led by two supreme committees, the Medicines Policy Committee and the National Board for the Selection of Drugs (NBSD) [6]. The former committee is in charge of establishing the general outlines for medicines policy in the country. The NBSD is responsible for enlisting and authorizing medicines in Iraq. The NBSD categorizes medicines in Iraq under two lists which are the national essential medicine list (EML) and the comprehensive list. The national EML is further subdivided into three levels, L1, L2, and L3, as will be described later.

The state company for marketing drugs and medical appliances, or more widely known as “KIMADIA”, is the procurement arm of the Iraqi MoH. Its main responsibility is providing the government hospitals and healthcare centers with the necessary medicines (those enlisted in the Iraqi EML), vaccines, medical supplies, and equipment and materials for laboratories and hospitals [7]. The company has a flexible procurement system where it can use the tendering process with certain medicines and appliances or direct procurement with others. It is within KIMADIA regulations and procurement conditions that the product must be enlisted and registered in Iraq, especially when it comes to medicinal products. However, in certain circumstances, KIMADIA has the power to bypass these conditions to provide essential medicinal products for the country’s health institutions. It is also worth mentioning that KIMADIA is responsible for providing the public sector with the medicines enlisted in the L1 level of the national EML as well as providing other commodities to this sector. On the other hand, medicines enlisted in L2 and L3 levels of the national EML can be procured directly by the local health directorates and healthcare institutions when KIMADIA does not have enough funds to procure them [8].

The Iraqi MoH has been facing challenges to provide the necessary safe and effective medicines, especially those in the national EML, where part of them are essential for sexual and reproductive health and rights (SRHR) which are the focus of this paper [4]. The challenges are mainly monetary which might be alleviated by increasing the total expenditure on healthcare and procurement of medicines by the government. Other challenges have been related to a loose grip by the Iraqi MoH and other concerned departments within the Iraqi state in imposing the necessary rules and regulations that monitor the Iraqi pharmaceutical sector [5].

The availability of necessary SRHR medicines and other commodities in any country decides the effective implementation of the SRHR recommendations and guidelines of that country [9]. Countries develop and update their EMLs based on World Health Organization (WHO) global EML [10] and the changing epidemiology and requirements at the country level. Inclusion of all the necessary national SRHR-guidelines medicines in the national EMLs facilitates the availability of such medicines, though it is not necessarily ensuring their availability. The inclusion of certain medicines in EMLs provides a strong background to create the initial stimulus for the availability of these medicines in countries. Furthermore, registration of medicines with local drug registration authorities and inclusion in public procurement lists are essential steps to ensure their availability [11, 12].

This study aims to sort out all the SRHR medicines required to implement national guidelines on preconception care, maternal care, family planning, safe and post-abortion care, and infertility in Iraq to identify the existing gaps in the availability of these medicines and advocate for registration and inclusion of missing ones in national EML.

Materials and Methods

A qualitative desk review assessment of the situation of availability of essential medicines that are required for national SRHR guidelines implementation was conducted through the direct communication of the researcher with the concerned MoH officials and employees to facilitate the process of conducting the assessment and collecting the available national SRHR guidelines. It is important to mention that most of the Iraqi SRHR guidelines are not available online; however, they had been printed and distributed to the Iraqi healthcare providers (HCPs) in the form of printed booklets and periodicals.

Once the current national SRHR guidelines were collected, reviewing and sorting out the necessary medicines to implement these guidelines was carried out. Mainly, tables were used to organize the information on each medicine or group of medicines with a focus on addressing the following questions; Is the medicine included in the national EML? Is the medicine included in the national comprehensive medicines list? Is the medicine registered by the drug regulatory authority of the country? if yes, how many products have been registered? Does Iraq have a pharmacovigilance system? if yes, is this medicine included in the pharmacovigilance system for quality control? Is the medicine included in the government procurement or tender lists? Has the medicine been procured in the past 24 months via recognized procurement agents that serve the public sector? Do the forecasting tools for medicines include this medicine?.

The prepared lists of medicines were mapped with the global EML [10], national EMLs [13], the comprehensive medicines list [14], and the list of registered medicines in Iraq [15] to identify the gaps. If gaps exist then remedies are to be identified to fortify the country’s ability to secure all the EML required to implement SRHR guidelines and ensure continuity of supply of these medicines in Iraq.

Results and Discussion

To present the large amount of data obtained in this study and to help a better understanding of the findings, the collected medicines from the available national SRHR guidelines and documents were categorized into several categories and subcategories and listed in tables with proper color coding, as shown in the coming sections. The most prominent findings from each category and subcategory were explained under each of the corresponding results and discussion sections.

Situation of medicines and commodities for contraception

The collected information on medicines and commodities for contraception following the methodology of this study are summarized in Table 1. The most prominent findings that can be inferred from this table are explained here. Firstly, only ethinylestradiol plus levonorgestrel (as tablets) are procured regularly by KIMADIA among all the medicines mentioned in the national guidelines, national EML and, global EML. Second, several medicines are enlisted in the global EML and are mentioned in the national SRHR guidelines but are not enlisted in the national EML, such as an etonogestrel-releasing implant, levonorgestrel tablet, estradiol cypionate plus medroxyprogesterone acetate injection, and ulipristal tablet.

Finally, condoms and diaphragms are not enlisted in the national EML, instead, they are enlisted in the national list of commodities. Quantities needed were estimated by the Need Estimation Department in the DOTA but were not procured by KIMADIA in 2019.

Situation of medicines related to antenatal care

The most prominent findings on medicines related to antenatal care are summarized in Table 2. Firstly, medicines for prevention and management of anemia, antacids, and medicines for the management of nausea and vomiting, and medicines for prevention and management of preeclampsia and eclampsia seem to be regularly estimated in the forecast and procured for the public sector. A reasonable number of these medicines have a valid registration status. Secondly, labetalol is not enlisted in the global EML but is available in Iraq; however, the situation is the opposite with bisoprolol. Thirdly, medicines for the management of diabetes complicating pregnancy seem to be regularly estimated in the forecast and procured for the public sector. A reasonable number of these medicines have a valid registration status.

All medicines for the prevention of mother-to-child transmission of the human immunodeficiency virus (HIV) and other common infections that are mentioned in the available guidelines are enlisted in the national EML. Some of these medicines are procured and regularly estimated in the forecast every two or three years. However, Table 2 shows many other HIV medicines are enlisted in the global EML but not enlisted in the national EML, such as atazanavir, darunavir, dolutegravir, tenofovir disoproxil fumarate, and raltegravir.

Medicines for the prevention and management of preterm births are covered within the national EML. Nifedipine is enlisted under L3 which means it can be procured at the healthcare institution level and not centrally through KIMADIA. Atosiban, even though this medicine is not enlisted in the global EML, it is included in the national guidelines and national EML. The results also show that albendazole is enlisted in L3 in the national EML and can be procured at the healthcare institution level, while mebendazole and adrenaline were not procured in 2019 even though they were regularly estimated in the forecast.

Situation of medicines required for intrapartum care

The situation of medicines required for implementing intrapartum care guidelines is summarized in Table 3. The table shows that antiseptics, including chlorhexidine solution and ethanol solution, are purchased at the healthcare institutions-level according to their needs. Only the povidone-iodine solution was decided to be procured by KIMADIA in Iraq. Povidone-iodine was not procured by KIMADIA in 2019 but was estimated in the forecast of the subsequent year (2020). A reasonable number of this product has a valid registration status.

IV fluids including normal saline and glucose solutions seem to be regularly estimated in the forecast and procured for the public sector. A reasonable number of these medicines have a valid registration status. For Induction of labor, misoprostol 25 μg vaginal tablet is not enlisted in the national EML in Iraq at any level (L1, L2, or L3) nor was procured by KIMADIA. Instead, a 200 μg-strength tablet is enlisted in the national EML under L1.

Under the section of pain relief, codeine is not enlisted in the national EML, but fentanyl, morphine, and pethidine are enlisted, even though pethidine is not enlisted in the global EML. Morphine injection was not procured in 2019; however, the quantity needed was projected in the forecast of the subsequent year (2020). On the other hand, medicines used in epidural analgesia are all enlisted in the national EML, procured, and regularly estimated. Lidocaine injection (1% and 2%) in vial or ampule were not procured in 2019 but was estimated in the forecast of the subsequent year (2020).

Regarding uterotonics, the combination of oxytocin and ergometrine (5 IU/500 µg) or oxytocin and ergometrine fixed-dose combination is not enlisted in the national EML nor mentioned in the guidelines. Ergometrine/ methylergometrine (200 µg, IM/IV), misoprostol (either 400 µg or 600 µg, orally), and tranexamic acid were not procured in 2019 but were estimated in the forecast of the subsequent year (2020). Oxytocin seems to be used as an alternative uterotonic to carbetocin in Iraq [16].

Finally, the plasma substituents dextran 70 is not enlisted in the national EML. However, human albumin use in Iraq might provide an alternative to this product [17].

Situation of medicines required for postpartum care

The most prominent findings from the situation of medicines required for postpartum care are summarized in Table 4 (part1) and can be described as following. Medicines for postpartum care seem to be regularly estimated in the forecast and procured for the public sector. A reasonable number of these medicines have a valid registration status. Anti-D immunoglobulin was not procured in 2019, but it was found that 54983 injections were procured by KIMADIA in December 2018. In addition to that, this product is included in the forecast for 2020.

The situation for enoxaparin 4000 IU is the same as for anti-D immunoglobulin above, where this product was not procured in 2019, but it was found that 762312 prefilled syringes were procured by KIMADIA in June 2018. In addition to that, this product is included in the forecast for 2020.

Finally, erythromycin (tablets, capsules, or injections), ampicillin injections, and clindamycin injections or capsules were enlisted under either level 2 or 3 of the national EML.