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Essential medicine required for national SRHR guidelines implementation in Iraq

Khalid Kadhem Al-Kinani1*

1 Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad, Iraq.

Correspondence: Khalid Kadhem Al-Kinani, Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad, Iraq. Khalidalkinani @ copharm.uobaghdad.edu.iq


ABSTRACT

This study is intended to assess the situation of essential medicines for the implementation of the sexual and reproductive health and rights (SRHR) guidelines in Iraq to provide a clear picture of the availability of these medicines and identifies gaps to be filled. The medicines were grouped into categories and subcategories and the assessment was begun after collecting information from the current national SRHR guidelines, global EML, national EML, registration index, and other relevant documents. The assessment included several points to be addressed about each medicine or group of medicines in the format of closed-ended questions to draw a clear picture on status of that medicine. The collected data organized in the form of informative tables and bar graphs showed that about 125 SRHR essential medicines are addressed in this study. Of these essentials medicines, 80 medicines (64%) are fairly covered in Iraq in terms of their clear recognition by the Iraqi healthcare system. The analysis also shows that only about 62% of the SRHR medicines were procured in 2019. The results suggest that more work needs to be done to provide better SRHR service in Iraq. This includes, but is not limited to, working on updating and publishing all the national management guidelines related to SRHR. It also includes revisiting the national EML and comprehensive list of medicines to provide better coverage of SRHR medicines. Finally, a robust strategy needs to be put together to harmonize the work of all the stakeholders to provide the necessary medicines when needed.

Keywords:  Reproductive, Sexual, Essential medicines, Iraq, Enlisting, Procurement


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.

 

 

Table 1. Situation of medicines and commodities for contraception

Name of the Medicine

Included in the global EML

Included in the national FP guidelines

Included in the naional EML

If not included in the national EML, is it included in the comprehensive list?

Registered drug with the national drug control authority (number of products registered)

Amount procured in 2019

Included in the procurement list

Included in the forcasting tools for medicines

Included in the PV system

Oral hormonal contraceptives

                 

Ethinylestradiol + levonorgestrel. Tablet: 30 micrograms + 150 micrograms

Yes

Yes

Yes (L1)

 

Yes (1)

9991506

Yes

Yes (9991510)

No

Ethinylestradiol + norethisterone:  Tablet: 35 micrograms + 1 mg.

Yes

Yes

Yes (L3)

 

No

np

No

No

No

Injectable hormonal contraceptives

                 

Estradiol cypionate + medroxyprogesterone acetate: Injection: 5 mg + 25 mg

Yes

No

No

No

No

np

No

No

No

Medroxyprogesterone acetate:  Injection (intramuscular): 150 mg/ mL in 1- mL vial. Injection (subcutaneous): 104 mg/0.65 mL in pre-filled syringe or single-dose injection delivery system

Yes

Yes

Yes (L1)

 

Yes (1)

np

No

No

No

Norethisterone enantate: Oily solution: 200 mg/mL in 1- mL ampoule

Yes

Yes

No

No

No

np

No

No

No

Intrauterine devices

                 

Copper-containing device

Yes

Yes

Yes (L3)

 

No

np

No

No

No

Levonorgestrel-releasing intrauterine: system with reservoir containing 52 mg of levonorestrel

Yes

Yes

Yes (L3)

 

Yes (1)

np

No

No

No

Barrier methods

                 

Diaphragms

Yes

Yes

Yes*

 

N/A

np

Yes

Yes (9905)

No

Condoms

Yes

Yes

Yes*

 

N/A

np

Yes

Yes (575549)

No

Implantable contraceptives

                 

Etonogestrel-releasing implant: Single-rod Etonogestrel-releasing implant, containing 68 mg of etonogestrel

Yes

Yes

No

Yes

No

np

No

No

No

Levonorgestrel-releasing implant:  Two-rod Levonorgestrel-releasing implant, each rod containing 75 mg of levonorgestrel (150 mg total).

Yes

Yes

No

No

No

np

No

No

No

Intravaginal contraceptives

                 

Progesterone vaginal ring: Progesterone-releasing vaginal ring containing 2.074 g of micronized progesterone

Yes

Yes

No

No

No

np

No

No

No

Emergency contraceptives

                 

Levonorgestrel: Tablet: 30 micrograms; 750 micrograms (pack of two); 1.5 mg

Yes

Yes

No

Only 30 micrograms tab

No

np

No

No

No

Ulipristal Tablet: 30 mg (as acetate)

Yes

Yes

No

No

No

np

No

No

No

np: not procured

PV: pharmacovigilance

FP: family planning

     

* enlisted in the National List of Commodities

                 

 

 

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.

 

 

Table 2. Situation of medicines related to antenatal care

Name of the Medicine

Included in the global EML

Included in the national maternal care guidelines

Included in the naional EML

If not included in the national EML, is it included in the comprehensive list?

Registered drug with the national drug control authority (number of products registered)

Amount procured in 2019

Included in the procurement list

Included in the forcasting tools for medicines (amount estimated)

Included in the PV system

Prevention and management of anemia

                 

Ferrous salt (Ferrous sulphate  200mg Tablet)

Yes

Yes

Yes (L1)

 

No

np

Yes

Yes (7150012)

No

Ferrous salt (Ferrous gluconate 400mg/15ml Syrup)

No

Yes

Yes (L1)

 

Yes (2)

456816

Yes

Yes (314187)

No

Ferrous salt + folic acid

Yes

Yes

Yes (L1)

 

Yes (8)

88148160

Yes

Yes (87646662)

No

Folic acid 5 mg tablet

Yes

Yes

Yes (L1)

 

Yes (8)

25773540

Yes

Yes (24445951)

No

Folic acid 400 microgram tablet

Yes

Yes

Yes (L1)

 

No

np

No

No

No

Vaccines

                 

Influenza vaccine

Yes

No

Yes (L1)

 

Yes (2)

~ 2200000

Yes

Yes (2200000)

No

Tetanus toxoid vaccine

Yes

yes

Yes (L1)

 

No

not specified

Yes

Under Study

No

Prevention and management of preeclampsia and eclampsia

                 

Calcium tablet

Yes

Yes

Yes (L1)

 

Yes (4)

3845900

Yes

Yes (3664639)

No

Acetylsalicylic acid (aspirin, 300 mg)

Yes

Yes

Yes (L1)

 

Yes (2)

524000

Yes

Yes (431325)

No

Magnesium sulfate

Yes

Yes

Yes (L1)

 

Yes (2)

50200

Yes

Yes (50210)

No

Hydralazine 20 mg ampule and 25 mg or 50 mg tablet

Yes

Yes

Yes  (L1)

 

Yes (1)

37575

Yes

Yes (79922 inj)

No

Methyldopa tablet  250 mg

Yes

Yes

Yes (L1)

 

Yes (4)

2638670

Yes

Yes (1633675)

No

bisoprolol tablet 1.25 mg and 5 mg

Yes

No

No

Yes

Yes (14)

np

No

No

No

Labetalol injecion and tablet

No

Yes

Yes (L1)

 

Yes (1 for inj)

19490 inj.

Yes

Yes (19441 for inj) and (56719 for tab)

No

Prevention and management of preterm births

                 

Dexamethasone or betamethasone (IM)

Yes

Yes

Yes (L1)

 

Yes (2)

397463 (dexa)

Yes

Yes (7208189)

No

Nifedipine (a calcium channel
blocker) 10 mg tablet

Yes

Yes

Yes (L3)

 

Yes (1)

np

No

No

No

Atosiban injection

No

Yes

Yes (L1)

 

Yes (1)

No need

Yes

Yes (2193)

No

Context specific medicines

                 

Preventive anthelminthic treatment: using single-dose albendazole (400 mg)

Yes

Yes

Yes (L3)

 

No

np

No

No

No

Preventive anthelminthic treatment: using mebendazole 500mg or 100 mg

Yes

Yes

Yes (L1)

 

Yes (1)

np

Yes

Yes (3014125)

No

Intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP)

Yes

No

Yes (L3)

 

No

np

No

No

No

Azithromycin

Yes

Yes

Yes (L1)

 

Yes (17)

3395421

Yes

Yes (3415172)

No

Adrenaline

Yes

Yes

Yes (L1)

 

No

np

Yes

Yes (247414)

No

Co-trimoxazole prophylaxis for adults

Yes

Yes

Yes (L1)

 

Yes (8)

16805160 tablet 480 mg

Yes

Yes (14287048)

No

Ciprofloxacin 500 mg tab

Yes (250 mg)

Yes

Yes (L1)

 

Yes (25)

7152780

Yes

Yes (6989879)

No

np: not procured

PV: pharmacovigilance

           

 

 

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].

 

 

Table 3. Situation of medicines required for intrapartum care.

Name of the Medicine

Included in the global EML

Included in the national intrapartum care guidelines

Included in the naional EML

If not included in the national EML, is it included in the comprehensive list?

Registered drug with the national drug control authority (number of products registered)

Amount procured in 2019

Included in the procurement list

Included in the forcasting tools for medicines

Included in the PV system

Antiseptic

                 

Chlorhexidine Solution: 5% (digluconate)

Yes

Yes

Yes (L3)

 

No

np

No

No

No

Ethanol Solution: 70% (denatured)

Yes

Yes

Yes (L3)

 

No

np

No

No

No

Povidone iodine solution: 10% (equivalent to 1% available iodine)

Yes

Yes

Yes (L1)

 

Yes (5)

np

Yes

Yes (654758)

No

I.V. fluids

                 

Saline solution

Yes

Yes

Yes (L1)

 

Yes (6)

9583175

Yes

Yes (9527198)

No

Glucose solution

Yes

Yes

Yes (L1)

 

Yes (4)

7686725

Yes

Yes (4803048)

No

Induction of labour

                 

Misoprostol 25 μg vaginal tablet

Yes

Yes

No

No

No

np

No

No

No

Oxytocin injection

Yes

Yes

Yes (L1)

 

Yes (6)

1913425

Yes

Yes (2882012)

No

Pain relief

                 

Codeine 30 mg tab (phosphate)

Yes

No

No

Yes

No

np

No

No

No

Fentanyl

Yes

No

Yes (L1)

 

Yes (2)

214210

Yes

Yes (154783 inj)

No

Morphine injection

Yes

No

Yes (L1)

 

Yes (3)

np

Yes

Yes (76114 inj)

No

Pethidine

No

No

Yes (L1)

 

Yes (1)

11290

Yes

Yes (142283 inj)

No

Epidural analgesia

                 

Bupivacaine Injection: 0.25%; 0.5% (hydrochloride)

Yes

Yes

Yes (L1)

 

yes (1)

114980

Yes

Yes (139699)

No

Lidocaine Injection: 1%, 2% (hydrochloride) in vial

Yes

Yes

Yes (L1)

 

Yes (3)

np

Yes

Yes (243018)

No

Ephedrine Injection: 30 mg (hydrochloride)/ mL in 1- mL ampoule. (For use in spinal anaesthesia during delivery, to prevent hypotension)

Yes

Yes

Yes (L1)

 

No

179750

Yes

Yes (104657)

No

Uterotonics

                 

Oxytocin injection

Yes

Yes

Yes (L1)

 

Yes (6)

1913425

Yes

Yes (2882012)

No

Carbetocin (100 µg, IM/IV)

Yes

No

Yes (L3)

 

Yes (1)

np

No

No

No

Ergometrine/ methylergometrine (200 µg, IM/IV)

Yes

Yes

Yes (L1)

 

Yes (1)

np

Yes

Yes (1118398)

No

Misoprostol (either 400 µg or 600 µg, PO)

Yes

Yes

Yes (L1)

 

Yes (1)

Yes

Yes

Yes (468717)

No

Combination of oxytocin plus ergometrine (5 IU/500  µg) oxytocin and ergometrine fixed-dose combination

Yes

No

No

No

No

np

No

No

No

Tranexamic acid (TXA) 1 g in 10 mL (100 mg/mL)

Yes

Yes

Yes (L1)

 

Yes (1)

np

Yes

Yes (189107)

No

Blood components

                 

Coagulation factor VIII (500 IU/vial)

Yes

No

Yes (L1)

 

Yes (4)

150525

Yes

Yes (155260)

No

Coagulation factor IX (500-1000 IU/vial)

Yes

No

Yes (L1)

 

Yes (3)

42077

Yes

Yes (39090)

No

Plasma substitutes

                 

Dextran 70

Yes

No

No

Yes

No

np

No

No

No

                   

np: not procured

PV: pharmacovigilance

           

 

 

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.

 

 

Table 4. Situation of medicines required for postpartum care and comprehensive abortion care

Name of the Medicine

Included in the global EML

Included in the national guidelines

Included in the naional EML

Registered drug with the national drug control authority (number of products registered)

Amount procured in 2019

Included in the procurement list

Included in the forcasting tools for medicines

Included in the PV system

Part 1: Postpartum care section

Iron and folic acid supplementation

Yes

Yes

Yes (L1)

Yes (8)

88148160

Yes

87646662

No

Anti-D immunoglobulin Injection: 250 micrograms in single-dose vial

Yes

Yes

Yes (L1)

Yes (2)

80903 (300 microgram PFS)

Yes

Yes (64855)

No

Erythromycin tablet, capsule, or injection

Yes

Yes

Yes (L3) only tab or cap

Yes (3)

np

No

No

No

Amoxicillin and clavulanic acid (“co-amoxiclav”)

Yes

Yes

Yes (L1)

Yes (30 for tab) and (25 for susp)

29749280 (tab), 2476728 (susp)

Yes

Yes (1434639 for susp) and ongoing for tab

No

Ampicillin injection

Yes

Yes

Yes (L2)

Yes (3)

np

No

No

No

Gentamicin injection

Yes

Yes

Yes (L1)

Yes (9)

906980

Yes

Yes (3248298)

No

Clindamycin

Yes

Yes

Yes (L3)

Yes (3 for inj) and (2 for cap)

np

No

No

No

Enoxaparin 4000 IU

Yes

Yes

Yes (L1)

Yes (1)

np

Yes

Yes (1015566)

No

Part 2: Comprehensive abortion care

Mifepristone

Yes

No

Yes (L3)

No

np

No

No

No

The combination regimen (mifepristone and misoprostol)

Yes

No

No

No

np

No

No

No

Ibuprofen (400–800 mg) tablet

Yes

No

Yes (L1)

Yes (18)

57531200 (200 mg tab.)

Yes

Yes (45171807)

No

Diazepam 5–10 mg tablet

Yes

No

Yes (L1)

Yes (10)

5169000

Yes

Yes (3556904)

No

Opioid analgesia for pain relief

               

Codeine tablet 30mg (phosphate)

Yes

No

No

No

np

No

No

No

Fentanyl

Yes

No

Yes (L1)

Yes (2)

214210

Yes

Yes (154783 inj)

No

Morphine injection

Yes

No

Yes (L1)

Yes (3)

np

Yes

Yes (76114 inj)

No

Pethidine injection

No

No

Yes (L1)

Yes (1)

11290

Yes

Yes (142283 inj)

No

Epidural analgesia/anasthesia

               

Bupivacaine Injection: 0.25%, 0.5% (hydrochloride)

Yes

No

Yes (L1)

Yes (1)

114980

Yes

Yes (139699)

No

Lidocaine Injection: 1%, 2% (hydrochloride) in vial. Injection

Yes

No

Yes (L1)

Yes (3)

np

yes

Yes (243018)

No

Ephedrine Injection: 30 mg (hydrochloride)/ mL in 1- mL ampule (for use in spinal anaesthesia during delivery, to prevent hypotension)

Yes

No

Yes (L1)

No

179750

Yes

Yes (104657)

No

np: not procured

PV: pharmacovigilance

         

 

 

Situation of medicines required for comprehensive abortion care

The situation of medicines required for comprehensive abortion care is summarized in Table 4 (part 2). It is important to mention that there are no national comprehensive guidelines dedicated to abortion care in Iraq. However, some of these medicines are included in the basic health services package for Iraq (2009) which covers this section. The table shows that mifepristone is enlisted only under L3 of the national EML. Mifepristone in combination with misoprostol is not enlisted in the national EML or the comprehensive list of medicine. The non-steroidal anti-inflammatory drug (NSAID) Ibuprofen 200 mg tablet was procured for the public health sector in 2019. A reasonable number of this medicine (generic products) have valid registration status. Diazepam seems to be regularly estimated in the forecast and procured for the public sector. A reasonable number of this medicine has a valid registration status. Morphine injection was not procured by KIMADIA in 2019; however, it is included in the 2020 forecast. Finally, for epidural analgesia, every medicine seems to be covered in Iraq except for the lack of procurement of lidocaine injection in 2019 and the lack of registered products for ephedrine injection.

Situation of medicines required for preconception and fertility care

There are no national comprehensive guidelines dedicated to preconception care in Iraq. However, some of Table 5 (part 1) medicines are included in the basic health services package for Iraq (2009). The situation indicates no ferrous sulphate tablet products are registered or have valid registration status in Iraq. This medicine was not procured in Iraq in 2019 but was included in the 2020 forecast. On the other hand, ferrous gluconate syrup is included in the national guidelines (the basic health services package for Iraq, 2009), included in the national EML, registered, and procured regularly by KIMADIA. However, the ferrous gluconate syrup dosage form is not enlisted in the global EML.

Folic acid preparations (alone or in combination) are included in the national guidelines and enlisted under L1 of the national EML. A significant number of these products have been registered and procured in 2019.

Regarding the vaccines, the table shows that influenza vaccines were not procured in 2019. Two influenza vaccine products are registered and 2200000 doses are estimated for 2020. On the other hand, the human papillomavirus vaccine (HPV) is not yet part of the Iraqi immunization schedule. All other vaccines seem to be regularly estimated in the forecast and procured by KIMADIA. However, most of these vaccines were not registered in Iraq.

Finally, clomiphene citrate tablets were not procured for the public sector in 2019 but are included in the 2020 forecast. Two products are registered and this medicine is enlisted under L1 of the national EML.

 

 

 

Table 5. Situation of medicines required for preconception and fertility care, and newoborn care

Name of the Medicine

Included in the global EML

Included in the national guidelines

Included in the naional EML

If not included in the national EML, is it included in the comprehensive list?

Registered drug with the national drug control authority (number of products registered)

Amount procured in 2019

Included in the procurement list

Included in the forcasting tools for medicines

Included in the PV system

Part 1: Preconception and fertility care

Ferrous salt (Ferrous sulphate  200mg Tablet)

Yes

No

Yes (L1)

 

No

np

Yes

Yes (7150012)

No

Ferrous salt (Ferrous gluconate 400mg/15ml Syrup)

No

No

Yes (L1)

 

Yes (2)

456816

Yes

Yes (314187)

No

Ferrous salt + folic acid

Yes

No

Yes (L1)

 

Yes (8)

88148160

Yes

Yes (87646662)

No

Folic acid 5 mg tablet

Yes

No

Yes (L1)

 

Yes (8)

25773540

Yes

Yes (24445951)

No

Influenza vaccine

Yes

No

Yes (L1)

 

Yes (2)

np

Yes

Yes (2200000)

No

HPV vaccine

Yes

No

No

Yes

No

np

No

No

No

Rubella vaccine

Yes

No

Yes (L1)

 

Yes (1)

Procured

Yes

Yes (4103235)

No

Tetanus vaccine

Yes

No

Yes (L1)

 

No

Procured

Yes

Yes (56037 for DT vaccine) and (3034016 for D.T.P)

No

Infertility

 

No

             

Clomifene Tablet: 50 mg (citrate)

Yes

No

Yes (L1)

 

Yes (2)

np

Yes

Yes (539241)

No

Part 2: Newborn care

Chlorhexidine (7.1% chlorhexidine digluconate aqueous solution or gel, delivering 4% chlorhexidine)

Yes

Yes

Yes (L3)

 

No

np

No

No

No

Surfactant

Yes

Yes

Yes (L1)

 

Yes (1)

13028

Yes

Yes (71614)

No

Oxygen therapy

Yes

Yes

Yes

 

NA

np

NA

NA

No

Vitamin K1

Yes

Yes

Yes (L1)

 

Yes (1)

np

Yes

Yes (146355)

No

Tetracycline hydrochloride 1% eye ointment

Yes

Yes

Yes (L1)

 

Yes (2)

np

No

No

No

Erythromycin 0.5% eye ointment

Yes

No

No

 

No

np

No

No

No

Povidone iodine

Yes

Yes

Yes (L1)

 

Yes (5)

np

Yes

Yes (654758)

No

Chloramphenicol 1% eye ointment

No

No

Yes (L1)

 

Yes (3)

202800

Yes

Yes (721045)

No

Phenobarbital ampule

Yes

Yes

Yes (L1)

 

No

186830

Yes

186783

No

Midazolam injection

Yes

Yes

Yes (L1)

 

Yes (3)

np

Yes

Yes (206518)

No

Lidocaine injection

Yes

Yes

Yes (L1)

 

Yes (3)

np

yes

Yes (243018)

No

Aqueous benzyl penicillin 100000–150000 U Procaine penicillin 50000 U

Yes

Yes

No

Yes

No

np

No

No

No

Hepatitis B vaccine

Yes

Yes

Yes (L1)

 

Yes (1)

621000

Yes

Yes (1992831)

No

Oral polio vaccine

Yes

Yes

Yes (L1)

 

No

21000000

Yes

Yes (22601828)

No

BCG vaccine

Yes

Yes

Yes (L1)

 

No

Procured

Yes

in process

No

Cloxacillin

Yes

Yes

No

No

No

np

No

No

No

Ceftriaxone 1g vial I.V. injection

Yes

Yes

Yes (L1)

 

Yes (7)

6161458

Yes

6051458

No

Spectinomycin 25 mg/kg

Yes

No

No

No

No

np

No

No

No

np: not procured

PV: pharmacovigilance

           

 

 

Situation of medicines required for newborn care

The situation of medicines required for newborn care is summarized in Table 5 (part 2). The most prominent findings are described as following. Chlorhexidine is enlisted under L3 of the national EML. Surfactants seem to be regularly estimated in the forecast and procured for the public sector, where two of these medicines have a valid registration status. Vitamin K is enlisted under L1 of the national EML with one product that has a valid registration status. Vitamin K is included in the 2020 forecast but was not procured by KIMADIA in 2019. Tetracycline eye ointment is included in the guidelines and enlisted under L2 of the national EML but erythromycin eye ointment seems to be absent from the national guidelines, national EML, registration, procurement, and forecast. Phenobarbital ampules seem to be regularly estimated in the forecast and procured by KIMADIA. However, no product has a valid registration status. Midazolam and lidocaine injections were not procured in 2019. These two products however are included in the 2020 forecast. Aqueous benzylpenicillin 100000–150000 U, procaine penicillin 50000 U, and cloxacillin seem to be no longer part of the national EML. Vaccines for newborns are adequately covered by the Iraqi MoH. Spectinomycin is not enlisted under any level of the national EML, no product has a valid registration status, and lastly, this medicine has not been procured or enlisted in the forecast.

Putting all the data from Tables 1, 2, 3, 4, and 5 together can provide a global look at the situation of essential medicine required for the implementation of national SRHR guidelines in Iraq. The number of SRHR medicines grouped under different categories is shown in Figure 1, where one can see that about 64% of the SRHR medicines enlisted in the global EML are fairly covered in Iraq. The meaning of fairly covered is that the SRHR medicine (only enlisted ones in the global EML) is well recognized by the Iraqi regulatory authority and healthcare system through enlisting in the national EML, comprehensive list, procured, and/or forecasted to be procured. The figure also clearly shows the number of SRHR medicines that are not included in the guidelines (32 out of 125), not enlisted in the national EML or comprehensive list (19 out of 125), not registered but in the national EML (26 out of 125), not procured in 2019 but enlisted in national EML-L1 (23 out of 125), and finally not included in the forecast but enlisted in national EML-L1 (3 out of 125).

 

Figure 1. Number of SRHR medicines grouped under different categories (as labeled inside the figure)

 

Furthermore, the calculations show that about 61.7% of the medicines mentioned in the national SRHR guidelines were procured in 2019 (50 medicines out of 81 medicines), as shown in Figure 2a, assuming that is the contracted medicines were supplied to KIMADIA smoothly and no contract was rescinded. However, the analysis also shows a higher percentage (71.4%) of procurement when comparing the number of medicines enlisted in national EML (L1) to the number of these medicines procured in 2019 (Figure 2b).

 

a)

b)

Figure 2. (a) Number of SRHR medicines mentioned in the national guidelines compared to a number of these medicines procured in 2019. (b) Number of SRHR medicines included in the national EML (L1) compared to the number of these medicines procured in 2019.

 

The most prominent findings from the results section can be discussed following the same categorization of the SRHR medicines used in the previous section and as below:

Situation of medicines and commodities for contraception

It seems that the Iraqi MoH supplies its healthcare institutions through KIMADIA with only ethinylestradiol plus levonorgestrel tablets for family planning. As it can be seen from the registered drug column, there are two more products (medroxyprogesterone acetate I.M. injection and levonorgestrel-releasing intrauterine system) having a valid registration status and can provide alternatives in the private sector and/or procured at the healthcare institution level (enlisted under L3 level). Many other means of family planning medicines are enlisted in the global EML and are mentioned in the national SRHR guidelines but not enlisted in the national EML. Therefore, these medicines need to be considered by NBSD as additional or alternative medicines to the national EML enlisted family planning medicines [18]. To our knowledge, emergency contraceptives mentioned in Table 1 are available in the private sector and might need to be registered by the Iraqi MoH to ensure a safe and effective medicine for the public.

Finally, condoms and diaphragms were not procured by KIMADIA due to the lack of cost estimation of these two commodities. Cost estimation is supposed to be provided to KIMADIA by DOTA for the tender announcement. Therefore, work needs to be accelerated by the division of cost estimation units within the DOTA to facilitate the procurement of these two sexual commodities.

Situation of medicines related to antenatal care

It seems that even when a medicine is not registered nor has no valid registration status, it can still be procured by KIMADIA, if necessary (an example is ferrous sulphate 200 mg tablet) [8]. However, it is worth mentioning that every batch of medicine procured by KIMADIA has to be tested in the national quality control (QC) laboratories for release purposes to ensure a minimum level of safety and efficacy of the unregistered medicine. Bisoprolol is not enlisted in the national EML but there seems to be a good alternative beta-blocker medicine, which is labetalol. However, the use of labetalol might need to be validated by specialized healthcare professionals if it can serve the purpose here [19]. Ranitidine was not procured by KIMADIA in 2019 probably because of the n-nitrosodimethylamine (NDMA) impurities of the medicine [20], but it might also be because of the available stock balance (590270 ampules were procured in September of 2018). Alternative injectable antiulcer medicines were found to be enlisted recently by NBSD, such as omeprazole and esmoprazole vials. Based on the NDMA issue, the global EML might need to be revised where the removal of ranitidine from the list and finding other alternative, beside injectable omeprazole, need to be considered by the WHO [21].

The National EML contains only the lyophylisates dosage form of ondansetron tablet. Conventional tablet dosage form of this drug enlisted in the global EML might also need to be proposed to the NBSD for possible cost-saving and widening the basket of alternatives to this medicine in Iraq, even though the orally disintegrating tablets offer a more elegant choice [22]. For HIV medicines, the analyses show many other HIV medicines that are enlisted in the global EML but not enlisted in the national EML such as atazanavir, darunavir, dolutegravir, tenofovir disoproxil fumarate, and raltegravir. These medicines can be proposed for enlisting in the national EML, if necessary, depending on the prevalence of HIV infection in Iraq [23]. Finally, atosiban is included in the national guidelines (management of preterm labor) and is included in the forecast but was not procured in 2019, when checked across KIMADIA procurement lists, suggesting the need to urge KIMADIA to make it available at least for healthcare institutions or procuring the alternative medicine, nifedipine [24, 25].

 

Situation of medicines required for intrapartum care

Even though misoprostol 25 μg vaginal tablet has been recommended in the national guidelines for induction of labor, it was not included in the national EML probably due to the presence of the alternative oxytocin, lack of reliable suppliers of this vaginal tablets, and/or the extra cautions implied by the WHO statement in using this medicine for induction of labor, where the global EML stipulated the following in using this medicine: “Misoprostol vaginal tablet 25 micrograms can only be used for induction of labor where appropriate facilities are available” [10, 26].

Codeine phosphate is enlisted only in the comprehensive list. However, no product has been registered yet. Registration of this product might need to be encouraged to take this medicine at least available in the private market. Also, registering ephedrine injection used in epidural analgesia should be encouraged by the Iraqi MoH to ensure an acceptable quality, safety, and efficacy of such product when procured by KIMADIA.

Lastly, the combination of oxytocin and ergometrine (5 IU/500 µg) or oxytocin and ergometrine fixed-dose combination can be proposed to the NBSD if there is a significant advantage of using these products as uterotonics and when doing so, the intrapartum guidelines can be updated accordingly.

 

Situation of medicines required for postpartum care

There seems to be only one enoxaparin product registered in Iraq and that is the brand product (Clexane®). Biosimilar products to enoxaparin sodium have become widely available. It is highly recommended that the Iraqi MoH consider some biosimilar enoxaparin products to improve access to enoxaparin and ensure the continuity of the supply chain of this medicine [27].

Additionally, erythromycin (tablet, capsule, or injection), ampicillin injection, and clindamycin were not procured by KIMADIA because these products are enlisted under either level 2 or 3 of the national EML and are supposed to be procured by the healthcare institutions directly. There are reasonable numbers of registered products of these medicines which can enable the healthcare institutions to directly procure them.

Situation of medicines required for comprehensive abortion care

The results show that mifepristone alone or in combination with misoprostol has not been considered for comprehensive abortion care. However, misoprostol seems to be regularly estimated in the forecast and procured for the public sector and can provide a good alternative [28]. The necessity of mifepristone alone or in combination medicines might need to be proposed to the NBSD by the concerned MoH department(s).

Opioid analgesia is not included in the guidelines column of Table 5 due to the absence of national comprehensive guidelines dedicated to abortion care in Iraq. However, most of these analgesics are enlisted in the national EML, regularly estimated in the forecast, and procured for the public sector. Pethidine and fentanyl can provide an alternative to morphine injection enlisted in the global EML [29]. Regarding epidural analgesia, even though no ephedrine injection is registered, but as was mentioned before, KIMADIA can still procure the medicine when it is needed [8]. Registration of ephedrine injection should be encouraged in Iraq to assure appropriate quality for such medicines. Lidocaine injection needs to be procured, as estimated per 2020 and subsequent years forecast, to avoid any shortage of this essential medicine since this medicine was not procured in 2019. However, it is worth mentioning that this medicine was procured twice in 2018 (106780 injections in June and 238380 injections in September) which means that the country stockpile of this medicine is adequate for the Iraqi MoH needs.

 

Situation of medicines required for preconception and fertility care

Instead of using ferrous sulphate syrup for anemia as per the global EML, ferrous gluconate syrup has been used in Iraq. It is known that ferrous gluconate has a low stability profile and is more prone to oxidation and conversion to the less absorbable ferric ion than the sulphate salt of iron [30]. Therefore, the removal of ferrous gluconate syrup from the national EML and replacement with ferrous sulphate syrup is a necessity.

The results collected from the available resources also show that influenza vaccines are needed to be procured yearly since the expiration date of these products is typically one year based on the possible changes in the vaccine virus strains. The vaccine is included in the forecast for 2020. Even though the perception of this vaccine by the general public is still weak, it might need to be at least provided for high-risk people and encourage people to take it, especially with possible benefits of the vaccine in reducing COVID-19 complications [31].

Also, HPV needs to be proposed to the NBSD and related parties within the Iraqi MoH to be included in the Iraqi routine immunization schedule, as per WHO recommendations for routine immunization, to help reduce cervical cancer in female individuals [32, 33]. A study by the concerned MoH department(s) is recommended to decide accordingly.

Vaccines registration should be encouraged in Iraq to ensure a safe and effective vaccine reaches the general public. Even though the majority of vaccines are not registered in Iraq but they can still be procured by KIMADIA only when they are prequalified by WHO. It is also worth mentioning that every vaccine batch procured by KIMADIA has to be tested in the national QC laboratories for release purposes to ensure a minimum level of safety and efficacy of the unregistered vaccine.

 

Situation of medicines required for newborn care

Aqueous benzylpenicillin 100000–150000 U, procaine penicillin 50000 U, and cloxacillin are no longer part of the national EML mainly due to suspected bacterial resistance to these antibiotics in Iraq. Flucloxacillin 500 mg vial is enlisted under L3 of the national EML and a suggestion to move it to L1 might need to be pursued in Iraq.

When looking at the totality of data collected in Tables 1, 2, 3, 4, 5, 6, and 7 one can note that none of the SRHR medicines are included in the Iraqi pharmacovigilance system for quality control. Even though Iraq has a spontaneous pharmacovigilance reporting system, active (mandatory) pharmacovigilance is lagging [34]. Such a gap would need to be filled and a swift and urgent collaboration between the Iraqi Pharmacovigilance Center and the SRHR-specialized healthcare institutions should be pursued to ultimately ensure an effective and safe medicine at the same time.

The overall situation of SRHR medicines looks better for 2019 compared to previous years, especially in 2018, where only 12% of all medicines enlisted in the national EML were procured in that year [5]. However, several other actions can be taken as discussed above to make the situation even much better and provide a possible improvement in the sexual and reproductive health in the country and ultimately reach 100% coverage for SRHR medicines in Iraq.

Conclusion

This comprehensive assessment of the situation of essential medicines required for the implementation of national SRHR guidelines in Iraq can provide a solid basis for all the stakeholders involved in providing better SRHR services based on the current ground and by taking into account the data and suggestions reported in this study.  The work also suggests the necessity of developing national guidelines for safe and post-abortion care, preconception, and infertility by Iraqi MoH concerned programs’ managers and technical experts. It is also important to update the national SRHR guidelines and makes them available online continuously, taking into consideration the most recent scientific achievements, to make sure that they are providing the best treatment practice in Iraq and better wellness.

Furthermore, more work is required for enlisting all essential medicines that are reported in the national guidelines and classify these medicines according to the available budget to one of the priority levels (i.e. L1, L2, or L3) assigned by the NBSD. Work is also needed to enhance the communication & coordination among healthcare programs managers, need estimation, and KIMADIA to ensure regular procurement for the L1 medicines, and to avoid any gaps in these essential medicines. On the other hand, improving the accessibility and affordability of quality and safe medicines in the local market by encouraging the registration of more medicines, vaccines, and pharmaceutical companies according to solid registration criteria becomes a necessity. Finally, more work is also needed to attain an adequate level of pharmacovigilance control over SRHR medicines to ensure their safety.

Acknowledgments: The authors would like to express their thanks to Dr. Nilmini Hemachandra (Technical officer at the Reproductive and Maternal Health Unit, WHO Regional Office for the Eastern Mediterranean), Dr. Zinah E. Nooruldeen, (Pharmaceutical coordinator, UHC/Life Course Health System, WHO), and Dr. Hanan Hasan (MCH National Program Officer, WHO) for their support in implementing this study. The author would also like to thank all the Iraqi Ministry of Health-affiliated decision-makers, healthcare providers, and employees for providing the necessary information reported in this study and giving precise insights into the situation of SRHR medicines in Iraq.

Conflict of interest: None

Financial support: None

Ethics statement: None

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Noida-Greater Noida Expressway,
Noida-201301 [Delhi-NCR] India