Interviews were done over the phone, and the recordings and transcripts were produced. NVIVO version 10 and the thematic framework method to qualitative data analysis were employed in the analysis (18, 19). Consumption data for DMPA-SC and other injectables were analyzed using Tableau, a public visualization tool, and presented using Microsoft Excel.
As shown in Table 1, a total of 19 participants were interviewed for the study between August to September 2020. There were no refusals, drop out or repeat interviews. Each of the interviews lasted between 30 minutes and one hour. More than half (68.4%) were females, and (68.4%) were aged 40 and up, with a mean age of 42.9 ± 7.9 years. About half (55.5%) were healthcare providers, while about 42% were chosen from family planning partners who have supported the government's role in DMPA-SC scale-up in Nigeria, and one participant (5.6%) was a community resource person.
Table 1
Sociodemographic Characteristics of Participants (N = 19)
Variable
|
n (%)
|
Gender
Female
Male
|
13 (68.4)
6 (31.6)
|
Designation
Healthcare providers
Community resource person
Family planning partners
|
10 (55.5)
1 (5.6)
8 (42.1)
|
Please see Table 2 for a comprehensive list of active policies affecting DMPA-SC and self-injection scale-up in Nigeria.
Table 2
Policies and activities aimed at advancing the scale-up of DMPA-SC accelerated introduction in the country
|
Policy and Activities
|
Startup-end date*
|
Year
|
Contribution to DMPA-SC scale-up
|
1
|
Approval and registration of DMPA-SC branded product by the National Agency for Food and Drug Administration and Control (NAFDAC) for provider administration
|
|
2011
|
This regulatory endorsement paved the way for the legal use of DMPA-SC.
|
2
|
Approval of DMPA-SC updated label to include an indication for self-injection
|
|
2016
|
Provided necessary information for the implementation of self-injection.
|
3
|
National DMPA-SC accelerated introduction and scale-up plan
|
Feb 2017-Dec 2017
|
2018
|
Provided modalities for coordinating the activities of various stakeholders in the process of introducing and scaling up DMPA-SC.
|
4
|
National guidelines for the introduction and scale-up of DMPA-SC self-injection
|
Oct 2018- Jan 2019
|
2019
|
Serves as a guide for the implementation of the DMPA-SC self-injection intervention
|
5
|
Revision of task-shifting/task-sharing policy
|
May 2018- Mar 2019
|
2019
|
The TSTS policies allowed the expansion of provider cadre that can administer injectables, inclusive of DMPA-SC. It allowed pharmacists, proprietary patent medicine vendors PPMVs, as well as community-based distributors to administer DMPA-SC.
|
6
|
Inclusion of DMPA-SC in the Essential Medicines List (EML)
|
Sept 2017- Sept 2019
|
2019
|
The EML is the list of priority medicines, considered to be most effective, procured by the country to meet the healthcare needs in a health system (39). Inclusion of DMPA-SC in both the prescriptive medicine and Patent and proprietary medicine vendors (PPMV) lists of the document. This review was to allow DMPA-SC to be listed as an essential medicine so it can form part of the national procurement, and also allow dispensing in Nigeria.
|
7
|
Inclusion of DMPA-SC in the Approved Patent Medicines List (APML)
|
July 2018- Dec 2019
|
2019
|
The APML, a list of medicines that licensed PPMVs are legally allowed to stock and dispense (40), gave policy backing for DMPA-SC to be stocked and dispensed by PPMVs.
|
8
|
The Family Planning Costed Implementation Plan (CIP) 2019–2023 was created and it included DMPA-SC
|
Mar 2019-Dec 2020
|
2019
|
This is aimed at ensuring the integration of DMPA-SC into broader Family Planning programming/reducing siloed support.
|
* These dates reflect when input into the policies was completed not the launch dates. In most cases, implementation of the policies had begun before they were launched. |
Regulatory approval of DMPA-SC
The National Agency for Food, Drug Administration, and Control (NAFDAC) approved and registered the DMPA-SC branded product for provider administration in 2011. Then, in 2016, NAFDAC approved the DMPA-SC updated label, which included the indication for self-injection. The justification for this approval and registration was thought to be based on evidence of the safety and efficacy of pilot programs from other countries, among other things.
“Justification for approval and registration was provided to NAFDAC based on evidence from all the pilots and even from other countries, you know, neighboring countries those African countries and other countries in highlighting safety, efficacy, based on data from the studies carried out for similar processes in other countries.” (Healthcare Provider)
Following the revision of the DMPA-SC label, the FMOH began the full process of incorporating DMPA-SC self-injection into the country's introduction and scale-up plan. The scale-up plan, a 5-year roadmap, lays the groundwork for the long-term integration of the DMPA-SC into Nigeria's healthcare cocktail of family planning methods. (1).
National DMPA-SC accelerated introduction and the scale-up plan
The National DMPA-SC accelerated introduction and the scale-up plan was introduced in 2018. The scale-up plan was developed in response to DKT and UFNPA pilots of DMPA-SC in the southwest and southeast Nigeria in 2015 and 2016, which documented key challenges in implementing DMPA-SC in Nigeria. The respondents confirmed that the plan was created to serve as a road map for the implementation of DMPA-SC as well as to aid in its adoption. Other responses are listed below:
“You know it facilitates the uptake of DMPA-SC by considering some key implementation challenges, and even solutions to address them.” (Healthcare Provider)
“Well, the gap is, for me, two things. First of all, set a roadmap because this is a new intervention. This is a new product. That is the DMPA-SC. So, without a policy guiding how this can be ruled out, then it’s almost difficult for the state to be able to implement that intervention.” (Healthcare Provider)
This policy update was timed to coincide with the conclusion of pilots assessing feasibility, allowing it to serve as a context-informed "roadmap."
Revision of the task-shifting/task-sharing policy
In 2019, the task-shifting/task-sharing policy was revised. This policy allows lower-cadre health workers, such as CHEWs, to perform tasks that were previously reserved only for doctors and nurses. This revision was carried out in response to the difficulties encountered in terms of the health care worker cadre permitted to administer DMPA-SC, according to the responses from the interviews. Some of the responses are provided below in the form of quotes:
“There were difficulties in terms of which health worker cadre could provide it but subsequently, the task-shifting task sharing policy, CHEWs, and even JCHEWs were permitted to give injectable contraceptives.” (Family Planning Partner)
“The task shifting and the task sharing policies that allow the lower cadre of providers like the community health officers, the CHEWS, and then also the PPMVs to be able to provide injectable contraceptives including the DMPA-SC is one policy that has also helped to facilitate the accelerated use of DMPA-SC.” (Healthcare Provider)
The revision made it possible for more cadres of health workers to administer DMPA-SC, which facilitated its uptake.
“The thing that is very, very clear is that the SOP captures PPMVs and community pharmacists to provide DMPA-SC, you know, but the policy document itself does not because, at the time, we were revising, reviewing it, the sheer accreditation had not been approved by the President at that time. It was still awaiting presidential assent. And I think we're no longer following up on that. But that is a gap. (Healthcare Provider)
The revision of the task-shifting/task-sharing policy emphasizes the importance of supporting documents. While the National DMPA-SC Accelerated Introduction and Scale-Up Plan outlined scale-up processes, it could not be fully implemented in the absence of TSTS policy authorizing DMPA-SC administration by the cadres included in the scale-up plan.
National guidelines for the introduction and scale-up of DMPA-SC self-injection
In 2019, the National guidelines for the introduction and scaling-up of DMPA-SC self-injection were completed. The guidelines were deemed important because they assisted in providing adequate instructions to ensure that self-administration is done safely and properly. According to the health managers:
“So why that guideline is so crucial and adherence to it is very important is because you want to be sure that this woman administers DMPA-SC to herself safely, can follow the instruction, can calculate the next date for the following dose, and also can keep the used unit safely until she’s returning to the facility when she will now have to hand it over to the provider who will check that the used unit is complete.” (Family Planning Partner)
“Well, it did focus a little bit. It mentioned a few things on self-injection. Let me see. It mentioned a few components of self-injection but again, I will say most of it is health facility focused. It is around the health worker rather than more of how do we empower women to give themselves the injection.” (Family Planning Partner)
The national guidelines for the initiation and scaling-up of DMPA-SC self-injection are especially important because they provided comprehensive guidance and a complete sketch of a woman's journey through self-injection from the point of initiation to administration and follow-up. Following the policy's official launch in April 2019, there was a rapid increase in partner rollout of DMPA-SC training, possibly because partners were now more confident in beginning full implementation of self-injection as part of their FP training. In addition, there was an observable increase in the proportion of DMPA-SC in the injectable method mix from 6–11% (before and after the policy's implementation) and a subsequent trend of continuous increase (20).
Inclusion of the DMPA-SC in the Essential Medicines List and Approved Patent Medicines List
In 2019, DMPA-SC was added to the Essential Medicines List (EML) and the Approved Patent Medicines List (APML). According to respondents, this inclusion increased the country's contraceptive method mix and helped to ensure that the product was easily accessible in both public and private facilities:
“Okay, so for inclusion in the EML and APML of course it improved method mix, so thereby increasing choices for users. Then assured procurement of the commodity because the government buys what is in the EML and then it dispels at batches to enable a wider range of providers. Consequently, still expanding the market and reach to communities, especially hard to reach communities. (Healthcare Provider)
“The inclusion of DMPA-SC also reduced the level of stock out rate through the fact that when there is stock out in the facilities, for example, women can have access to go to the private facility to ask that. And then it aided the last mile for commodity distribution and then an emergency of focal commodities can be procured from government-approved facilities within the country. (Family Planning Partner)
“Without DMPA-SC being on the EML list and as an over-the-counter product, it means that the PPMVs won’t be able to stock it and that means refill will be a challenge at the community level. So that’s the major thing there”. (Family Planning Partner)
As a result of the inclusion of DMPA-SC in the EML and APML, a bridge was created to ensure continuous procurement of the product, which is a critical step in supporting scale-up.
DMPA-SC and Family Planning Costed Implementation Plan
In 2019, the Family Planning Costed Implementation Plan (CIP) 2019–2023 was created, which included DMPA-SC. The inclusion of DMPA-SC was done to ensure a consistent supply of the product while also ensuring a steady demand.
“It ensures that on the supply side, that we make provision for DMPA-SC forecast, quantification and procurement planning. Of course, without the commodity being available, there’s nothing you can do around it. So that was the key thing on the supply side. Then, so the other thematic area in the blueprint… was demand generation. Demand generation effort in the country, we have to incorporate DMPA-SC into it. So, all our demand generation activities now are incorporated with DMPA-SC and self-injection. So all these were contributions from the CIP.” (Family Planning Partner)
Perceived success levers for scale-up
When asked what they believe are the key success levers for the scale-up of DMPA-SC, some respondents mentioned the Federal Government's collaboration with other implementing partners in the provision of policies and guidelines. Furthermore, the significance of clear policies and a bottom-up approach and guidelines, in which sub-national experiences inform national policies, to stakeholder engagement was emphasized.
“Okay, so, for me, I think the key lever is government buy-in and buy-in of stakeholders. If everybody is on the same page, that's one. Secondly is the availability of evidence as well. You understand. I think these are the two key levers that come to mind now.” (Doctor, NGO)
“So awareness is quite very important even among us policymakers as well as program managers and even service providers. Then articulating policies and guidelines to create enabling environment to be all-inclusive. The bottom-up approach has been very effective because of ownership.” (Senior Health Manager, FMOH)
Consumption and stockout data for DMPA-SC and other injectables
Figure 1 shows that, while the uptake of other injectables appears to be declining (Noristerat) or plateauing (Depo-Provera), the uptake of DMPA-SC (Sayana Press) gradually increases during the study period. The rise in DMPA-SC consumption was accompanied by a strong linear trend (R2 = 0.97). The increase observed from early to late 2019 appears to correspond with policy interventions – revision of the TSTS policy, the inclusion of DMPA-SC in the EML and APML (all in 2019).
Figure 2 depicts injectable stockout data from April 2018 to December 2020. According to available data, DMPA-SC stockout was higher than that of other injectables in 2019, and stockout for all injectables generally spiked in the second half of 2020. According to the two-tailed, paired T-test, there was no statistically significant difference in stock out rates between Sayana Press and Depo Provera (p = 0.38) or Sayana Press and Noristerat (p = 0.81).