|Emergency Contraceptive Pills (WHO - OMS, 1998, 44 p.)|
As with other contraceptive products, the introduction of emergency contraceptive pills (ECPs) should be carefully planned and monitored to ensure quality services responsive to client needs. Important activities within the introductory process include:
· identifying factors that influence patterns of choice and potential use of ECPs;
· understanding user perspectives on ECPs and other contraceptives and on the service delivery system;
· identifying the service delivery and managerial adaptations necessary to provide quality ECP services; and
· using the outcomes of these activities to develop national strategies for the introduction and subsequent widespread availability of ECPs.
It is important to note that ECPs are a backup method for unprotected intercourse or contraceptive method failure and, as such, represent one of a range of contraceptive methods provided by national programmes. Therefore, the introductory process should ensure that ECPs are included in a programmes overall family planning training materials/curricula; information, education, and communication (IEC) materials; and logistics and distribution systems.
The nine steps presented below may assist countries to develop strategies for introducing ECPs with appropriate quality of care within the context of overall reproductive health services. The specific activities outlined in each of these steps can be adapted to reflect local needs and conditions.
Step 1: Assess user needs and service capabilities
An initial assessment of client information and service needs, regulatory requirements, and service delivery capabilities can provide useful information about the need for ECP services as well as help guide the development of an introductory plan. The assessment could be done locally, regionally, or nationally. The assessment should focus on identifying:
· Client needs and perspectives - Are potential clients aware of family planning in general and the method in particular? When told about the method, do potential clients perceive a need for it? What questions do they have about it? Are rumors/misinformation about the method widespread? Which population groups report the greatest need for ECP services? What distribution mechanisms would be most convenient/acceptable to potential clients? What are user perceptions of existing services through which ECPs might be provided? What information channels (both formal and informal) are preferred by potential clients?
· Regulatory system requirements - Is a post-coital contraceptive or specially packaged ECP product registered for use? If not, what requirements must be met for registration approval? What are the procedures for change of labelling for existing products? Can medical providers prescribe combined oral contraceptives (COCs) for off-label uses? Are pharmacists and other non-medical health professionals authorized to distribute COCs? If so, does that authorization also apply to ECPs?
· Service delivery capabilities - What is the current overall knowledge among providers of family planning methods in general and ECPs in particular? Do providers perceive a need for ECPs? What standards of care would affect ECP services? What are provider capabilities? What mechanisms exist for the distribution of regular COCs (clinics, hospitals, pharmacies, social marketing, community-based distribution, commercial distribution systems)? What is the capacity of these distribution channels to take on an additional closely related product? What is the capacity of non-family planning/reproductive health care providers (i.e. hospital emergency rooms, maternal and child health clinics, sexual assault crisis centres) to supply ECPs? What level of provider training would be required to ensure high-quality services? What training and information mechanisms are preferred by providers? What do providers consider as barriers to providing quality ECP services?
The assessment can be done using a variety of information-gathering techniques, including individual in-depth interviews and/or informal group interviews with local health and regulatory authorities, clinic managers, providers, policy-makers, community leaders, and potential clients; sample surveys of potential users and providers; and review of service delivery statistics. In conducting the assessment, it is important to consider including specific populations that might be potential users, such as young people, people using contraceptive methods with the potential of use failure (e.g. barrier methods and oral contraceptives), women who have infrequent and/or unplanned intercourse, and women in refugee or emergency situations.
If the assessment results indicate that introduction of ECPs is warranted, the next steps are to build community and policy-maker support and select a product for introduction.
Step 2: Build support for ECP introduction at appropriate levels
Gaining the support of key government officials and community leaders early on in the introduction process can help to ensure initial acceptance of the method and facilitate the introduction process. This is especially true of ECPs because of confusion about the methods safety and efficacy, the misinformation that exists regarding its mode of action (i.e. the erroneous belief that ECPs act as abortifacients), and the concern among many providers that promoting the availability of ECPs will lead to irresponsible contraceptive behaviour (which has not been borne out in practice, even in programmes that have mounted national-level mass media campaigns). It is important to listen to the concerns of these groups and take them into consideration when making decisions about how to introduce ECPs. Involving a broad range of individuals and groups in the assessment process is a first step towards that end. In addition, providing clear, scientifically based information to government and community groups can help to address any concerns they may have. The Questions and Answers for Decision-Makers section of this resource packet and the materials for training media spokespersons provide useful language for responding to challenging questions about ECPs.
Step 3: Select a product
Depending on regulatory requirements, access to product, and funding, programme managers should as their first choice consider the procurement of a specially packaged ECP (such as Postinor-2, Tetragynon/PC4, or Fertilan). These specially packaged ECPs are currently registered in only a limited number of countries. They have advantages for service delivery in that they are specifically identified for emergency contraception and contain appropriate instructions as well as the required number of pills for their correct use. Specific packaging makes them easier to supply through pharmacies and social marketing programmes.
In the absence of specially packaged ECPs, there are several approaches to the use of existing COCs as ECPs. During the Step 1 assessment, programmes can identify available COC products that are appropriate for use as ECPs (see the Consortium Medical and Service Delivery Guidelines for a list of formulations that can be used). Possible approaches to using COCs as ECPs include:
· repackaging 4 high-dose or 8 low-dose COC pills in small glass bottles or other suitable containers, with special labelling for ECP use;
· cutting COC pill packets into strips of 4 high-dose or 8 low-dose pills and dispensing strips in envelopes with instructions for emergency use; and
· supplying clients with an entire packet of COCs with instructions about how to use them as ECPs.
Because COCs are readily available in most countries, these options represent practical, low-cost ways to ensure access to ECPs. Disadvantages of using COCs as ECPs include the possibility for error in repackaging or cutting up pill packets (including mishandling or mislabelling the product), the lack of specific approval for such use (in many countries, however, off-label use of drugs is permitted), and the potential for confusion between instructions for regular COC use and ECP use.
Step 4: Develop a distribution plan
In addition to the normal family planning programme service delivery points, such as MCH/FP clinics and community-based distribution systems, the distribution of ECPs should be considered through a variety of other channels. These include private health practitioners of many types, hospital emergency rooms, pharmacies, social marketing programmes, school-based clinics, and sexual assault crisis centres. The results of the assessment (Step 1) of potential user needs and perceptions, provider perceptions, local regulations and existing distribution channels for hormonal contraceptives can help define which channels are most appropriate in a given setting. Once distribution channels have been selected, systems must be put in place to ensure that these channels have a consistent supply of the product (typically this can be done through the existing contraceptive logistics system). In addition, record-keeping systems must be updated to include ECPs.
Given the short timeframe in which ECPs must be used (within 72 hours of unprotected sex), every effort should be made to ensure that ECP distribution channels are not only convenient but also acceptable to clients. Factors influencing acceptability include the supply source location, hours of service, and efficiency of service. In an effort to make ECPs easily accessible to clients, some providers routinely supply ECPs to their clients at the time of regular consultations and instruct the clients to use the pills if they experience a contraceptive accident. Providing an advance supply of pills helps to ensure women know about the method and have easy access to it when they need it. Other providers require women to come to the clinic and request pills each time they need to use them. While this protocol ensures a high degree of medical oversight, attending a clinic within the 72-hour timeframe for initiation of services may be difficult or impossible for many women. Supply sources such as pharmacies may be more convenient for many women.
Step 5: Train providers
Before a product is introduced to clients, providers will need training in the issues related to providing ECPs, including the special counselling needs of ECP clients. Of key importance is ensuring that providers treat women respectfully and maintain a nonjudgemental attitude while providing services. The training related to ECP service delivery provides an opportunity to strengthen provider knowledge and skills concerning other contraceptive methods; the importance of their routine use; and sexually transmitted disease (STD) risk assessment, diagnosis, and management. Information on ECPs must also be incorporated as part of overall training on family planning, including all basic and refresher training for service providers. It must be stressed in all training activities, however, that EC does not protect against STDs or subsequent unprotected intercourse.
In addition to service providers, staff who interact with clients (including receptionists and other non-clinical staff) should receive basic information about ECPs so that they can answer enquiries about availability of the method and help clients obtain services in a timely way. A provider training curriculum, Emergency Contraceptive Pills, Module 5, A Comprehensive Training Course, is available from Pathfinder International. (To request a copy contact Pathfinder International Medical Services, 9 Galen Street, Suite 217, Water-town, MA 02172, U.S.A.)
Step 6: Meet client information needs
In order for the method to have an impact on reducing unplanned pregnancy, women must know about the availability of ECPs before they need to use them. Women need to know that ECPs are a safe and effective method and that they can be used up to three days after unprotected sex. A key way to inform women about ECPs is to provide basic information about available dedicated products or the use of oral contraceptives as ECPs at the time of regular family planning or health care visits. This can be done verbally during counselling and/or in writing (through information brochures or waiting room posters). Providing information about ECPs is especially important for women who choose to use methods that are highly dependent upon correct use, such as condoms or natural family planning. Because many of the women who need ECPs are not regular family planning clients, alternative mechanisms for informing women about ECPs also are needed. These could include use of the mass media (such as TV, radio, newspaper, magazines); advertising campaigns; traditional folk media (such as songs, local theater); or discussions at local community, school, or womens groups. Information from the Step 1 assessment about where clients get information can be helpful in identifying appropriate communication strategies.
Women who request ECPs need more specific information about the method, including its effectiveness, safety, common side-effects, use instructions, and follow-up requirements. Ideally, this information should be provided to all ECP clients during counselling as well as in simple written materials that the client can take home. Prototype client informational brochures that can be adapted for use in various settings are included in this packet.
Step 7: Introduce the product
Once Steps 1-6 have been completed, the designated ECPs (whether assembled locally using COC supplies or purchased as a dedicated ECP product) can be introduced through a variety of established mechanisms for the distribution of contraceptives and emergency health services.
Step 8: Monitor and evaluate ECP services
Ongoing monitoring and supervision of method provision and further user perspective and service delivery research can identify necessary adaptations to service management, IEC materials, and other aspects of providing ECPs before the method is introduced more widely within a country. Evaluation activities should include assessments of user and provider perceptions and experiences with ECPs and of the service delivery channels through which they are being provided. Evaluation activities can assist in ensuring that ECPs are used appropriately and that they serve as a bridge to regular contraception for clients who require it.
Step 9: Disseminate evaluation results
The results of the monitoring and evaluation activities included in Step 8 are most useful if they are disseminated to and discussed by a broad group of constituencies and are subsequently used in the development of strategies for the broader provision of ECPs within the country. As with the previous elements of the introductory process, this activity should be participatory in nature and should be aimed at ensuring that expansion of services is done in a way that ensures appropriate quality and acceptability of services.