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    Albanian Safety of Injection Plan (2003 2007)





    (2003 2007)

    Ministry of Health

    Institute of Public Health

    Expanded Program on Immunization (EPI)



    Albanian Safety of Injection Plan (2003 2007)

     1. Situation analysis

    Before economic and social changes of early 1990s Albania immunization programme reported high immunization coverage with both locally produced vaccines (BCG, DTP, DT, Td, TT and Measles) and imported ones, such as OPV. Effective control of some important infectious diseases was the result of an adequate for the time immunization policy. However, vaccine shortage, destroying of the cold chain system, deterioration of health services, intensive internal and external migration of the population and other socio-economic events undermined immunization activities and some well-controlled vaccine-preventable diseases (VPDs) reemerged.

    In 1994, when EPI was established UNICEF began supplying childhood vaccines and cold-chain equipment. Until then, glass sterilizable syringes were only used in Albania. In the same year, universal infant immunization against hepatitis B was introduced through the support of the Italian Rotary Club and disposable single-use syringes were supplied for hepB vaccine implementation onlyIn 1996, disposable syringes started to

    be used for all injection practices and by 1999 they were already universally used in countrywide.

    Auto-disable syringes (ADs) for childhood immunization were introduced in 1996. However, until 2000 supplying was limited and EPI injectable antigens were given with both ADs and standard disposable syringes. Safety boxes were also supplied but not universally used.

In 2000, the Albanian Government adopted the “bundling” policy for immunization

    campaigns of the 1999 WHO/UNICEF/UNFPA joint statement. “Bundled” supplying for the Measles/Rubella (MR) mass campaign for children from 1 to 14 years of age (November 2000) became the turning point for the development of National Policy for Injection Safety in Albania.

    ADs were also exclusively used with the corresponding quantity of safety boxes during the MR mass immunization of WCBA (October 2001- December 2002).

    These highly effective campaigns (immunization coverage 98% in children and 96.5 in women from 16 to 35 years of age) represented a great challenge for Albanian EPI in terms of training of not only traditional vaccine providers but also midwives, gynecologists etc in SIP and appropriate collection and disposal of huge quantities of used injection equipment.

    Rapid assessment of injection practices was carried out 2 months before the 2000 campaign by a team of WHO consultants. Guidelines on and assessment of safe injection practices (SIP) and safe disposal and destruction of used immunization equipment during the campaign were based on findings and recommendations of the WHO team.

    Observations and lessons learnt from the two mass supplementary immunization activities were then used in preparing the present Plan of Action on Immunization


    Albanian Safety of Injection Plan (2003 2007)

    Injection Safety. The Plan is intended to serve as a basis for the developing of a

    comprehensive Plan on Injection Safety in Albania.

2. Objective and strategies of the injection safety plan of action (2003-


    Objective: To ensure the safe administration of all immunization injections and appropriate disposal of injection waste throughout the country by the year 2005


    a) Ensure central and district governments commitment

    b) Sustain exclusive use of ADs in immunization services

    c) Improve planning and distributing so that to ensure reliability of estimates of

    equipment requirements, minimum stock levels and effective supply/

    distribution of injection and disposal equipment

    d) Ensure the safe collection (establish a collection procedure) and disposal of

    used injection equipment through uninterrupted supply of safety boxes to all

    immunization sites and appropriate incineration

    e) Institute monitoring and supervising procedures to ensure adequate supplies at

    all levels and correct practices by HCWs

    f) Improve training of HCWs and managers on safe injection and disposal


    g) Secure the required budget for injection safety including safe disposal of used


3. Choice of injection equipment

The National Policy on Injection Safety requires using only ADs for both routine

    immunization and vaccination campaigns. Exclusive use of ADs for immunization

    started in late 2000 and since then uninterrupted provision has been secured by

    UNICEF. In compliance with the 1999 WHO/UNICEF/UNFPA statement Albanian 1Government started EPI vaccines procurement applying the “bundling” strategy.

4. Calculation of annual requirements

Spreadsheet calculation for the annual requirements of injection and disposal

    equipment is updated yearly. The calculation method is as follows:

    Auto-disable syringes:

     1 In conformity with the Memorandum of Understanding between the Albanian Government and

    UNICEF for Procuring of basic EPI Vaccines (2000) the Government procured in 2002 MR vaccines in

    a “bundle”, i.e. assured also the respective quantities of ADs and safety boxes.


    Albanian Safety of Injection Plan (2003 2007)

    Number of immunization injections per year X Wastage factor of 1.1

    + 25% reserve established at the district level

Safety boxes (5 liters):

    Number of injections/100

5. Distribution of injection equipment

Distribution of ADs, reconstitution syringes and safety boxes is done quarterly together

    with the EPI injectable antigens on the basis of the districts annual plans for

    immunization. Number of eligible for immunization children by districts is updated

    yearly. However, in the near past, it happened that some small villages with low

    workload (10-20 immunization injections per month) to be irregularly supplied with

    ADs and safety boxes and as a result in some Health Centers was found several months

    supplies of ADs. The new inventory system introduced at the end of 2002 improved

    communication between the national and the district level.

    Some activities envisaged for maintaining adequate supplying to all levels are the


    ? Prepare guidelines on estimating injection equipment/safety boxes needs and

    minimum stock for district and community levels

    ? Up-date supplies inventory and introduce new reports permitting rapid

    assessment from the national and district level

    ? Strengthen supervision by district EPI managers and logistic officers to ensure

    adequate supplies for all levels and correct vaccine providers malpractices

6. Disposal of used equipment

The assessment of SIP carried during the 2000 MR campaign (Annex 1) found that

    99% of immunization providers dropped the used equipment in the safety box without

    recapping. However, the situation might be not strictly the same in routine

    immunization practices despite of the regular and uninterrupted supply with safety

    boxes ensured by UNICEF. Overfilling of safety boxes observed in 11% of

    immunization sites visited (both urban and rural) during the assessment in the presence

    of boxes in stock suggests misunderstanding of their role as a preventing means.

No collection procedures existed before the MR campaign and in reality there were no

    written guidelines for used injection equipment disposal. Filled boxes were most often

    discarded in the general waste despite that district PHCs recommended burning in pits

    and burial of the residuals.

Only 13 of the 36 district hospitals have got high temperature incinerators. The only

    high temperature incinerator in the capital is situated in the National Blood Center.

    However, none of these incinerators is used regularly for destruction of immunization


    A safe disposal strategy was developed by the Institute of Public Health (IPH) well

    before the start of the 2000 MR campaign and was approved by the Vice Minister of


    Albanian Safety of Injection Plan (2003 2007)

    Health. In addition to extensive training of district health facilities managers and

    vaccination providers, guidelines based on the strategy were distributed to all

    vaccination posts. In Tirana and the districts’ capitals filled safety boxes were kept in a

    safe place until the end of the campaign when they were collected, transported to a

    burning place, previously designated by the town hall/local environment authority and

    burned under supervision. Polyclinics, health centers and ambulatories were instructed

    to burn safety boxes in a pit near the health facility immediately after they were filled.

Supervision during the campaign showed that practically all immunization sites visited

    took care for proper storage and destruction of used equipment according to the


A similar disposal strategy was applied in the MR campaign for WCBA. However, this

    time, local health administrations in some districts agreed the hospital incinerators to

    be used for final disposal of filled safety boxes.

Recently developed Guidelines about "Immunization Injection Safety Through

    Disposal and Destruction of Used Injection Equipment" (Annex 1) and after that

    National Policy for "Injection Safety and Safe Disposal of Injection Equipment"

    (Annex 2) represent the first comprehensive state document dealing with safe disposal

    of used injection equipment from bio-safety point of view. Further intensive efforts of

    national health, environmental and financial authorities are needed to find the most

    appropriate, affordable and environment-friendly options for treatment of medical

    waste countrywide.

The present Plan aims to ensure safe collection and safe final disposal of used injection

    equipment from all levels where immunization injections are given. Some important

    activities to be carried out are as follows:

    ? Up-date all guidelines, education and training materials on immunization so

    that National Policy requirements for collection, final disposal and destruction

    of filled safety boxes become universally available

    ? Designate officers responsible for immunization waste disposal/destruction at

    the national and district levels (preferably 2 professionals-an epidemiologist

    and a specialist in environment health from the public health network).

    Consider involvement of district administration.

    ? Prepare a job-description of the above officers to include monitoring and

    supervision of collection and destruction of health facilities’ medical waste at

    the respective level

    ? Recruit operation officers for safe collection, disposal and incineration of

    medical waste at the prefecture level

It is considered feasible, polyclinics (in small towns), health centers and ambulatories

    to continue open burning of filled safety boxes at a specially designated place. It is

    envisaged, used equipment produced in the district capitals to be collected from each

    immunization site, disposed of at reserved and protected places and burned under the


    Albanian Safety of Injection Plan (2003 2007) supervision of the logistic officer. At present, building of incinerators is considered for

    the prefecture level. Five of the 12 prefectures have a high temperature incinerator.

    Building of high-temperature incinerators in 6 of the 12 prefecture hospitals and in

    Tirana should be considered taking into consideration the working status and the

    capacity of the existing incinerators as well. Building of low-temperature incinerators

    for the district level health facilities will be discussed with the National Environment

    Agency and Ministry of Finance.

The disposal strategy developed for the MR campaigns will continue to be applied for

    eventual future mass immunization campaigns.

7. Indicators to monitor SIP, disposal mechanisms and supplies

    Adequacy of syringe and needle supplies at health facility level:

    ? Proportion of health facilities provided with ADs target 100% (achieved, to

    be sustained)

    ? Proportion of health facilities provided with reconstitution disposable syringes

     target 100% (achieved, to be sustained)

    ? Proportion of health facilities with one month stock of ADs target 100% by


    ? Proportion of health facilities with one month stock of reconstitution disposable

    syringes target 100% by 2004

    ? Proportion of health facilities with adequate quality and sterility of injection

    equipment (integrity of package, expiry date, certified brand) target 100% by


Adequacy of used injection equipment disposal

    ? Proportion of health facilities provided with adequate quantity of safety boxes

    (one safety box in use, and at least another one on stock) target 100% by 2004

    ? Availability of an incinerator or non incineration safe facility targets 90% by

    2004 and 100% by 2005

    ? Proportion of health facilities with presence of used syringes and needles in

    garbage, dumping areas or close to the health facility

Sterility of immunization injections

    ? Number of abscesses following immunization injection reported

    ? Proportion of immunization injections observed with following of aseptic

    injection technique (supervision reports, SIP assessment) target 95% by 2004


    Albanian Safety of Injection Plan (2003 2007) 8. Management and operation

The results from the assessment of SIP during the MR immunization campaign of

    children cannot be considered absolutely valid for routine immunization as well

    because of different supplying and distribution systems, intensive training of

    immunization providers (behavior changes require time and positive motivation), close

    supervision and a number of psychological factors during the campaign. Nevertheless,

    the assessment proved that immunization providers are capable to follow SIP in their

    everyday work if all SIP aspects and components are properly addressed.

    Some activities considered important for improving management and reinforce

    implementation of SIP are as follows:

    ? Distribute the “National Policy on Injection Safety” to the District governments,

    DPHs and primary health care settings authorities down to the commune level

    ? Distribute “Guidelines on SIP in immunization” and ensure in-job training of

    immunization providers

    ? Update all education/training materials and guidelines on immunization,

    including medical university students’ and nurses’ curricula

    ? Organize KAPB studies on injection safety issues at district level and use

    findings for dealing with weak aspects of SIP during training and supervision

    ? Strengthen supervision on immunization providers’ adherence to SIP

9. Training requirements

    The National Safe Immunization Injection Plan must be accepted as an immanent part of the Primary Health Care Strategies not only because more than half of Albanian

    children residing in the countryside are served by general practitioners but also because

    Safe Injection principles should be applied to the whole population.

Training of existing HCWs aiming at increasing their awareness about the important

    role they have in exposing to risk/preventing their own, their patient’s health and the

    community will be mainly done on-job during supervision. Observations on adherence

    to SIP will be used to tailor training upon the concrete needs.

Training needs will be also assessed through KAPB studies covering all vaccine

    providing health facilities in the respective district.

Training courses for vaccine providers will be organized at the district level when

    supervision shows needs of improving knowledge on EPI theoretical issues so that to

    promote behavior changes. Training 1-2 days seminars to cover other aspects of EPI

    will be periodically organized for newcomers to EPI at the district/national level.

    Safe injection curriculum for in-service staff training will cover:

-Proper use of ADs and disposable syringes (for reconstitution of lyophilized vaccines)

    from the standpoint of injection safety


    Albanian Safety of Injection Plan (2003 2007)

-Safe disposal of used injection equipment

    -Vaccine and equipment supplies management including forecasting needs for injection and disposable equipment as well as supplies monitoring

     -Cold Chain importance for ensuring immunization injection safety. Temperature monitoring (VVM, CCM, FW)

-AEFI surveillance (reporting, investigation, recording)

10. Advocacy requirements

    The pre-campaign rapid assessment of SIP showed that 30% of prescribed injections were unnecessary. Over-prescribing is mainly due to general public belief in greater effectiveness of injectable medicines as compared to oral ones. Messages to the population on that wrong belief and on injection safety implications of injectable medicines will be made through mass media (newspapers, popular journals, TV- and radio broadcasts) and posters hanged in health facilities waiting rooms.

    Messages to the population concerning patients/clients rights to SIP will be also given through the same channels.

    The IPH will summarize available information on nosocomial transmission (including occupational hazards) of bloodborne pathogens in countries with similar to Albania prevalence of HBV and HCV, Infection Control practices in this field and cost-effectiveness of preventive measures. This information will be used to further sensitize decision makers and HCWs on safety of invasive procedures including SIP, universal blood precautions, safe disposal of medical waste etc.

11. Surveillance and management of AEFI

    The AEFI surveillance has been probably the weakest component of the Albania EPI. All guidelines on immunization issued since the establishment of the immunization program in the 1950s contain requirements for reporting, investigation, recording and analyzing AEFI. However, single if any AEFI are annually reported to the EPI manager. Recently restored National Regulatory Agency for immunobiological products, which was proactive in the past when vaccines and other bioproducts were locally produced, is being involved in AEFI surveillance.

    Despite the special emphasis put on AEFI reporting during the MR campaigns, a few cases were reported during the first and no cases during the second one.

    Some possible explanations of not reporting are fear of punishment and under-evaluation of AEFI reporting significance. Older HCWs have preserved conviction installed in totalitarian times that AEFI are most often due to immunization malpractices. To overcome that prejudice, the IPH is to update Guidelines on AEFI by summarizing information accumulated in developed countries. AEFI surveillance system has to be reorganized according to WHO recommendations.


    Albanian Safety of Injection Plan (2003 2007)

12. Budget estimates

Since the 1999, UNICEF has been supplying injection equipment and safety boxes

    bundled with the respective vaccines. According to the Memorandum of

    Understanding between the Albanian Government and UNICEF for Procuring of basic

    EPI Vaccines (2000), the country is to become self-sufficient by 2005. In 2003 the

    Government’s contribution will rise from 20% to 40% of the EPI antigens, ADs and

    disposals equipment costs. This represents the cost of the MR vaccine for 2 age-

    cohorts (the 12 months and the 5 year olds) bundled with the respective quantity of

    ADs and safety boxes. The Government is taking the responsibility to also procure

    hepB after the ending of GAVI support in 2006 and of safe injection equipment to be

    eventually supplied by GAVI. Budget estimates for the year 2003 2007 are

    represented in Table attached.


    Albanian Safety of Injection Plan (2003 2007)

    Timetable of activities of the National Plan for Immunization Injection Safety in Albania (2003-2007)

     Partners Activities 2003 2004 2005 2006 2007 Nr GoA UNICEF GAVI WHO Others 1 Injection safety assessment at district level through supervision X X X X X X X X 2 Medical waste management assessment X X X X Red Cross X

    3 Introduction of the injection safety policy X X X X

    Policy adoption and development of injection safety and waste

    4 management plans at prefecture/district/health center/health facility X X X


    Develop training curriculum for physicians, nurses, and other health 5 X X X professionals on injection safety

    6 Train health care workers on injection safety and AEFI surveillance X X X X X

    Inclusion of injection safety in the education curriculum for medical 7 X X students and nurses

    8 Advocacy and communication on injection safety X X X X X X X

    Provision of adequate supplies of safe injection and disposal equipment 9 X X X X X X X X (safety boxes) at the national and subsequent levels

    Local adaptation/implementation of the waste management plan 10 X X X X according to destruction methodologies chosen.

    11 Revise the open vial policy at national level X X ?

    Establish AEFI monitoring and surveillance system at all levels of 12 X X X service delivery

    Revise and refine the safe immunization policy in compliance with 13 ? ? WHO recommendations

    14 Evaluate impact of injection safety policy X X


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