Consultation on a draft Global action plan to address antimicrobial

Consultation on a draft Global action plan to address antimicrobial resistance
The questionnaire is divided into four sections. The questions are broadly framed and intended to
give you the opportunity to enter into some depth and explain your organization's viewpoint. While
only questions marked with * are mandatory, we would appreciate answers to as many as possible.
Where a choice of answer needs to be selected please highlight your answer.
Before answering the questions, please refer to our list of supporting documents.
http://www.who.int/drugresistance/amr-consultation/en/index.html
About You
1. Name of Individual Respondent:
Ali ALKAN
2. Email Address:
[email protected]
3. Are you authorised to represent your organization or interest group?
Yes
4. Organization Name:
Türkiye İlaç ve Tibbi Cİhaz Kurumu (TITCK)
Turkish Medicines and Medical Devices Agency
5. Address of the Organization:
Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya/ANKARA TURKEY
6. Organization Website:
http://www.titck.gov.tr
7. Country
Turkey
8. Type of Organization
Government department, ministry or agency.
9. Main sector of interest
Human health.
10. Would you like to be added to our mailing list to receive updates on the development of the
global action plan?
Yes
General Questions
1. From the perspective of your organization, what are the most important areas of concern in AMR?
AMR has become an important issue in Turkey, like in rest of the world. AMR and Rational Use of
Antibiotics are primary topics in the Rational Drug Use National Action Plan 2014-2017 which is
prepared by TITCK. Studies related to AMR are being conducted by TITCK, Turkish Public Health
Agency and other stakeholders. Detecting problems related to AMR provide an important basis for
the solution.
Since TITCK is responsible for obtaining and evaluating consumption data, determining consumption
data is the main area of concern in AMR from agency’s perspective. This data is also important to
carry out other interventions and actions mentioned in the global AMR draft action plan. We believe
that once you know how big the problem is, it’s easier to tackle it. That’s why surveillance of
antimicrobial resistance and antibiotic use should be given a high profile in the action plan.
Tüm dünyada olduğu gibi ülkemizde de antibiyotik direnci ciddi bir sorun haline gelmiştir. TITCK
tarafından hazırlanan Akılcı İlaç Kullanımı Ulusal Eylem Planı 2014-2017’de “Akılcı Antibiyotik
Kullanımı” ve “Antibiyotik Direnci” öncelikli konular arasında yer almaktadır. Antibiyotik direnci ile
ilgili çalışmalar TITCK, THSK ve ilgili paydaşların tamamının katkı sağlayacağı şekilde yürütülmektedir.
Antibiyotik Direnci konusundaki problemin tespit edilebiliyor olması sorunun çözümü konusunda
daha hızlı yol alınmasını sağlayacaktır.
2. Is your organization currently involved in work related to AMR?
Yes
If Yes, How?
Turkey launched Rational Drug Use National Action Plan in 2014. Each action in the plan steered by
TITCK in collaboration with related stakeholders of health industry. Rational use of antibiotics is one
of the main topics in the plan. Since Turkey has one of the highest antibiotic consumption in Europe,
TITCK tries to promote rational use of antibiotics by increasing awareness between public and health
professionals, education activities and administrative arrangements. Also TITCK has functional
software system named Prescription Information System (RBS) for monitoring and evaluating
physicians’ prescription behaviour. Also in collaboration with Turkish Public Health Agency, TITCK
has started to work on specific strategic action plan on AMR. Once the plan gets its final shape and
launched, TITCK is going to take necessary responsibility for AMR related actions.
Türkiye 2014 yılında Ulusal Akılcı İlaç Kullanımı Eylem Planını devreye soktu. Plandaki her eylem
TITCK’nın liderliğinde ve sağlık endüstrisinin ilgili paydaşlarının işbirliğinde yürütülmektedir. Plandaki
ana konulardan birisi de antibiyotiklerin akılcı kullanılmasıdır. Türkiye Avrupa’daki en yüksek
antibiyotik tüketimine sahip ülke olduğundan dolayı, TITCK halkta ve sağlık çalışanlarında bilincin
arttırılması, eğitim aktiviteleri ve idari düzenlemelerle antibiyotiklerin akılcı kullanımını teşvik etmeye
çalışmaktadır. Ayrıca Prescription Audit and Feedback Sistemi TİTCK bünyesinde faaliyet
göstermektedir. Aynı zaman THSK ile birlikte TITCK, AMR üzerine spesifik bir stratejik plan üzerinde
çalışmaktadır. Plan son halini aldıktan sonra devreye girecek ve gerekli sorumluluğu AMR ile ilgili
konularda üstüne alacaktır.
Questions about the draft global action plan outline document
Before the WHA resolution was adopted, two WHO AMR Strategic Technical Advisory Group (STAG)
meetings were held in anticipation, which included members plus a large number of representatives
from other organizations. These meetings identified key issues, concerns and led to the
development of a draft outline.
As this consultation progresses and stakeholder meetings are held, the secretariat will harvest and
incorporate the input into the draft global action plan.
1. How would you rate your understanding of WHO’s intention in the development of a global action
plan to address AMR?
Very good
2. From the perspective of your organization, are the major issues relating to AMR outlined in the
draft global action plan?
Yes
If No, what additional issues need to be addressed?
Questions on the ‘Building blocks’ described in the draft outline.
You will notice, the global action plan has been constructed around “building blocks” in recognition
that different countries will have different starting points. In this situation, countries can choose
building blocks to concentrate upon. Each building block specified has been identified as a key area
where specific attention, planning and work are needed to achieve progress in addressing AMR.
Through questions in this section, we would like to hear your opinions on these building blocks in
more detail.
I. Building block-1: Increasing awareness and understanding about AMR and of the actions and
changes needed
a) What do you consider to be the main issues under this priority?
Each stakeholder has responsibilities with different levels to contain AMR as mentioned by WHO.
The point of view of the health professionals, public and other stakeholders fail to understand the
AMR’s importance and further results of this problem. There is a need to constitute sufficient
awareness on AMR for all stakeholders. After then there will be a chance to implement related
policy, approaches because attitude of stakeholders is the main factor of actions against AMR.
WHO ve TİTCK Akılcı İlaç Kullanımı Ulusal Eylem Planı 2014-2017’de de belirtildiği gibi her paydaşın
AMR’nin kontrol altına alınmasında farklı seviyelerde sorumlulukları vardır. Sağlık çalışanlarının,
halkın ve diğer paydaşların bakış açısı ve AMR’nin önemini anlayamaması bu problemle neden
olmaktadır. AMR konusunda tüm paydaşlar için yeterli farkındalık gereklidir. Ancak ondan sonra ilgili
uygulamalar ve yaklaşımlar gerçekleştirilebilir. Çünkü AMR’ye karşı yapılan faaliyetlerde paydaşların
tutumları belirleyici rol oynamaktadır.
b) What are the main actions that needs to be done -- and who are the main actors/stakeholders
who need to take action -- to go beyond the status quo?
Main priority should be educating public and raising awareness between health professionals.
Perception of public’s “antibiotics are good” should be changed into the fact that misuse and
overuse of antibiotics can lead to resistance. Education programmes, campaigns, public service
announcements, activities in schools with regard to importance of AMR may be helpful to improve
the knowledge and awareness of public about AMR. To educate public, main demographic target,
should be younger population to make a permanent change about behaviour. These activities should
be conducting under control of specific advisory committee which is consisted of professionals, in
particular from Universities and Ministry of Health.
Akılcı İlaç Kullanımı Ulusal Eylem Planı 2014-2017’de idari düzenlemeler ve planlamalar, tanıtım,
eğitim ve izleme ve değerlendirme çalışmaları başlıkları yer almaktadır. Antibiyotik direnci
konusunda verilecek eğitimlerde paydaşlarımız; hekimler, eczacılar, yardımcı sağlık personeli, halk ve
ilaç sektörüdür. Ana öncelik paydaşlarda bilgi ve bilinç düzeyinin artırılması ve bu konuda farkındalık
oluşturulmasıdır. Bu kapsamda yapılacak olan çalışmalar, profesyonel olarak kabul edilen spesifik bir
danışman komitesinin kontrolünde yürütülmeli, bu komite özellikle üniversitelerden ve Sağlık
Bakanlığından oluşmalıdır.
c) What steps have already been taken to address this priority? (Please provide references where
possible)
TITCK established Rational Drug Use teams in each city which consisted of health professionals from
different local authorities. Informative meetings for public and health professionals are being carried
out by local health authorities under Turkish Ministry of Health. These informative meetings also
include peer review studies. Each year RDU teams started to gather around and discuss what they
have done in their local areas. One of the main topics in these discussions and activities is AMR. As a
part of European Antibiotic Awareness Day symposium for professionals, activities for public have
been conducted in 18 November since 2008 by Turkey Republic Ministry of Health. Awareness
campaigns on Rational Drug Use will start in 2015 for public. Peer reweiw
TITCK her şehirde yerel otoritelerdeki sağlık çalışanlarından oluşan Akılcı İlaç Kullanımı ekipleri
oluşturmuştur. Türkiye Sağlık Bakanlığı’na bağlı yerel sağlık otoriteleri tarafından halka ve sağlık
çalışanlarına yönelik bilgilendirici toplantılar yürütülmektedir. Her sene AİK ekipleri bir araya gelerek
lokal olarak neler yaptıklarını tartışmaya başlamıştır. Bu toplantılardaki ve aktivitelerdeki önemli
konulardan biri de AMR’dir. Avrupa Antibiyotik Farkındalığı Günü’nün parçası olarak sağlık çalışanları
ve halk için sempozyumlar, aktiviteler 2008 yılından itibaren her 18 Kasım’da T.C. S.B. tarafından
yürütülmektedir. Akılcı İlaç Kullanımı ile ilgili olarak bir bilinçlendirme Kampanyası halka yönelik
olarak 2015 yılı içerisinde düzenlenecektir. Yerelde ise her il kendi bölgesinde bulunan doktorlar için
küçük gruplarla eğitimler düzenleyecektir.
d) What are concrete and measurable indicators of progress for this priority? (Including, for
example, global and national goals to be achieved within 2, 5 and 10 years)
Consumption of J01 class antibiotics per 1000 inhabitants will be our indicator. This data is being
calculated by using ATC/DDD methodology. We aim to have 2 unit reduction in antibiotic
consumption annually. So the consumption rate is predicted to be 35 DID at the end of 2017.
Ülkemizdeki J01 grubu antibiyotiklerin 1000 kişi başına düşen yıllık tüketimi indikatörümüz olacaktır.
Bu veri DSÖ’nün ATC-DDD metodolojisi ile hesaplanmaktadır. DDD hesaplamaları antibiyotik
tüketiminin uluslararası alanda karşılaştırılmasını sağlayacak doğru bir göstergedir.
DID metodolojisi kullanılarak antibiyotik tüketiminde bir önceki yıla göre her yıl 2 birim azalma
hedeflenmektedir. 2017 yılı sonu itibariyle 35 DID olması planlanmaktadır.
II. Building block-2: Identifying the most important approaches for preventing development of
infections and the steps needed to move beyond guidance to more effective implementation of such
approaches
a) What do you consider to be the main issues under this priority?
Increasing awareness of public and health professionals on hygiene is one of the main priorities.
b) What are the main actions that needs to be done -- and who are the main actors/stakeholders
who need to take action -- to go beyond the status quo?
c) What significant work has already been done to address this? (Please provide references where
possible)
A web site on hygiene rules is prepared to increase awareness.
El hijyeni konusunda bir web sayfası oluşturulmuştur.
d) What are concrete and measurable indicators of progress for this priority? (Including, for
example, global and national goals to be achieved within 2, 5 and 10 years)
III. Building block-3: Optimizing the use of existing antimicrobials for human and animal health and in
agriculture
a) What do you consider to be the main issues under this priority?
b) What are the main actions that needs to be done -- and who are the main actors/stakeholders
who need to take action -- to go beyond the status quo?
c) What steps have already been taken to address this priority? (Please provide references where
possible)
d) What are concrete and measurable indicators of progress for this priority? (Including, for
example, global and national goals to be achieved within 2, 5 and 10 years)
IV. Building block-4: Identifying and closing critical gaps in knowledge needed to address AMR
a) What do you consider to be the main issues under this priority?
There is a need to understand current situation of member states on AMR. For this reason,
surveillance of antibiotic consumption and resistance should be conducted with standardized
methodology that enable to compare the data among regions and member states. By this way, the
main problems and objectives will be detected more effectively. Rapid diagnostic tests and new class
antibiotics researches are also one of the important component of this topic.
AMR konusunda üye ülkelerin şu anki durumlarını anlamaya ihtiyaç vardır. Bu sebeple antibiyotik
tüketimi ve direnç konularında sürveyans çalışmalarında standardize bir metodoloji kullanılmalı ve
bu sürveyans üye ülkeler ve bölgesel alanlar arasında karşılaştırmaya olanak vermelidir. Bu sayede,
ana problemler ve çözüm yolları daha efektif bir şekilde tespit edilecektir. Hızlı tanı testleri ve yeni
sınıf antibiyotiklerin araştırılması da bu konunun önemli bileşenlerinden biridir.
b) What are the main actions that needs to be done -- and who are the main actors/stakeholders
who need to take action -- to go beyond the status quo?
The calculating of antibiotic consumption data with WHO ATC/DDD methodology and using the
standardized laboratory methodology with common language for antibiotic resistance surveillance
will provide comparable situation about AMR. The assessment of resistance and consumption data
together can also guide to identify the important areas in the action plan with evidence based. As a
result of this, more sustainable and effective actions could be implemented against AMR. For this
purpose there is need of collaboration between WHO Regional Offices, Ministry of Health,
Universities, Pharmaceutical Industry and relevant institutions.
DSÖ ATC/DDD yöntemi ile antibiyotik tüketiminin hesaplanması ve antibiyotik direnci sürveyans
çalışması için standardize laboratuvar yöntemlerinin kullanılması AMR için ortak bir dilin kullanıldığı
ve karşılaştırılabilir verilerin elde edilmesine olanak sağlayacaktır. Tüketim ve direnç verilerinin bir
arada değerlendirilmesi eylem planındaki öncelikli alanların kanıta dayalı bir şekilde belirlenmesine
yardımcı olacaktır. Bunun bir sonucu olarak AMR’ye karşı daha sürdürülebilir ve etkin eylemler
uygulanabilir. Bu amaçla DSÖ yerel ofisleriyle, Sağlık Bakanlıkları, üniversiteler, ilaç endüstrisi ve ilgili
kuruluşlar arasında işbirliğine ihtiyaç vardır.
c) What steps have already been taken to address this priority? (Please provide references where
possible)
TİTCK has calculated antibiotic consumption data with WHO ATC/DDD methodology. These data are
being reported annually and shared with WHO. These results are being took into account while
deciding actions and regulations to contain AMR.
TİTCK antibiyotik tüketim verisini DSÖ ATC/DDD metodolojisi ile hesaplamıştır. Bu veriler yıllık olarak
rapor edilmekte ve DSÖ ile paylaşılmaktadır. Sonuçlar AMR üzerine yeni faaliyetler ya da yasal
düzenlemeler tasarlanırken göz önünde bulundurulmaktadır.
d) What are concrete and measurable indicators of progress for this priority? (Including, for
example, global and national goals to be achieved within 2, 5 and 10 years)
The level of decreasing for antibiotic consumption and resistance can be determined as an indicator
for this topic. TİTCK aims to achieve 2 unit decrease on antibiotic consumption data when compared
the previous year as mentioned in TİTCK Strategic Plan. This indicator also included in the Strategic
Action Plan of Turkish Ministry of Development. These results will be considered while conducting
new actions and administrative arrangements.
Bu başlık için antibiyotik tüketiminde ve rezistansında saptanacak azalmalar indikatör olarak
kullanılabilir. TİTCK stratejik planında bahsedildiği gibi her yıl, bir önceki yıla göre antibiyotik
tüketiminde 2 birim azalma gerçekleşmesini hedeflemektedir. Ülkemizin Kalkınma Bakanlığı Stratejik
Eylem Planında da bu indikatör ve hedef kullanılmıştır. Bu sonuçlar AMR üzerine yeni eylemler ya da
yasal düzenlemeler tasarlanırken göz önünde bulundurulacaktır.
V. Building block-5: Developing an innovative and sustainable approach to develop and distribute
critical products and technologies needed to address AMR
a) What do you consider to be the main issues under this priority?
Implementation of current available tools and development of new technologies on rapid diagnosis
confirmation tests should be one of the priorities in this area.
b) What are the main actions that needs to be done -- and who are the main actors/stakeholders
who need to take action -- to go beyond the status quo?
Studies on development of new technologies on rapid diagnosis confirmation tests should be
encouraged. Universities, ministry of health, private sector are the main actors.
c) What steps have already been taken to address this priority? (Please provide references where
possible)
A study on Rapid PCR test for diagnosis of group A beta haemolytic streptococcal infections has been
started. Starting a study on implementation of current available fast antigen test for detection of
group A beta haemolytic streptococcal infections.
d) What are concrete and measurable indicators of progress for this priority? (Including, for
example, global and national goals to be achieved within 2, 5 and 10 years)
Determination of the effectiveness of diagnostic tests on physicians prescription behaviour by pilot
study is our indicator for this priority.
VI. Building block-6: Assessing the long term economic, developmental and social costs and
implications of AMR as a basis for sustainable investment and action
a) What do you consider to be the main issues under this priority?
b) What are the main actions that needs to be done -- and who are the main actors/stakeholders
who need to take action -- to go beyond the status quo?
c) What steps have already been taken to address this priority? (Please provide references where
possible)
d) What are concrete and measurable indicators of progress for this priority? (Including, for
example, global and national goals to be achieved within 2, 5 and 10 years)
Concluding questions
3. What contribution would your organization be able to make in implementing the global action
plan?
After AMR Global Action Plan launched TITCK can provide collaboration between human health
stakeholders. We monitor and evaluate antibiotic consumption both in provincial and general
manner as TİTCK Rational Drug Use and Drug Supply Management Department. We are obtaining
physicians’ prescription data through web-based Prescription Information System (PIS) which is
approximately 21.000 family physician’ data included. These data have also been evaluated with
respect to the proportion of antibiotic containing prescription, injectable antibiotic containing
prescription and a lot of different parameter in the general and provincial level. According to the
results of evaluation, we hold meetings that include discussion part session for the stakeholders’
problems and educational session about antibiotic resistance. Rational Drug Use National Action
Plan 2014-2017 was launched with 6 Titles / 20 Strategic Objectives / 99 Actions. Rational antibiotic
use took place in the action plan as one of the preferential area. Finally TİTCK have sufficient
experience and system to implement Global Action Plan Chapters related to actions towards misuse,
overuse of antibiotics and conducting surveillance of antibiotic consumption.
Global Action Plan yayımlanması sonrasında ülkemizde Gıda Tarım ve Hayvancılık dışında kalan diğer
paydaşlarla koordinasyonu kurumumuz tarafından sağlanabilir. Ayrıca, Kurumumuz tarafından il ve
ülke genelinde antibiyotik tüketimini izlenmekte ve değerlendirilmektedir. Hekimlerin reçeteleme
verilerini web tabanlı bir yazılım olan ve yaklaşık olarak 21.000 aile hekiminin kayıtlı olduğu Reçete
Bilgi Sistemi (RBS) ile elde ediyoruz. Bu veriler yerel ya da genel düzeyde antibiyotik içeren reçete
yüzdesi, enjektabl antibiyotik içeren reçete yüzdesi gibi birçok farklı parametreler ile
değerlendirilmektedir.
Değerlendirme sonucu elde ettiğimiz sonuçlar sayesinde, paydaşların sorunlarının da ele alındığı
antibiyotik direnç üzerine eğitim içeriği bulunan toplantılar düzenlenmektedir. 6 Başlık/20 Stratejik
Hedef/99 Elem’i içeren 2014-2017 Akılcı İlaç Kullanımı Ulusal Eylem Planı başlatılmıştır. Eylem
planında akılcı antibiyotik kullanımı öncelikli başlıklar arasında bulunmaktadır. Son olarak TİTCK
Küresel Eylem Planında geçen yanlış, gereksiz antibiyotik kullanımına yönelik müdahale ve antibiyotik
tüketimi üzerine sürveyans çalışmalarını yerine getirebilecek yeterli deneyim ve sisteme sahiptir.
4. Additional input that you feel would be facilitate development of the GAP.