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MainSurveillance and monitoringImplementation of international recommendations on NTP (2007-2011)Management of medicines and other commodities

Management of medicines and other commodities

Status of implementation of recommendations for section Management of medicines and other commodities

Recommendations Status Implementation Institution responsible for implementation Deadlines
Management of medicines and other commodities
General recommendations        

1. The harmonization of drug regulatory procedures should be continued, including drug quality control, with European Union standards. Transparency and accountability in the regulation of medicines should be enhanced.
Partially

On May 28, 2013 the Guidelines “Medicinal Products. Good Regulatory Practice” No. 247 took effect, which was developed by the Ministry of Health of Ukraine and state institution “State Expert Centre of the Ministry of Health of Ukraine”.

This document complies with WHO recommendations specified in the guidelines for the National Medicines Regulatory Authorities (NMRAs): “Marketing authorization of pharmaceutical products with special reference to multisource (generic) products – 2nd ed”.
MOH

2. Pharmaceutical management should be strengthened at all levels to ensure consistent access to TB first- and second-line medicines of assured quality and their appropriate use.
Partially

On the national level (state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine”), management over medicinal products and consumables for laboratory diagnosis is coordinated by specialists of procurement and supply department. Functional responsibilities of employees in this department include, in particular, coordination of order placement, distribution and re-distribution of anti-TB drugs procured for the money from the state budget, Global Fund and Global Medical Fund. Compliance of drug and consumables use is inspected by specialists of treatment and laboratory diagnosis during monitoring visits and through analysis of data entered to the electronic register of TB patients.

On the regional level, currently there is no separate FTE responsible for pharmacological management and pharmacological surveillance. These functions are imposed to deputy chief doctors for treatment and to non-tenured regional phthisiatricians. Control over pharmacological management and pharmacological surveillance on the regional level is exercised in the course of monitoring visits which have been financed since 2012 with Global Fund and USAID grants.
Regional healthcare departments
Special recommendations        

3. Major funding gaps in drug procurement should be overcome by giving preference to solid forms of anti-TB medicines over expensive and often unnecessary injectable products (isoniazid, fluoroquinolones).
Implemented

Anti-TB drugs are procured based on calculations provided in the “Method for Calculation of Need for Anti-TB Drugs” approved with the Order of the Ministry of Health of Ukraine dated 25.03.2011 No. 163 (as revised by the Order the Ministry of Health of Ukraine dated 22.02.2013 No. 156, registered with the Ministry of Justice of Ukraine on June 22, 2011 under No. 742/19480).

This method gives preference to application of solid dosage forms of anti-TB drugs rather than prescription of more expensive injectable preparations.

4. The registration of first- and second-line TB medicines according to current national standards should be facilitated, to enable their procurement and distribution through the Green Light Committee, national budget or other sources.
Not implemented

Anti-TB drugs of the first and the second line that are procured for the money from the state budget are registered, but not all of them have the WHO prequalification. 

All anti-TB drugs of the second line that are procured for the Global Fund grant have WHO prequalification, however the majority of them are still not registered in Ukraine (Levofloxacin, Ethionamide, Moxifloxacin, Capreomycin and Kanamycin). For supply of these drugs to Ukraine, a permit for single import to Ukraine should be obtained for each delivery.

Meanwhile, the procedure for registration of drugs which have the WHO prequalification is simplified in Ukraine. Moreover, the International Charitable Foundation “International Alliance of Ukraine” together with the state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine” holds active negotiation with the manufacturers concerning registration of additional forms of anti-TB drugs which comply with the requirements of quality control set by the Global Fund. According to the preliminary data, all drugs except for Kanamycin and Capreomycin will have been registered until the end September 2014.
International HIV/AIDS Alliance in Ukraine
30.09.14

5. A risk−benefit analysis approach should be used to the quality, safety and efficacy of medicinal products at all stages of the regulation of medicines, including post-marketing quality control, and unnecessary duplication of regulatory activities avoided.
Partially

In 2014, state institution ”Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine” started to cooperate with the state institution “State Expert Centre of the Ministry of Health of Ukraine” with regard to analysis of side effects of anti-TB drugs.

Currently, spontaneous reporting on side effects (regulated with the Order of the Ministry of Health of Ukraine “On Approval of the Procedure for Supervision of Side Effects Made by Medicinal Products Allowed for Medical Use” dated 27.12.2006, No. 898 (last revised on 29.12.2011) is on a very low level at TB service. Reported data are not exhaustive and may not be used as a source for making managerial decisions concerning quality and replacement of drugs procured.

Active pharmacological surveillance as a component of pharmacological surveillance is not applied in Ukraine at all.
State Expert Center

6. The necessary human resources and public funds should be made available to support the regulatory activities that protect public health and ensure drug safety.
Partially

The function of drug safety control is performed by the state institution “State Expert Centre of the Ministry of Health of Ukraine” having its structural divisions in all regions of Ukraine.

However, pursuant to the Order of the Ministry of Health of Ukraine “On Staff Standards and Typical Staff for Healthcare Facilities” dated 23. 02. 2000, No.33, TB facilities do not have a position of a pharmacist and a pharmacist-in-charge, who would be responsible for drug quality control.
Regional healthcare departments

7. The efficiency of pharmaceutical management should be strengthened and improved to ensure consistent access to TB first- and second-line medicines of assured quality. This should be done through:
a) updating the instructions for calculating the drug needs for TB drugs and clarifying the policy on buffer stocks;
b) implementing integrated access to TB and antiretroviral medicines in AIDS and TB facilities;
c) facilitating the introduction of the appropriate use of fixed-dose combinations;
d) clarifying the roles and responsibilities of personnel responsible for managing medicines, and developing standard operating procedures and job descriptions where necessary.
Partially

a) “Method for Calculation of Need for Anti-TB Drugs”, which was updated in 2013), requires improvement with the consideration of the WHO recommendations to the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (drawn up in 2012).
Currently, a draft Order on a new method for calculation of need for anti-TB drugs is pending approval with the Ministry of Health of Ukraine. A draft unified clinical protocol was developed and proposed for general discussion.
b) A Draft National Plan for TB/HIV Co-infection Monitoring and Assessment in Ukraine for 2013-2016 provides for indicators that show coordination between two services concerning access to TB and ARV drugs. Moreover, such indicators are included to checklists used during the monitoring visits. Whereas in 2012 only 45% of registered HIV-infected patients with TB were receiving ART during TB treatment, there exists a vital need for improved coordination between AIDS and TB services.
c) Within the framework of state procurements, it is impossible to procure combined medicinal products, as the domestic pharmaceutical manufacturers do not produce combined anti-TB drugs (anti-TB drugs of Ukrainian pharmaceutical companies are procured for state money in accordance with the effective laws). Therefore, since 2005 combined anti-TB drugs have been received by the state on a free-of-charge basis under the Global Medical Fund grant. Despite numerous recommendations of WHO experts on switching to domestic production of combined anti-TB drugs, none of the national pharmaceutical manufacturers launched such production.
d) On the national level (state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine”), management over medicinal products and consumables for laboratory diagnosis is coordinated by specialists of procurement and supply department.
On the regional level, currently there is no separate FTE responsible for pharmacological management and pharmacological surveillance. These functions are imposed to deputy chief doctors for treatment and to non-tenured regional phthisiatricians. Pursuant to internal orders, all facilities have a person responsible for accounting of anti-TB drugs; efficient use of anti-TB drugs is controlled with the Central Medical Consultative Board responsible for pharmacological surveillance. In the course of reforming TB service, it would be reasonable to separate such FTE.
UCDC
Regional healthcare departments
 On an ongoing basis

8. Manual and electronic reporting and recording systems for TB should be strengthened to facilitate the appropriate diagnosis and management of TB cases, evaluate treatment outcomes and improve the management and use of TB medicines.
Not implemented

In 2014 it is planned to revise existing manual and electronic system of TB reporting in accordance with WHO recommendations. Moreover, respective amendments will be made to “Drug” modules in the electronic register of TB patients (e-TB manager), which would make it possible to calculate need for anti-TB drugs of the first and second line and to control their use.
UCDC
31.01.15

9. Efforts to strengthen pharmaceutical management should be coordinated between programmes, donors and partners across the civil, penal and other sectors.
Implemented

On the national level (state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine”), management over medicinal products and consumables for laboratory diagnosis is coordinated by specialists of procurement and supply department. Functional responsibilities of employees in this department include, in particular, coordination of order placement, distribution and re-distribution of anti-TB drugs procured for the money from the state budget, Global Fund and Global Medical Fund.
UCDC
 On an ongoing basis

10. The prescribing and dispensing of first- and second-line medicines should be evaluated to identify patterns of inappropriate drug use and develop interventions to address them.
Implemented

Prescribed therapy compliance is estimated during monitoring visits by the treatment specialists of the national and regional levels. Moreover, electronic register of TB-patients (e-TB Manager) allows for control over prescription of treatment regimens on the national and regional levels.
UCDC
 On an ongoing basis

11. Legal, regulatory, policy or other barriers to effective management of first- and second-line TB medicines and other commodities should be identified and addressed. An intersectoral approach should be used to address those areas governed by laws and regulations outside the Ministry of Health.
Not implemented

Considering that procurement of anti-TB drugs on the state level is realized under incomplete schemes, and that supply agreements do not envisage any penalties for a failure to comply with delivery terms, anti-TB drugs are not available at the national and regional warehouses from time to time.
Thus, according to the report on audit performed for the state budget funds allocated to the Ministry of Health of Ukraine, and humanitarian aid from non-governmental organizations for measures targeted at TB prevention and treatment in 2013 (Kyiv: Accounting Chamber of Ukraine, 2013), regional healthcare authorities were provided with anti-TB drugs in 2011 – for 8-24%, in 2012 – for 60-75%, which led to incompliance with or interruption of the treatment regimen and purchase of drugs for other funds.
The majority of anti-TB drugs of the second line (Levofloxacin, Ethionamide, Moxifloxacin, Capreomycin and Kanamycin), which are procured for the Global Fund grant, still are not registered in Ukraine. For supply of these drugs to Ukraine, a permit for single import to Ukraine should be obtained for each delivery, which also complicates the process of drug management.
MOH
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