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Cambodian experiences on quality of antimalarial medicines. Dr. Duong Socheat, National Malaria Centre, Cambodia. Workshop on GMP and Quality Assurance of Antimalarial Medicines for WHO/SEARO and WHO/WPRO regions 18-22 October, Bangkok, Thailand.

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Cambodian experiences on quality of

antimalarial medicines

Dr. Duong Socheat,

National Malaria Centre, Cambodia

Workshop on GMP and Quality Assurance of Antimalarial Medicines for WHO/SEARO and WHO/WPRO regions

18-22 October, Bangkok, Thailand


Location of CambodiaThe Kingdom of Cambodia shares its borders with Thailand and Laos on the north, with Vietnam on the East and South, and with the Gulf of Siam and Thailand on the South and West.


Over view
Over view

  • Malaria situation in Cambodia

  • Problems faced earlier to 1999

  • Policy of prepackaged drugs (2000)

  • Blister packaged Artesunate and Mefloquine (ACT)

  • Experience of blister packaging – GMP concerns

  • Challenges of Quality assurance

  • Current Malaria Treatment Policies

  • A Recent Study of Quality of Anti-Malarial Drugs

  • Study findings of counterfeit antimalaria drugs

  • Future approaches for good quality antimalaria drugs

  • Strategy of Drug Quality Assurance in Pharmaceutical Development


Malaria situation in cambodia
Malaria Situation in Cambodia

  • High malaria occurrence among migrants, casual workers during harvest season, forest workers, gem miners, road construction workers, soldiers,and ethnic minorities

  • Limited accessibility to public health services

  • Lack of knowledge about correct treatment among risk groups and private health care providers

  • Imprecise diagnosis as poor quality microscopy persists in remote areas even in the public sector because of low salaries

  • Improper, inadequate, expensive and ineffective treatments including counterfeit drugs in the private sector


HISTORICAL PERSPECTIVE

  • Malaria, a major scourge in Cambodia for several decades.

  • Monotherapy mainly followed until 1999

  • - 1993: Shifted from Chloroquine to Quinine + Tetracycline

  • - 1994: Changed from Quinine + Tetracycline to Mefloquine

  • Combination therapy recommended for the first time in 1999 -Artesunate and Mefloquine (without packaging)

  • Treatment guidelines revised in 2000 introducing prepackaging of Artesunate and Mefloquine

  • Further revisions are due depending on the outcomes of current research underway


Problems accumulated until 1999 which prompted the shift to combination therapy
Problems accumulated until 1999(which prompted the shift to Combination therapy)

  • Increasing levels of multi drug resistance especially in border areas with Thailand

  • Huge burden of counterfeit or low quality antimalarial drugs in the open market

  • Inappropriate prescription practices in the private sector

  • Inappropriate treatment seeking behavior and drug use


Reasons for pre packaging by the national programme
Reasons for pre-packaging by the National Programme

  • Necessity to stabilize drug resistance, control counterfeit drugs, and improve drug use of antimalaria drugs for both providers and patients

  • Particular response requirements to the malaria burden (ACT)

  • Combination treatment of artesunate and mefloquine was not commercially available

  • Local pharmaceutical manufacturers were not ready for blister-packaging with GMP standard

  • Malaria Program need to provide ACT in blister to assure proper use for both public and private sector


Policy of pre packaged drugs 2000
Policy of pre-packaged drugs (2000)

  • The Sub-Cocom of Ministry of Health declared the country’s malaria treatment policy:

    • A combination of Mefloquine® + Artesunate® is the first line treatment for uncomplicated Pf malaria

    • The regimen have to be pre-packaged in different age/weight groups

  • MOH decided to locate the packaging facility in the compound of Central Medical Store.

-


Antimalarial combinations currently in use

Two channels of distribution

Public Sector

Routine distribution system (CMS)

Public HealthServices

Commercial distribution

Social marketing scheme

Private Sector

Private Drug sellers


Advantage of pre packaged drugs
Advantage of pre-packaged drugs

  • To improve or stabilize resistance levels:

    • Standardized and effective treatment nationwide

    • Combination of artesunate and mefloquine

  • To improve the patient’s compliance

    • Short duration of treatment

    • Pre-packaged treatment

  • To improve the patient’s understanding of the treatment administration

    • User friendly IEC approach (outer box and instruction notice)


Experiences of production
Experiences of production

  • Ministry of Health agreement / WHO’s support

  • Determine required equipment

  • Design moulds for blistering

  • Develop packaging unit

  • Train workers

  • Import raw materials like aluminum foil and PVC as well as drugs

  • Maintain program to supply drugs on time


Good manufacturing procedures concerns
Good Manufacturing Procedures concerns

  • Quality assurance issues have been addressed

  • Cambodia GMP guidelines was published in 2000

  • Constant monitoring system for GMP / Routine inspection to manufacturers is under development

  • Specifications for raw materials must be robust

    • Obstacles encountered during procurement process

  • Management of the packaging plant must be comprehensive in order to be efficient and effective

  • Concerns with the GMP criteria for drugs and other raw materials

    • No pre-qualified mefloquine is available


Challenges of quality assurance of blister packaging a m
Challenges of Quality Assurance of blister packaging A+M

QC of

Law materials

Storage

Storage

Ports

National malaria center

Air conditioning

Unstable power supply

Central Medical Store

Air conditioning

QC of blisters

Stability test

Packaging

Storage

Storage

Central Medical Store

National malaria center

Central Medical Store

Storage

Health Center

No air conditioning

Patients

OD pharmacy store

No air conditioning

Transport without air conditioning


Results of A+M quality

  • Before blister package:

    • Mefloquine 250 mg from Denmark : Conform to specification

    • Artesunate 50 mg from China : Conform to specification

    • Artesunate 50 mg from Vietnam : Problem of Friability

  • After blister package:

    • A+M4: Conform to specification

  • Quality after 3 month in the field

    • A+M4: Conform to specification

  • Stability tests for A+M and Malarine was conducted and passed


Current Malaria Treatment Policies

Public Sector

  • Treatment guidelines for 3 Day combination therapy using mefloquine and artesunate after obligatory use of rapid diagnosis test or microscopy

  • Pre-packaging and distribution of dipsticks and anti-malarial combination treatment for hospitals & health centers free of charge

    Private Sector

  • Social Marketing ofRapid Diagnostic Test & a brand-named pre-packaged combination therapy

  • Health Education through advertisement of the product on Mass Media

    Village Malaria Workers

  • I male and I female villagers are trained for RDT and ACT

  • 300 villages will be covered under GF round 2


Handing over of blister packaging of a m to pharmaceutical manufacturer

Handing over of Blister packaging of A+M topharmaceutical manufacturer

Cambodia Pharmaceutical Enterprise (CPE) has been established since 1999

MOU between the National Malaria Centre and the Cambodia Pharmaceutical Enterprise (CPE) in May 2004

Renovation of Blister Packaging Room

Australia Business Volunteers for GMP Jan, 2005

(Training manager of GMP and Quality Assurance, Abbott Australia)

CPE will start blister-packaging for A+M early 2005


Counterfeit Antimalaria Drugs

Preliminary Investigation of Quality

1. To obtain and document evidence-based data from the field on the quality of selected antimalarial drugs in Cambodia

To quantify fake antimalarials using MiniLab technology along Thai border areas

To assess the prevalence of drug shops where fake anti-malaria drugs are sold

To increase skills of provincial health staff in research methodology including sample collection, analysis using MiniLab, and reporting

2. To present suggestions to policy-marker on developing and implementing appropriate strategies to address the drug quality problems


Drug sellers in Cambodia

There are 3 kinds of legal drug shops in the country

Pharmacy= responsible by Pharmacist, 393

Depot A= responsible by assistant Pharmacist, 175

Depot B = responsible by retired midwives or nurses, 446

Illegal drug outlets in Cambodia, 2461

(Department of Drug and Food, 2002)


Sites for preliminary study 10 operational districts in 4 provinces
Sites for preliminary study 10 Operational Districts in 4 provinces

No. of outlets

in the 4 provinces

  • 23 Pharmacies

  • 12 Depot A

  • 72 Depot B

  • 391 illegal drug outlets


171 498 34 drug outlets visited for collection 240 samples in 4 provinces samples claimed to be

Results

171/ 498 (~34%) drug outlets visited for collection 240 samples in 4 provinces

Samples claimed to be


Overall results from 3 rounds in10 districts in 4 provinces
Overall results from 3 rounds in10 districts in 4 provinces

CF: Counterfeit drugs

* Brainy: unidentified manufacturer

**Sophisticated counterfeit of Guilin artesunate blister


Summary of the study findings

Summary of the study findings

The burden of fake antimalarials is significant

Impossible to determine the source of the counterfeit drugs

Difficult to identify counterfeit drugs by visual means

Counterfeit drugs were found both in legal and illegal shops

No counterfeit drugs were found in registered drugs sampled

Drug registration appears important to reduce problems

Anecdotal evidence

Community awareness campaigns appeared to have some beneficial outcomes – TV campaign for “Brainy drugs”

Drug sellers buy drugs without knowing the quality


Main causes of the problem of counterfeit drugs in cambodia
Main causes of the problem of counterfeit drugs in Cambodia

  • Effort has developed pharmaceutical law and regulations, but are still weak

  • The weak law enforcement

  • The weak education campaign

  • The poverty of Cambodian population

  • The insufficient number of drugs inspectors

  • The unsuccessful intervention of the MoH in previous years due to the limited collaboration and cooperation among concerned regulatory agencies


Future approaches for good quality antimalaria drugs
Future approaches for good quality antimalaria drugs

  • Continued monitoring of drug resistance to guide the revision of national drug policy

  • Continued monitoring of anti-malarial drug usage

  • Implementation of regular quality control of anti-malaria drugs in the private as well as public sector (including storage conditions)

  • Ensuring the adequate supplies of combination drugs in the public and private sectors

  • Strengthen procurement capacity

  • Enacting legislation prohibiting the selling of non-recommended regimens

  • Building up all possible partnership networks for improving implementation of national treatment guidelines.

  • Conduct sustained community awareness campaigns


Strategy of drug quality assurance in pharmaceutical development
Strategy of Drug Quality Assurance in Pharmaceutical Development

  • Strengthen management of pharmaceuticals and other medical supplies by introducing GMP, GPP, GLP, GSP and appropriate inventory system

  • Improve access of consumers to appropriate good quality pharmaceuticals in the public and private sector

  • Promote the quality of prescription and dispensing and appropriate use of drugs

  • Improve attitudes of pharmaceutical service providers towards consumers for improving communication

  • Strengthen the implementation of drug policies, laws and regulations for public safety

  • Reduce potential for harm to people’s health from counterfeit, sub-standard, poor quality and other dangerous drugs

  • Strengthen Drug Quality Control

  • Increase the skill of pharmaceutical workers in the private and public sector to follow national policy and procedures and achieve desired quality of work

  • Strengthen procurement and distribution of essential medical supplies country-wide (3 years rolling plan of Department of Drug and Food)


Partners
Partners

  • National Center for Parasitology Entomology Malaria Control program

  • Provincial Health Departments

  • National Laboratory for Drug Quality Control

  • Department of Drugs and Food

  • Cambodia Pharmaceutical Enterprise

  • US Pharmacopoeia / Drug Quality Information

  • USAID/AusAID/World Health Organization



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