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Potential reason behind
AMR and Risks in
Bangladesh
Md. Mehedi Hasan | HSS | EDM | Bangladesh www.searo.who.int/bangladesh
MD. MEHEDI HASAN
National Consultant- Essential Drugs and Medicines
World Health Organization (WHO) Bangladesh
12 November’ 2018
 Biggest threats to global health, food security, and development
today.
 Affect anyone, of any age, in any country.
 Occurs naturally.
 A growing number of infections are being untreatable as the
antibiotics used to treat them become less effective.
 Antibiotic resistance leads to longer hospital stays, higher
medical costs and increased mortality.
 Increasing health expenditure
19/11/2018 | Potential reason behind AMR and Risks in Bangladesh 2
Key facts of AMR
1. Irrational prescription for human and animal
2. Misdiagnosis of disease
3. Misuse of antibiotics in humans and animals by people
4. Sharing of unused antibiotics
5. Lack of counseling and awareness
6. Low quality antibiotics by potency, dissolution, stability etc.
7. Lack of proper storage of Antibiotics.
8. Low quality packaging of antibiotics.
9. Frequent use of antibiotics in animal health care
10. Unconscious disposal of unused antibiotics.
19/11/2018 3
Potential Reason behind AMR
| Potential reason behind AMR and Risks in Bangladesh
1. Policy Maker (MOHFW, DOE, LGED, DGDA, DGHS, DLS)
2. Antibiotic Manufacturer
A. Raw material manufacturer
B. Finished medicine manufacturer
1. Health Care Professional (Doctor, Nurse, Pharmacist)
2. Retail pharmacy
3. Antibiotic user (General Public)
4. Regulator (DGDA)
5. Education Institute
19/11/2018 4
Who are responsible for AMR
| Potential reason behind AMR and Risks in Bangladesh
1. Policy to control irrational prescription due to potential
conflict of interest with prescription generation.
2. Policy to control unethical pharmaceutical promotion.
3. Policy to control prescription diagnostic test reagent,
equipment and expertise.
4. Policy to control depot, distribution center and retail
pharmacy.
5. Policy for overall health education instead of physical
education in school level.
19/11/2018 5
How policy makers are responsible?
| Potential reason behind AMR and Risks in Bangladesh
1. Prescription generation with INN name by physician.
2. Quality evidence based medicine selection among hundreds
of marketed generics by graduate pharmacist.
3. Two step medicine prescription will promote accountability.
4. Evidence generation, ADR reporting by pharmacist
5. Regulation of diagnostic centers facilities, equipment's,
reagents and expertise.
6. Controlling permission to sale specific medicines by specific
category of retail pharmacy.
7. Inclusion of health education instead of physical education in
school level.
19/11/2018 | Title of the presentation 6
Recommendations to change
1. Manufacturing & marketing unregistered SF product
2. Lack of preclinical, clinical & development studies
3. Formulation problem whereas products quality parameters
are not matched with innovator products (RLD).
4. Weak GMP & quick production
5. Low quality API & Excipients for more profit
6. Low quality packaging
7. Improper distribution and storage
8. Discriminatory price competition and business promotion
9. Ethical marketing
19/11/2018 | Title of the presentation 7
How manufacturers are responsible?
1. Valid registration and marketing authorization of product
2. Continuous research
3. Appropriate formulation development
4. Proper GMP
5. Quality sourcing of API & Excipients
6. Good Packaging
7. Good distribution ensuring transportation and storage
8. Affordable pricing
9. Ethical marketing
19/11/2018 | Title of the presentation 8
Recommendations to change
19/11/2018 | Title of the presentation 9
How Health care professionals are
responsible?
1. Misdiagnosis
2. Deliberate investigation being influenced by diagnostic
center.
3. Lack of concentration to patients notice
4. Writing medicine name being influenced by pharmaceutical
company
5. Difficult accessibility of patients to physician
6. Lack of interest for patient counseling.
7. Lack of interest for collecting patients feedback like ADR
reporting.
8. Expecting prompt response that’s a matter of good
reputation of physician.
1. Concentration to patients notice and history.
2. Motivation of physician for suggesting proper investigation.
3. Writing medicines INN name (not trade name) by physician.
4. Use of low cost resource for better patient counseling.
5. Enhancing patients accessibility to hear their notice.
6. ADR reporting and evidence based data collection.
7. Not to promote prompt response, better promote
counselling.
19/11/2018 | Title of the presentation 10
Recommendations to change
1. Procurement of medicine currently not based on quality
evaluation rather now its 1st priority is investment profit ratio.
2. Inventory management of medicine not available.
3. Proper storage condition are not recorded in most of the retail
pharmacy.
4. Lack of established medicine disposal system.
5. Dispensing medicine without prescription of registered health
care professionals.
6. Lack of patients oriented responsibility.
7. Lack of patient counseling system.
8. Lack pharmacy practice knowledge.
19/11/2018 | Title of the presentation 11
Source: General observation in Bangladesh
How retail pharmacy are responsible?
1. Quality evaluation system should be in exist for procurement
and supply of medicine.
2. Inventory management should be followed by proper
guideline.
3. Proper storage condition should be maintained in all
pharmacy.
4. Expired and SF medicine disposal system should be well
established.
5. Not to dispense medicine without prescription of registered
health care professional.
6. Need more awareness building.
7. Establishment of community pharmacy, hospital pharmacy
and clinical pharmacy.
19/11/2018 | Title of the presentation 12
Recommendations to change
1. Health care seeking behavior e.g prompt relief expectation.
2. Lack of knowledge and practice for health and hygiene.
3. Environmental pollution.
4. Treatment discontinuation when feeling better for
negligence, financial issue or accessibility.
5. Sharing medicine discussing their symptoms each other.
6. Disposal of unused medicine in the environment.
7.
19/11/2018 | Title of the presentation 13
How public are responsible?
1. Health care seeking behavior should be changed.
2. Awareness about practice for health and hygiene.
3. Awareness & motivation to prevent environmental pollution.
4. Counseling for continuation of medicine dose.
5. Counseling not to share medicine just discussing each
other.
6. Community based drug take away policy and system should
be established.
19/11/2018 | Title of the presentation 14
Recommendations to change
1. Regulation of 115,186 pharmacy, about 858 manufacturers,
42,398 products, Medical device, Raw Material, Import,
export is very difficult to manage by existing human
resource.
2. New drug act yet not approved.
3. Pharmacovigilance system yet not well established in each
and every hospital, pharmacy and pharmaceutical industry
in collaboration with DGDA.
4. Lack of proper clinical and non-clinical evaluation of product
during registration.
19/11/2018 | Title of the presentation 15
Source: http://www.dgda.gov.bd/
How regulators are being responsible
1. Approval for manufacturing of Antibiotics in specific classes of
facilities that are maintaining proper GMP.
2. Regulation to ensure sourcing of High quality API & excipients.
3. Active pharmacovigilance countrywide.
4. Registration of antibiotics complying potency, dissolution profile
and bio-equivalence.
5. Control of post marketing variation of medicines.
6. Control of total inventory of antibiotics in pharmacy.
7. Up gradation of model pharmacy initiative.
19/11/2018 | Title of the presentation 16
Recommendations to change
1. Lack of proper health education system in school level.
2. In school there have a mandatory subject physical
education but no essential health education.
3. Lack of school health campaign.
19/11/2018 | Title of the presentation 17
How education system is responsible?
1. Physical education should be a part of health education.
2. Health education should be a mandatory subject in school level.
3. School Health campaign.
4. Community based health education program.
5. Health education in hospital and family planning center.
6. Health education in Madrasha and Mosque.
19/11/2018 | Title of the presentation 18
Recommendations to change
19/11/2018 | Title of the presentation 19
Overall outcomes
Medicine
Health Care
Life
expectancy
Life Security
Less Out of
Pocket Exp.
Decreased
MMR
Decreased
IMR
Economic
Growth
19/11/2018 20
Way forward
Taskforce formation
New policy development
Resource utilization
Development of Hospital & Pharmacy Care
Industrial regulation and research for new antibiotics
Education System focusing health and hygiene
Combined Strategic Plan
Combat AMR
Good Animal Health Care, & Food safety
Environmental sanitation & Biosafety
19/11/2018 | Title of the presentation 21
19/11/2018 | Title of the presentation 22
Who we are, what we do
Our goal is to build a better, healthier future for people all over the world. WHO staff work side by side with
governments and other partners to ensure the highest attainable level of health for all people. The primary role of
WHO is to direct and coordinate international health within the United Nations’ system.

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Potential reason and risk behind Anti-Microbial Resistance in Bangladesh

  • 1. Potential reason behind AMR and Risks in Bangladesh Md. Mehedi Hasan | HSS | EDM | Bangladesh www.searo.who.int/bangladesh MD. MEHEDI HASAN National Consultant- Essential Drugs and Medicines World Health Organization (WHO) Bangladesh 12 November’ 2018
  • 2.  Biggest threats to global health, food security, and development today.  Affect anyone, of any age, in any country.  Occurs naturally.  A growing number of infections are being untreatable as the antibiotics used to treat them become less effective.  Antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality.  Increasing health expenditure 19/11/2018 | Potential reason behind AMR and Risks in Bangladesh 2 Key facts of AMR
  • 3. 1. Irrational prescription for human and animal 2. Misdiagnosis of disease 3. Misuse of antibiotics in humans and animals by people 4. Sharing of unused antibiotics 5. Lack of counseling and awareness 6. Low quality antibiotics by potency, dissolution, stability etc. 7. Lack of proper storage of Antibiotics. 8. Low quality packaging of antibiotics. 9. Frequent use of antibiotics in animal health care 10. Unconscious disposal of unused antibiotics. 19/11/2018 3 Potential Reason behind AMR | Potential reason behind AMR and Risks in Bangladesh
  • 4. 1. Policy Maker (MOHFW, DOE, LGED, DGDA, DGHS, DLS) 2. Antibiotic Manufacturer A. Raw material manufacturer B. Finished medicine manufacturer 1. Health Care Professional (Doctor, Nurse, Pharmacist) 2. Retail pharmacy 3. Antibiotic user (General Public) 4. Regulator (DGDA) 5. Education Institute 19/11/2018 4 Who are responsible for AMR | Potential reason behind AMR and Risks in Bangladesh
  • 5. 1. Policy to control irrational prescription due to potential conflict of interest with prescription generation. 2. Policy to control unethical pharmaceutical promotion. 3. Policy to control prescription diagnostic test reagent, equipment and expertise. 4. Policy to control depot, distribution center and retail pharmacy. 5. Policy for overall health education instead of physical education in school level. 19/11/2018 5 How policy makers are responsible? | Potential reason behind AMR and Risks in Bangladesh
  • 6. 1. Prescription generation with INN name by physician. 2. Quality evidence based medicine selection among hundreds of marketed generics by graduate pharmacist. 3. Two step medicine prescription will promote accountability. 4. Evidence generation, ADR reporting by pharmacist 5. Regulation of diagnostic centers facilities, equipment's, reagents and expertise. 6. Controlling permission to sale specific medicines by specific category of retail pharmacy. 7. Inclusion of health education instead of physical education in school level. 19/11/2018 | Title of the presentation 6 Recommendations to change
  • 7. 1. Manufacturing & marketing unregistered SF product 2. Lack of preclinical, clinical & development studies 3. Formulation problem whereas products quality parameters are not matched with innovator products (RLD). 4. Weak GMP & quick production 5. Low quality API & Excipients for more profit 6. Low quality packaging 7. Improper distribution and storage 8. Discriminatory price competition and business promotion 9. Ethical marketing 19/11/2018 | Title of the presentation 7 How manufacturers are responsible?
  • 8. 1. Valid registration and marketing authorization of product 2. Continuous research 3. Appropriate formulation development 4. Proper GMP 5. Quality sourcing of API & Excipients 6. Good Packaging 7. Good distribution ensuring transportation and storage 8. Affordable pricing 9. Ethical marketing 19/11/2018 | Title of the presentation 8 Recommendations to change
  • 9. 19/11/2018 | Title of the presentation 9 How Health care professionals are responsible? 1. Misdiagnosis 2. Deliberate investigation being influenced by diagnostic center. 3. Lack of concentration to patients notice 4. Writing medicine name being influenced by pharmaceutical company 5. Difficult accessibility of patients to physician 6. Lack of interest for patient counseling. 7. Lack of interest for collecting patients feedback like ADR reporting. 8. Expecting prompt response that’s a matter of good reputation of physician.
  • 10. 1. Concentration to patients notice and history. 2. Motivation of physician for suggesting proper investigation. 3. Writing medicines INN name (not trade name) by physician. 4. Use of low cost resource for better patient counseling. 5. Enhancing patients accessibility to hear their notice. 6. ADR reporting and evidence based data collection. 7. Not to promote prompt response, better promote counselling. 19/11/2018 | Title of the presentation 10 Recommendations to change
  • 11. 1. Procurement of medicine currently not based on quality evaluation rather now its 1st priority is investment profit ratio. 2. Inventory management of medicine not available. 3. Proper storage condition are not recorded in most of the retail pharmacy. 4. Lack of established medicine disposal system. 5. Dispensing medicine without prescription of registered health care professionals. 6. Lack of patients oriented responsibility. 7. Lack of patient counseling system. 8. Lack pharmacy practice knowledge. 19/11/2018 | Title of the presentation 11 Source: General observation in Bangladesh How retail pharmacy are responsible?
  • 12. 1. Quality evaluation system should be in exist for procurement and supply of medicine. 2. Inventory management should be followed by proper guideline. 3. Proper storage condition should be maintained in all pharmacy. 4. Expired and SF medicine disposal system should be well established. 5. Not to dispense medicine without prescription of registered health care professional. 6. Need more awareness building. 7. Establishment of community pharmacy, hospital pharmacy and clinical pharmacy. 19/11/2018 | Title of the presentation 12 Recommendations to change
  • 13. 1. Health care seeking behavior e.g prompt relief expectation. 2. Lack of knowledge and practice for health and hygiene. 3. Environmental pollution. 4. Treatment discontinuation when feeling better for negligence, financial issue or accessibility. 5. Sharing medicine discussing their symptoms each other. 6. Disposal of unused medicine in the environment. 7. 19/11/2018 | Title of the presentation 13 How public are responsible?
  • 14. 1. Health care seeking behavior should be changed. 2. Awareness about practice for health and hygiene. 3. Awareness & motivation to prevent environmental pollution. 4. Counseling for continuation of medicine dose. 5. Counseling not to share medicine just discussing each other. 6. Community based drug take away policy and system should be established. 19/11/2018 | Title of the presentation 14 Recommendations to change
  • 15. 1. Regulation of 115,186 pharmacy, about 858 manufacturers, 42,398 products, Medical device, Raw Material, Import, export is very difficult to manage by existing human resource. 2. New drug act yet not approved. 3. Pharmacovigilance system yet not well established in each and every hospital, pharmacy and pharmaceutical industry in collaboration with DGDA. 4. Lack of proper clinical and non-clinical evaluation of product during registration. 19/11/2018 | Title of the presentation 15 Source: http://www.dgda.gov.bd/ How regulators are being responsible
  • 16. 1. Approval for manufacturing of Antibiotics in specific classes of facilities that are maintaining proper GMP. 2. Regulation to ensure sourcing of High quality API & excipients. 3. Active pharmacovigilance countrywide. 4. Registration of antibiotics complying potency, dissolution profile and bio-equivalence. 5. Control of post marketing variation of medicines. 6. Control of total inventory of antibiotics in pharmacy. 7. Up gradation of model pharmacy initiative. 19/11/2018 | Title of the presentation 16 Recommendations to change
  • 17. 1. Lack of proper health education system in school level. 2. In school there have a mandatory subject physical education but no essential health education. 3. Lack of school health campaign. 19/11/2018 | Title of the presentation 17 How education system is responsible?
  • 18. 1. Physical education should be a part of health education. 2. Health education should be a mandatory subject in school level. 3. School Health campaign. 4. Community based health education program. 5. Health education in hospital and family planning center. 6. Health education in Madrasha and Mosque. 19/11/2018 | Title of the presentation 18 Recommendations to change
  • 19. 19/11/2018 | Title of the presentation 19 Overall outcomes Medicine Health Care Life expectancy Life Security Less Out of Pocket Exp. Decreased MMR Decreased IMR Economic Growth
  • 20. 19/11/2018 20 Way forward Taskforce formation New policy development Resource utilization Development of Hospital & Pharmacy Care Industrial regulation and research for new antibiotics Education System focusing health and hygiene Combined Strategic Plan Combat AMR Good Animal Health Care, & Food safety Environmental sanitation & Biosafety
  • 21. 19/11/2018 | Title of the presentation 21
  • 22. 19/11/2018 | Title of the presentation 22 Who we are, what we do Our goal is to build a better, healthier future for people all over the world. WHO staff work side by side with governments and other partners to ensure the highest attainable level of health for all people. The primary role of WHO is to direct and coordinate international health within the United Nations’ system.