Adverse Drug Reaction Reporting

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 DG

Major General Md. Mustafizur Rahman

MBBS, MPH (HM), MBA (HRM), FCGP, CCD UNITAR (POCI)
Director General, Directorate General of Drug Administration
Ministry of Health & Family Welfare
Government of the People's Republic of Bangladesh

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স্বাস্থ্য ও পরিবার কল্যাণ মন্ত্রণালয়ের স্মারক নং- ৪৫১৩৭১১৬০০০০০০৪২০১২-৬৪৬ , তারিখ- ১৩-০৫-২০১৩ এর প্রেক্ষিতে মন্ত্রিপরিষদ বিভাগের স্মারক নং- ০৪০০০০০০২৩২৩৫০০৬১৩২১, তারিখ-২৫-০৪-২০১৩ এর আলোকে ঔষধ প্রশাসন অধিদপ্তর এর নিম্নবর্ণিত কর্মকর্তাদের সমন্বয়ে একটি ইনোভেশন টিম গঠন করা হইলঃ

১।

জনাব রুহুল আমিন ,পরিচালক(চঃদাঃ),

ঔষধ প্রশাসন অধিদপ্তর,ঢাকা।

ইনোভেশন অফিসার

২।

জনাব মোঃ আইয়ুব হোসেন, সহকারী পরিচালক, ঔষধ প্রশাসন অধিদপ্তর,ঢাকা।

সদস্য

৩।

জনাব মোঃ আকতার হোসেন, সহকারী পরিচালক, ঔষধ প্রশাসন অধিদপ্তর,ঢাকা।

সদস্য

৪।

জনাব মোঃ নাইম গোলদার, সহকারী লাইসেন্সিং অফিসার,ঔষধ প্রশাসন অধিদপ্তর,ঢাকা।

সদস্য

৫।

জনাব মোঃ মুহিদ ইসলাম, ঔষধ তত্ত্বাবধায়ক, ঔষধ প্রশাসন অধিদপ্তর,ঢাকা।

সদস্য সচিব

                            কার্যপরিধিঃ

১।

ঔষধ প্রশাসন অধিদপ্তরের সেবা দান প্রক্রিয়া এবং কাজের আভ্যন্তরীন প্রক্রিয়ায় গুণগত পরিবর্তন আনয়ন।

২।

এই সংক্রান্ত কার্যক্রমের বাৎসরিক কর্মপরিকল্পনা প্রণয়ন এবং বৎসরের শুরুতে মাসিক সমন্বয় সভায় অনুমোদন গ্রহণ ও বাস্তবায়ন ।

৩।

প্রতি মাসে টিমের সভা অনুষ্ঠান, কর্মপরিকল্পনার বাস্তবায়ন অগ্রগতি পর্যালোচনা এবং মাসিক সমন্বয় সভায় উপস্থাপন।

৪।

মন্ত্রনালয় / বিভাগ পর্যায়ে গঠিত অন্যান্য ইনোভেশন টিমের সহিত যোগাযোগ ও সমন্বয় সাধন।

৫।

প্রতি বৎসর ৩১ শে জানুয়ারীর মধ্যে পূর্ববর্তী বৎসরের একটি পুর্নাঙ্গ বাৎসরিক প্রতিবেদন প্রণয়ন, উহা মন্ত্রিপরিষদ বিভাগে প্রেরণ এবং স্বীয় ওয়েব সাইটে প্রকাশ ।

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Work Plan

                         

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Ministry of Health and Family Welfare

World Health Organization

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A case report in pharmacovigilance can be defined as : A notification relating to a patient with an adverse medical event (or laboratory test abnormality) suspected to be induced by a medicine.

A case report should (as a minimum to aim at) contain information on the following elements:

1. The patient: age, sex and brief medical history

2. Adverse event: description (nature, localization, severity, characteristics), results of investigations and lets, start date, course and outcome.

3. Suspected drug(s) : name (brand or ingredient name + manufacturer^ dose, route, start/stop date, indication for use.

4. All other drugs used (including self medication): names, doses, routes, start/stop dates.

5. Risk factors (e.g. impaired renal faction, previous exposure to suspected drug, previous allergies.

6. Name and address of reporter (to be considered confidential and to be used only for date verification, completion and case follow-up)


What to Report

The reporter should bear in mind that he will often be reporting only suspicions in his own mind that a drugs has caused particular adverse event. He should not wait until he feels certain that a causal link can be considered proven or disproven. In any case of doubt it is better to report than not to report.
He should report :

(a) Apparent ADRs previously unknown to the reporters
(b) Serious ADRs
(c) All suspected ADRs to new drugs
(d) Cases of suspected dependence

Who Should Report

Government/ Private Hospitals/ Clinics : Every hospitals and clinics must decide for itself how the reporting system should be operated and by whom. The arrangements will depend on the hospital's/clinics own organisation and traditions.

Generally the physicians themselves act as reporters, completing the reporting form, keeping a record and sending them to the ADRM Cell, Directorate of Drug Administration, 105-106, Motijheel Commercial Area, Dhaka-1000, Bangladesh. The hospital pharmacist may also act as a reporter, completing the forms in consultation with the reporting physician.

Collaboration with WHO

After evaluation of ADRs report by the Adverse Drug Reactions Advisory Committee (ADRAC), the ADRM Cell of Directorate of Drugs Administration, 105-106, Motijheel Commercial Area, Dhaka-1000, Bangladesh may provide the essential ADRs data to WHO collaborating center for International Drug Monitoring & Exchange of Drug Information.

NB : A Adverse Drug Reactions Reporting Form is available in this website, please download ADR Reporting Form.

 

 

 

 

 

 

 

 

 

 

 

The Directorate General of Drug Administration mission is to ensure that the common people have easy access to useful, effective, safe and good quality essential and other drugs at affordable price. 

 

 

WHO Uppsala Report, April-2015

Historical background

Before 1971 -An organization under the Central Govt of Pakistan under the Controller of drugs. After the war of liberation- An attached department of the Ministry of Health and Population Control. Since 1976 -A separate Directorate directly under the Ministry of Health and Family Welfare, 17 January 2010 upgraded as the Directorate General of Drug Administration.


Introduction

Directorate General of Drug Administration (DGDA) is the organization entrusted with the responsibility of ensuring the quality, efficacy and safety of pharmaceutical products though the implementation of relevant legislation. The organization is trying its best to fulfill the requirements of the pharmaceutical sector of the country and thereby meeting the needs of the people of the country by ensuring the safety, efficacy and quality of the medicines.

Responsibility

The responsibilities of this organization are as follows :

a. To ensure the quality, safety, efficacy and usefulness of all kinds of drugs and medicines including Homeopathic, Unani, Ayurvedic and Herbal drugs which are produced , imported and marketed in the country and also exported to overseas.

b. To make essential drugs available and affordable to the common people of the country.

Drug Testing Laboratory

Testing of drugs are required for evaluating pre-registration and post-marketed drugs and medicines quality. At present, there are two Govt. Drug Testing Laboratories in the country, one unit in Chittagong and another in Dhaka.

Legislation

All the activities of DGDA are governed & guided by

*  The Drug Act 1940

*  The Drug Rules 1945 and their amendments

*  The Drug Rules 1946 and their amendments

*  The Drug (Control) Ordinance 1982 and its amendments

*  The Drug (Control) Ordinance Amendment Act 2006

*  National Drug Policy 2016

The Ordinance provides for the following legislative powers and responsibilities with respect to drugs and medicines:

1. Formation of a Committee of experts, called the DCC or Drug Control Committee, for consideration of registration of medicines and/or their cancellation.

          2. Prohibition of manufacture and sale of drugs without the supervision of pharmacists.

          3.  Restriction on import of certain pharmaceuticals and finished drugs.

          4.  Review of under-licensing agreements.

          5.  Fixation of prices of essential drugs.

          6.  Control of advertisements and claims in respect of drugs.

         7.  Implementation of GMP in the manufacturing units as recommended by WHO.

          8.  Formation of Drug Courts for trying offenses related to drugs.

         9.  Formation of a National Drug Advisory Council for advising the Govt. on matters related to essential drugs.

         10. Formation of an Appellate Authority.

         11. Recognition of Traditional and Homeopathic medicines as drugs.

         12. Imposition of penalty for :

                - manufacture and sale of adulterated, spurious and restricted drugs.
                - manufacture and sale of substandard drugs.
                - unauthorized import of drugs and raw materials.
                - sale of medicines at prices higher than the Maximum Retail Price (MRP) by the Licensing Authority.
                - theft of Drugs from Govt. hospitals and stores.
                - illegal advertisement of drugs and claims about their qualities and uses.


Major Function of DGDA

1.  Evaluation of the proposals of new projects of all systems of medicines.

2. Issue  and renewal of drug manufacturing licenses.

3. Issue and renewal of retail and whole sale drug licenses.

4. Registration and renewal of drug products.

5. Fixation of price and certification of price for drug products.

6. Inspection of pharmaceutical establishments

7.   Approval of block list for the import of raw- and packaging materials.

8. Approval of indent for import of finished drugs.

9. Surveillance and pharmacovigillance activity

10.  Prosecution of cases in the drug courts   and other courts

11. Issue of export licenses, FSC (Free Sales Certificate), GMP (Good Manufacturing Practices) Certificate & CPP ( Certificate for Pharmaceutical Products.)

 

In 1962, in the wake of the thalidomide disaster, World Health Assembly requested WHO to establish an international system of monitoring adverse reactions to drugs using information derived from national centres. Before an effective international system could become operative, a common reporting form had to be developed, agreed guidelines for entering information had to be formulated, common terminologies and classifications had to be prepared and compatible systems for transmitting, storing, retrieving and disseminating data had to be created. Upon the successful completion of these tasks the operational activities subserving the international data base were relocated 1978 to a WHO collaborating centre situated in Upsala, Sweden.

 
ADRM in Bangladesh


In regard to safety and efficacy of drugs particularly those concern ADR's in Bangladesh left unanswered mainly due to lack of a systematic mechanism of monitoring.

Under the guidance of WHO, a cell has been established in Directorate of Drug Administration in 1996. Initially the cell circulated posters, bearing awareness slogans of drug use throughout the country, organized awareness meeting among the chemists of different area and also published awareness instructions in the daily newspapers and broadcasted these awareness slogans in Radio Bangladesh. The cell is trying to introduce a systematic mechanism for ADR monitoring program in Bangladesh for collection, analysis & compilation of ADRs which will be spontaneously reported by the medical & pharmaceutical professional from all health services outlets of the country.

The Ministry of Health & Family Welfare formed 10 (Ten) Members ADR Advisory Committee (ADRAC) on 6 July 1997 to evaluate, analyze & make recommendations for solving problems of medicinal hazards due to ADRs.

From the year 2000, Directorate of Drug Administration organized ADR monitoring workshops/ meetings in five Medical Colleges & Hospitals of the country and distributed printed ADR reporting forms for spontaneous report.


Side Effect


A side effect is 'any unintended effect of a pharmaceutical product occurring at doses normally used in man, which is related to the pharmaclological properties of the drug'. Essential elements in this definition are the pharmacological nature of the effect, that the phenomenon is unitended and that there is no overt overdose.

Adverse Reaction

An adverse reaction is 'a response to a medicine which is noxious and unintended and which occurs at doses normally used in man,. In this description it is of importance that it concerns the response of a patient, in which individual factors may play an important role, and that the phenomenon is noxious (an unexpected therapeutic response, for example, may be a side effect but not an adverse reaction.

 

Serious adverse events can be defined as those that:


a. are life-theratening or fatal
b. cause or prolong hospital admission
c. cause persistent incapacity or disability; or
d. concern misuse or dependence.

Type A effects ('drug actions') are those which are due to (exaggerated) pharmacological effects. Type A effects are tend to be fairly common, dose related (i.e. more frequent or severe with higher doses) and may often be avoided by using doses which are appropriate to the individual patient. Such effects can usually be reproduced and studied experimentally and are often already identified before marketing.

Type B effects (patient reactions) characteristically occur in only a minority of patients and display little or no dose relationship. They are generally rare and unpredictable and may be serous and are notoriously difficult to study. Type B effects are either immunological or non-immunological and occur only in patients, wich often unknown-predisposing conditions. Immunological reactions may range from rashes, anaphylaxix, vasculitis, inflammatory organ injury, to highly specific autoimmune syndromes. Aslo non-immunological Type B effects occur in a minority of predisposed intolerant patients, e.g. because of an inborn error of metabolism or acquired deficiency in a certain enzyme, resulting in an abnormal metabolic pathway or accumulation of a toxic metabolite. Examples are chloramphenicol aplastic anaemia and isoniazid hepatitis.

Type C effects refer to situation where the use of a drug, often for unknown reasons, increases the frequency of a spontaneous disease. Type C effects may be both serious and common (and include malignant tumours) and may have pronounced effects on public health. Type C effects may be coincidental and often concern long term effects there is often no suggestive time relationship and the connection may be very difficult to prove.

 

 

 

 

 

 

 

The Directorate General of Drug Administration (DGDA) under the Ministry of Health & Family Welfare, Government of the People's Republic of Bangladesh, is the Drug Regulatory Authority of the country. This DGDA supervises and implements all prevailing Drug Regulations in the country and regulates all activities related to import, procurement of raw and packing materials, production and import of finished drugs, export, sales, pricing, etc. of all kinds of medicines including those of Ayurvedic, Unani, Herbal and Homoeopathic systems.drugs and medicines. At present, there are 55 district offices under the DGDA in the country. All the officers of the DGDA function as "Drug Inspector"  in pursuant to the Drug Laws and assist the Licensing Authority to  discharging his responsibilities properly. Besides, a number of Committees, such as Drug Control Committee (DCC), Standing Committee for imports of raw materials and finished drugs, Pricing Committee and a number of other relevant Committees, which comprise of experts of different fields, are there to advice  Licensing Authority and recommend him about the matters related to drugs and medicines.

 

 

 

 1.      Who is the Licensing Authority of Drugs?

 Ans: Director General Of Drug Administration.

 

2.      Under Which Ministry Directorate General of Drug Administration belongs to?

Ans: Ministry Of Health and Family Welfare.

 

3.      How many system of medicine available in Bangladesh?

Ans: Allopathic, Unani, Homeopathic, Biochemic, Ayurvedic and Herbal. {source}

4.      What is the legal basis of control of drugs in Bangladesh?

Ans: The Drug Acts 1940 and its amendment. The Drug (Control) Ordinance 1982 and its amendment.

 

5.      How many manufacturing unit of drugs in the country?

Ans:  Allopathic-258

         Unani-268

         Homeopathic-79

         Ayurvedic –201

         Herbal-17

 

6.     How many drug shop (pharmacy) in the country?

Ans: 1,01,917 (One lac one thousand nine hundred and seventeen).

 

7.      What is the market size of Drugs in the country?

Ans: 10000 croretaka(approx.).

 

8.      How many generics of Allopathic medicine available in the country?

Ans: 1268 (One thousand two hundred sixty eight)

 

9.      How many brands of allopathic medicine available in the country?

Ans: 23,568 (Twenty three thousand five hundred and sixty eight)

 

10.  What are the different fees for different purpose?

Ans: Click  “Information Center=>Forms=>Different Fee” button and then check the desired ones.

 

11.  What are the necessary documents/papers required for different activities of DGDA?

Ans: Click  “Information Center=>Forms=>Required Document for Different Activities” button.

 

12.  What are the prescribed forms for application of different activities?

Ans: Click “Information Center=>Forms=>Application Forms” button.

 

13.  In how many countries drugs are being exported from Bangladesh?

Ans: 87 countries.

 

14.  How many valid sources for importing raw material of Drugs?

Ans: 2550. For details please click  “Information Center=>List of Foreign Drugs”  button.

 

15.  How many FSC(Free Sales Certificate)  required for importation of Pharmaceutical Finished Product?

Ans: a) For Human Products –FSC  from country of Origin and one FSC out of any of the following countries.   (UK, USA, GERMANY, AUSTRALIA, FRANCE, SWITZERTLAND, JAPAN)

        b) For Veterinary Products- FSC from country of Origin and one FSC out of any of the 24 following countries.

        c) For Medical Devices—FSC from country of origin.

 

16. Where to submit complain related to drugs?

Ans: In Dhaka – DGDA Head Office

        In District- Office of the super intendent of Drugs.

 

17.  How much time needed to get retail Drug License and Manufacturing License of Drugs?

Ans:  2-3 months needed to get the Retail Drug License and 3-4 months needed to get a Manufacturing License of Drugs.

 

18.  Is it needed to take prior approval to import any Drug?

Ans:  Yes. Prior approval needed from DGDA to import any Drugs.

 

19. Does the government Control the price of the manufactured drugs?

Ans: Government controls the price of 117 generic drug in specified dosage form. All imported medicines and all APIs produced in the country.

 

 

 

 

The Directorate General of Drug Administration under the Ministry of Health & Family Welfare, Government of the People's Republic of Bangladesh is the Drug Regulatory Authority of the country. This Directorate supervises and implements all prevailing Drug Regulations in the country and regulates all activities related to import, procurement of raw and packing materials, production and import of finished drugs, export, sale, pricing, etc. of all kinds of medicine including those of Ayurvedic, Unani, Herbal and Homoeopathic systems. At present, there are 271 Allopathic, 205 Ayurvedic, 268 Unani, 32 Herbal and 79 Homeopathic drug manufacturing companies in the country. The Directorate General of Drug Administration monitors and regulates all the activities of these 855 companies. The chief of the Directorate, designated as the Director General, is also empowered by the Govt. to act as the Licensing Authority (LA) of drugs for the purpose of issuing licenses to manufacture, store, sell, import and export drugs and medicines. At present, there are 55 district offices of the Directorate in the country. All officers of the Directorate function as "Drug Inspector" pursuant to the Drug Laws and assist the Licensing Authority for properly discharging his responsibilities. Besides, a number of Committees, such as Drug Control Committee (DCC), Standing Committee for procurement and import of raw materials and finished drugs, Pricing Committee and a number of other relevant Committees, which comprise of experts, are there to advise the Licensing Authority and to recommend to him matters related to drugs and medicines.

 

 

 

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