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Banned Drugs Still Available in Bangladesh after the Declaration of the

Regulatory Authority: A Cross Sectional Study Conducted in Chittagong City

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 International Journal of Public Health Research
2015; 3(3): 83-87
Published online May 10, 2015 (http://www.openscienceonline.com/journal/ijphr)

Banned Drugs Still Available in Bangladesh after the

Declaration of the Regulatory Authority: A Cross
Sectional Study Conducted in Chittagong City
Md. Jakaria, Md Ibrahim Tarek, Abul Hasanat, A. T. M. Mostafa Kamal, Mohammed Abu Sayeed,
Md. Hazrat Ali
Department of Pharmacy, International Islamic University Chittagong (IIUC), Chawkbazar, Chittagong, Bangladesh

Email address
pharmajakaria@rocketmail.com (M. Jakaria)

To cite this article

Md. Jakaria, Md Ibrahim Tarek, Abul Hasanat, A. T. M Mostafa Kamal, Mohammed Abu Sayeed, Md. Hazrat Ali. Banned Drugs Still
Available in Bangladesh after the Declaration of the Regulatory Authority: A Cross Sectional Study Conducted in Chittagong City.
International Journal of Public Health Research. Vol. 3, No. 3, 2015, pp. 83-87.

Abstract
We aimed to determine the proportion of pharmacies in Chittagong that sold the banned drugs and to increase awareness by
simple survey study. A cross sectional study of sample of 150 pharmacies was conducted in Chittagong, the city of Bangladesh,
in November 2014. The sample was taken randomly from different regions of Chittagong city. A simulated client methodology
was used. Data were analyzed using simple statistics. Minimum one drug was available in one hundred thirty six (90.66% &
95% CI= 90.66 ± 4.66) pharmacies. In fourteen pharmacies (9.33% &95% CI= 9.33 ± 4.65) there no banned drugs were
available. From the total pharmacy, one hundred and twenty six pharmacies (84% & 95% CI= 84 ± 5.87) offered
fluphenthioxol-melitracin combination tablet. Pioglitazone was offered by sixty six pharmacies (44% &95% CI= 44 ± 7.94) and
sixty two (41.33% & 95% CI= 41.33 ± 7.88) pharmacies offered rosiglitazone. Gatifloxacin as an antibiotic oral tablet was found
in seventy four pharmacies (49.33% & 95% CI= 49.33 ± 8). Thirty seven pharmacies (24.66% & 95% CI= 24.66 ± 7.08) offered
tegaserod and sibutramine were offered by thirty pharmacies (20% & 95% CI= 20 ± 6.40). In conclusion, the practice of banned
drugs was terrifyingly high among the population of Chittagong city. If it is not stops right now in near future there is utmost
possibility of ours country people to suffer for a dangerous health disaster. This study has also opened gateways for further
research in this issue.

Keywords
Survey study, pharmacies, banned drug, Chittagong city

are toxic at some dose [3]. The development of new medicines

1. Introduction (drugs) is an exercise in extrapolation from laboratory studies
in vitro and in vivo (animals), in order to predict what agent
The ancient Greeks believed drugs to be both poison and will do in humans [4] and drugs also undergo rigorous testing
medicine. In modern society, a drug is whatever is ingested to before introducing in the market. Drug efficacy as well as
treat any medical or psychological condition. According to safety profiles are tested. Most drug candidates fails to reach
clinical sense, a drug is a therapeutic agent; any substance the market, but the drug discovery and development is the
other than food, used in the prevention, diagnosis, alleviation, effective assessment and management of risk versus benefit
treatment or cure of disease in man or animals. The general and non total risk avoidance and below one third of the drugs
definition of drug, it is a substance other than food intended to tested in clinical trials reach the market place. Federal law in
affect the structure or function of a physiological system such the USA and ethical considerations require demands that the
as the human body [1]. Alternatively, a drug can be defined as study of new drugs in human should be conducted in
a chemical substance of known structure, other than a nutrient accordance with stringent guidelines [3].
or an essential dietary ingredient, when administered to a Phases of clinical development: Human experiments
living organism produces a biological effect [2] and all drugs progresses in a common sense manner that is conventionally
84 Md. Jakaria et al.: Banned Drugs Still Available in Bangladesh after the Declaration of the Regulatory Authority:
A Cross Sectional Study Conducted in Chittagong City

divided into four phases [4-5]. range of circumstances over an extended period of time. Such
Phase I studies asses the safety of a drug or device. This surveillance is much more likely to detect previously
initial phase of testing, which can takes several months to unrecognized positive or negative effects that may be
complete, usually include a small number of healthy associated with a drug. The majority of post marketing
volunteers (20 to 100), who are generally paid for surveillance concerns with adverse drug reactions (ADRs)
participating in the study. The study is designed to determine monitoring and evaluation [8].Drug safety surveillance relies
the effects of the drug or device on humans including how it is heavily on the techniques of pharmacoepidemiology, which
absorbed, metabolized, and excreted. This phase also includes voluntary reporting, prescription event monitoring,
investigates the side effects that occur as dosage levels are medical record linkage and population statistics [5].
increased. About 70% of experimental drugs pass this phase of According to the FDA, a drug is removed from the market
testing. when its risks outweigh its benefits. It is the duty of U.S. Food
Phase II studies test confirms the efficacy of a drug or and Drug Administration to approve drugs by evaluating their
devices that last from several months to two years, and safety and efficacy in respective indications but sometimes
involves up to several hundred patients. Most phase II studies FDA withdraw approved drugs due to the risk of unexpected
are randomized trials where one group of patients receives the adverse effects associated with the use of those drugs. There
experimental drug, while a second “control group” receives a were different drugs time to time banned or withdrawn by
standard treatment or placebo. Often this studies are "blinded" FDA due to dangerous risk e.g., thalidomide (due to the risk of
which means that neither the patients nor the researchers know teratogenicity), phenacetin (due to the risk of cancer and
who has received the experimental drug beside principle kidney disease), rofecoxib (because of risk of heart attack and
investigators. This allows investigators to provide the stroke), cerivastatin (due to rhabdomyolysis leads to kidney
pharmaceutical company and the FDA with comparative failure), pemoline (due to liver toxicity), propoxyphene (due
information about the relative safety and effectiveness of the to serious toxicity to the heart), phenformin (due to lactic
new drugs. About one-third of experimental drugs acidosis) etc. [9-10]. The Directorate General of Drug
successfully complete both Phase I and Phase II studies. Administration (DGDA) under the Ministry of Health &
Phase III studies involve randomized and blind testing in Family Welfare, Government of the People's Republic of
several hundred to several thousand patients. This large-scale Bangladesh, is the Drug Regulatory Authority of the country
testing, which can lasts several years, provides the and this authority entrusted with the responsibility of ensuring
pharmaceutical company and the FDA with a more thorough the quality, efficacy and safety of pharmaceutical products
understanding of about the effectiveness of the drug or device, though the implementation of relevant legislation. The DGDA
the benefits and the range of possible adverse reactions. 70% is trying its best to fulfill the requirements of the
to 90% of the drugs that enter Phase III studies successfully pharmaceutical sector of the country and thereby meeting the
complete this phase of testing. Once Phase III is complete, a needs of the people of the country by ensuring the safety,
pharmaceutical company can request FDA approval for efficacy and quality of the medicines. If any drug shows major
marketing the drug. adverse effects the DGDA bans the drugs to manufacture or
Phase IV studies, often called Post Marketing Surveillance sold in the market [11].
Trials, are conducted after a drug or device has been approved Pioglitazone and rosiglitazone are used for the treatment of
for consumer sale. Pharmaceutical companies have several diabetes acts by lowering blood sugar. Flupentixol-melitracine
objectives at this stage: (I) to compare a drug with other drugs is an antipsychotic drug used to treat schizophrenia and other
already in the market; (II) to monitor a drug's long-term central nervous system diseases like depression. Gatifloxacin
effectiveness and impact on a patient quality of life; and (III) is used as an antibiotic, to treat a variety of bacterial
to determine the cost-effectiveness of a drug therapy relative infections. Tegaserod is used to treat irritable bowel syndrome
to other traditional and new therapies. Phase IV studies can in women who have constipation as a major symptom.
result in a drug or device being taken off the market or Tegaserod relieves constipation by shortening the time stool
restrictions of use could be placed on the product depending remains in the bowel, reducing stomach pain and bloating.
on the findings in the study. Sibutramine is used for treating obesity. It regulates chemicals
The adverse effects are detected through a process of in the brain that reduce hunger or craving for food. These six
regular monitoring after the drug is released called drugs banned previously in different country from time to time
pharmacovigilance [6]. “An appreciably harmful or for their major adverse effects [12]. These drugs were
unpleasant reaction, resulting from an intervention related to available in the market of Bangladesh for rational
the use of a medicinal product” is known as adverse drug manufacturing, prescribing and dispensing up to March 2014
reaction (ADR) [7]. Pharmacovigilance is the science and but after report of Adverse Drug Reaction Advisory
activities relating to the detection, assessment, understanding Committee (ADRAC) on March 30, the final decisions on
and prevention of adverse effects or any other drug-related banning or canceling these generic drugs [12]. However, these
problems, particularly long-term or short-term side effects of regulations are not applied in the actual practice of pharmacies
medicine [6]. Post marketing drug surveillance refers to the in Chittagong, the city of Bangladesh. In our study, we aimed
monitoring of drugs once they reach the market after clinical to determine the proportion of pharmacies in Chittagong
trials. It evaluates drugs taken by individuals under a wide related to supply of these drugs by using simple survey study.
 International Journal of Public Health Research 2015; 3(3): 83-87 85

2. Study Methodology corporation area.

For this study, a simulated client methodology was used
A cross sectional study on sample of 150 pharmacies was [13]. Each pharmacy was visited once by one investigator who
conducted in Chittagong, the city of Bangladesh, in November asked the retailer as a buyer about the availability of these
2014. Chittagong district was established in 1666 including drugs with their brand name or generic name. Immediately
three hill districts. The district of Chittagong hill tracts was after leaving the pharmacy, investigator completed a
established in 1860 with the hill region of the district. Later, standardized data form that included information about the
Chittagong district was further divided into Chittagong and name and location of the pharmacy. The availability of banned
Cox's Bazar districts. The district consists of one City drug recorded in the data sheet with marking with tick sign.
Corporation, seven municipalities, 16 thanas, 14 upazilas, 197 The actors used to lay language and refrained from using any
union parishads and 1,319 villages. The sample was taken jargon.
randomly from different regions of Chittagong city

9.33%

Banned drugs available

t No banned drugs available

90.66%

Fig. 1. Banned drugs available versus no banned drugs available in total percentage of pharmacies.

Table 1. Number of pharmacies offered banned drugs.

Name of banned drug No. of pharmacies offered % of pharmacies 95% CI

Pioglitazone 66 44% 44 ± 7.94
Rosiglitazone 62 41.33% 41.33 ±7.88
Fluphenthioxol-Melitracine 126 84% 84 ± 5.87
Gatifloxacin 74 49.33% 49.33 ± 8
Tegaserod 37 24.66% 24.66 ± 7.08
Sibutramine 30 20% 20 ± 6.40

CI: Confidence Interval

The study was conducted according to the principle (section

12) of the WMA declaration of Helsinki. This survey study 3. Results
was logistically supported by the Department of Pharmacy,
International Islamic University Chittagong. The human From one hundred fifty (n= 150) pharmacies were selected
subjects involved in this study did not use any hazardous randomly from different region of the city and one hundred
agents and samples were not collected from them. As the and fifty (150) pharmacies were visited that means all selected
human subjects only participated in the interview, it was not a pharmacies (100%) was visited. Minimum one drug was
prerequisite to take any further approval from the institutional available in one hundred and thirty six pharmacies (90.66% &
ethics committee to conduct this survey based research. 95% CI= 90.66 ± 4.66). In fourteen pharmacies (9.33% &95%
Each investigator analyzed the data individually and CI= 9.33 ± 4.65) there no banned drugs were available (Fig.
submitted the report to the principle investigator. The 1). From the total pharmacy, one hundred and twenty six
principle investigator then accumulated all the data. In this pharmacies (84% & 95% CI= 84 ± 5.87) offered
regard, simple statistics were applied to the collected data fluphenthioxol-melitracin combination tablet. Pioglitazone
using Microsoft Excel 2003 and 95% confidence interval done was offered by sixty six pharmacies (44% &95% CI= 44
by online calculator, calculator.com. Results were finally ±7.94) and sixty two pharmacies (41.33% & 95% CI= 41.33 ±
expressed in percentages. 7.88) pharmacies offered rosiglitazone. Gatifloxacin as an
antibiotic oral tablet was found in seventy four pharmacies
86 Md. Jakaria et al.: Banned Drugs Still Available in Bangladesh after the Declaration of the Regulatory Authority:
A Cross Sectional Study Conducted in Chittagong City

(49.33% & 95% CI= 49.33 ± 8). Thirty seven pharmacies of awareness, to maintained business policy of pharmaceutical
(24.66% & 95% CI= 24.66 ± 7.08) offered tegaserod and company and to minimized loss of pharmaceutical company,
sibutramine were offered by thirty pharmacies (20% & 95% improper monitoring system of manufacturing and dispensing
CI= 20 ± 6.40) (Table 1). of drugs, improper utilization of established law etc.
To minimize this type of medication error, firstly physician
4. Discussion should have updated knowledge’s about drugs specially those
drugs under post surveillance study and physician can play
The objective of our study was to determine the proportion important role by prescribing alternative drugs. Secondly,
of pharmacies in Chittagong that sold these banned drugs by proper functions of retail pharmacist should be implemented
simple survey study. An adverse reaction that occurs in fewer and if any improper prescribing seen in the prescription than
than 1 in 3,000 – 5,000 patients are unlikely to be detected in retail pharmacist consults with respective physician and
Phase I–III investigational clinical trials, and may be unknown suggest him. Thirdly, pharmaceutical company should obey
at the time a drug is approved. These rare adverse reactions are the role of regulatory authority, and should be given priority of
more likely to be detected when large numbers of patients are patient safety before their benefits. Fourthly, monitoring
exposed to a drug after it has been approved and marketed. system of regulatory authority of government (especially,
Some drugs have been withdrawn from the market because of health ministry and drug administration) for manufacturing
risks to the patients [14]. The National Coordinating Council and dispensing should be implemented more actively.
for Medication Error Reporting and Prevention defines a
“medication error as any preventable event that may cause or 5. Conclusion
lead to inappropriate medication use or patient harm, while the
medication is in the control of the healthcare professional, The practice of banned drugs was terrifyingly high among
patient or consumer. Such events may be related to the population of Chittagong city. If it is not stops right now in
professional practice, healthcare products, procedures and near future there is utmost possibility of ours country people
systems, including prescribing; order communication; product to suffer for a dangerous health disaster. This study has also
labeling, packaging and nomenclature; compounding; opened gateways for further research in this issue, besides
dispensing; distribution; administration; education; showing that it is a real problem and should not be ignored.
monitoring and use” [15].
Our subjected drugs such as pioglitazone, rosiglitazone, Acknowledgement
fluphenthioxol-melitracine, gatifloxacin (except. eye drop),
tegaserod, sibutramine were not included any pharmacopoeia The authors greatly acknowledge to faculty members of
and these drugs were called INN (International Non Department of Pharmacy, International Islamic University
Proprietary Name) drugs. All these drugs were under post Chittagong (IIUC).
surveillance study. After post surveillance study due to risk of
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