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Development of a microbiological potency evaluation method

DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 1
1. CHAPTER 1: INTRODUCTION
1.1. BACKGROUND OF THE STUDY
According to the World Health Organization (WHO), antimicrobial resistance has gained
global attention over time. One of the resolutions come up within the 68
th
World Health Assembly
was to persuade the member states to develop national action plans to fight antimicrobial resistance
by 2017. According to the WHO, nowadays, antibiotics become less effective, and resistance to
some severe bacterial infections is rising too high levels in all parts of the world. In other words,
new resistance mechanisms are emerging and spreading globally, threatening the ability to treat
common infectious diseases. Infection affecting people- including pneumonia, tuberculosis, blood
poisoning, and gonorrhea- and animals alike are becoming harder, and sometimes impossible,
treating as antibiotics become less effective (UN News, 2017).The national action plans are set to
outline the efforts to treat the common bacterial infections by stating the strengthening outlook of
the pathogens prioritized, initiating the research process and optimizing the use of antibiotics.
The WHO in 2014 came up with the new and relevant meanings for classification of poor-
quality antibiotics and offering clarifications to the issue of substandard medical products as the
products which do not meet the quality specifications and standards set out by the organization.
Additionally, some means have been set out to help in testing antibiotics against public criteria in
evaluating the strength, quality, identity, and the purity of the antibiotics as a regulation of the
class of antibiotics. However, not all the countries have initiated these national regulation efforts
to help curb antimicrobial resistance and currently only 67 member states of the WHO out of the
194 states have launched such national initiatives while 62 other member states are in the process
of doing so. The disparity makes it a hard task solving antimicrobial resistance given the ease and
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 2
frequency with which people now travel, antibiotic resistance is a global problem, requiring efforts
from all sectors (World Health Organization, 2014).
Research has shown that when people get exposed to subtherapeutic levels of antibiotics,
the effect is that it induces increased virulence and the development of resistant bacterial strains.
Increased virulence provides health threats as they can lead to even more deadlier infections to
people. Nonadherence to clinical medication advised is one of the significant factors influencing
to antimicrobial resistance (Holmes et al., 2016). Nonetheless, low-quality medicines can also
form barriers to patients who follow medication instructions correctly, leading to similar
subtherapeutic results, which seemingly lead to treatment failure. The use of low-quality medicine,
according to research, increases the mortality rate of patients admitted with bacterial infections.
On the other hand, it complicates the process of detecting and monitoring resistance as the
significant epidemiologic factor to poor disease results.
The failure to treat bacterial infections due to poor-quality medicine at times may be
mistakenly accredited to a particular resistant disease, including cases in which the medication
instructions are strictly followed. Such a situation is a considerable concern in low-income as well
as middle-income countries where the accessibility and use of susceptibility testing are uneven in
some cases or otherwise time-consuming and expensive (Holmes et al., 2016). From the research
of disease infections, it has been established that several instances in which drug resistance was
presumed were in fact of drug-sensitive diseases that were treated using poor-quality antibiotics.
Situations as such may lead to additional changes to other forms of aggressive treatment processes
where different types of quality-assured first-line treatment processes would have been more
successful. Also, patients who change to new regimens of treatment may still experience
challenges associated with the quality of medication (World Health Organization, 2014).
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 3
Even though data from disease-specific research show that poor-quality medicines are
significant factors in the development process of antimicrobial resistance, there is no
comprehensive data to support the level to which poor-quality prescription lead to antimicrobial
resistance. Attempting to evaluate the degree to which other vital factors, such as antimicrobial
application in animal production also experiences similar challenges. Nonetheless, the existing
evidence on the implementation of antimicrobials in animal production has led to various
stakeholders coming together to develop proactive measures founded on the principles of
precaution as inscribed in public health regulations. Such justifications should initiate actions to
solve the problem of poor-quality antibiotics in the fight against antimicrobial resistance,
principally because various certified methods help improve medicinal quality (World Health
Organization, 2014).
Therefore, to optimize the use of antimicrobials, adequate evaluation of the antimicrobial
quality should be the main area in which the effort is applied. The level to which an antimicrobial
work is entirely dependent on the quality assurance of the antimicrobial, from the manufacturer
right through the distribution process and storage of the antimicrobials and finally to the point
where the patient uses the antimicrobial. Additionally, access expansion to otherwise non-quality
assured antimicrobials in some cases accelerate the increase of antimicrobial resistance through
the exposure of larger populations to the subtherapeutic doses of antibiotics.
There is limited comprehensive data on the exact proportion of low-quality medicines, but
estimations of the WHO show that 1 of 10 medicinal products in middle-income countries, as well
as low-income countries, is of falsified or substandard quality. Additionally, antibiotics are one of
the most commonly reported medicinal products of substandard and falsified quality. Currently,
most of the national action plans developed towards antimicrobial resistance put more emphasis
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 4
on the significance of improving the availability of the antimicrobials while also optimizing their
applicability. Few of those federal action plans clearly outline comprehensive measures which are
applicable in ensuring the quality of the antimicrobials (World Health Organization, 2014).
There are several approaches which have been suggested to ensure antibiotic quality from
organizations such as the WHO and Promoting the Quality of Medicines Programme. The
approaches suggested can be incorporated into global strategies and national action plans of
reducing the antimicrobial resistance. The procedures outlined may help address the challenge of
quality assurance and represents some of the action plans that countries all over the world could
adapt to address the challenge of poor-quality medicine. A lot of work is required to come up with
a full action plan relevant in solving the problem of poor-quality medicine as part of the war against
antimicrobial resistance (World Health Organization, 2014).
The gaps in antimicrobial resistance diagnosis and study are well-recognized yet limited
efforts made to solve the surveillance and develop a capacity for quality assurance, specifically in
implementing risk-based after-marketing quality assurance surveillance and offering support on
quality control laboratories. The disparity makes it difficult to correctly verify the antibiotic quality
as the quality assurance surveillance system is unable to provide accurate and reliable data on drug
quality. Provision of safe and timely data on drug quality assurance is essential in coming up with
a comprehensive action plan which can help fight antimicrobial resistance as a public health
imperative. The quality assurance system should work together with the public health imperative
to address the quality issues as the challenges faced in drug quality may exhibit evidence for the
risk of the potential pending development of drug resistance, and the reverse is also true from the
various studies conducted.
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 5
Promoting the Quality of Medicines Programme as an agency has been working for the
past decade to ensure the quality of medicine in low-income and middle-income countries. The
agency supports various regulatory bodies in identifying any poor-quality drugs and helping the
institutions implement evidence-based enforcement actions such as recalling the medicine
products. Information from the quality assurance activities is often transmitted to Medicines
Quality Database where medicinal quality results are kept. From the database, the medicines are
commonly antimicrobial products from various locations across Africa, Latin America, and Asia.
The database, together with other health initiatives is in the process of unveiling information on
medicine quality. Such efforts require continuous investments and continued harmonization
process to continue collecting data crucial in assessing and monitoring the quality of antibiotics in
various countries (Europeans Medicines Agency, 2019).
Ensuring that the manufactured antibiotics meet the set international quality standards by
bodies such as the WHO prequalification is an important step which may put barriers for poor-
quality antimicrobial products from reaching the patients. In improving the quality of
antimicrobials, the manufactures should increasingly pay attention to the global action plans
stipulated, thereby improving the accessibility and continuous supply of quality-assured
antimicrobials. The strategy has made it possible to produce critical antibiotics such as those
essential in the treatment of widespread bacterial infections such as tuberculosis with the
production of medicines such as rifampicin, moxifloxacin, and kanamycin (World Health
Organization, 2014).
The failure to incorporate essential quality assurance measures like the antimicrobial drug
quality surveillance, in the various action plans projected towards fighting antimicrobial resistance
is a possible factor of resistance. Therefore, building around the quality assurance of medicines is
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 6
an essential step in mitigating antimicrobial resistance through methods such as strengthening
quality surveillance, improving the availability and supply chain of antibiotics as well as
optimizing the rational use of the antibiotics. Quality-assured medicines, therefore, form an
essential section of the strategies that should build part of the action plan in combating the
challenge of increased antimicrobial resistance.
1.2. STATEMENT OF THE PROBLEM
Antimicrobial resistance has increasingly become an issue of global concern due to the failure
of most countries to manufacture quality-assured drugs in the fight against bacterial infection. The
WHO came up with a resolution in the 68
th
World Health Assembly that would ensure that each
country comes up with a national action plan as an effort to fight the antimicrobial resistance faced
globally. However, only 67 member countries out of the 194 countries have come up with the
national action plans, and it is reported that 62 other states are in the process of coming up with
the national action plans. The national action plans were set to outline the efforts made by each
member country in fighting antimicrobial resistance for most of the bacterial infections through
interventions and strategies. The strategies and interventions include strengthening the quality
surveillance of some of the standard priority pathogens that are spread worldwide, improving the
research efforts made towards these pathogens and optimizing the rational use of antimicrobials
among other interventions and strategies stipulated by the WHO in the 68
th
assembly resolution
(UN News, 2017).
From data collected from various research, it has been recognized that most low-income and
middle-income countries still produce antibiotics of poor quality. Poor-quality medicine has
resulted in the increased mortality rate of patients who suffer from bacterial infections outlining
the massive problem that is experienced as a result of the poor-quality medicine produced by these
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 7
countries (Holmes et al., 2016). Poor-quality drugs increase the antimicrobial resistance among
patients with bacterial infections making it challenging to treat these specific diseases among a
broader population leading to further deaths or even the development of more harmful viruses
among the patients which are challenging to treat. From research, it has been noted that proper
treatment does not depend on the medicine instructions outlined when being administered with
antibiotics but the quality of drugs being delivered to the patients (Holmes et al., 2016).
It is, therefore, of great importance to look into the challenges faced by low-income and
middle-income countries in producing quality-assured drugs in fighting antimicrobial resistance.
The research consequently was conducted to evaluate the barriers and factors that make these
countries produce poor-quality drugs and from this critical evaluation come up with a
comprehensive method which can be used to assess the quality of medicines manufactured in these
countries. Most of these low-income and middle-income countries do not have national action
plans to ensure quality-assured medications in the fight against antimicrobial resistance which
makes it difficult for them to evaluate the quality of medicines manufactured in these countries.
The potency evaluation will also help to regulate the quality of drugs produced to ensure continued
availability and supply of quality-assured medications in the country to ensure patients only use
the correct medicine required for treatment of their bacterial infection (Dafale et al., 2016).
As the main focus, the research was conducted in Syria, which is a middle-income country,
make it a suitable state for the analysis. The country also has numerous cases of poor-quality
antibiotics applied in the treatment of bacterial infections resulting in antimicrobial resistance
among patients within the state.
Research Topic: The Development of a microbiological potency evaluation method to facilitate
the Quality of locally made antibiotics in Syria.
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 8
Research Objectives:
1. Identify the key factors leading to the manufacture of poor-quality antibiotics in Syria in
the treatment of bacterial infections like the war crisis.
2. Evaluating the impact of the poor-quality antibiotics in Syria and the extent of the effects
on the population.
3. Looking into the various methods which can be used to solve the problem of poor-quality
antibiotics in the fight against anti-microbial resistance.
4. Coming up with a comprehensive microbiological potency evaluation method to ensure
proper surveillance over the quality of antibiotics manufactured.
5. Evaluate the risks associated with this project as well as the advantages that the
pharmaceutical companies will gain.
1.3. PURPOSE OF THE STUDY
For various antibiotics, testing their pharmacological potency requires testing through the use
of microbiological assays. The antibiotic activity is measured through a comparison of the growth
inhibition of the susceptible strains, developed from the various concentrations of the sample
serving as a test sample. The results obtained are then compared to the other sample obtained from
a reference preparation. The advantage of microbiological potency method, as opposed to other
assays, is that it presents the likelihood to evaluate the activity directly on a particular
microorganism considering the availability of the active substance in the antibiotic and the ability
to assess the action of an element without necessarily acquiring information on the accurate
qualitative composition of the material (Dafale et al., 2016).
The effectiveness of antibiotics is described in terms of potency, and accurate measurement of
strength is critical in pharmacology to safe and proper use of antibiotics. Microbiological method
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 9
is the most convenient way to determine the strength of medicines. The purpose of this study is to
help managers and decision-makers implement a microbial plan to assess the bioactivity and
resistance of locally made antibiotics in Syria to present a quality and safe product to the market.
This paper will evaluate the risks associated with this project as well as the advantages that the
pharmaceutical companies will gain (Dafale et al., 2016).
Also, this paper will supplement other research projects by looking into how the war crisis in
Syria affected the pharmaceutical industry in the country. From previous research, it is believed
that the pharmaceutical industry in the country was the most crucial sector in both social and
economic development. The pharmaceutical industry covered almost 90% of the domestic needs
in the country, and some of the drugs were also exported to provide income revenues to the
country. But the political situation in the country has led to a war crisis which has destroyed major
infrastructure quite crucial for the pharmaceutical industry. The destruction of infrastructure
critical in the production of antibiotics makes it difficult to manufacture drugs of high quality in
the country. It is evident with how the quality of life has drastically reduced in the country during
the war period. The research will, therefore, supplement other research by expounding on how the
war crisis affected the pharmaceutical industry and thereby, the quality of antibiotics produced in
the nation (Kherallah et al., 2012).
The study will also provide a potency evaluation method which will go a long way in reviving
the pharmaceutical industry in the country. The challenge that came with the war crisis in Syria is
the poor-quality antibiotics produced in the country. Previously the country’s economy depended
mainly on the pharmaceutical industry with 90% of the domestic needs surviving on the sector.
But the war has resulted in the destruction of infrastructure used in the manufacture of antibiotics,
thereby significantly affecting the quality of drugs produced in the country (Kherallah et al., 2012).
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 10
The potency evaluation method to be developed will help the country to ensure high-quality
medicines are provided both for domestic consumption and export to other countries in Asia and
around the world. Quality assurance of the drugs produced will help mainly in reducing
antimicrobial resistance that is currently being experienced across the globe (Dafale et al., 2016).
It is therefore evident that the study is aimed at tackling a major health issue that is currently
affecting the whole world, which is antimicrobial resistance. At the end of the research, it is
expected that a microbiological potency evaluation method developed will work effectively in
ensuring the quality of antibiotics which will help in reducing antimicrobial resistance as a result
of bacterial infections.
1.4. THEORETICAL BASIS AND ORGANIZATION
Numerous studies have been conducted under this area of research, which corresponds to the
research being undertaken in this project. Previous research done has examined how Syria’s
pharmaceutical industry is affected by the war crisis and the political turmoil being experienced in
the country. The previous research done in this topic indicated that before the war, Syria’s domestic
needs were primarily provided for by the pharmaceutical industry. Also, the pharmaceutical
products of the country are exported to provide export revenue for the country and therefore
support the economic development of the country. The pharmaceutical products of the country are
shipped to 52 other nations, including most parts of the Asian continent (Kutaini, 2010). It,
therefore, signifies the number of individuals who depend on antibiotics from Syria for the
treatment of their bacterial infections. When the country experienced political turmoil and the war
crisis that came with it most of the infrastructure which was used in the manufacture of drugs were
compromised or destroyed making it difficult to manufacture of drugs of high quality by the
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 11
pharmaceutical industry in the country. The poor-quality drugs, therefore, affect a large population
which depends on the country’s pharmaceutical products.
This research, on the other hand, takes the problem that the globe is facing, and that is
antimicrobial resistance. According to the study, the primary cause of antimicrobial resistance is
the use of poor-quality drugs in the treatment of bacterial infections as well as other diseases. Syria
is a significant manufacturer of most of the medications used in the treatment of diseases in 52
countries in Asia and other countries around the world (Kutaini, 2010). Therefore, poor-quality
medicines produced in the country results in the global spread of antimicrobial resistance. The
research thus builds on other research evaluations that the war in Syria affected the quality of drugs
produced in the country leading to antimicrobial resistance. From this hypothesis is where the
current research forms the basis and tries to evaluate how we can improve the quality of antibiotics
manufactured in the country, thereby reducing antimicrobial resistance. The study currently,
evaluates ways in which we can improve the quality of drugs produced in the country, and that is
through the development of a microbiological potency evaluation method (Dafale et al., 2016).
Other research has also indicated that a country’s level of income also is a significant
contributor to the quality of drugs produced. From previous research, it is evident that most low-
income and middle-income countries produce drugs of low quality. The same countries experience
challenges in coming up with proper and effective national action plans in dealing with
antimicrobial resistance as a result of poor-quality drugs. It results in the drastic reduction of the
quality of life in such countries due to the treatment of patients with such kind of drugs. Syria is a
middle-income country is therefore faced with similar challenges, and that forms the reason why
the country has been hit by a significant reduction in the quality of life during the war period which
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 12
has crippled the pharmaceutical industry in the country resulting in the production of low-quality
drugs (Yadav, & Rawal, 2015).
It is, therefore, of great importance to look into the challenges faced by low-income and
middle-income countries in producing quality-assured drugs in fighting antimicrobial resistance.
The research consequently was conducted to evaluate the barriers and factors that make these
countries produce poor-quality drugs and from this critical evaluation come up with a
comprehensive method which can be used to assess the quality of medicines manufactured in these
countries. Most of these low-income and middle-income countries do not have national action
plans to ensure quality-assured medications in the fight against antimicrobial resistance which
makes it difficult for them to evaluate the quality of medicines manufactured in these countries.
The potency evaluation will also help to regulate the quality of drugs produced to ensure continued
availability and supply of quality-assured medications in the country to ensure patients only use
the correct medicine required for treatment of their bacterial infection (Dafale et al., 2016).
The research will be majorly based on the key factors that led to the production of low-quality
drugs in the country, which is precisely the political turmoil and war crisis experienced in the
country. The country has consequently failed to come up with a method of ensuring the quality of
drugs produced in the country. As a solution to the problem being experienced, the research will
go further and develop a microbiological potency evaluation method to be used in assessing drug
quality before they are let out to the market for consumption. This microbiological potency
evaluation method will help in ensuring all drugs that are used domestically within the country or
exported to other countries are of the required quality thereby guaranteeing an improved quality
of life and reduced antimicrobial resistance. The microbiological potency evaluation method will
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 13
be based on the findings of the research which includes the types of drugs produced within the
country and the other factors leading to the production of poor quality drugs (Dafale et al., 2016).
To overcome quality problems in any company, Dr. Deming explained in his book Quality,
Productivity, and Competitive Position (Deming, 1982) that the company could take action
regarding the established process that can improve the existing operation, such as adding a new
process or implementing a project that can improve the overall process and quality operation. In
this study, adding the new microbiological method at the end of the production process could
improve the quality of the antibiotics and prevent antibiotic resistance in the long term.
The Plan, Do, Check, and Action (PDCA) methodology is the framework for this research.
The study will develop a reliable bioassay antibiotic potency testing by using a standard plan, do,
check, act (PDCA) approach to build a strong foundation of quality control in Syrian
pharmaceutical companies.
The four steps of the PDCA theory briefly are:
1. Plan: Design a blueprint to follow
2. Do: Implement the designed project
3. Check: Identify the weakness points
4. Act: Improve and fix the flaw
During the implementation phase, the US. Pharmacopeia Antibiotics-Microbial Assays will be the
primary reference for bioassay antibiotic potency testing.
The implementation of the PDCA methodology for this project will be executed as follow:
Plan
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 14
1. Assemble the team to prepare the method:
Assembling a diverse quality management team is the first step to apply the new approach as it
establishes many perspectives, cooperation, and information sharing. This team is tasked with
working together to ensure the subsequent steps are appropriately developed, managed, and
executed. The Syrian Ministry of Health should develop a document describing the process for
setting up a team for quality management system implementation that can be used as a reference
to every pharmaceutical company (Deming, 1982).
2. Document and describe the method:
A full analysis (including the development of a flow diagram of a microbiological method). This
step is a collection of best available information and data about implementing the new approach
and use external experts. The US Pharmacopeia and FDA regulations provide primary resources
that can be used for guidance in documenting and describing the new process (Deming, 1982).
Do
1. Establishment of specification, standards, sampling plans, and standard operating
procedures (SOP) that must be written, approved, documented, and justified.
2. Training programs: It is recommended that an analyst (microbiologist) who is familiar with
the test participate in the analysis.
3. Preparing all the apparatuses needed for the new method such as the spectrophotometer,
receptacles, media, and diluents (Deming, 1982).
Check
1. Enforcement of standards and training requirements.
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 15
2. Internal audit, which will ensure that the project is executed as planned.
3. Corrective actions will be assigned in this stage and will be executed in the Action stage
(Deming, 1982).
Act
1. Based on the information from the previous phase, corrective actions (steps taken for
identification and mitigation and elimination of problems) can be made to eliminate causes
of non-compliances.
2. Management reviews are necessary to ensure proper implementation and operation of the
new method. These reviews include the performance evaluation of the new process as well
as the identification of opportunities for improvement (Deming, 1982).
1.5. LIMITATIONS OF THE STUDY
As this research was undertaken, a lot of challenges were faced both in the collection and
analysis of data. It is, therefore, essential to outline both the methodological limitations and the
content limitations that were experienced in the collection and analysis of the data. The barriers
were considered during the discussion to accommodate the disparities in data collection and
analysis and therefore ensure that the information presented was at the very minimum close to
accurate.
1.5.1. Methodological Limitations
There were various challenges faced in the methodology applied in the collection of data
for analysis. First, the country at the moment is in political turmoil and experiencing a prolonged
war crisis. It, therefore, makes it difficult in movement and in visiting the different manufacturing
plants that manufacture antibiotics. Consequently, this makes it difficult to collect comprehensive
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 16
first-hand information on why these manufacturers are producing poor-quality drugs used in the
treatment of bacterial infections. Therefore, for the research, only a few pharmaceutical industries
were visited to represent the other manufacturers in trying to collect a wide range of information
for analysis.
Also, culture and language affected the collection of data from the country of research. The
place has a different culture to what the researchers are accustomed to, and this made them be
viewed inaccurately by the inhabitants of the research areas. However, the researchers tried to
incorporate much of the culture as they could like in clothing and greetings to other people. The
country also has a different language to what the researchers speak, therefore making it challenging
to communicate with the respondents. For this, the researchers acquired a translator who knew
both languages. It could have affected the quality of information obtained from the research,
thereby limiting the accuracy of data collected.
1.5.2. Content Limitations
There were also content limitations faced in the collection of data and the analysis of the
data. First, medical research conducted in Arab countries are generally low, Syria included. It,
therefore, makes it an uphill task for the researchers, other healthcare institutions, clinicians and
related government agencies to have significant information on the risk factors leading to the
production of poor-quality drugs, the outcomes and the distribution of the various conditions and
diseases. Such information is crucial to understand the problem of antimicrobial resistance and its
relation to the production of poor quality drugs within the country and to other countries which
use the drugs.
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 17
Another issue is that most of the low-income and middle-income countries have researched
on antimicrobial resistance, but the number of those who have implemented or written policies to
curb the resistance is relatively low. Therefore, getting information on some of the policies input
or planned to ensure reduced antimicrobial resistance within these countries is relatively tricky.
Such is also information on measures implemented in ensuring that drugs manufactured by these
countries are quality assured. It, therefore, makes it challenging to find some basis for the research
or some ground to build the content information of the study. Nonetheless, the researchers
conducted extensive research on all information that could be found both on the internet and books
to collect as much data as possible.
1.6. DEFINITION OF TERMS
Antimicrobial resistance – This is the ability of a microorganism to resist any medication
effects that are applicable in thoroughly treating the microbe (World Health Organization,
2014).
Poor-quality drugs – These are drugs which are considered to be substandard as a result of
poor manufacture or counterfeit and falsified in a certain way (Yadav, & Rawal, 2015).
Quality Assurance – This is the conservation of a required standard of quality of a product
primarily through paying proper attention to each step in the production and delivery
process of the product (World Health Organization, 2014).
War crisis – This is the situation in which a country is in a prolonged period of war with
itself or with other nations (Kherall et al., 2012).
Pharmaceuticals – It is anything related to medicinal drugs or the preparation, application,
and sale of the medicinal products (Kutani, 2010).
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 18
Microbiological potency – It is an assay used in the evaluation of the quality of antibiotics
through the maintenance of the appropriate standards of excellence in the service or
product, more so through analysis of each stage of production and delivery (UN News,
2017).
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 19
REFERENCES
Dafale, N. A., Semwal, U. P., Rajput, R. K., & Singh, G. N. (2016). Selection of appropriate
tools to determine the potency and bioactivity of antibiotics and antibiotic
resistance. Journal of pharmaceutical analysis, 6(4), 207-213.
Deming, W. E., (1982). Quality, Productivity, and Competitive Position. Massachusetts Institute
of Technology, Center for Advanced Engineering Study.
European Medicines Agency. (2019, May 15). Antimicrobial resistance. Retrieved from
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-
threats/antimicrobial-resistance
Holmes, A. H., Moore, L. S., Sundsfjord, A., Steinbakk, M., Regmi, S., Karkey, A., ... & Piddock,
L. J., (2016). Understanding the mechanisms and drivers of antimicrobial resistance. The
Lancet, 387(10014), 176-187.
Kherallah, M., Alahfez, T., Sahloul, Z., Eddin, K. D., & Jamil, G. (2012). Health care in Syria
before and during the crisis. Avicenna journal of medicine, 2(3), 51.
Kutaini, D., (2010). The pharmaceutical industry in Syria. Journal of medicine and life, 3(3), 348.
UN News. (2017). Antibiotic resistance is ‘crisis we cannot ignore,’ UN warns, calling for
responsible use of these medicines. Retrieved July 28, 2018, from
https://news.un.org/en/story/2017/11/635832-antibiotic-resistance-crisis-we-cannot-
ignore-un-warns-calling-responsible-use.
DEVELOPMENT OF A MICROBIOLOGICAL POTENCY EVALUATION METHOD 20
World Health Organization. (2014). Antimicrobial resistance: global report on surveillance.
World Health Organization.
Yadav, S., & Rawal, G., (2015). Counterfeit drugs: problem of developing and developed
countries. Int J Pharmceut Chem Anal, 2(1), 46-50.

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