performed about 200 medical board subsidized inpatient care, with an av- How the field of Urology evolved
already and over 500 challenging erage discount of 15 percent. This is in terms of diagnosis approach
Uro-Oncological cases. We are also accomplished through philanthropy in Bangladesh from when you
providing Continued Medical Edu- and a cross-subsidy model, in which started in BSMMU30 years ago?
cation (CME) for GP, Students and higher-income patients pay more for
Urologist on all the cancers affecting nonclinical amenities, such as pri- Urology has been an evolving spe-
GU Tract through physical and virtual vate recovery rooms. Since the total cialty since the time of Hippocrates.
platform where national and inter- charges are still far below the cost The Department of Urology was de-
national faculties were involved. We of comparable services at other pri- veloped first in Bangladesh in 1965
have done Two international congress vate hospitals, In UTFB Urology health and was headed by Professor Idris
on Urooncology and third may hap- is still an attractive option for such Laskar. Successfully he was able to
pens during the end of this year. consumers. This health system’s busi- develop a meaningful department
ness model is sustainable because of during the then time.
Do you have any program to its ability to attract so many patients
Cater to the need of larger who can pay full price. I joined the Department of Urolo-
unprivileged population since gy at IPGM&R now BSMMU in 1988 as
the treatment is expensive? Mission and vision of UTFB Assistant Professor. Professor Wahab
Service with Gratitude, Compassion, was working with Associate Professor
UTFB currently dealing more with Uro- Care & Respect to Individuals through SAM Golam Kibria a few days later
logical Oncology. Cancer is considered transparent and Cost Effective meas- Professor AKM Anwarul Islam Joined
to be a very dreaded disease. It was ure, irrespective of caste, creed, reli- the department as 4th faculty at the
once considered a life-threatening one gion and financial status. then IPGM&R.
and the mortality rate of the disease l To emerge as a premier Institute in
used to be very high. But nowadays It was a tough time for me and An-
with the medical advancements and Bangladesh: Diagnosis, Treatment & warul Islam to cope with the demand
the various methods invented for ear- Cure of Cancer at affordable cost with of advanced urology as traditional
ly detection and the knowledge about best possible infrastructure along surgery was unable to solve the com-
preventive steps for the disease it is with compassionate and trained mon and advanced and complex is-
no more considered a life-threatening Medical and Paramedical staff. sues in Urology. We were desperately
or dreadful disease. The treatment for l To be a pain free hospital. Reach in need of Advanced knowledge and
the disease is also largely available out to terminal patients with best skills to deal with the complex Uro-
and hence getting rid of the disease supportive care (Palliative Care) logical issues.
has also become possible. The cancer though IPD, OPD and Home Care.
treatment cost in India depends upon l To introduce Academics by pro- The evaluation tools for the urol-
the type of cancer he/she would be moting Post graduate Super spe- ogy patients were extremely inad-
suffering from and needs treatment. cialty fellowship courses, & PhD equate. Treatment facilities was also
program. limited. We had to fight fiercely for
The cost associated with new tech- l To be involved in active Research to equipment for diagnosis and treat-
nologies such as robot-assisted sur- find out cause of Cancer, its preven- ment particularly endoscopic tools
gery, advanced imaging techniques, tion, better molecular diagnostics for lower tract intervention for ex-
sophisticated radiation treatment and customized treatment for each ample urethral surgery, treating the
options, and the introduction of new patient. Obstructive BPH patients and Re-
therapeutic drugs have all driven up l To carry out Cancer Awareness pro- moving the bladder Neoplasm.
the cost of cancer care. The cost to grams in rural & urban areas for
deliver high-quality cancer care is primary and secondary prevention We developed our Bangladesh
rising as a result of inflation, increas- l Fund Raising Now we are in a rent- Association of Urological Surgeon
ing regulatory burden, and increasing ed accommodation in a very prime (BAUS Bangladesh) in 1988 and called
overhead costs—not the least of which and expensive area of Dhaka City. and International Congress in the
is the need for additional personnel to This is a big obstacle to cope with. same year. We had the first Interna-
meet payers’ administrative demands. l Cost Reduction without cutting the tional Congress 1988. Following that
An accumulating body of data sug- Quality: To reduce the cost we need we received international attention
gests that patients are deferring treat- to have our own hospital and we could understand the sphere
ment because of high out-of-pocket l To achieve Collaboration with Na- of global standard of Urology.
costs. We need to find the best ways to tional and International.
manage costs effectively while main- l Emerge as a premier Institute of MS Urology course was introduced
taining the same, if not better, quality Eastern India in the Diagnosis, in Dhaka Medical College and BSMMU
of life among our patients. Treatment & Cure of Cancer at af- in 1995. Eventually the MS course
fordable cost with best possible was introduced in Chittagong, Sir
We need to find the best ways to infrastructure along with compas- Sallimullah Medical College and Na-
manage costs effectively while main- sionate and trained Medical and tional Kidney Disease and Urology.
taining the same, if not better, qual- Paramedical staff. Today we are blessed with 342 Urolo-
ity of life among our patients. Most of gists and are serving the nation.
the Nonprofit institutions worldwide
THE PHARMA WORLD 51
Will bacterial infection send us
back to the medical dark age?
n By Catherine Taylor This promising new drug, with the uninspir-
ing name QPX9003, has placed the pair on the
Tony Velkov and Jian Li share the kind of cusp of achieving something that hasn’t been
geeky science story that would work per- done for decades.
fectly as a Hollywood script.
On quiet weekends at the Monash Univer- No new antibiotics in this class — polymyx-
sity science labs 20 years ago, the pair dis- ins, which target hard-to-kill “gram-negative”
covered they were the only ones crazy — or bacteria — have been approved since the 1950s.
obsessed — enough to be working on their
projects while everyone else was at home en- For anyone researching bacteria and anti-
joying a few days off. biotics, getting a new drug to a clinical trial is
the holy grail. But it’s been a lonely, gruelling
Then, when Velkov and Li realised they process for Velkov and Li, who have at times
shared not only a work ethic but a passion for stumped up their own cash to keep the re-
researching bacteria, their personal and pro- search going.
fessional friendship was sealed.
Without new antibiotics, the world is on
Over the past 12 years, the two scientists track to re-enter the medical dark ages by
have been developing a new antibiotic that 2050, when a simple cut could kill 10 million
recently began phase 1 clinical trials in the US. people a year.
Their intravenous drug targets deadly “su- So why are they so hard to find?
perbugs” that are difficult to treat but can run
rampant in hospital settings, causing pneu- A hidden crisis
monia, blood infections, urinary tract infec- For most of us, antibiotics don’t feel like a
tions, peritonitis and meningitis. big deal. At the slightest sign of a cough or a
rash many GPs will dash off a prescription for
52 THE PHARMA WORLD
antibiotics and we’re all “popping them ceutical companies don’t have time to make IN DEPTH
like Tic Tacs”, Velkov says. a profit. Of the antibiotics that do make it to
market, most are lucky to have a 10-year life
While our medical and pharmaceuti- span before bacteria become resistant. And
cal resources have been (importantly) ab- when it costs up to $1 billion to develop a mar-
sorbed in solving the COVID-19 pandemic, ketable drug, a decade isn’t enough time for
the problem of antibiotic resistance is con- pharmaceutical companies to get their money
tinuing to gain pace. back and deliver a profit. Tweaking the drugs
to give them longevity isn›t much help be-
A medical miracle cause when global patent laws run out, typi-
Just 100 years ago, as many as one in three cally after about 25 years, the generic manu-
deaths was caused by bacterial infections facturers move in.
developing from injuries that would barely
raise an eyebrow these days. Instead, big pharma is investing in drugs
for conditions like rheumatoid arthritis, mela-
Back then, if bacteria entered a cut or in- noma and blood clots — which made up three
fection took hold after surgery, the wounds of the top five biggest-selling drugs of 2021.
were doused in bromide — hugely painful Pfizer’s COVID vaccine came in at number one.
and deadly to healthy cells too — or treat- Moderna at number three.
ed with bloodletting and leeches.
Solutions to the superbug
Then, in September 1928, British scien- Four avenues are being explored to combat
tist Alexander Fleming returned from his the rise of the superbug.
summer holiday to find one of the petri
dishes of Staphylococcus bacteria in his One is to continue to push the message
lab had a big blob of mould growing in the that existing antibiotics must be used spar-
middle of it. Yet the area around the mould ingly and carefully to minimise the potential
was free of bacteria and Fleming wanted to for bacteria to become immune.
know why.
Another is reviving antibiotics that were
The answer led to the development of previously passed over because something
the first antibiotic – penicillin – and by better came along. Returning to these discov-
the mid-1940s it had become widely avail- eries saves research and development money,
able. Medical care was transformed. making them a more attractive investment.
Has the post-antibiotic era already arrived? Scientists are also searching for ways to
Those golden staph outbreaks we hear of in- support or boost the effectiveness of existing
vading hospitals provide a glimpse of what a antibiotics by using other drugs and thera-
post-antibiotic world could look like. Or worse pies, known as “potentiators”.
still, a return to the bubonic plague pandemic
that devastated Europe, Asia and North Africa Then there is the phage therapies, a branch
in the 1300s. of medical science that harnesses viruses to
attack and kill bacteria.
There are plenty of medical experts who
believe the post-antibiotic era is already here Finally, there is immune modulation known
and COVID has supercharged the need to ad- as “inflabiotics”, which uses similar strategies
dress the problem. Without effective antibiot- to the immune therapies being used success-
ics, the healthcare we take for granted – from fully in cancer treatment.
giving birth and knee replacements to heart
bypass operations and surgery for cancer – Is time running out?
would carry the risk, once again, of exposing Cooper calculates that fewer than 1,400 re-
the patient to a life-threatening infection. A searchers — experts in bacteria and antibi-
professor of Molecular Bioscience at the Uni- otics — remain working around the world. Of
versity of Queensland terms it as the slow those, he estimates most are in their 50s and
pandemic. 60s and due to retire in the next decade.
So where are the new antibiotics coming from? “At some stage, not only will there be no
The speed with which bacteria challenge and money for research but all those experts will
overcome new antibiotics isn’t just a scientific leave the field,” he says. “Ninety years of knowl-
problem. It is also an economic one: pharma- edge about how to discover and develop an-
tibiotics, these miracle drugs that have saved
more lives than any other drug, will be gone.”
Courtesy: ABC News
THE PHARMA WORLD 53
“NIKDU is the only dedicated govt INTERVIEW
institution providing research &
services for kidney diseases & urology”
Prof. Dr. Mizanur Rahman Theoretically development of BPH can be prevented. But
Director & Professor that will hamper the physiological & sexual activities of male.
National Institute of Kidney
Diseases & Urology (NIKDU), Dhaka Haematuria is often the symptom of underlying problems.
What are the common causes and how to prevent it?
As an eminent urologist of our
country, could you please, tell Yes, haematuria is a very common problem in our day to day
us in brief about the types practice. It can be microscopic or gross; painful or painless.
of genito-urinary disorders Most common causes of haematuria are:
prevalent in Bangladesh?
a. Urinary tract infection, b. Renal stone diseases, c. Renal
Bangladesh is very populous cell carcinoma, d. Transitional cell carcinoma, e. Carcino-
country. So genitourinary prob- ma prostate, f. Genito-urinary TB.
lems are also very common
here. Surprisingly urological Haematuria can’t be prevented completely. But some precau-
problems are prevented in all tion may reduce its incidence. Like maintenance of personal
age groups. But some of them hygiene adequate hydration, avoidance of salted & fast food,
are common. like, stone diseas- avoidance of cigarette smoking, precaution during Fertilizer
es, urinary tract infection, BEP, distribution & cultivation.
cancers, different types of con-
genital anomalies and sexual As the Director of NIKDU, please tell us in brief about
disorder are plenty here. the institution? What are the services provided?
What causes benign prostatic NIKDU is the only dedicated government institution providing
hyperplasia (BPH)? Who education, research & services for the kidney diseases & urol-
are at Risk for BPH? Can ogy. At present NIKDU is providing a wide range of services like
BPH be prevented? that as any developed Nephro-urological centres of the world.
Renal Transplantation is resumed hare again. Different types
Benign prostatic hyperplasia of dialysis are given here. Only one area we lack in is Robotic
is a very common problem of Surgery. That will also be established in the future, Inshallah.
the ageing male in all over the NIKDU conducts many community based research works for
world. The exact cause is still early detection and prevention of kidney diseases.
unknown, but there are differ-
ent hypothesis for its genesis What are the challenges in healthcare for people with
like, hormonal hypothesis, ne- kidney diseases in Bangladesh? What is the role of
oplastic hypothesis. Basically NIKDU in prevention, early detection and treatment
this is multifactorial. Male pop- of urological and kidney diseases in our country?
ulation after the age of 40 are at
risk for developing BPH. There are many challenges in Bangladesh for the management
kidney disease patients, like lack of awareness, poverty,
superstition, very limited facility, high cost of treatment etc.
NIKDU is basically a national referral centre for the kidney
patients. Besides the treatment, it is campaigning through
different medias to raise the awareness among the people
about the kidney & urological diseases. We have programmes
for early detection of diseases such as examinations, different
infections and also we provide health educations to prevent
renal disease.
What does the future hold for the institution in terms
of research and technological advancement?
In near future, we also have a plan to cater to the needs of un-
derprivileged patients. We have different plans like developing
national guidelines for the kidney & urological patients, manage-
ment of robotic surgery & cadaveric transplantation.
THE PHARMA WORLD 55
“We believe, it is the trust and confidence of
our valued customers that led to the success”
Nazmul Hossain Since its inception, we have cal doctors. We believe in continuing
Deputy Managing Director witnessed an amazing growth of medical education and support par-
UniMed UniHealth Pharmaceuticals Ltd. UniMed UniHealth Pharmaceuticals ticipation of the medical profession-
Ltd. What is the secret behind it? als in local and international scientific
In 2018, the pharma- and medical congresses.
ceutical market size of Thank you very much! UniMed Uni-
Bangladesh was about Health group started its journey in As an accomplished pharmaceutical
$2.42 billion, which 1997 in Bangladesh health arena with professional, how do you evaluate
increased to $3 billion an objective to bring products and the changes in trends in the
in 2019. According to a services which were not available pharmaceutical industry during
finding by Research and at that time. We have introduced in- your long 30 years of experience?
Markets, the pharma- ternational companies like Rhone
ceutical market size will Poulenc (Bangladesh), Abbott (USA), The pharmaceutical industry in Bang-
reach more than $6 bil- Grunenthal (Germany), Terumo (Ja- ladesh is moving forward with great
lion by the year 2025 pan) and Ortho Clinical Diagnostics, potential as 98% of the country’s total
USA (Johnson & Johnson Company) demand for medicine is being met by
with their pharmaceutical products, domestic institutions. In addition to
diagnostic products and medical de- meeting the domestic demand, the
vices. While starting this venture, we companies also export medicines to
have considered to create our own fa- several countries of the world. In the
cilities to manufacture international fiscal year of 2019- 20, Bangladesh’s
standard pharmaceutical products pharmaceutical export revenue was
back in 2001. $136 million. Bangladesh has set a
target to export $180 million worth of
The pharmaceutical industry is one pharmaceuticals in fiscal 2021-22. Ex-
of the most technologically advanced porters have already achieved 71% of
sectors currently in existence in Bang- the target in the first six months.
ladesh. It has grown in the last two dec-
ades at a considerable rate. The skills The pharmaceutical industry in
and knowledge of the professionals Bangladesh began in the 1950s in the
and innovative ideas of the people in- hands of some MNCs and local firms.
volved in this industry are the key fac- After independence in 1971, Bangla-
tors for these developments. desh, as a least developed country, got
patent exemption in the pharmaceuti-
The success story of UniMed Uni- cal industry under the British Patents
Health Pharmaceuticals Ltd. is not a and Designs Act, 1911. As a result, the
very pleasant one. It had to travel a production of generic medicine in the
long way to achieve the present pres- country began to increase. However,
tigious position in domestic market. the growth of the pharmaceutical in-
dustry began in the 1980s. In 1981,
We believe, it is the trust and con- there were 166 licensed pharmaceuti-
fidence of our valued customers that cal factories in Bangladesh. However,
led to the success. The trust has been the country’s pharmaceutical produc-
achieved definitely because of the tion was then dominated by 8 multi-
quality and the performance of the national companies such as Fisons,
products. We depend on the pre- Ciba- Geigy, ICI, Glaxo, Pfizer, Squibb,
scription and tried to earn the con- Hoechst and they supplied 75% of the
fidence of the prescribers through country’s medicine.
quality of the products and quality
prescriptions with various scientific In March 1982, then government
informations and clinical trials. That formed an expert committee to de-
is why our marketing department is velop a drug policy. The committee
supported by qualified profession- formulated policies for both the for-
als including pharmacists and medi-
56 THE PHARMA WORLD
mulations sector and the API sector. However, agnostic products and medical devices. When FACE TO FACE
the government only allowed the issuance of the question comes regarding our core values,
Drugs (Control) Ordinance for the formulations firstly there is the trust and confidence of our
sector, and two more new rules were enacted in customers on our products and services. Be-
June. One was to ban the manufacture, import sides, patient-centric focus, continually striving
and sale of unnecessary and harmful drugs, to evolve and improve, ethical operations, indi-
and the other was to ban the products of MNCs vidual and corporate social responsibility and
which did not have their own manufacturing operational autonomy are the core values of
plants in the country. This gave MNCs a chance UniMed UniHealth Pharmaceuticals Ltd.
to reorganize their operations, but a number
of organizations, such as Squibb had to shut What Makes UniMed UniHealth different
down their operations in Bangladesh. In 1995, from other pharma companies?
Bangladesh signed the TRIPS agreement with
the World Trade Organization. Bangladesh, as From the very beginning of UniMed UniHealth
one of the least developed countries, received Pharmaceuticals Ltd., focusing on providing
the benefit of manufacturing and marketing and maintaining high quality international
medicines without patents. As a result, Bang- standard medicines from well reputed inter-
ladesh can produce medicines at lower costs national sources of API makes the difference.
at the consumer level, which was very impor- We are very grateful and happy for the trust
tant for an underdeveloped health sector like and confidence our products have earned. This
Bangladesh. is due to continued commitment relating to
sourcing of good quality materials by maintain-
With a market value of about $3 billion, it ing integrity and consistence in supply. Where
currently accounts for about 1.83% of Bangla- possible, DMF and COS grade ingredients have
desh’s GDP that contributes to the country’s been selected and obtained. Our brands have
pharmaceutical industry. been successful because of the quality and
confidence of the prescribers as well as for the
According to a report by the Directorate clinical performance of the products. Besides,
General of Drug Administration (DGDA), there we believe in continuing medical education
are currently 257 licensed pharmaceutical fac- and support participation of the medical pro-
tories in Bangladesh. From which, 150 facto- fessionals in local and international scientific
ries are continuing to operate as usual, meet- congresses.
ing about 98% of the total demand of the
country. Although, declared as a thrust sector,
lack of clinical trial laboratory is
Over the past five years, the pharmaceutical standing on the way of BE Study, which
industry in Bangladesh has been growing at a in turn, hampering exports. How do
CAGR of 15.6% every year. In 2018, the pharma- you want to address this issue?
ceutical market size of Bangladesh was about
$2.42 billion, which increased to $3 billion in I have a limited scope in addressing this issue as
2019. According to a finding by Research and we are not very active in export market till today.
Markets, the pharmaceutical market size will BE (Bioequivalence) studies are important to
reach more than $6 billion by the year 2025. At ensure that our products are equivalent to the
present, the pharmaceutical industry in Bang- originator brand which is required in a number
ladesh is trying to capture about 10% of the of regulated markets for exporting. BE studies
world market. Six organizations of the country required for export markets are already done by
have already been able to get approval from the relevant companies from Clinical Research
the top regulatory bodies like World Health Or- Organizations (CROs) of countries like India, Ma-
ganization (WHO), WTO, and WIPO. laysia, Europe & USA. Currently in Bangladesh,
several clinical trial laboratories or CROs are
As a company, what are the core already being developed. Availability of CROs in
values of UniMed UniHealth? Bangladesh is likely to reduce the overall cost
burden as the BE studies are very expensive
Currently we have footprints in different thera- when done in abroad. BE studies are important
peutic areas like Urology, Gastroenterology, for oral dosage form but not for injectables and
Cardiology, Endocrinology, Dermatology, Neu- ophthalmic products. As exporting countries are
rology, Respiratory Medicines, Gynecology, getting BE studies through their foreign CROs, it
Hepatology, Nephrology, Hematology, Psychia- is not hampering our exports.
try, ENT, Orthopedics, Dentistry and Oncology
with our pharmaceutical products as well as di-
THE PHARMA WORLD 57
Another burning issue is Adverse What about the global footprint duced through good quality APIs. For
Drug Reaction (ADR) monitoring. of UniMed UniHealth? producing an international standard
How your company plans to product, the need for a development
create awareness among all At this moment, we do not have much department with proper machinery and
the stakeholders about ADR footprint in global market. Till now we manpower is mandatory and accord-
to make it successful? have more focus on developing local ingly we have developed our own R&D
market. However, we have exported department in the factory.
Thank you very much for raising a some quantity of medicines to Canada
very important topic. Pharmacovigi- and Guatemala. But we have a busi- How do you evaluate the
lance is a very important area where ness development department which opportunities and challenges of
marketed products are monitored is actively working. We have already Bangladesh pharma sectorafter it’s
for their clinical effects, how they submitted registration documents to graduation from LDC? Where do you
are benefiting the patients and any Afghanistan, Sri Lanka & Yemen and see the industry in next 10 years?
adverse drug reaction (ADR) reported some are processing in African mar-
or not. ADRs are harmful effects of a ket. Since most of our products are We believe, this graduation will not
medicine and sometimes inappro- produced with expensive APIs, we are be a major threat to Bangladesh.
priate use and dose may lead to its facing challenges on the pricing point. Because, the supply of the existing
development. Monitoring ADR is very However, a number of our formula- pharmaceutical products will be con-
important for developing country tions have already been accepted by tinuing but access to absolutely new
like Bangladesh as new drugs are be- international companies and we are chemical entities will be challenging.
ing introduced frequently and these trying to negotiate. TRIPS waiver, once it is withdrawn, ex-
need close monitoring. As a top listed actly at that time and forward to that,
company in Bangladesh, we are fol- R&D is very important to any any new chemical entities cannot be
lowing the directives of the Directo- pharmaceutical company. How made easily available. Since it will not
rate General of Drug Administration much it matters to you? be easily available, so the only alter-
(DGDA) related to Pharmacovigilance native will be to go to the originator
monitoring and reporting. We regu- R&D is a very crucial department for any and ask for those products. If the
larly train our sales and marketing pharmaceutical company. Formulation product is life-saving, we have to im-
colleagues to educate them about development is very important as we port that product, no matter, whether
the importance of reporting ADR. are operating in a branded generic mar- the price is high or low. That is the
Our organization have a team which ket. We are allowed to produce products only impact we believe will happen.
is regularly following up the issue. which are already marketed in the world
Besides, the retail sector can play a especially in USA and Europe and the Majority of the products which we
very important role in providing ADR research related to the molecules are al- use today and are likely to use in the
feedback as most patients buy their ready done by them and some of them next 10 years in Bangladesh are al-
medicines from them. Hospitals and are already included in Pharmacopeias. ready in the market. Only we can im-
clinics are also very important to re- We believe a properly formulated prod- prove a little bit on side-effects pro-
port any adverse reaction using pa- uct should be developed and supplied files or formulation development with
tient records and report to regulatory to the market which need to be backed slight changes in molecular structures.
authority and respective company. up by certain protocols and studies that In the long term, we need to develop
If there is no reaction, a nil report proves the product is equivalent to the policies and strategies to have access
should be submitted. international brand despite being pro- to newer generics and also improve
access to medicines for all.
HELLO Answer I Nephrology
DOCTOR
Please send us your Success
Stories, Case Studies etc.
for publication in
E-mail: [email protected]
Telephone: 88-02-58155677
58 THE PHARMA WORLD
Quantitatively assessing the health risk of antibiotic AMR
resistance genes will help manage AMR
A metagenomic analysis involving 4,573 samples from six types of habitats detected
2,561 antibiotic resistance genes (ARGs) that collectively conferred resistance to 24
classes of antibiotics. The health risk for each ARG, defined as the risk of clinical
treatment complications, was evaluated using a framework integrating human ac-
cessibility, mobility, pathogenicity, and clinical availability. The findings revealed
that 23.78% of the ARGs studied posed a health risk.
WHO endorsed a Isolated strains from wild
catalog of mutations honey could lead to novel
to assist prediction antibiotic discovery
of drug resistance
Bacillus strains isolated from wild honey were
With 500,000 more deaths from evaluated for potential antimicrobial effective-
tuberculosis (TB) in 2020 than ness against human and plant bacterial and
in 2019, the diagnosis and ap- fungal pathogens. The isolated strain, Khuz-2,
propriate treatment of patients has suitable antimicrobial and antifungal po-
with drug-resistant TB is an ur- tential for further pharmaceutical research.
gent global health need. Using Isolation and identification of beneficial bacte-
a candidate gene approach to ria from natural sources could advance future
identify mutations associated pharmaceutical and industrial innovation.
with resistance or consistent with
susceptibility for antituberculosis Training in specimen collection and management
drugs, researchers built a WHO- is critical for AMR surveillance
endorsed catalog of mutations to
serve as a global standard for in- A quasi-experimental study was conducted to determine the feasibility
terpreting molecular information and benefits of the Global Antimicrobial Resistance Surveillance System
for drug resistance prediction. (GLASS) as part of antimicrobial stewardship strategies in hospitals in
The availability of the catalog Thailand. Data on the bacterial isolates and their antibiotic susceptibil-
should facilitate the implementa- ity during 2019 and between January and April 2020 were retrieved from
tion of molecular diagnostics by participating hospitals. Hospital-acquired infection (HAI)-related bacteria
national TB programs. were observed in 59% of isolates, while community-acquired infection
(CAI)-related bacteria were observed in 41%. Antibiotic resistance in CAIs
WHO handbook was high and may have been related to the misclassification of colonized
for national action bacteria. Researchers concluded the study results might not be valid be-
plans (NAP) on AMR cause of inadequate data collection and specimen contamination.
provides guidance
for the human For most countries, it is challenging to achieve NAP implementation that
health sector is evidence-based and demonstrates sustained action. The handbook pro-
vides a practical, stepwise approach to NAP on AMR implementation within
the human health sector and a process and collation of tools to prioritize,
cost, implement, monitor, and evaluate NAP activities. The process begins
with establishing multisectoral and sectoral coordination and governance
mechanisms, prioritization of activities, and development of costed and
budgeted operational plans. Finally, the handbook provides guidance for
resource mobilization, implementation, and monitoring and evaluating.
THE PHARMA WORLD 59
PHARMACOVIGILANCE 10 Critical steps to improve
patient safety worldwide
New 10-point plan lenges of global pharmacovigilance are as
urged to improve important and urgent as ever.
detection, analysis,
and reporting of harms “The harms caused by medicines and
from medicines and medical devices are badly letting patients
devices to improve down,” said Carl Heneghan, professor of
patient safety evidence-based medicine and director
of the University of Oxford’s Centre for
Serious global challenges exist in rec- Evidence-Based Medicine (CEBM). “Patient
ognising and minimising harms from safety should be a priority for all health-
medicines and devices. That is the care systems, for all practitioners and at
message of a diverse, multi-stakeholder the forefront of policy, but all too often, it
group calling for urgent improvements in isn’t.”
the detection, analysis, and reporting of
harms in the interests of patient safety. Within this context, a multi-disciplinary
group has released a public statement
The work of pharmacovigilance is driven of their common concerns along with 10
by an ideal of patient safety that can never recommendations for improving patient
be reached but must always be pursued. safety worldwide. The theme of the 4Es (Ex-
For all the patient safety advances made ploring, Enhancing and Empowering Safer
in the past five decades by the WHO Pro- Medicines) Forum meeting was “Improving
gramme for International Drug Monitoring the detection, analysis and reporting of
and other stakeholders, the ongoing chal- harms in medicines” and, over three in-
tense days, health professionals, research-
ers, academics, journalists, patient advo-
cates, and consumers worked to identify
today’s key problems and point to practical
solutions.
The forum was structured to explore
three distinct areas of modern patient
safety – pre-marketing approvals, post-
licensing surveillance, and pharmacovigi-
Imroving 01 03
patient
safety Raise public and pro- Enforce existing regulations,
fessional awareness of revise ineffective ones, and im-
recommendations the harms from medi- plement effective regulations in
cines and devices. those areas lacking appropriate
regulatory infrastructure.
02
04
Shift the culture within
regulatory and health Transfer from industry to
care management healthcare systems the respon-
systems from one sibility for providing information
of secrecy to one of and support to healthcare pro-
transparency. viders on the use of medicines
and devices.
60 THE PHARMA WORLD
lance communication and dissemi- addressing major deficiencies in cur- entire system, from research, to regu-
nation. For each area, participants rent medicines safety systems and latory and marketing authorisation
collaborated to develop a range of promoting higher levels of patient processes, to post-licensing usage, to
perspectives on how to ensure safe- safety and awareness. the way we communicate safety infor-
ty from the harms of medicines and mation to the public (see infographic
devices. The statement – Improving “There are multiple systemic is- for details).
the detection, analysis, and reporting sues that contribute to harms, and all
of harms in medicines and devices – stakeholders – including industry, reg- Furthermore, the statement con-
represents valuable collaboration ulators, policymakers, academics, and tends that “patient safety requires
between the disciplines of evidence- healthcare professionals – need to constant vigilance of safety systems,
based medicine and pharmacovigi- always be challenging and improving structures, organisations, and pro-
lance. It recommends action from their existing practices,” said Rebecca cesses,” and calls for “open, inclusive,
multiple stakeholders – including in- Chandler, medical doctor at UMC. and collaborative efforts to identify
dustry, regulators, policymakers and challenges and develop practical, im-
healthcare professionals – aimed at To this end, the statement lays out plementable solutions that improve
a set of 10 recommendations to im- patient safety worldwide”.
prove global patient safety across the
05 07 09
Encourage and enable Recognise case reports, Recognise the importance of
prescription and use of including those written patients and carers, as well as
medicines and devices that by patients, as a valid and healthcare professionals, in studying
are appropriate and tailored important form of evidence all aspects of therapy.
to the needs of individual of harms.
patients. 10
08
06 Establish and continuously develop
Improve baseline and effective communication with pa-
Facilitate access to all rel- continuing eduction of all tients and other relevant stakehold-
evant data. stakeholders, including ers about the potential benifits and
healthcare profession- harms of interventions to improve
als, policymakers, and the the basis for shared decision making
public. about treatments.
Source: UMC
THE PHARMA WORLD 61
“The most important reason INTERVIEW
behind patients going abroad for
transplantation is the donor crisis”
Prof. Dr. Md Kamrul Islam As an eminent urologist and transplant
Managing Director surgeon of our country, could you please,
Centre for Kidney Diseases and tell us in brief about the types of urological
Urology Hospital, Dhaka conditions prevalent in Bangladesh?
We always look at the Urology means diseases of kidney and genitourinary
cost of treatment & tract, requiring surgery mostly. The commonest urologic
want to keep it as low problems prevail in the country is prostatic problems
as possible. So that it with obstruction in urine flow. Next common is stone
can be affordable to diseases i.e. stone in kidney, ureter, bladder or ure-
middle-class people. thra. Cancer in kidney, ureter, bladder & prostate are
We could not provide not uncommon. As we are doing renal transplantation
corporate standard more, so renal failure patients also constitute a good
services as it add to the number in our OPD patients. Commonest surgery done
cost of treatment. on our inpatients is stone surgery, which is now a days
almost always done with endoscopic or laparoscopic
way with or without LASER. Next commonest surgery is
prostatic surgery i.e. TURP with conventional or bipo-
lar machines. Cancer surgery like radical nephrectomy,
nephroureterectomy, Cystectomy with urinary diversion
and Radical prostatectomy are done quite commonly.
Surgery for congenital anomalies in children are also
done regularly.
Why is a kidney transplant considered
better than dialysis?
Renal failure patient has to take dialysis at least 2-3 ses-
sions per week. Each session requires 4 hours on ma-
chine at hospital, which is really painful, time-consum-
ing and costly also. Each month, dialysis patients have
to spend at least 30-40 thousand taka. But in transplant
patient, once transplant is over he has to take some
regular medicine only which cost around 7-10 thousand
per month. Dialysis patients has to follow many re-
strictions in food, water and cannot travel easily but in
transplant patient can take plenty of water, have many
choices in food and can travel anywhere easily. Trans-
plant patients can work like a healthy man, can have
every social engagements including marriage and hav-
ing baby. So quality of life in transplant patients are far
better than dialysis patients.
Kidney transplantation often becomes a
necessity at the end-stage renal disease.
What are the post-transplant complications
and outcome of kidney transplant?
The commonest complication after transplantation is
rejection and infection. About 20% of patients show re-
jection episodes within the first 3 months of operation.
Of them more than 80% responded well with medica-
THE PHARMA WORLD 63
tion and few required plasmapher- What is your message to the provide corporate standard services
esis. Transplant patients remain common people to avoid renal as it add to the cost of treatment.
immune suppressed after the op- complications and keeping their
eration. So chest infection and diar- kidneys healthy, as we know We give much importance to re-
rheal diseases are quite common in prevention is better than cure? search & innovation. We continu-
these groups of patients. Systemic ously carry out different research
infection with different viruses par- The common causes of renal failure projects in this hospital. We invent
ticularly CMV and BK virus is com- in our country are diabetes, hyper- a solution in this hospital for pres-
mon. Tests for the detection of those tension, glomerulonephritis and ervation of kidney outside body. It
viruses are costly. Surgical complica- some diseases of kidney and urinary is very cheap & effective. We use it
tions like wound infection (<0.5%), tract. Healthy lifestyles for avoiding in every transplant. An article was
Bleeding (1-2%), Thrombosis (2- 3%), Diabetes Mellitus, and hypertension published on this fluid in an interna-
Lymphatic leakage (1%), and Ureteric is to be followed i.e. regular physical tional journal.
obstruction (<0.5% can occur imme- exercise, taking low salt and sugar,
diately after operation but these are avoiding obesity, taking fruits and We also collaborate with other
uncommon. vegetables, adequate clear water hospitals of the country to start
intake, maintaining standard body transplantation services in those
The outcome of transplant is weight and careful about taking any places. Our team already performed
measured by graft survival rate at 1 medicine, particularly pain killers. several transplantation surgeries at
year, 3 years, 5 years and 10 years A yearly checkup also helps in the Combined Military Hospital (CMH),
etc. 1-year graft survival in our series early detection of many diseases. National Institute of Kidney Diseases
of 1103 patients is around 94-96%. As Yearly or biannual checking of blood & Urology (NIKDU) & Dhaka Medical
we do only live-related donor trans- pressure, blood sugar, urine routine College & Hospital (DMCH). We are
plants, rejection episodes in our test, USG, and plain x-ray of the KUB working hard to start cadaver trans-
series are not very aggressive and region is enough to detect renal dis- plant programs in Bangladesh.
controlled with medications. In our eases.
series 3 years, 5-year, and 10-year Cost of kidney transplantation
graft survival rates are 80%, 70%, Would you please tell our in Bangladesh is almost 10 times
and 50% respectively. Long-term re- readers about Centre for Kidney lower than overseas hospitals. Why
sults are not satisfactory because of Diseases and Urology Hospital? do you think patients are still going
non-compliance to medications. abroad spending huge amount
It is a tertiary care hospital for kid- of money. What can be done for
Our patients are poor and quite ney & urological patients in Bang- the transplant procedure to get
often they fail to take medications ladesh, which started its journey more recognition in our country?
properly. So a good number of pa- in 2014. It is a 100 bedded hospital
tient loses graft early. If they com- which provides specialized urologi- The most important reason behind
ply with medications properly and cal & nephrological services with patients going abroad for transplan-
follow a healthy lifestyle to avoid outpatients & inpatients facilities & tation is the donor crisis.
infection, their grafted kidney may 24/7 emergency services.
remain alive for long periods. Quite a good number of renal
It is equipped with modern ma- failure patients of our country are
What rules must a patient chinery and served by a handful of going outside for transplantation.
follow after their kidney highly specialized group of doctors. The most important reason behind
transplant surgery? We want to give best outcome to our patients going abroad for trans-
patients, so we use best machiner- plantation is the donor crisis. Many
The most important thing in a trans- ies like LASER, Laparoscopes, CT of these patients do not have any
planted patient which can keep their scan, Color Doppler, Urodynamics, blood-related donors. In our country,
kidney alive for long period is com- CRRT, Plasmapheresis SLED, LC-MS only blood-related close relatives
pliance to medication. They are tak- MS for drug level, LUMINEX for HLA, can donate organs for transplan-
ing steroids, tacrolimus, and MMF. DSA & molecular labs for viral detec- tation. So they go to neighbouring
These three medications are to be tion etc. We did the highest number countries for transplantation, where
taken very punctually at the exact of kidney transplants in the country they got some relaxation for being
time and in exact dose prescribed (till date 1100 transplants) was done foreign nationals. The next common
by the doctor. I think this is the most with highest success rates. We did reason is affluency. In our country, a
important rule to be followed by more than 11,000 PCNL operations at good number of patients are quiet
every transplant patient. The next this hospital. This is our volume of affluent and they took international
important thing is the prevention work. treatment even for simple ailments
of chest infection and diarrheal dis- Ignorance and lack of confidence in
eases. So they should be careful in We always look at the cost of our treatment are also responsible
wearing masks, avoiding crowded treatment & want to keep it as low as for travelling abroad.
places, taking fresh food and clean possible. So that it can be affordable
water. to middle-class people. We could not
THE PHARMA WORLD 65
“Organizing Infrastructure, Financial INTERVIEW
Support and Development of
Qualified & Dedicated Manpower
are the Major Challenges”
Prof. Dr. Sarwar Iqbal As an eminent nephrologist of our country, could
Professor & Head you please, tell us in brief about the types of
Dept. of Nephrology kidney disorders prevalent in Bangladesh?
BIRDEM General Hospital & Ibrahim
Medical College There are two types of kidney disease prevailing in our coun-
try, acute and chronic. Acute kidney injury (AKI) is potentially
Donor issues are a reversible disease and improves completely with treat-
one of the barriers ment. Common causes of AKI in our country are low blood
that could have pressure from diarrhea, vomiting, bleeding or burn, acute
been overcome by glomerulonephritis, acute tubular necrosis, acute interstitial
cadaveric kidney nephritis, rhabdomyolysis, hepatorenal failure and urinary
transplantation, which tract obstruction by stone, prostate and stricture. Chronic
is again yet to be kidney disease (CKD) is not reversible. It is the most devastat-
initiated. ing disease, progressive by nature and ultimately turns into
end stage renal disease (ESRD). The most common cause of
CKD is diabetes mellitus, hypertension and glomerulone-
phritis. Obstructive diseases, cystic diseases, infection of the
kidneys, analgesics and misuse of herbal medication are not
uncommon. The incidence of CKD due to diabetes mellitus is
increasing gradually in our country. It is because of the fact
that the treatment of DM has achieved remarkable improve-
ment in the last decades and as a result people are surviving
more years to face these complications. In a different screen-
ing program in the country 16 - 20 % of general population
found to have some sort of kidney diseases. Yearly increase
is about 10%.
Early chronic kidney disease has no signs or
symptoms. But, are there any non-specific
symptoms that patients can be aware of?
Chronic kidney disease is a slowly developing disease and
does not usually show any symptom at the early stages.
Suspected patient after investigation are found to have the
disease. Common non-specific symptoms of CKD are nau-
sea, vomiting, loss of appetite, fatigue, weakness, vague ill
health, decreased mental alertness, swelling of the feet,
itching, high blood pressure and shortness of breath are
common. Patients of diabetes mellitus should have their
kidneys checked at the time of diagnosis and then yearly
thereafter. Similar is true for the patients with hypertension.
Other people should consult a physician if any of the above
symptoms develop. Mass screening program may be carried
out to detect the silent disease.
THE PHARMA WORLD 67
What are the dialysis-related can contribute to better survival on di- and periodic health check-up after
factors that may influence alysis. For example, patients with coro- the age of 40 are the important steps
recovery of kidney function nary artery disease should undergo to protect the kidneys. It takes only
in Acute Kidney Injury? evaluation by coronary angiogram and 300.00 taka to detect 3 major dis-
subsequent angioplasty or bypass sur- eases i.e. diabetes mellitus, hyper-
Incidence of AKI is approximately 3 to gery whatever is indicated. Poor vas- tension and kidney disease if a mass-
7% in hospitalized patients but in in- cular access for hemodialysis is also screening program is arranged.
tensive care units (ICU) it varies from a problem to continue hemodialysis
20 – 50 %, and even higher in sepsis in these diabetic patients. Frequent What are the challenges in
patients. Renal replacement therapy hypoglycemia is a major complication healthcare for people with kidney
(RRT) should be initiated earlier in during hemodialysis. Reasons that are diseases in Bangladesh? Where
AKI, unlike in CKD where we can delay. associated with an increased risk of does Bangladesh stand as far as
Conventional intermittent hemodialy- hypoglycaemia in these patients in- treatment of kidney disorders
sis (IHD), slow low efficiency dialysis clude decreased gluconeogenesis by is concerned, compared to the
(SLED), continuous renal replacement the damaged kidneys, decreased insu- advanced countries with regards
therapy (CRRT), online hemodiafiltra- lin clearance, malnutrition and glucose to expertise and technology?
tion (OL-HDF), acute peritoneal di- loss through the dialyzer during hae-
alysis (APD), continuous peritoneal modialysis. The USA and most of the Other than some rich countries
dialysis (CPD) using flexible catheter European countries use glucose con- throughout the world there is defi-
(Tenckhoff catheter) are the main taining dialysis fluid. But in our country ciency of standard treatment of renal
mode or RRT in ICU. Intensive he- glucose containing fluid is not available diseases due to economic drawback.
modialysis in AKI patients is associ- because addition of glucose and extra Some diagnostic tests, equipment
ated with decreased urine output causation for sterilization to prevent and advanced treatment facilities
and delayed renal recovery. Chances bacterial and fungal contamination of are still lacking in our country as
of AKI are much higher in critically the fluid will increase the manufactur- compared to advanced countries.
ill than other hospitalized patients. ing cost. Infection, withdrawal from For ESRD patients, hemodialysis is
In this group of critically ill patients, dialysis, cardiac and sudden death are the main mode of renal replacement
dialysis is usually required for a pro- the major causes of death in diabetic therapy not only in Bangladesh but
longed period. Moreover those who patients on dialysis. Patients with poor also throughout the world. Hemodi-
survive after dialysis are at greater cardiac functions fare better on con- alysis is available in many parts of
risk of permanent loss of renal func- tinuous ambulatory peritoneal dialysis our country. CAPD has gained popu-
tion. Since hemodialysis is associ- (CAPD). Elderly diabetic subjects with larity by this time and is being carried
ated with delayed renal recovery, the poor general conditions and pediatric out successfully in some centers. But
overall renal prognosis and long-term patients are also the best candidates being the best mode of renal replace-
survival is better in peritoneal dialy- for peritoneal dialysis. ment therapy, kidney transplantation
sis patients. Continuous peritoneal is still based in Dhaka only and very
dialysis (CPD) using flexible catheter What is your message to the few cases are done per year. Donor
(Tenckhoff catheter) is a good option issues are one of the barriers that
for these patients because there is no common people to avoid renal could have been overcome by cadav-
chance of hypotension, it can be used eric kidney transplantation, which is
for prolonged period and if there is complications and protect again yet to be initiated. Most of our
permanent loss of renal function they patients on maintenance hemodi-
may continue it as CAPD for the rest their kidneys, as we know alysis are suffering from inadequate
of their lives. dialysis and malnutrition due to lack
prevention is better than cure? of quality dialysis. More than 90% of
How does diabetes affect the end stage renal failure patient
recovery and prognosis of Kidney diseases are common and in our country cannot afford dialysis
dialysis in ESRD patients? harmful, it complicates other dis- because of the financial constraints.
eases and the treatment is very ex- Present government’s target is to
In comparison to non-diabetic cases, pensive. The disease is preventable, provide 10 hemodialysis machines
diabetic patients usually have other so general people should be made per district and 50 for every medical
comorbidities including micro and aware about this alarming disease. college, which is a very appreciable
macro vascular complications by the It is a universal truth that preven- step indeed. Infrastructure, financial
time they develop ESRD. So morbidity tion is better than cure so healthy support and development of quali-
and mortality is much higher in dia- life style, increased physical activity, fied and dedicated manpower are the
betic patients on dialysis. Careful con- less sugar and salt intake, cessation challenges for the establishment of
trol of diabetes and timely intervention of smoking and alcohol intake, con- standard healthcare for our kidney
and treatment of other comorbidities trol of diabetes mellitus and hyper- patients.
tension, healthy food intake, control
of overweight and obesity, avoidance
of analgesics and herbal medications
THE PHARMA WORLD 69
Kidney Transplant safe when organ donor has COVID
Even before the pandemic, the demand the second year of the pandemic. At the
for donor kidneys far exceeded supply. time of transplantation, about two-thirds
That shortfall only worsened when hospi- of the recipients were on dialysis. About
tals started refusing to use kidneys from two-thirds had also been vaccinated
COVID-positive donors. However, new re- against COVID-19 with a full two-dose
search now suggests that kidneys from regimen. On the flip side, all 34 donor pa-
deceased COVID-19 patients have almost tients had been diagnosed with COVID-19
zero risk of viral transmission to the re- at least once during the 11 weeks preced-
cipient: In the new study, out of 55 pa- ing their death. The result: Following sur-
tients who received such a kidney, none gery, none of the donor recipients tested
developed COVID-19 after transplant. positive for COVID-19. And 14 weeks post-
All of the patients enrolled in the study surgery, all the transplanted kidneys
underwent a kidney transplant during were found to be functioning well.
Experimental Are antibiotics the cause, not Men’s Urinary
pill may fight solution, of recurrent UTIs? issues tied to
antibiotic- shorter lives
resistant UTIs Urinary tract infections (UTIs) are common and of-
ten easily managed, yet some women are plagued Urinary incontinence can
Urinary tract infections are by one infection after another. A new study offers plague men as they age,
common and usually simple early evidence of a potential reason: The antibiot- but a new study suggests
to treat. But for people who ics used to treat UTIs might set the stage for repeat it may be more than just a
become sick enough to land infections by depleting the gut microbiome of ben- bothersome condition and
in the hospital with one, an eficial bacteria. Researchers found, women with might actually be a har-
experimental antibiotic may recurrent UTIs had a gut microbiome that looked binger of early death. The
soon offer a new treatment different from other women’s. They had much less study team analyzed lower
option -- taken by mouth diversity in their good bacteria, and fewer microbes urinary tract symptoms in
instead of delivered by IV. In that produce butyrate – a fatty acid that helps con- more than 3,000 men. In this
a clinical trial, researchers trol inflammation. Meanwhile, women in the com- study, men who had mod-
found that the pill, called parison group were just as likely to show UTI-caus- erate to severe bladder-
tebipenem HBr, a carbap- ing E. coli in their guts, and those bugs sometimes emptying symptoms (such
enem, worked as well as traveled to their bladders, but were UTI-free. as hesitancy, weak stream
a standard IV antibiotic in and straining) had a 20% in-
treating patients hospital- creased risk of death during
ized with “complicated” the study period. Those who
UTIs. That included people had what are considered
infected with bacteria that “storage” symptoms, such as
resist many other oral anti- frequent daytime urination,
biotics. The drug is not yet incontinence and nocturia,
available, but developer had a 40% increased risk of
Spero Therapeutics an- death during the study. Even
nounced that the USFDA for those in the study with
had granted its new drug mild symptoms, if they had
application priority review. daytime frequency, death
The company said that, if risk was increased by 30%.
approved, the oral antibi- If they had nocturia, death
otic could potentially allow risk was increased by 50%.
some patients to recover at Needing to urinate at night
home, or at least leave the or more than every three
hospital sooner. hours in the daytime could
be “patient-important,” es-
pecially if persistent, the re-
searchers said.
70 THE PHARMA WORLD
Obesity raises a man’s odds for fatal Prostate Cancer
A man’s risk of dying from pros- prostate cancer rose along with
tate cancer increases 7% for every increases in all of these meas-
4-inch increase in belly fat, new ures, and every five-point increase
research suggests. For the study, in BMI resulted in a 10% increase
the researchers reviewed data in the risk of dying from prostate
on 2.5 million men who didn’t cancer, the study showed. What’s
have prostate cancer at the start more, a 5% rise in total body fat
of the studies. Weight was as- percentage raised the risk of dying
sessed via body mass index (BMI, from prostate cancer by 3%, and
an estimate of fat based on weight each 0.05 increase in waist-to-hip
and height), waist circumference, ratio upped the risk of dying from
waist-to-hip ratio, and/or body fat prostate cancer by 6%, the investi-
percentage. The risk of dying from gators found.
Bacteria linked to Prostate Cancer Thinking of donating RESEARCH UPDATE
a kidney? New data
Researchers have identified five types of bacteria as- shows it’s safe
sociated with aggressive prostate cancer, and they say
their findings could lead to new treatments for the dis- If you’re thinking about donating a kid-
ease. These bacteria were common in urine and tissue ney, new research could alleviate your
samples from men with aggressive prostate cancer. All concerns. “The results of this study are
of the bacteria are anaerobic, meaning they can grow extremely reassuring for individuals
without oxygen present, the researchers reported. For who are considering being living kid-
the study, the investigators analyzed urine or tissue ney donors. We found that this lifesav-
samples from more than 600 patients with or without ing surgery, when performed at experi-
prostate cancer. Men who had one or more of the spe- enced transplant centers, is extremely
cies in their urine, prostate or tumour tissue were 2.6 safe,” said study co-author. The study
times more likely to see their early-stage cancer pro- included donors who underwent lapa-
gress to advanced disease than men who did not. roscopic surgery to remove the do-
nated organ from 2000 to 2019. They
Men with heart disease can safely were followed for up to 120 days after
mix their nitrates with ED drugs surgery. Only 2.5% of patients had ma-
jor complications, and all of them had
Doctors have long types of drugs. Men are complete recoveries. None of the living
thought it dangerous to not more likely to suffer donors died. “While this study reinforc-
prescribe erectile dys- a heart attack, stroke or es the safety of this surgical procedure,
function drugs like Via- cardiac arrest if they’ve it does highlight the importance of fol-
gra alongside chest pain been prescribed both lowing up with the donors after dona-
pills containing nitrates. an ED drug and a ni- tion. That ensures any complications
“It’s always been a big red trate medication. can be treated quickly without any
line,” said the researchers. long-term damage,” the author said.
“You do not mix. Don’t go
there.” Now, a new study THE PHARMA WORLD 71
indicates there might be
little to no potential risk
in co-prescribing the two
CONCERN A nightmare for most patients
High costs for kidney dialysis, treatment
A round 80 per cent of kidney patients Professor Dr Harun Ur Rashid, Director of
succumb after failing to get proper treat- Kidney Foundation Hospital and Research In-
ment in the country, where more than 10 stitute Bangladesh, said that around 40,000
per cent of them cannot bear the costly treat- people are suffering from chronic kidney prob-
ment. Therefore, most of the patients from low lems. The disease worsens at one stage, and
income, underprivileged and marginal families the kidneys stop working completely. Then,
succumb to their illness without proper treat- there is no option left but to transplant kidneys
ment. or have dialysis -- both very expensive. For
this reason, around 80 per cent of patients die
Terming it as one of the most prominent rea- without treatment, he said.
sons behind kidney failure, esteemed nephrol-
ogists say long-term exposure to certain pain- The shortage of nephrologists, physicians,
killers could damage the small filtering blood nurses, technicians, and dialysis machines
vessels in the Kidney. This can cause analgesic are behind the patients’ reluctance in govern-
nephropathy, a chronic kidney problem, which ment hospitals. There is only one nephrologist
is a common disease suffered by patients who against 15 lakh kidney patients in the country,
tend to take unprescribed painkillers and other said Professor Dr M A Samad, Chief Consult-
medicines. Lack of awareness about diabetes, ant and Head of Nephrology Department at
hypertension, adulterated foods are also con- Anwar Khan Modern Medical College and Hos-
tributing to kidney disease. pital adding that more than 20 million people
72 THE PHARMA WORLD
are affected by kidney disease in the ments are still so expensive in the shasthaya Kendra, Insaf Barakah Kid-
country. country. ney and General Hospital offer kidney
dialysis sessions for only Tk 1,000. But
“In most cases, these hospitals Meanwhile, Professor Dr Harun Ur the patients have to bear the addition-
have not adequate machinery to con- Rashid said that approximately 10,000 al costs for medicine and surgical kits.
duct a limited number of dialysis, but Kidney patients get dialysis from both
they are either broken or too back- government and private hospitals a In January 2020, the High Court
dated to conduct necessary tests,” he year. About 75 to 80 per cent of them issued a nine-point guideline to
said. continue the treatment process till the regulate kidney donation by close
end. He added that thousands of peo- relatives or known donors. With the
“Kidney dialysis and treatment fa- ple get affected by various Kidney re- amendments made in the Transplan-
cilities are so high priced that it re- lated problems and avail the treatment tation of Human Organs (Amendment)
main out of reach of underprivileged, facilities every year. Act 2018, the High Court has allowed
low-income and middle-class people kidney donation by close relatives or
of the country to date. Sheer negli- “Only 2 to 3 per cent of the patients known persons, stipulating that a do-
gence on the governments’ part in up- can afford kidney transplant facilities nor must give his or her Kidney to the
grading the healthcare facilities to aid in Bangladesh, while the vast remain- recipient under a well-regulated legal
the kidney patients is condemnable,” ing portion loses their lives failing to framework.
said Dr Zafrullah Chowdhury, public get proper treatment. Therefore we
health activist and the founder of the need to prepare and adequately train However, this has not become
Gonoshasthaya Kendra. the doctors, nurses and technicians to a common practice in Bangladesh.
prevent these unfortunate deaths,” Dr Most of the severely affected kidney
According to the data of the Kidney Harun Ur Rashid added . patients who need prompt kidney
Foundation Hospital and Research In- transplantation prefer going to Indian
stitute Bangladesh, one of the promi- The director further mentioned hospitals, which cost around Tk 20 to
nent specialised hospitals in the that Sylhet, Joypurhat, and Bonogram 30 lakh, said Dr Harun.
country, around 0.5 per cent of people of Pabna are the most kidney disease-
(approximately 40,000 to 45,000 peo- prone areas of the country. Addressing the issue, Professor Dr
ple) of the total population suffers Md Kamrul Islam, Managing Director
from kidney-related complications Cost of Kidney Dialysis: and Urologist at Center for Kidney
and need treatment such as dialysis Diseases (CKD), who has recently won
or transplantation. The cost of treatment for Kidney re- the Independence Award-2022 (Sha-
lated diseases is relatively high in the dhinota Padak) for his contribution
Of the 0.5 per cent, about 20 to 25 country. Private hospitals and clinics to kidney treatment, said 70 to 80 per
per cent of the kidney patients can charge between Tk 3,500 and 5,000 cent of patients damage their kidneys
save their lives if they get proper for a single kidney dialysis session. due to late diagnosis.
treatment, according to the data. The However, hospitals such as the Gono-
Research Institute said kidney treat- ‘More than 80 per cent of people
in our country cannot afford the high
cost of kidney treatment, causing in-
tense sufferings to the patients and
resulting in an increased number of
deaths from the disease,” said the
national award-winning doctor, who
transplanted more than 1000 kidneys
for free to aid the underprivileged
kidney patients.
“We have around 500 kidney dialy-
sis machines across the country op-
erating both in the government and
private hospitals. It is not enough to
handle such a large number of pa-
tients,” said Dr Babrul Alam, Project
Director of the National Kidney Dialy-
sis and Nephrology Project.
According to a statistics survey of
the Bangladesh Bureau of Statistics
(BBS), a total of 28,017 patients died
from kidney-related diseases in 2020.
It was 10,622 in the previous year.
Source: The Business Post
THE PHARMA WORLD 73
“Our nephrologists are taking INTERVIEW
the responsibility to treat
renal disorders even more
efficiently than ever before”
Prof. Dr. Muhammad Nazrul Islam As an eminent nephrologist of our country, could
Chairman you please, tell us in brief about the types of
Department of Nephrology kidney disorders prevalent in Bangladesh?
BSMMU, Dhaka
The types of kidney diseases prevalent are Diabetic ne-
A successful kidney phropathy, nephritis, hypertensive kidney diseases, ob-
transplant has a structive nephropathy, interstitial nephritis, heredofamil-
good outcome in ial nephritis etc. Among them Diabetic nephropathy and
term graft & patient nephritis are contributing the major percentage.
survival. 5 years
graft survival with Early chronic kidney disease has no signs or
adequately matched symptoms. But, are there any non-specific
donor and proper symptoms that patients can be aware of?
immunosuppression is
more than 90%. Kidney diseases are called the silent killer because of
scarcity of symptoms and signs in early stage. Though in
patients suffering from diabetes and nephritis with oc-
casional leg oedema, puffy face, frothy urine & detection
of high blood pressure or uncontrolled blood pressure
which was previously controlled, together with nausea,
vomiting, lack of appetite, weakness, itching, shortness of
breath may be present.
What causes blood in the urine and foamy
urine? How are these conditions treated?
Blood in the urine is medically termed as hematuria. It
has lot of causes other than kidney disease such as kid-
ney stone diseases, Urinary tract infections, bleeding dis-
orders, trauma and tumor. But when it is associated with
renal diseases, it indicates very active renal diseases and
found in primary as well as secondary glomerular diseas-
es. In primary glomerular diseases mesangial proliferative,
membrano-proliferative glomerulonephritis are impor-
tant and in secondary post infectious glomerulonephritis,
lupus nephritis, connective tissue diseases that involves
kidney are important. Treatment according to cause.
Kidney transplantation often becomes a
necessity at the end-stage kidney disease.
What are the post-transplant complications
and outcome of kidney transplant?
Transplantation is the definitive treatment of end stage
renal diseases. But there are lot of complications that
may occur such as rejection, surgical complications such
as urinoma/urine leak, lymphocele, engraftment failure,
vessel stenosis, post-transplant viral & bacterial infections
known as opportunistic infections. Among viral infections
cytomegalovirus infection, BK virus infections, Pneumocys-
THE PHARMA WORLD 75
tis infections are common and among abuse of antibiotics, analgesics & Thirdly– In established renal disease,
bacterial infections, gram positive & over-the-counter traditional medica- lack of adequate dialysis & transplant
gram negative bacterias, tuberculosis tion protect from various types of in- facilities and overpricing of CAPD fluid
infections are common. Moreover fun- terstitial nephritis. In addition proper as an imported product. However, re-
gal infections with candida, mucormy- treatment of connective tissue dis- cently the government has taken the
cosis, Aspergilosis may occur. eases such as SLE will retard the renal initiative to setup dialysis and trans-
involvement. However plenty of water plant facilities in all divisional cities.
A successful kidney transplant has a intake is required in urinary tract in-
good outcome in term graft & patient fection & renal stone diseases. Regarding the treatment facilities
survival. 5 years graft survival with ad- of kidney disease compared to ad-
equately matched donor and proper What are the challenges in vanced countries in the world, I be-
immunosuppression is more than 90%. healthcare for people with kidney lieve we are not lagging behind. All
diseases in Bangladesh? Where types of treatment is now available
What is your message to the does Bangladesh stand as far as in Bangladesh and our nephrolo-
common people to avoid treatment of kidney disorders gists are taking the responsibility to
complications and protect is concerned, compared to the treat the renal disorder even more
their kidneys, as we know advanced countries with regards efficiently than ever before. Moreo-
prevention is better than cure? to expertise and technology? ver, pharmaceutical companies are
also launching newer products in
In general, no specific rules are to be A lot of challenges are being faced by the market once it is launched in
followed by the people to prevent kid- the doctors and patients in regard to the advanced countries in an afford-
ney diseases. But if a person is suffer- kidney disease management. able price. I think, we are slightly
ing from diabetes and hypertension, behind in terms of investigations fa-
good control will offer protection Firstly– proper knowledge of disease cilities such as renal histopathology
from kidney involvement. However in pattern and lack of awareness in the (Electron Microscopy), some investi-
primary glomerulonephritis no such management of primary disorders gations related to transplantation etc.
ways are present but in secondary such as diabetes and hypertension.
glomerulonephritis such as post in- Because of progressive improvement
fectious glomerulonephritis; proper Secondly- Monetary issues in regard of renal treatment, the number of treat-
maintenance of hygiene which pro- to treatment in proper time by the ment tourism for renal disease to vari-
tect the disease. More over stopping patient & lack of adequate budget in ous countries is decreasing gradually.
kidney disease treatment.
76 THE PHARMA WORLD
FOCUS
What’s new in prostate
cancer treatment?
New treatments and new researchers recommended
combinations of them giving this combination
are giving men with ad- only to “adequately fit men.”
vanced prostate cancer more
help than ever. “Never before Ongoing Research
have we had such a wide array Clinical trials continue to look
of options,” says an associate at other combinations of treat-
professor of radiation oncology ments. One is exploring the pair-
at the Hospital of the University ing of the chemotherapy drug
of Pennsylvania. cabazitaxel with ADT and radiother-
apy for high-risk men.
New Treatments
The FDA has approved new anti-an- Other trials are exploring how well
drogen medications. These drugs stop the immunotherapy prostate cancer
prostate cancer tumors from growing by drug sipuleucel-T works with radiation
bringing testosterone levels down. That therapies like radium-223. Sipuleucel-T,
starves prostate cancer cells of the fuel sold under the brand name Provenge, is
they need. also called a cancer vaccine. It’s already
These new medicines include: used to treat other cancers. Pembrolizum-
l Abiraterone acetate ab is another immunotherapy drug used for
l Apalutamide certain types of prostate cancers that have a
l Enzalutamide DNA change.
Apalutamide and enzalutamide are androgen Researchers are now on the hunt for new ways
receptor (AR) inhibitors that go to work outside to use the body’s immune system to target pros-
the cells. Abiraterone acetate is a CYP17 inhibitor tate cancer tumors. Possibilities include combin-
that slows production of androgens inside the cells. ing sipuleucel-T with the checkpoint inhibitors in-
Research has shown how well these drugs can delay doximod or ipilimumab. Checkpoint inhibitors are
cancer growth, in many cases by years. designed to boost body’s immune response. Other
clinical trials are testing different immunotherapy
New Combinations treatments and checkpoint inhibitors.
New pairings of approved therapies that improve pros-
tate cancer treatment are also in use, including: Researchers are looking beyond cancer drugs, too.
l A combination of radiation therapy and androgen depri-
vation therapy for men with recurrent prostate cancer. The diabetes drug metformin (Glucophage) is safe and in-
l Giving the chemotherapy drug docetaxel along with ADT. expensive. A large clinical trial in the United Kingdom and
But because the chemotherapy drug can be hard on the body, Switzerland is looking at whether adding metformin for
folks who are treated with hormone therapy can help pre-
vent metabolic syndrome and help people live longer.
THE PHARMA WORLD 77
“We need a dedicated & INTERVIEW
committed team to sustain the
ever advancing technology”
Prof. Dr. Isteaq Ahmed Shameem As an eminent urologist of our country, could
Chairman you please, tell us in brief about the types of
Department of Urology urological disorders prevalent in Bangladesh?
BSMMU, Dhaka
Urological disorders are of two types (a) Congenital
Multidisciplinary Present since or before birth. (b) Acquired
approach are required
to treat Oncological A. Congenital anomalies are
and Renal failure 1) Pelvi-ureteric junction obstruction
patients. For the 2) Posterior urethral valve in male children
utmost benefit of 3) Abnormalities of sex differentiation
the patients we need 4) Nocturnal Enuresis
to improve facilities 5) Hypospadias & Epispadias
both diagnostic and 6) Mega Ureter
therapeutic. 7) Undescended testis
8) Neurogenic bladder etc.
B. Acquired
1. Kidney, ureteral and bladder stone diseases
2. Kidney, ureter, Bladder, Prostate, Testis & Penile
cancer
3. Benign enlargement of prostate (BEP)
4. Urinary tract infection
5. End stage Renal disease requiring dialysis &
Renal Transplantation.
6. Injuries to urethra, Bladder, Kidneys
7. Neuropathic Bladder
8. Painful bladder syndrome etc.
What are the types of kidney and ureteral stones?
What causes them? What lifestyle changes can
help reduce the risk of developing stones?
a) Types of kidney and ureteral stones
Calcium oxalate-80-85%
Uric Acid-5-10%
Calcium Phosphate, Calcium oxalate 10%
Strurite 2-20%
Cystine 1%
b) Factors affecting stone formation
1. Intrinsic- to the individual
2. Extrinsic (Environmental)
3. Combination of Intrinsic-Extrinsic factors
Intrinsic factors
1. Obesity
2. Age-between 20-50 years
3. Lack of exercise
THE PHARMA WORLD 79
4. Inadequate fluid intake less than 1200ml/day 7) Epididymitis- Inflammation of the epididymis
5. Sex- Males are affected more than Females 8) Pelvic Inflammatory disorder (PID)
Testosterone a male hormone increases oxalate
Painful urination is always not a symptom of urological
production in the liver predisposing to calcium cancer.
oxalate stone formation
Women have higher urinary citrate concentration What causes benign prostatic hyperplasia (BPH) ?
inhibiting calcium stone formation Who are at risk for BPH ? Can BPH be prevented?
6. Family history- 25% patients report a family
The causes of BPH is not completely understood but
Extrinsic factors seems to be multifactorial and endocrine controlled. A
1. Geographical location, Climate & Season positive correlation exists between levels of free testos-
Stone disease is common in hot climate terone and estrogen and the volume of prostate. BPH
2. Diet a) high animal protein- Red meat etc might result from the increased estrogen levels due
b) high salt intake to aging, causing induction of the androgen reception
3. Occupation- Sedentary occupation predisposes to which thereby sensitizes the prostate to free testoster-
stone formation one.
Life style changes - That can help reduce the risk of stone Benign Prostatic Hyperplasia (BPH) is characterized
formation by an increase in epithelial and stromal cell numbers
in the peri-urethral area of the prostate. The increase in
1. Low animal protein intake prostate cell number could reflect proliferation of epi-
2. Low salt intake thelial and stromal cells, impairment of apoptosis cell
3. Adequate fluid intake 2.5 L/ day death or a combination of both
4. Regular exercise
Risk factors for the development of BPH are also
How are ureteral stones treated? poorly understood. Some studies have suggested a ge-
netic predisposition and some have noted racial differ-
Treatment of ureteral stones ences
Different modalities of treatment for ureteral calculi
At the moment with available data it is not clear
are applied depending upon size, location of stone in whether BPH can be prevented. Studies are ongoing
ureter and Excreting/ Function of kidney. which can light us in future.
ESWL- Extra Corporeal Shock Wave Lithotripsy Where does Bangladesh stand as far as
1. ESWL- Extra Corporeal Shock Wave Lithotripsy, Less treatment of urologic disorders is concerned
compared to the advanced countries with
than 1cm either in situ or after push back and D-J regards to expertise and technology?
stent.
2. Ureterorenoscope + Intracorporeal Lithotripsy with Bangladesh has almost all the treatment options as far
pneumatic or Laser. as Urologic disorders are concerned.
3. PCNL-Percutaneous Nephrostolithotomy.
4. Open ureterolithotomy . Well experienced expertises are presently treating
5. Laparoscopic ureterolithotomy. urological disorders in Bangladesh.
Is painful urination always a symptom of urological Globally urological technology is evolving very rapid-
cancers? What could cause painful urination? ly. Bangladesh is not behind in many aspects. Updated
treatment of Urinary stone, Pediatric, Female & Neuro-
Painful urination (dysuria) is a broad term that de- urology are available in Bangladesh.
scribes discomfort during urination.
Renal Transplantation is being done regularly in
Causes of painful urination Bangladesh.
1) Urinary tract infection- A UTI can be the result of a
bacterial infection and also due to inflammation of Multidisciplinary approach are required to treat On-
the urinary tract. Female are more likely to develop cological and Renal failure patients. For the utmost ben-
UTI than male. efit of the patients we need to improve facilities both
2) Sexually transmitted infection (STI)- include geni- diagnostic and therapeutic. Since, we have to cater a
tal herpes, gonorrhea & chlamydia large number of patients all facilities in the hospital
3) Prostatitis -which is the inflammation of the pros- and OR demand attention. The other area which has be-
tate gland. come very important is advanced technology & research
4) Cystitis- inflammation of the bladder. based curriculum.
5) Interstitial cystitis also known as painful bladder
syndrome To overcome the short comings.
6) Urethritis- Inflammation of the urethra usually due Processing technology, developing skill manpower
to an infection by bacteria behind the machine is very difficult task. We need a
dedicated & committed team to sustain the advancing
technology and treat patient with utmost care & respect.
80 THE PHARMA WORLD
Among vaccinated, omicron CORONA UPDATE
symptoms ease earlier
If you’re vaccinated and get COVID-19 anyway, booster cut that to 7.7 days for Delta and 4.4 for
which variant you have and whether you›ve Omicron. The researchers also found that loss of
been boosted make a difference. Symptoms last smell was much less common in those with Omi-
longer when breakthrough infections are caused cron (17%) than with Delta (53%), but the risk of
by the Delta variant and not the more conta- sore throat was 55% higher and hoarseness 24%
gious Omicron variant, according to European higher among those with Omicron. Patients with
researchers who are reporting other differences Omicron also were about half as likely to have
in how SARS-CoV-2 variants affect vaccinated pa- at least one of three classic COVID symptoms --
tients. On average, researchers found, vaccinated fever, loss of smell and persistent cough – than
patients with Delta had symptoms for nine days; those with Delta, the study found. In addition,
those with Omicron, for seven. Booster shots Omicron patients were 25% less likely to admit-
shortened the number of days spent suffering ted to the hospital than Delta patients (1.9% vs.
even more, the study showed. For patients who 2.6%), and Omicron patients were 2.5 times more
had two doses, symptoms averaged 9.6 days likely to recover within a week than those with
for Delta and 8.3 for Omicron. Two shots plus a Delta, the findings showed.
Rare cases of COVID FDA approves
relapse seen with first breath
Pfizer Pill Paxlovid test for COVID
Rare cases of COVID patients relapsing after tak- People who suspect they may have COV-
ing the antiviral pill Paxlovid are raising questions ID-19 could soon find out with a simple
among some experts. An earlier study of 1,000 breath test that delivers results in three
adults showed that Paxlovid was highly effec- minutes. USFDA has granted an emergen-
tive at preventing severe COVID. But there have cy use authorization for a device called
been reports of symptoms returning in patients the InspectIR Covid-19 Breathalyzer. The
several days after completing the five-day regimen test, which must be administered by a
of Paxlovid, prompting some doctors to wonder if trained operator, demonstrates a high
these patients are still contagious and should take degree of accuracy while taking up no
a second round of the drug. But the USFDA ad- more space than a piece of carry-on lug-
vised against a second round, saying there is lit- gage. InspectIR can run 160 samples per
tle risk of severe illness or hospitalization among day and may be used at mobile testing
patients who relapse after taking Paxlovid. The sites, hospitals and doctors’ offices. The
Pfizer drug was tested and authorized based on test uses gas chromatography gas mass-
its effectiveness against the Delta variant and may spectrometry, a technique that separates
be less effective against Omicron. In the original and identifies chemical mixtures, to spot
study, virus levels rose after 10 days in 1% to 2% in the presence of five compounds associ-
those taking either the drug or dummy pills, Pfizer ated with the coronavirus. Its accuracy
and the FDA have noted. That rate was about the was confirmed in a large study of just
same among people taking the drug or dummy over 2,400 people, including those with
pills, “so it is unclear at this point that this is relat- and without symptoms. In the end, the
ed to drug treatment,” the FDA stated, the AP said. test was shown to have 91.2% sensitivity
Another possible explanation for rare cases of re- (the percent of positive samples the test
lapse among patients taking Paxlovid is that the correctly identified) and 99.3% specificity
dose isn’t strong enough to fully suppress the vi- (the percent of negative samples the test
rus in all people, said a virologist at Johns Hopkins. correctly identified). The test performed
That could lead to coronavirus mutations that are just as well in a follow-up study focused
resistant to the medication, he said. on the Omicron variant.
THE PHARMA WORLD 81
Finerenone in patients Daprodustat for Macrophage infiltration
with type 2 diabetes anemia treatment in and response to
and less severe diabetic nondialysis chronic immunosuppression
kidney disease kidney disease in IgA nephropathy
Patients with type 2 diabetes and Hypoxia-inducible factor prolyl hy- In patients with IgA nephropathy
diabetic kidney disease (DKD) droxylase inhibitors (HIF PHIs) are (IgAN), immunosuppressive thera-
should generally be treated with a novel class of oral erythropoie- py is generally reserved for those
an angiotensin converting en- sis-stimulating agents (ESAs) that who are at high risk for disease
zyme (ACE) inhibitor or angioten- are being evaluated for treatment progression; however, tools to
sin receptor blocker (ARB) plus of anemia in patients with chronic identify which patients are likely
a sodium-glucose cotransporter kidney disease (CKD). In a trial of to benefit from treatment are lack-
2 (SGLT2) inhibitor. Finerenone, nearly 4000 patients with nondi- ing. In a study of over 600 Chinese
a nonsteroidal selective miner- alysis CKD and anemia that com- patients with IgAN at high risk for
alocorticoid receptor antagonist pared the safety and efficacy of the disease progression who received
(MRA), was shown to slow the HIF PHI daprodustat with darbepo- immunosuppressive therapy for
progression of kidney function etin, hemoglobin concentrations a median of 18 months, higher
loss in a large trial of patients increased more with daprodustat levels of macrophage infiltration
with type 2 diabetes and severe at approximately two years. How- within glomeruli on kidney biopsy
DKD. In a similar trial that tested ever, major cardiovascular events were associated with a markedly
the effects of this drug in over (a composite of death, nonfatal increased probability of response
7000 patients with less severe stroke, and nonfatal myocardial in- to immunosuppression when com-
DKD, finerenone, compared with farction) were also more frequent pared with lower levels. Combin-
placebo, reduced the risk of heart with daprodustat, a difference that ing the intensity of macrophage
failure hospitalization and non- was statistically significant during infiltration with clinical and histo-
significantly lowered the rate of the active treatment period but logic data accurately predicted the
kidney failure and all-cause mor- not by the end of post-treatment response to immunosuppression.
tality; the benefit from finerenone follow-up. Although these data While these findings may help
was similar in those treated and indicate that anemia can be ef- identify patients who will benefit
not treated with an SGLT2 inhibi- fectively treated with daprodustat, from immunosuppressive therapy,
tor. As a result of these two trials, they raise some safety concerns additional validation in other pa-
some experts add finerenone, about this drug. tient populations is needed.
where available, to SGLT2 therapy
provided the patient has a nor-
mal serum potassium while tak-
ing an ACE inhibitor or ARB.
Anti-nephrin Minimal change disease (MCD) is of patients with active disease.
antibodies in a common cause of the nephrotic Punctate immunoglobulin G (IgG)
minimal change syndrome in children and adults, deposits colocalized with nephrin
disease but the underlying pathogenesis in the kidney biopsies of patients
remains unclear. In a recent study who were serologically positive for
of over 60 adults and children with anti-nephrin antibodies, whereas
biopsy-proven MCD and no known no deposits were present in those
genetic basis, circulating autoan- who were serologically negative.
tibodies targeting nephrin, an These findings suggest a possible
essential component of the glo- autoimmune etiology for MCD in a
merular slit diaphragm, were iden- subset of patients.
tified in approximately one-third
82 THE PHARMA WORLD
Neutralization of In transplant recipients, administration of a third NEPHROLOGY UPDATE
SARS-CoV-2 variants in COVID-19 mRNA vaccine dose has been shown to
transplant recipients improve the immune response without causing
after three doses short-term adverse events; however, data on vac-
of mRNA vaccine cine immunogenicity against SARS-CoV-2 variants
are limited. In a secondary analysis of a recent ran-
domized trial, sera obtained from participants after
receipt of the third vaccine dose had greater abil-
ity to neutralize wild-type SARS-CoV-2 and Alpha,
Beta, and Delta variants when compared with sera
obtained after the second dose and sera from par-
ticipants who received placebo. The third dose was
well tolerated; no cases of rejection were reported,
and graft function remained stable in all patients
for three months after the third dose. These find-
ings support administering a three-dose primary
vaccine series among transplant recipients and
other immunocompromised patients.
Effect of regular Antihypertensive Mode of delivery
acetaminophen use effect of and pregnancy
on blood pressure chlorthalidone outcomes in
in advanced CKD kidney transplant
Nonsteroidal anti-inflam- recipients
matory drugs have well-es- It is a commonly held belief
tablished effects on blood that thiazide diuretics are not Most pregnant kidney trans-
pressure; however, there effective in patients with ad- plant recipients will under-
are fewer data about the ef- vanced chronic kidney disease go a cesarean delivery, but
fects of acetaminophen. In (CKD); however, several studies there is no clear evidence to
a crossover trial of approxi- indicate that thiazide diuretics support its routine use. In a
mately 100 patients with are effective in such patients. registry study of over 1400
treated hypertension, regu- In a randomized trial of 160 female kidney transplant re-
lar acetaminophen (at maxi- patients with advanced CKD cipients with live births, ap-
mum dose, 1 g four times (estimated GFR 15 to 29 mL/ proximately two-thirds un-
daily) given for two weeks min/1.73 m2) and uncontrolled derwent a trial of labor (most
increased both systolic and hypertension despite antihy- with a vaginal delivery) and
diastolic blood pressure as pertensive therapy, chlortha- one-third had a scheduled
compared with placebo (by lidone substantially reduced cesarean birth. Compared
5/2 mmHg). These results, in 24-hour ambulatory blood with scheduled cesarean
addition to those of a prior pressure (by 10.5/3.9 mmHg) birth, a trial of labor was not
trial, suggest that acetami- compared with placebo. Hy- associated with an increase
nophen may have adverse pokalemia, hyponatremia, and in severe maternal morbidity
effects on blood pressure in dizziness were more common and was associated with low-
patients with hypertension. with chlorthalidone. These er odds of neonatal morbid-
data confirm findings from ity. Among kidney transplant
other studies and indicate recipients, vaginal birth is the
that thiazide diuretics can be preferred mode of delivery,
effective in controlling blood and cesarean birth should
pressure among patients with be reserved for patients with
advanced CKD. obstetric indications only.
THE PHARMA WORLD 83
“Primary health care centers can INTERVIEW
play a major role in preventing
non-communicable
diseases like CKD”
Prof. Dr. Md. Nazrul Islam As an eminent nephrologist of our country, could
Head you please, tell us in brief about the types of
Department of Nephrology kidney disorders prevalent in Bangladesh?
Dhaka Medical College and Hospital
The prevalence of CKD among the general population
In Bangladesh, the worldwide was estimated at around 11%-13%, whereas
overall prevalence of the prevalence was reported to be higher in developing
CKD was estimated at countries compared to developed countries. According
around 14%. Around to an earlier report, in 2015 around 109.9 million people
35,000-40,000 patients from developed countries had CKD while these numbers
developed end stage were around 387.5 million for developing and lower in-
kidney failure in Bang- come countries. In South-East Asia, the prevalence of CKD
ladesh in every year. was ranging from 10.6% in Nepal to 23.3% in Pakistan.
Bangladesh is also experiencing huge burdens in the to-
tal number of CKD patients. In Bangladesh, the overall
prevalence of CKD was estimated at around 14%. Around
35,000-40,000 patients developed end stage kidney fail-
ure in Bangladesh in every year who need to undergo re-
nal replacement therapy (Dialysis & Transplantation). Ac-
cording to the latest WHO data published in 2018, Kidney
Disease Deaths in Bangladesh reached 16,948 or 2.18%
of total deaths. The age adjusted Death Rate is 14.83 per
100,000 of population ranks Bangladesh #94 in the world.
The most common type of kidney disease is chronic
kidney disease (CKD). Other diseases include acute kid-
ney injury, stones, infections, cysts, and cancer.
Chronic kidney disease (CKD): CKD slowly damages the kid-
neys over time. 10% of the population worldwide is affect-
ed by chronic kidney disease (CKD), and millions die each
year because they do not have access to affordable treat-
ment. The important causes of ‘end stage kidney failure’
(ESRD) in our country are chronic nephritis (40 percent),
diabetes (34 percent) and high blood pressure (15 percent).
Acute kidney injury (AKI): AKI causes kidney damage or fail-
ure within a short period of time. AKI may damage other
organs as well, such as the heart, lungs, and brain. It occurs
more often in older individuals and hospitalized patients,
especially those who require intensive care. Around 30%
patients in ICU develop AKI.
Glomerulonephritis: Glomerulonephritis is inflammation
of the tiny filters in the kidneys (glomeruli). Glomerulo-
nephritis may be primary or as part of another disease,
such as lupus or diabetes. Severe or prolonged inflam-
mation associated with glomerulonephritis can damage
the kidneys.
THE PHARMA WORLD 85
Diabetic Nephropathy: Diabetic nephropathy – kidney What causes blood in the urine and foamy
disease that results from diabetes -- is the number one urine? How are these conditions treated?
cause of kidney failure. Almost a third of people with dia-
betes develop diabetic nephropathy. Hematuria is the presence of blood cells in the urine. He-
maturia can be called either gross or microscopic.
Kidney stones: Also called renal stones, kidney stones are
hard deposits of minerals or salts formed inside the kid- Gross hematuria occurs when there is enough blood
neys. They can form inside the ureter (tubes that carry present in the urine that it is visible to the naked eye. It
urine from the kidneys) or urinary bladder (structure that can turn toilet water a pale pink or bright red color.
receives urine from the kidneys via the ureters). Kidney
stones generally occur when there is an excess of mineral Microscopic hematuria is a result of there being
salts, such as calcium oxalate or calcium phosphate, or an amount of blood in the urine that can only be seen
uric acid in the body. through a microscope.
Kidney infections: Kidney infections or pyelonephritis oc- Dipstick hematuria results when oxidation of the urine
cur when infection from the urethra or the urinary blad- test strip causes a color change. It does not always mean
der travels upward to the kidneys. Less commonly, the that blood cells are present in the urine.
infection may spread from other sites in the body to the
kidneys via blood or following kidney surgery. There can be a number of different causes of hematu-
ria which includes:
Kidney cysts: A kidney cyst is a fluid-filled pouch or sac-
like structure. Also called simple kidney cysts, these are l Urinary tract infection (UTI)
different from a genetic condition called polycystic kid- l Pyelonephritis (UTI that has reached as far as the kidney)
ney disease (PKD) that causes the formation of numerous l Urinary stone disease
cysts that damage the kidneys. l Enlarged prostate (benign prostatic hypertrophy)
l Injury to the urinary tract
Early chronic kidney disease has no signs or l Glomerulonephritis
symptoms. But, are there any non-specific l Sickle cell disease
symptoms that patients can be aware of? l Bladder cancer
l Kidney cancer
Early-stage kidney disease usually has no symptoms, and l Prostate cancer
many people don’t know they have CKD until it is very ad-
vanced. Kidney disease often gets worse over time and may The treatment of hematuria depends strongly on the ac-
lead to kidney failure and other health problems, such as tual cause of blood in the urine. The information collected
stroke or heart attack. In fact, CKD is sometimes known as from the medical history, physical exam, and any test re-
a “silent” condition because it’s hard to detect—and most sults will be used to determine the best treatment option.
people with early stage CKD are completely unaware of it.
Foamy, frothy or bubbly urine are the symptoms of protein
If patients are at risk for CKD, especially if they have in the urine, also known as Proteinuria. Normal amount of
high blood pressure or diabetes, it’s recommended that protein in the urine are less than 150mg/day. This condition
they get screened at least once a year for any evidence can be a sign of kidney damage. When the glomeruli or tu-
of kidney disease. Estimated glomerular filtration rate bules are damaged, if there is a problem with the reabsorp-
(eGFR) and creatinine levels help determine the level of tion process of the proteins, or if there is an excessive protein
kidney function. The earlier CKD is detected, the greater load, the proteins will flow into the urine. The two most com-
the benefit of early treatment. mon risk factors are diabetes and high blood pressure.
Patients should consult with their doctors immediately Other serious conditions that can cause proteinuria include:
if any of the following symptoms occur: l Immune disorders such as lupus
l Kidney inflammation (glomerulonephritis)
l Changes in urination l A blood cancer called multiple myeloma
l Swelling in hands, legs, or feet l Preeclampsia, which affects pregnant women
l Puffiness around eyes l A buildup of protein in your organs (amyloidosis)
l High blood pressure l Cardiovascular disease
l Fatigue l Intravascular hemolysis, a condition in which red
l Itching
l Shortness of breath blood cells are destroyed
l Pain in the small of your back l Kidney cancer
l Decreased appetite l Heart failure
l Abnormal levels of phosphorus, calcium, or vitamin D l Treatment depends on underlying cause.
l Abnormal urine test
What are the risk factors of renal stone disease?
Do you have any advice for prevention?
The prevalence of kidney stones in the world is increasing
and environmental factors seem to play a major role in
this issue. Factors that increase your risk of developing
kidney stones include:
THE PHARMA WORLD 87
Dehydration: This is the most common cause and the eas- By 2023, Bangladesh government is going
iest to remedy.
to establish 50 bed dialysis centers in 23
Diet: Studies have shown that eating a high sodium diet
can increase the risk of certain types of kidney stones. Too government medical colleges and 10 bed
much sodium increases the amount of calcium that the
kidneys must filter and significantly increases the risk of dialysis unit at 44 district hospital.
kidney stones. In addition, diets that are high in protein
and sugar can increase kidney stone risk. Limit animal protein: A high-protein diet also reduces lev-
els of urinary citrate, the chemical in urine that helps pre-
Family or personal history: If someone with a family his- vent stones formation.
tory of kidney stones is more likely to develop stones than
someone without a family history. Avoid stone-forming foods: Beets, chocolate, spinach,
rhubarb, tea, and most nuts are rich in oxalate, which can
Obesity: High body mass index (BMI), large waist size, and contribute to kidney stones. If you suffer from stones,
weight gain have all been associated with an increased your doctor may advise you to avoid these foods or to
risk of both a single episode and recurrent episodes of consume them in smaller amounts.
kidney stones.
For everyone else, particular foods and drinks are un-
Digestive diseases and surgery: Certain disorders of the likely to trigger kidney stones unless consumed in extreme-
digestive system can affect calcium, electrolyte, and water ly high amounts. Some studies have shown that people
absorption, which may increase the risk of forming kidney who take high doses of vitamin C in the form of supple-
stones. Common disorders include gastric bypass surgery ments are at slightly higher risk of kidney stones. That may
and inflammatory bowel diseases, such as Crohn’s dis- be because the body converts vitamin C into oxalate.
ease and ulcerative colitis.
What are the challenges in healthcare for people
Metabolic disorders: Metabolic conditions that may in- with kidney disease in Bangladesh? Where does
crease the risk of kidney stones include renal tubular aci- Bangladesh stand as far as treatment of kidney
dosis, cystinuria, and hyperparathyroidism. disorders is concerned, compared to the advanced
countries with regards to expertise and technology?
Urinary tract infections: Patients who suffer from chronic
urinary tract infections may form larger stones up in the kid- We are still facing problem in approach for non-com-
ney. These are commonly called struvite or infection stones. municable disease like CKD. The main problem is in late
diagnosis of kidney disease. We have a strong infrastruc-
Other Risk Factors of Kidney Stones: ture of primary health care system. We have established
l Anatomical abnormalities that may increase the risk community clinic, functioning important role in primary
of kidney stones health care. If we can incorporate community clinic and
l Obstruction of the kidney or ureter other primary health care centers to early diagnosis of
l Calyceal diverticulum renal disease, we’ll be able to ensure early detection and
l Horseshoe kidney treatment of renal disease and decrease mortality and
l Ureterocele morbidity.
l Vesicoureteral reflux
l Ureteral stricture This can be achieved by measuring regular blood pres-
l Medullary sponge kidney sure and laboratory test of Urine R/M/E, random blood
sugar and serum creatinine in primary health care centers.
How to avoid kidney stones
Here are the several ways to help prevent kidney stones: Our nephrologists are working in different level of the
Drink plenty of water: Drinking extra water dilutes the country. We have standard diagnosis facilities for diagno-
substances in urine that lead to stones. Strive to drink sis of renal disorders. We are doing interventions for di-
enough fluids to pass 1.5-2 liters of urine a day, it may agnosis and therapeutic procedures regularly as standard
help to include some citrus beverages, like lemonade and protocol. By 2023, Bangladesh government is going to es-
orange juice. The citrate in these beverages helps block tablish 50 bed dialysis centers in 23 government medical
stone formation. colleges and 10 bed dialysis unit at 44 district hospital.
Eat calcium rich foods: Dietary calcium binds to oxalate Regarding management, our expertise and infrastruc-
in your intestines and thereby decreases the amount of ture is equivalent to the advanced countries. We are trying
oxalate that gets absorbed into the bloodstream and then to attain a more comparable standard with international
excreted by the kidney level in our diagnosis and treatment of renal disorders. In
near future we hope that Bangladesh will be an important
Reduce sodium: Current guidelines suggest limiting total center for training, education and research in the field of
daily sodium intake to 1500 mg. This will also be good for renal disorders.
your blood pressure and heart.
88 THE PHARMA WORLD
Nephrology BRAIN TEASER
ACROSS • 3. High amounts of this in an analogue of this diuretic
• 2. Marked hyponatremia in a the urine may interfere with
cAMP generation in the col- • 14. The agent involved in the
‘night club’ lecting duct leading to loss of SALT -1 and SALT -2 trials of
• 4. It is difficult to drown in free water and DI hyponatremia
this body of water, which • 5. Risk factor for in-hospital • 15. _________’s disease or
contains 340 gm of NaCl/l hyponatremia central DI, optic atrophy, dia-
• 7. This weight loss drug can betes mellitus, and sensori-
cause nephrogenic diabetes • 6. An autosomal recessively neural deafness
insipidus (DI) transmitted defect in this
• 9. Elderly widow’s hypona- transporter can lead to DI • 17. _________meal for break-
tremia is from a low-solute fast does not cause the
(_______ and toast) diet • 8. A young female with crani- syndrome of inappropriate
• 11. An opportunistic infection opharyngioma presents with antidiuretic hormone hy-
in an HIV patient that can Na of 200 mmol/l, a serum persecretion (SIADH), but
lead to asymptomatic hy- osmolarity of 345 mosm/l, _______ cell cancer does
ponatremia (abbrev) and urine osmolarity of
• 13. This mountainous study 743 mosm/kg. Besides a par- • 18. Bodily fluid that has the
showed that the treatment of tial central DI, she also has least sodium concentration
patients with tolvaptan with ________ hypernatremia
heart failure did not improve • 19. Bodily fluid that has the
mortality • 10. A healthy, 26-year-old fe- highest sodium concentra-
• 15. DI was differentiated from male has a maximally dilute tion
mellitus in 1674 by this indi- urine osmolality of 50 mos-
vidual mols/kg. If her daily solute • 21. Lack of this perception
• 16. The organism that causes excretion is 600 mosmols, can lead to extreme hyperna-
a walking pneumonia, diar- how much water must she tremia
rhea, and a serum sodium of drink before she becomes
127 mEq/l hyponatremic (in liters)? • 23. A 45-year-old male with
• 18. Psychotropic drugs can HIV, now being treated for tu-
cause this • 12. Benzamil used to treat berculosis (TB), has SIADH. As
• 20. A _______producing tu- patients with cystic fibrosis is his TB and sodium improves,
mor of the lung presents with this anti-TB drug leads to an-
new-onset hypertension and ion gap metabolic acidosis
diabetes, chloride resistant
metabolic alkalosis, hypoka-
lemia, and hypernatremia
• 22. Initially developed to
treat uric acid stones, this
drug can substitute for so-
dium in several sodium
channels, particularly the
sodium-hydrogen exchanger
in the proximal tubule (NHE3)
and the epithelial channel of
the cortical collecting tubule
(ENaC)
• 24. Atomic number of the
substance that was first dis-
covered by Sir Humphry Davy
in 1806
DOWN
• 1. Hang 3% of this and watch
the hyponatremic patient
wake up
How many did you get right? Compare with the answer key at page 56
THE PHARMA WORLD 89
“In recent years, there has been INTERVIEW
tremendous advancement
and expansion in urology”
Prof. Dr. A.K.M. Shahadat Hossain As an eminent urologist of our country, could
Head you please, tell us in brief about the types of
Department of Urology urological disorders prevalent in Bangladesh?
Dhaka Medical College & Hospital
About 30% of surgical patients presents with urological
BPH is a disease problems. The pattern of urological disease varies with
of aging male and age. Urological disorders are common in elderly and as
the cause is poorly the life expectancy has increased in our country, the bur-
understood. So, den of urological disorders have also increased. Overall,
importance should the common urological disorders are –
be given on early l Urinary Tract Infections
detection of its l Urinary Stone Disease
complications and l Benign Enlargement of Prostate
timely intervention. l Urological Cancers – Prostate, urinary bladder and kid-
ney cancers
l Stricture Urethra
l Voiding Dysfunction
l Male Sexual Dysfunction
l Developmental Anomalies of Genito-Urinary System
What are the types of kidney and ureteral stones?
What causes them? What lifestyle changes can
help reduce the risk of developing stones?
Urinary stones can be classified according to various as-
pects, e.g., causes, composition, location, size and X-ray
characteristics. According to composition, urinary stones
are calcium containing stones and non-calcium contain-
ing stones. Majority (> 80 %) are calcium containing stones
and among the non-calcium containing stones, important
are uric acid, struvite and cystine stones.
The cause of urinary stones is multifactorial. The impor-
tant risk factors are metabolic, infective, genetic and ana-
tomical abnormalities of urinary tract.
Metabolic cause is the most common etiological fac-
tor in urinary stone formation and individual’s lifestyle
contributes to the metabolic factors. So, lifestyle modi-
fication is very important to reduce the risk of develop-
ing stones and as well as to reduce the recurrence after
treatment.
Recommended general advice for lifestyle modifica-
tions are –
l Consume enough fluids to produce at least 2 L of urine
per day
l A diet with reduced animal protein (meat) and high in-
take of fruits and vegetables and restriction of sodium
(common salt)
l Regular exercise and avoidance of obesity.
THE PHARMA WORLD 91
How are ureteral stones treated? SOURCES: NATIONAL KIDNEY FOUNDATION, NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Ureteral stones cause obstruction to the kidney
outflow and the ultimate consequence is damage to
the kidney function. Ureteral stones usually present
with severe pain and treatment depends on the lo-
cation of the stone, size of the stone, presentation
of the patient and the functional status of kidney.
Modalities of treatment are –
l Extracorporeal Shockwave Lithotripsy
l Push back and Percutaneous Nephrolithotomy
l Laparoscopic Ureterolithotomy
l Open Ureterolithotomy
Is painful urination always a symptom
of urological cancers? What could
cause painful urination?
Urological cancers are usually painless specially at
the early stages. Common causes of painful mictura-
tion are –
l Urinary tract infection
l Bladder outlet obstruction
l Urinary bladder stone
l Interstitial Cystitis
l Chronic Pelvic Pain Syndrome
What causes benign prostatic hyperplasia (BPH)?
Who are at Risk for BPH? Can BPH be Prevented?
BPH is the most common benign tumor in men and
the cause is not completely known, but it seems to
be multifactorial. Risk factors for the development
of BPH are –
l Aging (> 50 years)
l Genetic and familial
l Endocrine – Androgen and estrogen
BPH is a disease of aging male and the cause is
poorly understood. So far, no preventable meas-
ure has been discovered. So, importance should be
given on early detection of its complications and
timely intervention.
Where does Bangladesh stand as far as
treatment of urologic disorders is concerned
compared to the advanced countries with
regards to expertise and technology?
In recent years, there has been tremendous ad-
vancement and expansion in urology in regards to
treatment expertise and technology. Urology is no
more a single speciality, it has grown into differ-
ent subspecialities like General Urology, Paediat-
ric Urology, Reconstructive Urology, Endourology,
Uro-Oncology, Andrology & Female Urology and
Neurourology. At present, in Bangladesh, all sorts
of expertise and technology are available except
Robot Assisted Surgery.
92 THE PHARMA WORLD
Methylphenidate: Erenumab: Risk of Statins: Removal of DRUG SAFETY
Potential risk of hypertension contraindication for
birth defects and pregnant women
malformations The Therapeutic Goods Ad-
ministration (TGA) has an- The US Food and Drug Ad-
The TGA has announced nounced that the product ministration (FDA) has re-
that the product informa- information for erenumab quested revisions to the
tion for methylphenidate, a prophylaxis of migraine information in the pre-
a CNS stimulant has been in adults has been updated scribing information for the
updated with new infor- with a warning statement entire class of statin medi-
mation about use in preg- about a potential causal cines about use in pregnan-
nancy. Updated safety relationship between the cy. These changes include
information relating to drug and hypertension. The removing the contraindi-
birth defects and malfor- TGA reviewed cases of the cation against using these
mations is included and development of hyperten- medicines in all pregnant
the pregnancy category sion and worsening of pre- patients. Statins are a class
has now been changed existing hypertension re- of medicines that have
so that methylphenidate ported following use of the been used to lower low-
should not be prescribed drug in the postmarketing density lipoprotein choles-
for women of childbearing setting internationally. In terol (LDL-C) in the blood.
age unless, in the opinion the majority of cases, the Medicines in the statin
of the physician, the poten- onset or worsening of hy- class include atorvastatin,
tial benefits outweigh the pertension was reported fluvastatin, lovastatin, pita-
possible risks. The TGA re- after the first dose of er- vastatin, pravastatin, rosu-
viewed large observational enumab. vastatin, and simvastatin.
studies and observed a It was concluded that con-
small increased occurrence traindicating these drugs in
of foetal cardiac malfor- all pregnant women is not
mations in women who appropriate.
received methylphenidate
during the first trimester of Magnesium sulfate: Risk of rickets-like
pregnancy, compared with bone lesion in neonates at birth
non-exposed pregnancies.
The MHLW and the PMDA have announced that the product
Cefuroxime: information for magnesium sulfate (injection) indicated for
Potential risk of eclampsia should be revised to include the risk of rickets-
Kounis syndrome like bone lesion in neonates at birth with prolonged admin-
istration of this drug during pregnancy. The MHLW and the
The SFDA has released a PMDA reviewed cases of rickets-like bone lesion reported in
potential safety signal con- neonates born to patients treated with magnesium sulfate in
cerning Kounis syndrome Japan and concluded that a causal relationship between the
associated with the use of drug and event was reasonably possible in all the cases. The
cefuroxime. Cefuroxime is shortest duration of administration with magnesium sulfate
cephalosporin antibacte- (injections) to the mother was 18 days.
rial drug indicated for the
treatment of infectious
diseases caused by sen-
sitive bacteria. The SFDA
reviewed 11 case reports,
three of which supported
the association, and the lit-
erature.
THE PHARMA WORLD 93
What’s the Best Approach
to Treating BPH?
There’s no one-size-fits-all approach when Prescription Medications
you have an enlarged prostate and you’re try- Three types of medications are available to
ing to decide what to do next. People react in treat moderate BPH. Each works differently in
their own way to the symptoms of benign the body, and each has its own side effects.
prostatic hyperplasia (BPH), a common con-
dition for men as they age. You can talk about The three classes of drugs for an enlarged
your symptoms with your doctor, and togeth- prostate are:
er you can decide on the best way for you to
handle your case. Your options may include: • Alpha blockers, which relax muscles of
the prostate and neck of the bladder to
• Watchful waiting and lifestyle changes relieve symptoms. Examples of alpha
• Medications or supplements blocker medications include: alfuzosin
• Surgery ,doxazosin, tamsulosin, and terazosin.
Watchful Waiting • 5-alpha reductase inhibitors (5-
If your symptoms don’t bother you much and ARIs), which help shrink the prostate and
you haven’t gotten any complications, you prevent additional growth. Examples of
may choose to just have you and your doctor 5 ARIs include: dutasteride and finaster
keep a regular eye on things. This means see- ide.
ing your doctor once a year -- or sooner if
your symptoms change. • Phosphodiesterase 5 inhibitors (PDE5
inhibitors), which have been shown
Some things to watch include: to improve prostate symptoms by
increasing flow rate. Examples of PDE5
• Needing to pee a lot inhibitors include: sildenafil, vardenafil,
• The sensation that your bladder is full, tadalafil, and a more recently approved
drug, avanafil.
even after you’ve just gone
• An urgent need to go out of the blue Men with very enlarged prostates may need
• A weak stream or dribbling at the end combination therapy, to reduce the need for
• Trouble starting surgery. However, men taking both might also
• Having to stop and start peeing several get hit with the side effects of both drugs.
times Procedures
• Urine leakage Sometimes BPH doesn’t respond enough to
lifestyle changes, medications, or supple-
If you choose to monitor or observe there are ments. In that case, there are both minimally
a couple of things you can do to ease things: invasive procedures and surgical options avail-
able. With the minimally invasive procedures,
• Make simple changes in your hab- doctors make much smaller cuts or are able
its. Drinking fewer liquids before bedtime. to work with probes they insert through penis.
Drink less caffeine and alcohol generally. These types of treatments often mean faster
recoveries and less pain and scarring.
• Avoid some over-the-counter medi-
cations. Take a pass on cold and si-
nus medicines that have decongestants or
certain antihistamines, such as diphen-
hydramine (Benadryl), that can make
a prostate problem worse. Read labels on
these products before you buy them.
94 THE PHARMA WORLD
What can you do to prevent or WORTH KNOWING ABOUT
delay diabetic kidney disease?
Diabetic kidney disease is a potential compli- People with chronic kidney disease need
cation of diabetes. Over long periods of time, to limit the amount of potassium they con-
insufficiently controlled blood sugar can lead sume because their kidneys cannot process
to kidney damage. While it is not possible potassium properly, causing it to build up in
to reverse kidney damage, people can pre- the blood. Medications used to treat kidney
vent or delay kidney disease. Evidence sug- disease can also raise potassium levels. One
gests that 1 in 3 adults with diabetes may the best ways to manage potassium levels is
have chronic kidney disease. by making dietary changes. This may mean
avoiding high-potassium foods and replacing
Diabetes can harm the kidneys by: them with low-potassium alternatives.
• Damaging blood vessels: Over time, High-potassium foods to avoid
high blood sugar levels can cause mi-
crovascular damage due to the extra People with CKD should avoid or limit foods
stress on this filtration system. that are high in potassium. High-potassium
levels can cause serious symptoms, including
• Increasing blood pressure: Damage an irregular heartbeat and muscle cramping.
to blood vessels and kidneys due to Low-potassium levels can cause muscles to
diabetes can also cause hypertension. become weak.
This increase in blood pressure can
put further strain on blood vessels Some high-potassium foods that people with
around the kidneys, causing them to CKD should limit or avoid include:
narrow, weaken, or harden.
• nuts
• Damaging nerves: Hyperglycemia can • beans and legumes
also cause nerve damage, or diabetic • potatoes
neuropathy. A type of this condition • bananas
that health experts call autonomic neu- • most dairy products
ropathy can affect functions such as • avocados
urination. This can lead to a person not • salty foods
knowing when their bladder is full. This • fast foods
pressure can also cause further damage • processed meats, such as luncheon
to the kidneys.
meats and hot dogs
Tips for healthy kidneys • bran and whole grains
• spinach
There are many steps people can take to en- • cantaloupe and honeydew
sure the health of their kidneys, including: • tomatoes
• vegetable juices
• exercising regularly
• following a balanced diet Dietary restrictions can help prevent further
• staying hydrated damage to the kidneys in those with CKD.
• adhering to treatment plan
• reaching blood glucose and blood pres-
sure goals.
• quitting smoking
• limiting or avoiding alcohol consumption
• modifying the diet, for example, by eat-
ing less salt and protein
• getting sufficient sleep
THE PHARMA WORLD 95
Nifedipine: Risk The TGA has announced that the traindicated in pregnancy and during
of pulmonary product information for nifedipine lactation. The TGA reviewed four ad-
oedema when products has been updated to pro- verse event reports involving off-label
used in pregnancy vide new information about the risk use of nifedipine in pregnancy. The
of acute pulmonary oedema when risk was higher in cases of multiple
used as a tocolytic agent (inhibiting pregnancy (twins or more), with an
myometrial smooth muscle contrac- intravenous administration route or
tions) for the treatment of preterm concomitant use of beta-2 agonists.
labor in pregnancy. Nifedipine is con-
Ivermectin: Risk Hydrocortisone: Hypertrophic
of disturbed cardiomyopathy in infants
consciousness
The MHLW and the PMDA have announced that the
The MHLW and the PMDA have product information for hydrocortisone preparations
announced that the product in- (oral and injectable dosage forms) should be revised
formation for ivermectin should to include the risk of hypertrophic cardiomyopathy in
be revised to include the risk of neonates and infants. Hydrocortisone preparations
disturbed consciousness. Iver- are used for various indications including endocrine
mectin is indicated for the treat- and allergic diseases. The MHLW and the PMDA re-
ment of intestinal strongyloidia- viewed cases of hypertrophic cardiomyopathy report-
sis and scabies. ed in neonates and infants treated with hydrocorti-
sone preparations overseas.
Tramadol: Risk of urinary retention
India. The NCC-PvPI, IPC has advised the procedures and surgical pain. NCC-PvPI, IPC
CDSCO to revise the PIL for tramadol to in- reviewed seven reports of tramadol-associ-
clude urinary retention as an adverse drug ated urinary retention and a causal relation-
reaction. Tramadol is indicated for the treat- ship between them was found.
ment of moderate to severe pain, diagnostic
Remdesivir: Potential Sertraline: Potential risk RED ALERT
risk of sinus bradycardia of microscopic colitis
Health Canada has announced that it will The Health Sciences Authority (HSA) has an-
work with the manufacturer of remdesi- nounced that it is working with the manufactur-
vir to update the product information to ers of sertraline-containing products to update
include a warning on the potential risk the product information to include microscop-
of sinus bradycardia. Sinus bradycardia ic colitis as an adverse event. Microscopic coli-
occurs when the heart beats slower than tis is a rare inflammatory disorder of the colon.
normal. Remdesivir is indicated to treat Sertraline is a selective serotonin reuptake in-
COVID-19 in adults with pneumonia who hibitor (SSRI) indicated for the treatment of de-
require oxygen. Health Canada assessed pression, obsessive compulsive disorder, panic
case reports of sinus bradycardia in pa- disorder, post-traumatic stress disorder, social
tients receiving remdesivir in their data- phobia and pre-menstrual dysphoric disorder.
base and in the literature and concluded The HSA reviewed a case-control study, three
that a link between the use of remdesivir case reports of microscopic colitis related to
and the risk of sinus bradycardia is pos- the use of sertraline and the decisions by other
sible. regulatory authorities.
THE PHARMA WORLD 97
TECHNOLOGY Bladder-on-a-Chip and Bladder
Organoids Reveal Dynamics of UTIs
UTIs are a common infection, which can recurring urinary tract infections (UTIs).
frequently reoccur, even after treatment The first involves bladder organoids,
using antibiotics. With drug-resistant bac- which allow the researchers to study
teria on the rise, understanding how and bacterial-bladder cell interactions un-
why UTIs reoccur is important. Swiss re- der realistic conditions, which include
searchers developed two complementary the 3D multi-layered architecture of the
benchtop bladder models that could help bladder wall. The second is a bladder-
in understanding the mechanisms behind on-a-chip, which includes additional
features that mimic the bladder envi-
ronment, including the mechanical ef-
fects of bladder filling and voiding and
bladder vasculature. “By imaging mul-
tiple organoids, we managed to identify
heterogeneity and diverse outcomes of
host-pathogen interactions. This proof-
of-concept system has shown promis-
ing potential for follow up studies on
bacterial persistence to antibiotics and
the dynamics of immune cell responses
to infection,” said a researcher involved
in the project.
AI System Spots AI Powered
Prostate Cancer During Localized Prostate
Routine CT Scans Cancer Therapy
Researchers in Australia created an AI system Avenda Health, a US based medtech
that can identify prostate cancer during routine company developed a Focal Therapy
CT scans. It is typically difficult to spot prostate System that uses AI to design a per-
cancer in CT images. However, if men are under- sonalized treatment plan for each
going abdominal or pelvic scans for other rea- patient. Using a large database of
sons, this latest system can help spot prostate cancer imaging and pathology, in
cancer and let clinicians initiate early treatment. conjunction with a patient’s own clin-
The Aussie researchers trained their AI software ical information, a cancer probability
to identify prostate cancer in CT scans using a map and treatment plan is created to
dataset of scans of asymptomatic men with and calculate precisely where treatment
without prostate cancer. So far, the system has should be applied, preserving the
been able to rapidly identify subtle signs of can- nerves around the prostate and the
cerous growth, and outperformed radiologists urethra. The system recently received
who viewed the same images. FDA breakthrough device designation.
98 THE PHARMA WORLD
Implantable Bladder Wrap for
Improved Urinary Control
Researchers have developed an
implantable device to solve prob-
lems with underactive bladder.
Current treatments for underactive
bladder include drug therapy, sur-
gery or self-catheterization, which
present various drawbacks ranging
from limited efficacy, side-effects,
pain, and inconvenience. The new
device is designed to avoid such
inconveniences. The device is a
polymer wrap that encircles the
bladder and can expand and contract as the bladder fills and empties. It also
contains sensors that can detect when the bladder is full and needs to be
emptied. The device can then send a signal to an electric thread which begins
contracting, providing mechanical assistance in emptying the bladder.
First Dedicated Advanced Tissue Control INNOVATION
Pediatric and System to Treat Benign
Neonatal Acute Prostatic Hyperplasia
Dialysis Machine
Released US Teleflex has launched the Urolift Advanced Tissue
Control system, a product designed to treat patients
Medtronic is releasing The Carpedi- with benign prostatic hyperplasia (BPH). The system
em (Cardio-Renal Pediatric Dialysis can be used to open the urethra by inserting small
Emergency Machine), the industry’s implants that hold the lobes of the prostrate in a re-
first and only dedicated pediatric and tracted position. The device is specifically tailored to
neonatal acute dialysis machine. Hav- treat those with challenging prostatic anatomy, in-
ing now received FDA marketing au- cluding those with large lateral lobes and an obstruc-
thorization, Medtronic is now making tive median lobe. The Urolift system aims to provide
it available to hospitals throughout a minimally invasive approach to treating the condi-
the US. tion and does not require an incision or destructive
enlargement of the urethra. Patients can be treated
The continuous renal replacement in an outpatient procedure that takes only about
therapy (CRRT) device is indicated for an hour or two. A urologist can advance the device
patients between 2.5 and 10 kilograms into the urethra under cystoscopic visualization, and
(5.5 to 22 pounds) with acute kidney
injury, or that are fluid overloaded, then use it to insert small implants
and requiring hemodialysis or hemo- around the enlarged prostatic
filtration therapy. lobes, pushing them aside
to create more space.
Typically, CRRT machines designed
for adults are used off-label to treat THE PHARMA WORLD 99
neonates and young children, and the
Carpediem device overcomes some of
the limitations and risks associated
with that approach.
The words you are searching are inside this book. To get more targeted content, please make full-text search by clicking here.
Nephrology and Urology
Discover the best professional documents and content resources in AnyFlip Document Base.
Search