TPW July-August 2022

formation exists on the Prevalence of reproductive tract Vitiligo mostly affects people with skin types III and I
infections/ STI. and has been associated with a variety of skin conditions,
eg, atopic dermatitis, psoriasis and alopecia areata. Un-
Research on STI in Bangladesh is low and studies sug- fortunately there is Paucity of data on the cause of vitiligo.
gest low prevalence of infection in the general population
with 1% of women in rural population having gonorrhea. Many studies have documented a higher incidence of
vitiligo among Patients suffering from systemic disorders,
Is Herpes Simplex dangerous long term? especially autoimmune disorders. More than 10% of Pa-
How is it treated? Is it curable? tients with pernicious anemia have been reported to de-
velop vitiligo. Defective vitamin B-12 absorption has been
As the infection lasts for lifetime, people experience re- observed in vitiligo cases.
peated symptoms during reactivation. Herpes simplex vi-
rus typically doesn’t cause severe problems but it can be Vitiligo has been reported to be associated with thyroid
dangerous in infants & people with low immune systems. disorder in 0.6%- 38% of Patients. But treatment of thyroid
The following complications may develop in long term – disorder does not alter the course of vitiligo.

l Herpetic pharyngitis. Diabetes mellitus reportedly occur in 1% - 7% of vitiligo
l Herpetic arthritis patients but link between the two is not clear. An intimate re-
l Aseptic meningitis lation between vitiligo and melanoma has been highlighted.
l Urinary retention
l Erythema multiform & Steven-Johnson Syndrome The course of the disease is unpredictable and uncertain.
l Dissemination of herpetic infection in immunosup- Many lesions remain static for an indefinite period, some
show, and spontaneous regression. At times pigmented
pressed individuals. sports in response to some therapy disappear but may
l Women with recurrent HP are prone to CA & advised reappear. Complete spontaneous cure is rare.

yearly checkup. There is no indicator for permanent or good prognosis. In
Treatment: As per WHO recommendation, following regi- absence of a clear understanding of pathogenesis there is
men has been advised. Tab- Acyclovir 400mg 3 times daily no ideal treatment. Some medications help, surgical treat-
for 10 days. ment and cosmetic camouflaging and bleaching are the
available managements.
The infection last for lifetime. After epithelial inocula-
tion, the virus travels along the sensory nerves to reach Despite the efforts to eliminate leprosy as a public
the regional sensory ganglia, via retrograde intra axonal health threat, Bangladesh’s leprosy burden is still
transport. very high. Why is that so? What can be done to prevent
permanent damage in patients with leprosy?
In the ganglia, the virus remains dormant. It may be re-
activated either by ganglionic or skin trigger. In the former, Leprosy is a disease which causes Neuropathy by affecting
on reactivation the virus travels down the peripheral nerve the skin and peripheral Nerves resulting long-term conse-
to the epidermal cells, producing skin lesions. In the latter, quences including deformities and disabilities.
microfoci of infection are continuously produced but are
eliminated by the immune defenses. Despite its efforts to eliminate leprosy as a public health
threat, Bangladesh leprosy burden ranks fourth- highest in
However, if the immunity is lowered, these microfoci the world. Still about 4000 fresh cases are being detected
become symptomatic. Deactivation may be triggered by fe- every year is Bangladesh, and 8% suffer from disabilities.
ver, infection, menses, physical trauma, emotional stress,
sunburn, administration of corticosteroids & immunosup- The disease is associated with stigma, especially when
pressive drug. Hence it is assumed that this infection is deformities are present. The fight against leprosy has
incurable. achieved considerable success. But now detection rate of
this disease is slowly declining.
What causes vitiligo? Are there any trigger
factors for onset of vitiligo? Is there any Are there any innovations on the horizon that you feel,
permanent solution for vitiligo? are particularly note-worthy in the field of dermatology?

The origin of the term vitiligo is obscure. Vitiligo denotes Newer drugs have opened newer horizon in the field of
an acquired primary, usually progressive, melanocyto- dermatology which includes rarest diseases even with ge-
penenia of unknown etiology. netic etiology. The breakthrough that has been described
as phenomen one such is the biologics such as- Infliximab,
The disease affects subjects of either sex with a herita- ustekinumab, Rituximab, Secukinumab, Etanersept.
ble constitutional predication. The possibility of the inher-
ent instability of the cells of melanocyte system in afflicted Once dreaded disease like- Pemphigus Vulgaris, Psoria-
individuals has long been postulated. sis can be mentioned.

Vitiligo affects all races all over the world. Highest inci- These new drug has opened newer horizons of all pain-
dence has been reported is Indian subcontinent and Mex- ful limitations, once un-thought of and good news is many
ico (3% - 4%). In Indian sub-continent there is erroneous more such drugs are on its way of production. All these
notion that dietary intake of Vitamin C worsens vitiligo. have increased the quality of life of patients.

THE PHARMA WORLD 51

PHARMACOVIGILANCE Rising tide in adverse
drug reactions

Researchers at the University of Liverpool have Dr Rostam Osanlou, Specialist Registrar in
identified an increasing trend in medicine- Clinical Pharmacology, said: “Our work suggests
related harm leading to hospital admission. adverse drug reactions place a significant bur-
The trend is connected to a rising tide of mul- den on patients and hospital admissions. This
tiple long-term health conditions (called multi- has a large associated cost to the NHS (over £2
morbidity) associated with the use of many med- billion pounds per year) and further efforts in
icines simultaneously (called polypharmacy). this area could both improve patient care and
This prospective observational study formed an save money for the NHS.”
update to the original seminal study published by
Professor Sir Munir Pirmohamed and colleagues in Dr Lauren Walker, Senior Clinical Lecturer at
the BMJ in 2004. At that time, 6.5% of hospital ad- the University of Liverpool said: “It is important
missions were found to be associated with adverse for patients to report any adverse drug reactions
drug reactions (ADRs). This updated figure identi- to the MHRA via the yellow card system. It is im-
fies a significant increase in that burden, rising to portant for patients to discuss any side effects
16.5% of admissions being caused by, or compli- with their healthcare professional, and they
cated by, an adverse reaction to a medicine. should not stop medicines of their own accord.”
Polypharmacy is usually defined as taking
five or more regular medicines. The researchers Professor Sir Munir Pirmohamed, David
identified that those who suffered an ADR were Weatherall Chair of Medicine said: “Our updat-
on average taking more medicines and had more ed analysis highlights the continuing burden
comorbid conditions than those without an ADR. placed on patients and the NHS by adverse drug
Polypharmacy can become burdensome for reactions. There is no single simple solution to
patients, particularly when it occurs in the context prevent this, and therefore a multi-layered ap-
of overprescribing, that is, where people are giv- proach, ranging from education on better pre-
en medicines they don’t need or want, or which scribing through to the use of technologies is
may do them harm. Overprescribing has grown needed. This would be consistent with the aims
dramatically over the last 25 years. This was high- of the NHS long-term plan.”
lighted in a recent NHS report on overprescribing
which stated that 10% of prescriptions (approxi- The researchers’ analysis suggests that the
mately 110 million) should not have been issued. annual cost of ADRs causing hospital admission
This updated study confirms that the problem is at least £2 billion. A concerted national effort,
is increasing and that a whole-systems approach beyond those outlined in the NHS overprescrib-
is needed to address the societal, systemic and ing report, is needed to improve the benefit-risk
cultural contributors to overprescribing. balance of prescribed medicines, and thereby
reduce the burden of ADRs on patients and
healthcare services.

Source: ScienceDaily.

52 THE PHARMA WORLD

Pharmacovigilance ARTICLE
in Bangladesh:
Scope, challenges
and way forward

Dr. Md. Akter Hossain (M. Pharm, PhD)
Deputy Director, DGDA, and
Focal Point, National Pharmacovigilance Centre

Abstract Introduction

Medicines are essential components for sav- World Health Organization (WHO) defines Phar-
ing lives and improving population health and macovigilance (PV) as the science and activities
quality of life. We should also be in mind that relating to the detection, assessment, under-
there are risks also in the use of medicine be- standing and prevention of adverse effects or
sides its usefulness. There is a common practice any other drug-related problem. Pharmacovigi-
in Bangladesh to sell and use medicines with- lance basically targets the safety of medicine.
out any prescription from a registered doctor- Medical doctors, Pharmacists and Nurses have
which is unfortunate. The country’s easy access a crucial role in health systems to maintaining
to medicines and/or the general public’s igno- the rational and safe use of medicine as they
rance or carelessness towards medications are are experts in patient management & medica-
major causes. As a result, most of the essential tion. Effective role-playing of healthcare pro-
life-saving antibiotics are becoming resistant, fessionals will improve the outcome of the
many medicines are not showing therapeutic pharmacotherapy as well as identify adverse
effects in the human body against diseases. drug reactions earlier than others thereby re-
ducing high healthcare costs.
To protect public health from such a disas-
ter, it is an urgent demand of time to ensure Pharmacovigilance is the study of detect-
the safer use of medicines and to take the right ing the undetected adverse effects of any drug
steps to search for more harms (if any). Phar- after global marketing when the drug is con-
macovigilance is one of the important func- sumed by millions of patients over the years. PV
tions of the Directorate General of Drug Admin- data are vital to ensure on-going safety and
istration (DGDA), the National Drug Regulatory effectiveness of medicines and to provide in-
Authority (NRA) to ensure the safer use of med- formation concerning regulatory actions such
icines and vaccines which reflects on patient’s as drug safety alerts, labeling changes to the
safety. Pharmaceutical companies, Hospitals, product information, drug recalls or withdrawal
Public Health Programs are coming forward of a drug from the market. These activities are
to conduct Pharmacovigilance activities as re- important for identifying adverse events and
quired. It is expected that the rational and safer understanding, to the extent possible, their na-
use of medicines would be ensured by increas- ture, frequency, and potential risk factors. 
ing awareness and active participation of all
related stakeholders in Pharmacovigilance in According to the WHO, in many developing
Bangladesh. countries patients are not adequately safe-
guarded from accessing harmful and ineffective
Keywords medicines due to poor PV systems.  This may
result in treatment failures. The WHO Uppsala
Directorate General of Drug Administration monitoring program recommends that, ideally,
(DGDA), Pharmacovigilance (PV), Adverse Drug a national PV center should send over 200 re-
Reaction (ADR) reporting, Healthcare profes- ports per million inhabitants per year. The re-
sionals (HCPs), health system, Rational Use of porting rate for ADRs was low.
Medicines or Vaccines, Marketing Authorization
Holders (MAHs), Now a days, the rate of morbidity and mor-
tality has increased due to ADRs. Research

THE PHARMA WORLD 53

showed that in the USA estimate for about 30% of hos- ADE reporting status up to 2021
pital admissions, and costs around $170 billion yearly be-
cause of ADRs.  Geriatric patients are at high risk of suf- 1400
fering ADRs, most of which can be preventable. There are
different factors that are responsible for ADRs. In a study 1193
on PV it was observed that 50% and 44.2% of respondents
thought that the unethical practice of the healthcare pro- 1200
fessionals and polypharmacy correspondingly was the
main factors for ADRs. 1000 740 704 563
665
Pharmacovigilance in Bangladesh & Flowchart 800
476
In Bangladesh, DGDA has started PV in 1996 with the support 600
of WHO. Then ADRM Cell was established and some steps
were taken to build awareness and communication. But the 397
initiatives become dormant owing to lack of adequate sup-
port, funding, legislation, knowledge, and attitudes of the 400
stakeholders. In 2013, DGDA has restarted these activities
by reforming ADRM Cell and conducting PV activities with 200
the support of the USAID-MSH/SIAPS program.
0 2015 2016 2017 2018 2019 2020 2021
Ministry of Health & Family Welfare reconstituted ADR
Advisory Committee (ADRAC) for causality assessment, Breakdown of ADE reports received in 2021
case review and providing regulatory recommendations
when needed to NRA related to drug safety issues. Min- Multinational
istry also declared DGDA as the National Drug Monitoring Pharma Company
Centre through a notification issued on 03.09.2013. A tech- National Pharma
nical subcommittee (TSC) of ADRAC is also functioning for Company
risk-benefit assessment of the pharmaceutical products Pharma Importer
based on Individual Case safety Reports (ICSRs) and any Hospitals
drug safety decisions or signals published in recognized PHP
journals (i.e. WHO Pharmaceutical newsletters, The Phar-
ma World). Bangladesh is the 120th full member country of country have formed PV cell/team within the company for
the WHO-Uppsala Monitoring Centre (WHO-UMC), Sweden. conducting PV and providing reports/statements to ADRM
cell of DGDA. Other companies are also coming forward to
Initially, only multinational companies had there PV do the same. As per Drug Policy 2016 with request from
structure and activities in Bangladesh. At present most DGDA all the 100 and above bed hospitals have been in-
of the big/large scale pharmaceutical companies in the structed by Directorate General of Health Services (DGHS)
(vide memo no DGHS/hos/5113 dated 05 Dec 2018) to form
PV team/ committee for searching and reporting Adverse
Events (AE) if found in the patients in the hospitals. DGDA

Pharmacovigilance Work Flowchart, Bangladesh

COVID-19 Vaccines EPI Vaccines Drugs and other vaccines
Online Reporting by UHFPOs, CHOs/MMOs, District PV Committee
RPs/RMOs, Statisticians, HO, AHO,
SIMOs/Zonal Officers, Civil Surgeons, Online/Offline AEFI Reporting from Serious Online/Offline ADE &
MAH/Distributor, Superintendent/Head National and Sub-national levels ADR/AEFI AEFI Reporting
of Private Health facilities. investigations
Investigation of Serious AEFI by District/City District/City Corporation AEFI
Corporation AEFI Committee for COVID-19 Investigation Committee Adverse Drugs Reaction Monitoring
Vaccines AEFI Expert Review Committee of (ADRM) Cell for preliminary assessment
Causality Assessment by Divisional AEFI EPI for Causality Assessment Technical Sub Committee for Causality
Causality Assessment Committee for Assessment
COVID-19 Vaccines
National AEFI Advisory Committee for Adverse Drug Reaction Advisory Committee (ADRAC)
COVID-19 Vaccines for regulatory recommendation/decision

DGDA

MoHFW/other stakeholders Regulatory Actions WHO-UMC VigiFlow

54 THE PHARMA WORLD

is receiving AEs from hospitals and public health programs Guide documents and legal framework
(i.e. EPI, NTP, Kala-azar). Incoming AE reports from different
sources are increasing over time. Safety issues of the drug products are very much concern
with DGDA’s registration process from the beginning. How-
Safety Surveillance of COVID-19 vaccines ever, the National Drug Policy 2016 {section 4.13 Effective
Monitoring of Pharmacovigilance or Adverse Drug Reac-
As per instruction of the ministry of health & family wel- tions (ADR)}, PV guidelines, EPI safety surveillance guide-
fare, DGDA has developed the Pharmacovigilance Protocol lines, COVID-19 safety surveillance protocol are the guide
for COVID-19 vaccines and is receiving Adverse Event Fol- documents for Pharmacovigilance in Bangladesh.
lowing Immunization (AEFI) reports of COVID-19 vaccines Directorate General of Drug Administration (DGDA)
through online system. There are four levels of committee launched on 15 August 2018 the National Guideline on
in this regard. the Pharmacovigilance System in Bangladesh to provide
a basic framework for detection, assessment, understand-
l Pharmacovigilance & COVID-19 Safety Surveillance ing and prevention of adverse effects of pharmaceutical
Cell (for Scrutinizing & Primary evaluation) products. Such products include, vaccines, medical de-
vices, biologics, blood products, herbal medicines as well
l District/City Corporation AEFI Committee (for Investi- as traditional and complementary medicines. It was an
gation of Serious Adverse Events) initiative to ensure the safety and efficacy monitoring of
pharmaceutical products in Bangladesh.
l Divisional AEFI Causality Assessment Committee (for
Causality Assessment of SAEs using WHO causality as- Ministry circular mandating pharmacovigilance has been
sessment tools) published in the Government Gazette and PV issues have
been mentioned clearly in the proposed new Drugs Act 2022
l National AEFI Advisory Committee for COVID-19 Vac- awaiting for final approval in the National Parliament.
cines (Overall assessment and necessary decisions
for making the vaccination safe) Pharmacovigilance activities at DGDA in brief

AEFI Reports for COVID-19 Vaccines received at l Publishing PV Newsletter regular basis
DGDA online platform (as on 20 August 2022) The Pharmacovigilance newsletter provides the latest

Total number of AEFI cases 4386 information on the safety of medicine, vaccines & regula-
Non-Serious 4305 tory decisions of the Directorate General of Drug Adminis-
Serious tration (DGDA). It is one of the important means of com-
Reviewed by the National AEFI Advisory Com- 81 munication with the pharmacovigilance stakeholders of
mittees 71 Bangladesh and international organizations. It includes the
Investigation/causality assessment ongoing status of the evaluation of AEFI of COVID-19 vaccines, ADR/
10 AEFI of drugs and other vaccines (other than EPI program

Total 71 Serious AEFI cases reviewed by the National AEFI Advisory
Committee for COVID-19 vaccines

Type Serious AEFI Astra Zeneca Pfizer Sino Pharm Mordena Sinovac
Number

Vaccine Product Related 24 9 4 8 3 –
Reaction (33.8%)

Coincidental (42.2) 30 21 1 7 1 –

Immunization Anxiety 6 2 1 2 1 –
related Reaction (8.5%)

Indeterminate (15.5%) 11 1 1 8 0 1

TOTAL 71 33 7 25 5 1

THE PHARMA WORLD 55

vaccines), regulatory decisions of other National Regula- ening PV system in Bangladesh. It was conducted virtually
tory Authorities, Signals detection, Training, coordination division-wise in eight phases. It also covered the govt. level
with different stakeholders and the regulatory decisions graduate officers from Unani, Ayurvedic and Homoeopathic
and actions. It also covers the news of PV visit to the Phar- systems of treatment. More than 800 healthcare profession-
maceutical companies, Hospitals and health programs. als/officials have been trained. Bangladesh Association of
Pharmaceutical Industries (BAPI) has arranged four phased
l Conducting regular meetings and communication training on PV with DGDA collaboration at BAPI office meet-
DGDA is conducting regular meetings with the PV stake- ing room this year and provided targeting 100 Pharmaceuti-
cal companies for understanding PV and encouraging them
holders and communication as required. ADR monitor- to provide ADE reports to DGDA. It has been completed suc-
ing cell meets ones a month, Technical Subcommittee cessfully. In the recent financial year DGDA has also taken
meets quarterly and ADR Advisory Committee (ADRAC) similar initiatives. Awareness materials (i.e. posters, leaflets,
usually meets half yearly. Committees at DGDA for COV- pamphlets) distribution and video playing are also usual
ID-19 vaccines’ Pharmacovigilance also meet frequently practices of DGDA for creating awareness on PV.
when needed. The responsibilities of a pharmacovigi-
lance professional include conducting the risk-benefit l Visiting Pharmaceutical companies, Hospitals and
analysis;  tracking all drug-related reports; reviewing and Public health Programs
assessing all drug-related documents; entering database ADRM cell members plan-wise visit to the Pharmaceuti-
reports and performing label assessments.
cal companies, Hospitals and public health Programs to
l Conducting Training and Awareness program increase the bonding, sharing Pharmacovigilance knowl-
DGDA is building its capacity within the team mem- edge and practices and strengthening PV system & team
working within the organizations or institutions.
bers by gathering training and also conducting training-
workshops for enhancing knowledge, improving skills and DGDA is providing all the safety information and regula-
strengthening the Pharmacovigilance system within the or- tory decisions in the website for transparency and massive
ganizations or institutions and developing reporting culture exposure. Through letter, email, phone, fax and awareness
in Bangladesh. Almost all of these activities are being done materials or scientific publication based on data DGDA
by technical supports from USAID MTaPS, a development provides safety information to the MAHs, HCPs and public.
partner. WHO is also providing support in some area. DGDA
got some budget in the previous financial year (2021-’22) for Outcomes
PV training and arranged mass training program for all level
PV committees working in the national and sub-national Awareness among MAHs, HCPs & public, participation of
levels (divisions, districts and city corporations) strength- MAHs & Hospitals in PV increasing and PV system within
the organization strengthening gradually. Coordination
with PHPs is improving in Safety Surveillance. Academic
institutions of HCPs are including PV in the course cur-
riculum and teaching their students. Growing attention to
both in public and private level.

WHO Global Benchmarking of DGDA

DGDA has faced WHO interim benchmarking assessment in
Sept 2018 followed by a formal benchmarking assessment
in July 12-23, 2021for achieving WHO Maturity Level 3, which
is a recognition of a functional NRA. Pharmacovigilance is
one of the nine functions of a DGDA and scored the high-
est (88%) marks in the formal benchmarking with WHO-
Global Benchmarking Tools. As per WHO assessors’ recom-
mendation of a working committee has been formed for
updating the PV guidelines and developing Good Phar-
macovigilance Practices (GVP) guidelines for Marketing
Authorization Holders. The committee has conducted a
series of meetings and discussions, developed and sub-
mitted a final draft of the GVP guidelines to the Director
General of DGDA & Chairperson of ADRAC for taking the
necessary steps for final approval.

Scope of Pharmacovigilance

Pharmacovigilance is a continuous process designed for
safety evaluation accompanied by steps to improve safe
usage of medicines. It is a science important to reverse

56 THE PHARMA WORLD

most of the adverse effects by modifying the dose or omit- graduation level of education for the healthcare profes-
ting the offending drug. Pharmacovigilance knowledge on sionals and also in other educations.
the safety of drugs is obtained from clinical usage prac-
ticed daily involving patients, health professionals, regula- Positive pharmacovigilance throughout the product
tory authorities and pharmaceutical companies. Pharma- life cycle is the way forward and the future direction for
covigilance in companies is characterized in monitoring drug safety. There is an immense need to understand and
safety of the drug post-launch. implement pharmacovigilance and it is also important to
build, maintain and implement a robust pharmacovigi-
Challenges lance system for various stakeholders in Bangladesh. All
the stakeholder especially healthcare professionals are
l Required capability to understand PV and to detect expected to come forward for conducting Pharmacovigi-
drug risks & ADR lance activities and to provide ADE & AEFI reports regular
basis to DGDA
l Lack of human, technical and financial resources
l Large number of different PV systems and large num- Conflict of Interest: There is no conflict of interest.

ber of stakeholders Acknowledgements: The author is grateful to the honor-
l Awareness, knowledge, skill, attitude, trust and con- able Director General and ADRM Cell of DGDA.

fidence References
l Under reporting and quality of adverse event reports
l Timely reporting, investigation and causality assess- WHO. WHO | Pharmacovigilance. WHO. https://www.who.int/medicines/
areas/quality_safety/safety_efficacy/pharmvigi/en/. Published 2015.
ment Accessed February 28, 2019.
l Lack of partnership, trust, collaboration and proper
Hossain A. M, Amran S. M. A Cross-Sectional Pilot Study on Pharmacovig-
coordination ilance to Improve the Drug Safety in Bangladesh. Biomed Pharmacol J
l Engagement of patients & hcps and implementation 2019;12(3).

of guidelines. WHO. WHO | The Anatomical Therapeutic Chemical Classification Sys-
tem with Defined Daily Doses (ATC/DDD). WHO. https://www.who.int/
Way forward classifications/atcddd/en/. Published 2010. Accessed February 28, 2019.

l Mindset towards pharmacovigilance and team building Meyboom RHB, Egberts ACG, Edwards IR, Hekster YA, de Koning FHP,
l Continuous training, education & awareness programs Gribnau FWJ. Principles of Signal Detection in Pharmacovigilance. Drug
l Strengthening of PV systems for drugs and vaccines Saf. 1997;16(6):355-365. doi:10.2165/00002018-199716060-00002.
l Developing a good collaboration & ADE/AEFI report-
Meyboom RHB, Gribnau FWJ, Hekster YA, de Koning GHP, Egberts ACG.
ing culture Characteristics of Topics in Pharmacovigilance in The Netherlands†. Clin
l Good communication and more engagement of all Drug Investig. 1996;12(4):207-219. doi:10.2165/00044011-199612040-
00006.
level stakeholders
l Full implementation of guidelines and availability of WHO. WHO | WHO Collaborating Centre for International Drug Moni-
toring. WHO. https://www.who.int/medicines/areas/quality_safety/
tools safety_efficacy/collab-centre-uppsala/en/. Published 2015. Accessed
l Recruitment of “Graduate Pharmacists” in all the February 28, 2019.

hospitals and pharmacies Venulet J. Aspects of standardization as applied to the assessment of
l More research and development on pharmacovigilance drug-event associations.  Drug Inf J. 1984;18(3-4):199-210. http://www.
l Robust active reporting systems to complement ncbi.nlm.nih.gov/pubmed/10268551. Accessed February 28, 2019.

spontaneous reporting. S N. Importance of Pharmacovigilance and the Role of Healthcare Profes-
l Encourage reporting from all sectors of the health- sionals. J Pharmacovigil. 2018;06(01):1-2. doi:10.4172/2329-6887.1000252.

care system including patients, doctors, nurses, Biswas P. Pharmacovigilance in Asia.  J Pharmacol Pharmacother.
pharmacists, traditional and herbal practitioners/ 2013;4(Suppl 1):S7-S19. doi:10.4103/0976-500X.120941.
medicine providers (WHO 2006).
Leporini C, De Sarro G, Russo E. Adherence to therapy and adverse drug
Conclusion reactions: is there a link? Expert Opin Drug Saf. 2014;13(sup1):41-55. doi:1
Pharmacovigilance is highly important to ensure the safe- 0.1517/14740338.2014.947260.
ty of medicines and vaccines, which reflects on Patients’
Safety. Pharmaceutical companies and Healthcare provid- Heller MK, Chapman SCE, Horne R. Beliefs about medication predict the
ers are the main stakeholder for reporting any kind of side misattribution of a common symptom as a medication side effect — Evi-
effects/adverse events of drugs and vaccines. Collabora- dence from an analogue online study. J Psychosom Res. 2015;79(6):519-
tive actions between government and private institutions 529. doi:10.1016/j.jpsychores.2015.10.003.
and moral obligations must be ensured. Education for
knowledge regarding PV should be ensured in the post- Ahmed B, Nanji K, Mujeeb R, Patel MJ. Effects of polypharmacy on ad-
verse drug reactions among geriatric outpatients at a tertiary care hos-
pital in Karachi: a prospective cohort study. PLoS One. 2014;9(11):e112133.
doi:10.1371/journal.pone.0112133.

Nahar N, Karim A, Paul P, Khan T. Response of Reporting Adverse Drug
Reactions among Medical Practitioners. Bangladesh Med J. 2011;40(2):13-
18. doi:10.3329/bmj.v40i2.18498

SN A, BA D. Pharmacovigilance Practices: Knowledge and Attitudes
among the Healthcare Professionals at the Volta Regional Hospital of
Ghana. J Pharmacovigil. 2017;05(03):1-5. doi:10.4172/2329-6887.1000229.

THE PHARMA WORLD 57



“Digital technologies are on the way to INTERVIEW
help dermatologists to diagnose and
treat skin diseases more efficiently”

Prof. Dr. Md. Siraj Uddin As a tropical country, what kinds of skin
Ex. Professor and Head of Dermatology disorders are prevalent in Bangladesh?
Sylhet MAG Osmani Medical College
Senior Consultant, Dermatology Following skin diseases are more prevalent in Bangladesh:
& Aesthetics Eczema l Fungal infections l Scabies l Pyodermas l Acne
Square Hospitals Ltd, Dhaka l Hair loss l Pigmentation disorders l Urticaria l Psoriasis
l Vitiligo
Researchers are
working on various Usually, people may have acne with oily & sebaceous
innovations to shorten skin. What are the various types of skin that may suffer
the healing process from Acne? What are the reasons for Acne flare ups?
and accelerate
the human body’s There are several Skin types like Oily, Dry, Normal, Com-
natural responses for bination & sensitive skin. Among these, Oily skin reach in
more effective skin sebaceous glands are prone to develop Acne.
regeneration.
Followings are the reasons for Acne flare ups:
l Hormonal Changes.  Changes in the balance of hor-

mones, especially estrogen and progesterone, can re-
sult in severe breakouts. This is most likely to occur in
women who are pregnant, taking birth control, or going
through menopause.
l Genetics. If one of your direct relatives had acne at any
point in their life, you are more likely to develop it as
well. For many patients with hereditary acne, it is com-
mon to have flare-ups into adulthood.
l Stress. Some studies show a positive correlation be-
tween stress levels and the severity of acne break-
outs. When your body produces more androgens, it
can overstimulate oil glands in your skin, leading to
clogged pores.
l Skin & Hair Products. Makeup and certain lotions can
cause acne flare-ups to happen if they are too oily or
thick. In addition, conditioners can make the skin too
greasy if it’s not thoroughly rinsed out of your hair.
l Certain Medications. Some medications, most com-
monly steroids and birth control peels, can alter hor-
mone balances in the body and lead to acne. 
l Diet. Diet has the potential to balance or disrupt your
hormonal levels. Not only that, but some evidence
suggests that people can reduce or prevent acne
flare-ups by eating healthy and well-balanced meals.
Heavily salted food, dairy products, saturated fats,
and refined sugars, on the other hand, may cause in-
flammation and clogged pores.
l Certain lifestyle habits. Some habits may seem small
but make a big impact on the skin. Smoking and alco-
hol intake may be significant triggers for acne flare-
ups. Poor sleeping habits and frequent stress also
puts individuals at risk. Instead, patients should in-
vest in living a healthy lifestyle with positive habits,
including frequent diet and exercise.

THE PHARMA WORLD 59

60 THE PHARMA WORLD

What causes eczema or Atopic dermatitis? Can systemic therapies (e.g. Dupilumab help
Can it be cured? What can patients do to to permanently change the appearance
prevent & sooth their eczema flare ups? of the skin in Atopic dermatitis.

Eczema (atopic dermatitis) is caused by a combination of In the systemic treatment of Atopic dermatitis, Dupilumab
immune system activation, genetics, environmental triggers has been recently approved for the management of moder-
and stress. ate to severe atopic dermatitis in both children & adults. It
reduces the signs and symptoms of atopic dermatitis, in-
l Immune system.  If you have eczema, your immune cluding pruritus, symptoms of anxiety and depression, and
system overreacts to small irritants or allergens. This quality of life. Trials of longer duration are needed to assess
overreaction can inflame your skin. the long-term effectiveness and safety of dupilumab.

l Genetics. You’re more likely to have eczema if there is a What causes vitiligo. Are there any trigger
history of dermatitis in your family. You’re also at a higher factors for onset of vitiligo. Is there any
risk if there’s a history of asthma, hay fever and/or al- permanent solution for vitiligo.
lergens. Allergens are substances like pollen, pet hair or
foods that trigger an allergic reaction. Also, there might be Exact cause of vitiligo is not clear but for some reason, the
a change in your genes that control a protein that helps pigment-forming cells known as melanocytes have been
your body maintain healthy skin. Without normal levels destroyed. It might be an autoimmune condition, in which
of that protein, your skin will not be completely healthy. the body’s defense system destroys its own cells instead of
attacking invading germs and kill the pigment cells- mel-
l Environment. There is a lot in your environment that anocytes in the skin, resulting in the formation of white
can irritate your skin. Some examples include expo- patches
sure to tobacco smoke, air pollutants, harsh soaps,
fabrics such as wool and some skin products. Low hu- Vitiligo may be triggered by events such as:
midity (dry air) can cause your skin to become dry and l Stressful events such as childbirth. l Skin damage such
itchy. Heat and high humidity can cause sweating and as severe sunburn or cuts. l Exposure to certain chemicals
that can make the itchiness even worse. at work.

l Stress. Your stress levels can cause or worsen your Treatment: The goal of treatment of vitiligo is to stop the
eczema. disease process & to restore the lost color of the skin. How-
ever, the effects of treatment are not always permanent & it
Atopic dermatitis cannot be cured completely, but there are may not control the spread of disease.
treatments that minimize the symptoms of Atopic derma-
titis. Common treatments include camouflage therapy, re-
pigmentation therapy, light therapy and surgery. Counseling
There are steps that patients can take to prevent eczema may also be recommended.
flare ups:
Are there any innovations on the horizon that you feel
l Establish a routine skin care as recommended by are particularly noteworthy in the field of Dermatology?
healthcare professional.
Digital technologies are on the way to help dermatologists
l Wear gloves for wet works. Wear cotton gloves under to diagnose and treat skin diseases better and more effi-
plastic gloves to absorb sweat, and wear gloves out- ciently.
side, especially during the winter months.
Tele dermatology service options are booming which
l Use mild soap for bath or shower, and pat your skin may connect patients from even remote places with an
dry instead of rubbing. Apply a moisturizing cream or online dermatologist for a consultation within a very short
ointment immediately after drying your skin to help time.
seal in the moisture.
Robotics: High-tech robotic platforms have been intro-
l Take baths or showers with tepid (lukewarm) rather duced as whole-body skin lesion mapping system which is
than hot. able to perform a 360-degree scan of the whole body and
identify any lesions on the skin.
l Drink adequate amount of water each day. Water
helps to keep your skin moist. In the next few years, laser therapies will be performed by
“robotic surgeons” with humans controlling the process.
l Try to avoid getting too hot and sweaty.
Tissue Regeneration: Skin wounds take a long time to heal.
l Wear loose clothes made of cotton and other natural Researchers are working on various innovations to shorten
materials. Avoid wool. the healing process and accelerate the human body’s natural
responses for more effective skin regeneration.
l Avoid sudden changes in temperature and humidity.
Development of Stem cell, Skin cell spray & extracellular
l Learn to recognize stress in your life and how to manage matrix have the potential to regeneration of organ & tissue
it. Regular aerobic exercise, hobbies and stress-man- repair.
agement techniques, such as meditation or yoga, might
help.

l Limit your exposure to known irritants and allergens.

l Avoid scratching or rubbing itchy areas of skin.

THE PHARMA WORLD 61

When health cost is a
catastrophe for a family

A recent study titled “Disease-specific distress The study comprised local and foreign researchers
healthcare financing and catastrophic out-of-pock- who analysed household survey data on 1,83,757 indi-
et expenditure for hospitalisation in Bangladesh” viduals from 45,423 households. The household sur-
shows 26% of households in the country incurred vey data covers patients who has been hospitalised
catastrophic health expenditure (CHE) on hospitali- and their hospitalisation expenditure including trans-
sation in the past couple of years. The highest inci- port cost, informal tips, and other formal charges.
dence of CHE was for cancer (50%), followed by liver
diseases (49.2%), and paralysis (43.6%). Dr Abdur Razzaque Sarker, health economist of
Bangladesh Institute of Development Studies, also
The World Health Organization labels health ex- one of the researchers of the study, said, “To reduce
penditure as catastrophic when a family’s medical out-of-pocket expenditure, medicine costs and un-
bills account for 40% or more of their income avail- necessary tests should be reduced. There should be
able after buying food. Every year, approximately prescribed guidelines for treatment. If medicine use
44 million households throughout the world face is monitored, unnecessary medicine use will be re-
catastrophic expenditure, and about 25 million duced and financial pressure on people will also be
households are pushed into poverty because of cat- lessened.” He also advocated for introducing health
astrophic healthcare payments, the WHO says, refer- insurance to check the distress financing.
ring to low household capacity, poor public budget The Health Economics Unit of the Ministry of Health
for health and lack of insurance contributions. and Family Welfare says patients spend a whopping
64% of their health expenses on medicines, while
The study also shows the CHE incidence in hos- 23% for meeting hospital expenses (indoors and
pitalisation in the country has been rising – from outdoors) and 8% for diagnosis purposes. Only 3%
14.2% (at 10% of total household consumption ex- patients receive medication from government hos-
penditure or THCE) in 2010 and 24.6% in 2016 to pitals and 14.9% obtain diagnostic services. Most
26.1% in 2021. patients have to buy medicines from private phar-
macies and go to private diagnostic centres.
The findings of the study, published in BMJ, shed
light on rising out-of-pocket expenditure and a Dr Nurul Amin, director (research) at the Health
whopping 58% of the households facing distress Economics Unit, said that government healthcare
financing on hospitalisation. Distress financing in- facilities must be more functional to reduce out-
cludes funding for out-of-pocket expenditure by of-pocket expenditure. Otherwise, it would not be
selling or mortgaging household assets, lands, bor- possible to attain the SDG target to bring down the
rowing money and receiving assistance from friends expenditure to 30% by 2030.
and relatives.

treNd of out-of-Pocket healthcare exPeNditure iN BaNgladesh

73 73.9
71 (% current health expenditure) 72.7

69

67

65

63

61 61.1
59

57

55 2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019

Source: WHO, (updated on 15 Dec 2021)

62 THE PHARMA WORLD

out-of-Pocket healthcare exPeNditure GLEANINGS FROM LOCAL PRESS
iN selected couNtries iN 2019

(% CURRENT HEALTH EXPENDITURE)

Bangladesh 34.6 72.7
India 30.2 54.8
30.2 53.8
Pakistan
Malaysia 17.1 Source: WHO, (updated on 15 Dec 2021)
South Korea 14.2
Singapore 12.9
United Kingdom 12.8
Denmark 12.2
11.3
Japan
Germany
New Zealand
United States

The government To reduce the cost burden on ing for health in the annual budget,
healthcare families, the study strongly suggests advanced economies have mas-
facilities must be introducing national-level social sive health insurance coverage with
more functional health security schemes with a par- a maximum cap for out-of-pocket
to reduce out- ticular focus on low-income house- payments for patients. The ceiling
of-pocket holds, regulating the private sector ranges between $1,688 and $3,375 in
expenditure. health cost and implementing sub- Korea depending on the personal in-
Otherwise, it sidised healthcare for cancer, heart, come of insured patients. If the cap
would not be liver, and kidney patients. in Switzerland – $728 – is concerned,
possible to attain Sirajul Islam, the Bangladeshi farm-
the SDG target to Abdul Aziz, a member of parlia- er, has already spent 13 times higher.
bring down the ment and the Parliamentary Stand-
expenditure to ing Committee on Health and Family Bangladesh’s budget allocation for
30% by 2030. Welfare, said the government has health has been less than 1% of GDP -
___ introduced health insurance in some the lowest among 46 least developed
areas on a trial basis. There are plans countries –  for the last two decades,
Dr Nurul Amin to expand the facility across the requiring families to spend beyond
Director (research), country. Studies show how health in- their means for the treatment of non-
Health Economics surance helped countries reduce the communicable diseases which need
Unit burden of health costs on families treatment and hospitalisation for
by cutting their out-of-pocket pay- longer periods. “Finally, to reduce re-
ments. Different health insurance liance on out-of-pocket expenditure,
policies for different income groups the government should consider in-
introduced in China dramatically re- creasing its allocations to the health
duced the CHE since 2007. sector,” the study concludes.

Despite their higher public spend- Source: TBS

THE PHARMA WORLD 63



“It is the high time to include dermatology
with dermatosurgery, dermatocosmetology,
dermatopharmacology under the same umbrella”

Prof. Dr. Masuda Khatun country, fungal infections are very or eczema? And in that case,
Professor common and now it is a burning how do you treat the various
Department of Dermatology & problem for the dermatologists and conditions that can sometimes be
Venereology, DMCH, Dhaka the patients. “conflicting” with each other?

What types of skin diseases For prevention, we can counsel the Acne can also appear in association
are common in Bangladesh? patients about their daily hygiene, with other diseases. In those with
Common skin diseases in Bang- change the hot humid work place, and dermatoses, where steroid is used
ladesh- l Scabies l Fungal in- try to stay in a cool place etc. Try to topically or systemically, there are so
fection at different sites at the take medications properly with dose many papular eruptions like disease
body l Acne vulgaris l Neuro- and duration, avoid taking treatment which resemble Acne vulgaris. Those
dermatitis l Atopic dermatitis l from the quacks. are milia, papular urticaria, miliaria,
Seborrheic dermatitis l Irritant xanthoma, syringoma. Diagnosis
contact dermatitis l Vitiligo l How do you determine when a should be properly done.
Psoriasis l Impetigo l Arsenico- mole needs further examination
sis l Connective Tissue disease for skin cancer? Is there an age you What causes eczema? Can it
l Skin cancers etc. believe patients should consider be cured? What can patients
having their moles evaluated? do to prevent and soothe
As Bangladesh is a tropical their eczema flare ups?
country, are fungal “ABCDE” — we can apply this formula
infections common in this to determine the mole for evaluation, Eczema is a chronic inflammatory
weather and what is your A= increase the Area of the mole, B= skin disease characterized by pruri-
suggestion to prevent this? irregular Border, C=change of Colour, tus and a chronic course at exacer-
As Bangladesh is a tropical D=change in Diameter, E= Erythema- bation and remission. There are so
tous border. Elderly patient should be many causes of eczema both inter-
examined very carefully. nal and external i.e. different infec-
tions, food allergy, aeroallergen, and
Usually people associate acne same drugs.
with oily, sebaceous skin: what
are the various types of skin that Patients should evaluate properly
may suffer from acne? What are and avoid the factors which causes
the reasons for acne flare ups? the diseases. Patients should be
counselled and awaremade about
There are three types of skin — oily their diseases.
skin, dry skin and mixed (oily+dry)
skin. Oily skin is usually acne prone As eczema is a chronic disease,
skin. Sebaceous gland activity is more it cannot be cured; it is controlled
during puberty and teenage years. So, by maintaining the hydration of the
sebum secretion is increased during body by moisturizer only. Prevention
this period. should be avoiding the trigger factors.

Sebum is composed of lipid. There Are there any innovations on
are so many factors which flare acne, the horizon that you feel, are
i.e. use of oily cosmetic products, particularly noteworthy in
some steroidal drugs or spray either the field of dermatology?
topically or systemically and un-
healthy life style. It is the high time to include derma-
tology with dermatosurgery, derma-
Can acne also appear on a tocosmetology, dermatopharma-
skin that has other problems cology under the same umbrella.
such as dermatitis, psoriasis, Dermatosurgery should be included
in the curriculum of dermatology.

THE PHARMA WORLD 65



“Psoriasis Awareness Club INTERVIEW
is a unique and innovative
dream we have envisioned”

Professor Mohammad Samiul Huq As Bangladesh is a tropical country, are
Ex- Senior Consultant , Dermatology, contagious skin diseases like fungal and parasitic
Square Hospital infections more common in this weather?
President, Psoriasis Awareness Club What is your suggestion to prevent this?
Councilor, International Psoriasis
Council (IPC) Well humid, wet and damp conditions during the rainy
season make it perfect for the growth and multiplication
Our field continues to of various fungi, but we are observing the condition to
be at the forefront of prevail all through years. Same is applied for parasitic dis-
clinical immunology eases. Overall scenario of fungal disease in Bangladesh
with new targeted is simply horrible, getting difficult to control. Drugs are
biologics providing not working, Patients compliance is inappropriate. Mal-
dramatic disease treatment and under-treatment is there. As a whole, we
responses for dermatologists are not happy regarding the outcome of
patients with serious treatment. An appropriate preventive measure is needed
inflammatory skin to control in addition to drugs. Avoid wearing tight cloths
conditions. for a longer time. Keep yourself dry particularly in groin,
armpit and neck. Wear loose cotton cloths, Control of dia-
betes is a must. Avoid scratching, Be sure to practice good
hygiene.

Scabies is a WHO neglected tropical disease which is
common in low and middle income countries with tropi-
cal climates. We all know scabies is a parasitic disease
with night itching and skin lesions. It spreads by physi-
cal contact and it occurs in crowded places, common in
hostel (School and Madrasa), even police camp. Scabies is
prevented by avoiding direct skin to skin contact with an
infested person or with items such as clothing or bedding
used by the infested person. Treatment should be given
to all members of the family.

How important is it to recognize the type of acne
for the treatment? And what are the differences in
treatments for comedonal acne compared to nodules?

Acne may be non-inflammatory or inflammatory.
Subtypes of acne within these two categories include:
Black heads, Whitehead, Papules, Pustule, nodules, cyst.
Treatment should be done according to the types of acne.

For non-inflammatory acne or mild acne: Salicylic acid
or topical retinoids.

For Inflammatory or moderate acne: Topical antibiotic,
Benzyl peroxide,or combination

Severe acne: Oral antibiotic, oral Isotretinion, Oral Con-
traceptive (For hormonal acne), Steroid injection for
Nodular acne, Surgical drainage for large cyst.

THE PHARMA WORLD 67



Can Acne also appear on a skin Through education help to permanently improve
that has other problems such the appearance of the skin
as dermatitis, psoriasis or and advocacy, we in atopic dermatitis?
eczema? What is the treatment
in such cases where various promote awareness and Eczema (Atopic Dermatitis) is caused
conditions can sometimes be by a combination of immune system
“conflicting” with each other? understanding, ensure activation, genetics, envirnonmental
triggers and stress. If you have ecze-
Acne can appear to any skin or in any access to treatment and ma, your immune system overreacts
skin conditions. Eczema and acne are to even small irritants.
two unrelated skin conditions. Their support research that
symptoms can look similar, making For preventing flare up: l Moistur-
it hard to distinguish between them. will lead to effective ize your skin often l Avoid sudden
Acne causes pimples to erupt. Eczema changes in temperature or humidity l
causes a red or discoloured, bumpy management and, Try not to sweat or get too hot l Man-
rashes, which may look like pimple. age stress, and take time for yourself
ultimately, a control. to relax l Avoid scratchy materials,
A condition called perioral der- such as wool l Don’t use harsh soap,
matitis, where pimple like outbreak muscle weakness, and joint pain. detergents or solvents
around the mouth may look like acne. People with GPP tend to have sud-
Sometime eczema, acne and rosacea Dupilumab is a biologic that may
look alike called periorificial dermati- den flares that last for a few weeks, be used to treat moderate-to-severe
tis, which is difficult to treat. Mild ir- followed by spontaneous remission AD in adults and children aged 6
ritant contact dermatitis, may cause where their skin partly or completely months and older whose disease is
small red pimple that can easily be clears up. not adequately controlled with topi-
mistaken for acne. cal prescription therapies or when
The most frequent causes for GPP those therapies are not advisable.
When bacteria mixes with the are infections, stress, corticoster- Dupilumab does effectively reduce
trapped debris and multipies, pim- oid treatment withdrawal, antifun- symptoms in the majority of people
ples can become red from inflam- gal drugs and pregnancy. GPP flares prescribed it, such as: l Itching l The
mation. This can be confused with during pregnancy are called pustular appearance of the rash l The fre-
guttate psoriasis, inflamed red spots, psoriasis of pregnancy, previously quency of AD flares l Improving skin
usually on the trunk and limbs. Acne known as impetigo herpetiformis, and quality l Improving sleep l Improving
that becomes deep pustules or cysts usually occur in the third trimester. the quality of life.
can look like another form of psoria-
sis, called pustular psoriasis. Generalised pustular psoriasis can Are there any innovations on
be life-threatening, so hospitalisation the horizon that you feel, are
SLE in young girls can be confused is usually required. The aim is to pre- particularly noteworthy in
with acne. vent further fluid loss, stabilise body the field of dermatology?
temperature and restore electrolyte
Some skin condition can cause imbalance. Specialist care is essential. Dermatology is a small field, however,
acne-like symtoms including rosacea, from an innovation stand point, we
keratosis pilaris and psoriasis. Proper Affected areas are treated with have always felt that dermatology
diagnosis must be done before start- bland topical compresses using emol- punches way above its weight.
ing the treatment, as you know there lients and low potency topical steroid
is high chance of developing steroid creams. Over the last 20 years, the in-
induced acne in these cases of ecze- creased knowledge of the underlying
ma and psoriasis. Systemic medications may include: pathophysiology of skin diseases has
l Antibiotics for confirmed or sus- led to critical insights that have yield-
Although many of us are familiar pected infection l Acitretin l System- ed new therapeutic options:
with plaque psoriasis, generalized ic corticosteroids (cautiously) lCiclo-
pustular psoriasis (GPP) is not sporin (cautiously) l Methotrexate l l Our field continues to be at the
something that many of us come Colchicine l Biologic agents including forefront of clinical immunol-
across. Please tell us, what is infliximab, etanercept, adalimumab, ogy with new targeted biologics
GPP and its treatment thereof? and Secukinamab. providing dramatic disease re-
sponses for patients with serious
Generalized Pustular Psoriasis (GPP), What causes eczema or atopic inflammatory skin conditions.
also known as von Zumbusch psoria- dermatitis? What can patients
sis, pustules often cover large areas of do to prevent and soothe their l Non-invasive laser/light and
the body and typically presents with eczema flare ups? Can systemic other energy-based products
fever, shivers, intense itching, a rapid therapies (e,g. Dupilumab) are bright spots in medical de-
pulse, fatigue, headache, nausea, vice innovation.

l Breakthrough advances in gene

THE PHARMA WORLD 69



therapy and stem cell science
hold great promise in treating
fatal blistering diseases.
l Botulinum toxin and fillers, driv-
en forward by dermatologists,
have fueled the increasing de-
mand for non-invasive aesthetic
treatments.
l Finally, artificial intelligence and
other health IT tools have al-
ready entered our field in mean-
ingful ways.

You are the Founder President
of Psoriasis Awareness Club
Bangladesh, what is the moto
of this organization?

We all know about Psoriasis and the
huge number of people this disease
affects. It is both a social and eco-
nomic burden currently affecting
nearly 125 million people worldwide.

Psoriasis Awareness Club is a
unique and innovative dream we have
envisioned. Psoriasis Awareness Club
is the first of its kind in Bangladesh
bringing together Doctors, Patients
and Social Workers together in a com-
mon quest.

Mission is to improve the quality of
life of people who have psoriasis and
psoriatic arthritis. Through education
and advocacy, we promote awareness
and understanding, ensure access to
treatment and support research that
will lead to effective management
and, ultimately, a control.

Five objectives we want to achieve
1. To provide support, encourage-
ment, and a sense of community
to psoriasis patients
2. To be the voice of psoriasis pa-
tients – to the medical communi-
ty, to the government, to officials
making decisions about health-
care and access to treatment
3. To be an authority on the dis-
ease
4. To create awareness that psoria-
sis is a serious, noncommunica-
ble, systemic disease and finally
5. If we don’t speak for those suf-
fering with psoriasis, who will?

Thank you all!

THE PHARMA WORLD 71

DERMATOLOGY QUIZ Q uestion 1 Q uestion 4

An elderly lady presents to her doctor How does impetigo present?
with a raised, round discoloured plaque, a. Golden honey coloured crust over an
‘stuck on appearance’ on her face. What erythematous base
skin condition is this? b. Salmon coloured plaque with silvery scale
c. Comedones, pustules and nodules
a. Rubella d. Flesh coloured papule with a rough surface

b. Seborrheic keratosis

c. Basal cell carcinoma

d. Melasma

Q uestion 2 Q uestion 5

What disorder is characterised by an ini- What condition is associated with acanthosis
tial ‘herald patch’ which is then followed nigricans?
by scaly erythematous plaques usually in
a ‘Christmas tree’ distribution? a. Type 2 diabetes and gastric adenocarcinoma
b. Rubella
a. Pityriasis rosea c. Varicella zoster
b. Herpes Varicella d. Basal cell carcinoma
c. zoster virus
d. Erysipelas suomauqs ngineb a si sisotarek ciehrrobeS( B .1 A
)ylredle eht ni yltneuqerf nees si dna noitarefilorp N
Q uestion 3 S
a htiw stneserp yllacissalc aesor sisairytiP( A .2 W
What is the most common causative ’hctap dlareh‘ hctap yratilos deruoloc nomlas E
agent of erythema multiforme (EM)? R
yb dewollof syad wef a revo segralne hcihw S
a. Penicillin and sulphonamides selucam cirtemmys dna laretalib desilareneg
b. Systemic lupus erythematosus -serp semitemos si sutirurP .elacs etteralloc htiw
c. HSV infection
d. Malignancy ).skeew 8 – 6 nihtiw sevloser fles tI .tne

72 THE PHARMA WORLD tnega cigoloite nommoc tsom eht si VSH( C .3
dna hsar diotegrat a sa stneserp hcihw ,ME fo
detaicossa osla era snoitpo rehto eht llA .eallub

).ylnommoc ssel tub ,redrosid eht htiw

desuac noitcefni niks laicifrepus a si ogitepmI( A .4
yltneuqerf tI .senegoyp pertS ro suerua hpatS yb

dna nillicinep htiw detaert si tI .nerdlihc stceffa
).nicoripum .g.e snoitaraperp lacipot

aisalprepyh lamredipe si snacirgin sisohtnacA( A .5
eht ni yllaicepse ,niks eht fo gninekrad htiw
htiw detaicossa si tI .niorg ro kcen ,allixa

ro amonicraconeda TIG yllaicepse ycnangilam
dna setebaid 2 epyt ni nees sa ecnatsiser nilusni

).emordnys cilobatem

Apremilast for mild Allogenic bone marrow DERMATOLOGY UPDATE
to moderate plaque mesenchymal cells for
psoriasis in adults recessive dystrophic
epidermolysis bullosa
Although apremilast, an oral phosphodies-
terase 4 inhibitor, is an established therapy A skin-derived allogenic MSC population
for moderate to severe plaque psoriasis, (ABCB5+ MSC) with immunomodulatory, an-
the role of apremilast in the treatment of ti-inflammatory, and tissue-healing prop-
mild psoriasis has been less clear. In the erties was evaluated in a phase I/II trial in
first randomized trial to assess apremilast patients with recessive dystrophic epider-
for mild to moderate plaque psoriasis (n = molysis bullosa (RDEB). At 12 weeks, treat-
595), more patients assigned to apremilast ment was associated with reductions in the
achieved the specified level of response Disease Activity and Scarring Index score,
(clear or almost clear by the Physician as well as with a reduction of itch and pain.
Global Assessment with prespecified im- Treatment-related adverse events included
provement parameters) compared with mild lymphadenopathy in one patient and
patients in the placebo group (22 versus hypersensitivity reaction in two patients,
4 percent. These findings support use of all of which resolved with treatment with-
apremilast for mild to moderate plaque drawal. Based on the results of this trial,
psoriasis that cannot be managed with ABCB5+  MSCs, has been granted orphan
topical treatments. drug designation by the USFDA and EMA.

Alpelisib for Klippel- Tapinarof: Plaque Psoriasis
Trenaunay syndrome
A new study shows 4 in 10 plaque psoriasis pa-
Klippel-Trenaunay syndrome (KTS) is a rare con- tients achieve complete disease clearance
genital disorder belonging to the PIK3CA-related with tapinarof cream, 1 percent. Researchers
overgrowth spectrum (PROS). In a retrospective assessed the long-term safety, efficacy, remit-
study of with PROS, treatment with  alpelisib, tive effect, durability of response, and tolera-
an orally available, direct inhibitor of  PIK3CA, bility of tapinarof for the treatment of mild-to-
induced improvement in pain, fatigue, vascular severe plaque psoriasis. The analysis included
malformation, limb asymmetry, and coagulopa- 763 patients who completed the 12-week trial
thy in most patients at 24 weeks. The most com- and were eligible for 40 weeks of open-label
mon treatment-related adverse effects were treatment and four weeks of follow-up. The
hyperglycemia, aphthous ulcers, and stomatitis. researchers found that 40.9 percent of pa-
tients achieved complete disease clearance.

New guidelines for nevoid basal cell
carcinoma (Gorlin) syndrome

Nevoid basal cell carcinoma syndrome (NB- evidence-based guidelines have been pub-

CCS, Gorlin syndrome) is a rare inherited dis- lished for the diagnosis and management Source: Up to Date
order caused by germline pathogenic vari- of patients with NBCCS. They recommend
ants in the PTCH1 or SUFU tumor suppressor screening for skin tumors, developmental
genes. Individuals diagnosed with NBCCS are delay, bone deformities, cardiac fibromas,
at risk for developing benign and malignant medulloblastoma, and ophthalmologic ab-
and other multisystem complications. New normalities starting in early childhood.

THE PHARMA WORLD 73



“A previous study in Bangladesh INTERVIEW
showed a high prevalence of syphilis
and chlamydia or gonorrhea”

Dr. SM Bakhtiar Kamal As Bangladesh is a tropical country, are
Chief Consultant contagious skin diseases like fungal and parasitic
Kamal Hair & Skin Centre, Dhaka infections more common in this weather?
What is your suggestion to prevent this?
Eczema, psoriasis and
acne are different Skin diseases very common in the tropics include illnesses
skin conditions, but like ringworm, impetigo and scabies. Infectious skin diseas-
they can have certain es are on the rise as a warming climate supports the growth
overlapping symptoms. of bacteria and funguses.
It’s possible to
experience both acne Prevention
and eczema, psoriasis
at the same time, but Try to keep the following tips in mind to help prevent a fun-
they’ll usually show up gal & parasitic skin infection from developing:
on different parts of
your body. l Be sure to practice good hygiene.
l Don’t share clothing, towels, or other personal items.
l Wear clean clothes every day, particularly socks and

underwear.
l Choose clothing and shoes that breathe well. Avoid cloth-

ing or shoes that are too tight or have a restrictive fit.
l Make sure to dry off properly with a clean, dry, towel

after showering, bathing, or swimming.
l Wear sandals or flip-flops in locker rooms instead of

walking with bare feet.
l Wipe down shared surfaces, such as gym equipment

or mats.
l Stay away from animals that have signs of a fungal &

parasitic infection, such as missing fur or frequent
scratching.

How do you determine when a mole needs further
examination for skin cancer? Is there an age you believe
patients should consider having their moles evaluated?

The ABCDE rule helps health professionals assess different
features to tell a normal mole from skin cancer.

A is for asymmetry. One-half of a mole does not have
the same shape as the other half.

B is for border. The edge of a mole is uneven (irregular).
C is for color.
D is for diameter.is it increasing in size
E is for evolving or evolution

Old persons having these features should be evaluated

Can acne also appear on a skin that has other problems
such as dermatitis, psoriasis or eczema? What is the
treatment in such cases where various conditions
can sometimes be “conflicting” with each other?

Eczema, psoriasis and acne are different skin conditions,
but they can have certain overlapping symptoms. It’s pos-
sible to experience both acne and eczema, psoriasis at the
same time, but they’ll usually show up on different parts of
your body.

Treat acne first, because it is easily controlled by medi-
cations.

THE PHARMA WORLD 75

What causes eczema? Can it be cured? initial visit, during routine preventive exams, and if
What can patients do to prevent and you see signs of STDs.
soothe their eczema flare ups?
Eczema can be caused by exogenous agents e.g. Hair dye, 2. Encourage STD testing among young people.
cement, cosmetics, metals or environmental pollution.
3. Adhere to screening recommendations.
Endogenous causes include genetic susceptibility, im-
munologic and epidermal barrier dysfunction. Abnormal Is Herpes Simplex dangerous long term?
body reaction to normal agent (Atopic eczema) How is it treated? Is it curable?
Complications associated with genital herpes may in-
Eczema can be easily cured by medication. clude: Other sexually transmitted infections. Having geni-
Patients can prevent eczema by avoiding the inciting tal sores increases your risk of transmitting or contracting
agents. other sexually transmitted infections, including AIDS or
Newborn infection.
Please tell us in brief about the prevalence and
risk factors for sexually transmitted diseases Oral herpes may spread to other person in oral sex or
(STDs) in Bangladesh. What can be done to increase oral-genital sex, kissing.
awareness about STDs among common people?
A previous study in Bangladesh showed a high prevalence Herpes simplex is treated by oral Acyclovir, famciclovir,
of  syphilis (57%, 169/296), and chlamydia or gonorrhea valaciclovir.
(28%, 82/296).
Herpes infection is not curable.
What can Providers do to help
young people avoid STDs? Are there any innovations on the horizon that you feel,
are particularly noteworthy in the field of dermatology?
1. Ensure a sexual history is taken during a patient’s Dermoscopy & Trichoscopy are new innovations in the
field of dermatology & trichology.

Key facts you need to know about Monkeypox

Media reports about an outbreak of monkeypox may The virus variant that is circulating is from West Africa,
sound scary, but there’s no need for most people to take and is milder than a Central African variant. Its infection
special steps to avoid getting the viral illness, an infec- fatality rate is estimated at 1% and even lower in healthy,
tious disease expert says. young people.

Normal precautions recommended to prevent other As of June 21, the United States had 142 confirmed cas-
diseases are sufficient, according to an associate profes- es of monkeypox, according to the U.S. Centers for Disease
sor of medicine and pediatrics in the Division of Infec- Control and Prevention.
tious Diseases.
Though the smallpox vaccine can be protective, it pro-
Those with greatest risk of getting monkeypox are folks vides only imperfect protection against monkeypox. Only
engaging in intimate contact with multiple sex partners, a severe outbreak of a deadlier variant of monkeypox or
especially new ones. However, he said, even among this a reemergence of smallpox would justify its use. As a live-
group the risk is still low. virus vaccine, the smallpox shot causes a small percent-
age of recipients to contract smallpox and creates severe
Practicing safe sex and avoiding intimacy if you or your reactions in many others.
partner feels ill – even if monkeypox lesions have not yet
appeared – are key. “Right now, there isn’t a need for the general public to
be vaccinated against monkeypox, but we shouldn’t un-
Symptoms of monkeypox include fever, chills, headache, derestimate the potential impact of this virus, especially
muscle aches, fatigue, swollen lymph nodes and a rash that among the immunocompromised. Containing its spread
turns into pus-filled blisters, or lesions. But not everyone will require an all-hands-on-deck public health response,”
infected with the virus develops all of these symptoms. says an assistant professor of family medicine at New York
Institute of Technology College of Osteopathic Medicine.
The associate professor said it doesn’t appear that
monkeypox spreads from people who have no symptoms. While the professor notes that it’s unusual for one out-
But it seems to be more contagious once flu-like symp- break to follow on the heels of another, as monkeypox has
toms start and even more so once lesions appear several done with COVID-19, he urges public health officials to view
days later, he said. this as an opportunity to prepare for the next “big one.”

“Previous research documents transmission via drop- He also notes that, just as federal lawmakers allocated
lets exhaled past oral lesions onto someone else, but that’s funding for COVID-19 research, they should plan to do the
rare,” Cennimo said in a Rutgers news release. “Widespread same with monkeypox.
airborne transmission – i.e., one sick person infecting an
entire subway car – seems extremely unlikely.” Source: Newswise: Public Health.

76 THE PHARMA WORLD

Dietary exclusions may modestly
improve atopic dermatitis symptoms

Patients with mild to moderate atopic include cow’s milk, egg, meat, rice potato, WHAT’S NEW
dermatitis experienced slight and po- brassica (cabbage), fruit, peanut, cashew,
tentially unimportant improvements cod and/or wheat.
with dietary elimination, according to a new
study. However, these improvements should All 10 studies examined the effect of di-
be balanced against risks that elimination etary elimination on eczema severity using
diets present, the researchers continued. SCORing Atopic Dermatitis, or SCORAD, for
“The role of diet in atopic dermatitis, also which an 8.7-point improvement was con-
commonly known as eczema, has long been sidered a minimally important difference
debated with conflicting views as to the use (MID). Among 547 patients with these data, a
of dietary elimination as a treatment,”  says greater proportion of those who participated
an  assistant clinical professor (adjunct) of in dietary elimination achieved this MID than
medicine. those who did not eliminate foods (50% vs.
The researchers analyzed 10 randomized 41%; risk difference, 9%; 95% CI, 0-17). How-
controlled trials (n = 599; 44% female) with ever, the researchers also noted that these
a mean number of 60 patients each (range, results had low certainty.
15-113). Dietary eliminations ranged from 2 to
32 weeks. Four of these studies eliminated Based on daytime itch scores, three of
foods due to positive testing and/or oral the studies (n = 157) found that dietary
food challenges. The other six eliminated elimination slightly improved skin pruritis
foods regardless of food-specific IgE sensiti- compared with no dietary elimination (mean
zation or histories of reactions to the elimi- difference, –0.21; 95% CI, –0.57 to 0.15).
nated foods. Examples of foods eliminated These results also had low certainty, the
researchers wrote. Two studies (n = 77) found
that dietary elimination  slightly reduced
sleeplessness  compared with no dietary
exclusion (mean difference = –0.47; 95% CI,
–0.8 to –0.13), although these results again
had low certainty.

Considering the slight effect that dietary
elimination had on eczema severity, through
ingestion or contact,  food may be a minor
contributor  to the causes and perpetuation
of AD, with allergic or nonallergic mecha-
nisms, according to the researchers.

“Many fully informed patients may not
consider worthwhile a slight improvement
in eczema control against the potential for
developing anaphylactic-type food allergy,
particularly given an increasing number of
therapeutic options to treat atopic dermati-
tis,” the clinical professor explained. “Thus,
the health benefits, harms and practical im-
plications of dietary elimination should be
carefully weighed in a shared-decision mak-
ing framework.”

THE PHARMA WORLD 77



“Dermatology is a highly visual INTERVIEW
field with a high clinic volume
that is somewhat fast-paced in
comparison to other specialities”

Dr. Mahmud Chowdhury the transmission of other infections via insects, contami-
Consultant nated water, or contaminated soil, making management
Specialist Dermatology & or elimination difficult.
Venereology
Labaid Specialized Hospital Keep the following things in mind to help avoid fungal
Dhanimondi, Dhaka and parasitic skin infection:

As Bangladesh is a tropical l maintain good hygiene
country, are contagious l do not share clothing, towels, and other personal
skin diseases like fungal
and parasitic infections belongings
more common in this l wear clean clothes every day, including socks and
weather? What is your
suggestion to prevent this? underwear
l choose breathable clothes and shoes. avoid wear-
Parasitic diseases are more
widespread in developing ing clothing or shoes that are too small or have a
countries in the tropical and tight fit
subtropical areas. These areas l after showering, bathing, or swimming, make sure to
are frequently hot and humid— thoroughly dry off with a clean, dry towel
ideal conditions for the estab- l avoid direct skin-to-skin contact with an infested
lishment of numerous fungi person or with items such as clothing or bedding
(like, tinea pedis, tinea cruris, used by an infested person.
tina versicolor etc.) and para- l avoid animals that show indications of a fungal in-
sites like scabies. Furthermore, fection or parasitic infestation.
tropical countries like ours are
frequently characterized by Can high blood sugar level cause skin problems?
poverty, poor sanitation, insuf- What are some skin conditions linked to
ficient healthcare facilities, and diabetes and how are they managed?
a low educational level. These
variables frequently enhance Diabetic people usually develop dry skin, which may be
brought on by high blood sugar. High blood sugar leads
to poor circulation and nerve damage. Hence, people with
diabetes get some skin conditions more easily. These in-
clude bacterial infections, fungal infections, and itching.
Other skin problems happen mostly, or only, to people
with diabetes. These include diabetic dermopathy, necro-
biosis lipoidica diabeticorum, diabetic blisters, and erup-
tive xanthomatosis etc.

What causes eczema or atopic dermatitis? Can
it be cured? What can patients do to prevent
and soothe their eczema flare ups?

A combination of immune system activity, genetics, en-
vironmental factors, and stress contribute to the devel-
opment of eczema (atopic dermatitis). In people with
eczema, the immune system tends to overreact to minor
irritants or allergens and causes inflammation. This re-
sponse causes inflamed reddish brown or gray patches,
especially on hands,  feet, chest, neck, and inside the
bends of elbows and knees.

THE PHARMA WORLD 79

Although there is no available cure for eczema, for many, l A precipitating event, such as stress, intense sunburn,
the symptoms improve with age. To prevent flare-ups, first or chemical damage to the skin, vitamin B12 deficien-
of all the patient should identify trigger factors and avoid cy Trauma etc.
them. Emollients or moisturisers can be applied daily to
prevent the skin from getting dry. Creams and ointments Vitiligo is difficult to cure. If a person decides to pursue
containing topical corticosteroids may aid in reducing treatment, the aim is generally to restore pigment and
inflammation and redness when flare-ups occur. Topical prevent depigmentation from affecting more skin. Limit-
creams called calcineurin inhibitors like pimecrolimus or ing sun exposure is one of the most effective ways to pre-
tacrolimus that protect the skin and prevent eczema out- vent depigmentation and damage. Steroids, camouflage
breaks. For strong eczema itching, oral antihistamines of therapy, repigmentation therapy, phototherapy, cultured
steroids and other immuno suppresive medicines should Epidermal melanocyte Trasplantation and surgery are all
be taken. There is also a light therapy option. common treatments.

What causes vitiligo? Are there any trigger Are there any innovations on the horizon that you feel
factors for onset of vitiligo? Is there any are particularly noteworthy in the field of dermatology?
permanent solution for vitiligo?
Dermatology is a highly visual field with a high clinic vol-
Vitiligo develops when pigment-producing cells (melano- ume that is somewhat fast-paced in comparison to other
cytes) die and cease generating melanin, the pigment re- specialities. It is also a field that includes both medical/
sponsible for the color of skin, hair, and eyes. The affected clinical and procedural aspects. Dermatology has outper-
skin areas lighten or turn white. It is unknown what causes formed its peers in terms of innovation for a long time.
these pigment cells to fail or die. However, it might be con- There are phototherapy, dermatoscopy, lasers, cryosur-
nected to: gery, gene-therapy, stem-cell technology, nano technology
… and recently we are seeing a great influx of biologics in
l Immune system dysfunction (autoimmune condition) the field of dermatology.

l Family history (heredity)

80 THE PHARMA WORLD

Why Paxlovid is not for everyone DID YOU KNOW?

It’s getting harder to avoid COVID-19, thanks Despite the drug’s increased popularity, for
to the  dominance of BA.5  and the growing people who are otherwise healthy and not at
number of other Omicron subvariants. Fortu- high risk of getting severely ill, there are limited
nately, Pfizer’s antiviral treatment Paxlovid can data supporting the benefits of taking antivi-
minimize illness from the disease. rals like Paxlovid. “For the average healthy per-
But it’s not meant for everyone. Only those son—even a 55-year-old with no major medi-
who are at increased risk for severe disease cal problems—they might not benefit,” says the
from COVID-19 qualify for the drug, including Johns Hopkins scholar. “You have to go back to
people over age 12 who have weakened im- the primary purpose of prescribing Paxlovid:
mune systems or other health conditions that to prevent severe disease, hospitalization, and
increase risk of serious effects of COVID-19— death.”
like asthma, cancer, liver disease, lung disease,
heart disease, and obesity. Paxlovid also comes Prescribing by age
with a list of potential adverse reactions with Although there are no hard and fast rules,
common drugs, such as cholesterol-lowering even when it comes to age, Dr. William Durkin,
statins. an emergency physician at Alvarado Medi-
Because the drug is not approved by the cal Center in San Diego, recently decided not
USFDA, but allowed under an emergency use to prescribe Paxlovid to an older patient who
authorization, doctors generally can’t prescribe was otherwise healthy and did not have any
it outside of the authorization criteria. From symptoms. For such patients who don’t have
December 2021, when Paxlovid was author- symptoms when they test positive, doctors may
ized, to June 2022, prescriptions for the drug write a prescription proactively and tell them
have jumped from 2,500 to nearly 1 million in to reach out if they do develop symptoms in a
the United States according to data provided to day or so. Because Paxlovid is most effective if
TIME by health-data company Iqvia. taken within five days of symptoms appearing,
Here’s what prescribers say about who having the prescription ready could ensure that
should get Paxlovid at this point in the pan- people take advantage of the short window in
demic: which the drug works.
The future of Paxlovid
People at higher risk benefit more Used properly, an antiviral like Paxlovid can
Studies  conducted by Pfizer before Paxlovid help to slow transmission as the highly conta-
was authorized have found that the drug re- gious Omicron variants continue to spread. By
duces the risk of hospitalization and death by limiting the amount of severe disease in com-
up to 89% among unvaccinated people at high munities, the drug is another way to keep the
risk for bad COVID-19 outcomes. That efficacy virus under control.
has become less impressive as vaccination has
increased: the company’s latest data show that
Paxlovid is about  57%  effective at achieving
these outcomes in vaccinated people at lower
risk of severe illness, such as those who have at
least one of the risk factors that raise the risk of
serious COVID-19 illness.

With improved access, some experts believe
the drug may now be overprescribed. Paxlovid
is still one of only a few COVID-19 antiviral treat-
ments authorized by the FDA (others include a
pill called  molnupiravir  and remdesivir, an IV
therapy) so people are still asking for it. “There
is probably some overprescribing or prescrib-
ing in low-risk people,” says a senior scholar at
the Johns Hopkins Center for Health Security
and an infectious disease physician.

THE PHARMA WORLD 81

DRUG SAFETY Topiramate Chloramphenicol Clindamycin
(Topamax)
The Medsafe has an- The TGA has announced
Safety review triggered by nounced that the product that the product informa-
a study reporting an in- information for chloram- tion for clindamycin cap-
creased risk of neurode- phenicol eye drops will be sules and injections have
velopmental disabilities in updated to include dosing been updated to include
children with prenatal ex- recommendations for chil- a warning about the po-
posure. dren aged under two years. tential risk of acute kidney
The recommended dose is injury. Clindamycin prod-
We have initiated a new one drop in the affected ucts are indicated for the
safety review into topira- eye(s) four times daily for treatment of serious infec-
mate as a result of an ob- five days. The paediatric tions caused by suscepti-
servational study report- dose, reflecting the con- ble strains of streptococci,
ing an increased risk of ventional dosing regimen pneumococci, staphylococ-
neurodevelopmental dis- for children, is associated ci and anaerobic bacteria.
abilities in children whose with a boron exposure be- Product information for
mothers took topiramate low the threshold of con- topical clindamycin prod-
during pregnancy. Topira- cern for reproductive tox- ucts will not be updated.
mate is known to be as- icity. The TGA reviewed five re-
sociated with an increased ports of renal impairment
risk of congenital malfor- and five cases of acute kid-
mations and effects on ney injury associated with
fetal growth if used dur- systemic clindamycin.
ing pregnancy. Continue to
counsel patients who can Metformin and reduced vitamin B12 levels:
become pregnant on the new advice for monitoring patients at risk
known and emerging risks
of topiramate for an un- Decreased vitamin B12 levels, or vitamin B12 deficiency, is now
born baby and on the need considered to be a common side effect in patients on met-
to use effective contracep- formin treatment, especially in those receiving a higher dose
tion throughout use. or longer treatment duration and in those with existing risk
factors. We are therefore advising checking vitamin B12 se-
Ceftriaxone rum levels in patients being treated with metformin who have
symptoms suggestive of vitamin B12 deficiency. We also advise
The Therapeutic Goods that periodic monitoring for patients with risk factors for vita-
Administration (TGA) has min B12 deficiency should be considered.
announced that the prod-
uct information for ceftri- l Cladribine (Mavenclad): new advice to minimise risk of
axone has been updated serious liver injury
to include a warning about
hepatitis and encephalop- l Liver monitoring requirements for cladribine in the treat-
athy as potential adverse ment of multiple sclerosis have been introduced follow-
events. There were 52 re- ing uncommon cases of serious liver injury.
ports of hepatitis and re-
lated symptoms and three l Amiodarone (Cordarone X): reminder of risks of treat-
reports of encephalopathy ment and need for patient monitoring and supervision
for patients treated with
ceftriaxone. Health-care Amiodarone has been associated with serious and potential-
professionals should be ly life-threatening side effects, particularly of the lung, liver,
aware of reports of en- and thyroid gland. We remind healthcare professionals that
cephalopathy particularly patients should be supervised and reviewed regularly during
in the elderly with severe treatment.
renal impairment or central
nervous system disorders.

82 THE PHARMA WORLD

Denosumab 60mg (Prolia): should not be used in patients
under 18 years due to the risk of serious hypercalcaemia

Serious and life-threatening hypercalcaemia authorised for use in adults with osteoporosis
has been reported with denosumab 60mg and other bone loss conditions – it should not
(Prolia) in children and adolescents in clinical be used in children and adolescents younger
trials for osteogenesis imperfecta and dur- than 18 years.
ing off-label use. Denosumab 60mg (Prolia) is

Amoxicillin Antiepileptic drugs

Health Canada has announced that The HPRA has announced that the product information
the product safety information for for antiepileptic drugs (AEDs) (including phenytoin, phe-
amoxicillin-containing products nobarbital, carbamazepine, pregabalin and valproate) are
will be updated to include the po- to be updated based on the latest evidence of risks as-
tential risk of aseptic meningitis. sociated with in-utero exposure to AEDs. For some medi-
Twenty-one case reports of asep- cines in this class, use during pregnancy has been asso-
tic meningitis in adult patients ciated with major congenital malformations (MCMs) and
receiving amoxicillin-containing neurodevelopmental disorders in children exposed in-
products were obtained and all of utero. When prescribing AEDs for a woman of childbear-
them were found to be possibly or ing potential for any indication, health-care professionals
probably linked with the use of the should fully consider and discuss what is known about
amoxicillin-containing products. the potential risks associated with in-utero exposure.

Cladribine tients treated with cladribine. A recent review
of available safety data has concluded that
The European Medicines Agency (EMA) an- there is an increased risk of liver injury fol-
nounced that the product information for clad- lowing treatment with cladribine. During treat-
ribine will be updated to include liver injury as ment, liver function tests should be conducted,
an adverse drug reaction. Liver injury, including and repeated as necessary.
serious cases and cases leading to discontinu-
ation of treatment, has been reported in pa-

Hydroxychloroquine or chloroquine, COVID-19 vaccine RED ALERT
and macrolide antibiotics Janssen

The MHRA has announced that the product information The PRAC has recommended that
for hydroxychloroquine, chloroquine and macrolide anti- product information for COVID-19
biotics (azithromycin, erythromycin or clarithromycin) will vaccine Janssen should be up-
be revised to include the increased risk of cardiovascu- dated to include small vessel vas-
lar events and cardiovascular mortality if hydroxychloro- culitis with cutaneous manifesta-
quine or chloroquine is taken with a macrolide antibiotic. tions as a possible adverse event
Study shows that co-administration of azithromycin with of unknown frequency. Ten cases
hydroxychloroquine in patients with rheumatoid arthritis reported single organ cutaneous
is associated with an increased risk of angina, chest pain vasculitis (vasculitis affecting a
or heart failure and cardiovascular mortality. single organ).

COVID-19 vaccine Moderna Risk of paraesthesia

The PRAC has recommended that the product in- ports of paraesthesia which were possibly caused
formation for COVID-19 vaccine Moderna should by vaccination. Results of clinical trials were re-
be updated to include paraesthesia as an adverse viewed, and a higher number of paraesthesia cases
event. The PRAC assessed 1,425 international re- were reported in people who received the vaccine.

THE PHARMA WORLD 83

Knitted Fabric DeliversTECHNOLOGY
Laser Light to Treat
Skin Conditions Source: Medgadget

A number of diseases are treated using
light therapy. These include  acne, ac-
tinic keratosis, jaundice, Paget’s disease,
and psoriasis. A new device by Texinov
Medical Textiles features optical fib-
ers throughout its body that carry light
from an external laser toward the skin.
Called  FLUXMEDICARE, the knitted soft
flexible fabric delivers high-intensity la-
ser light directly onto the skin. The light
activates a reaction between oxygen
in the air and a photosensitizer cream,
making the skin more sensitive to the
light therapy. In terms of pain levels, in
trials of the FLUXMEDICARE, patients re-
ported nearly unfelt levels of pain when
treated with the device.

“Spray-On Skin” Can Ultra High-Tech Acne
Treat Serious Burns Management Shows Promise

RECELL Autologous Cell Harvesting Device, While there is a myriad of acne treat-
an FDA approved device from AVITA Medical, ments on the market, your average teen-
can treat serious burns in adult patients. The ager  knows  that they’re not very effective.
process of creating the therapeutic “Spray- Sebacia, a clinical-stage medical device
On Skin” involves separating the sampled company have developed a novel approach
skin and treating it so that the outcome to treating acne using a high-tech combi-
contains keratinocytes, fibroblasts, and mel- nation of ultrasound, gold coated particles
anocytes, cells that that help wounds heal. and lasers. The injection is done with the
The process only takes 30 minutes, so it can assistance of an ultrasound transducer,
be used soon after a burn occurs and unlike which shakes and pushes the nanoparticles
traditional autografts doesn’t require a lot through the follicle and into the sebaceous
of skin to be harvested (only 1/80 the size glands. The nanoparticles are sensitive to
of the wound), though it can be used along- this frequency of light, in turn resonating
side autografts. Not only is this easier on and generating local points of heat. This
patients, it is easier and less costly on the heat is able to prevent the treated seba-
providers. ceous glands from generating any more se-
bum, preventing any potential blockage of
follicles and stopping acne at the source.

84 THE PHARMA WORLD

Surgical dressing 3D Printed Skin Ready for Transplants INNOVATION
helps kill Melanoma,
Regenerate A collaboration of Spanish re-
Healthy Cells searchers and  BioDan Group,
a bioengineering company,
Melanoma is a highly aggressive can- have reportedly developed
cer, and once detected, surgical re- a 3D printer that produces
section is the most common option. human skin ready for trans-
Scientists have created a surgical plantation. Besides obvious
dressing that is specifically designed applications such as produc-
to facilitate and enhance photother- ing replacement skin for burn
mal therapy following melanoma re- victims, it can be used to test
section. The dressing, containing gra- drugs, new therapies for skin conditions, and for evaluating the safety and
phene oxide (a photothermal agent, effectiveness of cosmetic products. The researchers believe it will function
which converts the energy from light about as well as natural skin and it is already being evaluated by European
to heat, killing cancer cells), elastin, regulatory agencies for clinical use.
and ethanol, allows for near-infrared
photothermal therapy that lasts just Microneedle Patch Releases
15 seconds every 48 hours. The con- Immunotherapy Directly
cept involves killing any remaining into Melanoma Tumors
melanoma cells, while encouraging
healthy cells to regenerate within North Carolina researchers have created patches layered
the resection site. with microneedles to deliver cancer immunotherapy
right into the skin where melanoma has been detected.
Synthetic Melanin The patches deliver anti-PD-1 antibodies that prevent
Protects from the cancer from confusing T cells into ignoring the tumor.
Radiation Damage The antibodies are placed within nanoparticles which are
then loaded within the microneedles along with glucose
In medical imaging, air travel, and oxidase. When the patches are applied to cancer sites,
space travel, there is often unwanted the blood enters the needles, the glucose reacts with glu-
exposure to radiation. Traditional ra- cose oxidase producing acid that breaks up the nanopar-
dioprotective materials such as lead ticles. This allows anti-PD-1 to be released in a controlled
are heavy, making transportation and manner right into the tumor.
use difficult and in many cases unfea-
sible. Now, researchers developed a THE PHARMA WORLD 85
new biomaterial, selenomelanin, that
can help protect people from radia-
tion. The new substance, chemically
synthesized and produced by bacte-
ria, helps protect cells from radiation
more effectively than other forms of
melanin. One day, it may be used in
sunscreens, medical treatments, or
for long-term spaceflight as a radio-
protective material.



Should You Use Antibiotic WORTH KNOWING ABOUT
Creams on Your Skin?

Whether your skin is dry, cracked or prone l Keep your skin injury clean. Wash your
to cuts and bleeding, a skin expert says hands before touching the wound, and
you should resist the urge to use anti- gently wash the wound daily with mild
biotic creams or ointments. While it might seem soap and water to keep out germs. As long
sensible to use topical antibiotics to combat as the wound is cleaned daily, an antibiotic
germs and prevent infection with cuts, they can ointment isn’t needed.
irritate your skin even more and cause a painful
and/or itchy rash called contact dermatitis. l Apply plain petroleum jelly to keep the
wound moist. Use petroleum jelly from a
“The widespread use of antibiotics -- includ- tube instead of a jar to prevent spreading
ing in instances when they aren’t needed -- has dirt and bacteria.
contributed to a major public health challenge
known as antibiotic resistance,” a dermatolo- l Keep your wound covered with an adhe-
gist warns. The only time antibiotics are typically sive bandage. For large scrapes, sores or
needed is when there is an infection. Signs of in- burns, hydrogel or silicone gel sheets may
fection include: pus, pain, yellow crusts, red or be better.
purple skin, reddish streaks, swelling or warmth,
feeling very hot or cold, or fever. According to the Centers for Disease Control and
Prevention, more than half of all antibiotics used
If your wound doesn’t have any signs of an are not needed.
infection, skip the antibiotics and take the fol-
lowing steps instead, the dermatologist advised:

Skin tags? Moles? Products promising to treat them can do real harm

It may seem tempting to remove a mole or skin The FDA released an advisory earlier this

tag you don’t like with a product that promises month warning that there is no approved pre-

to make them disappear quickly. Don’t do it, ex- scription or over-the-counter drug for treating
perts say. Dermatologists and the USFDA both moles, skin tags or seborrheic keratosis. Prod-

warn about the dangers of using unregulated ucts sold for this purpose — such as ointments,
products for do-it-yourself removal of moles, gels, sticks and liquids — may contain high con-
skin tags and another type of growth known centrations of  salicylic acid  and other harmful
as seborrheic keratosis. Not only doing so could ingredients, the FDA warned. Simply making the
cause scarring and infection, but it can also claim that it’s “organic,” “natural,” “herbal” or
mask skin cancer and make it harder for doctors “homeopathic” doesn’t make it safe, according
to identify and treat promptly. to the FDA.

THE PHARMA WORLD 87

FACTS on gus eats keratin, which is a type of skin for 2 to 4 weeks. There are many
protein that makes up the nails, hair non-prescription products available
FINGER TIPS and outer layer of the skin. Dermato- to treat ringworm, including: l Clotri-
phytes attack the skin, scalp, hair, and mazole l Miconazole l Terbinafine l
Ringworm, also known as  Dermato- nails because those are the only parts Ketoconazole
phytosis, refers to several types of of the body with enough keratin to at-
contagious fungal infections of the tract them. Dermatophytes are micro- Ringworm on the scalp (tinea capi-
top layer of the skin, scalp, and nails. scopic spores that can survive on the tis) usually needs to be treated with
It is called ringworm because the itchy, surface of the skin for months.  They prescription antifungal medication
red rash has a ring-like appearance are very resilient and can also survive taken by mouth for 1 to 3 months.
in the soil, towels, combs and other Creams, lotions, or powders don’t
Symptoms household objects. People who have work for ringworm on the scalp. Pre-
l a rash with a ring-like appearance l weakened immune systems may be scription antifungal medications used
skin may be red and inflamed around especially at risk for infection and to treat ringworm on the scalp in-
the outside of the ring, but it may look may have problems fighting off a ring- clude: l Griseofulvin l Terbinafine l
normal in the middle l merging rings worm infection. Itraconazole l Fluconazole
l rings feel slightly raised l itchiness,
especially under the rash l raw, open Treatment Prevention
skin and raised, soft, spongy patches Treatment depends on the type of l keeping skin clean and dry l wear-
that weep l flaky and scaly skin ringworm. ing shoes that allow air to circulate
freely l avoid walking barefoot in
Causes Ringworm on the skin like athlete’s public areas l clipping fingernails
Ringworm is caused by a type of fun- foot (tinea pedis) and jock itch (tinea and toenails short and clean l chang-
gus  called  dermatophytes. This fun- cruris) can usually be treated with ing socks and underwear at least once
non-prescription antifungal creams, a day l washing clothes in hot water
lotions, or powders applied to the with antifungal soap l not sharing
clothing, towels, sheets, or other per-
sonal items.

GLOSSARY OF
DERMATOLOGY TERMS

Acanthosis: Involves thickening of the skin, which results Erythrasma: A skin infection where irregular pink patches
in papules and plaques forming. are localized or generalized, and turn to brown scales.

Acitinic Purpura: A skin condition that results from chronic Herpes Simplex: A recurrent, self-limited viral disease that
sun-exposure and increasing age. causes the eruption of fluid-containing vesicles.

Acrochordon: A small skin tag that can be located almost Herpes Zoster: Also known as Shingles, is a painful, viral
anywhere on the body or face. infection of the nerves that causes a painful rash with
small blisters.
Basal Cell Carcinoma:  The most common, slow-growing
form of skin cancer where small bumps form on the skin Liver Spots: Discoloration of the skin due to aging and sun
and may bleed. Basal Cell Carcinoma is derived from cells exposure.
in the basal cell layer of the lower epidermis.
Lymphangioma:  A benign proliferation of lymphatic ves-
Bullous Pemphigoid: A skin disorder producing large blis- sels causing a raised, yellow-tan or red mark on the skin.
ters. Bullous Pemphigoid often occurs in the elderly and is
often chronic. Ringworm:  A fungal skin infection with the formation of
red, blistery, ring-shaped patches. Ringworm is very conta-
Cellulitis: A common deep skin infection caused by bacte- gious and spreads easily through touch. Ringworm should
ria resulting in localized area inflammation. be treated at first sign of appearance to help avoid spread-
ing.
Cherry Angioma: Small red to purple papules on the skin
containing abnormal proliferation of blood vessels. Squamous Cell Carcinoma:  Result from skin cancer and
becomes an open sore.
Cryosurgery: A dermatological procedure, done by freez-
ing the lesion with liquid nitrogen. Tinea versicolor:  A chronic non-inflammatory fungal in-
fection where white or light brown patches appear on the
Dermatofibroma:  A small, non-cancerous red or brown skin.
bump in the skin normally found on the legs.

88 THE PHARMA WORLD

Written by Deborah Lynn Blumberg. SKIN HEALTH
She is a health and wellness writer
at WebMD.

Your flam-
skin needs matory can
the right balance also absorb the
of nutrients to do its energy from UV light,
main job: a barrier that which damages skin and
protects the rest of your body leads to wrinkles, sagging,
from things outside it. To help and skin cancer. It works with
keep your skin looking, working, vitamin C to strengthen cell walls.
and feeling good, feed it well from
the inside. Zinc
The outer layer of your skin has five
Healthy Fats times more of this mineral than the layer
Focus on monounsaturated and polyun- underneath. Zinc helps your skin heal af-
saturated fats from plants like nuts, seeds, ter an injury. It’s needed to keep cell walls
and avocados and from fish. These help your stable and for cells to divide and specialize
skin stay moist, firm, and flexible. Omega-3 as they grow. Too little zinc can look like ec-
fatty acids are a kind of polyunsaturated fat, zema, but the itchy rash won’t get better when
which your body can’t make but needs to build you put moisturizers and steroid creams on it.
cell walls. They also block a chemical that lets
skin cancer grow and spread, and they may low- Selenium
er inflammation. Selenium is a mineral that helps certain antioxi-
dants protect your skin from UV rays. Selenium
Protein deficiency has been linked with a greater chance
Your body turns the proteins you eat into build- of skin cancer.
ing blocks called amino acids and reuses them to
make other proteins, including the collagen and Foods and Supplements
keratin that form the structure of skin. Amino ac- In general, fruits and vegetables are good choices
ids also help slough off old skin. Some amino ac- because they have skin-friendly vitamins and other
ids are antioxidants that protect skin cells against antioxidants. Some foods pack more than one nu-
UV rays and from “free radicals”. trient for your skin, which often helps them work
better:
Vitamin A l Fatty fish (salmon, sardines, tuna): protein,
Both the upper and lower layers of skin need omega-3s, selenium l Leafy dark greens (kale,
vitamin A. It seems to prevent sun damage by spinach, collards): vitamins A, C, and E; omega-
3s; protein -- plus selenium in spinach l Eggs:
interrupting the process that breaks down protein, vitamins A and E, selenium, zinc l
collagen. Since it’s an antioxidant, it may give Flaxseeds: omega-3s, selenium l Legumes
your skin some protection against sunburn (lentils, chickpeas): protein, zinc l Avoca-
dos: healthy fats, vitamins C and E l Extra
(although not as much as wearing sun- virgin olive oil: healthy fats, vitamin E
screen). Talk to your doctor if you’re concerned.
Fish oil is a source of omega-3s, for
Vitamin C example, but taking it may not be
Think “C” for collagen. It’s also a pow- a good idea if you’re on blood
erful antioxidant, protecting you thinners or have a weakened
from free radicals and possibly immune system. And zinc
lowering your chance of skin supplements can make
cancer. some antibiotics
Vitamin E less effective.
This antioxidant
and anti-in-

THE PHARMA WORLD 89

Science Reveals Acne’s Secrets, Moving
Closer to Better Treatments

A type of skin cell that plays a significant role in fighting  acne  has been
identified – a finding researchers say could lead to new ways to treat the
common skin ailment. The cells – called fibroblasts – are common in con-
nective tissues throughout the body. The researchers specifically looked at
the role of these cells, which typically provide structural support in the skin’s
deeper layers. “What we uncovered was that these cells were activated to
produce large amounts of an important antimicrobial, cathelicidin, in re-
sponse to acne-causing bacteria called Cutibacterium acnes,” said the first
author. “Cathelicidin being so highly expressed in acne biopsy tissue was a
very interesting finding to us…Knowing this will be helpful in developing a
more targeted therapy to treat acne”, he added.

Psoriasis Tied to Higher Risk for
Nonalcoholic Fatty Liver Disease

Researchers found that those with psoriasis had a higher prevalence of
nonalcoholic fatty liver disease or NAFLD (32.7 versus 26.6 percent) com-
pared with participants without psoriasis. “Because some antipsoriatic
agents are potentially hepatotoxic, the association between psoriasis
and NAFLD in U.S. adults found in this study may be worth considering
in psoriasis management,” according to the researchers.

Sleep Disturbance Highly Prevalent
in Psoriasis Patients

Sleep disturbance is highly prevalent among patients with psoriasis and is
associated with  pruritus, anxiety, and depression, according to a recently
published study. Scientists examined sleep characteristics and factors asso-
ciated with sleep disturbance in a cross-sectional study. They found that 59
and 34 percent of patients and controls had sleep disturbance, respectively.
Compared with patients with strong and very strong pruritus, those without
pruritus had less impaired sleep. “Patients with psoriasis should be assessed
for sleep impairment, pruritus, anxiety, and depression,” the authors write.

Smoking Is Causally Associated
with Psoriasis Risk

Smoking, but not alcohol consumption, is causally associated
with  psoriasis, according to a recent study. Researchers ex-
amined the causal associations of alcohol consumption and
smoking with psoriasis using genome-wide association study
(GWAS) summary-level data for alcohol consumption, smok-
ing initiation, cigarettes per day, and smoking cessation from
the Sequencing Consortium of Alcohol and Nicotine use con-
sortium and for lifetime smoking from the U.K. Biobank. The
researchers identified genetic correlations between smoking
and psoriasis. In addition, there was a suggestive causal effect
of smoking cessation on psoriasis.

90 THE PHARMA WORLD

Sodium Intake Risk for Ectopic Pregnancy RESEARCH UPDATE
Linked to Risk for Increased for Women
Atopic Dermatitis with Psoriasis

Increased consumption of dietary so- Women with  psoriasis  have a significantly in-
dium may increase your risk for atop- creased risk for  ectopic pregnancy  (EP), which is
ic dermatitis. Researchers examined highest for those with moderate-to-severe pso-
the association between sodium in- riasis, according to a new study. Researchers ex-
take and atopic dermatitis in a cohort amined the association between psoriasis and
of 13,183 children and adults. They adverse pregnancy outcomes (APOs) in a nation-
found that the average dietary so- wide register-based case-control study involving
dium intake was 3.30 g and 6 percent data collected from 1973 to 2017. Cases were APOs,
of participants reported current der- including spontaneous abortion, EP, intrauterine
matitis at the time of the survey, while fetal death, and stillbirth; controls were singleton
12 percent of participants reported live births. Women with moderate-to-severe pso-
dermatitis in the previous year. A 1-g riasis found to have the highest odds ratio for EP
increase in dietary sodium intake was (odds ratio, 2.77). Compared with those without
associated with an increased risk for psoriasis, women with moderate-to-severe pso-
current dermatitis. riasis had a 2.48 percent higher absolute risk for
EP (3.98 versus 1.50 percent).

Could Omega-3 Fatty Acids Fight Acne?

Researchers may have found a new weapon to fight acne deficits in omega-3s, lower than 4%, had even more IGF-1
— one without harsh side effects. A study in Germany has hormone. Fatty acids reduce inflammation by stimulating
pinpointed omega-3 fatty acids — found in fish oil, wild the body to produce anti-inflammatory prostaglandins E1
salmon, nuts and seeds — as a nutrient helpful for reduc- and E3 and leukotriene B5, and lowering levels of IGF-1.
ing acne. Among 100 participants with acne, about 94%
had low levels of the fatty acid in their blood (below the
recommended amounts of 8% to 11%.), the study discov-
ered. Looking at individual diets, the team found those
who regularly ate chickpeas and lentils, while abstaining
from sunflower oil, had higher levels of omega-3s. Sun-
flower oil has been found in past research to aggravate
acne. The study patients who had lower levels of ome-
ga-3 fatty acids also had higher levels of IGF-1, a hormone
known to stimulate acne production. Those with severe

THE PHARMA WORLD 91



Vitamin B6 Scientists measured the impact of potential role of Vitamins B6, which HEALTH TIPS
supplements high doses of Vitamin B6 on young is known to increase the body’s pro-
could reduce adults and found that they reported duction of GABA (Gamma-Aminobu-
anxiety and feeling less anxious and depressed tyric Acid), a chemical that blocks
depression after taking the supplements every impulses between nerve cells in the
day for a month. brain. Raised levels of GABA among
participants who had taken Vitamin
The study provides valuable evi- B6 supplements were confirmed by
dence to support the use of supple- visual tests carried out at the end of
ments thought to modify levels of the trial, supporting the hypothesis
activity in the brain for preventing or that B6 was responsible for the re-
treating mood disorders. duction in anxiety. Subtle but harm-
less changes in visual performance
The lead author said: “Vitamin B6 were detected, consistent with con-
helps the body produce a specific trolled levels of brain activity. Many
chemical messenger that inhibits foods, including tuna, chickpeas and
impulses in the brain, and our study many fruits and vegetables, contain
links this calming effect with reduced Vitamin B6.
anxiety among the participants.”

The new study focused on the

Mineral supplement could stop in the longer studies. A recently completed pilot phase
fatty liver disease progression trial in healthy patients at risk for colorectal cancer
showed that the mineral supplement didn’t pose any
Results from a preclinical study add new evidence safety or tolerability issues, including any potential
that a multi-mineral dietary supplement known as Aq- liver damage.
uamin could be a simple and effective way to reduce
the long-term health consequences of non-alcoholic
fatty liver disease. Aquamin, which is derived from cal-
cified red marine algae, is rich in calcium, magnesium
and 72 other minerals and trace elements.

Studies revealed a dramatic reduction in late-stage
consequences of NASH in the animals that were fed
the high-fat diet and received the multi-mineral sup-
plement, compared to those that didn’t receive the
supplement. In short-term studies lasting about 24
weeks, the researchers identified protein changes as-
sociated with the NASH and reduced tumor formation

THE PHARMA WORLD 93

FDA UPDATE FDA Approves Arcutis Biotherapeutics, Inc. treatment of plaque psoriasis,
Roflumilast announced that the USFDA has Zoryve provides rapid clear-
Cream for approved the New Drug Ap- ance of psoriasis plaques and
Plaque plication (NDA) for  Zoryve  (ro- reduces itch in all affected ar-
Psoriasis flumilast) cream 0.3% for the eas of the body. Zoryve — a
treatment of  plaque psoriasis, once-daily, steroid-free cream
including intertriginous areas, in a safe and well tolerated, pa-
in patients 12 years of age or tient-friendly formulation — is
older. The first and only topical uniquely formulated to simplify
phosphodiesterase-4 (PDE4) disease management for peo-
inhibitor approved for the ple living with plaque psoriasis.

Tapinarof Cream Approved For FDA Approves
Plaque Psoriasis In Adults
Tirzepatide Injection
The USFDA has approved Dermavant Sciences’ Vta-
ma  (tapinarof) cream, 1%, an aryl hydrocarbon re- for Type 2 Diabetes
ceptor agonist, indicated for the topical treatment
of  plaque psoriasis  in adults. This approval makes The USFDA approved Mounjaro (tirze-
Vtama cream the first and only FDA-approved ster- patide) injection, Eli Lilly and Com-
oid-free topical medication in its class. Vtama cream pany’s new once-weekly GIP (glu-
that provides not only efficacy over 52 weeks but can
also be used on all body areas, including on sensi- cose-dependent insulinotropic
tive locations, such as face, skin folds, neck, genita-
lia, anal crux, inflammatory areas, and axillae. In ad- polypeptide) and GLP-1 (glucagon-
dition, Vtama also demonstrated remittive effect of
approximately four months in patients off therapy. like peptide-1) receptor agonist in-
dicated as an adjunct to diet and
New Treatment Approved exercise to improve glycemic control
for the Treatment of H. in adults with type 2 diabetes. Moun-
pylori Infection in Adults jaro has not been studied in patients
with a history of pancreatitis and is
Phathom Pharmaceuticals, Inc. announced that the not indicated for use in patients with
USFDA approved both Voquezna Triple Pak™ (vono-
prazan tablets, amoxicillin capsules, clarithromycin type 1 diabetes mellitus. As the first
tablets) and Voquezna™ Dual Pak™ (vonoprazan and only FDA-approved GIP and GLP-1
tablets, amoxicillin capsules), for the treatment
of Helicobacter pylori (H. pylori) infection in adults. receptor agonist, Mounjaro is a single
Voquezna treatment regimens contain antibiotics molecule that activates the body’s re-
conveniently packaged with vonoprazan, a novel ceptors for GIP and GLP-1, which are
potassium-competitive acid blocker (PCAB) and the natural incretin hormones. Mounjaro
first innovative acid suppressant from a new drug will be available in six doses (2.5mg,
class approved in the U.S. in over 30 years. 5mg, 7.5mg, 10mg, 12.5mg, 15mg).

FDA Approves Bristol Myers Squibb announced that the US- Partial-Onset Seizures’
New Treatment FDA approved  Camzyos  (mavacamten, 2.5 mg, New Treatment Approved
Obstructive 5 mg, 10 mg, 15 mg capsules) for the treatment
Hypertrophic of adults with symptomatic NYHA class II-III Azurity Pharmaceuticals, Inc., an-
Cardiomyopathy obstructive hypertrophic cardiomyopathy (ob- nounced the USFDA approval of Zon-
structive HCM) to improve functional capacity isade™ (zonisamide oral suspension),
and symptoms. Camzyos is the first and only 100 mg/5 mL as adjunctive therapy
FDA-approved allosteric and reversible inhibi- for the treatment of partial seizures
tor selective for cardiac myosin that targets the in adults and pediatric patients aged
underlying pathophysiology of obstructive HCM. 16 years and older with epilepsy. The
efficacy and tolerability of zonisamide
has been established in three double-
blind, placebo-controlled, multicent-
er clinical trials. Zonisade™ should
be administered once or twice daily.
Efficacy and safety of Zonisade™ in
patients below 16 years of age have
not been established.

94 THE PHARMA WORLD

FDA APPROVALS

Brand Name Generic Name Manufacturer Date of Treatment
Approval

Zoryve Cream-formerly Roflumilast Arcutis Biotherapeutics, July 29, 2022 Treatment for Plaque Psoriasis
ARQ-151 Inc.

Zonisade Oral Suspension Zonisamide Azurity Pharmaceuticals, July 15, 2022 Treatment of partial-onset
Inc. seizures in adults and pediatric

patients 16 years of age and older.

Bludigo Injection Indigotindisulfonate Provepharm July 8, 2022 Urological and gynecological
sodium open, robotic, or endoscopic
surgical procedures.

Amvuttra Injection Vutrisiran Alnylam June 13, 2022 Treatment for Amyloidogenic
Pharmaceuticals, Inc Transthyretin Amyloidosis

Priorix Injection Measles, Mumps, & GlaxoSmithKline June 3, 2022 Treatment for Measles
Prophylaxis, Mumps Prophylaxis,
Rubella Virus Vaccine, Live Rubella Prophylaxis

Fylnetra Injection Pegfilgrastim-pbbk Amneal Pharmaceuticals May 26, 2022 Treatment for Neutropenia
LLC Associated with Chemotherapy

Vtama Cream Tapinarof Dermavant Sciences May 23, 2022 Treatment for Plaque Psoriasis

Mounjaro Injection Tirzepatide Eli Lilly and Company May 13, 2022 Treatment for Diabetes, Type 2

Radicava ORS Oral Edaravone Mitsubishi Tanabe May 12, 2022 Treatment for Amyotrophic
Suspension Pharma Corporation Lateral Sclerosis

Voquezna Triple Pak Amoxicillin, Clarithromycin Phathom May 03, 2022 Treatment for Helicobacter
Co-Packaged Pylori Infection
& Vonoprazan Pharmaceuticals, Inc.

Voquezna Dual Pak Amoxicillin & vonoprazan Phathom May 03, 2022 Treatment of Helicobacter pylori
Co-Packaged Pharmaceuticals, Inc. (H. pylori) infection in adults.

Camzyos Capsules Mavacamten Bristol-Myers Squibb Treatment for Hypertrophic
Company Cardiomyopathy

Cuvrior Tablets Trientine Tetrahydrochloride Orphalan SA Apr 28, 2022 Treatment for Wilson’s disease.

Vivjoa Capsules Oteseconazole Mycovia Apr 26, 2022 Treatment for Vaginal Yeast
Pharmaceuticals, Inc. Infection

Epsolay Cream (Benzoyl Peroxide) Sol-Gel Technologies, Ltd. Apr 22, 2022 Treatment of inflammatory
lesions of rosacea in adults

Alymsys Injection Bevacizumab-maly Amneal Pharmaceuticals Apr 13, 2022 Treatment for Colorectal Cancer,
LLC Non-Small Cell Lung Cancer,
Glioblastoma Multiforme, Renal
Cell Carcinoma, Cervical Cancer,
Ovarian Cancer, Fallopian Tube
Cancer, Peritoneal Cancer

Vijoice Tablets Alpelisib Novartis Pharmaceuticals Apr 05, 2022 Treatment for PIK3CA-Related

Corporation Overgrowth Spectrum.

Igalmi Sublingual Film Dexmedetomidine BioXcel Therapeutics, Inc. Apr 05, 2022 Treatment of agitation

Tlando Capsules - formerly Testosterone Antares Pharma, Inc. Mar 28, 2022 Treatment for Hypogonadism,
LPCN 1021 Male

Pluvicto Injection Lutetium lu 177 Vipivotide Novartis Pharmaceuticals Mar 23, 2022 Treatment for Prostate Cancer

Tetraxetan Corporation

Xelstrym Transdermal System Dextroamphetamine Noven Pharmaceuticals, Inc. Mar 22, 2022 Treatment for ADHD

Ztalmy Oral Suspension Ganaxolone Marinus Mar 18, 2022 Treatment for CDKL5 Deficiency
Pharmaceuticals, Inc. Disorder

Opdualag Injection Nivolumab and Bristol-Myers Squibb Mar 18, 2022 Treatment for Melanoma
Relatlimab-RMBW

Nasonex 24HR Allergy Nasal Mometasone furoate Perrigo Company Mar 17, 2022 Treatment for Allergic Rhinitis

Spray monohydrate

THE PHARMA WORLD 95

CONFERENCES TITLE VENUE SCHEDULE

19th DIA Japan Annual Meeting 2022 Tokyo, Japan Oct. 09–11, 2022

AAPS 2022 Annual Meeting and Exposition Boston, Massachusetts Oct. 16–19, 2022

3rd Edition of Global Conference on Addiction Orlando, USA Oct. 24–26, 2022
Medicine, Behavioral Health and Psychiatry

2022 ISPE Annual Meeting & Expo Orlando, Florida Oct. 30–Nov. 02, 2022

CPhI Worldwide Frankfurt, Germany Nov. 01–03, 2022
San Francisco, USA Nov. 02–04, 2022
Global Bioprocessing Summit & Exhibition Paris, France Nov. 14–16, 2022

Global Conference on Pharmaceuticals and
Clinical Research

2nd Pharma Middle East Congress Abu Dhabi, UAE Dec. 05–06, 2022
2022 ISPE Pharma 4.0™ and Annex 1 Conference  Vienna, Austria. Dec. 07–08, 2022
12th World Gastroenterology & Hepatology Conference Dubai, UAE Dec. 10–11, 2022

2023 ISPE Aseptic Conference N. Bethesda, USA Mar 06–07, 2023
33rd Annual European Pharma Congress 2023 Frankfurt, Germany Mar 13–14, 2023 
Clinical Trial Supply Europe 2023 Milan, Italy Mar 15–16, 2023 

European Conference on Pharmaceutics 2023  Marseille, France Mar 20–21, 2023

International Summit on Hematology and Blood Disorders Orlando, USA Apr. 17–19, 2023
Apr. 24–26, 2023
Global Pharma & Drug Delivery Summit 2023 Frankfurt, Germany

M Myth: Plucking one gray hair will lead to more Myth: Pricey, professional facials are my
growing in its place. only solution for perfect skin.
RVS Reality: Your scalp is made up of follicles Reality: Be your own esthetician!  Unclog
and only one strand of hair grows from that those pores with a simple two-step system
MYTH VS root.  Gray hairs can appear more dull and that’s as easy as exfoliating.  First, exfoliate
REALITY wiry, making it seem like they are multiply- using an acid-based cleanser, such as Gly-
ing every time you pluck one.  More grey tone Gel Wash sold in our office that gets
hairs do not grow out if you pluck one.  deep into the pores to remove embedded
To blend greys, try using hair powder like sebum and dirt.  Then, with a rotating elec-
Bumble and Bumble’s Hair Powder. tric brush such as Clarisonic’s Mia, slough
away dead skin cells with a gentle cleanser. 
Myth:Wash with hot water to open your pores This regimen will help your skin absorb the
Reality: Pores don’t actually “open” or product for a deep clean.
“close” due to temperature. When you wash
your face with hot water, your skin swells, Myth: Greasy foods cause acne
making it appear that your pores have Reality: It’s not so much the oil but the carbs
opened, but all you’ve done is stressed that can trigger breakouts. The intake of high
your skin. Wash your face with lukewarm glycemic, starchy, and sugary foods has been
water, which is less irritating. linked to the contribution of blemishes.

96 THE PHARMA WORLD

Mohammad Hanif has recently joined Globe Pharmaceuticals, APPOINTMENTS & PROMOTIONS
Globe Agrovet, Globe Drugs Ltd. as Chief Executive Officer. Prior to
this, he worked as Chief Operating Officer in Somatec Pharmaceu-
ticals, Executive Vice President in Beacon Pharmaceuticals, Chief
Marketing Officer (CMO) in DBL Group & General Manager, Mar-
keting in Square Pharmaceuticals & Square Consumer Products
Ltd. In his 26-year long career in Pharma Marketing, he worked in
different positions & applied his vast expertise in different core
areas of operation. He is a well-known personality in the arena of
Pharmaceutical Marketing by virtue of his strong leadership skill,
team making ability and above all, his pleasant personality. He
obtained his MBA from Institute of Business Administration (IBA),
University of Dhaka and M. Pharm from University of Dhaka.

Mr. Mohammod Shafiqul Islam has recently joined in Popular
Pharmaceuticals Ltd. as Senior General Manager, Marketing. Prior
to this, he has worked as Business Lead in ACI, Divisional Head
in Business Operation at Purnava (Renata), and General Manager
(Marketing & Business Development) in Somatec Pharmaceuti-
cals. Previously he has also worked in Renata, ACI and Beximco at
diverse capacities.

He has comprehensive in-depth business understanding in
Pharmaceutical Marketing, Sales & Distribution having solid work-
ing experience about 24 years. He has area of expertise in building
strong brands through market research, smart product develop-
ment and creative brand positioning to penetrate the target niche
market through strategic planning, brand building and strong
market research. He has completed his B. Pharm (Hons.), M. Pharm
and Masters in Social Science (MSS) from University of Dhaka.

Your skin is your largest l The average person’s skin l Your skin constantly sheds
organ and plays a vital covers an area of 2 square dead cells, about 30,000 to
role in detecting hot and meters. 40,000 cells every min-
cold, regulating your ute! That’s nearly 9 lbs. per
body temperature and l Skin accounts for about 15% year!
protecting your muscles, of your body weight.
bones and internal l Some sources estimate that
organs from outside in- l The average adult has ap- more than half of the dust in
fection and disease. But proximately 21 square feet of your home is actually dead
that’s just for starters. skin, which weighs 9 lbs and skin.
There is so much more to contains more than 11 miles
your skin than you might of blood vessels. l Dead skin comprises about
think. Here are some a billion tons of dust in the
of the most interesting l The average person has about earth’s atmosphere.
facts about your skin: 300 million skin cells. Single
square inch of skin has about l Your skin is home to more
19 million cells and up to 300 than 1,000 species of bacteria.
sweat glands.
l Skin that is severely dam-
l Your skin is its thickest on aged may try to heal itself by
your feet (1.4mm) and thin- forming scar tissue, which is
nest on your eyelids (0.2mm). different from normal skin
tissue because it lacks hair
l The skin renews itself every and sweat glands.
28 days.

These fun facts are just some of the thousands of important aspects of your skin and its health. Forefront Dermatology’s skin care experts
have all of the information you need, including how to best care for the health and beauty of your skin, and the advanced expertise and
experience to help you protect it throughout your lifetime.

THE PHARMA WORLD 97

Wish to export to Indonesia?

Overview Category 5: registration of minor changes to
registered drugs that require approval
Indonesia, an archipelago of over 10,000 islands, Category 6: registration of minor changes to
has a population of over 255 million, making it the registered drugs that require notification.
fourth most populous country in the world. Indo-
nesia is Southeast Asia’s largest economy, with a 3. Re-Registration
GDP adjusted for Purchasing Power Parity (PPP) of Category 7: Re-Registration of Registered Drugs
over $3 trillion (International Monetary Fund; IMF). Regulation 17 now exempts Category 4 reg-
With its growing economy and large population, istrations (registration of major changes to
Indonesia’s pharmaceutical market will continue a registered drug) from the pre-registration
to expand considerably in upcoming years. process. Category 5 and 6 registrations are
already exempted from the pre-registration
Indonesia drug registration process process, which involves steps such as deter-
mining the category of registration and type
Regulations of evaluation.
Indonesia’s food and drug regulatory authority
is the National Agency of Drug and Food Control New application vs. Variation application
(NA-DFC). Recently, the NA-DFC has enacted new
regulations to ease the drug registration process. The Indonesian drug registration process is divid-
In mid-2016, the NA-DFC enacted Regulation 17 to ed into two categories: (1) new drug applications
make three changes to the registration process. and (2) drug variation applications. A new drug
Currently, there are three types of drug registra- application is required for the following types of
tion and seven categories of registration: products or product changes: a new active ingre-
dient, a new derivative or combination, or a new
1. Registration of New Drugs dosage form, strength or indication. A drug vari-
Category 1: Registration of New Drugs, Bio- ation application is needed for drugs which have
logical Products, and Biotherapeutic Products already been granted a marketing authorization
Category 2: Registration of Copy Drugs license, but have undergone a modification of one
Category 3: Registration of Supplies Contain- of the following:
ing Drugs
l License-holder
2. Registration of Changes to Registered Drugs l Trade name
Category 4: registration of major changes to l Manufacturing site or factory name
registered drugs (changes have an impact on l Importer
efficacy, safety, and/or quality)
Brunei
MALAYSIA

Singapore

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l Inactive ingredient The following list of the documents and infor- REGISTRATION RULES
l Excipient mation required for the dossier:
l Specification
l Method of analysis l Good Manufacturing Practice (GMP)
l Packaging or labeling certificate

Pre-Registration l Specifications and method of analysis
l Pharmacodynamic, pharmacokinetic
The Indonesia drug registration process con-
sists of two stages: (1) pre-registration and (2) and toxicity data
submission of the registration dossier. l Clinical trial report
l Labeling and packaging materials, in-
The pre-registration process is conducted
to determine the application review and eval- cluding materials for the label, box, outer
uation pathway. The NA-DFC reviews drug ap- packaging, blister strip and catch cover
plications via one of three pathways (Path I, l Product insert/leaflet
II or III). Path I includes drug applications for l Product sample
products used to treat serious or life-threat-
ening diseases, or for essential generic drugs Approval Process
for public health programs. New drugs already
approved in certain designated countries may The head of the NA-DFC is responsible for is-
qualify for the Path II registration process. suing the marketing authorization approval/
Any drug application for products that do not non-approval decision. In some cases, the NA-
qualify for Path I or Path II evaluation process- DFC may request additional data in order to
es will be reviewed via the Path III process. determine the product approval/non-approv-
al. In this situation, the applicant will have 120
Generally, applications are reviewed within days to submit this requested information. If
the following timeframes: the applicant is unable to provide the data
within the given timeframe, the application
Path I: 100 working days will be rejected. However, the applicant has
Path II: 150 working days the option of resubmitting the dossier as a
Path III: 300 working days for new drugs; for new Indonesia drug registration application.
all other drugs, 80 working days
Non-approval Appeals
Registration Dossier Requirements
If an application is reviewed by the NA-DFC
Marketing authorization licenses are valid for and the NA-DFC decides that the product can-
five years in Indonesia. The Indonesia drug not be approved, the applicant has the option
registration forms and accompanying docu- of submitting an appeal. The written appeal
ments can be in Bahasa Indonesian or Eng- should be submitted within six months from
lish. Drugs produced for export-only are not the date of application rejection. The appeal
required to have labels in Bahasa Indonesian; should be accompanied by additional product
only English labels are required. data in order to better justify approval of the
product. Applicants are allowed a maximum of
two appeals.

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