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THE PHARMA WORLD 51 Quality or marketing technique, which one is more important to achieve the goals of a pharma company? As I have mentioned earlier without Quality, only marketing gimmick is not feasible for the long run. The blend of a quality product with vibrant marketing technique can bring the success. Addressing the need or requirements of customer by placement of quality people and offering the unique solution should be the key objective. As an accomplished pharmaceutical professional, how do you evaluate the changes in trends in the pharmaceutical industry during the decades of your experience? Humbly speaking, I am still in the learning phase and will try to be a life-long learner Inshallah. At the same time, Alhamdulillah I admire the journey that I have come through. We have observed the high & lows of the Bangladesh Pharma industry deeply in the last decade. The industry has shifted vastly from product centric industry to a more customer centric one. Acute care product market got comparatively stagnant than the chronic care markets. Antibiotics markets have been in a negative slope because of the increasing awareness. In addition, COVID pandemic has brought a significant change in the entire healthcare system. What are some of the challenges the industry is facing now and what are the solutions in your opinion? Bangladesh Pharmaceutical industry has come a long way pretty successfully crossing several hurdles and with a healthy competition with the giant MNCs (Multinational Companies). 98% of our local needs is now fulfilled by the local companies and we are earning billions of dollars by exporting per annum. Besides our enormous success stories, we are still dependent on the imported APIs (Active Pharmaceutical Ingredients). The recent inflation of dollar exchange rate affected the purchase price of APIs, excipients etc. To cater the local medicines with affordable price, pharma companies are struggling to run their regular operations smoothly. Besides, very few companies produce a very limited amount of API for their needs which is very insignificant. The matter of hope is that, our development in the API park is growing rapidly and we all hope that we can produce majority of our generic APIs by ourselves in the near future which will resolve the crisis at a satisfactory level. Moreover, sophisticated R&D labs, BE (BioEquivalence) study facilities with vigilant monitoring from the authority should be ensured for the good practices. How do you evaluate the opportunities and challenges of Bangladesh pharma sector after its graduation from LDC? Where do you see the industry in next 10 years? It will be quite challenging after the LDC graduation for Bangladesh Pharma market since there will be rigid requirements of the approval of new molecules and the coordination between the local pharma giants. The authority of the health sectors (Both Govt. & Private) need to contribute equally towards a common goal which is the affordability of medicines for the people of Bangladesh. More & more emphasis on the R&D will be the key to develop our generic medicines as well as the APIs. The Bangladesh pharma industry will be having more sophisticated products on the market like Biosimilars, mAbs, rDNA products in the near future if the policy makers can synchronize with local & MNCs. Collaboration with several MNCs will likely to take place in this sector in near future. If we can tackle the challenges together, pharma industry of Bangladesh will create enormous employment opportunities along with the positive impact in the healthcare eco system. Then the industry will reach to a newer height contributing majorly in our GDP (Gross Domestic Product). Being one of the youngest Head of Marketing in the industry, would you please share secret or success tips for newly joined pharma marketers? The ultimate truth is that, there’s no shortcut to success! To be successful in pharma marketing, in depth knowledge of the products & diseases, market analysis, customer response & identification as well as upright communication of superiority over existing therapeutic options are some of the required tools. One has to be out of their comfort zones & visionary at the same time to stand out from the crowd. Being trustworthy to customer end by fulfilling their needs can add additional mileage to their career. n Mohammad Ziauddin is the General Manager & Head of Marketing at The ACME Laboratories Ltd. He brings 18 years of experience in pharmaceutical marketing in some leading pharma companies like Incepta, Novartis, Ziska & ACME. In his tenure, he has worked with a diverse portfolio. He has completed his B.Pharm (Hons), M.Pharm (Clinical Pharmacy & Pharmacology) & MBA (Marketing) from University of Dhaka with all through outstanding academic records. A brief profile of Mohammad Ziauddin

INTERVIEW THE PHARMA WORLD 53 Dr. Kazi Naushad Un Nabi Senior Consultant & Coordinator, Paediatrics & Neonatology Bangladesh Specialized Hospital “Poor nutrition and worm infection are the two common reasons of anaemia in childhood” c. Regular health checkup during pregnancy. d. Safe delivery by trained personnel. e. Steps to prevent infection. f. Timely referral to higher center if problem arise during labour or delivery. Prevalence of anemia is very high in children of our country. What is your opinion on this? What advice would you like to give to the parents for the prevention of childhood anemia? Anaemia is by far the single most common problem in all age groups. Poor nutrition and worm infection are the two common reasons of anaemia in childhood. Regular deworming and appropriate food like meat & fish of different kinds of vegetable will prevent anaemia. Water-borne diseases like jaundice, typhoid and dysentery are some of the common summer illnesses in children. How to prevent and treat them? It is very simple to prevent this disease, First and foremost is personal cleanliness. Secondly, keeping surroundings in the household fresh and clean. Water should be preferably filtered or at least boiled. What are some common developmental disorders that affect children? What are the signs and symptoms of these disorders, and what treatment options are available? This is a very large subject. It’s not possible to discuss it in a very brief way. But there are some development disorder worth mentioning. Physical and mental handicap has roots to prematurity, birth injury or Hypoxia at or around birth. Autism are other examples. Management of treatment options area available but mostly limited in many cases. Where do we stand as regards paediatric/neonatal care? What is your suggestion for improving the total scenario in the child healthcare system? The Pediatric & Neonatal healthcare services are quite insignificant. At least one child with modern facilities & resources could be built in every district. The Expenditure should be within reach of all sections of population. Referral to tertiary hospital should be well coordinated with availability of bed seen online. All hospitals should be interlinked with internet. Consultants’ advice should be available online. Live saving medicine should be available in all district hospitals. Adequate health personnel should be available too. These are the few steps that can revolutionize the health care system of Children in Bangladesh. n As an eminent Paediatrician of the country, would you please give us, in brief, an overall scenario of Paediatric Diseases and their treatment in Bangladesh? According to the latest UNICEF data the children under 5 years are 16.3 million & under 17 years is 57 million. So, we have a large, young population. Disease mostly prevalent are infectious in character and a large percentage are waterborne intestinal disease and chest infections. Prematurity is one of the major killers of children under 5. What can be done to combat this and improve the survival and well-being of premature babies? There are many reasons for premature birth. All of these are to be taken to task to have a significant impact on overall death and disability. I will mention some of these, a. Maternal health and Nutrition. b. Too young mother or too old mother.

Sleep Apnea in Childhood Could Affect Developing Brain Teenagers with the nighttime breathing disorder  sleep apnea  may have brains that look a little different from their peers’, a new study suggests. Researchers found that among teens who underwent brain scans, those with obstructive sleep apnea (OSA) tended to have thinner tissue at the brain’s surface, and some signs of inflammation in a brain area key to memory and learning. According to the researchers, OSA could affect kids’ brains for two broad reasons: It repeatedly disrupts the brain’s oxygen supply, and it deprives kids of the deep “restorative” sleep necessary for healthy brain development and functioning. In children, sleep apnea commonly stems from chronically inflamed tonsils or adenoids (tissues high in throat). In those cases, surgery to remove the tissue is the standard treatment. In other cases, kids may need to sleep with a device that keeps the airways open by gently blowing air through a mask worn over the nose. 1 in 4 kids with type 2 Diabetes isn’t obese It’s easy to blame the childhood obesity epidemic for growing cases of type 2 diabetes, but a new study finds nearly one-quarter of all diagnoses are not related to obesity. Researchers have hypothesized that there are likely children who do not produce enough insulin or are resistant to insulin, even at a normal body size. For the new study, researchers found that 75% of children with type 2 diabetes had obesity. Boys were more likely to be obese than girls. Asian participants had the lowest prevalence of obesity compared to other racial groups. “The biological functions of fat tissue, and not just amount, can profoundly impact metabolic health and may differ between those children with a normal measured body mass and those with a high body mass,” said the lead researcher of the study. Children with diabetes also can develop other health issues, including nonalcoholic fatty liver disease, an imbalance of  lipids, polycystic ovary syndrome and deteriorating kidney function. As kids’ obesity rises, brain health declines Kids who are overweight or obese often struggle with schoolwork, and now new research provides clues on how excess weight may harm the developing brain. For the study, researchers looked at several types of brain scans in more than 5,100 kids aged 9 to 10 who took part in the ongoing Adolescent Brain Cognitive Development (ABCD) study. Of these, 21% were overweight and 17.6% were obese. There were structural and functional brain impairments in kids who were overweight or obese when compared to kids who weren’t, and these changes could contribute to poor academic performance. Specifically, kids who were overweight or obese showed a thinning of the outermost layer of their brain (the cortex), and this has been linked with impaired executive functioning skills, such as planning and juggling multiple tasks. What’s more, the integrity of the brain’s white matter was impaired in the corpus callosum (which connects the brain’s two hemispheres) and in the pathways within the brain’s hemispheres that connect the lobes of the brain in kids who are overweight or obese. 54 THE PHARMA WORLD Household Factors Can Raise a Child’s Odds for Inflammatory Bowel Disease Pediatric IBD cases are rising globally. What puts kids at risk for pediatric inflammatory bowel disease (IBD) and what could help prevent it? A review of 36 observational studies that included 6.4 million kids offers some key clues. Taking antibiotics at an early age, eating a Western diet and living in a more affluent family were associated with an increased IBD risk. But living in a household with pets and siblings and eating plenty of veggies were linked to a lower risk. The new analysis, found that kids who took antibiotics before age 5 had triple the risk for pediatric IBD. Their risk was 3.5 times higher if they had received four or more courses of antibiotics by that age. Exposure to secondhand smoke doubled IBD risk. “A Western diet, high in sugars and ultra-processed foods and low in vegetables, is a prime example,” explains the lead author.

CAR-T therapy helps kids battling deadly nervous system tumors A therapy that arms the immune system to find and destroy tumor cells has shown early promise against a rare and aggressive childhood cancer called  neuroblastoma. The researchers tried a tactic that has worked very well for some aggressive cases of blood cancer but is not yet proven for other types of cancer: CAR T-cell therapy. CAR T-cell therapy enlists the immune system by genetically altering the T-cells of the patients, allowing them to be armed with chimeric antigen receptors, or CARs. Those CARs allow the T cells to recognize certain markers on the surface of specific cells that are no good – like cancer cells. Once the T cells are infused back into the patient, they can launch a targeted attack on the enemy cells. Within six weeks of treatment, 63% of the children responded, meaning their cancer at least partially regressed. After three years, 40% of all kids in the trial were still alive, but survival was higher – 60% – in the small subgroup given the highest CAR T-cell dose. RSV in infancy could raise a child’s risk for Asthma Kids who were infected with respiratory syncytial virus, better known as RSV, in their first year may be at greater risk for asthma, according to researchers. Their new study looked at the effects of RSV infections of different severities on childhood asthma risk. The study included more than 1,900 healthy infants who were 6 months old or younger at start of RSV season. Researchers then checked on the infants annually and evaluated them for asthma at age 5. Infants who weren’t infected with RSV in the first year of life had a 26% lower risk of asthma at age 5, the study found. THE PHARMA WORLD 55RESEARCH UPDATE About half of extremely preterm babies have at least one life-threatening bacterial infection in their bloodstream after 72 hours of life. Now, new research points to the babies’ own gut microbiomes as the source. Knowing that the most common bacteria in bloodstream infections are also commonly found to colonize the gut without causing disease at first, researchers set out to test whether the bloodstream infections came from the gut or from external transmission. The researchers found this theory that the bloodstream infections started in the gut to be true in 58% of cases by computational profiling to precisely track the identical strain, seeing a nearly identical disease-causing bacterial strain in the gut right before a bloodstream infection was diagnosed. Some of the strains of bacteria that caused bloodstream infections were shared among the NICU infants, the study found. Even in controlled environments there still could be an exchange of microbes, shared by hospital staff or transferred from NICU surfaces, the study authors explained. Maternal infection linked to increased risk for childhood Leukemia Maternal infection, especially genital and urinary tract infections, during pregnancy are associated with an increased risk for childhood leukemia in offspring, according to a new study. Researchers conducted a populationbased cohort study using data for all live births over 20 years period to examine the association of maternal infection during pregnancy with childhood leukemia among offspring. Compared with offspring of mothers without infection, children born to mothers with infection during pregnancy had a significantly increased risk for leukemia. The risk for childhood leukemia was further increased in association with maternal genital and urinary tract infections. There was no association observed for respiratory tract, digestive, or other infections. Dangerous infections in ‘Preemie’ babies may begin in the gut

THE PHARMA WORLD 57 INTERVIEW “To help the children with kidney diseases we need the government to come forward, we need philanthropists to come forward and aid for the ailing children” Prof. Mohammed Hanif Professor, Department of Paediatric Nephrology Anawer Khan Modern Medical College & Hospital, Dhaka As an eminent paediatric nephrologist, please tell us, in brief, about the common nephrological disorders prevalent among children in Bangladesh. How do childhood kidney diseases differ from kidney diseases that affect adults? Thank you very much. We’ll discuss the prevalence of kidney diseases among Bangladeshi children. I’ll briefly discuss how paediatric nephrology started in Bangladesh. Paediatric Nephrology was first established at BSMMU in 1982 with a group of paediatric patients suffering from acute kidney injury (AKI) caused by adulteration of paracetamol  syrup. Around 99% of children died during that tragedy. Due to this incident, paediatricians recognised the importance of establishing a nephrology department for children. The most prevalent kidney diseases in children, which may not always be obvious, include acute kidney injury which is a sudden episode of kidney failure or kidney damage, chronic kidney disease (CKD), which is a gradual loss of kidney function over time, nephrotic syndrome which causes too much protein to pass in patient’s urine and urinary tract infections, which may or may not always have prominent symptoms, causing damage to the kidney silently. Hypertension is yet another silent killer. People may wonder, “Is there any hypertension among the paediatric population?” Of course, there is. I have recorded the blood pressure (BP) of many paediatric patients reading about 200/160. These children usually present with headaches but are often dismissed by their parents as an excuse to skip school. However, when the BP is measured by a paediatrician, they are diagnosed with hypertension. Besides these, there are other causes of kidney problems e.g., diseases related to metabolic disorders like hypercalciuria. Most of these disorders start at a very early age. Many congenital anomalies may develop during the antenatal period in the mother’s womb. If diagnosed early by screening during that period, we can save the functionality of the kidney and prevent further deterioration. Other diseases include obstructive uropathy, renal vascular disease, vasculitis, and vasculitis due to lupus nephritis which is an autoimmune disease. Liver diseases can also affect the kidney. We have data that indicates around 5% of admitted children in the hospital has some kind of kidney problem. The difference between kidney diseases in children and adults is mostly the continuation of paediatric kidney diseases. In adults, common causes of kidney diseases are hypertension and diabetes, while some are related to renal

stone disease. Some childhood kidney diseases, particularly those with a genetic or congenital basis, may have lifelong implications. What are the first signs and symptoms of nephrotic syndrome in children? What causes nephrotic syndrome in children? Is it curable? How is it treated? What happens in nephrotic syndrome is that the child is losing protein from the body through the kidney. Due to low protein in the body, the blood vessels cannot hold fluid, so it comes out of the circulation. The fluids can move to other parts of the body and cause swelling in the face. So, puffy face, especially in the early morning, is a very important symptom of nephrotic syndrome. When the protein volume further decreases even more, urine output also becomes lower. In case of congenital nephrotic syndrome, the baby in the womb becomes very oedematous. The cause of nephrotic syndrome is not often known. But a renal biopsy can identify the changes in the kidneys. Histological causes refer to abnormalities in the structure and function of the kidney’s glomeruli. Minimal Change Disease and Focal Segmental Glomerulosclerosis are two examples. Congenital nephrotic syndrome can occur due to some genetic mutations. Environmental factors can sometimes play a role to express the genetic component of nephrotic syndrome. Nephrotic syndrome is curable. At least 90% of the cases improve in the long run. 10% of the cases may progress to CKD. Treatment is given depending on the type of nephrotic syndrome. A corticosteroid called prednisolone is used. Prednisolone works by suppressing the immune system, reducing inflammation, and repairing the damaged glomerulus to prevent proteinuria, which can help alleviate the symptoms and control the underlying disease process in nephrotic syndrome. Another drug, levamisole, usually used to treat worm infestations, is used in nephrotic syndrome to prevent relapses. Cyclophosphamide, an anticancer drug is also used to manage nephrotic syndrome. Other agents are ciclosporin, tacrolimus, mycophenolate, rituximab (an anti-CD20 monoclonal antibody), etc., which are all available in our country. Prevalence of anaemia is high in Bangladeshi children. What is your opinion on this? What advice would you like to give the parents to prevent childhood anaemia? Indeed, the prevalence of anaemia is high as the majority of our children are malnourished. Many of the children are also suffering from various chronic diseases. So, anaemia is common in the children of Bangladesh. Moreover, mothers while delivering baby also have iron deficiency. To prevent anaemia, we must take measures from early motherhood. If the mother has low haemoglobin, we must diagnose it early and provide treatment. If the mother has any genetic or chromosomal disease or abnormality in the haemoglobin i.e., thalassemia, we have to screen and detect early to take timely measures. We must offer an iron and folic acid supplement to the anaemic mother very early in the pregnancy. If the infant is preterm, a supplement is also provided because the newborn gets iron from the mother. This is especially important during the last trimester. Infections and worm infestations must also be considered since they might interfere with nutritional absorption in the body. We must ensure that the mother consumes iron-rich foods such as bananas, apples, and liver, generally with lemon, which is high in vitamin C and aids in iron absorption. Are there any genetic factors that increase a child’s risk of developing kidney diseases? If so, what are they? Yes, there are several genetic factors that can increase a child’s risk of developing kidney diseases. The total genome sequencing of the human body revealed that there are around 60 genetic variables responsible for renal disorders. Some of these variables may be directly responsible for the condition, while others may have an impact on the disease’s development. So, genetic identification, nowadays, has become an undeniable necessity to treat these kidney diseases. For example, for patients undergoing transplantation, we can identify whether the patient will develop the disease again or not. When you know the genetic basis of the disease, it becomes easier to predict the prognosis and treat the patient. Mutations in numerous genes, such as NPHP1, NPHP2, NPHP3, and NPHP4, are some of the most common causes of kidney disease pathology. Then there are PKD1, PKD2, and PKHD1 genes, which are responsible for polycystic kidney disease. So,  in  modern  medicine,  genetic analysis is essential. How important is early detection and treatment of kidney disease in children, and what are the long-term consequences if left untreated? Acting early is critical not only for kidney diseases, but for all diseases. Many illnesses can even be avoided if detected early enough. As I previously stated, several kidney disorders begin in the womb of the mother. So, maternal diet, maternal medication, radiation exposure, and overall environments, such as smoking or pollution, have an important role in a baby’s growth, and many diseases may be avoided with quality maternal care. For example, if urinary tract infections are detected early, and there is a structural anomaly in the kidney, if it is detected and managed early, further development of chronic disease can be prevented. I have already mentioned the importance of maternal care in case of congenital anomalies of the kidney of the baby in the womb. So, regular ultrasonography is vital to detect any anomaly early on and also, to check immediately after birth. As I’ve said before, kidney diseases in the adult are often the continuaTHE PHARMA WORLD 59

60 THE PHARMA WORLD tion of childhood kidney diseases. So, if treated timely, we can avoid the severity of the disease. Treatment of nephrological diseases/disorders in children is very expensive and most of the people in the country cannot afford it. What can be done to cater to their needs? Yes, treatment becomes very expensive when the disease becomes chronic or there is a need for transplantation. Prevention is always better. We should detect kidney diseases early so that we can prevent the deterioration of the kidney. Mass awareness is important. We need to educate the mother and the family. Diarrhoea or vomiting can even cause kidney damage, as the patient becomes dehydrated. The solution is to take orsaline. Educating and creating awareness in this matter is crucial. Urinary tract infections can cause structural damage to the kidneys and also related to congenital kidney anomalies. So, along with the treatment of infections, the identification of kidney anomaly with ultrasound is important. Recording BP after 3 years is important. Additionally, it is crucial to be aware of the risk factors, which include family history of congenital anomalies, preterm delivery and history of cardiac illnesses like stroke. To help the children with kidney diseases we need the government to come forward, we need philanthropists to come forward and aid for the ailing children. In the western world, there are organisations and support groups which help the children. Only BSMMU has renal transplant facilities, so we need to expand the number of transplant facilities with expert nephrologists and transplant surgeons. Similarly, we need more centres to offer haemodialysis. For early detection, we need consultant for paediatric kidney diseases at district level health centres and we should use media to create awareness, so that kidney diseases can be diagnosed early and prevented. n

CONCERN Francis Godwin, director of the US Food and Drug Administration’s Office of Manufacturing Quality said benzene contamination is a “hot topic” that is causing “a lot of issues” in the quality space. He also said he is concerned about the growing number of contaminated products containing diethylene glycol (DEG) or ethylene glycol (EG), which are some of the “scariest things” his office is seeing. An issue of concern is the growing number of recalls and warning letters tied to drug products that contain benzene, which he said is a “known carcinogen.” This chemical is typically used as an industrial solvent and is “not a friendly chemical.” He noted that “its use as a solvent for pharmaceutical use is restricted.” Last year, FDA issued a warning letter issued to Mirfeel in South Korea for contaminated hand sanitizers containing benzenes. This year, FDA issued a warning letter to Voyant Beauty, a division of Accra-Pac, which makes over-thecounter (OTC) topical drug products. After inspecting the firm’s site in Elkhart, IN, inspectors said the firm failed to investigate products for benzene contamination. These mounting concerns led FDA to issue a statement in December 2022 alerting manufacturers to the risk of benzene contamination in certain drugs. The FDA said in the statement that any drug containing more than 2 parts per million (ppm) benzene is adulterated and should be recalled. Godwin said the “scariest” trend, however, are the poisonings related to diethylene glycol (DEG) and ethylene glycol (EG) contamination in excipients. Godwin said that “these are words that raise the hair on the back of peoples’ necks, this is why people at FDA don’t sleep because they’re worried about this.” “DEG is an industrial chemical, it is not a drug, it is antifreeze, you put this in your car when it gets cold … it is poison,” he told the audience. “If you drink it, you will hurt and you are going to die. FDA has a long history with diethylene glycol.” In 1937, DEG was used an excipient in sulfanilamide, and resulted in the death of more than 100 people. This tragedy prompted the passage of the Food, Drug, and Cosmetic Act in 1938. The reason it is used is because its cheaper than other chemicals and cannot be easily detected. Godwin said that “sadly history is repeating itself,” with more DEG poisoning occurring in 2007 with DEG-tainted toothpaste from China, and more recently, DEG substitution for glycerin in Central America in the late 2000s. More recently, there have been a number of reports of DEG contamination in children’s cough syrups found in several countries, which have resulted in the death of 300 children, he said. These concerns prompted the World Health Organization (WHO) to issue guidance to assist pharmaceutical manufacturers in assessing the quality of excipients to prevent poisoning. Source: ISPE FDA official cites concerns with benzene and DEG contamination The growing number of contaminated products containing diethylene glycol (DEG) or ethylene glycol (EG), which are some of the “scariest things” his office is seeing THE PHARMA WORLD 61

THE PHARMA WORLD 63 INTERVIEW “Early detection & intervention can change a child’s developmental path and improve outcomes for children, families and communities” Prof. Dr. Md. Selimuzzaman Professor of Paediatrics Former Head of Department Paediatric Medicine Child Health Specialist Bangladesh Shishu Hospital & Institute, Dhaka As an eminent Pediatrician of the country, what are some of the most common disorders you find in children of our country? Most common childhood disorders are: l Uncontrolled behavior: ADHD, Conduct disorder l Over controlled behavior: Childhood fears and anxiety disorders l Mental retardation l Autism Can you explain some of the warning signs of childhood asthma? How can parents help their children manage this condition? Warning signs of childhood Asthma: Asthma is a disease with many variations. Typical symptoms are wheeze, shortness of breath, chest tightness and cough that occur variably over time and vary in intensity, often occur or are worse at night or on waking, often triggered by exercise, allergens, cold air or viral infection. Warning signs of severe attack includes, severe coughing, severe breathing difficulty, difficulties in feeding, talking and daily activities, turning pale or blue in lips and/ or fingernails. Management of Asthma: Plan will include ways to manage child’s asthma symptoms and prevent asthma attack, such as: l Strategies to avoid triggers l Short term relief medications i.e. inhaler with short acting bronchodilators l Control medicines i.e., combination of inhaled corticosteroid with long acting beta agonist Water borne diseases like jaundice, typhoid and dysentery are some of the common summer illnesses in children. How to prevent and treat them? Prevention of waterborne illness: Waterborne diseases like jaundice, typhoid, dysentery, spread by drinking contaminated water. To prevent these, following measures are required: l Decontamination of drinking water by filtration, boiling, sedimentation and chemical treatment of water. l Water resources/reservoirs should be periodically decontaminated/ disinfected. l Standard practices of hygiene should be strictly maintained. l Vaccination against typhoid and hepatitis. l Treatment: There are general principles of waterborne disease management: l Adequate rest, hydration

l Correction of fluid and electrolyte imbalance l Anti pyretics as required l Zinc supplementation l Antibiotic therapy: Typhoid fever: Fluroquinolone/ cefixime/ ceftriaxone/ azithromycin Dysentery: ciprofloxacin/ ceftriaxone/ cefixime/ azithromycin What are some common developmental disorders that affect children? What are the signs and symptoms of these disorders and which treatment options are available? Common neuro developmental disorders are: l Intellectual disabilities: Impaired mental functions in conceptual, social, and practical aspects l Communication disorders: difficulties in language, speech, phonetic fluency or social communication l Autism spectrum disorder (ASD): persistent deficit in reciprocal social communication and interaction as well as restricted, repetitive patterns of behavior, interests or thoughts l Attention deficit hyperactive disorder (ADHD): impaired attention with bursts of hyperactivity/ impulsivity l Specific learning disorder (SLD): difficulties with learning skills like reading , writing, spelling l Motor disorder: impaired execution of coordinated motor skills, or repetitive motor behaviors l Tic disorder: habitual sudden, rapid, recurrent and non-rhythmic motor movements or vocalizations Treatment options for developmental disorder: l Medication: certain cases of ASD and severe forms of ADHD can be treated in part with medications l Individual and group therapy l Behavioral training and occupational therapy l Aftercare and support Would you please enlighten us on the importance of early diagnosis and intervention for developmental and behavioral disorders in children? The earlier the developmental disorders are detected and interventions begins, the greater the chance a young child has of achieving his or her best potentials. Early detection and intervention can change a child’s developmental path and improve outcomes for children, families and communities. Families benefit from early intervention by being able to better meet their children’s needs from an early age and throughout their lives. n THE PHARMA WORLD 65 Promise for pancreatic cancer vaccine A vaccine to treat pancreatic cancer has shown promise in a small, initial trial. Ninety percent of pancreatic cancers return seven to nine months after surgery. In the study, tumours did not return in 8 of the 16 people in the trial a year and a half after receiving a personalized mRNA vaccine following surgery. Cord-blood therapy to treat cancer The US Food and Drug Administration has approved a therapy to treat blood cancer with stem cells from umbilical-cord blood. People treated with omidubicel, which will be sold as Omisirge, saw their  white blood cells and platelets recover faster, experienced fewer infections and spent less time in hospital than those treated with standard cord blood. WHAT’S NEW Source: Nature

THE PHARMA WORLD 67 INTERVIEW “In the last decade, Bangladesh has done a lot to establish neurodevelopmental institutes, Shishu Bikash Kendra in all the tertiary and secondary care health facilities” Prof. S. K. Banik Professor & Head of the Department of Neonatology and Pediatrics Sir Salimullah Medical College, Dhaka Faculty Member of Pediatrics, BCPS Vice President Bangladesh Neonatal Forum nutritional disorders, cardiac diseases, hematological conditions, endocrine diseases, kidney diseases, skin disease and many communicable diseases are also affecting the children. Some common childhood illnesses and their treatments can be mentioned in brief: 1. Common Cold and cough l Colds are caused by viruses in the upper respiratory tract. Many young children-especially those in child care home can get 6 to 8 colds per year. Symptoms of a cold (including runny nose, congestion, and cough) may last for up to ten days.   Green mucus in the nose does not automatically mean that antibiotics are needed; common colds never need antibiotics. However, if a sinus infection is suspected, doctor will carefully decide whether antibiotics are the best choice based on child’s symptoms and a physical exam.  l Coughs are usually caused by viruses and do not often require antibiotics. l Cough medicine is not recommended for all children 2. Bronchiolitis l Bronchiolitis is common in infants and young children during the cold and flu season. Doctor may hear “wheezing” when child breathes. l Bronchiolitis is most often caused by a virus, which does not require antibiotics. Instead, most treatment recommendations are geared toward making child comfortable with close monitoring for any difficulty in breathing, eating, or signs of dehydration. Medicines used for patients with asthma (such as albuterol or steroids) are not recommended for most infants and young children with bronchiolitis. Children who were born prematurely or have underlying health problems may need different treatment plans. 3. Pneumonia & Respiratory Infections Respiratory infections such as influenza and pneumonia are common diseases in Bangladesh, and they are one of the leading causes of death. They rank second in the top ten causes of death in Bangladesh, with lower respiratory infections alone resulting in seven percent of total deaths in the country. Protective measures like exclusive breastfeeding, adequate complementary feeding high immunization coverage and vitamin A supplementation provide the foundation for keeping children healthy and free of disease. Only 37% of children are taken to a health care provider when they show symptoms of pneumonia, so increasing health awareness and education is a crucial step to reducing deadly respiratory infections. Antibiotics are critical for treating pneumonia. As an eminent Paediatrician of the country, would you please give us, in brief, an overall scenario of Paediatric Diseases and their treatment in Bangladesh? There are many diseases that are prevalent in paediatric age group. Worldwide Malaria, pneumonia, diarrhoea, HIV and tuberculosis  are preventable and treatable. But they are still killing children in large numbers. Major causes of death among children vary by age. Children under 5 are especially vulnerable to infectious diseases like Bronchiolitis, pneumonia and other Respiratory illness; Diarrhoeal diseases, and tuberculosis. Beside these, neonatal conditions like prematurity, asphyxia, septicemia & neonatal Jaundice are prevalent. Neurodevelopmental disorders,

4. Diarrhoeal illness: In recent years, significant progress has been made reducing child deaths from diarrhoea. But diarrhoea remains a leading killer of young children, particularly in humanitarian settings. .  Diarrhoea is a common and often dangerous condition for many in Bangladesh.  The dangers are especially true for young children. Though diarrhoea is sometimes a symptom of more serious issues, diarrhoea itself can be caused by diseases like cholera that are a result of poor water and sanitation. In 2019, diarrhoea killed approximately 480,000 young children across the globe, accounting for 9 per cent of all deaths among children under age 5. Better knowledge about the dangers of contaminated water along with increased access to safe water and proper sanitation can prevent the spread of these bacteria. For those already afflicted, oral rehydration therapy helps reduce dehydration and prevent further sickness or death. Gastroenteritis means an inflammation of the lining of the stomach and intestines and it presents in children primarily as vomiting and/ or diarrhoea. Viral gastroenteritis is responsible for about half of all cases of gastroenteritis; babies and young children from 6 months – 3 years are particularly prone. The most common virus causing this condition is rotavirus. Viral gastroenteritis can cause large outbreaks of vomiting and diarrhoea at schools and other childcare organizations. Gastroenteritis can also be bacterial or parasitic. The main danger with children – and especially young babies – is that they become dehydrated due to not being able to keep down fluids, or from excessive fluids lost through loose bowel movements. Small babies cannot tolerate becoming dehydrated and any spell of vomiting or diarrhoea that lasts more than three hours needs an urgent visit to the doctor. The younger the child, the greater the risk of dehydration. 5. Sore Throat Sore throats are common in children and can be painful. However, a sore throat that is caused by a virus does not need antibiotics. In those cases, no specific medicine is required, and your child should get better in seven to ten days. In other cases, a sore throat could be caused by an infection called streptococcal(Strep). A lab test or in-office rapid strep test, which includes a quick swab of the throat, is necessary to confirm the diagnosis of strep and necessitate antibiotic full course. 6. Ear Pain Ear pain is common in children and can have many causes—including ear infection (otitis media), swimmer’s ear (infection of the skin in the ear canal), pressure from a cold or sinus infection, teeth pain radiating up the jaw to the ear, and others. Amoxicillin is the preferred antibiotic for middle ear infections. Many true ear infections are caused by viruses and do not require antibiotics. 7. Urinary Tract Infection Bladder infections, also called urinary tract infections or UTIs, occur when bacteria build up in the urinary tract. A UTI can be found in children from infancy to the teen age. Symptoms of a UTI include pain or burning during urination, the need to urinate frequently or urgently, bedwetting or accidents by a child who knows to use the toilet, abdominal pain, or side or back pain. Doctor will need a urine sample to test for a UTI before determining treatment and provide antimicrobial accordingly. 8. Skin Infection In children skin infections is very common. A skin test (culture or swab) may be needed to determine the most-appropriate treatment protocol. 9. Asthma  If a child sometimes wheeze and experience tightness or pain in the chest, difficult to breathe, or has a cough that won’t go away - he or she may have gotten asthma. With asthma, a child’s airways become sensitive and inflamed. It is very common, affecting about 7-10 percent of children in Bangladesh.    Treatment involves using an inhaler immediately as instructed by the doctor. Repeating the procedure every 20 minutes up to an hour is the mainstays of treatment. Avoidance of common triggers, such as dust, pollen, animal fur, tobacco smoke and stress. A child is to visit a doctor immediately if the asthma symptoms are not relieved or have worsened, or if the symptoms return within four hours 10. Constipation  Is a baby or child not pooping as often as he usually does? Has his poop pattern slowed down a lot, and are his stools harder than usual? He may have constipation. Other symptoms include a hard abdomen, discomfort and crankiness. It is rare for breastfed babies to suffer from constipation as breast milk is easily digested.  Laxatives and purgatives are easy remedies beside modifications of food habits.  11.Tuberculosis (TB) Is a disease that the world knows how to prevent and treat. Yet, over 600 children under the age of 15 die from it every day – nearly a quarter million each year. Most of these deaths occur among children under the age of 5.   While countries have developed methods for TB prevention, surveillance, diagnosis and treatment in adults, children are still falling through the cracks. Among the one million children estimated to fall ill with tuberculosis each year, less than half are identified and registered by national programs.   12.Prematurity, Preterm Birth Complications and Neonatal Encephalopathy Preterm birth complications and neonatal encephalopathy (commonly known as birth asphyxia) are two common diseases in Bangladesh that center around infancy. Together, these two diseases made up 40% of neonatal deaths. About 28,000 children in Bangladesh die the day that they are born. However, many of these deaths could be prevented with better prenatal and postnatal care. Improving medical facilities and making them more accessible to everyone, especially those in rural areas, will help more babies survive and live a healthy life. 13.Malnutrition Tragically, the rates of malnutrition 68 THE PHARMA WORLD

THE PHARMA WORLD 69 in Bangladesh are among the highest in the world. More than 54% of preschool-aged children, equivalent to more than 9.5 million children, are stunted, 56% are underweight, and more than 17% are wasted (FAO, 2019) The following are the most common nutritional problems in Bangladesh l Vitamin D Deficiency l Vitamin A Deficiency l Vitamin C Deficiency l Vitamin B12 Deficiency l Protein Deficiency l Iron Deficiency l Folate Deficiency 14. Drowning: Each year, over 14,000 children in Bangladesh die due to drowning. Although largely unrecognized, drowning is the second leading cause of death for children under the age of five in the country, making it a major public health problem. Drowning is the leading cause of death in children aged 1-17 years in Bangladesh. • Age is a major risk factor for drowning. The highest rates of fatal drowning are found in the 1-4 year age group, when children start to walk and venture away from supervision. However rates of near drowning in Bangladesh are several times higher than those of fatal drowning (118/100,000 near drowning; 28.6/100,000 drowning) among children 1-17 years. • Rates of drowning are higher in rural populations. Drowning is preventable. The International Drowning Research Centre - Bangladesh is currently implementing a number of successful drowning prevention pilot interventions. Prematurity is one of the major killer of children under 5. What can be done to combat this and improve the survival and wellbeing of premature babies? Prematurity and other neonatal death comprises about 67% of the under 5 mortality in our country. To combat this situation and improve the survival and wellbeing of the premature babies, action is to be started before the delivery of the baby. Obstetrician have a major role to play in prevention of prematurity that is premature delivery. Judicious termination of the pregnancy with providing antenatal corticosteroid (ACS) can improve the survival of the premature baby. Delivery is to be done at a place where neonatal care is available. Other option is in-utero transfer of the baby to a center where combined neonatal and obstetric service are present at the same floor. Further options are proper transportation of the baby from a primary or secondary center to a tertiary care NICU where meticulous management of this baby can be done. Mainstay of management are thermal care providing respiratory support, circulatory management, prevention of infection and management of complications. After discharging from the NICUs proper supplementations of nutrient, ROP screening (Retinopathy of prematurity), hearing assessment, developmental therapy, growth assessment, immunization can improve the survival and wellbeing of the neonates. Prevalence of anemia is very high in children of our country. What is your opinion on this? What advice would you like to give the parents to prevent childhood anemia? Well, this is a big nutritional problem of micronutrient deficiency starting from the pregnancy period. Some mothers have anemia that has to be managed properly. After delivery in the neonatal period, proper supplementations should be given to prevent the anemia in neonate and children. Iron deficiency is a shadow below the lamp. We have food but due to lack of knowledge about the balanced diet and nutritious diet, iron containing diet anemia occurs even in the affluent society. To combat iron deficiency, the mainstays of preventive measures that parents are advised to take is to provide nutritious diet, iron supplementation and regular use of anti-helminthes. What are some common developmental disorders that affect children? What are the signs and symptoms of these disorders, and what treatment options are available? Common developmental disorders that may affect the children arel Autism spectrum disorder l Learning disorders l ADHD (Attention Deficit Hyperactivity Disorder) l Hearing loss l Cerebral palsy l Intellectual disability l Visual Impairment l Physical challenges l Syndromic babies like Down syndrome l And other developmental diseases In most of the cases the signs and symptoms are very obvious. But in others the sign symptoms are subtle and can be found out only by careful observations. Hyperactivity, excessive irritability, communication problem, lack of eye to eye contact, hand preference, delayed milestones of development, language disorder, hearing and visual impairments, intellectual inability are some common signs and symptoms of the developmental disorders. Treatment options remain early recognitions of problem, proper diagnosis, use of medications and multidisciplinary approach with therapies can improve the quality of life. Would you please enlighten us on the importance of early diagnosis and intervention for developmental and behavioral disorders in children? Neurodevelopmental disorder is an emerging problem in our country and at a large in the world. Early detection of the problem, proper referral of the child to a neurodevelopmental care center and proper management by the neurodevelopmental physicians, therapist, psychologist and neurologist, behavioral therapist can make a difference in treating and improving the disabilities of the affected children. In the last decade, Bangladesh has done a lot to establish neurodevelopmental institutes, Shishu Bikash Kendra in all the tertiary and secondary care health facilities. The mainstay of interventions are maximizing developmental potential, enhanced academic achievement, improved social and emotional wellbeing, support for families and prevention of secondary issues like communication disorder, feeling of frustration, isolation and poor self-esteem. n

70 THE PHARMA WORLD One recent case involving a potentially dangerous fake antibiotic drug has brought to the fore systemic weaknesses that can only be remedied by group action. Substandard, also called “out of specification”, and falsified (or counterfeit) medicines pose a real barrier to delivering high-quality health services, and are a significant contributor to longer hospital stays and deaths. These include branded and generic medicines that have failed to meet international good manufacturing practices, pharmaceuticals fraudulently produced with the wrong or no active ingredient, and poor quality products deliberately mislabelled to boost the ever-growing trade in medicines bought over the internet. Antibiotics are among the most counterfeited medicines, particularly in poorly regulated developing countries, and contribute to driving high prevalence of drug-resistant pathogens with poor infection control. This could well lead to therapeutic failure that necessitates the prescription of FAKE DRUGS Mohamed A. Elhawary Clinical Pharmacologist ISoP Egypt Chapter Clinical Pharmacist, Editor Jeehan El-Hefny Medical Affairs Director, Medical Union Pharmaceuticals

THE PHARMA WORLD 71 broader-spectrum, relatively more expensive antibiotics. In Egypt untrained drug vendors have replaced pharmacists as the main source of medicines in most private retail pharmacies. Recently, safety issues stemming from counterfeit batches of Unictam 1500 mg vials by Medical Union Pharmaceuticals (MUP) were found in several provinces across Egypt. Between 2 February and 17 April 2022, the pharmacovigilance department at MUP received 48 individual case safety reports (ICSRs) of suspected adverse reactions associated with Unictam. This led to a series of rapid investigations in 12 governorates, including Cairo, Alexandria, and the Nile Delta region. Aspects of this signal involved, among others, an increasing number of spontaneous reports submitted in a noticeably short period of time, the nature and prevalence of adverse drug reactions (ADRs), and the difference between adulterated and real pharmaceuticals with respect to product characterisation and impurity profiling. Along with some subtle differences in packaging and labelling, initial laboratory tests conducted on the seized counterfeits found that they contained a potentially harmful and unapproved substance of low quality, which did not meet the correct specification. At this point, nearly two-thirds of the documented cases of drug counterfeiting were hospitalised with symptoms of chest pain, haemoptysis, high blood pressure, syncope, and tachycardia. Healthcare professionals (HCPs) also took to social media to highlight the issue and voice their concerns over serious pregnancy-related complications in which one of the cases had experienced a miscarriage due to counterfeit Unictam administration. For those patients who were unknowingly harmed by the counterfeit Unictam, the coverage for claimsmade insurance policies ruled out unapproved products – including counterfeit medicines, with no financial protection against the costs of recalls sparked by such products. Signals involving counterfeit medications at a broader level so as to help identify important potential risks, and to update our overall approach for managing Risks. Based on information corroborated by MUP, the relevant drug safety alerts that ensued have exposed the extent of the problem and led to calls for better harmonisation and coordination among pharmacovigilance stakeholders to ensure comprehensive implementation of regulatory and legal measures. Our findings require using a risk management approach to identify areas of exposure to counterfeit pharmaceuticals and provide for a national track-and-trace system in the pharmacy sector that would guarantee a reliable stock of authentic medicines all the way to patients. Poor supply chain management contributes to exhausted stocks that force patients to buy medicines of whatever sort outside the legitimate sales sector. This creates the possibility to infiltrate counterfeit drugs at every node of the entire distribution network. It is clear that linking manufacturers directly to drug stores and hospitals, while bringing into force primary packaging serialisation to uniquely identify items at the unit level, will allow for a full audit trail and create a viable eco-system of concerned stakeholders all with the same goal. From an overall perspective, advanced authentication and increased technological sophistication will set up successful anti-counterfeiting systems that make it easier for HCPs and patients to determine the legitimacy of suspect products by cross-referencing a unique product identifier in barcodes against a database. Raising public awareness of the hazards connected to counterfeit medicines continues to be challenged by supply chain vulnerability and the risks arising from the presence of counterfeit drugs in unregulated markets. A pragmatic set of policies needs to be implemented to increase the availability of lowestpriced generics and to restore faith in genuine medicine, particularly in areas where the lure of affordable or unauthorised products tends to overwhelm the safety message. Switching of brands as well as loss of public confidence in the treatments they rely upon, and perhaps reputational damage, should be of concern to Egyptian pharmaceutical industry leaders as they position themselves to be among the primary pharmaceutical export markets in Africa and beyond. Acknowledgements. The authors wish to thank Dr Hadir Rostom, President of the ISoP Egypt Chapter, for her support in undertaking the project; with a special thank you to those who collaborated to produce this piece of work. Source: UMC

THE PHARMA WORLD 73 INTERVIEW “To combat prematurity, neonatal death interventions is essential even from the antenatal period and it is a collaborative work between obstetricians and neonatologists” As an eminent Neonatologist of the country, would you please give us, in brief, an overall scenario of Neonatal Diseases in Bangladesh? Bangladesh has made remarkable progress in reducing childhood mortality. For this, it has achieved MDG 4 goal. But trend of decrease of neonatal mortality is a bit slower than under 5 mortality. As per BDHS 2022, newborn mortality comprises of 64% of under 5 mortality (31/20). That means to reduce under 5 mortality, newborn mortality should be addressed on priority basis. Prematurity is one of the major killers of children under 5. What can be done to combat this and improve the survival and well-being of premature babies? To combat prematurity, neonatal death interventions is essential even from the antenatal period and it is a collaborative work between obstetricians and neonatologists. To reduce preterm birth, early marriage and late marriage need to be discouraged. Regular antenatal checkup, maternal nutrition, management of maternal illness during pregnancy as well as chronic diseases has also impact in reducing prematurity. For survival and wellbeing, antenatal corticosteroid is to be ensured in case of preterm babies to reduce Respiratory Distress Syndrome, to deliver the baby in hospital where infrastructural and human resources are available to handle preterm babies. Taking care of hypothermia, prevention of infection, adequate nutrition, judicious use of oxygen , blood and blood product also play role. Kangaroo Mother Care (KMC) is an excellent and proven intervention for premature babies for maintenance of temperature, adequate nutrition, prevention of infection and also for good developmental outcome . ROP screening, hearing screening, vaccination will ensure wellbeing of premature babies by preventing morbidities like hearing and visual impairment. What are the major causes of sepsis in newborns? What can be done to prevent it? There are 2 types of sepsis in newborn; Early and late onset sepsis: Major causes of Early Onset sepsis are of maternal origin like premature rupture of membrane, maternal fever, chorioamnionitis, UTI within 2 weeks of delivery, repeated unclean per vaginal examination. For late onset sepsis, causes are prelacteal feed, poor infection control measures, poor umbilical cord care, dealing babies by unclean hands, frequent blood sampling, procedures during hospital stay. Prof. Dr. Sanjoy Kumer Dey Chairman Department of Neonatology BSMMU, Dhaka

Prevention: Prompt treatment of maternal infection, breast feeding, maintenance of hand hygiene, address nutrition. What causes neonatal jaundice and what are the risk factors? Is there a way to prevent it? Majority of causes of jaundice in neonate in Bangladesh are poor feeding/ dehydration, hemolysis, infection, prematurity, neonatal cholestasis Risk factors are: Rh and ABO incompatibility, prematurity, infection, asphyxia, hypothermia, concealed haemorrhage Preventive measures: Ensure early and adequate breast feeding, immunoglobulin to mother in case of Rh negative mother, regular antenatal care, infection prevention measures, prompt management of asphyxia. What are some of the most common congenital anomalies you encounter in newborns, and how do you typically diagnose and treat them? Common congenital anomalies are Club foot, cleft lip, cleft palate, myelomeningocele, congenital heart disease, congenital renal problems Physical examination, X Ray and imaging, ECHO and some lab test are tools to diagnose congenital anomalies For treatment, it is a team approach like collaborative work between neonatologist, paediatric surgeon, neurosurgeon, orthopedic surgeon, peadiatric nephrologist, paediatric cardiologist, physiotherapist and nutritionist Finally, How do you balance the need for aggressive medical intervention with the desire to minimise the stress and trauma of newborns in the neonatal intensive care unit (NICU)? What is your suggestion for improving the accessibility and affordability of NICU for all people of our country? Newborn admitted in NICU needs aggressive, sometimes overtreatment considering life and future outcome. To minimize trauma and stress in newborn, it is recommended to create an environment like intrauterine state such as maintenance of temperature, minimizing sound and light in NICU, minimum procedure, cluster care, nesting, swaddling. Expressed breast milk/ breast feeding during procedure works as analgesic. Except surgical procedure pain killer/ narcotic drugs are discouraged. Family integrated care is nowadays a proven concept to involve family members in newborn care for better outcome of NICU admitted newborn. Accessibility and affordability of NICU A substantial number of babies are being delivered in private hospital by LSCS and thereafter admitted in private NICU. Evidences shows that a significant number of deliveries undergone unnecessary LSCS and moreover cost of NICU in private hospital is more. A promising information is that GoB has established 79 SCANUs in medical colleges and district hospitals. Neonatologists, Paediatrician and trained nurses are working there. Despite that support these SCANUs can’t accommodate a large number of babies requiring NICU/SCANU support and they are admitted in private hospital. Referral linkage is not well established in Bangladesh till date. A good referral linkage can ensure accessibility in appropriate hospital. For affordability, there is no alternative to increasing support of newborn in government hospitals by establishing more SCANU/ NICU, by preparing more neonatologists, more skilled nurses. More budgetary allocation for newborn service will also reduce financial burden to parents. n 74 THE PHARMA WORLD

THE PHARMA WORLD 75NEURO DEVELOPMENT Among kids with Autism, Girls are more prone to anxiety disorders than boys Boys are four times more likely to be diagnosed with autism than girls are, but girls may be more likely to experience anxiety alongside the disorder than boys, new research reveals. For the study, kids with autism underwent brain scans when they were toddlers and at three other time points. Their parents were interviewed about their anxiety symptoms to help tease out whether anxiety was related to autism symptoms or a distinct entity. Overall, the girls had higher rates of anxiety than the boys, particularly in the presentations of anxiety that are distinct to autism, including fear of change. They also had higher rates of more traditional forms of anxiety, such as social anxiety, generalized anxiety and separation anxiety, the study showed. ‘Harsh’ parenting can Bring Mental Health harms to kids Parents who harshly discipline their young children may be putting them on a path toward lasting mental health symptoms, a new study suggests. Hostile parenting can mean frequently yelling, unpredictably doling out punishment, name-calling or physically punishing a child. Researchers found that among 7,500 children followed from age 3 to 9, about 10% fell into a “high risk” group where mental health symptoms – ranging from persistent sadness to acting out – worsened over the years. And children whose parents often used harsh discipline, including yelling or physical punishment, were about 50% more likely than their peers to end up in that group. Intervening early helps Curb Autism A leading doctors’ group recommends that toddlers get screening for autism at 18 months old. That may not be a moment too soon — and earlier may be even better, researchers say. A new randomized clinical trial, the gold standard for studies, backs up the recommendation from the American Academy of Pediatrics. Intervention at 18 months for children on the autism spectrum led to better gains in language, social communication and daily living skills than when individual coaching was delayed until 27 months old, the researchers found. These findings highlight how early intervention can capitalize on brain plasticity, said the lead author. “Babies’ brains are changing rapidly in the first three years of life. If we can intervene and provide these developmental supports for kids to learn new skills as early as possible, we can capitalize on how rapidly their brains are changing anyway,” she explained.

DRUG SAFETY Systemic corticosteroids Risks of pheochromocytoma crisis The Medsafe has announced that the product information for systemic corticosteroids is to be updated to include the risk of pheochromocytoma crisis. Pheochromocytomas are tumours in the adrenal medulla that typically secrete cat - echolamines and pheochromocytoma crisis (PC) is a rare, life-threatening emergency in which pheochromocytomas release high levels of catecholamines. Ibruti n i b Risk of serious cardiac events The EMA has published direct health-care professional commu - nication (DHPC) following PRAC discussions on the increased risk of fatal and serious cardiac ar - rhythmias, and cardiac failure with the use of ibrutinib (Imbruvica®). Ibrutinib is indicated for the treatment of mantle cell lym - phoma, chronic lymphocytic leu - kaemia (CLL) and Waldenström’s macroglobulinaemia. The DHPC provides the follow - ing advice: Patients with advanced age, Eastern Cooperative Oncology Group (ECOG) performance sta - tus ≥2, or cardiac co-morbidities may be at greater risk of cardiac events including sudden fatal car - diac events. Prior to initiating ibrutinib, clinical evaluation of cardiac his - tory and function should be per - formed. In patients with risk factors for cardiac events, benefits and risks should be assessed before initiat - ing treatment with Imbruvica; al - ternative treatment may be con - sidered. Risk of hy poglycaemia Newer antidiabetic medicines used with insulin and/or sulfonylureas The Medsafe has alerted health-care pro - fessionals on the risk of hypoglycaemia as - sociated with newer antidiabetic medicines (glucagon-like peptide 1 (GLP-1) receptor agonists, sodium-glucose co-transporter 2 (SGLT-2) inhibitors or dipeptidyl pepti - dase-4 (DPP-4) inhibitors) used concomi - tantly with insulin and/or sulfonylureas.Pa - tients on concomitant therapy may require a lower dose of insulin or the sulfonylurea to prevent episodes of hypoglycaemia. Val proate Risks in pregnancy and potential risks in male patients The CHM has recommended a number of regula - tory actions to further strengthen safety measures for valproate, which will be introduced over the coming months and include: No patients (male or female) under the age of 55 years should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. For patients under 55 years currently receiving valproate, two specialists should independently consider and document that there is no other effec - tive or tolerated treatment or the risks do not apply. Hydroxychloroqui ne Risk of acute febrile neutrophilic dermatosis The MHLW and PMDA have announced that the product in - formation for hydroxychloroquine (Plaquenil®) should be revised to add the risk of acute febrile neutrophilic derma - tosis (Sweet’s syndrome). Hydroxychloroquine is indicated for the treatment of cutaneous lupus erythematosus and systemic lupus erythematosus. The MHLW and PMDA con - cluded that acute febrile neutrophilic dermatosis (Sweet’s syndrome) should be added as a clinically significant ad - verse reaction. 76 THE PHARMA WORLD Febuxostat Updated advice for patients with CVD Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease (CVD), par - ticularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy.

THE PHARMA WORLD 77RED ALERT Methotrexate Risk of PML The MHLW and PMDA have announced that the product information for methotrexate (oral dosage forms, intravenous infusions and parenteral preparations) should be revised to include the risk of progressive multifocal leukoencephalopathy (PML). A total of 12 patient mortalities were reported internationally during the previous three years. Healthcare professionals are advised to monitor patients carefully during and after administration of this drug. If symptoms such as disturbance of consciousness, cognitive dysfunction, paralysis, dysarthria, and aphasia are observed, MRI imaging and cerebrospinal fluid examination should be performed, and administration should be discontinued. Ceftriaxone and cefotaxime Risk of severe hypersensitivity reaction The EPVC, EDA has issued DHPC to remind health-care professionals of safety measures to minimize the risk of severe hypersensitivity reaction, anaphylaxis and other life-threatening adverse events. Ceftriaxone and cefotaxime are antibiotics indicated for the treatment of various infections, and are strictly contraindicated in patients with history of immediate type hypersensitivity to cephalosporins. The EPVC received reports of hypersensitivity, anaphylaxis and other life-threatening adverse events which could be linked to these medicines administered improperly or without sensitivity testing. Prior to administration, Health-care professionals should verify if the patient has had previous hypersensitivity reactions to cefotaxime sodium, ceftriaxone, cephalosporins, penicillin, or other medicine. A sensitivity test should be performed before each dose. It is recommended to administer these medicines in hospital settings with preparations for emergency measures. Acetaminophen Risk of drug-induced hypersensitivity syndrome The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) have announced that the product information for acetaminophen should be revised to include the risk of drug-induced hypersensitivity syndrome. Acetaminophen products are in the form of oral dosage forms, suppositories or injections. The MHLW and PMDA concluded that drug-induced hypersensitivity syndrome should be added as a clinically significant adverse reaction. Health-care professionals are advised that symptoms of drug-induced hypersensitivity syndrome initially manifest as rash and pyrexia, followed by serious delayed symptoms of hypersensitivity accompanied by hepatic impairment, swollen lymph nodes, increased eosinophil counts and appearance of atypical lymphocytes. Gabapentin Risk of drug dependence and withdrawal symptoms The HPRA has announced that the product information for gabapentin indicated to treat neuro pathic pain and epilepsy will be updated to indicate that drug dependence at therapeutic doses and withdrawal symptoms following discontinuation can occur. Health-care professionals should carefully evaluate an individual patient’s risk of misuse, abuse and dependence before prescribing gabapentin. Patients treated with gabapentin should be monitored for these symptoms. Pseudoephedrine Risks of PRES and RCVS Following reports of the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), the PRAC has started a review of pseudoephedrine. Pseudoephedrine is taken orally and is used for the treatment of nasal congestion resulting from a cold, flu or allergy. It has a known risk of cardiovascular and cerebrovascular ischemic events, including stroke and heart attack. These restrictions and warnings are already included in the product information.

THE PHARMA WORLD 79 INTERVIEW “Treatment of the diseases should be disease specific as well as organism specific and by proper antibiotics in proper dose and proper duration” Prof. Iffat Ara Shamsad Professor and Head Department of Paediatrics Dhaka Medical College Hospital As an eminent Paediatrician of the country, would you please give us, in brief, an overall scenario of paediatric diseases and their treatment in Bangladesh? First of all, I would like to give an overview on child health status over last 30 years. The 2017-18 Bangladesh Demographic and Health Survey (BDHS) is the eighth survey which was started in 1993, so it is the longest running series of health care surveys in Bangladesh. According to that survey we observed that, we have a tremendous improvement on child health indicators. Under-five mortality (U5M) followed a steady downward trend from 1993 up to 2014 but after that the decline appeared to flatten. U5M declined from 133 to 46 per 1000 live births during 1993-2014. Our Prime Minister Sheikh Hasina received MDG award-2010 for outstanding success in reducing U5M. Causes of U5M are due to acute respiratory infections (mostly pneumonia), diarrhoea, measles, malaria, or malnutrition — and often due to combination of these conditions. Among these, pneumonia and diarrhoea are responsible for death of more than 3 million children under five years old each year. The improvement of management of these conditions through Integrated Management of Childhood Illness (IMCI) in the primary (Community clinics and Thana Health Complexes) to tertiary level hospitals is revolutionary in the history of child health in Bangladesh. Under this programmatic management we can address common diseases of the children as well nutrition. Another achievement is Expanded Programme on Immunization (EPI) of children which was launched in 1979, providing protection against the major vaccine-preventable diseases (tuberculosis, diphtheria, pertussis, tetanus, hepatitis, haemophilus influenzae type B, poliomyelitis, Pnemococcal pneumonia, and measles-rubella), is globally recognized as one of the most cost-effective programmes to reduce infant and child morbidity and mortality. Again, Prime Minister Sheikh Hasina received Vaccine Hero Award-2019 for outstanding success in vaccination to immunise the children. In fact, these two achievements changed the overall child health situation of the country. Is asthma hereditary? How does asthma manifest in children, and what are some effective ways to manage it? Asthma is a condition that likely results from complex interactions between multiple genetic and environmental influences. That means asthma runs in families but range of heritability of asthma is from 25 to 80 percent. One study estimated that children are up to 3 times more likely to develop asthma if their mothers have it, and 2.5 times more likely if their fathers do. On the other hand environmental factors play an impor-

80 THE PHARMA WORLD tant role, some are called triggering factors. Common asthma triggers are dust, mites, outdoor air pollution, cold, some foods, pets, tobacco smoke etc. Children presented with recurrent episodes of cough, especially at night or early morning, breathing problems such as shortness of breath, rapid breathing, and tightness of chest. Sometimes there is seasonal predilection. Currently, there is no cure of asthma but we can control it with proper treatment. So the aim of asthma management is to control the symptoms and reduce the number of attacks to ensure a normal, active life to the child. To keep the asthma under control, it is very important to know the specific asthma triggers and avoid them. If a child prescribed with medicine, one should follow the doctor’s instruction properly. Parents should know how to nebulize the child with proper dose of the medicine and duration. On the other hand if the child especially the younger one prescribed with inhaler, it should be with spacer. There are 2 main types of medicines used to manage asthma: quick-relief and long-term controllers; no role of antibiotics. Can environmental factors such as air pollution or cigarette smoke worsen respiratory symptoms in children with asthma and other respiratory conditions? Yes, air pollution or cigarette smoke worsen respiratory symptoms in children with asthma and other respiratory conditions. These are the important asthma triggering factors. Inhalation of high polluted air or cigarette smoke can cause acute exacerbation of asthma. Exposure to these factors is responsible for recurrent attacks which injure the airways and lungs. What are the best ways to prevent respiratory infections, such as pneumonia and the flu in children? To prevent respiratory infections, such as pneumonia and the flu the children should get breast feeding properly. First three days milk which is called colostrum is the first immunization to the children. Then, to ensure that under the EPI programme, a child is properly vaccinated, he/she gets immunisation against some organism which are responsible for childhood pneumonia e.g. Haemophilus influenza type-b, Pneumococcus etc. In special situations, there are provisions for other vaccines like Covid-19 vaccine, Influenza vaccine etc. Water-borne diseases like jaundice, typhoid, and dysentery are some of the common summer illnesses in children. How to prevent and treat them? Waterborne illnesses are caused by drinking water and food contaminated by disease-causing microbes or pathogens. Children should drink disinfected water e.g. boiled cold water, tube well water or properly treated water. Parents should learn fundamentals of food safety and then can serve the food to the children with proper safety. Again we must follow the recommendations of breast feeding i.e. exclusive breast feeding for first six months and continue along with complementary food for two years. Parents as well as children should practice good personal hygiene. Treatment of the diseases should be disease specific as well as organism specific and by proper antibiotics in proper dose and proper duration. Where do we stand as regards paediatric care? What is your suggestion for improving the total scenario in the child health care system? Now we are on the way of Sustainable Development Goals (SDG) targeted to U5M rate 25 per 1000 live births to be achieved by 2030. The under-5 mortality rate has declined gradually over the last 2 decades but between the 2014 BDHS and the 2017-18 BDHS the decline was slowed noticeably. Infant and neonatal mortality as well as breast feeding status have remained same during this period. So to achieve SDG target Go and NGO collaboration is very much needed to reach the grass root level children. We need to strengthen the IMCI management through community clinics. Increase the coverage of vaccination. As most of the children are from poor family, they should be provided with medicine and food during illness. Breast feeding should be encouraged with complementary food with proper quality and quantity. Ensure food security and food safety for every child. Then we can hope that healthy child will make future healthy nation. n

THE PHARMA WORLD 81 Now vaccination field workers can collect reports on adverse events following immunisation (AEFI) using a phone, tablet, or laptop even in the remotest of locations. UMC has launched a new offline app in partnership with the pharmacovigilance team at WHO for reporting possible side effects from vaccines. Directly connected to UMC’s VigiFlow data management system, the VigiMobile app makes it possible for immunisation field workers to collect AEFI reports electronically on their smartphones, tablets, or laptops, with or without an internet connection. Vaccine safety surveillance is essential to the success of immunisation programmes. If safety concerns around vaccines aren’t dealt with rapidly and correctly, they can dent people’s confidence in vaccines and undermine vaccination programmes. But getting data to decision-makers quickly so potential safety issues can be investigated, understood, and managed is not always easy. According to WHO, there are several countries without an effective system for monitoring vaccine safety. “Effective AEFI reporting is the first step in making sure vaccines are being safely administered,” says Dr Madhava Ram Balakrishnan, Medical Officer Vaccine Safety at WHO. “In VigiMobile and VigiFlow for AEFI, we have a frontline system for monitoring vaccine safety right in the hands of the vaccinator and their supervisors. Such tools are particularly vital in countries where large parts of the population live in remote areas and essential to ensure the safety of vaccination programmes and see whether further public health or regulatory actions are needed.” In many countries vaccine monitoring and reporting is often paper-based due to traditional work practices, limited internet access, or high internet costs. This can delay information sharingand impact decision-making at district or state level where events or clusters of events may trigger more in-depth investigations. Jenny Jansson Liikamaa, portfolio manager of pharmacovigilance offerings at UMC, says because the app is uniquely designed to capture structured vaccination and patient location data at time of reporting, VigiMobile can help investigators to pinpoint clusters of adverse events and make informed decisions based on actionable insights. “Using their smartphone, tablet or laptop, immunisation workers can capture events as soon as they happen even when they are offline and queue them for sending later. They now have the confidence that in the unfortunate case of a rare serious adverse event, rapid reporting is possible in a few minutes. This reduces the risk of vital information being lost in the field and enables officials to respond faster to a serious event that demands urgent investigation and a rapid response.” UMC adapted VigiFlow to collect and analyse AEFI data during the coronavirus pandemic. Working closely with WHO, it set out to help national immunisation programmes and regulatory authorities meet the new guidelines around vaccine surveillance and safety monitoring. Before then VigiFlow had mainly been used by countries in the WHO Programme for International Drug Monitoring to collect and analyse reports of potential side effects from drugs. Now it has been customised to do the same for vaccines, with UMC successfully expanding its expertise in ICSR management to AEFI data. Source: UMC PHARMACOVIGILANCE UMC mobilises offline app for vaccine adverse event reporting The app is uniquely designed to capture structured vaccination and patient location data at time of reporting, VigiMobile can help investigators to pinpoint clusters of adverse events and make informed decisions based on actionable insights.

INTERVIEW THE PHARMA WORLD 83 Prof. Dr. Syed Shafi Ahmed Muaz Professor and head Department of Paediatric, Gastroenterology, Hepatology & Nutrition, Bangladesh Shishu Hospital & Institute, Dhaka “Proper antenatal care should start from mother’s womb” As an eminent Paediatric gastroenterologist in the country, could you provide an overview of the most common Gastrointestinal (GI) diseases observed in children? Are there any specific age groups that are more susceptible? Most common GI diseases observed in children are: 1. Diarrhoea: a) Acute watery diarrhoea b) Persistent chronic diarrhoea. Children between the ages of 6 months and 3 years are especially susceptible to diarrhoea. 2. Acute gastritis: Prevalent in children between the ages of 6 months and 15 years. 3. Peptic ulcer disease (PUD): Children between the ages of 4 years and 16 years mostly suffer from PUD. 4. Acute Viral Hepatitis: Most common in children aged 2 years to 12 years. 5. Constipation: Usually is presented with abdominal pain. Common in children aged 2 years to 16 years. 6. Acute liver failure 7. Acute pancreatitis: May occur in children between the ages of 5 years and 15 years. 8. Painless per rectal bleeding due to rectal polyp: May occur in children between the ages of 5 years and 15 years. 9. Inflammatory Bowel Disease: Most common in children aged 5 years to 15 years. 10. Chronic liver disease 11. Abdominal tuberculosis 12. Recurrent abdominal pain: Mostly due toa) Functional irritable bowel syndrome (IBS) a) Helminthiasis As a whole, GI diseases typically affect those between 18 months and 15 years of age. Children complain about abdominal pain a lot. When should parents be concerned about their child’s stomach pain? Parents should be concerned about their child’s stomach pain when it is acute, severe in intensity and restricts the activity of children. Stomach pain that makes the child nauseous or vomit with pain. stomach pain that does not improve in 24 hours. The most common causes of acute stomach pain are: a) Acute appendicitis b) Acute pancreatitis and c) Acute Cholecystitis. Parents should also be aware if their child experiences abdominal pain at least once a week lasting for two months which hampers routine activities. The causes can be categorised into organic and non-organic. Organic causes include Constipation, PUD, IBD, helminthiasis abdominal tuberculosis, etc.

On the other hand, functional abdominal pain, IBS, abdominal migraine etc. are among the non-organic causes. PUD is the likely etiology if the stomach discomfort is associated with vomiting and hematemesis. What are the primary causes and symptoms of acute gastroenteritis in children? How is it treated? Gastroenteritis is an infection of the gastrointestinal tract (intestines). It causes diarrhoea and may also produce symptoms such as nausea, vomiting and abdominal pain. The infection usually clears up within a few days, although it can take longer in certain situations. The primary danger is a lack of fluid in the body (dehydration). Primary causes of acute gastroenteritis in children: 1. Infection a) Bacterial – Enterotoxigenic E.coli – Entero adherent E.coli – Entero Pathogenic E.coli – V. Cholerae 01, 0139 – Campylobacter Jejuni a) Viral – Rotavirus – Noro Virus 2. Over Feeding 3. Frequent Feeding 4. Faulty Feeding: Food that does not support digestion according to the age of the children. Symptoms: – Initially low-grade fever – Frequent vomiting – Passage of Loose watery stool – Abdominal fulness – Loss of appetite – Decreased urine output – Dehydration. Treatment: Rehydration is the key treatment and symptoms resolve generally without specific therapy. For effective management of gastroenteritis, it is necessary to assess dehydration by 2 of 4 clinical features. The following should be done if dehydration is present – – Ors-N 75ml/kg orally over 4 hours – If orally not possible due to vomiting, then NG tube or IV. For severe dehydration– Cholera Saline should be started. a) For children <1 y: –30 ml/kg over 1 hour, 70 ml/kg over 5 hours b) For children >1 yr: 30 ml/kg over ½ hr, 70ml/kg over 2 ½ hr In both age groups there should be half hourly monitoring of pulse, BP, RR, CRT, Urine output. When patient is recovering from Dehydration– a) Offer as much food and breast feeding as possible. b) ORS-N (WHO), homemade ORS, Chira Pani, cooked rice water after each purging for children aged 6 months to 10 years c) Children under 6 months of age should continue breast feeding. d) Children older than 6 months should be given yoghurt, homemade fresh food, green banana, atap chal. e) Zinc supplementation f) Folic acid supplementation g) Vitamin D supplementation h) Antibiotics if needed (depending on whether the diarrhea is secretary or osmotic) i) Dietary modification may sometimes help in osmotic diarrhea. What is the connection between nutrition and GI diseases in children? There is a strong connection between nutrition and GI diseases. Many GI disease causes undernutrition/malnutrition in children due to loss of appetite, lowered intake of food, malabsorption of food, and decreased absorption of micronutrients jeopardising children’s growth and development. Children who are undernourished suffer from GI diseases due to different causes. Malnutrition can have farreaching effects throughout the body, not just limited to the GI system. What causes neonatal jaundice and what are the risk factors? Is there a way to prevent it? Neonatal jaundice is a common condition in newborn babies characterised by the yellowing of the skin and eyes. It occurs due to the accumulation of bilirubin, produced by the breakdown of red blood cells. Bilirubin is typically processed by the liver and excreted from the body. However, in newborns, the liver is still maturing, and the process of bilirubin metabolism may not be fully functional, leading to its buildup and resulting in jaundice. Neonates may be born with jaundice. One should think about types of jaundice and the age of the child first for proper evaluation of causes. The following are the causes, according to the type of jaundice: a) Unconjugated hyperbilirubinemia – RH incompatibility – ABO incompatibility – G-6 PD, pyruvate kinase deficiency – Septicemia – Physiological jaundice – Breast milk – Congenital hyperthyroidism – IHPS – Familial non-hemolytic jaundice (Crigler – Najjar, Gilbert’s syndrome) a) Conjugated hyper bilirubinemia – Idiopathic neonatal hepatitis – Biliary atresia – Choledochal cyst – TORCH infections – Congenital hypothyroidism – Familial non-hemolytic (Dubin–Johnson and Rotor) – Metabolic diseases like galactosemia, hemochromatosis, hereditary tyrosinemia. There are measures that can help prevent and reduce the severity neonatal jaundice: a) In case of Rh incompatibility, it is crucial to administer anti-D immunoglobulin (anti-D injec84 THE PHARMA WORLD

THE PHARMA WORLD 85 tion) to the Rh-negative mother within 72 hours of delivery if the baby is Rh-positive. b) Managing maternal TORCH infection: TORCH infections refer to a group of infections that can be transmitted from mother to fetus during pregnancy i.e., Toxoplasma, Rubella, Cytomegalovirus Herpes simplex virus , and other (such as syphilis, varicella-zoster, parvovirus B19). Proper management of antenatal care (ANC) plays a vital role in the prevention, detection, and treatment of TORCH infections. If an infection is detected, appropriate treatment options, such as antiviral medications or antibiotics, may be prescribed to manage the infection and reduce the risk to the foetus. c) Preventing low birth weight: Premature newborns should be cared for in neonatal intensive care units (NICUs) that can provide medical treatments and monitoring.  Neonatal low birth weight can be avoided by proper antenatal care, proper nutrition, treatment of chronic illnesses such as hypertension or diabetes in the mother and encouraging the mother to maintain a healthy lifestyle. d) Infection control: Promoting good hygiene practices, such as regular handwashing, safe food handling, and avoiding exposure to known infectious agents. The delivery room should also follow infection prevention and control protocols. Where do we stand as regards paediatric care? What is your suggestion for improving the total scenario in the child healthcare system? Health indicators are decreasing dayby-day, which means we are improving. – Neonatal Mortality Rate: Neonatal mortality declined from 27/1000 to 20/1000 live births between 2017 and 2022. (BDHS 2022). – Infant Mortality Rate: The under-5 mortality rate decreased from 43 to 31 per 1000 live births. (BDHS 2022). – Nutrition (stunting, wasting, underweight): The prevalence of stunting among children under the age of five fell from 31% to 24%, showing improved child nutrition. However, the number of children who were underweight remained steady at 22%, underlining the importance of continuing efforts to combat childhood malnutrition (BDHS 2022). – Immunization status: Our country has successfully maintained the elimination of neo-natal tetanus since 2008, received the polio-free certificate in 2014 and between 1990 and 2012, reduced deaths of children under five by 73 per cent (UNICEF). Proper antenatal care should start from mother’s womb. Perinatal care includes –delivery room hygiene practice, safe delivery (neonatal care) – Proper immunization – Exclusive breast feeding – Proper complementary feeding – Safe drinking water – Development of subspecialty – Establishment of adolescent medicine and proper evaluation. n FAST FACTS Pneumonia accounts for 14% of all deaths of children under 5 years old, Jaundice is a common condition in newborns, affecting 50 percent to 60 percent of full-term babies and 80 percent of those born prematurely. According to World Health Organization, nearly 45% of under-five deaths account for neonatal death, with 75% occurring in the first seven days of life, and sepsis being the second most common cause. The Global Burden of Disease (GBD) estimated 1.3 million annual incident cases of neonatal sepsis According to the World Health Organization (WHO), preterm birth accounts for 30% of global neonatal deaths In 2020, nearly half (47%) of all under-5 deaths occurred in the newborn period (the first 28 days of life), an increase from 1990 (40%), because the global level of under-5 mortality is declining faster than that of neonatal mortality. Preterm birth, intrapartum-related complications (birth asphyxia or inability to breathe at birth), infections and birth defects are the leading causes of most neonatal deaths.

DID YOU KNOW? 86 THE PHARMA WORLD From birth, babies can see and hear. The baby sees the caregiver’s face and loves to respond to her smiles and sounds. The caregiver’s face is the favorite thing the young baby wants to look at. The caregiver should begin to talk to her baby from birth – and even before birth. Young babies need consistent responsive care. Babies communicate by responding to the slightest movement and sound, even smell of the caregiver. When the caregiver responds back, the interaction between the caregiver and the baby becomes like a dance. This special relationship may be established during feeding from the very first days. The baby securely “attaches” to the person who consistently holds her, loves her, and helps her feel safe. This connection or bond lasts for a lifetime. Much of what children learn, they learn when they are very young. The brain develops most rapidly before birth and during the first two years of life. Good health, good nutrition and nurturing are especially important during this time. Eighty per cent of human brain’s structure takes shape between the ages of 0-3 and the 90 percent of the human brain’s structure takes shape until the age of 5. Children need a safe environment as they learn. Children are always exploring new things and learning new skills. They need a clean, safe, and protected physical environment to be safe from injuries and accidents while they are playing and learning. More than 200 million children under 5 years are not fulfilling their developmental potential. Children are curious. They want to find out how they can change and affect people and things around them, even from the first months of age. Children learn by playing and trying things out, and by observing and copying what others do.There is an ongoing interaction between the child and her environment which effects the child’s development. Children are the first scientists. Play gives children many opportunities to think and solve problems. Children can learn by playing with pots and pans, cups and spoons, and other clean and safe household items. They learn by banging, dropping, and putting things in and taking things out of containers. Children learn by stacking things up and watching things fall, and testing the sounds of different objects by hitting them together. Play is like children’s “work”. Pay attention to your children’s movements, sounds, and cries. Children communicate to express their needs. For example babies show hunger by becoming fussy, sucking their hand, or moving their heads toward the breast. Using these clues, a caregiver can learn Facts about Early Childhood Development you need to know!

THE PHARMA WORLD 87 Kids who face more adversity during childhood may have a higher risk for type 2 diabetes in early adulthood, according to a Danish population-wide cohort study. Childhood adversity can involve experiences such as maltreatment, physical or mental illness in the family, and poverty and has been associated with the development of diabetes even in young adults. Adverse events and circumstances can trigger physiological stress responses and affect the behaviour of the nervous system, hormones and the body’s immune response. They can also impact mental wellbeing and lead to behavioural changes that negatively impact health such as poor sleep, smoking, reduced physical activity and sedentary behaviour, increased alcohol use, and unhealthy eating which can lead to obesity and an elevated risk of developing T2D. The researchers used data from the Danish life course cohort study (DANLIFE) which includes on the backgrounds and childhood adversities of children born in Denmark since 1 January 1980. To enable follow-up from age 16 onwards, the study sample was limited to those individuals born up to 31 December 2001 and excluded individuals diagnosed with diabetes in childhood, those with insufficient data on covariate factors, and anyone who emigrated or died before age 16. This study population was divided into five childhood adversity groups based on annual counts of exposure (from 0 to 15 years of age) to adversities in each of three dimensions: material deprivation (family poverty and parental long-term unemployment), loss or threat of loss (parental somatic illness, sibling somatic illness, parental death, sibling death) and family dynamics (foster care placement, parental psychiatric illness, sibling psychiatric illness, parental alcohol abuse, parental drug abuse and maternal separation). The authors found that compared with the “Low adversity” group, the risk of developing T2D in early adulthood was higher in all other adversity groups for both men and women. In the “High Adversity” group, which was characterised by high rates of adversity across all three dimensions, the risk of developing diabetes was 141% higher in men and 58% higher in women. The study reveals that individuals exposed to childhood adversity, such as poverty, illness or death in the family, and dysfunctional households are at higher risk of developing type 2 diabetes in young adulthood compared with those who experience low levels of adversity in childhood. These findings are strengthened by the large size of this population-based study, as well as its freedom from selection or recall bias. In addition, the authors point out that there is a close relationship between parental education levels children’s experience of adversity which explains some of the observed association. The researchers conclude that a share of the T2D cases arising in young adulthood could likely be prevented through early interventions targeting the fundamental causes of childhood adversity, to reduce or even eliminate their negative effect on children’s lives. Source: EASD to recognize that a child is hungry before the child starts to cry. Child development can be promoted by simple age appropriate activities that can be easily done at home. For example, to help the baby follow an object you can show a colorful cup to your baby, just out of reach. When you are sure the child sees the cup, move it slowly from one side to the other and up and down, in front of the child. Then move the cup closer. Encourage the baby to reach for the cup and grab the handle. Praise her efforts. Efforts to improve early child development are an investment, not a cost. For every dollar spent on improving early child development, the return can be 8.14 dollars. The return/cost ratio is highest in early childhood. Copying the baby’s sounds and gestures starts a good communication game. It helps the caregiver to look closely at the child, be sensitive to the child’s sounds and movements, and follow – respond to – the child’s lead. Even before the child is able to speak, he delights in being able to communicate through his sounds and movements. In many countries around the world, millions of children with developmental risks, difficulties and disabilities are unable to develop to their full potential unlike their peers growing up in more advantaged environments. The International Developmental Pediatrics Congress aims to play a role in addressing this inequity by creating an “international transdisciplinary home” for clinicians, researchers, advocates and policy makers in the field of developmental pediatrics and other disciplines related to child development and disability. Source: IDPA Childhood adversity leads to increased risk of type 2 diabetes as young adults

88 THE PHARMA WORLD Cerebral palsy and maternal injury during pregnancy The underlying causes of cerebral palsy (CP) are often unknown, though several perinatal risk factors have been identified (eg, prematurity, hypoxic-ischemic injury, intrauterine infections). In a large cohort study that included over 2 million children, those with in utero exposure to accidental maternal injury requiring emergency department or inpatient care had a higher prevalence of CP compared with unexposed children (3.6 versus 2.5 per 1000 children, respectively). CP risk correlated with severity of maternal injury. These findings highlight the importance of prevention efforts to reduce the risk of severe injury during pregnancy (correct use of seat belts and airbags). Exercise in children and adolescents with depression Prescribing exercise for depression in adults is supported by multiple trials. Physical activity also appears to benefit children and adolescents with depression. In a meta-analysis of 21 studies of more than 2400 youths (mostly randomized trials), a variety of aerobic exercise programs (generally prescribed as monotherapy) were associated with moderately improved depressive symptoms compared with usual care or no treatment. However, after a mean follow-up of 21 weeks, improvement of depressive symptoms in the two groups was comparable. For children and adolescents with unipolar major depression, physical exercise as an adjunct treatment along with pharmacotherapy and/or psychotherapy is suggested. Semaglutide for obesity in adolescents Glucagon-like peptide (GLP-1) analogues are important options for the treatment of type 2 diabetes and/or obesity in adults. In a 68-week randomized trial in 201 adolescents with obesity, patients assigned to weekly subcutaneous  semaglutide had substantial weight loss compared with lifestyle intervention alone (17.7 kg greater weight loss compared with placebo; 6 kg/m2 greater decrease in body mass index [BMI]). Gastrointestinal adverse events were common in both groups but were generally mild and rarely led to treatment discontinuation. Evidence suggests greater weight loss with semaglutide than the alternatives, including  liraglutide and metformin. Newborn pulse oximetry screening for congenital heart disease Delayed postnatal diagnosis of critical congenital heart disease (CHD) is associated with an increased risk of morbidity and mortality. Universal newborn pulse oximetry screening (POS) is thought to improve timely detection of critical CHD and reduce adverse consequences of delayed presentation. A recent study found that CHD-related emergency hospitalizations within the first three months after birth were lower in states that had implemented mandatory newborn POS compared with the pre-implementation era and states without mandatory screening. Investigational antisense therapy fitusiran for hemophilia Fitusiran is an investigational antisense oligonucleotide that reduces levels of antithrombin, promoting hemostasis in individuals with hemophilia A or B, including those with inhibitors. Previous trials showed this therapy was effective, but thrombotic complications occurred, including one death and several nonfatal thromboses. A new, larger randomized trial has now been completed using an adjusted dosing protocol with more modest antithrombin reductions. Fitusiran prophylaxis reduced the annualized bleeding rate compared with on-demand bypassing agents (1.7 versus 18.1); however, there were two thrombotic events among 38 participants in the fitusiran group. Ongoing monitoring for thrombotic complications is warranted. Improved survival for TDT Survival for transfusion-dependent thalassemia (TDT) continues to improve with advances in managing iron overload and other complications. A new longitudinal cohort of individuals with TDT reported improved survival (survival to age 30 in 93 percent, versus 84 percent in earlier birth cohorts). Heart disease remains a major risk factor for – and cause of – death. Outcomes in other centers are poorer, emphasizing the need for multidisciplinary specialized centers in caring for individuals with TDT.

89PEDIATRICS UPDATE THE PHARMA WORLD HFNC oxygen therapyfor mild to moderate acute hypoxemic respiratory failure in children Evidence is limited regarding the role of high-flow nasal cannula (HFNC) oxygen therapy for children with mild to moderate acute hypoxemic respiratory failure (AHRF). In the multicenter PARIS-2 trial, over 1500 children hospitalized with AHRF defined as increased work of breathing, respiratory rate ≥35 per minute, and oxygen requirement to maintain pulse oximetry over 90 to 92 percent were randomized to HFNC or standard oxygen therapy; wheezing was present in approximately threequarters of patients. Patients assigned to HFNC oxygen therapy, compared with standard oxygen therapy, had longer length of stay (1.77 versus 1.50 days) and more ICU admissions (12.5 versus 6.9 percent). Adverse events were low in both groups. These findings do not support the routine use of oxygen delivery by HFNC in young children with mild to moderate AHRF. Immunotherapy to delay type 1 diabetes Immunotherapies have been investigated extensively as a means of preserving pancreatic beta cell function and thereby delaying or preventing progression to type 1 diabetes in high-risk individuals. Teplizumab  is the first disease-modifying immunotherapy for type 1 diabetes to receive USFDA approval. Teplizumab, administered as a single 14-day course of daily intravenous infusions, delays the diagnosis of type 1 diabetes by a median of two years in individuals at high risk for developing the disease (ie, abnormal glucose tolerance and presence of at least two diabetes autoantibodies). Adverse effects include transient lymphopenia, rash, anemia, and fever. The clinical use of teplizumab remains uncertain and will require additional data regarding its benefits and risks, as well as the development of clearly delineated strategies for identifying optimal candidates for treatment. Novel oral type 2 poliovirus vaccine (nOPV2) in newborn infants In 2020, the World Health Organization (WHO) authorized emergency use of a novel oral  poliovirus vaccine  (nOPV2) to prevent outbreaks of polio caused by type 2 vaccine-derived strains; however, data in individuals <18 weeks had previously been limited. In a randomized, placebo-controlled trial of 330 healthy newborn infants with no prior poliovirus vaccination, nOPV2 was safe, well tolerated, and immunogenic (99 percent had protective antibody levels after two doses). Shedding of vaccine-derived virus in stool was low and of short duration, suggesting that sustained transmission of nOPV2 is unlikely. Many countries, including the United States, use injectable vaccines composed of inactivated poliovirus that cannot cause infection. However, for those countries that still use oral vaccines, these data are reassuring and support continued use of nOPV2 in infants. Antenatal corticosteroids for anticipated preterm birth before 23 weeks The value of antenatal corticosteroids (ACS) in pregnancies between 21 and 23 weeks of gestation is controversial. In an observational cohort study including over 400 infants born at 220/7 to 236/7 weeks of gestation, administration of a complete course of ACS was associated with higher survival to discharge compared with no ACS (54 versus 36 percent); however, most survivors had major morbidity when evaluated at 36 weeks postmenstrual age (survival without major morbidity: 27 percent with ACS, 10 percent without ACS). Shared decision-making (parents, obstetrical and neonatal staff) is particularly important at this gestational age when parents are faced with a decision affecting their child›s survival and quality of life. Source: Up To Date

THE PHARMA WORLD 91 FACTS on FINGER TIPS GLOSSARY OF Neonatal Terms THE PHARMA WORLD 91 Typhoid fever is an illness caused by the bacterium Salmonella Typhi (S. Typhi). It infects small intestines (gut) and causes high fever, stomach pain and other symptoms. Typhoid fever is also called enteric fever. Symptoms Typhoid fever gets its name from a high fever that can last for weeks if left untreated. Other symptoms of typhoid fever include: l Headache l Chills l Loss of appetite l Stomach (abdominal) pain l “Rose spots” rash, or faint pink spots, usually on chest or stomach l Cough l Muscle aches l Nausea, vomiting l Diarrhea or constipation Causes Typhoid fever usually spreads through food or water contaminated with S. Typhi. Stages of typhoid fever You can develop symptoms of typhoid fever gradually in four stages. Stage 1: Symptoms start from five to 14 days after coming in contact with S. Typhi. The first symptom is a fever that gets higher over a few days — called “stepwise” since it goes up in steps. Stage 2: Around the second week of fever, the bacteria is multiplying. Symptoms i.e., abdominal pain and other stomach symptoms, like diarrhea or constipation and “rose spots” may appear. Stage 3: If not treated with antibiotics, the bacteria can cause severe damage, usually around the third week and cause serious complications, like internal bleeding and encephalitis. Stage 4: People begin to recover. Patients may still be contagious even after they feel better. Medications l Ciprofloxacin, levoflaxin or ofloxacin. l Ceftriaxone, cefotaxime or cefixime. l Azithromycin. l Carbapenems. l In severe cases steroids like dexamethasone is used. Management of Symptoms NSAIDS like ibuprofen, naproxen sodium or acetaminophen can be taken for pain or fever. Vaccines Typhoid vaccine can prevent typhoid fever. l Inactivated typhoid vaccine is an injection and may be given to people 2 years and older. l Live typhoid vaccine  is administered orally and may be given to people 6 years and older Safe food practices l Washing hands with soap and water before and after preparing food or eating and after going to the bathroom. l Washing surfaces and utensils used for food prep and eating before and after use. l Avoiding drinking untreated water or eating food prepared with untreated water i.e., street foods. TYPHOID FEVER AB Spell: A pause in your baby’s breathing, which then lowers his or her heart rate. Anemia: Too few red blood cells. Apnea: A pause in breathing for a short period. Common in premature babies. Bilirubin: A pigment produced from the breakdown of red blood cells. When in excess, bilirubin appears as yellow skin known as jaundice. Blood Gases: A blood test to check the level of oxygen, carbon dioxide and acidity. Bradycardia: Slowing of the heart rate to lower than normal. Carbon Dioxide (CO2): Waste gas eliminated by the lungs. CPAP: Continuous positive airway pressure. This is continuous pressure applied to the lungs through a mask or endotracheal tube and helps the baby’s breathing. Gavage: Feeding by a tube passed through the mouth into the stomach. Gestational Age: The time period in weeks from conception to delivery. Hyperalimentation: Nourishing the baby with a glucose, fat and protein solution through the veins. Also called Total Parenteral Nutrition (TPN). Hypoglycemia: Blood sugar level below normal. Jaundice: Yellow color in the skin from excess bilirubin. Meconium: Dark greenish waste products that accumulate in the bowel during fetal life and are eliminated shortly after birth. Meconium Aspiration: The condition in which the baby breathes in meconium that is in the amniotic fluid. P02: Blood oxygen level. pH: Amount of acid in the blood. Phototherapy: Treatment of jaundice by use of special lights on the baby’s skin to breakdown the bilirubin. Pulse Oximeter: A probe that wraps around a hand or foot, connected to a machine, which measures how much oxygen the blood is carrying. Sepsis: Infection in the blood or other body tissues. SGA: Small for gestational age; lower birth weight than expected for age. Suction: Mechanical removal of mucous from the nose or throat or endotracheal tube with a plastic tube. Transcutaneous Oxygen or Carbon Dioxide Monitor (TCOM): A button-like probe placed on the baby’s skin to measure the amount of oxygen or carbon dioxide in the blood without taking a blood test. Umbilical Catheter: A small plastic tube inserted into one of the arteries of the umbilical cord. Ventilator: Also known as a respirator; a machine used to deliver air and oxygen into the lungs with pressure to help the baby breathe. Vital Signs: Temperature, heart rate, respiratory rate, blood pressure.

92 THE PHARMA WORLD One of the reports concerning automation in the biopharmaceutical sector has gone on to show that the market is estimated to grow at a CAGR of 5.7% during the forecast period of 2023–2033. According to the data, the market’s global revenue value is expected to cross $1855 million this year. The report also found out that 75% of the pharmaceutical organisations intend to use automated solutions more often. This is mostly being driven by the trend that has been observed in injectables and other individualised drugs. It is well to be noted that the injectables’ popularity has also gone on to elevate the sterility focus. Apparently, automated solutions, especially those that happen to be assisted by artificial intelligence, can increase product safety, as per the report. The pandemic has lessened investment when it comes to investment in the biopharmaceutical sector, and it has also gone on to impact the number of clinical trials that have been conducted. In turn, this has had a negative effect on the demand for biopharmaceutical automation solutions. As per the authors, clinical trials Next decade to witness automation driving Biopharma sector Babies that end up in the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU) are monitored via a complex collection of sensors, each of which has a wire connected to a patient monitor. While necessary, all these wires around the baby may bring anxiety for parents, as well as difficulties for clinicians to access their patients. Now, engineers have developed flexible, wireless sensor patches that are able to collect the same vital signs while offering other additional features. The new sensors can track heart rate, respiration rate, temperature, and blood oxygenation as well as conventional sensors, and they also allow for monitoring of body movement and orientation, recording heart sounds, crying, and other audio biomarkers, and even provide a pretty accurate estimate of systolic blood pressure. The sensors are powered by internal batteries and are cheap to manufacture, so should be applicable for use in low-resource areas and varying clinical settings. Advanced Wireless Neonatal Body Monitors to Improve Outcomes Smart Jumpsuit Tracks Motor Development in Children Issues with motor development can be related to wider neurodevelopmental problems, so tracking a young child’s activity can provide a window into their overall development. Previously, this required someone to sit and watch the child, or footage of them. This is time consuming and laborious, and is not particularly objective or quantitative. To address this, these researchers have created the MAIJU (Motor Assessment of Infants with a Jumpsuit) smart jumpsuit for toddlers and young children. The suit contains a series of motion sensors. The researchers trained a machine learning algorithm to identify specific movements children made while wearing the suit, which was achieved by a state-of-the-art deep learning. The advantages of the suit include its ability to monitor children objectively over long periods of time and in their natural surroundings, such as at home.

TECHNOLOGY THE PHARMA WORLD 93 Microfluidic Photoreactor for Neonatal Jaundice Neonatal jaundice is relatively common, and requires little or minimal treatment. However, in severe cases, the condition can cause neurological damage and can even lead to death. In such serious cases, it is treated by replacing newborn blood with donor blood. However, it is necessary to conduct the transfusion procedure twice, making it time-consuming, and risky. In an effort to develop a safer and more convenient alternative, researchers have designed a device that can break down bilirubin, the pigment in the blood that is responsible for jaundice. The technique involves pass - ing the blood of the patient through a microfluidic de - vice that contains a high-intensity LED light at a wave - length of 470 nanometers, which causes the bilirubin to break down into more excretable components without causing any appreciable damage to the blood cells’ DNA. The technique is similar to another method used to treat jaundice called whole-body phototherapy. How - ever, as the new technology directly illuminates the blood itself, it is more targeted and efficient. So far, the researchers have tested the photoreactor with bilirubinrich human blood on the lab bench, and in a rat model. happen to be the key drivers of demand for automated solutions because of their need for large quantities of high-quality drugs that have to be produced in no time and that too with the utmost accuracy. Automated solutions are the ones that can support machine adaptability by handling fre - quent changeovers because of the wider variety of sizes and formats. The fact is that pharma production lines happen to be challenged by customised prod - ucts and dosages like pre-filled syringes, and hence, the manufacturers are looking for equip - ment that is able to handle the greater range of formats that get generated in smaller batches, thereby reducing the downtime. One of the examples shared in the report was that of robotics. These systems happen to be increasingly important when it comes to biop - harmaceutical operations. By way of integrating advanced robotic systems, biopharma compa - nies can seamlessly streamline and optimise the manufacturing process, boost productivity, as well as product quality. The report also noted that so as to strength - en their present market standing, leading com - panies have gone on to implement tactics like mergers and acquisitions, enhance their R&D investment, expand their business into new ar - eas, go ahead with collaborations and partner - ships, and come up with new products. Source: Pharma Advancement Source: Medgadget

THE PHARMA WORLD 95 FDA APPROVALS Brand Name Generic Name Manufacturer Date of Approval Treatment Yuflyma Injection Adalimumab-aaty Celltrion, Inc. May 23, 2023 Treatment for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa. Brixadi ExtendedRelease Injection Buprenorphine Braeburn Inc. May 23, 2023 Treatment for Opioid Use Disorder Xacduro Kit for Injection co-packaged Sulbactam and Durlobactam Innoviva, Inc. May 23, 2023 Treatment of certain types of Acinetobacter pneumonia. Opvee Nasal Spray Nalmefene Hydrochloride Opiant Pharmaceuticals, Inc. May 22, 2023 Treatment for Opioid Overdose Vyjuvek Topical Gel Beremagene Geperpavec-svdt Krystal Biotech, Inc. May 19, 2023 Treatment for Dystrophic Epidermolysis Bullosa Epkinly Injection Epcoritamab-bysp AbbVie Inc. May 19, 2023 Treatment for Diffuse Large B-Cell Lymphoma Miebo Eye Drops - formerly NOV03 Perfluorohexyloctane Bausch & Lomb Inc. May 18, 2023 Treatment for Dry Eye Disease Veozah Tablets Fezolinetant Astellas Pharma US, Inc. May 12, 2023 Treatment for Menopausal Disorders, Hot Flashes Elfabrio Injection Pegunigalsidase alfa-iwxj Protalix BioTherapeutics, Inc. May 09, 2023 Treatment of adults with confirmed Fabry disease Mydcombi Ophthalmic Spray Phenylephrine Hydrochloride and Tropicamide Eyenovia, Inc. May 05, 2023 Treatment for Pupillary Dilation Arexvy Suspension for Intramuscular Injection Respiratory syncytial virus vaccine, adjuvanted GlaxoSmithKline May 03, 2023 Treatment for Prevention of RSV Infection Lumryz - formerly FT218 Sodium oxybate Avadel Pharmaceuticals plc May 01, 2023 Treatment for Narcolepsy Uzedy Extended-Release Injectable Suspension Risperidone Teva Pharmaceuticals and Medin Cell Apr 28, 2023 Treatment for Schizophrenia Abilify Asimtufii Extended-Release Injectable Suspension Aripiprazole Otsuka Pharmaceutical Co., Ltd Apr 27, 2023 Treatment for Schizophrenia, Bipolar Disorder Vowst formerly SER-109 Fecal Microbiota spores, live-brpk) Seres Therapeutics, Inc. Apr 26, 2023 Treatment for Prevention of Recurrent Clostridioides difficile Infection Qalsody Injection Tofersen Biogen Inc. Apr 25, 2023 Treatment for:Amyotrophic Lateral Sclerosis Omisirge Suspension for Infusion Omidubicel-onlv Gamida Cell Ltd. Apr 17, 2023 Treatment for:Stem Cell Therapy Omisirge RizaFilm  Oral Film Rizatriptan IntelGenx Corp. Apr 14, 2023 Treatment for Migraine

APPOINTMENTS & PROMOTIONS Nasim Ahmed has recently joined Hamdard Laboratories (Waqf) Bangladesh as Deputy Manager, Product Management & Training, Marketing Department. Prior to this, he has been working in The ACME Laboratories as Assistant Manager, Strategic Brand Management Department, Marketing Division. He completed his Bachelor of Unani Medicine & Surgery (BUMS) from Dhaka University at Government Unani and Ayurvedic Medical College & Master of Public Health (MPH) from Northern University Bangladesh. Md. Abu Sajid has recently joined Hamdard Laboratories (Waqf) Bangladesh as Assistant Manager, Product Management & Training, Marketing Department. Prior to this, he has been working in The IBN SINA Natural Medicine Ltd. as Senior Executive, Strategic Marketing Department. He completed his Bachelor of Unani Medicine & Surgery (BUMS) from Dhaka University at Government Unani and Ayurvedic Medical College & Hospital. Md. Jafar Imam has recently joined Pharmasia Limited as Assistant Manager, Global Business Operation. He started his career in General Pharmaceuticals at Global Marketing Department. He obtained his B. Pharm from Stamford University Bangladesh & M. Pharm from State University of Bangladesh. Dr. Tarek Mohammad Nurul Islam has recently joined as Head of Medical Services & Training in Pharmasia. Prior to this, he has been working served as Head of Medical Affairs & Training at Navana Pharmaceuticals Limited, Apex Pharma Limited & Ziska Pharmaceuticals Limited. He started his career at ACI Limited in 2008. He had completed his MBBS from Sir Salimullah Medical College & Mitford Hospital, Dhaka. He also obtained MPH from State University of Bangladesh. He has 14 years of experience in pharmaceutical industries. Ahmed Saman Tashrif has joined as Brand Executive at Everest Pharmaceuticals. Tashrif completed his B.Pharm (Professional) from North South University. THE PHARMA WORLD 97

98 THE PHARMA WORLD Wish to Export to Cambodia? The pharmaceutical market of Cambodia is moderately regulated and in growing phase. Medicines are sold on the basis of prescription of physicians as well as without prescription for OTC drugs. Some important information required for the registration of an exporting company and its product are mentioned below: Registration Regulatory Authority: CFDA (Cambodian Food and Drug Administration). l Registration fee for the registration of an exporting company: 1200 USD. l Estimated time for the registration of the company: 6 months to 1 year. l Registration fee for the registration of a product of exporting company: 500 USD. l Estimated time for the registration of products: 6 months to 8 months. l In order to start export to Cambodia, getting registration of a product is first requirement. l Once a product is registered to CFDA, it can be exported to Cambodia without the prior approval of company registration for a period up to 2 years. Then company registration is a must for the continuation of export. l Inspection of the manufacturing facilities of the exporting company is not required by CFDA, although factory inspection is a must in case of many countries. Documents required for product registration: A Product Dossier usually containing the following information is required: a) Administrative documents: l Letter of authorization l Company profile (exporting company) l Certificate of Pharmaceutical Product (CPP) l GMP Certificate l Copy of Manufacturing License l Proforma statement l Product information l Pharmaceutical documents: l Generic and brand name of the product l Product formulation, references of each

REGISTRATION RULES THE PHARMA WORLD 99 ingredient and justification of its use in the formulation l Pharmacopoeia of each ingredient used in the formulation data on physical and chemical properties of each formulating ingredient l Analytical methods of active ingredient(s) and excipients l Certificate of analysis of ingredients l Quality Control of raw materials l Standard manufacturing procedure l In-process quality control l Test parameters and testing methods l Finished product report l Disintegration and dissolution profile l Analytical procedures and certificate of analysis of finished product l Packaging specifications l Quality control report on packaging l Stability test data b) Pharmacological documents: l Information on basic pharmacological and microbiological studies, such as, toxicity, teratogenicity, efficacy, general pharmacology, pharmacokinetics, etc. l Information on clinical studies, such as, clinical pharmacokinetics, bioavailability, drugs interaction, etc. Documents required for company registration: l Site Master File is a must that usually contains the following documents: l Complete company profile (exporting company) l Certificate of Pharmaceutical Product (CPP) or Free Sales Certifiate4 (FSC) l GMP of Manufacturing Licence l Letter of authorization l Factory layout l List of qualified persons l List of machineries and equipment’s l Information on GMP training program (factory personnel) l Waste disposal management l Environmental pollution control document l Health care system of factory personnel l Standard Operating Procedure (SOP) l Standard Manufacturing Procedure (SMP) l Hygienicity l Dispensing and distribution system etc. Event Venue Date 19th World Congress of Basic & Clinical Pharmacology (WCP2023) — British Pharmaco-logical Society & the International Union of Basic and Clinical Pharmacology Glasgow, Scotland July 02–07, 2023 WCP2023 - CIOMS meeting ‘Guidance for Medicines Safety’ — British Pharmaco-logical Society & the International Union of Basic and Clinical Pharmacology Glasgow, Scotland July 05, 2023 International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) 2023 Nova Scotia, Canada Aug. 23–27, 2023 FIP 2023 — Pharmacy building a sustainable future for healthcare — aligning goals to 2030 Brisbane, Australia Sept 24–28, 2023 ISPE 15th Asian Conference on Pharmacoepidemiology Bangalore, India Oct 26–28, 2023 ISoP 2023 Annual Meeting Bali, Indonesia Nov 06–09, 2023 N.B. Dates/Venues of forthcoming events are subject to change/cancellation etc. with or without notice. So, intending participants are advised to check all details relating to VISA and other relevant matters before departure. Source: UMC Upcoming pharmacovigilance events

100 THE PHARMA WORLD COURSES & CONFERENCES N.B. Dates/Venues of forthcoming events are subject to change/cancellation etc. with or without notice. So, intending participants are advised to check all details relating to VISA and other relevant matters before departure. TITLE VENUE SCHEDULE 2nd International Conference on Pediatric and Nutritional Research Roma, Italy July 24–25, 2023 Pediatric Hospital Medicine (PHM) Conference 2023 Philadelphia, USA, Aug 03–06, 2023 36th World Pediatrics Conference Paris, France Aug 07–08, 2023 24th Annual World Congress on Pediatrics Richmond, Canada Aug 11–11, 2023 International Workshop on Development Nephrology (IWDN) 2023 Quebec, Canada Aug 13–18, 2023 9th International Conference on Pediatrics Barcelona, Spain. Aug 23–24, 2023 5th Edition of Euro-Global Conference on Pediatrics & Neonatology London, UK  Aug 28–30, 2023 8th Int’l Conf. on Advances in Neonatal and Pediatric Nutrition Frankfurt, Germany Sept 04–05, 2023 8th International Neonatology Association Conference (INAC) 2023 Dublin, Ireland Sept 07–10, 2023 This International Pediatrics Congress 2023 Singapore Sept 08–09, 2023 2023 World Pediatric Conference Bangkok, Thailand Sept 08–09, 2023 6th International Conference on Pediatrics and Neonatology Roma, Italy Sept 18–20, 2023 61st Annual Meeting of the European Society for Pediatric Endocrinology Hague, Netherlands Sept 21–23, 2023 Bhutan For The Active Traveler Wilderness Medicine CME Conf. Bhutan, Thimphu Sep 21–Oct 02, 2023 3rd International Conference on Pediatric, Child Neurology 2023 Frankfurt, Germany Oct 02–03, 2023 The 16th Asian Pan-Pacific Society for Pediatric Gastroenterology, Hepatology and Nutrition, (APPSPGHAN 2023) Seoul, South Korea Oct 05–08, 2023 The 44th Malaysian Paediatric Association (MPA) Annual Congress Malaysia, Kuala Lumpur Oct 12–14, 2023 48th European Paediatric Ophthalmological Society Meeting 2023 Leuven, Belgium Oct 19–21, 2023 International Pediatric Nephrology Conference 2023 Lahore, Pakistan. Oct 28–29, 2023 6th International Primary Immunodeficiency Congress (IPIC 2023) Rotterdam, Netherlands Nov 08–12, 2023 The 18th Asia Pacific Congress of Pediatrics (18th APCP) Manila, Philippines Nov 14–17, 2024 1st Emirates Health Services International Neonatal Conf. 2023 Dubai, UAE Nov 17–18, 2023 3rd International Conference On pediatrics And Neonatology Dubai, UAE Nov 21–20, 2023 15th Asian Congress of Pediatric Nephrology 2023 Dubai, UAE Nov 23–26, 2023 21st National Pediatric Conference 2023 Peshawar, Pakistan Nov 24–26, 2023 International Congress on Pediatrics and Neonatology Rome, Italy Dec 04–05, 2023 18th International Conference on Neonatology and Pediatrics Dubai, UAE Dec 07–09, 2023 The 5th International Pediatrics Conference (IPC 2023) Bangkok, Thailand Dec 15–17, 2023 International Conference on Paediatrics and Child Health 2024 Tokyo, Japan Jan 07–08, 2024 International Conference on Neonatology and Perinatology 2024 Bengaluru, India Jan 28–29, 2024 International Conference on Cardiac Rehabilitation in Pediatrics Bangkok, Thailand Feb 04–05, 2024 33rd Int’l Conf. on Pediatrics, Neonatology & Pediatric Nursing ‘24 Paris, France Apr 04–05, 2024 Pediatrics and Neonatology Conference 2024 Dubai, UAE Apr 22–03, 2024 Int’l Conf. on Pediatric Dermatology & Atopic Dermatitis 2024 Istanbul, Turkey Sep 27–28, 2024