EDITORIAL

EDITORIAL

Dept of Pharmacy practice introduced an unique programme , titled SAHELI - scheme to provide awareness, help and empower ladies in India with an aim to educate women  on various aspects of family planning . One of the main aims of the program was to evaluate knowledge level of women in rural area, the attitude and practice of family planning,  the drugs/Pills they use, the contraceptive agents they employ and to assess their reproductive morbidity. Pharm D students have visited rural areas and organized various awareness classes to the  village women community about family planning and reproductive morbidity. They also provided information about the pills as well as the  contraceptive they use. Also the dept of pharmacy practice  organized a health screening campaign at pathiripaddam Govt lower primary school in the same village. As a part of the programme, our dept could unify a cluster of health care professional, including pharmacist working in private and public sectors, health inspectors etc under a roof  for the common cause of improving the health.  I acknowledge the team members for their commitment brimmed with  enthusiasm and proposing a novel concept SAHELI for the progression of  women in the community and the highlights have been given in the current issue. Dr Ernest R Anderson has penned an article titled - give and you will receive , where he mentions that pharmacy leaders should  inculcate the habit of giving abundantly in order to get better results.. Also we have two  articles  From Malaysia and Japan  and the first article portrays the community pharmacy practice in Malaysia and  the second article  produces an insight about pharmaceutical education in Japan. Dr Mohanta has presented an article titled- hypnotic solution as intravenous fluid therapy in children needs discontinuation is an intriguing and informative study. Kerala private pharmacy association( KPPA) has felicitated and handed over awards to the  rank holders of Alshifa college of Pharmacy on 4th august 2016 on one day seminar titled Medicine law awareness seminar and the same has been covered in this issue. Let me thank Dr Ernest Anderson, Dr Dr. Ooi Guat See, Dr. Yoko Amagase, Dr. Sarath chandran C, Dr G.P Mohanta for their invaluable benefaction to the news letter. Along with these, coverage  of dept activities assures  all our readers this issue as a premium one.

Dr Dilip.C

Editor In Chief.

M.Pharm students attended one day seminar titled- quest-stepping towards qualitative perspective of research at Kims academic hall, KIMSALSHIFA HOSPITAL

M.Pharm students attended one day seminar titled- quest-stepping towards qualitative perspective of research at Kims academic hall, KIMSALSHIFA HOSPITAL

World Vitilago day was observed on June 25th at KIMS ALSHIFA HOSPITAL

World Vitilago day  was observed on June 25th at KIMS ALSHIFA HOSPITAL

World vitilago day was observed on June 25th at KIMS ALSHIFA HOSPITAL. Dr. Ashique,Consultant Dermatologist briefed the public with a lucid and informative lecture with the aim of fighting the social stigma attached to the disease and discussed the treatment options available.

SAHELI: THE DAWN OF RURAL WOMEN EMPOWERMENT

SAHELI: THE DAWN OF RURAL WOMEN EMPOWERMENT

(ArdraMariet Jose, Aswathi S, Asifa.R Pharm D intern)

A good healthy society doesn’t automatically emerge on its own and stands firm. It needs to be emerged and for that, women play a pivotal role. Being a woman has a significant impact on health, due to both biological and gender-related differences. The physical, mental and sexual health of women and girls is of particular concern because, in many societies, they face severe restrictions due to several discriminations rooted in socio-cultural factors. While health care disparities affect women in every community, barriers to care for rural women are exceptionally complex. Women in rural areas are known to experience health disparities with regard to sexual and reproductive health services, and many other key primary care areas. Reproductive morbidities are quite common among rural women. But due to the inhibition to share their sexual health concerns with a doctor, these problems remain untreated and finally leads to several complicated diseases which might even end up in their death.

Aiming to put in the services of clinical pharmacists in educating women on the program of Family Planning and evaluation of Reproductive Morbidity (FP&RM), we decided to introduce a Scheme togive Awareness, Help and Empower Ladies in India – SAHELI. The purpose of this scheme was to evaluate the rural women’s knowledge, attitude and practice of family planning and examined the drugs or pills they use, contraceptive agents they employ and assess their reproductive morbidity. We visited the rural areas and hold awareness classes to the village women community about family planning and reproductive morbidity, and gave information about the pills or contraceptives they use.

Around160 women belonging to various rural areas were evaluated during the first phase of SAHELI. They were later given proper guidance and awareness on the concepts of FP & RM. We carried out these activities in association with the Department of Pharmacy Practice of Al-Shifa College of Pharmacy, Edakkara village panchayat and the primary health centre (PHC) at the village.

As a part of introduction of SAHELI, we conducted a campaign at Pathirippadam government lower primary school in the village. Pharmacists working in publicand private sectors and other health workers were involved in the campaign.Most of the women folk at the village were unaware about various reproductive diseases and uses of contraceptive pills, and they showed a great deal of interest to know moreabout FP&RM. Besides, they were eager to understand the various family planning techniques. Their enthusiasm and satisfaction were evident from their responses. And all of this definitely helps touplift our profession from product oriented to patient oriented one.

The department of pharmacy practice at Al Shifa College of Pharmacy has decided to introduce the scheme in each village panchayat with the help of the local bodies andhealth centers. We hope that SAHELI can make healthy changes in the lives of the rural women with the involvement of the pharmacist community.We strongly believe that “there is nothing powerful than an idea whose time has come” as said by Victor Hugo and thus we hope to bring some healthy changes in the lives of rural women and thereby lighting up their lives with the help of SAHELI.

ANTIBIOTIC RESISTANCE BY ENVIRONMENTAL ANTIBIOTIC POLLUTION- A MATTER OF SERIOUS CONCERN IN INDIA

TIDES OF INDIAN PHARMA, BY LEVINTHOMAS

ANTIBIOTIC RESISTANCE BY ENVIRONMENTAL ANTIBIOTIC POLLUTION- A MATTER OF SERIOUS CONCERN IN INDIA

Antimicrobial resistance (AMR) is defined by the WHO as the resistance of a microorganism to an antimicrobial  drug which was originally effective for  treatment of infections caused by it. AMR  threatens the effective prevention and  treatment of an ever-increasing range of  infections caused by bacteria, parasites,  viruses and fungi. A report (August 2014) in the journal The Lancet Infectious Diseases, said that in 2010, India consumed 13 billion units of antibiotics, the highest in the world (10.7 units per person).  Between 2005 and 2009, consumption shot up by 40 per cent. And the impact of this unregulated usage is already showing. Between 2008 and 2013, E.coli bacteria resistant to third-generation cephalosporins increased from 70 to 83 per cent; it went up from 8 to 13 per cent in the case of carbapenems and 78 to 85 per cent in the case of fluoroquinolone, notes a paper published on March 3, 2016 in PLOS Medicine. Environmental antibiotic pollution is a major driver for this antibiotic resistance.

Environmental antibiotic pollution encourages the transfer of resistance genes to human commensal and pathogenic bacteria. In particular, waste water treatment plants serving antibiotic manufacturing facilities have been implicated in the transfer of resistance genes into human microbiota and pose a serious threat to antibiotic effectiveness given the size of India’s pharmaceutical sector. In 2007, the first in a series of papers by a Swedish researcher Joakim Larsson was published, showing very high emissions of pharmaceuticals from drug manufacturers in Patancheru, near Hyderabad, India. Tests on effluent from a treatment plant receiving waste water from about 90 manufacturing plants showed that concentrations for some pharmaceuticals were greater than those found in the blood of patients  undergoing treatment. The researchers found that concentrations of antibiotics in the river sediment further downstream were so high that if “ciprofloxacin had been more expensive, we could mine it from the ground.”!! Since India is one of the leading pharmaceutical producers, there needs to be stringent mechanisms for disposing waste into local public water streams such as lakes, rivers and water bodies. There are several hundred manufacturers of APIs in India (active pharma ingredients), out of which only a small percentage are compliant. Compliance here refers to effective waste management, following good manufacturing practices, following the guidelines issued by central and state pollution boards. Manufacturers don’t either have waste treatment plants or don’t use them due to the costs involved. Some pharma companies make use of common facility centres for waste treatment, others don’t have, or have not constructed any. They simply dump the waste into nearby rivers and water streams. Weak enforcement and current gaps in law further aggravate the problem. Environmental criteria that enforce responsible production of antibiotics and regulate the discharge of antibiotics in the environment are missing from regulations and policies related to the procurement, prescription and reimbursement of antibiotics.  Today, environmental regulation and its enforcement are left up to national regulators. Compliance with ‘Good Manufacturing Practices’ (GMP), a mandatory requirement for accessing the EU and US markets, do not include environmental criteria.

Another cause of antibiotic resistance is the routine feeding of antibiotics to animals in industrial livestock production to help them endure crowded, dirty, and stressful conditions and grow faster. According to the WHO reports, more antibiotics are given to healthy animals than are used to treat diseases among human patients. The extensive use of antibiotics in animal breeding stems from the 1940s and 1950s when the industry discovered that antibiotics could serve as growth stimulants and for disease control, which made it possible to rear large flocks of chickens or herds of cows in confinement. The prophylactic use of antibiotics in animal breeding is problematic because the regular administration of low doses of drugs wipes out weaker bacteria and leaves the field open for stronger strains. When the manure is sold on as fertiliser or washed downstream into rivers and groundwater, the resistant genes are spread to the wider bacterial community. In 2012, Chinese researchers studying the manure from pig farms in China found 149 unique resistance genes. In the U.S. in 2013, the Food and Drug Administration (FDA) found that 65 percent of chicken breasts and 44 percent of ground beef carried bacteria resistant to tetracycline, and 11 percent of pork chops carried bacteria resistant to five classes of drugs. The rising global demand for cheap meat is expected to further increase the already extensive use of antibiotics in livestock rearing. In light of the huge threat to human health and animal welfare posed by antibiotic resistance, numerous organisations have launched major campaigns aimed at putting a stop to the non-therapeutic use of antibiotics in animals and calling for the restriction of some types of antibiotics exclusively for human use. The European Union is considering banning the prophylactic use of antibiotics and some countries such as Denmark and Sweden have already begun to drastically reduce their consumption. Currently, India does not have regulatory provisions for the use of antimicrobials in cattle, chickens, and pigs raised for domestic consumption. Recent studies in various regions of India have discovered antimicrobial residues in food animal products (such as chicken meat and milk), indicating that antibiotic use in food animal production is widespread. There are no standards for tolerance of antibiotic residues in poultry, although such standards do exist for seafood—including shrimps, prawns, or any other variety of fish and fishery products—under the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations of 2011.

 

A few urgent priorities for immediate implementation stand out. Improved capacity of drug regulatory bodies is essential to safeguard against powerful antibiotics being sold over the counter and to phase out the use of antimicrobial growth promoters in livestock. These capabilities are also needed to ensure the safety and reliability of India’s pharmaceutical manufacturing sector, which now supplies a significant proportion of the world’s pharmaceutical needs. India should phase out antimicrobial growth promoters from livestock when these drugs are medically important and when these are premixed with feed. Such a move would have regional consequences and would send a strong signal of the country’s commitment to tackle this issue. The government should also urgently regulate drug companies discharging antimicrobial waste into the environment and regulate the use of antibiotics in animal feed to combat antibiotic resistance and obtain healthier animal products. Better sanitation and effective infection control measures in health-care settings will also drastically cut the spread of drug-resistant strains.

Ketoconazole oral tablets for skin and nail infections linked to patient death

Ketoconazole oral tablets for skin and nail infections linked to patient death

 ADR BULLETEIN-- BY SHINU.C

Ketoconazole is an antifungal medication that fights infections caused by fungus.This medicine should be used only when you cannot use other antifungal medications.FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not, approved uses of the drug.

FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. In the 18 months ending in June 2015, skin and nail fungal infections were the only diagnoses cited for the use of oral ketoconazole in an office based physician surveys database. Since the 2013 labeling change, one patient death has been reported to the FDA due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails.

Health care professionals should use ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available. Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Other treatment options are available over-the-counter and by prescription, but are also associated with risks that should be weighed against their benefits.

Patients should discuss with their health care professionals the risks and benefits of available therapies before using any medicine to treat skin and nail fungal infections. Patients taking ketoconazole tablets should seek medical attention right away if they experience any of these signs and symptoms of liver problems, which include loss of appetite, nausea, vomiting, or abdominal discomfort; yellowing of the skin or the whites of the eyes (jaundice); unusual darkening of the urine or lightening of the stools; or pain and discomfort in the right upper abdomen where the liver is located.Ketoconazole in tablet form is indicated to treat serious infections caused by fungi and should be used only when other effective therapy is not available or tolerated. It works by killing the fungus or preventing it from growing. The topical forms of ketoconazole

that are applied to the skin or nails have not been associated with liver damage, adrenal- problems, or drug interactions. We urge health care professionals and patients to report side effects involving ketoconazole.

PREDICTING EFFECTIVE DRUG REGIMEN FOR TUBERCULOSIS

Pharma pulse by LinuMohan

PREDICTING EFFECTIVE DRUG REGIMEN FOR TUBERCULOSIS

Tuberculosis (TB) is a communicable infectious disease caused by Mycobacterium tuberculosis. It can produce silent, latent infections, as well as progressive, active disease. Globally 2 billion people are infected and roughly 2 million people are die from TB each year.

Inappropriate or incorrect use of antimicrobial drugs or use of ineffective formulations of drugs, and premature treatment interruption can cause drug resistance. A report by WHO reveals that, in the year 2014, about1.5 million people died of TB and out of that, about 480,000 had multidrug-resistant TB (MDR-TB), which means the organism, is resistant to at least two of the most potent TB drugs available. Because of this resistance, TB drug therapy can extend for months or even years, with drugs having harmful side effects, and results in treatment failure. Therefore, there is an urgent need to develop a more potent, combination of drugs to tackle TB. However, very few new TB drugs have been developed in recent decades. So, to prevent TB from developing resistance, it must be treated with ideal combination of multiple drugs.

Recently the scientists has developed a method of gene regulatory network analysis in which researchers used mapped gene regulatory network model of mycobacterium tuberculosis, to identify how the organism  become tolerant to the relatively new anti-TB drug bedaquiline. Using network analysis, they distinguished 2 key regulatory genes whose activation appeared to control the changes that drive organism into a drug-tolerant state. When either of these genes was disrupted, the bacteria were once again susceptible to the drug. They used this network-enabled knowledge to find a second drug (pretomanid) to counteract tolerance against bedaquiline.In laboratory experiments, the team found that when pretomanid was used with bedaquiline the drugs acted synergistically to kill TB bacteria

This gene regulatory network analysis will help to explain the effectiveness of an experimental drug combination against drug-resistant tuberculosis bacteria, which can be used for the development of effective combination drug regimens against tuberculosis.

PACING CAPSULE-TRANSCATHETER PACING SYSTEM

Arrhythmia is loss of cardiac rhythm, especially irregularity of heartbeat. This may cause clinical manifestations ranging from no symptoms to minor palpitations or irregular pulse to severe and even life threatening symptoms. During an arrhythmia, the heart can beat too fast, too slow, or with an irregular rhythm. A heartbeat that is too fast is called tachycardia and a heartbeat that is too slow is called bradycardia. The heart may not be able to pump adequate amount of blood to the body parts during an arrhythmia. This can develop symptoms such as fatigue, shortness of breath, or fainting. Severe arrhythmias can damage the body's vital organs and may even cause loss of consciousness or death.

A pacemaker is a small device that is placed in the chest or abdomen to help control abnormal heart rhythms. This device uses electrical pulses to induce the heart to beat at a normal rate. Recently FDA has given approval for new Transcatheter Pacing System (TPS) which is the world’s smallest pacemaker.

This device is administered percutaneously with minimum invasive approach, directly into the right ventricle. The Transcatheter Pacing System (TPS) is a single chamber pacing system it paces only the right ventricle of the heart.Using a catheter delivery system, TPS is implanted directly into the heart through the femoral vein. It generates electrical impulses that results the heart to contract or beat. Once in place, the pacemaker monitors the heart rate and adjusts therapy in response to the patient’s activity level. This device is indicated to be used in patients who have slow or irregular heart rhythms and who may benefit from a single chamber pacemaker system. There are no known contraindications for the use of pacing as a therapy to control heart rate. The selection of the pacing system, the mode of operation, and the implant technique used, are influenced by patient’s age and medical condition.

Pharmacy education system of Japan: An insight

Pharmacy education system of Japan: An insight

Authors:

Dr. Sarath chandran C, M.Pharm, Ph.D, Assistant Professor, Department of Pharmaceutics, Academy of Pharmaceutical Sciences, Pariyaram Medical College, Pariyaram- 670 503, Kerala, India

.

Dr. Yoko Amagase, B.Sc., Ph.D, Assistant Professor, Department of Pathophysiology, Faculty of Pharmaceutical Sciences, Doshisha Women’s College of Liberal Arts, Kodo, Kyotanabe City, Kyoto, 610-0395, Japan.

Japan “land of rising sun” is a small island nation located in Pacific Ocean. The approximate population of 126 million makes them worlds tenth largest. The Japanese economy is fastest growing and country itself is considered to be most developed and innovative in the world. Even though, Japan is super developed in most of the sectors, but their professional pharmacy sector may be still in infancy! The situation may be more or less comparable with what we have in India. But the country, which has long history and tradition of ‘no compromise’ with quality has made strong attempts to make a positive change in pharmacy sector by bringing updated policies in pharmaceutical education and professional regulations.

In early part of 2000, there were only 46 pharmacy schools available across Japan which could educate and train only 8000 odd graduates. But after 2006, there was huge rise in number of pharmacy schools. At present, 74 pharmacy schools function under different universities across Japan, which can admit approximately 13000 students each year. This reason for rise in number of pharmacy schools in Japan may not be same as that of ours! This rise in pharmacy schools was mainly because of government policy to employ more pharmacists to work as experts of drugs and pharmaceuticals in Japan.

The pharmaceutical education in Japan had two phases ie before and after 2006. The situation of pharmacy education in Japan before 2006 was more or less similar to what we have in India. It was a 4 year undergraduate course awarding bachelor degree of pharmacy to the student. This was prescribed education qualification for a student to enrol for national examination to become a registered pharmacist in Japan. But after 2006, the pharmacy education program in Japan was modified and pharmacy schools started offering two types of courses. Along with existing 4 year course, a new 6 year course was introduced. But unlike in India, this decision to introduce a new 6 year course was done with more precise objective. The name of the pharmacy course depends up on the university which offers it. For eg: Doshisha Women’s College of Liberal Arts (DWCLA) founded in 1876 call it “Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences”.

The 6 year course was introduced to train the student as a drug specialist in clinical as well as community pharmacies and to enable them as registered pharmacist in Japan. As part of modernising pharmaceutical education, the traditional 4 year undergraduate course was retained to train the students who are aiming for master’s degree or PhD and others get jobs at industry, government or education. The student who has completed 4 year course is no more qualified to take part in national examination for pharmacist. This clearly laid down objectives for both programs, proves the vision of policy makers in Japan.

The medical and pharmaceutical technology is in rapid transformation. With changing trends, Japanese policy makers decided to change their existing pharmacy regulations and completely separated pharmacy from clinic. This change in policy created more independent pharmacy establishments under community as well as hospital sector. These pharmacies required professionally skilled, competent and knowledgeable pharmacist. This situation was compensated with new 6 year pharmacy course with modern curriculum. In a 6 year course, student is getting enriched with humanism, integrity and ethical value as a healthcare professional. The successful completion of this course helps the pharmacist to acquire abilities to discover and resolve problems in a clinical setting. During the 6 year course, the students are provided with basic knowledge and techniques of pharmacy. The liberal arts and clinical onsite training is also provided to a pharmacy graduate. Since the 4 years were not sufficient enough for students to learn and acquire all these skills and knowledge, the new 6 year course was quite effective.

The curriculum for 6 year pharmacy course may be slightly different for each pharmacy school of Japan. Therefore, we explain about the course using the case of Doshisha Women’s College of Liberal Arts (DWCLA) as an example in this article. The Fig No.1 summarises the key areas covered by a student in a 6 year pharmacy course. The student admitted for 6 year pharmacy course; generally learn the basic pharmaceutical sciences, health care system and medical ethics in the first 4 years of the course. The skill to improve basic communication and skills essential for communication during clinical practice will be taught in the first 4 years of the course. These are done through regular theory and practical classes. From the 5^th year onwards student gets exclusive practical training at hospital and community pharmacies. But prior to enrolling for 5^th year practical training, the student must pass the pharmaceutical common achievement test. This test ensures that a pharmacy student has skills and knowledge to get trained at hospital and community pharmacy.

Fig No. 1: Key areas of exposure for pharmacy student in 6 year course at DWCLA (http://www.dwc.doshisha.ac.jp/english/faculty_dep_info/pharmacy/clinical/index.html)

The pharmaceutical common achievement test comprises of Computer Based Testing (CBT) and Objective Structured Clinical Examination (OSCE). The CBT is performed to evaluate whether pharmacy students acquired the fundamental knowledge in basic science, pharmacology and ethics. This is purely a computer based examination, where student answer the questions displayed on a computer monitor. The questions for CBT is mainly based on physics, chemistry, biology, practical pharmacy, pharmacology, information science, humanism, health & environment, pharmacy & society and any previously learned theory or practical training topics. The questions for OSCE are based up on patient interview/counselling, dispensing of medicines, inspection of dispensed medicines, germ free operations and drug information services. The OSCE is done to evaluate the skills and attitude of a student as a prospective pharmacist. This examination is conducted before two examiners; one external and one internal examiner. The pharmaceutical common achievement test ensures that only skilled and knowledgeable pharmacy students are getting trained as future pharmacist of Japan.

Activities in the 5th year comprises of clinical training at hospital and community pharmacy (2.5 months each) and research activities in the laboratory. At DWCLA, students choose their laboratories in the middle of the third year. Once they reach to their opted laboratories, they get involved in the active practical works and spend their time with in the laboratory even when they don’t have regular lectures or practicals. In the laboratories, the students learn laboratory techniques, research skills, reading papers, presentation and so on. This activity continues until the first semester of the sixth year. In the sixth year, students are aimed to develop their advanced skills in the area of basic and clinical pharmacy. At the end of the first semester of 6th year, students have to write up a dissertation, make a poster and give a presentation. At the presentation, they have to defend their work successfully. The dissertation, poster presentation and defence are all required for achieving their degree. Other than that, 6th year students take lectures of more specialised professional topics such as nutrition, infusion, oriental medicine, immunology, infection, pharmaceutical management, the latest scientific achievements, and so on. At the end of each year, students have to submit a report what they have achieved in their research.

After the successful completion of 6 year pharmacy course, which includes regular examinations, CBT, OSCE and practical training and graduation examinations, the pharmacy student is entitled to appear for pharmacist national examination. This examination is carried out once in a year in the month of March. The passing of pharmacist national examination make a person eligible to work as a pharmacist in Japan. The passing of pharmacist national examination is not an easy task. The candidate has to answer 345 questions and should secure a minimum of 65% to pass this examination. The examination is based on approved subjects and each subject has two categories of questions ie compulsory questions and general questions. The general questions will have both theory and practical sections. Apart from 65% over all pass score, candidate should secure separate score of 70% from compulsory questions and 30% from each subject. The national pass rate for pharmacist national examination is only 63%, which shows how tough it may be for a person to get approved as a pharmacist in Japan.

The goal of Japanese pharmacy education system is to cultivate pharmacists as medical professionals on the basis of their educational principles. In addition to this, institution like DWCLA adopts principles of Christianity, internationalism and liberal arts within the pharmacy education system. The Japanese pharmacy education system attempts to produce pharmacists and researchers equipped with practical skills to work in various fields including medical practice, drug development and health service with high ethical standards, well-rounded character, international perspective, and broad knowledge. The educational as well as professional regulations designed and executed efficiently to create pharmacist who can be unavoidable partner of a society, which has probably highest percentage of ageing population in the world.

ACTIVITIES OF THE DEPARTMENT

Scheme to Aware ,Help and Empower Ladies in India( SAHELI)
New thoughts always makes new ways… Our Pharm D clerkship students (Aswathy, Ardra, & Asifa) conducted awareness and helping program on general hygiene measures for women & family planning, and health screening camp as a part of their project work under Dr. Dilip C, named SAHELI (Scheme to Aware, Help, and Empower Ladies in India), at Edakkara, Nilambur, Kerala. Hundreds of women from the rural areas of Edakkara participated in the programme

Hypotonic Solutions as Intravenous Fluid Therapy in Children Needs Discontinuation!

Hypotonic Solutions as Intravenous Fluid Therapy in Children Needs Discontinuation!

By Dr G.P Mohanta

It may be surprising to notice the use of hypotonic sodium chloride (ex: 0.45%) solution as intravenous maintenance fluid in children. The formulation scientists are always concerned to adjust the tonicity of hypotonic solution to make it isotonic as the former is associated with serious adverse events like haemolysis. 0.9% sodium chloride is recognised as isotonic solution with Sodium concentration at 154 mmol/L. Death and neurologic damage have been reported with hospital acquired hyponatremia in children administered hypotonic maintenance solutions. Intravenous fluid maintenance is necessary for hospitalised children who cannot eat or drink enough to remain hydrated especially after surgery or during stay in ICU.

Traditionally hypotonic sodium chloride intravenous solutions have been used as maintenance therapy. The hypotonic solutions were considered safe in most children due to adoptive mechanisms of the kidney. Kidney removes the excess free water and thus maintains sodium balance. However, increased levels of circulating antidiuretic hormone are more common in hospitalised children than as reported previously, decreasing their ability to excrete excess water and placing them at risk of hyponatraemia.The serious adverse effects, though rare, caused by intravenous fluids are linked to decreased salt level in the body.  Hyponatraemia is said to occur when serum sodium is less than 135 mmol/L representing an excess of water in relation to sodium in extracellular fluids.  Osmotic fluid shifts from the extracellular to intracellular space secondary to hyponatraemia can cause cerebral oedema, which can result in significant irreversible neurological morbidity and death.

More adverse events are reported from fluid administration than for any other individual drug. The incorrect prescription or administration of intravenous fluids are potentially very dangerous. Cochrane review confirms that one hundred and sixty-nine children per 1000 had low sodium levels in the blood when an isotonic fluid was given, compared with 338 children per 1000 when a hypotonic fluid was used. Isotonic sodium chloride solutions are safer bet than hypotonic intravenous fluids in reducing hyponatraemia and promoting patient safety.

Introduction

Dr. Ooi Guat See

MPharm (Hons)(UK), MPharm (Clinical Pharmacy)(USM), PhD (USM)

Faculty of Pharmacy, AIMST University, Jalan Bedong, Semeling, 08100 Bedong, Kedah, Malaysia.

Pharmacy service in Malaysia came into existence in 1951 with the enactment of three main legislations governing its profession namely, the Registration of Pharmacist Act 1951, Poison Act 1952 and Dangerous Drug Act 1952. The establishment of the basic structure of pharmacy service within the public healthcare system in Malaysia can be explained in part by the history of the country. During the British colonization, pharmacy service in Malaysia was restricted primarily to the procurement, storage and distribution of drugs from the United Kingdom through the Crown Agents.¹

Following independence, pharmaceutical service in Malaysia has grown from being the nation’s supply of pharmaceuticals to regulating and ensuring quality, safety and efficacy of pharmaceutical products. The establishment of a Drug Control Authority (DCA) and its executive arm, National Pharmaceutical Control Bureau (NPCB) established under the Control of Drugs and Cosmetics Regulations 1984 gave rise to a more systematic pharmaceutical regulatory system in Malaysia. ¹

In the 1990’s, further expansion of pharmacy service was hampered by the shortage of pharmacists in the public workforce. Hence, in order to raise the number of pharmacists in the country to World Health Organization (WHO) recommended pharmacist to general population ratio of 1:2000 by year 2020, governments have taken measures to increase the number of local academic institutions offering undergraduate pharmacy course. In addition, the Ministry of Health and Pharmacy Board amended pharmacist registration process in 2005 to require a period of 4 years (which was then shortened to 2 years in 2011) mandatory government service in order to retain sufficient manpower in the public sector. The increase in the number of pharmacists in the public sector had allowed the establishment and expansion of clinical pharmacy service within the MoH.

The private sector is an important component in Malaysia's healthcare system as a health services provider, through private hospitals and clinics, laboratories and community pharmacies. There are 10762 registered private doctors throughout the country in the year of 2011. ² Consultation, treatment and medicines costs are charged separately in private hospital

and clinic. There are approximately 1700 community pharmacies in the whole country. ³ The patients pay only the medication costs when they visit to a community pharmacy as pharmacist consultation and dispensing services are free of charged. Dispensing separation is not being practiced in Malaysia whereby private doctors are allowed to dispense their medications.

Community pharmacy practice

In Malaysia, according to the latest statistic report, there are 10,077 registered pharmacists and approximately 3300 pharmacies are working in the private sectors including community pharmacies.⁴

Community pharmacy benchmarking guideline has been introduced and revised from time to time by the Ministry of Health to provide an overview of the requirements that community pharmacies are expected to fulfil in the area of infrastructure, equipment, personnel and practice. ⁵

Community pharmacies are premises with at least one pharmacist holding a Type A license issued under the Poison Act 1952 who can supply poison either by retails only or both retail and wholesale. For all community pharmacies, the executive board and share equity shall be represented by pharmacists.⁵ Other requirements and guidelines are shown in the table below.

Community Pharmacy Benchmarking Guidelines ⁶

Premises	·	Area: a minimum of 200 Sq. ft.
	·  Designated area for counselling, waiting area.
	·  Designated area for wet and dry compounding/dispensing.
	·	Exterior display:
		Signboard: Pharmacy/Advertisement Ratio?
		Logo
	·  Display of types of services available e.g. blood glucose,
		cholesterol, pregnancy, blood grouping tests or electronic
		blood pressure monitoring.
	·	Security
		Locks to main door/gate.
		Lock to Psychotropic drugs.
		Poison products under lock and key.
	·	Insurance
		Professional indemnity
		Public liability
		Fire and burglary
	·  Level of cleanliness and hygiene.
		Pest control
	·  General Environment for clients.
		Conform to occupational and safety health requirements :
		escape way.
		Noise level
		Arrangement/ display of OTC products; ease of selection of
		products.
		Temperature, lighting and ventilation.
	·	Availability of refrigerator.
	·  Method of pharmaceutical waste disposal. (For info only)
Equipment	·	Inventory control : computerisation/ stock cards.
	·  Availability of mortar and pestle, weighing balance, counting
		tray and measuring cylinders.
Personnel	·	Image presented, both RPH and staff dressing code.
	·	Training for staff.
Dispensing of	·	Dispensing must be under the supervision of the pharmacist.
Medicines		Dangerous drugs and Psychotropic.
		Prescription and Pharmacy Only Medicines (Group C)
		OTC medicines
		Cases of referral to pharmacists by pharmacy/sales assistants.
	·  Screening of prescription by the pharmacist. The Pharmacist
		must ensure that the patient receives sufficient info and advice
		to enable the safe and effective use of the medicines.
	·	Interventions.
	·	Records
	·  Dispensing container: use of amber bottle.
	·  Labelling (printed and hand written) bears the
		proprietary/generic names, strength, quantity, manufacturer’s
		name, batch no and expiry dates.
	·  Maintenance of Patient Medication Record. (By means of
		card, a record book, by computer)
Dispensing errors	·	Steps to minimise e.g. incorrect selection, incorrect
		interpretation.
	·  Checking procedures and cautions.
Inventory	·	External use - preferably to store separately from internal use
management		items.
	·  Control of expired and expiring stocks.
	·	Storage space/compartments.