Creating Value for All Healthcare Stakeholders Vol:4
Guest Editorial
Issue: 23 March 15-31
2008 Price Rs 20/-
I AM STOPPING THE TUBERCULOSIS
Every year 24th of March is observed as World TB day. This was the day in 1882 when Dr. Robert Koch has announced his discovery of M.tuberculosis, the bacteria that cause disease tuberculosis. This is the 126th year of identifying Tuberculosis germs under microscope. But still the disease is a major public health problem in our country and many developing countries. The seriousness of problem can be understood by figures released. Tuberculosis kills 5000 people a day – 2 million every year, of them more than 0.1 million are children; hundreds of thousands children become orphan due to parentral tuberculosis; One third of world population are infected with tuberculosis infection and HIV and MDR-TB (multi drugs resistant TB) will make TB epidemic much serious. Thus the disease is global emergency. India is leading in tuberculosis cases, accounts 20% of world’s burden, next to China (15%). One thousand deaths every day are due to TB; 2 deaths in every three minutes. It kills more women than all causes of maternal mortality (Government of Gujarat has launched ‘Chiranjivee” scheme for reducing maternal mortality rate). Tuberculosis is the leading single infectious cause of death in India. If we calculate the socio-economic burden to our country, it is enormous. Tb is majority affecting to young adult of productive age. It has direct burden of some 3 billion dollar per year and 300 million dollar of indirect cost to society. But we can reduce all these problems and cost to society, as we have weapon to fight against the disease. WHO recommended DOTs (Directly observed treatment) strategy is the key weapon to fight against tuberculosis. Government of India has strong will to control the disease. Two years back on same day whole India has been covered under DOTs. Under RNTCP (Revised National tuberculosis control programme) diagnosis, treatment and follow up services are free of cost available in Government as well as private sectors. The recent new development in programme is the public private partnership. All facilities are now available in private sector with free of cost. The key diagnostic method in programme is sputum microscopy. If organism are seen under microscope it is the proof of diagnosis. X-ray is used as second line because of intra and inter observer variations. Treatment is provided in three categories as per diagnosis. This drugs are provided at door step of patients under direct supervision which ensures the drugs are swallowed and no dosed is missed. This accountability is very important in programme. This is the heart of whole programme. Our esteem dedicated workers are than saying “I am stopping tuberculosis” We should salute such workers. If they failed whole programme will failed. The major problem when DOTs compromised is the MDR TB and XDR TB (Extensively drug resistant tuberculosis). This XDR TB defined as TB organism resistance to isoniazid and rifampin and at least three of six main second line drugs aminoglycoside, polypeptides, fluoroquinolones, thioamides, cycloserine and para-aminosalicyclic acid. Between 2000-2004, 17,690 MDR TB were isolated from 49 countries and 2% of them were XDR TB. It was estimated that the median survival of XDR TB from sputum collection of 16 days (range 2 –210days). Almost 500 XDR cases are reported from South Africa. Very little data are available for India. These majority of cases of MDR and XDR are developed from poor treatment compliance. There is need to focus on early diagnosis and prompt treatment of tuberculosis with sense of “I am stopping tuberculosis” Dr. Niraj Pandit, Community Physician, Gujarat email- drniraj74@gmail.com
24TH MARCH WORLD TB DAY 2008
PhaRMeD TRADE NEWS
3-3-62/A New Gokhale Nagar, Ramanthapur, Hyderabad - 500 013 Tel Fax : 040-27030681, Mobile : 98495-51183 E-Mail : pharmedtradenews@yahoo.com www.pharmedtradenews.com
Editor & Publisher
V. Bhava Narayana Associate Editors
EDITORIAL BOARD Prof.B.Suresh, President Pharmacy council of India
Dr. Aniruddha Malpani, M.D Dr. Mahesh Sharma,
Dr. Jawahar Bapna, Rtd Director, IIHMR
Prof. G.P.Mohanta
S.W. Deshpande, DG, AIDCOC
M.D (Ayurveda)
Dr. P.Hanumantha Rao, ASCI, Hyd
This Publication is Only for the use of Medical & Pharmacy Professionals Printed, Published and Owned by V. Bhavanarayana, and printed at Kala Jyothi Process Pvt. Ltd., 1-1-60/5, R.T.C. 'X' Roads, Musheerabad Hyderabad - 20. Published at 3-3-62/A New Gokhale Nagar, Ramanthapur, Hyderabad - 500 013, R.R. Dist. Editor : V. Bhavanarayana * RNI No.: APBIL/2004/12036 Postal LIC NO : HSE 806/2004-06. C Pharmed Trade News, 2004 * Person responsible under PRB act for selection of news Pharmed Trade News does not neccesarily subscribe to the views expressed in the publication. All views expressed to the magazine are those of the contributors Pharmed Trade News not responsible or accountble for any loss incurred, directly or indirectly as a result of the information provided.
PATHOLOGY MCQ 1) A 35-year-old man with a history of rhinitis and asthma presents to his physician with complaints of intermittent severe abdominal pain and a chronic maculopapular rash. Peripheral blood smear demonstrates a marked eosinophilia. Biopsy of a skin lesion demonstrates necrotizing vasculitis with large numbers of eosinophils. Which of the following diagnoses is most likely? A.Churg-Strauss syndrome B.Leukocytoclastic angiitis C. Mönckeberg’s arteriosclerosis D.Temporal arteritis E. Wegener’s granulomatosis Explanation: The correct answer is A. The most likely condition is ChurgStrauss syndrome, also known as allergic granulomatosis and angiitis. This variant of polyarteritis nodosa is clinically associated with asthma and eosinophilia. The vascular lesions are those described in the question stem. Granulomas are present in many, but not all, cases. Pulmonary involvement may be prominent, but this is not always the case. In this case, the patient’s abdominal pain is related to GI vasculitis, and his skin rash is related to dermal vasculitis. Churg-Strauss syndrome should be suspected in any patient with vasculitic symptoms, eosinophilia, and asthma. In leukocytoclastic angiitis (choice B), the dominant inflammatory cells are neutrophils. In Mönckeberg’s arteriosclerosis (choice C), there is vessel calcification. In temporal arteritis (choice D), which especially affects the cranial vessels, giant cells are found. Wegener’s granulomatosis (choice E) affects the respiratory and renal systems. 2) An 11-year-old boy complains of pain in his left leg with no history of prior trauma. The pain is not relieved by acetaminophen and slowly progresses. Radiographic examination shows a femoral tumor with an “onion-skin” pattern of circumferential reactive periosteal bone. Examination of biopsy material stained with hematoxylin and eosin reveals small uniform blue round cells. On the basis of this information, which of the following is the most likely genetic mutation? A. del 1p B. t(2,13) C. t(11,22) D. t(12,22) E. t(X,18) Explanation: The correct answer is C. This is the chromosomal mutation for Ewing sarcoma. This case demonstrates the typical presentation of Ewing sarcoma, occurring mainly in the long bones of children and adolescents. It presents with pain and has a unique onion skin effect on x-ray. Histologically, it is known as a small, round, blue-cell tumor. A number of different tumors look similar, and molecular methods are increasingly used for diagnosis. del 1p (choice A) is associated with
PhaRMeD TRADE NEWS
leiomyosarcoma, which is mainly found in the extremities, subcutis, and retroperitoneum. It is located outside of bone in the soft tissues and histologically is composed of bundles of spindle cells. t(2,13) (choice B) is associated with alveolar rhabdomyosarcoma, a tumor of young persons that can affect the extremities. It is composed of small round blue cells that form small nests or alveoli. The radiographic appearance shows a soft tissue mass rather than a bony lesion. This is an aggressive malignancy. t(12,22) (choice D) is associated with clear cell sarcoma, also known as malignant melanoma of soft parts. It appears like a malignant melanoma, which arises in the soft tissue rather than the skin. It usually is found on the tendons of extremities of young patients. Histologically, the cells can have pigment or clear cytoplasm. t(X,18) (choice E) is associated with synovial sarcoma, which is a tumor arising around a joint space, usually in a young person. The knee and shoulder are the most common location. Histologically, the cells can be spindled or plump, pink, and epithelioid. 3) A terminally ill HIV infected patient develops focal neurologic signs, dementia, and coma. Amoebic parasites are demonstrated in CSF. Which of the following organisms is most likely to be the causative agent? A. Acanthamoeba sp. B. Entamoeba histolytica C. Giardia lamblia D. Naegleria fowleri E. Trichomonas vaginalis Explanation: The correct answer is A. Two types of free-living amoeba can infect the brain and meninges: Naegleria fowleri and Acanthamoeba species. The former affects healthy adolescent or adult divers, while the latter causes infection in patients with immunosuppression because of diabetes, alcoholism, cancer, or HIV infection. The brain infection characteristically has a prominent perivascular character, which causes a multifocal hemorrhagic necrotizing meningoencephalitis. Skin ulcers, nasal infection, or pneumonia may also be present. It is thought that the organisms may release a toxin causing host tissue necrosis. Systemic antifungal agents (e.g., amphotericin) have some activity against this organism, but most cases are fatal. Entamoeba histolytica(choice B) causes amoebic dysentery and liver abscess. Giardia lamblia(choice C) is a flagellate, rather than an amoeba, and causes diarrhea. Naegleria fowleri(choice D) is an amoebic cause of meningoencephalitis in previously healthy swimmers and divers. Trichomonas vaginalis(choice E) is a flagellate, rather than an amoeba, and causes vaginitis.
MARCH, 15-31, 2008
Page 2
PHARMED NEWS
own, the tuberculin skin test commonly gives falsely positive results if a patient has previously been vaccinated against TB. But the new
FASTER TB TEST RESULTS ON THE WAY A blood test which enables doctors to rule out tuberculosis (TB) infection in days rather than weeks has been developed by UK researchers. It could prevent patients having to undergo lengthy investigations and allow them to begin treatment more quickly, they said. TB is hard to diagnose because its symptoms, such as fever and fatigue, are associated with other conditions. The research is published in the Annals of Internal Medicine. Britain is the only country in Western Europe where TB is on the rise and London, which carries almost half the national burden, is Europe’s TB capital. At the moment, it can take quite a long time to figure out whether or not a patient has the disease, because it can mimic many different conditions and present in many different ways Professor Ajit Lalvani, study leader The blood test, developed by a team at Imperial College London, can determine that a patient does not have tuberculosis with 99% accuracy when used alongside a currently used tuberculin skin test. And most importantly, TB can be ruled out with 48 hours. Existing tests can take up to several weeks, the researchers said. Ruling out TB more quickly allows doctors to get on with looking for other explanations for patients’ symptoms. Immune response The ELISpot-Plus test works by detecting signs of an immune response specific to TB
test only picks out the immune cells present due to TB infection and not those induced by vaccination. Patients with a positive result would need further testing to assess whether they have a dormant or active form of the disease. The current “gold-standard” test requires growing TB bacteria in the laboratory from sputum samples. Patients being tested need to stay in hospital for three days, undergoing invasive procedures, to obtain necessary samples. Professor Ajit Lalvani, who led the study team, said the new test could “revolutionize” the way people with suspected TB are managed. “At the moment, it can take quite a long time to figure out whether or not a patient has the disease, because it can mimic many different conditions and present in many different ways.” The test, which has been trialed in 389 patients in the UK, is not yet licensed but the researchers’ hope it can be commercially produced at a price which would make it useful in developing countries as well as the NHS. Dr John Moore-Gillon, vice president of the British Lung Foundation said: “A quicker and earlier diagnosis of TB is a positive step in tackling a disease which is an increasing problem in this country.
“TB has been much ignored so we welcome the greater efforts now being devoted to research into this disease.”
infection. It checks for a type of protein known as interferon Y. On its
PhaRMeD TRADE NEWS
MARCH, 15-31, 2008
Page 3
STANDARDS CHECKLIST FOR REGISTERED PHARMACY PREMISES The following list is produced for guidance as to the basic standards that the Society’s Inspector will be looking for during a routine visit to registered pharmacy premises. External appearance (1) Fascia and paintwork, etc, should be kept clean and in good order. (2) Posters should be kept to a minimum but notices required under terms of the NHS contract such as hours of business and, when necessary, a rota notice should be conspicuously displayed and professionally produced. (3) Windows should reflect the professional nature of pharmacy. Cluttered displays, dust and handwritten signs all present an unprofessional image. Shop (1) Decoration should be up to a good standard and floor coverings clean and in good order. Regular cleaning schedules are necessary. (2) All Pharmacy medicines should be located so as not to be accessible to the public by self service. (3) The professional area of the pharmacy should be clearly defined. (4) The medicines counter should be kept for medicines and not cluttered with nonmedicinal goods such as sweets, jewellery, etc.
(4) The refrigerator should be regularly cleaned and defrosted and must contain a maximum/minimum thermometer. (5) Sinks should be clean. Hot and cold water must be available. (6) Arrangements for the proper storage and disposal of waste materials should be made. Covered receptacles are recommended in place of cardboard boxes, etc. These should be regularly cleaned. Stockroom(s)/storerooms/stairways and/or cellar (1) Decoration (walls, ceiling and all paintwork) should be up to a good basic standard. (2) Floor should be covered so as to be cleanable and should be clean. There should be no slits or tears in the material. (3) Adequate shelving should be provided so that no foods, medicines or containers used for dispensing (whether or not they are sealed) are stored on the floor. (4) The stairs and passageways should be kept clear of stock. (5) Oxygen cylinders should be stored safely. Some sort of restraint is recommended for the older, tall type of cylinder, to prevent the possibility of them falling, eg, a chain. However, for the newer, more stable, shorter cylinders restraint is unnecessary. Note: For safety reasons in the event of fire, restraining chains should not be locked. Toilet(s) (1) Decoration (walls, ceiling and all paintwork) should be up to a good basic standard.
(5) Medicines should be regularly checked for out of dates and stock properly rotated.
(2) Floors should be covered so as to be cleanable - properly fitted vinyl is recommended. They should be clean.
Dispensary
(3) Provision should be made of hand-washing facilities within the toilets or lobby area. Hot and cold water must be available along with soap and clean towels (on a rail or hook). The toilet should be kept clean.
(1) Decoration (walls, ceiling and all paintwork) should be up to a good basic standard. (2) Floor should be covered so as to be cleanable and should be clean. (3) Dispensary fixtures and fittings (including shelves and work surfaces) should be adequate for the purpose for which they are intended. Surfaces should be smooth and impervious to dirt and moisture. They should be clean and uncluttered. The surfaces should be intact and chipped or flaking surfaces should be properly repaired or replaced.
SUBSCRIPTION FORM To Manager, Subscription Dept
PHARMED TRADE NEWS
(4) The statutory notice “Now wash your hands” (professionally produced) should be displayed in the toilet area. (5) Heating and lighting should be provided. (6) The toilet area must not be used for storage. SOURCE-RPSGB
1 Year – 24 Issues - Rs 480 2 Years – 48 Issues - Rs 900 INTERNATIONAL-24 Issues By AIR MAIL US $ 100 E-Mail Edition - Rs 240
3-3-62a New Gokhale Nagar Ramnthpur, Hyderabad 500013
Register My / OUR subscrption for 1year / 2years. Enclosed D.D / Cheque / M.O in favour of PHARMED TRADE NEWS, payable at Hyderabad for Rs : _____________________________________________ Full Postal Address :
Pin
PhaRMeD TRADE NEWS
MARCH, 15-31, 2008
Page 4
PATIENT EDUCATION SECTION PREVENTION OF TB Prevention is the key. TB does not affect everyone it infects. But if your immune system is weak, you are an easy victim. In India, TB can be arrested with better nutrition building up weak immune
DO YOU KNOW
❂ 20% of the world’s births are in India; ❂ 25% of the world’s child deaths are in India;
systems, better indoor air quality, cleaner kitchens replacing fossil fuels with gas and so on. Many houses are ill ventilated especially in rural India where smoke from the kitchen adds to the poor indoor air quality all through the day. If you have unclean indoor air, the immunity of your lung is much lower allowing TB to get the better of you. If your immune system is weak, you are an easy victim. If windows are open for cross ventilation and the air is cleaner, there are greater chances that your lung will not be pressured as much and you will have better immunity. TB can also be controlled by early detection, ensuring that each
❂ 20% of the world’s maternal deaths are in India (the most of any country in the world); ❂ One woman dies every five minutes in India (more than 130,000 deaths a year) from causes related to pregnancy and childbirth; ❂ 50% of children under three in India are malnourished; and
patient takes the full dose and does not get re-infected. Identify the affected person and keep the person out of range so he or she does not spread the disease.
❂ 44% of preschool children are fully immunized.
As a part of our Corporate Social Responsibility Patient Education Section is offered free of cost on request, through E-mail Send your request to pharmednews1@gmail.com
One Million Indians die this year due to Smoking
Quit Smoking Today PhaRMeD TRADE NEWS
MARCH, 15-31, 2008
Page 5
A PRESCRIPTION FOR FLU SHOTS It is accepted sound public health policy to inoculate as many people as possible every year against influenza before they can become infected. That is why 47 states allow not just doctors and nurse practitioners but also pharmacists to administer vaccines. New York is one of the three states (Maine and West Virginia are the others) clinging to a wrongheaded policy that endangers everyone, especially the elderly and the very young. Every year, more than 2,000 people die of influenza or related pneumonia in New York City alone. City health officials believe they can reduce fatalities, as well as relieve emergency rooms that tend to more than 1,000 influenza-related cases daily, if they can expand access to vaccines. So, for a fourth year, a bill to let pharmacists administer flu shots is before lawmakers. The proposal makes sense. Even people who do not have regular doctors are likely to interact with a pharmacist, especially the elderly and families. There is hardly a major city block that does not have at least one pharmacy with druggists who are capable of doing much more than dispensing medication. Under the city’s proposal, only those who are certified would be entrusted to give shots. They could help improve New York’s dismal vaccination rate, one of the lowest in the nation.
Opponents of the proposal have tended to treat it as a turf issue, but it isn’t. Pharmacists would not be taking the place of a doctor, any more than a nurse practitioner does when injecting patients. Too many people are being overlooked in the yearly battle against the flu. It is time to enlist the help of the neighborhood pharmacist. From Editorial-Newyork times-March 09
SMS POLL We should adopt china family planning policy of one child per family Yes/No SMS to +91 98495 51183
Running a successful Medical practice can be hard work ! Do you find that there is too much work, too much hassle, ◆
Long energy-exhausting hours and crushing workloads leaving little or no free time for yourself or your family ?
◆
Demanding dissatisfied patients ?
◆
Inadequate payment for all your hard work ?
◆
You need help ! Successful Medical Practice – Winning Strategies for Doctors, is the first book on the art of practice management, written for Indian doctors. The purpose of this book is to help you find a truly satisfying way of practicing medicine which will:
◆
Give you control of your time;
◆
Allow you to do work which you felt was worthwhile, for patients that you enjoy seeing; and
◆
Pay you well for your effort, so that you enjoy going to work every day.
The secret is to learn how to manage yourself. This book will teach you time management, knowledge management, and relationship management skills, so that you can become a more productive, happier and more successful doctor. This 300 page book is packed with information, gleaned from many years of practice. You can apply this immediately to your own practice, and start flourishing !
Available only from : PTN Communications 3-3-62a, New Gokhale Nagar, Ramanthapur. HYDERABAD. Price Rs 250 only.Pl draw your DD/Cheque/ Mo in favour of PTN Communications.
PhaRMeD TRADE NEWS
MARCH, 15-31, 2008
Page 6
PhaRMeD TRADE NEWS
MARCH, 15-31, 2008
Page 7
PhaRMeD TRADE NEWS
MARCH, 15-31, 2008
Page 8
IPA’s TB Fact Card Project and Role of Pharmacist in Tuberculosis Background: India has the highest TB burden country, accounting for one fifth of the global incidence of TB. India is adding 1.8 million new TB cases annually. An estimated 5% of TB patients are HIV infected. About 370,000 die every year due to TB. Social and economic burden of TB in India is very high and indirect cost to the society is estimated to be $3 billion. The goal of Revised National Tuberculosis Control Programme (RNTCP) is to decrease mortality and morbidity due to TB and to cut transmission of infection until TB ceases to be a major public health problem in India. Political commitment of the government is through DOTS (Directly Observed Therapy, Short course) programme which is providing free TB medication under direct supervision for the complete duration of treatment. Minimum duration of TB treatment is for 6 to 8 months or longer. TB Fact Card Project In spite of the full coverage of the country by RNTCP, it is estimated that 50% of TB patients seek treatment in private sector & hence buy medicine from the retail pharmacies. Unlike DOTS, this private treatment is not under direct supervision & default rate (patients leaving the treatment halfway) is quite high. Pharmacists, as most easily accessible members of the primary health care team, can play a more proactive role in preventing and managing TB for the patients. This valuable resource was hardly tapped for TB Control. Pharmacy students could also certainly assist the pharmacists in this venture. Based on these views, a TB Fact Card project was launched by Indian Pharmaceutical Association in the year 2005 in Mumbai as a pilot project. The project was a collaborative project of IPA, with Commonwealth Pharmaceutical Association (CPA) & International Pharmaceutical Students Federation (IPSF), supported by the Maharashtra State Chemist & Druggists Association & the Mumbai District TB Control Society. The project activities involved creating awareness among TB patients by use of TB Fact Card (informative card made in local languages) & counselling the patients about use of medicines, nutrition & importance of adherence to treatment, monitoring of treatment by regular follow up. Total 60 pharmacists from Mumbai & Navi Mumbai area participated in this pilot & worked hard for the one year period of the project. The pharmacy students from 6 pharmacy colleges of Mumbai enthusiastically acted as “support system” to these pharmacists & helped in monitoring of patient treatment & maintaining patient records. Overall, this pilot was successful in reaching out to 5000 patients to create awareness. Most of the pharmacists showed keen interest in the work & wish to continue working for such social cause. Till now, worldwide, there are very few isolated reports of pharmacist’s contribution in TB management. Another major breakthrough which came up from the project is the participation of some Pharmacists as DOTS providers. Till now, Pharmacists have rarely participated in such National health programmes. But after involvement in this project, there has been tremendous interest & social attitude built up among many pharmacists & they are willing to work as DOTS providers. Some pharmacists in Mumbai & nearby Kalyan area are already trained for DOTS with the help of City TB Divisions. This is an excellent example of Public-Private Mix (PPM) effort for improvement of the community health. This PPM activity can be expanded to a national
PhaRMeD TRADE NEWS
scale. IPA is consistently working with the cooperation of Chemist Associations for these community health activities. Thus, pharmacists can play an important role in national health programmes of the Government & can contribute to improve the community health. Role of Pharmacist in Tuberculosis After completion of TB Fact Card project,& successfully initiating “DOTS Provider Pharmacists” concept in Mumbai, we are convinced about the potential role of pharmacists in TB control. Pharmacist can play role in the following capacity: Creating awareness ❖ Create awareness amongst all consumers about Tuberculosis,
distribution of TB information fact cards/leaflets in local language ❖ Display of posters about TB at prominent places in or outside the
pharmacy (especially TB awareness campaigns can be organized around World TB Day, 24th March each year) ❖ Creating awareness among the patients about Government’s free
diagnosis & treatment facility (DOTS services by Government) Case detection, referral & reporting: ❖ Looking out for the symptoms & in case of doubt of possibility of TB,
convincing & directing patient for diagnosis, following up with patients for outcome of diagnosis, looking out for the possibility of spread of TB to family members & required counseling & guidance ❖ Reporting to Government authorities in case suspected patient
doesn’t go for diagnostic tests ❖ Organizing sputum test (microscopy) camps with nearby Government
TB Hospital/ blood banks Monitoring of treatment & supportive care: ❖ In more focused efforts by way of counseling on various aspects of
treatment: dosage instructions, importance of treatment completion, side effects of drugs, nutrition during TB ,follow up with doctor ❖ Pharmacist can concentrate on treatment monitoring for improving
patient compliance (adherence) by keeping patient records, telephonic or personal follow up ❖ Monitoring body weight on regular basis & keeping its records
Participating in TB Control as DOTS provider: ❖ Active participation in Governments TB control programme by
becoming DOTS provider after the required training ❖ Provision of DOTS medicines, counselling & supportive care &
monitoring at Pharmacy ❖ Maintaining documentation requited for DOTS & strong follow up
with patients in case of default ❖ Constant communication with nearby Government centers/health
posts through whom patient was directed to Pharmacy ❖ At Pharmacist association level, they can collaborate with local
government TB offices & conduct TB awareness programmes for pharmacists on regular basis in which pharmacists can be sensitized for case detection & reporting.
Mrs Manjiri S. Gharat Hon.Secretary, Community Pharmacy Division, Indian Pharmaceutical Association symghar@yahoo.com
MARCH,15-31, 2008
Page 9
BOOK REVIEW Pharmacy Pathfinder (Part-1) Third Edition *UGC and CSIR Interviews. *Pharmacist Recruitment test (viz. 2008-2009 Railways, Defense, PHCs Under various State Governments). *NAPLEX – USA, Pharmacist recruitment test (Canada, Australia and Gulf Countries) and FPGEE Exams. *B. Pharmacy entrance exam for D. Pharmacy Holders. Gulf co-operative council interviews. *Recruitment of Drug Analyst in Central / State Drugs Testing Laboratories. * FDA Interviews for Chemist approvals (viz. Production, QA/QC, Microbiology & Sterility sections). *QA/QC Managers in Pharmaceutical Industry. *Drugs Inspector for inspection of Pharmaceutical Industries. *Medical Representatives and other Pharmacy Competitive Examinations.
The Pathfinder Part-1 Contains all the relevant information of Pharmacy Subjects including WHO GMP Guidelines and also updated with Good Clinical Practice Guidelines, List of Banned Drugs (Up to 2007), Current List of New Drugs (Up to 15-6-2007), WHO Guidelines for Validation, AHU Systems and Cleaning Validation, Test papers of WHO GMP Guidelines, Functions of Central / State drug control administration in india, National Pharmacovigilance Policy and Pathfinder Part-2 Contains GATE Question papers (19 years), Drug Inspector Recruitment Test Papers, WHO Guidelines for Herbal Medicines and MCQs for DI/GATE Examination. Shri Narendrabhai Modi, Hon’ble Chief Minister of Gujarat releasing the Pharmacy Pathfinder Third Edition (Author: Dr. A. Ramkishan, Assistant Drugs Controller (India), Incharge, CDSCO, Sub Zonal Office, Ahmedabad)
Author : Dr. A. Ramkishan, M. Pharm., Ph. D., Asst. Drugs Controller (I/c), Govt. of India Dr. A. Ramkishan has made sincere efforsts to bring out material for preparing various examinations both for question papers and their answers for various opening in Government, Pharma Industry and also for the Gate Examinations. This is a third edition where he has added new chapters quoting the requirements of Pharmaceutical Industry for their Quality Assurance / QC Managers, FDA Interviews for Chemist Approval Revcruitment of Drug Analyst in Central/ State Drug Testing Laboratories competitive Examinations.
SHARE/CARE/ LEARN WITH OTHER DIABETIC PATIENTS JOIN TODAY Group home page: http://groups.yahoo.com/group/ pharmeddiabetics Group email address: pharmeddiabetics@yahoogroups.com
This publication is useful for *Gate Examination (Nineteen Years question papers with answers). * Union and State Public Service Commission test for the recruitment of Drugs Inspectors and Lecturers.
PhaRMeD TRADE NEWS
MARCH, 15-31, 2008
Page 10
FAQ - XDR - TB 1. What is XDR-TB? XDR-TB is the abbreviation for extensively drug-resistant tuberculosis (TB). One in three people in the world is infected with dormant TB germs (i.e. TB bacteria). Only when the bacteria become active do people become ill with TB. Bacteria become active as a result of anything that can reduce the person’s immunity, such as HIV, advancing age, or some medical conditions. TB can usually be treated with a course of four standard, or first-line, antiTB drugs. If these drugs are misused or mismanaged, multidrug-resistant TB (MDR-TB) can develop. MDR-TB takes longer to treat with second-line drugs, which are more expensive and have more side-effects. XDR-TB can develop when Because XDR-TB is resistant to first-and second-line drugs. treatment options are seriously limited. It is therefore vital that TB control is managed properly. 2. what is the medical definitions of MDR-TB and XDR-TB? MDR-TB, or multidrug-resistant TB, is a specific from of drug-resistant TB. It occurs when the TB bacteria are resistant to at least isoniazid and rifampician, the two most powerful anti-TB drugs.XDR-TB is TB that is resistant to any fluoroquinolone, and at least one of three injectable secondline drugs (capreomycin, kanamycin, and amikacin), in addition to MDRTB. This definition of XDR-TB was agreed by the WHO Global Task Force on XDR-TB in October 2006. 3. How do people become infected with XDR-TB? People who are ill with pulmonary TB (i.e. TB of the lungs, the site most commonly affected) are often infectious and can spread the disease by coughing, or sneezing, or simply talking, as this propels TB bacteria into the air. A person needs only to breathe in a small number of these germs to become infected (although only a small proportion of people will become infected with TB disease). Sometimes the bacteria are already drug resistant if they come from a person who already has drug-resistant TB. A second way of developing MDR-TB or XDR-TB is when a patient’s own TB develops resistance. This can occur when anti-TB drugs are misused or mismanaged. This happens when TB control programmes are poorly managed, for example when patients are not properly supported to complete their full course of treatment; when health-care providers prescribe the wrong treatment, or the wrong dose, or for too short a period of time; when the supply of drugs to the clinics dispensing drugs is erratic; or when the drugs are of poor quality. 4. How easily is XDR-TB spread? There is probably no difference between the speed of transmission of XDRTB and other forms of TB. The spread of TB bacteria depends on factors such as the number and concentration of infectious people in any one place together with the presence of people with a higher risk of being infected (such as those with HIV/AIDS). The risk of becoming infected increases the longer the time that a previously uninfected person spends in the same room as the infectious case. The risk of spread increases where there is a high concentration of TB bacteria, such as can occur in closed environments like overcrowded houses, hospital or prisons. The risk will be further increased if ventilation is poor. The risk of spread will be reduced and eventually eliminated if infectious patients receive proper treatment. 5. Can XDR-TB be cured or treated? Yes, in some cases. Several countries with good TB control programmes have shown that cure is possible for up to 50-60% of affected people. But
PhaRMeD TRADE NEWS
successful outcomes also depend greatly on the extent of the drug resistance, the severity of the disease and whether the patient’s immune system is compromised. It is vital that clinicians caring for TB patients are aware of the possibility of drug resistance and have access to laboratories that can provide early and accurate diagnosis so that effective treatment is provided as soon as possible. Effective treatment requires that all six classes of second-line drugs are available to clinicians who have special expertise in treating such cases. 6. How common is XDR-TB? We do not know at the moment, but XDR-TB is rare. However, WHO estimates that there were almost half a million cases of MDR-TB worldwide in 2004, and MDR-TB usually has to occur before XDR-TB arises. We also know that findings from the only global study carried out so far showed that in some places perhaps as many as 19% of MDR-TB cases were in fact XDR-TB, but this is likely to be uncommon. Wherever second-line drugs to treat MDR-TB are being misused, the possibility of XDR-TB exists. Research is being carried out urgently to find out more. 7. How can a person becoming infected with XDR-TB? The majority of healthy people with normal immunity may never become ill with TB, unless they are heavily exposed to infectious cases who are not treated or who have been on treatment for less than about one week. Even then, 90% of people infected with TB bacteria never develop TB diseases. This applies to XDR-TB as well as to “ordinary” TB. people with HIV infection, However, in close contact with a TB patient, are more likely to catch TB and fall ill. The TB patients whom they meet should be encouraged to follow good cough hygiene, for example, covering, their mouths with a handkerchief when they cough, or even, in the early stages of treatment, using a surgical mask, especially in closed environments with poor ventilation. The risk of becoming infected with TB is very low outdoors in the open air. Overall, the chances of being infected with XDR-TB are even lower than with ordinary TB because cases of XDR-TB are still very rare. 8. How can a person who already has ‘ordinary’ TB i.e drug-sensitive TB, avoid getting XDR-TB? The most important thing is for a patient to continue taking all their treatment exactly as prescribed. No doses should be missed, but this is especially important if the course of treatment is meant to be taken every other day: so-called “intermittent treatment”. Above all, the treatment should be taken right through to the end. If a patient finds that side-effects are a problem, for example, the tablets make them feel sick, they should inform their clinician or nurse, because often there is a very simple solution, If they need to go away for any reason, patients should make sure they have enough tablets with them for the duration of the trip. 9. Why have we never heard of XDR-TB before? For some years we have seen isolated cases of very highly resistant TB around the world that we would today call XDR-TB. All the drugs used against TB have been around for a long time. If they are not used carefully, then resistance can develop. It is only recently as we carry out regular surveys of drug resistance in more countries, and with improvements in laboratory capacity, that these cases are being reported in greater numbers. This has led to the problem being more closely examined and given a name. 10. How do countries prevent XDR-TB?
MARCH, 15-31, 2008
Page 11
RNI NO : APBIL 2004/12036
Countries can prevent XDR-TB by ensuring that the work of their national TB control programmes, and all practitioners working with people with TB, is carried out according to the International Standards for TB Care. These emphasize providing proper diagnosis and treatment to all TB patients, including those with drug-resistant TB; assuring regular, timely supplies of all anti-TB drugs; proper management of anti-TB drugs and providing support to patients to maximize adherence to prescribed regimens; caring for XDRTB cases in a centre with proper ventilation, and minimizing contact with other patients, particularly those with HIV, especially in the early stages before treatment has had a chance to reduce the infectiousness. 11. Can the TB vaccine, known as the BCG vaccine, prevent XDR-TB? The BCG vaccine prevents severe forms of TB in children, such as TB meningitis. It would be expected that BCG would have the same effect in preventing severe forms of TB in children, even if they were exposed to XDR-TB, but it may be less effective in preventing pulmonary TB in adults, the commonest and most infectious form of TB. The effect of BCG against XDR-TB would therefore likely be very limited. New vaccines are urgently needed, and WHO and members of the Stop TB Partnership are actively working on new vaccines. 12. What is the link between XDR-TB and HIV/AIDS? Why in some places is XDR-TB so highly linked with or associated with HIV? Are most people with HIV-TB now infected with MDR-TB and XDR-TB? TB is one of the most common infections in people living with HIV/AIDS – because so many people are already infected with TB bacteria (see No. 1 above). In places where XDR-TB is most common, people living with HIV are at greater risk of becoming infected with XDR-TB, compared with people without HIV, because of their weakened immunity. If there are a lot of HIVinfected people in these places, then there will be a strong link between XDR-TB and HIV. Fortunately, in most of the places with high rates of HIV, XDR-TB is not widespread. For this reason, the majority of people with HIV who develop TB will have drug-susceptible or ordinary TB, and can be treated with standard first-line anti-TB drugs (see No. 1 above). For those with HIV infection, treatment with antiretroviral drugs will likely reduce the risk of becoming infected with XDR-TB, just as it does with ordinary TB. 13. How do I know if I have TB or XDR-TB? Symptoms of XDR-TB are no different from ordinary or drug-susceptible TB: a cough with thick, cloudy mucus (or sputum), sometimes with blood, for more than 2 weeks; fever, chills, and night sweats; fatigue and muscle weakness; weight loss; and in some cases shortness of breath and chest pain. If you have these symptoms, if does not mean you have XDR-TB, but it does mean you must go and see a doctor for a check-up. If you are already a patient with TB and you are taking treatment, if after a few weeks of treatment at least some of these symptoms are not improving, you should inform your clinician or nurse. 14. Is it safe to travel to please where XDR-TB has been identified? XDR-TB has been found in every region of the world, though it is still very rare. People who are at most risk, if they do come into contact with XDRTB, are those with reduced immunity to infectious diseases, such as those with HIV infection or other medical XDR-TB has been found in every region of the world, though it is still very rare. People who are at most risk, if they do come into contact with someone with XDR-TB, are those with reduced immunity to infectious diseases, such as those with HIV infection or other medical conditions that can weaken a person’s immunity. It is also advised
PhaRMeD TRADE NEWS
POSTAL LIC NO : HSE-806/2006-08
that such people should avoid high-risk areas where there are no infection control measures in place. Air travels itself carries only very minimal risks of infection with TB of any kind. Travelers with concerns about visiting countries with XDR-TB, or other health risks, should seek advice from their doctor, national authorities, or trusted travel web sites such as www.who.int/topics/travel 15. What should be done if a person has been in contact with a known or suspect case of XDR-TB? Anyone who has been in contact with someone known, or suspected of having, XDR-TB should consult their doctor or a local TB clinic and be screened to see if they have TB. This is most important if the person has any symptoms of TB (see No. 13 above). If they have a cough, they will be asked to provide a sample of sputum, which will be tested for evidence of TB. Several other tests will be performed in the clinic, including a skin test and a chest radiograph. If TB is found, treatment will be started with the drugs to which the person’s TB is most likely to respond. If there is any evidence of infection with TB bacteria but without TB disease, preventive treatment may be given (the choice of drugs will depend upon the known drug resistance pattern) or the person may simply be asked to attend regularly for a check up. 16. What risks do health-care workers face with XDR-TB, particularly those who may be HIV-positive themselves? To protect health-care workers who may come into contact with infectious TB patients, appropriate and strict infection control measures must be implemented in health-care facilities at all times. Health care workers are also encouraged to make sure they are aware of their HIV status so that they can avoid putting themselves at risk of exposure. 17. How quickly can XDR-TB be diagnosed? This depends on the patient’s access to health-care services. If TB bacteria are found in the sputum, the diagnosis of TB can be made in a day or two, but this finding will not be able to distinguish between drug-susceptible and drug-resistant TB. To evaluate drug susceptibility, the bacteria need to be cultivated and tested in a suitable laboratory. Final diagnosis in this way for TB, and especially for XDR-TB, may take from 6 to 16 weeks. To reduce the time needed for diagnosis, new tools for rapid TB diagnosis are urgently needed. 18. What is WHO doing to combat XDR-TB? First, WHO is ensuring that the health authorities responsible for TB control receive accurate information about XDR-TB. Second, WHO is emphasizing that good TB control prevents the emergence of drug resistance in the first place, and that the proper treatment of MDR-TB prevents the emergence of XDR-TB. This is completely in line with the new Stop TB Strategy launched in March 2006. Third, WHO is disseminating MDR-TB guidelines for national TB control programme managers published in May 2006 to help countries establish effective programmes to combat drug resistant TB. Fourth, the WHO Stop TB and HIV departments are coordinating an international response through a WHO Global Task Force on XDR-TB which met for the first time in October 2006. Latest information and regular updates on XDR-TB, and related TB issues, will be published on the WHO Stop TB web site at www.who.int/tband on the Stop TB Partnership web site at www.stoptb.org Source: W.H.O
MARCH, 15-31, 2008
Page 12