RIPER PDIC Bulletin Feb, 2013.pdf

RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)

1 February, 2013, Volume 4, Issue 31 [ISSN 2230-8741]

RIPER PDIC Bulletin Also known as

ISPOR India – Andhra Pradesh Chapter Newsletter Indexed in ISPOR India- Andhra Pradesh Chapter, Pharmainfo.net, New Jour, Open J-Gate,

Ulrichsweb Global Serials Directory & HINARI

http://sites.google.com/site/riperpdicbulletin/

http://www.pharmainfo.net/og/riper

http://www.ispor.org/regional_chapters/India-Andhra-Pradesh/index.asp

R I P E R P o i s o n & D r u g I n f o r m a t i o n C e n t e r ( P D I C ) , R D T H O S P I T A L , B a t h a l a p a l l i , A . P . & R a g h a v e n d r a I n s t i t u t e o f P h a r m a c e u t i c a l

E d u c a t i o n a n d R e s e a r c h ( R I P E R )

O f f i c i a l p u b l i c a t i o n o f R I P E R & I S P O R I n d i a - A n d h r a P r a d e s h C h a p t e r



RIPER PDIC Bulletin

R I P E R P o i s o n & D r u g I n f o r m a t i o n C e n t e r ( P D I C ) ,

R D T H O S P I T A L , B a t h a l a p a l l i , A . P. &

Raghavendra Institute of Pharmaceutical Education and Research (RIPER)

I S P O R I n d i a – A n d h r a P r a d e s h C h a p t e r

Volume 4, Issue 31

February 2013

Editorial team Page 03

Contents Page 05

Editorial Page 06

Articles Page 07

Drug news 1

Instruction to authors Page 22

‘RIPER’ is the premier educational institution promoted by Raghavendra Educational & Rural

Development Society. The institution is established in 2002 under the leadership of four pharmacy

graduates including Dr. Y. Padmanabha Reddy and Dr. J. Ravindra Reddy. Now the institution is

offering; M. Pharm, B. Pharm, D. Pharm, Pharm D and PharmD (PB) courses approved by AICTE, PCI

and Govt. of AP. The college is affiliated to JNT University, Anantapur (JNTUA) / SBTET, AP.



EDITORIAL BOARD Chief editor Dr. Y. Padmanabha Reddy, Principal, RIPER & President, ISPOR India - Andhra Pradesh Chapter Editor Mr. Dixon Thomas, Head, Dept. of Pharmacy Practice, RIPER & President-elect, ISPOR India - Andhra Pradesh Chapter AssociAte editors Dr. Adepu Ramesh, Professor, JSS University, Mysore Dr. Gerardo Alvarez-Uria, Head, Dept. of Infectious Diseases, RDT Hospital Dr. P. Selvam, Research Director & Professor, RIPER Dr. C. Sowmya, Professor, RIPER Dr. P. Ramalingam, Professor, RIPER Dr. Jyothi MV, Professor, RIPER Mrs. Seeba Zachariah, Assoc Professor, RIPER, Secretary, ISPOR AP Chapter Dr. S. Sriram, Professor, SRIPMS, Coimbatore Dr. Roger Walker, Chief Pharmaceutical Officer, Wales, U.K. Dr. Chris Wisniewski, MUSC Drug Information Center, USA Ms. Atefa Noorain, Associate Research analyst, Thomson Reuters, Hyderabad Editorial advisory Board Dr. M.S. Kannan, Medical Director, RDT Hospital & Director, ISPOR AP Chapter Dr. A.N. Nagappa, Professor, Manipal University, Karnataka Dr. G.P. Mohanta, Professor, Annamalai Univeristy, T.N. Dr. Gayathri Palat, Program Director, Palliative Access (PAX) Programme, India Dr. C. Vijaya Raghavan, Vice-Principal, PSG College of Pharmacy, T.N. Dr. Subhash C. Mandal, Vice President, IPA-Bengal Branch Dr. Sunil K Jain, Chief Pharmacist, AIIMS, New Delhi Dr. B. J. Mahendra Kumar, Prof, JDT Islam College of Pharmacy, Kerala Dr. Gunasakaran, Clinical Head, Azidus Laboratory Ltd, T.N. Dr. S.S. Rao, Pharmacist, Canada Mr. Ali Dulfikkar, Pharmacist, Dubai Prof. M.N. Femi Oyewo, Olabisi Onabanjo University, Nigeria Dr. Ugochi Nyere Ogudu, Lagos Island Maternity Hospital, Nigeria Dr. Azubike Okwor, President, Pharmaceutical Association of Nigeria Dr. Cheikh Saad, Univeristy of Thies, Senegal Dr. Stein Lyftingsmo, Pharmacist, Norway Dr. M.K. Unnikrishnan, Professor, Manipal University, Karnataka Mr. Sonal Sekhar, Sr. Lecturer, Manipal University, Karnataka Dr. Hari Hara Nadha Sarma, Medical Superintendent, RDT Hospital, Bathalapalli Dr. H. Harish, Head, Dept. of Anesthesia RDT Hospital, Bathalapalli Dr. Tadepalli Durgesh, Head, Children’s Hospital, RDT Hospital, Bathalapalli Dr. K. Sudheer Kumar, Head, Dept. of Surgery, RDT Hospital, Bathalapalli Dr. Alexander Daniel Sunad, Surgeon, RDT Hospital & Director, ISPOR AP Chapter Mr. K. Thejomoorthy, Chief Pharmacist, RDT Hospital Mr. Prasanth Kumar, Data Manager, Novartis Healthcare Pvt. Ltd. Mr. Tapan Kumar Shah, Clinical Operations, Boehringer Ingelheim India Pvt. Ltd Dr. Baghavan PS, Registrar, Karnataka Pharmacy Council Dr. Tarun Wadhwa, Asst Professor, KLE College of Pharmacy, Belgaum



PUBLICATION & PROGRAM COMMITTEE Chairman Dr. J. Ravindra Reddy, Correspondent, RIPER

Director of the ISPOR AP chapter Mr. Vigneshwaran, Asst Prof, RIPER

Scientific Coordinators Mr. G. Narayana, Asst Prof, RIPER Dr. Mohan Raj, Asst Prof, RIPER Y Samhitha Reddy T Rajavardhana

ISPOR India – Andhra Pradesh Chapter membership managers Umesh Venkatesh Lokesh R N. Jagadeesh

Logistics Avaneendra Reddy

Regulatory News Bharghav Reddy Lakshmikanth Tippu Sulthan

Proof Reading & language editing K. Balaji, Asst Professor, RIPER M Bhavani Abdul Salam

Conference Proceedings & News S Rubiya B Sahithi

Indexing & Distribution Mr. M. Jaffar, Asst Professor, RIPER KR Venkatesh

ISPOR Advisors Nancy Sun Zandra Yin

Conference registration & documentation M Maneesh Kumar Reddy B Sahithi

Chapter advisors Dr. N Udupa Dr. AN Nagappa

Website Administration K Umesh

Resource persons Simu Thomas Azmi Burhani Denny John Subhodh K

RIPER PDIC Bulletin

Raghavendra Institute of Pharmaceutical Education and Research (RIPER) Chiyyedu Post, Anantapur 515721, AP, India Phone: 91-8978541693 [email protected], www.riper.ac.in, http://sites.google.com/site/riperpdicbulletin/,

http://www.ispor.org/regional_chapters/India-Andhra-Pradesh/index.asp Notice: For healthcare professionals only. View of authors are independent to that of editorial team, it is highly advised for consulting other drug information sources also for your specific needs. Publisher, editorial team or authors are not responsible for any damage happens due to the information provided. RIPER PDIC Bulletin Published by the Principal, RIPER, Anantapur— 515721, A.P. Subject to Anantapur jurisdiction only.



RIPER PDIC Bulletin

Contents

1 Editorial Page 06

2 ISPOR and Health Technology Assessment (HTA) -

Robert Selby

Page 07

3 Overview of clinical outcomes research - Dixon Thomas

& Rajesh Balkrishnan

Page 09

4 Perspectives in current pharmacotherapy of multiple

sclerosis - Mark Decerbo

Page 11

5 A partnership among pharmacists for the

advancement of public health - Mary Kremzner

Page 15

6 The emerging market of pre filled syringes -

Aayush Agarwal

Page 16

7 Public health program in a rural village by PharmD

students - M Anusha

Page 17

8 Assessment of knowledge towards cancer among

rural women in India - Subramanyam Dasari

Page 18

9 Drug news Page 21

10 Instruction to the authors Page 22



Editorial

National Conference on Patient Reported Outcomes in Pharmacovigilance I welcome Dr. YK Gupta, HOD, Dept of Pharmacology, All India Institute of Medical Sciences, New Delhi as the Keynote speaker in the upcoming conference. Other speakers are Dr. Anantah Naik Nagappa, Secretary of ISPOR India- Karnataka Chapter and Dr. H Sarma, Medical Superintendent, RDT Hospital, Bathalapalli. This is the final call for participation in “National Conference on Patient Reported Outcomes in Pharmacovigilance” on March 24, 2013 in RDT Hospital, Bathalapalli, Anantapur, AP. Please find the program brochure in ISPOR website http://www.ispor.org/regional_chapters/India-Andhra-Pradesh/index.asp or

http://www.ispor.org/regional_chapters/India-Andhra-Pradesh/documents/Conference-on-PV-

Patient-reporting-March-24-2013.pdf. Let us meet in RDT hospital, Bathalapalli, Anantapur on March 24, 2013. We welcome oral and poster presentations so that there is a chance for the delegates to contribute to the knowledge & practice of pharmacovigilance. I really appreciate all the team members of our regional chapter and encourage more membership in 2013. Any communications shall be forwarded to [email protected].

Sincerely yours, Dr. Y Padmanabha Reddy, M.Pharm, PhD, FIC President, ISPOR India-Andhra Pradesh Chapter Principal, RIPER & Chief Editor, RIPER PDIC Bulletin [email protected] Think out of the box Dr. Sirish Kumar, CEO of RAChem Pharma Ltd., Hyderabad visited our institution recently and said; “pharmacists always think about pharmacy only” and he pointed out that we should start thinking out of the box. He quoted examples of pharmacists who were working in food industries and related business. In another point of view, we should try to prove the benefits of pharmacy services to the consumers again and again. It is better to attract them than restricting. As Prof. Anantha N Nagappa, Manipal College of Pharmaceutical Sciences mention, home reviews of medicines is a novel approach in delivering better health care. Let us all concentrate on providing value added services to the customers. Best Regards, Mr. Dixon Thomas, M.Pharm, M.S., M.Sc. President-elect, the ISPOR, India-Andhra Pradesh Chapter HOD, Pharmacy Practice, RIPER & Editor, RIPER PDIC Bulletin, [email protected] [email protected]



ISPOR and Health Technology Assessment (HTA)

Robert Selby Coordinator, Asia-Pacific Development, ISPOR COI: This report was compiled by using information provided by the ISPOR website and relevant task forces. An integral part of ISPOR’s mission has always been to bridge the gap between outcomes research and health care decisions for the rational, efficacious and fair allocation of scarce health care resources. Since health technology assessment (HTA) plays the indispensable role of providing outcomes research evidence for health care decision-makers, (e.g. regulatory agencies, health care payers, clinicians, hospitals, clinics, health authorities, and patients) ISPOR established guidelines for appropriate, transparent and otherwise “ideal” application of HTA. ISPOR Health Technology Assessment Vision 2020 (http://www.ispor.org/councils/HTACoucilVision.asp) laid the groundwork for an ideal HTA world by 2020, which included guidelines for future HTA information systems, the scope and cycle of HTA studies, HTA data and patient registries, HTA methodology and the translation of findings to the relevant decision makers. To ensure that tangible progress was made on this ambitious vision, the ISPOR Health Technology Assessment (HTA) Roundtables (http://www.ispor.org/councils/hta_council.asp) were formed. Beginning in 2007, ISPOR HTA Roundtables have provided a forum to discuss debate and share health technology issues as well as bridge the gap between HTA agencies, health care decision-makers and outcomes researchers and to optimize health care decisions using outcomes research, with key regional health care decision makers in attendance. The ISPOR HTA

Roundtables have been held in every ISPOR International Meeting, European Congress and Regional Conference, with the ISPOR 17th HTA roundtable scheduled during the upcoming ISPOR 18th International Meeting on May 18-22, 2013 in New Orleans. Following HTA roundtable discussions in North America, several key issues were identified as being essential for ensuring compliance with Vision 2020. These issues included the translation of HTA information to health policymakers, HTA methodologies and studies, HTA prioritization, HTA data, the need for HTA information, and the scope of HTA and the technology life cycle. HTAnetAsia In response to HTA’s dynamic progress in Asia, ISPOR Asia Consortium formed a Health Technology Assessment Network for the region, called HTAnetAsia (http://www.ispor.org/consortiums/asia/ISPOR-AsiaNetHTA.asp) in September 2010. HTAnetAsia was formed under the umbrella of ISPOR Asia Consortium in collaboration with HTA agencies throughout Asia. The mission of the HTAnetAsia is to support effective HTA collaboration in Asia by providing a platform for analysts, researchers, and managers from assessment agencies in Asia to share knowledge and tools to assist the production of HTA, to discuss and debate issues related to HTA for all health products, including drugs, and medical devices and diagnostics, and to



facilitate the efficient use of HTA in countries in Asia. HTAnetAsia has held three HTA roundtables in conjunction with the ISPOR Asia-Pacific Conferences. During discussions at the recent ISPOR Asia HTA roundtable, held following the ISPOR 5th Asia-Pacific Conference, 2-4 September 2012 in Taipei, Taiwan, roundtable delegates proposed creating an HTA survey to guide health care policymakers in their country-specific applications of HTA. The survey was compiled by Dr. Yen-Huei (Tony) Tarn, 2010-2012 Chair, ISPOR Asia Consortium Health Technology Assessment Agencies Committee, and follows 15 key principles of HTA as outlined by Professor Michael Drummond, et al. This tool is available at http://www.ispor.org/consortiums/asia/H

TA_Principles_Survey_Questionnaire_Final.pdf. HTAnetAsia welcomes your feedback on the survey at [email protected]. As HTA continues to gain momentum in Asia, ISPOR and Asia Consortium are committed to serving as a platform for providing evidence and guidance for HTA’s application in a manner that is beneficial and appropriate to each regional context. Reference: Drummond M, Schwartz JS, Jonsson B, et al. Key principles for the improved conduct of health technology assessments for resource allocation decisions. International Journal of Technology Assessment in Health Care 2008; 24:3 244–258.



Overview of clinical outcomes research

Dixon Thomas 1 & Rajesh Balkrishnan2

1Dept of Pharmacy Practice, RIPER, AP, India 2Center for global health, University of Michigan, USA Reducing trial and error in medical practice is one of the basic objectives of evidence based medicine. An experimental approach to the patient in regular practice is disturbing. Clinical trials or other experimental studies shall be planned to generate evidences which shall be used in routine patient care. High quality evidences are possible with well designed and conducted clinical trials. So the experimentation is restricted to a lower portion of the patient population. Now we have to explain, then which type of research is routine with regular patient care. Of course, it should involve minimal or no harm. As part of regular practice, different clinical interventions are performed for therapeutic, preventive and diagnostic needs. These interventions produce outcomes. Studies on those outcomes contribute to real world evidences. Observational research designs could be exercised to measure and analyze clinical outcomes. Outcomes research is gaining more importance as local evidences could be created through ongoing studies. These studies are observational and could be performed along with practice. Clinical outcomes include: clinical endpoints, health-related quality of life, and satisfactions with care. Here we could consider the perspectives from the patient, health care provider, managed care and societal angles. Theoretically patients were considered as one of the stakeholders in health care. But in real practice, patients remain as silent members of health care team. Patient

reported outcomes research is encouraging the patients to report the outcomes and be vigilant on them. So this process is helping to make the patient as an active participant in health care process. Outcomes evaluation is focusing on studying interventions based upon their clinical effect, their effect on patient’s sense of health and well-being, and their economic effects. The results of outcomes evaluation should allow patients, payers, and health care providers to make rational choices about their medical care by allocating funds to the most cost-effective therapies. There are five steps in outcomes research:

1. Identify and select indicators 2. Monitor and pool data 3. Describe variations and identify

problems 4. Analyze and explain variations 5. Feedback and disseminate results

from the segment of the database most appropriate to the concerns of each decision maker.

Effectiveness is one of the main components of outcomes research. It is the actually achieved benefit (effect on mortality, morbidity, health status). It also refers to the ability of a particular medical action in altering the natural history of a particular disease for the better, under actual conditions of practice and use. On comparison with clinical research, outcomes research measures effectiveness (effects of an intervention as



applied to broad populations in real practice). Clinical trials measures efficacy (effect of an intervention measured under controlled circumstances in clinical research). When clinical trials measure clinical and physiological endpoints, outcomes research measures quality of life, cost and resource utilization, and treatment satisfaction. Health outcomes research is defined as the studies that attempt to identify, measure, and evaluate the end results of health care services. ECHO Model explains the outcomes of medical care; Economic outcomes: direct, indirect,

and intangible costs compared with the consequences of medical treatment alternatives.

Clinical outcomes: medical events that occur as a result of disease or treatment. Clinical outcomes vary with each disease state but should include: disease effects, medication side effects or adverse effects, physical, psychological and biochemical changes.

Humanistic outcomes: consequences of disease or treatment on patient functional status or quality of life. Humanistic outcomes are very subjective. Patient rights and ethics categorize the outcomes on the basis of situation and available evidences. Emotional outcomes shall also be considered.

Costs are the value of the resources consumed by a program or treatment alternative versus consequences (effects, outputs, and outcomes). Direct costs include direct medical (hospitalization, drugs, medical supplies, and physician visits) and direct nonmedical costs (transportation to hospital, special food and family care). Indirect costs include lost productivity, loss of healthy life. Intangible costs include pain, grief, and death. While looking at the limitations, we could see that the health outcomes may be due to many factors, only some of which are under clinicians’ control. Although theory suggests that outcomes and process measures are closely linked, a poor outcome does not immediately tell us what needs to be changed; they are just probability statements. Outcomes information collection along with practice could be tedious. The ultimate outcome may lie too far in the future, forcing dependence on an intermediate outcome. Overall, outcomes research is an important tool in ensuring cost effective high quality medical care delivery if judiciously and rigorously applied. Further reading: http://www.ispor.org/workpaper/practices_index.asp



Perspectives in current pharmacotherapy of multiple sclerosis

Mark Decerbo Associate Professor of Pharmacy Practice, Roseman University of Health Sciences, Nevada, USA Multiple sclerosis (MS) is a chronic, autoimmune disease of the central nervous system characterized by inflammation resulting in widespread, irreversible myelin sheath and axon destruction. Affecting almost 2.5 million individuals worldwide, with nearly 500,000 of those in the United States and 3 out of every 100,000 individuals in India, the disease primarily afflicts individuals between the ages of 20-45, with a median and mean age of onset of 23.5 and 30 years respectively. Consequently, multiple sclerosis is a significant cause of disability, with 50% of all patients requiring some type of walking assistance 10 years after diagnosis, and an average decreased life-expectancy of 10-15 years. Familial risk for developing MS is 3-23% when a primary relative is affected, and the chance for monozygotic twins both developing MS is only 20-39%. Therefore, while genetic factors appear to most strongly contribute to the pathogenesis of multiple sclerosis, they do not completely account for the risk, with numerous other factors identified. While no medications have been associated with an increased risk of development of MS, and most vaccine studies also refute any causative link between immunization and disease precipitation, one case-control study did find that Hepatitis B vaccination was associated with increased risk for MS development. Gender plays a role, as MS occurs at a nearly three-fold higher rate in women, a gender disparity which has been increasing over the past half-century. Other risk factors for

development of the disease include: previous infection with Varicella-Zoster Virus (VZV) or Epstein Barr Virus (EBV), presence of other autoimmune disorders, month of birth, smoking, and more controversially, latitude of residence, with those residing at higher latitudes/colder climates having an increased risk of developing MS. Whether this is owed to the similar genetic makeup of individuals residing in these geographic areas, or is related to sunlight exposure is unclear, as both sunlight exposure and higher serum Vitamin D levels have been shown to be protective. Initial presentation of the disease (Clinically Isolated Syndrome- CIS) can vary widely from patient to patient, but generally can take one of three forms: optic neuritis, characterized by unilateral vision loss progressing over a period of days, painful eye movement, and diminished color perception; transverse myelitis, characterized by weakness, paresthesias, numbness, and sphincter dysfunction, or brainstem/cerebellar syndromes, characterized by diplopia, facial numbness/weakness, vertigo, and ataxia. Classically, MS has been a diagnosis of exclusion, relying on a combination of clinical, laboratory, and Magnetic Resonance Imaging (MRI) data requiring the presence of CNS lesions which are both Disseminated In Time (DIT) and Space (DIS) while excluding all other potential pathologies. In an attempt to allow for earlier diagnosis and more uniform applicability across populations, the McDonald Criteria for diagnosing MS



was simplified and updated in 2010. Pertaining strictly to those presenting with typical CIS, the new guidelines define DIS of CNS lesions as T2 weighted MRI findings of ≥1 lesion in at least 2 of 4 specific areas of the CNS (spinal cord, periventricular, juxtacortical, infratentorial). More importantly, whereas the previous criteria required the initial MRI be performed no sooner than 30 days after clinical onset, while requiring a second MRI scan, it is now possible to potentially make a diagnosis with just 1 MRI. Following diagnosis, patients are generally classified into one of four multiple sclerosis subtypes, based upon patterns of disease activity, with the Relapsing-Remitting MS (RRMS) subtype the most common variant. Due to the progressive nature of the disease, early intervention with Disease-Modifying Therapies (DMTs) is critical in delaying a patient’s progressive neurologic deterioration and conversion to the more aggressive sub-type of MS, Secondary Progressive MS (SPMS). Therefore, in order to slow the progression of the disease, reduce disability progression, and presumably prolong life, drug therapy initiated within the first two years following diagnosis has been shown to slow progression to a greater extent than those started after the initial period, with this benefit continuing to accrue over a decade later. Historically, prescribers and patients have selected their initial first-line agent from amongst three interferon-beta products (subcutaneous beta-1b given every other day, subcutaneous beta-1a given three times weekly & intramuscular beta-1a given once-weekly) or daily subcutaneous glatiramer acetate. Inteferons are replete with side effects, including injection site reactions, flu-like symptoms, and more

rare but serious effects such as hepatotoxicity, hypo/hyperthyroidism, and bone marrow suppression requiring laboratory monitoring. While patients can acclimatize to some side effects, and others can be managed with temporary dosage reduction or prophylactic NSAIDs or paracetamol, discontinuation of interferons for reasons other than treatment failure is common. Glatiramer acetate, the most commonly prescribed multiple sclerosis medication worldwide, has enhanced tolerability, requiring no laboratory monitoring and being endorsed as the treatment of choice in those with pre-existing liver disease or pregnancy. Current American Academy of Neurology (AAN) clinical practice guidelines do not recommend any one parenteral agent over another as a first-line agent, with the decision between interferon beta and glatiramer acetate made at the physician’s discretion. Of note, these guidelines do not reflect the newly approved daily oral agent, fingolimod, which has offered a new approach to therapy based upon its oral bioavailability as well as its unique mechanism of action. As clinical experience with this agent accrues, significant side effects such as fatal bradycardia, increased risk of infection, and macular edema have been noted, leading to updates to the agent’s prescribing information. Other MS guidelines similarly pre-date the introduction of natalizumab, an intravenous agent which has data suggesting potential superiority over other MS medication, while at the risk Progressive Multifocal Leukoencephalopathy (PML). PML, a potentially fatal demyelinating disease of the brain caused by reactivation of the JC virus, temporary lead to suspension of marketing of natalizumab, although the medication is again available for prescribing under specified parameters.



Presence of JC virus antibodies at baseline, as well as total duration of natalizumab therapy have been identified as risk factors for development of PML. A screening test for JC virus antibodies has been developed in an attempt to better stratify patients who may safely receive therapy with natalizumab treatment. Despite therapy with the above disease-modifying agents, approximately 85% of patients with MS (excepting those diagnosed with the PPMS subtype) will experience clinical exacerbations throughout the course of their disease. Alternatively referred to as flares, attacks, or relapses, exacerbations represent a heightened period of immune activity in which there is either a worsening of at least 1 or more previously existing neurological symptoms or disabilities or the appearance of new neurological deficits. The new or worsened symptoms must persist for at least 24 hours, represent a neurologic symptom that had previously been stable for at least 30 days, and occur in the absence of a better alternative explanation. Symptoms develop gradually over a period of hours to days (although onset may be acute in nature) with a peak within 1 week. The frequency and severity of exacerbations varies widely between patients, with attack rates varying from 0.14 to 1.1 relapses per patient per year, with men and those in the early stages of disease having higher rates. There is no single identified factor known to be responsible for triggering MS exacerbations, although infections are theorized to play a role. A careful screen for such, including Urinary Tract Infections (UTIs) and Upper Respiratory Infections (URIs) in all patients presenting in the midst of a suspected attack is therefore prudent. Infections, along with fever,

heat, or memantine therapy can also trigger pseudoexacerbations, a re-emergence of symptoms from a previous exacerbation occurring greater than 30 days prior. Pseudoexacerbations are owed to a temperature-dependent conduction block in demyelinated axons rather than to any new acute demyelinating process, and can be distinguished by the ability to resolve upon discontinuation of the offending agent(s) and cooling body temperature. Corticosteroids represent the mainstay of therapy in the management of acute exacerbations and are utilized to decrease both the duration and intensity recovery from considered the standard of care despite no such agents being FDA labeled specifically for this indication. Numerous studies have demonstrated the superiority of corticosteroids to placebo in speed recovery from an exacerbation. The exact mechanism by which corticosteroids exert their effect is unknown, although the derived benefit is postulated to occur from restoration of the blood-brain barrier, apoptosis of lymphocytes, and reduction in edema accumulation in the demyelinated area. While corticosteroids represent the first-line treatment of choice in speeding time to recovery from an exacerbation, there remain many unknowns as to the optimal dose, route, and duration of corticosteroid therapy. Intravenous methylprednisolone (IV MP) is the most studied corticosteroid in the setting of an attack, and is typically dosed at 1g per day for a total of 3-5 consecutive days. Commonly administered as a one-time daily dose over a period of 30-60minutes in 100ml NS, the dose may also be divided into a 250mg IV QID for improved tolerability. While MRI data from a trial analyzing IV MP at a dose of 2000mg per day suggests a potential dose response to steroids, doses exceeding



1000mg IV MP per day are generally not routinely used in clinical practice, with cases refractory to steroids generally switched to an alternate agent such as repository corticotropin injection, which is given intramuscularly for 14 days. Both patient and clinician preference plays a major role in determining the initial route of corticosteroid therapy, as hospitalization and establishment of venous access is not always practical in the patient experiencing an MS exacerbation. Oral steroids have also been studied with results similar to that of IV MP. No difference in outcomes were observed in studies comparing a 21 day taper of oral methylprednisolone versus 1000mg IV MP daily for 3 days or between 1000mg IV MP Daily vs. 1000mg orally both given for 5 days. Data with oral steroids has revealed a higher risk of recurrent optic neuritis as compared to patients initially treated with intravenous steroids, and lack of overall clinical

experience with oral steroids has left this approach unpopular. The optimal treatment of MS is evolving, with several new agents poised to enter the market with the potential to further alter treatment of the disease. Clinical experience with newer agents will help to define the newer agents’ proper place in therapy, with sorely needed head-to-head comparative studies of existing agents necessary to better define the optimal approach to therapy in the ever-changing landscape of MS pharmacotherapy. [Note: Dr. Decerbo presented on Multiple Sclerosis at 2 venues in India, they were; Indian Association of Colleges of Pharmacy (IACP) organized Inaugural Quality Pharmacy Practice – Advanced Learning Series – Module 2 in July 2012 at Sri Ramachandra College of Pharmacy, Chennai and the Module 2 Repeat at St. Peter’s Institute of Pharmaceutical Sciences, Warangal in the month of February 2013.]



A partnership among pharmacists for the advancement of public health Mary Kremzner

CAPT, US PHS, Division of Drug Information | Office of Communications Center for Drug Evaluation and Research | Food and Drug Administration, USA The Global Alliance of Drug Information Specialists (GADIS) invites you to participate in a unique forum to present and facilitate a discussion on a topic of interest to your practice and one that may benefit fellow GADIS members. Topic Requirements: GADIS provides drug information specialists a forum for the exchange of evidence- based best practices. As such, we want to facilitate discussion of topics that are current and relevant to practicing drug information specialists. These may include, but are not limited to, the use and management of drug product(s), the impact of a recent Drug Safety Communication (www.fda.gov/drugsafetycommunications), or the impact of a recent Agency regulations, initiatives, or guidance that may be relevant to practicing drug information specialists. Additionally when appropriate and upon request, we can include FDA Subject Matter Experts related to the topic of the presentation. For example in May 2012, GADIS held a webinar to discuss the use and management of Pradaxa (dabigatran): www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm304100.htm. For this webinar, the Supervisory Clinical Analyst and the Deputy Director for Safety as well as the Medical Officer and Clinical Efficacy Reviewer from the Office of New Drugs, Division of Cardiovascular and Renal Products were invited to present.

Presentation Requirements: The webinar will be roughly structured as follows: - Introductions (5 minutes) - Presentation (~ 25 minutes) - Discussion/ Questions & Answers (~ 25 minutes) - Wrap Up (5 minutes) Application Process: Please submit a proposal following the below template to: [email protected] by March 15, 2013.

- Title of Presentation: - Abstract (150 words or less): - Learning Objectives: - Statement of Need (2-4 sentences): Please address what gap(s) your session will address and provide documentation if appropriate (i.e. original FDA press release, etc). - Requesting an Agency SME? Yes/No. If yes, how do you foresee the SME being involved (i.e. serving as one of the presenters, being available for questions, etc)?

As a presenter, you have the opportunity to further enhance the community of drug information specialists. If you have any questions, please contact us at [email protected]. For GADIS membership please contact: [email protected] [Disclaimer by GADIS: This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.]



The emerging market of pre filled syringes

Aayush Agarwal General Manager F (R&D), Roselabs Group, India COI: Roselabs group manufacture or market pre filled syringes PFS is commonly known as Pre Filled Syringe. When we use the word PFS, it could be either Pre Fillable Syringe (an empty syringe) or it could be Pre Filled Syringe (a filled syringe). In this article PFS stands for the later meaning. A PFS can be of basically two configurations namely Staked Needle (with needle assembled) and Leur-Lock (without needle). A whole set of difference come into picture right from the manufacturing process to the regulatory requirements of these two different configurations. When talking about the volumes, it ranges from 0.2 ml to 10 ml usually, however in some customized requirements the volumes are as high as 20 ml and 50 ml. Some of the most commonly marketed drugs in PFS include insulin preparations like Novorapid and Novomix, treatment for rheumatoid arthritis namely Enbrel and Humira, co-treatment with chemotherapy in cancer patients namely Neulasta. In India, Enoxaparin is a popular product in PFS delivery system. Other diseases treatments where PFS products are seeing a tremendous growth and opportunity are Osteoporosis, Multiple sclerosis, Fertility, Anaemia, Haemophilia. The benefits of PFS in the market look very lucrative but there are a lot of challenges involved in technically manufacturing a PFS. These challenges increase with the number of components involved in creating a single unit. Basically there are 5-6 components involved in a

single unit of PFS which again depends on the material of construction of the barrel of a syringe. Some of these are;

- Luer Tip / Needle Shield - Luer Lock / Cannula - Barrel - Rubber Plunger - Plunger Rod - Flange - Thumb pad

Various factors affect the design and synchronization of these components which together as a single unit make the PFS function. Some of these factors are;

- Different Kind of patients would have a different comfort level depending on the disease, age group, strength etc.

- User could be a patient (self-medication), healthcare professional or the doctor himself

- Site of injection also influences the design and hence every different site needs to be customized

- Drug Viscosity, more the viscosity, stiffer plunger rod, and larger flange and thumb pad

- Needle Shield design – size, surface texture, material, grip, color, chemical properties, thickness

- Barrel design – Glass or Polymer, shape, grip, size, diameter, clearness, friability, strength, curvatures, surface texture, roll-ability



- Plunger Rod design – material, color, stiffness, structure, size, thickness, motion, stability

- Flange design – shape, size, grip, stiffness, material, grooved

- Label design – visibility, font size, color, material, transparency

- Thumb pad design – shape, size, surface slippery, strength, stability, edges

- Packaging – ease of pick up, unit size, handling

It’s very important for all these components to function is reasonable synchronization. Even during the design stage, synchronization is of utmost importance. This is best achieved when all the components are made under one roof hence giving the best quality standards and control uniform to each component. This also ensures zero dependency on an outside vendor thus significantly affecting the cost of the product.

------------------------------------------------------------------------------------------------------------------------

Public health program in a rural village by PharmD students

M Anusha PharmD Candidate, RIPER, Anantapur, India National Service Scheme (NSS) unit II of RIPER conducted mega camp in Mustooru village near Bathalaplli, Anantapur under the guidance of JNTUA coordinator Dr. T. Narayana Reddy and RIPER coordinator Mr. K. Somasekhara Reddy. The one week long camp included services such as awareness on prevention of infectious diseases, pediatric and geriartric care, nutrition, tobacco and its ill effects etc. The last day of the program was a medical camp. Nearly about 300 people have attended this medical camp and they

were screened by Dr. Chaitanya and Dr. Rajeshwari of Rural Development Trust Hospital, Bathalapalli. The doctors were felicitated by Dr. J Ravindra Reddy, Correspondent of RIPER.

Medical Camp team



Assessment of knowledge towards cancer among rural women in India

Subramanyam Dasari

Medico Social Work, RDT Hospital, Bathalapalli, Anantapur Dist, A.P.

Abstract Women’s health is of paramount importance to any nation. Breast and cervical cancers were the common cancers in women. The plan was to study the knowledge of women from rural villages in Anantapur, AP, India. Female social workers interviewed women who attended the cancer screening unit of a rural district hospital in the region. One hundred and two women who were diagnosed with breast or cervical cancers were interviewed. Most of them; 81.3% did not know of the risk factors of cancers, 60.8% had no idea about preventive measures, 78.4% did not know about early detection of breast or cervical cancers, and 81.4% did not know about treatment methods for those cancers. Intensive cancer education programs are required for women in India. Key words: breast & cervical cancer, rural women, knowledge

Introduction Women’s health is not only a state of physical well being but is an expression of the many roles she performs as a mother, care giver, wage earner and their interaction with the socio-economic and cultural circumstances which influence her daily life. Cancer of breast and cervix are the common cancers occurring among women.1 Prevention and early detection requires focus on self breast examination and opportunistic screening by Pap smear. Women’s perception, knowledge and communication towards Cancer disease refers to the ways in which symptoms are perceived, educated and acted upon by a person who recognizes some pain, discomfort or other signs of organic malformation. It is now increasingly recognized that the illness behavior can be and often is less normatively controlled rigid and static and it is variable and dependent on nature of illness, psychological, socio-cultural and situational factors.2,3

Methodology

Women belong to the weaker section villages covered by a 300-bedded secondary level rural referral Hospital located in Bathalapalli, which is 27 KM away from the district headquarter Anantapur, State of Andhra Pradesh. It is strategically located with easy access for about 500-600 villages around Dharmavaram, Kadiri, Tadipatri, Anantapur etc Thaluks. The population of all these villages would be around 7 lakhs. The Breast and Cervical Cancer patients attended to this Hospital form the population of the study. To elicit primary data a structured interview schedule was administered confidentially by female social workers. In addition to the primary data, secondary data from the official records/ publications were collected. Results & Discussion A total number of 20,496 women who visited to a rural referral Hospital for various gynecological complaints, 2,793 patients were referred to Cancer Detection clinic for their symptoms such as reproductive tract infections, painful or



painless swelling/lump of the breast during the period of January 2008 to December 2008. Among these 2,793 referrals, 102 women (3.6 percent) were diagnosed to have Cancer of the Breast

(45) and Cervix (57) respectively. These 102 cases were formed as our study population. The pre-cancer cases were not considered for the study.

Table.1. Knowledge about cancer risk factors

Knowledge about cancer risk factors (%) Total (%)

No Yes 83 19 102

(81.3%) (18.6%) (100%)

Table.2. Knowledge about Cancer preventive measures

Knowledge about Cancer preventive measures (%) Total (%)

No idea By avoiding

Tobacco Practicing Hygiene

Avoiding frequency of high fat diet

62 28 8 4 102

(60.8%) (27.4%) (7.8%) (3.9%) (100%)

Table.3. Knowledge about early detection methods of cancer

Knowledge about early detection methods of cancer (%)

Total (%) No Idea Mammogram

Breast Self Examination

Pap smear test

80 3 5 14 102

(78.4%) (2.9%) (4.9%) (13.7%) (100%)

Table.4. Knowledge about cancer treatment

Knowledge about cancer treatment (%) Total (%)

No Yes 83 19 102

(81.4%) (18.6%) (100%)



The study population had considerably less knowledge and understanding of breast and cervical cancer and that their access to this knowledge is limited. Lack of knowledge is closely connected to limited conversations among rural women about these issues to those who know about it as well as lesser reach to sources of information. Our study explains that the rural women in India are having very low knowledge about any aspects of cancer. Educational programs need to be developed to make them better understand and manage cancer. Cancer is one of the disease in which the patient is actively involved in the prognosis. Cancer education programs are vital component in women’s health of the country.4 Conclusion Our study states that the knowledge about cancer is low in rural women in India. Most of the rural women with breast and cervical cancers had no idea about the risk factors, early detection, prevention, and treatment of it.

Acknowledgement I thank RDT for giving me opportunity to do the study. I also thank all female social workers who helped in data collection. References

1. Aswathy S., Sumithra S., Valsala L.S. et al. Self Reported Morbidity and Awareness Regarding Common Cancers in elderly women. J. Commun. Dis. 2006; 38 (1):106-111.

2. Agarwal G, Pradeep PV, Aggarwal V, Yip CH, Cheung PS. Spectrum of breast cancer in Asian women. World J Surg. 2007; 31:1031–1040.

3. Kasturi J, Bhagwan MN, Rajendra AB, Nandkumar SP, Ranjit VT, Feroz YK. Rural Cancer Registry at Barshi, Maharashtra and its impact on cancer control. Natl Med India. 2010; 23:274–7.

4. Agarwal G, Ramakant P. Breast cancer care in India: current situation and challenges for the future. Breast Care. 2008; 3:21–27.



Drug News No risks to pregnancy with morning sickness drug ondansetron A drug commonly used to treat severe cases of morning sickness does not appear to be linked to birth defects or other risks to the baby, a large new study suggests. The Danish researchers said the findings, reported in the Feb. 28 issue of the New England Journal of Medicine, do not prove the medication is risk-free. But they said the study should reassure women who need the drug, called ondansetron. The findings are based on records from more than 600,000 Danish women who were pregnant between 2004 and 2011. Of those women, about 0.3 percent received prescriptions for ondansetron. About half had nausea and vomiting severe enough that they had been hospitalized. Overall, there was no evidence that the medication increased the risks of miscarriage, stillbirth, preterm delivery or major birth defects. Reference:http://www.drugs.com/news/no-risks-pregnancy-seen-morning-sickness-43359.html USFDA approves stivarga for advanced gastrointestinal stromal tumors The U.S. Food and Drug Administration in February expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. Stivarga was reviewed under the FDA’s priority review program, which provides an expedited six-month review for drugs that may provide safe and effective therapy when no

satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The drug was also granted orphan product designation because it is intended to treat a rare disease. Reference:http://www.drugs.com/newdrugs/fda-approves-stivarga-advanced-gastrointestinal-stromal-tumors-3702.html USFDA approves Pomalyst for advanced multiple myeloma The U.S. Food and Drug Administration in February approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow. Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment (relapsed and refractory). Pomalyst carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can cause severe life-threatening birth defects, and that the drug can cause blood clots. Reference:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm338895.htm



Instruction to the authors

Please send your articles to [email protected] or [email protected]

All correspondence would be through email. Please send the novel article related to therapeutics, drug or poison informatics, pharmacy practice / clinical practice, research, clinical nutrition, bed side teaching, clinical education etc.

Please contribute your articles in A4, Arial font size 12, single spacing, please give the references cited in the text with Arabic numerals as superscripts;

Original research (not more than 5 pages)

Review (not more than 5 pages)

Short communication (not more than 2 pages)

View point / message (not more than 2 pages)

Proceedings of conference / seminar (not more than 3 pages)

The article will undergo peer review process. Once it is accepted for publication, do the corrections if necessary and a copyright letter with the following wordings to be send as an e-mail to the editor within 5 days.

“The article titled as………………………………………………………………………………. by the ………………………………………………………………………………………………………(authors) is not send elsewhere for publication or is not published previously or not under consideration for publication other than RIPER PDIC Bulletin. Here we transfer the complete copyright of the article to publish or reproduce to RIPER PDIC Bulletin. The above mentioned article is plagiarism free. I the corresponding author have the right to sign the copyright transfer form on behalf of all the contributing authors.” Please describe in your own words if any conflict of interest exists. Editorial board holds the right to do the necessary editing as part of final editing.

Corresponding author ………………………………………………….(Name & Sign with date)

RIPER PDIC Bulletin Feb, 2013.pdf

Documents

Transcript of RIPER PDIC Bulletin Feb, 2013.pdf