RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter) 1 December, 2012, Volume 3, Issue 29 [ISSN 2230-8741] RIPER PDIC Bulletin Also known as ISPOR India – Andhra Pradesh Chapter Newsletter Indexed in ISPOR India- Andhra Pradesh Chapter, Pharmainfo.net and Open J-Gate http://sites.google.com/site/riperpdicbulletin/ http://www.pharmainfo.net/og/riper http://www.ispor.org/regional_chapters/India-Andhra-Pradesh/index.asp RIPER Poison & Drug Information Center (PDIC), RDT HOSPITAL, Bathalapalli, A.P. & Raghavendra Institute of Pharmaceutical Education and Research (RIPER) Official publication of RIPER & ISPOR India-Andhra Pradesh Chapter
Transcript
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
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 (ISPOR India – Andhra Pradesh Chapter Newsletter)
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
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
PUBLICATION & PROGRAM COMMITTEE Chairman Dr. J. Ravindra Reddy, Correspondent, RIPER
Director of the ISPOR AP chapter Vigneshwaran, Asst Prof, RIPER
Scientific Coordinators 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 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 Dr. Simu Thomas Dr. Azmi Burhani Dr. Denny John Dr. 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
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
When the science become applied science and the technology become user-friendly, it is important for the educational institutions to be collaborated with the industries to make the best products out of it. I would like to congratulate Azmi-Burhani Consulting Sdn Bhd, Malaysia and RA Chem Pharma Ltd., Hyderabad in their recent collaborations with our institution. The real world experience of competitive Pharma business exposure will be useful for our students. It would be also useful for our staff to be involved in cutting edge research.
I would encourage more industry-institute collaborations for making a better workforce for tomorrow. Wish you all a happy and prosperous new year 2013. 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], [email protected] Quality improvement in pharmacy education & practice
It is well known from the recent statistics that India is producing a significantly good number of pharmacy graduates every year. The quality remains the question yesterday, today and tomorrow. With increased numbers, the importance to have the quality also increases. Quality Improvement Programs (QIP) for the reaching staff by All India Council for Technical Education is an important step in assuring the quality of pharmacy education in the country. Poona College of Pharmacy, Bharati Vidyapeeth University, Pune organized a two week QIP program in three streams. One of that was on Pharmacotherapy Review for Advanced Clinical Pharmacy Practice with the leadership of Dr. Atmaram Pawar and Mrs. Asawari Raut. With the efforts of The Indian Association of Colleges of Pharmacy, Medication Therapy Management (MTM) is getting popular in India. The recent third module of the advanced learning series on MTM topics was conducted in Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore with the leadership of Dr. TK Ravi and Dr. S Sriram.
Both of these programs on pharmacotherapy and MTM are showing the futuristic
directions of evidence based pharmacy practice in India. 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]
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
Letter to Editor: The all new IDIS 4.0 Drug Database
Dear Editor, Greetings from The University of Iowa in Iowa City. I hope you have been having a good year in 2012. It is hard to believe that it has been more than a year since we worked together to publish the article on ‘drug information for evidence-based practice’ in the RIPER PDIC Bulletin. I continue to look forward to each monthly edition of the Bulletin and thank you for sending it to me. As you may know this past summer we launched a new version of our web-based service. It is now IDIS 4.0 Drug Database. More information about the new features, including video demonstrations is available from our website http://www.uiowa.edu/idis/succeed/. I am confident the new version has many advantages that are useful for pharmacy education, research and pharmacy services in India. We have also added more information to our website to assist faculty in teaching students to use the service http://www.uiowa.edu/idis/trainingtools.htm. Our database of drug information questions and answers, IDIN Answers, and the clinical case-study database, IowaTeach, are also available in the new IDIS 4.0 Drug Database. On a second matter, I would like to introduce to you, Mr. Sandeep Kumar, and Mr. Ujjwal Deo Kaushik, who are assisting us with communication about our services to reach more colleges of pharmacy in India. Contact information for each of them is below. Mr. Kumar has
excellent experience in India working with marketing and sales for pharmaceutical and health care services companies. Mr. Kaushik has a B. Pharm from Rajiv Gandhi University of Health Sciences (RGUHS) in Bangalore and also has sales and business development experience with the pharmaceutical sector in India. We are very pleased to have them on our team. They are planning to make as many personal visits to colleges as possible and we are considering placing an advertising notice in one or more of the professional journals or newsletters in India. I look forward to continuing to provide drug information to you and your University. With warm regards, Sincerely Yours, Kevin G Moores, PharmD, Associate Professor (Clinical) & Director, Division of Drug Information Service, College of Pharmacy, The University of Iowa, USA. Email: [email protected] Sandeep Kumar, Manager – India Sales Iowa Drug Information Service, c/o Softona Technologies Pvt. Ltd., B-213 Pacific Business Park, Plot-37, Site-IV, Sahibabad Industrial Area, Ghaziabad, Uttar Pradesh, India, Phone: 91-99109-93374, Email: [email protected] And Ujjawal Deo Kaushik, Sales Representative – India (same as above), Phone: 91-99109-93374, Email: [email protected]
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
Pharmacy representation in NIPER board and AICTE pharmacy board
RN Gupta Vice-President & Chairman Hospital Pharmacy Division, Indian Pharmaceutical Association & Professor, Department of Pharmaceutical Sciences, Birla Institute of Technology, Mesra
On going through the constitution of National Institute of Pharmaceutical Education and Research (NIPER) Board and All India Council for Technical Education (AICTE) - Pharmacy Board, it has been noticed that there is no representative of Indian Pharmaceutical Association in both Boards. There are 21 members in NIPER Board from different sectors including one each from Indian Drug Manufacturers’ Association (IDMA) and Organization of Pharmaceutical Producers of India (OPPI). Similarly in AICTE Pharmacy Board there are 15 members from different sectors including one representative of Hospital Pharmacists and one from Medical Council of India but not from Pharmacy Council of India (PCI). It was surprising to see that PCI, which also control pharmacy education in our country do not have a place in the pharmacy boards mentioned. It is again painfully observed that the representative pharmaceutical association of the country, the Indian Pharmaceutical Association (IPA) was not being provided due recognition in national boards. Indian Pharmaceutical Association is 74 years old premier pharmacy association of India representing all sections of the profession i.e. education, regulatory affairs, industry, research, hospital and community, having about 14000 members
throughout India at present. Further the final shape of NIPER was approved for setting up at Mohali by the Prime Minister of India in the year 1985 was after a strong persuasion by the then President of IPA, Dr. Parvinder Singh. And it is surprising that there is no member from IPA in NIPER Board. It is remarkable to note that the provision was made for representation of one nominee from IPA in Drug Technical Advisory Board (DTAB) in Drugs and Cosmetics Act 1940 after considering the role and importance of IPA by Government during that time in the year 1940. After that involvement the activities, professional role and membership of IPA have been increased much more. In view of above through this column, I would appeal our Union Minister of Chemical and Fertiliser, Govt. of India to direct the concerned Dept. of Pharmaceuticals to include President of IPA as ex-Officio member in Board of NIPER. Further I would appeal to Chairman, AICTE to include President of IPA as ex-Officio member in Pharmacy Board of AICTE to make it complete in all sense covering due representation in it.
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
Alex Flannery PGY1 – Pharmacy Practice Resident, Medical University of South Carolina, USA In February 2012, the American College of Chest Physicians (ACCP) released the Antithrombotic Therapy and Prevention of Thrombosis, 9th edition (AT9): American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.1 These guidelines serve as the authoritative reference for anticoagulation therapy in today’s practice. There are a number of important updates for the practicing clinician. While it is not feasible to cover all of the updates from such a complete guideline, Table 1 (after references) lists select updates from AT9, while the remainder of this article provides additional details. The newest version of the guidelines considers literature regarding patient-centered outcomes, which helps to explain some of the new recommendations and their evidence rating. Table 2 describes the evidence grading scale used by AT9. Readers are encouraged to view the full guidelines (http://chestjournal.chestpubs.org/content/141/2_suppl) for a comprehensive listing of recommendations and supporting evidence for the new guidelines. One of the most important changes that authors of the guidelines have stressed is a change in the appraisal and grading of evidence. As a result of a much more stringent process, AT9 contains far fewer 1A recommendations than the previous edition.1,2 A number of recommendations from the 8th edition had a drop in level of evidence rating, while a number of new recommendations are made in AT9 with a low level of evidence rating. As one
extreme example, in the previous version of the guidelines, aspirin was given a 1A recommendation against its use in any patient population for prophylaxis of venous thromboembolism (VTE). In the newest version, aspirin now carries a 1B recommendation for use as prophylaxis of VTE in certain orthopedic surgery patients.1,2 For readers already with a copy of AT9, the new recommendations, or those that have been changed since the 8th edition, are shaded in the text. A section on diagnosing VTE is new to the guidelines, providing readers with a framework for ordering and interpreting studies to make the diagnosis of VTE.1 The loading dose of warfarin (Coumadin®) recommendation was designed to allow patients to potentially reach a therapeutic international normalized ratio (INR) more quickly; however, note the wording of the recommendation: “for patients sufficiently healthy to be treated as outpatients.”1 Clinical decision making will dictate which patients are stable enough to receive loading doses while hospitalized. For those patients stabilized on warfarin with consistent INRs in goal range, the guidelines offer the suggestion of monitoring up to every 12 weeks versus every 4 weeks. For motivated patients, the guidelines also offer a recommendation for self-testing. These new guidelines also introduce dosing advice and management for a single out-of-range INR.1 AT9 does contain updated recommendations regarding the use of vitamin K in supratherapeutic INRs. For warfarin-associated bleeding, AT9 also
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
carries stronger recommendations for use of prothrombin complex concentrates (PCCs) than in the previous version.1 Some of the newer anticoagulants appear in the guidelines as recommended treatment options for VTE prophylaxis in orthopedic procedures. Newer data on some of these agents were not included in the guidelines due to the timing of their release; for some agents such as rivaroxaban (Xarelto®), this is the only section that mentions the agent. In terms of other newer agents, ticagrelor (Brilinta™) and prasugrel (Effient®) also are included in this edition of the guidelines as treatment options following acute coronary syndrome (ACS).1 The new guidelines suggest enoxaparin (Lovenox®) or fondaparinux (Arixtra®) over unfractionated heparin (UFH) for treatment of acute deep vein thrombosis or pulmonary embolism. Of note, the guidelines suggest once- over twice-daily dosing with the low molecular weight heparins (LMWHs).** An important caveat is that this recommendation only applies when the approved once-daily dose uses the same total daily dose as the twice-daily regimen. Hence, this recommendation regarding once- versus twice- daily essentially only applies to dalteparin (Fragmin®), not enoxaparin. The guidelines do not specifically recommend 2 mg/kg of enoxaparin once daily, nor do they claim the superiority of enoxaparin 1.5 mg/kg daily over 1 mg/kg twice daily.1 The guidelines also include major changes on the management of an isolated distal deep vein thrombosis (DVT) finding on whole-leg ultrasound. Whereas previous guidelines recommended 3 months of anticoagulation, AT9 recommends serial
imaging of the deep veins for 2 weeks as opposed to anticoagulation for those patients without severe symptoms or risk factors for extension.†† However, for those patients with an isolated distal DVT and severe symptoms or risk factors for extension, the guidelines suggest initial anticoagulation over serial imaging.1 With regard to atrial fibrillation, AT9 suggests a lower threshold for considering warfarin over aspirin now with a CHADS2 score of 1. In addition, a major change is that dabigatran has replaced warfarin as the suggested agent in atrial fibrillation. The guidelines continue to point out that there is no recommended antidote to dabigatran in the case of a serious bleed. AT9 also includes a number of tables and algorithms that readers are encouraged to seek out, including medications to avoid while on warfarin, diagnostic algorithms for VTE, and other clinically relevant decision-making tools. While AT9 continues to be the authoritative reference for matters concerning anticoagulation, readers are encouraged to consider patient-specific factors (e.g., risk versus benefit, cost, adherence), in addition to the new recommendations from AT9, when designing an anticoagulation plan for patients. References 1. Guyatt GH, Akl EA, Crowther M, et al.
Executive summary: antithrombotic therapy and prevention of thrombosis, 9thed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012 Feb;141(2 Suppl):7S-47S.
2. Hirsh J, Guyatt G, Albers GW, et al. Executive summary: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008 Jun;133(6 Suppl):71S-109S.
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
New Recommendations from AT9 (with level of evidence)1
Loading Dose for Warfarin Therapy
For patients beginning warfarin, the old guidelines suggested starting
with doses of 5 to 10 mg for 1 to 2 days then adjusting the dose based
on the INR (2C)
For patients sufficiently healthy to be treated as outpatients, the guidelines suggest initiating warfarin 10 mg daily for 2 days, followed by
dosing based on INR as opposed to starting with the patient’s estimated maintenance dose (2C)
Monitoring Frequency of
Warfarin
For those patients with consistently stable INRs, the old guidelines
suggested monitoring at least every 4 weeks (2C)
For those patients with consistently stable INRs, the guidelines suggest an INR testing frequency of up to every 12 weeks as opposed to every 4
weeks (2B) Single INR Out-
of-Range
No specific recommendations on single INR out-of-range
For those patients with consistently stable INRs with a single recorded INR ≤ 0.5 above or below therapeutic, the guidelines suggest continuing
the current dose and testing the INR in 1-2 weeks (2C)
Patient Self-Testing
For those patients self-trained, self-testing may be an alternative treatment model and may be
implemented where suitable (2B)
For those patients who are sufficiently motivated and can demonstrate competence
with the self-testing equipment, the guidelines suggest patient self-management rather than
usual outpatient INR monitoring (2B) Vitamin K for
Patients Taking Warfarin with Elevated INRs
without bleeding
INR in the range ≥ 5 but < 9 with no evidence of
bleeding: the old guidelines suggested 1 mg to 2.5 mg of
vitamin K orally as an alternative to omitting the
next 1 or 2 doses (2A) INR > 9 with no evidence of
bleeding: the old guidelines suggested administering vitamin K 2.5 mg to 5 mg
orally (1B)
INR in the range of 4.5 to 10 with no evidence of bleeding: the guidelines
suggest against the routine use of vitamin K (2B)
INR > 10 with no evidence of bleeding: the guidelines suggest oral vitamin K be
administered (2C)
Treatment of Warfarin-Associated Bleeding
For those patients with major bleeding secondary to warfarin therapy, the old guidelines suggested rapid reversal of anticoagulation with fresh frozen plasma, PCC, or recombinant factor VIIa (1C)
For those patients with major bleeding secondary to warfarin therapy, the guidelines suggest rapid reversal of anticoagulation with four-factor PCC rather than with plasma (2C)
The guidelines also suggest the administration of IV vitamin K 5 mg to 10 mg as opposed to reversal with coagulation factors alone (2C)
VTE Prophylaxis in Low Risk
Patients
No specific recommendations for medicine patients
For acutely ill hospitalized medical patients at low risk of experiencing a VTE, the guidelines
recommend against the use of pharmacological or mechanical prophylaxis (1B)
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
Table.1 (continued). Key Updates from the CHEST Guidelines Prevention of VTE in Orthopedic Surgery Patients Undergoing Total Hip or Knee Arthroplasty
In patients undergoing hip or knee replacement, the old guidelines recommended to use LMWH, fondaparinux, or warfarin (1A), with a recommendation to avoid aspirin or low-dose UFH (1A)
In patients undergoing the listed orthopedic surgeries, the guidelines suggest the use of LMWH, fondaparinux, apixaban, dabigatran, rivaroxaban, low-dose UFH, warfarin, aspirin (all grade 1B), or an intermittent pneumatic compression device (1C) for prevention of VTE
Dosing of LMWH No specific recommendations made on preference of once- versus twice-daily dosing
For those patients treated with therapeutic doses of LMWH, the guidelines suggest once- over twice-daily dosing (2C)**
Management of Isolated Distal DVT on Whole-leg Ultrasound
For those patients with a first isolated distal DVT that is unprovoked, the old guidelines recommended 3 months of anticoagulation (2B)
For those patients with isolated distal DVT detected on whole-leg ultrasound, the guidelines suggest serial testing to rule out proximal extension over treatment (2C)††
Atrial Fibrillation and CHADS2 Score of 1
For those patients with atrial fibrillation and a CHADS2 score of 1, the old guidelines recommended antithrombotic therapy with warfarin (1A) or aspirin dosed at 75 mg to 325 mg daily (1B)
For those patients with atrial fibrillation and a CHADS2 score of 1, the guidelines suggest oral anticoagulation rather than aspirin (2B)
Anticoagulation in Atrial Fibrillation
No specific recommendations regarding newer anticoagulants
For those patients in whom anticoagulation is indicated for stroke prevention in atrial fibrillation, the guidelines suggest dabigatran 150 mg BID over dose-adjusted warfarin (2B)
Primary Prevention of Cardiovascular Disease
Previous guideline recommendations for aspirin therapy as primary prevention were for those patients with a 10-year risk of a cardiac event > 10% (2A)
For those patients age 50 years or older without symptomatic cardiovascular disease, the guidelines suggest aspirin 75 mg to 100 mg daily (2B)
**††See text for important clarifications; INR = International Normalized Ratio FFP = fresh frozen plasma PCC = prothrombin complex concentrate VTE = venous thromboembolism LMWH = low molecular weight heparin UFH = unfractionated heparin DVT = deep vein thrombosis CHADS2 = congestive heart failure, hypertension, age greater than 75, diabetes mellitus, and prior stroke or transient ischemic attack
Are drugs safe? Critical thinking, analysis, prevention and management strategies
Pharmacovigilance- Current trends and future perspectives
Tarun Wadhwa Assistant Professor, Department of Pharmacy Practice, KLEU’s College of Pharmacy, Belgaum, Karnataka ‘Drug use could lead to better outcome’ is accepted by all but favorable outcome is not the only one seen with increased number of problems like irrationality, resistance, medication errors and lack of root cause analysis.1 The other side of the story is the adverse outcomes. The delayed reflexes were picked up way back in 1960s with Thalidomide tragedy and then origin of international drug monitoring activities in 1968 making it mandate for manufacturers, stake holders, regulators, drug authorities and healthcare professionals to vigilantly monitor drug use.2
Regulations for drugs are proposed by authorities but execution delay interrupted the whole network. Pharmacovigilance network is well sustained in developed countries but still on its way to progress in developing countries. With increased number of New Chemical Entities (NCE), pharmacovigilance has become mandatory requirement for pharmaceutical companies.3 With this view, phase-IV studies are critically analyzed and executed with the aim to monitor and capture long term safety outcomes and report ongoing safety review to regulatory authorities in terms of Periodic Safety Update Reports (PSUR). It also insists manufacturers to update safety information in product leaflet or summary of product characteristics (SPC) within stipulated time period.4
Regulatory authorities are concerned about drug safety and implementing risk minimization plan to:5,6
improve patient outcome prevent drug associated injury or
hazard minimize health care associated
cost especially cost attributed to Adverse Drug Reactions (ADRs)
create awareness among consumers, healthcare professionals, stake holders, third party payers and Managed Care Organizations (MCOs)
frame prevention strategies for highly vulnerable population
plan management strategies for effective care
disseminate safety information via communication network
develop guidelines for effective management of drug safety issues
execution and implementation of well framed guidelines based on recent information and ongoing safety review.
Regulatory authorities are constantly working to promote effective management strategies and risk minimization plan. Some of the responsibilities delegated to triage as follows:
I. Health care professionals 1. Vigilant monitoring of ADRs 2. Spontaneous reporting of ADRs 3. Root cause analysis 4. Signal detection and alert
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
5. Rational drug utilization 6. Publications and communication
network
II. Stake holders 1. Establishment of strong
pharmacovigilance network 2. Directions and regulations for
effective drug utilization
3. Encourage vigilant monitoring and efficient reporting
III. Consumers 1. Awareness of drugs 2. Self monitoring 3. Voluntary reporting
Good Reporting Practices (GRP) could improve the quality of ADR reports and also minimize the subsequent occurrence of ADRs.7,8 ADRs once notified should be subjected to analysis to establish causality. For analysis of ADR, standard scales are used to assess causality, severity and preventability aspects. Clinical interpretation of ADRs is of clinical importance to attribute the causality link between drug and reaction. In many clinical situations causality link is difficult to establish due to contradictory information or lack of proper data. Certain parameters which must be included for analysis are previous history, demographics, date of onset of reaction, onset time, time temporal relationship, suspected drug, description of the reaction, de-challenge, re-challenge, management and outcome of the reaction.9 The scales commonly preferred for analysis are:
Causality analysis (WHO probability scale, Naranjo’s algorithm, French imputation method, European ABO method etc.)
Severity analysis (Hartwig et al. scale)
Preventability analysis (Modified Schumock and Thornton scale)
In order to improve the patient outcome, constant efforts are required to build up a strong pharmacovigilance network. In India, we do not have robust structure which could in turn compromise the safety and lead to adverse outcome.10,11 We still remember the Rofecoxib adverse outcome experiences.12
In developing countries like India, the pharmacovigilance programme was initiated by Central Drugs Standard Control Organization (CDSCO) in Nov 2004
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
under the aegis of ministry of health and family welfare based on the recommendations made in the WHO document entitled “Safety monitoring of medicinal products guidelines for setting up and running a pharmacovigilance centre” with the objective to monitor ADRs and report through hierarchy of pharmacovigilance network and disseminate the information with global health care community through WHO Uppsala monitoring centre. Under this program, 26 peripheral centers, 5 regional centers and 2 zonal centers were established. The National Pharmacovigilance Advisory Committee (NPAC) was constituted to assess the performance and recommend possible regulatory measures based on the data received from various centers.13 Due to lack of sufficient funding, the programme was discontinued. The new Pharmacovigilance Programme of India (PvPI) started in June 2010 with the aim to expand the existing structure and proactively report ADRs. The purpose of PvPI is to collect, collate and analyze data to recommend regulatory interventions and communicating risks to health care professionals and consumers. The National Coordinating Centre (NCC) i.e. Indian Pharmacopeia Commission, Ghaziabad will operate under the supervision of a Steering Committee which would consist of Drugs Controller General of India (DCGI), New Delhi as Chairman and other government officials as constituent members. The following program will be executed and monitored by Steering Committee and Strategic Advisory Committee. Technical support for the programme will be provided under different panels: Signal Review Panel, Core Training Panel and Quality Review Panel.14 The five year PvPI has been scheduled under following five phases:
1. Initiation phase (2010-11) 2. Expansion and consolidation phase
(2011-12) 3. Expansion and maintenance phase
(2012-13) 4. Expansion and optimization phase
(2013-14) 5. Excellence phase (2014-15)
As per proposed plan by phase four, there will be around 300 centers in the programme. ADR information will be entered in safety database ‘Vigiflow’ programmed by WHO-Uppsala Monitoring Centre. The performance of individual centre will be continuously monitored and evaluated based on quality parameters and indicators.14
Prevention strategies: ADRs could be prevented through:
Intensive monitoring and timely reporting of ADRs
Prophylactic treatment for known reactions
ADR database for safety information and history of known allergy
Patient education Dissemination of safety
information Management strategies: Adverse drug reactions could be effectively managed by:
Strong build up of causality link De-challenge (discontinuation) of
drug therapy Re-challenge (reintroduction) of
drug therapy (if necessary) Definitive therapy in case of
certain or probable reactions Intensive monitoring and reporting
of ADRs Follow-up plan for patients who
experienced ADRs
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
Strategies to enhance ADR reporting: The following strategies could be adopted to enhance ADR reporting:
create ADR reporting culture awareness about monitoring and
reporting of ADRs sensitize healthcare professionals
for enhancing ADR reporting training sessions on ADRs15 ADR reminders ADR reporting aids such as ADR
drop box, ADR posters, ADR newsletter, fax and web reporting
Periodic meeting ADR scientific newsletters Appreciation to reporter
Pharmacovigilance network will be expanded further to cover broader region. There is a need for proactive monitoring and reporting. Quality control system should be installed to constantly monitor the quality of ADR reports generated and authenticate the channel of network. Adoption of Good Pharmacovigilance Practices (GPP) could create good reporting environment for healthcare professionals. Drug utilization may improve with strapping evidence based clinical practice and could lead to better patient outcomes.16
References
1. Bencheikh RS, Benabdallah G. Medication errors: pharmacovigilance centres in detection and prevention. Br J Clin Pharmacol 2009;67(6):687-690.
2. Pirmohamed M, Atuah KN, Dodoo AN, Winstanley P. Pharmacovigilance in developing countries- requires collaboration between stakeholders to develop novel models of funding. BMJ 2007;335:462.
3. Vallano A, Cereza G, Pedros C et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005;60(6):653-658.
4. Arora D. Pharmacovigilance obligations of the pharmaceutical companies in India. Indian J Pharmacol 2008 Feb;40:S13-S16.
5. Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol 2003;57(2):127-134.
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RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
Pharmacy Practice Module: Advanced Learning Series – III
Mohanraj Rathinavelu Asst. Professor, Dept of Pharmacy Practice, RIPER, Anantapur, AP The Pharmacy Council of India took the bold step of introducing Pharm.D program in 2008 in India. As the first group of pharmacy clinicians graduated we realized that consistent training is required in advancing the skills for the educators and students. To address this issue The Indian Association of Colleges of Pharmacy (IACP) has taken the initiative to launch an advanced learning series in improving the standard of education. IACP aims to provide ten such learning modules in three years with collaboration from its various stakeholders. The IACP, Chennai, and College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences (SRIPMS), Coimbatore jointly organized the module III from 11th December 2012 to 13th December 2012. This Trainers’ Training module for Pharm.D teachers and senior students was attended by more than 90 participants; at the College of Pharmacy, SRIPMS, Coimbatore with the topics:
Therapeutic Drug Monitoring (TDM) of cardiovascular medicines
Clinical Approach to the Cardiovascular Patients (HYPERTENSION & HEART FAILURE)
Medication Therapy Management (MTM) of cardiovascular medicines
The module was inaugurated with expert advice and words of wisdom from eminent scholars of pharmacy education
in India; Prof. Dr. K Chinnaswamy, President, IACP, Chennai, Dr. B Suresh, President, Pharmacy Council of India, New Delhi, Dr. Krishna Kumar, Professor, Howard University, USA, Dr. TK Ravi, Principal, College of Pharmacy, SRIPMS, Coimbatore and Dr. V Ravichandran, Director, School of Pharmaceutical Sciences, Vels University, Chennai. Day one of the sessions covered the areas of Therapeutic Drug Monitoring (TDM) of cardiovascular medications like digoxin and procainamide was addressed by Dr. Krishna Kumar. On day two, the principles of clinical approach to the cardiovascular patient and disease of heart, hypertension & heart failure was addressed by Dr. Jessica L Kerr, Associate Professor of Pharmacy Practice, School of Pharmacy, Southern Illinois University, Edwardsville (SIUE), USA. The final day of the module was MTM of cardiovascular medications, determining therapeutic goals & recommendations of optimal regimen for the treatment of cardiovascular diseases, hypertension, hyperlipidemia and Coronary Artery Disease (CAD) was addressed by Dr. Jingyang Fan, Clinical Associate Professor, Pharmacy Practice, School of Pharmacy, School of Pharmacy, SIUE, USA. The session was concluded with an address by Dr. S Sriram, Head of Department, Department of Pharmacy Practice, College of Pharmacy, SRIPMS, Coimbatore.
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
National conference on emerging trends in pharmaceutical sciences
The national conference on emerging trends in pharmaceutical sciences was conducted by Raghavendra Institute of Pharmaceutical Education and Research (RIPER) in its campus on December 22, 2012. The chief guest of the conference was Dr. K Govinda Rajulu, Director of Evaluation, Jawaharlal Nehru Technological University, Anantapur. In his message he pointed out that India has become a hub for education. The number of professional graduates produced in India is good but the challenge now is the quality. The scientific conferences with advanced knowledge will play an important role in standardization of education in India. Conferences also help in advancement of the professions. The conference was organized by the aegis of the Industry-Institute Interaction Cell of RIPER. Principal of RIPER, Dr. Y Padmanabha Reddy said “every institute shall have industry collaborations. It will help the students in understanding the trends in real competitive pharmaceutical world”. Morning session of the conference had the scientific sessions by the industrialists in Andhra Pradesh. Followed by poster and oral presentation in the noon time and the demo workshops on instruments and databases used in drug development and testing in afternoon session. Dr. R Sirish Kumar, CEO and Director, RAChem Pharma Ltd. Hyderabad spoke on career opportunities for pharmacy graduates. He warned the pharmacy graduates to think out of the box. He recollected that he was not clear what to
do when he was graduated in chemical engineering 25 years back. But he did realize later that he had his skills as a pharmaceutical industrialist. Eventually he did start an industry in 2003. He did discus on the number of pharmacy graduates passing each year. There are certain jobs which need specialized education but many of the other jobs are multi-disciplinary in nature for which qualification are not the primary criteria, but the competency to perform the duties are. He then discussed on various specialized jobs for pharmacists in pharmaceutical industry. And then he explained on other related industries where pharmacists could also deliver their duties. So the bottom line is that to think outside pharmaceutical. Dr. Y Ramalingeswar Rao, Managing Director, Vindhu Pharma Consultant, Hyderabad discussed on the emerging trends in the pharmaceutical field followed is a lengthy discussion with the participants. More than 400 delegates participated in the conference. Poster and oral presentation competitions were conducted to the delegates. The scientific demonstrations provided were analytical and pharmaceutical instrumentation and procedures, pharmacological screening procedures and drugs and poison information services. Mrs. M Geetha Vani was the organizing secretary of the conference. She conveyed the vote of thanks for all who supported and participated in the scientific event.
RIPER PDIC Bulletin (ISPOR India – Andhra Pradesh Chapter Newsletter)
Central Drugs Standard Control Organization (CDSCO) of India proposed important safety changes to the labeling for statins. The proposal was released on November 06, 2012 based on the USFDA news earlier this year. The key changes proposed were as follows; a removal of instruction for periodic monitoring of liver enzymes, addition of warnings on certain cognitive effects, addition of a warning of the risk of hyperglycemia and about drug interactions of lovastatin on its label.
Some of the baking ingredients such as cinnamon and nutmeg could be overused by children results in household poisoning including life-threatening conditions. Study reports from the Loyola University Health System's emergency department in USA revealed baking ingredient abusing behaviors in children. US poison information centers frequently receive call of poisoning with cinnamon and other baking ingredients. Playing in kitchen shall result in chocking and severe cough while trying to ingest the cooking ingredients.
USFDA warning on fatal rash by hepatitis drug telaprevir
Life threatening symptoms of skin rashes were observed in patients taking
telaprevir in combination with peginterferon alfa and ribavirin. FDA warns the patients to stop all the three medicines if they develop serious skin reactions. A boxed warning will be added to the drug label on the same. The manufacturer suggested that the possibility of this serious skin reaction is less than 1% and those patients could be treated by hospitalization and proper care. FDA encourages patients and health care professionals to report any related adverse events to the drug.
Draft safety considerations to product designs in reducing medication errors
The guideline is published in FDA website for inviting comments before finalizing. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov/ Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
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