Drug Information Bulletin

Drug Information Centre (DIC) Indian Pharmaceutical Association

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Volume: 06

Number: 45

17th February 2013

Content Pharmacists in India are getting greater role in Public Health Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration: Lancet Palliative Care Formulary-4th Edition (PCF4) of UK Now available MANUAL OF POLICIES AND PROCEDURES: Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act with effect from 12.02.2013 PMNCH comments on post-2015 UN goals Australian First: Using robotic patients in Virtual Clinical Placements makes for safer and more capable student pharmacists Mumbai project to adopt this model in their countries. As a result a joint statement by the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) on Engaging Pharmacists in TB care and control has been signed on 4th September 2011 during 71st FIP Congress at Hyderabad, India. Thereafter a memorandum of understanding has been signed between CTD of Govt. of India, Indian Pharmaceutical Association (IPA), All India Organization of Chemists and Druggists (AIOCD), SEARPharm Forum and Pharmacy Council of India (PCI) to set out the policy of engaging retail pharmacies (community pharmacies) in Revised National Tuberculosis Control Programme (RNTCP) on 27.04.2012. The present module is the outcome of this MOU.
Document is available at: http://www.tbcindia.nic.in/pdfs/MODULAR%20TRAININ G%20a.pdf

Pharmacists in India are getting greater role in Public Health Tomorrow Central TB Division, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is going to release Training of Master Trainers for Community Pharmacists Partnership with RNTCP at New Delhi. It will be released by Director General of Health Services, Govt. of India. The manual has been developed jointly by CTD, Govt. of India and Indian Pharmaceutical Association (IPA). It may be noted IPA is working in this field for the last one decade involving community Pharmacists and has shown tangible outcome. Initially this project started at Mumbai and thereafter it spread over some more states. This success has become a model to all stake holders in the world and representatives of different countries visited IPAs

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Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration: Lancet Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term effective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with efficient selection, procurement, and use of generic medicines. Furthermore, lowincome and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment offer useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off-patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent conflicts of interest need to be identified and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these

approaches can a difference be made to the lives of hundreds of millions of current and future patients with NCDs.
For details: http://www.thelancet.com/journals/lancet/article/PIIS0 140-6736%2812%2962128-X/fulltext

Palliative Care Formulary-4th Edition (PCF4) of UK Now available http://www.palliativedrugs.com/shop/boo ks.html The long-awaited fourth edition of our flagship publication Palliative Care Formulary (PCF) has been totally revised and updated by an expert editorial team. Along with meticulous revisions to each chapter, the UK PCF4 includes two completely new chapters, 16 new drug monographs, six new 'mini-monographs', and three more Quick Practice Guides. In all, PCF4 is almost 200 pages or 30% bigger than the previous edition. The PCF4 is not available through any other outlets. PCF is a comprehensive compendium containing a wealth of essential therapeutic information about drugs used in palliative and hospice care. With cumulative global sales of over 100,000 and the third edition highly commended by the British Medical Association book competition, PCF is the established resource in its field and receives worldwide acclaim. PCF is unparalleled in the range and depth of information it includes. It is an essential resource also for general practitioners, oncologists and other specialists who care for patients with advanced cancer or other progressive end-stage diseases.

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PCF provides the most authoritative and thorough guide to off-label indications or routes for drugs used in palliative care, and deals comprehensively with giving multiple drugs by continuous subcutaneous infusion. 'PCF [is] a core text for the specialty and has no serious rivals.' Palliative Medicine 'The information is up to date and prepared with extreme care. This handbook should be available to staff involved with inpatient consultation, inpatient units of care, and home visits.' Journal of Pain and Symptom Management. MANUAL OF POLICIES AND PROCEDURES: Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act with effect from 12.02.2013 This MAPP describes how the staff in the Office of Generic Drugs (OGD) should implement section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). On March 23, 2010, the President signed into law H.R. 3590, the Patient Protection and Affordable Care Act (the PPACA). Section 10609 of the PPACA added section 505(j)(10) to the FD&C Act. This section permits the Food and Drug Administration (FDA) to approve an abbreviated new drug application (ANDA) even if the approval coincides with certain changes to the labeling for the reference listed drug (RLD), as long as the ANDA applicant agrees to submit revised labeling corresponding to the RLD labeling changes within 60 days of notification of the change.

Reference: Office of Generic Pharmaceutical Science, USFDA

Drugs/Office

of

PMNCH comments on post-2015 UN goals

Call to Sign on PMNCH calls on Partners to sign its Statement on the Post 2015 framework Statement focuses children's health on women's and

13 FEBRUARY 2013 - The PMNCH is calling for the Post 2015 Framework to include a goal which will focus on the health of populations, positioning preventable deaths and morbidity, especially amongst women and children who are the most vulnerable. The Partnership for Maternal, Newborn & Child Health (PMNCH) has prepared a submission to the United Nations' Thematic Consultations process to establish sustainable development goals post-2015, which is the deadline for achieving the UN Millennium Development Goal (MDGs). The position paper reviews progress made in the improvement of womens and childrens health in light of the and recommends that the Post 2015 framework builds on the MDGs and places health, and particularly that of women and children at the center of sustainable development. The paper positions the need to adopt a rightsbased, equity-focused, gender- and health-sensitive approach to

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development. It argues health outcomes will only be improved by adopting a focus on health systems and a cross-sectoral approach that addresses social determinants of health. Executive summaries of this paper have been adapted for the non-health thematic groups and are available on the right.
For details: http://www.who.int/pmnch/media/press_materials/pr/2 013/20130213_post2015_framework/en/index.html

environment that allows the freedom to make mistakes and then learn from them so that they practice safely when they reach a clinical setting. Working with the simulation mannequins gives them an unprecedented degree of realism. Our students are placed in hospitals like Royal North Shore, Westmead Childrens, Prince of Wales and Wollongong so its a huge advantage to have this experience before dealing with patients and colleagues in these fast-paced clinical environments. Students experience simulated ward rounds and medication chart reviews in UTS new $5million simulated hospital facility. Daniel Nguyen, a Master of Pharmacy student, said that the workshops and simulations helped to increase his confidence ahead of his hospital clinical placement. It was a great experience the idea of working with patients in a hospital is a bit intimidating but I feel much more comfortable now having practiced on the robots. Having to make sure your clinical communication was right as well as practicing all the other skills at the same time was difficult at times but Ive got a good handle on it now and Im confident about going on placement. Students also benefited from the expertise of specialist pharmacists, attending workshops on drug administration led by Jane Luddington, a specialist hospital pharmacist at St Vincents Hospital and a practical workshop on blood sugar and anticoagulation point-of-care testing devices led by a specialist team from Roche Diagnostics.

Australian First: Using robotic patients in Virtual Clinical Placements makes for safer and more capable student pharmacists UTS Pharmacy has developed a cuttingedge Virtual Clinical Placement using clinical simulation mannequins or robotic patients for its Master of Pharmacy program. An Australian first, it allows students to interact with patients in real life acute and primary care scenarios in UTS state-of-the-art clinical education facilities and practice critical patient communication skills ahead of clinical placements in hospitals, specialist clinics, and industry. Run over two weeks, the sessions focus on consolidating the discreet skills learnt throughout the semester, mimicking the competencies required in a clinical environment. Associate Professor Beata Bajorek, who developed the Virtual Placement, says the sessions emphasise the reality of modern pharmacy workflow across the continuum of care and the diverse range of interactions with patients. The virtual placement gives our students an opportunity to develop complex technical and communication skills across transitions of care. Theyre gaining experience in a safe and supported

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