MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'guidance'. Sat, 03 Sep 2011 02:12:18 +0100 http://www.medworm.com/index.php?rid=5057722&cid=t_167186_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-new-details-about-the-fda-regulation-of-mhealth-apps%2F2011.07.23 Since the beginning of this year, there have been clues that the FDA will be heading toward clarification of the complex regulatory issues posed by mobile health devices and software. We have previously reported on testimony and public comments by Dr. Jeffrey Shuren, director of the  FDA’s Center for Devices and Radiological Health (CDRH) alluding to coming guidelines. Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software. This is what the Emergo group, regulatory compliance consultants, has gleaned from today’s FDA press release: (more…) *This blog post was originally published at iMedicalApps* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=5057722 Sat, 23 Jul 2011 16:00:04 +0100 5057722 http://www.medworm.com/index.php?rid=5140265&cid=t_167186_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FFEgcP17onvg%2Fdraft-guidance-released-for-medical.html While Pharma is still waiting on DDMAC to release guidelines on what should and shouldn't be done in social media marketing, the FDA has released guidance on medical mobile apps. It primarily focuses on augmented regulated medical devices and turning mobile devices into medical devices. The goal of the guidance is to protect patient information and addresses the functionality of the devices. According to MM&M, guidance is missing on medical books turned into digital formats. "The use of mobile medical apps on smart phones and tablets is revolutionizing healthcare delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, in a statement. "Our draft approach calls for oversight of only those mobile medical apps that present the greates... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=5140265 Wed, 20 Jul 2011 18:32:00 +0100 5140265 http://www.medworm.com/index.php?rid=4945129&cid=t_167186_147_f&fid=39266&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCreationInteractive%2F%7E3%2FtfIIu6iuEZE%2F No one wants to be wrong; ever. As much as there are trendy business mantras such as ‘Fail Fast’ which apparently encourage failure (as long as you learn quickly), it somehow just doesn’t translate to the world of a pharmaceutical company. In fact, ‘fail-fast’ is really an engineering concept that is most often considered in a research and development phase, long before a product reaches the general public where it might affect reputation. To be fair, any kind of ‘failure’ in the world of pharmaceutical companies can potentially result in a significant loss in some form or another which could include shareholder value, customer confidence, or general credibility, not to mention individual careers. Consequently, we are risk-averse. Rightly so. As much as no individual wants to... Creation Interactive blogs http://www.medworm.com/rss/comments.php?id=4945129 Fri, 17 Jun 2011 17:00:35 +0100 4945129 http://www.medworm.com/index.php?rid=4934334&cid=t_167186_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F14%2Flearning-how-to-die-the-handbook-for-mortals%2F In any bookstore, you will find aisles and aisles of self-help books coaching us how to live more fully, how to embrace life with passion, and how to age in a way that we aren’t getting older! But how to die? Are you kidding me? DEPRESSING! But we desperately need a teacher in this area. Because each of us is eventually going to perish, and how nice it would be to have a few guidelines as we are getting close. In their book, Handbook for Mortals: Guidance for People Facing Serious Illness, authors Joanne Lynn, MD, Joan Harrold, MD, and Janice Lynch Schuster, MFA discuss the topic of dying from several perspectives: living with serious illness, helping families make wise decisions, getting the help you need, controlling pain, planning ahead, and enduring loss. It is a comprehensive and in... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4934334 Tue, 14 Jun 2011 19:12:29 +0100 4934334 http://www.medworm.com/index.php?rid=4893910&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F06%2Ffirst-fda-social-media-guidance-to.html Yesterday, my post "FDA Drops Social Media from Its 2011 Guidance Agenda" (here) created quite a stir on Twitter. We had a good discussion of this on last nights #socpharm chat.All the hubbub revolved around the fact that FDA's 2011 guidance agenda did NOT include "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda. What IS included in the 2011 agenda, however, is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet."I didn't understand what "Responding to Unsolicited Requests" had to do with social media and technically, FDA's 2011 guidance agenda does NOT mention social media, hence the title of my blog post.Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC, ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4893910 Thu, 02 Jun 2011 14:07:00 +0100 4893910 http://www.medworm.com/index.php?rid=4762932&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F04%2Ffdas-proposed-web-study-will-further.html FDA has published in the Federal Register (click here) a series of proposed studies designed to test different ways of presenting prescription drug risk and benefit information on branded drug Web sites. This is BAD news for all us who have been waiting since November 2009 for the FDA to issues specific guidelines for use of the Internet and social media in promoting Rx drugs.In its proposal (find my highlighted, annotated pdf version here), the FDA states:"This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, a... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4762932 Thu, 28 Apr 2011 12:36:00 +0100 4762932 http://www.medworm.com/index.php?rid=4714689&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2011%2F04%2F15%2Fintroducing-solid-foods-giving-your-baby-a-better-start-in-life%2F Title: Introducing Solid Foods: Giving your baby a better start in life Skinny: ‘Start4Life is an initiative to help you give your baby a healthier start in life.’  This colourful booklet provides parents with some guidance on how and when to introduce babies to solid food. The booklet contains advice on things to look out for regarding healthy diets for toddlers, hygiene allergies and avoiding choking hazards. There are telephone numbers and website addresses for breastfeeding awareness and Staft4Life. Publisher: NHS Start4Life Size of Publication: 20p. Published: 05 April 2011 Filed under: Breast Feeding, Diet, Infants, Parenting, Public Health Guidance Tagged: Breastfeeding, Food, Food Hygiene, Guidance, Health Promotion, Healthy lifestyles, Infants (Source: Fade Library... Fade Library blogs http://www.medworm.com/rss/comments.php?id=4714689 Fri, 15 Apr 2011 11:25:49 +0100 4714689 http://www.medworm.com/index.php?rid=4714690&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2011%2F04%2F15%2Fsunbeds-regulation-act-2010-guidance-on-the-implementation-of-the-sunbeds-regulation-act-2010%2F Title: Sunbeds (Regulation) Act 2010: Guidance on the implementation of the Sunbeds (Regulation) Act 2010 Skinny: Guidence report for local authorities to support enforcement of the Sunbeds (Regulation) Act 2010 The purpose of this guidance is to support local authority authorised officers in successfully implementing the Sunbeds (Regulation) Act 2010 (the Act), which comes into force on 8 April 2011. The main purpose of the Act is to prevent the use of sunbeds on commercial business premises by children and young people under the age of 18. The Act also contains powers for further regulation. The Welsh Assembly Government intends to introduce the Sunbeds (Regulation) Act 2010 (Wales) Regulations 2011 in October 2011 to further regulate sunbed businesses in Wales. At this time, the Secreta... Fade Library blogs http://www.medworm.com/rss/comments.php?id=4714690 Fri, 15 Apr 2011 10:45:58 +0100 4714690 http://www.medworm.com/index.php?rid=4709424&cid=t_167186_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpR8BdZuodiU%2F Hello, everyone, and nice to see you again. A spot of rain is falling on the Pharmalot corporate campus, but as you know, our spirits are as sunny as ever and reinforced by a bit of wisdom from the Morning Mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So while we down our cup of stimulation, we present the news of the world in hopes this will help you cope with those meetings and deadlines. Have a great day and give someone a big smile… BioSante Says FDA Accepts Filing For Male Testerone Gel (Reuters) Merck To Outsource Work Done At Pennsylvania Plant (The Daily Item) Novartis Drug Wins FDA Panel OK For Rare Pancreatic Tumors (Bloomberg News) Pfizer Drug Wins FDA Committee Backing For Pancreatic Cancer (Bloomberg News) Roche’s Xenical Diet P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4709424 Wed, 13 Apr 2011 12:12:07 +0100 4709424 http://www.medworm.com/index.php?rid=4709388&cid=t_167186_147_f&fid=39266&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCreationInteractive%2F%7E3%2Flg0-QX0iXwY%2F It was ironically only a couple of weeks ago that Creation Healthcare published a piece about “Healthcare engagement in the absence of regulatory guidance”. In that article, I made the point that “specific social media guidance cannot keep pace with change”, and more importantly that when using 3rd party engagement platforms like Facebook, Flickr or Twitter, a pharmaceutical company needs to ‘plan for change’. In what I perceive as a positive step, the PMCPA recently issued guidance on ‘Digital Communications’. I was pleasantly surprised to see a certain level of clarity and an attempt to be non-technology specific. I still felt that in some cases it was too specific, which I will explain as you read on. Even so, the inevitable ‘What does it mean for me?’ has me once ag... Creation Interactive blogs http://www.medworm.com/rss/comments.php?id=4709388 Wed, 13 Apr 2011 11:56:35 +0100 4709388 http://www.medworm.com/index.php?rid=4684754&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F04%2Fbrits-beat-fda-phrma-issue-social-media.html The Brits have won the race to issue social media guidance for the drug industry! (OK, it's NOT a race. Still, everyone says the EU regulators FOLLOW FDA's lead. Here's a case where the horse is following the cart!)The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), just published "informal guidance" providing the drug industry advice on how to use online communications.You can access the PMCPA "informal guidance" here.While the US FDA (PhRMA too!) twiddles and delays, the British PMCPA tweets and delivers!Most of the advice, however, is merely to follow the existing ABPI Code of Practice, which "applies irrespective of the method of communication." NOTE: In contrast to the ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4684754 Tue, 05 Apr 2011 12:38:00 +0100 4684754 http://www.medworm.com/index.php?rid=4658623&cid=t_167186_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYFV1oMxRUvM%2F The moment you have all been waiting for has been delayed… again. For the second time in four months, the FDA has apparently postponed plans to issue widely anticipated guidance on social media. The guidance was initially expected last December and then rescheduled for release in the first quarter of this year, which was presumably to have occurred this month (back story). Now, though, the FDA is delaying again, according to (PR Week). We asked the FDA last night for some clarity about timing and received this response: “It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or ‘Good Guidance Practices’ (GGPs), which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA�... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658623 Wed, 30 Mar 2011 13:09:59 +0100 4658623 http://www.medworm.com/index.php?rid=4627008&cid=t_167186_147_f&fid=39266&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCreationInteractive%2F%7E3%2FDVC6nmv3B08%2F In early March 2011, at a pharmaceutical marketing conference in Munich, Heather Simmonds of the PMCPA gave very much the same perspective on UK and European regulatory guidelines that she has for the past few years. There were some murmurings amongst the crowd from those who had heard it all before. Refreshingly, at the same conference, Ray Chepesiuk of Canada’s Pharmaceutical Advertising Advisory Board presented a somewhat enlightened and progressive approach to emerging channels such as social media and forums – explaining how his organization established guidance on two-way engagement dating back to 2005. Having attended and presented at many pharmaceutical marketing conferences throughout Europe, Asia, and the United States (see where we’ll be in the coming months here), Cre... Creation Interactive blogs http://www.medworm.com/rss/comments.php?id=4627008 Wed, 23 Mar 2011 16:50:17 +0100 4627008 http://www.medworm.com/index.php?rid=4600791&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F03%2Ffda-promises-still-more-guidance-this.html "The Food & Drug Administration is planning to release guidance for mobile medical applications in 2011, according to Center for Devices and Radiological Health director Dr. Jeffrey Shuren." That was reported in this story relaying comments made at a "town hall meeting" held March 10 in Irving, Texas.I don't know nearly as much about Dr. Jeffrey Shuren as I do about Tom Abrams, his counterpart in FDA's DDMAC. But if he's making more promises that the FDA hasn't the ability to keep, then I urge that he resign along with Tom Abrams (see "Is It Time for Abrams to Leave?").As you probably know, DDMAC first "promised" that it would issue social media guidance for pharmaceutical promotion by the end of 2010. When they missed that date, Abrams "promised" it would be done by the end of Q1... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4600791 Wed, 16 Mar 2011 15:01:00 +0100 4600791 http://www.medworm.com/index.php?rid=4592395&cid=t_167186_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fa-social-media-guide-for-researchers%2F2011.03.15 I’ve recently come across a great guide about using social media in science. I cover this issue in my university course, Internet in Medicine, and I’ll definitely update my materials with these suggestions. From the Research Information Network: This guide has been produced by the [University of Derby] International Centre for Guidance Studies (iCeGS), and aims to provide the information needed to make an informed decision about using social media and select from the vast range of tools that are available. One of the most important things that researchers do is to find, use and disseminate information, and social media offers a range of tools which can facilitate this. The guide discusses the use of social media for research and academic purposes and will not be examining the many... Better Health blogs http://www.medworm.com/rss/comments.php?id=4592395 Tue, 15 Mar 2011 16:00:09 +0100 4592395 http://www.medworm.com/index.php?rid=4411700&cid=t_167186_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F28%2Fnice-updates-six-year-old-guidance-on-chronic-anxiety%2F 26th January 2011 Guidance on managing generalised anxiety disorder (GAD) in adults is being updated for the first time since 2004. GAD is a common condition with chronic, excessive worry about a number of different events associated with heightened tension. It can vary in its severity and complexity for each person. The National Institute for [...] (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4411700 Fri, 28 Jan 2011 18:59:31 +0100 4411700 http://www.medworm.com/index.php?rid=4394743&cid=t_167186_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDx7aLJbiiWw%2F After years of delay and anticipation, the FDA has finally issued a guidance on process validation, a chewy term that refers to being able to verify that one knows how to make a prescription drug and can back up the assertion with full-blown documentation detailing methodology and the like. For many, this is behind-the-scenes stuff, but the guidance is crucial for the countless number of people who are caught up in the nitty gritty world of manufacturing and related activities. In part, that’s because the FDA took so long to issue the guidance, creating a vacuum of uncertainty about requirements and a cash cow for consultants who attempted to step into the breach. As one source noted: “After years of effort, the draft came out in November 2008. Industry has been waiting and ru... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4394743 Tue, 25 Jan 2011 14:59:53 +0100 4394743 http://www.medworm.com/index.php?rid=4318544&cid=t_167186_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvdhD1CZE9KE%2F There is nothing like a Byzantine agency - or one that appears so - to create confusion, even among those who toil in its confines. And so the FDA, besieged by nearly all quarters to do everything better, faster and smarter - has just issued a checklist of steps to be taken to improve its performance, help everyone figure out what the agency does and how to find that information. To wit, the FDA has just released 19 steps to be taken in the quest for the ‘T’ word - transparency. Toward that end, the agency actually released the list more than an hour before a media briefing, so there is a little time to digest these moves. Basically, the FDA aims for better communication with industry and importers, which includes revamping its website, and improving outreach and interactions w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4318544 Thu, 06 Jan 2011 17:24:45 +0100 4318544 http://www.medworm.com/index.php?rid=4272599&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F12%2Fim-interviewed-about-pharma-social.html About 2.30 minutes into this 8-minute Marketplace Morning Report is a short piece about pharma's use of social media for promoting drugs. I am quoted in the piece. Essentially, it's the same quote/sound bite that TIME used about pharma being "marginalized" if they do not figure out how to participate in social media discussions (see "Pharma is "Cleverly Navigating" the Social Media Space Says TIME Magazine").My segment is preceded by an ad for Novo Nordisk, "since 1923 innovative developer of diabetes treatments and delivery devices." It's interesting that Novo Nordisk is a sponsor of this MarketPlace segment because its Race with Insulin campaign was also featured in the TIME magazine story, which called its twitter social media campaign "provocative."Both stories are ambivalent regarding... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4272599 Mon, 20 Dec 2010 13:56:00 +0100 4272599 http://www.medworm.com/index.php?rid=3644717&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2010%2F06%2F08%2Fimplementation-of-the-right-to-access-services-in-the-maximum-waiting-times-guidance-to-strategic-health-authorities-primary-care-trusts-and-providers%2F Title: Implementation of the right to access services within maximum waiting times. Guidance for strategic health authorities, primary care trusts and providers Skinny: Guidance on implementing the new patient rights to access services within maximum waiting times (18 weeks for non-urgent consultant-led elective care, and 2 weeks for urgent cancer referrals, from GP referral). Publisher: DH Size of Publication: 22p. Published: 07/06/10 Filed under: Grey Literature, NHS, Quality Tagged: Grey Literature, Guidance, NHS, Quality, Waiting Times (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=3644717 Tue, 08 Jun 2010 20:48:26 +0100 3644717 http://www.medworm.com/index.php?rid=3581555&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2010%2F05%2F20%2Fa-framework-for-staff-engagement-an-introduction-to-staff-engagement-in-the-nhs-and-guidance-on-starting-staff-engagement-policy%2F Title: A Framework for Staff Engagement: An introduction to staff engagement in the NHS and guidance on starting staff engagement policy Skinny: Presentation giving an introduction to staff engagement in the NHS and guidance on starting staff engagement policy with the aim of ensuring: increased commitment, a belief in their organisation, a desire to work to make things better, suggesting improvements, working well in a team, helping colleagues, a likelihood to ‘go the extra mile’ Publisher: DH Size of Publication: 24p. Published: 23/03/2010 Filed under: Grey Literature, Guidance, Human Resources, NHS, Stakeholder Engagement Tagged: Grey Literature, Human Resources, NHS, Organisational Development, Staff Engagement, Stakeholder Engagement (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=3581555 Thu, 20 May 2010 04:10:01 +0100 3581555 http://www.medworm.com/index.php?rid=3259242&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Fwaiting-for-goduidance.html In ACT I of Samuel Beckett's play Waiting for Godot (rhymes with go) the character Estragon looks about and says to Vladimir, the other main character in the play: "Charming spot." (He turns, advances to front, halts facing auditorium.) "Inspiring prospects." (He turns to Vladimir.) "Let's go."Vladimir says: "We can't."Estragon: "Why not?"Vladimir: "We're waiting for Godot."I was reminded of this play while listening to a panel discussion yesterday at the 9th Annual ePharma Summit in Philadelphia. At least one panel member -- a pharmaceutical marketer who shall remain anonymous -- advised attendees not to wait for the FDA to publish its much anticipated guidelines regarding regulation of pharmaceutical marketing on the Internet and social media sites."If you are expecting clarity in any ki... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3259242 Wed, 10 Feb 2010 16:27:00 +0100 3259242 http://www.medworm.com/index.php?rid=3212266&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2010%2F01%2F27%2Fchecklist-for-reporting-managing-and-investigating-information-governance-serious-untoward-incidents%2F Title: Checklist for reporting, managing and investigating information governance serious untoward incidents Skinny: Guidance for all NHS staff in managing information governance serious untoward incidents. It should be used in conjunction with previous issued guidance and local guidance issued by the SHAs. Publisher: DH Size of Publication: 16p. Published: 22/01/2010 Posted in Clinical Governance, Ethics, Grey Literature, Health and Safety, NHS, Quality, Risk Evaluation Tagged: Clinical Governance, Grey Literature, Guidance, Serious Untoward Incidents (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=3212266 Wed, 27 Jan 2010 14:48:34 +0100 3212266 http://www.medworm.com/index.php?rid=3129463&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F12%2F30%2Fguidance-on-the-completion-of-the-deprivation-of-liberty-safeguards-data-collation-sheet-24-december-2009%2F Title: MCA DOLS Data Collation Sheet User Guide – version 1.4 Skinny: Replaces previous guidance on completion of the Deprivation of Liberty Safeguards data collation sheet as the result of an additional data item added for the third quarter data collection period. Publisher: DH Size of Publication: 18p. Published: 29/12/2009 Posted in Grey Literature, Mental Capacity Act 2005, Mental Health, NHS Tagged: Deprivation of Liberrty Safeguards, Grey Literature, Guidance, Mental Capacity, Mental Capacity Act 2005, Mental Health, Statistical Data (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=3129463 Wed, 30 Dec 2009 08:30:03 +0100 3129463 http://www.medworm.com/index.php?rid=3096790&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F12%2F17%2Fguidance-on-the-consumption-of-alcohol-by-children-and-young-people-a-report-by-the-chief-medical-officer%2F Title: Guidance on the consumption of alcohol by children and young people Skinny: Over the last decade, public concern about the impact of alcohol on health and society has steadily mounted. Particular concern has centred on the level and pattern of drinking among children and young people and its consequences on health, crime, violence and antisocial behaviour. Built on the work of Professor Mark Bellis at Liverpool John Moores University this guidance details: Nature and extent of the problem provides an overview of drinking patterns and some of their consequences in young people in the UK. Guidance for the consumption of alcohol by children and young people presents each guideline followed by the rationale, the underpinning scientific evidence and implications. Reviews current policy,... Fade Library blogs http://www.medworm.com/rss/comments.php?id=3096790 Thu, 17 Dec 2009 11:30:57 +0100 3096790 http://www.medworm.com/index.php?rid=2934945&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fexpect-fda-social-media-draft-guidance.html Let me make a prediction: FDA's DDMAC will issue some version of draft guidance on the use of social medial for Rx drug/device promotion BEFORE the end of 2010. Just for the record, I tweeted about this last week (October 21, 2009; see here).Yesterday, at the ePatient Connections 2009 conference, I was a member of the Regulatory Panel that also included my friend Preeti Pinto, MS, MT (ASCP), Head of Medical Education and Regulatory Compliance at AstraZeneca, and Paul Loebach, Project Manager, DDMAC. I never met Loebach before, but I liked him even though he never fully revealed what he has been doing at DDMAC for the past 18 years. During that panel discussion, Loebach informed the audience that it was too late to request a seat at the upcoming November FDA public hearing on social media. ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2934945 Wed, 28 Oct 2009 12:13:00 +0100 2934945 http://www.medworm.com/index.php?rid=2930905&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F10%2F27%2Fa-resource-for-developing-sexual-assualt-referral-centres-sarcs%2F Title: A Resource for Developing Sexual Assualt Referral Centres (SARCs) Skinny: Guidance identifying the the minimum elements essential for providing high-quality Sexual Assualt Referral Centres (SARCs) for victims of sexual violence and sexual abuse, including forensic medical examination. Publisher: DH Size of Publication: 40p Published: 27/10/2009 Posted in Crime Prevention and Control, Grey Literature, NHS, Sexual Health, Violence Tagged: Crime Prevention and Control, Forensic Medicine, Grey Literature, Guidance, Sexual Abuse, Violent People (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2930905 Tue, 27 Oct 2009 15:03:04 +0100 2930905 http://www.medworm.com/index.php?rid=2930906&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F10%2F27%2Fadvice-for-mainstream-schools%2F Title: Advice for Mainstream Schools and Advice for Special Schools Skinny: Advice for schools resulting from a recognition that some groups are particularly vulnerable to any illness, including swine flu. This can include some children and young people with particular health conditions, including some complex disabilities such as cerebral palsy that can make it more difficult for them to fight off viruses. Publisher: Health Protection Agency (HPA) Size of Publication: 2p and 3p Published: 27/10/2009 Posted in Children, Disabilities, Grey Literature, Infection Control, Influenza, Young People Tagged: Children, Disabilities, Grey Literature, Guidance, H1N1, Infection Control, Influenza, Pandemic, Schools, Young People (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2930906 Tue, 27 Oct 2009 14:46:04 +0100 2930906 http://www.medworm.com/index.php?rid=2930916&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F10%2F27%2Fguidance-on-qualified-first-aiders%2F Title: Guidance on qualified first aiders Skinny: National Minimum Standards (NMS) state: ‘a qualified first aider should be available at all times’ (NMS 38.2 for Older People and 42.2 for Younger Adults). This guidance is aimed at providers so that they can ensure the right first aid provision for people who use their services. It explains the factors that a care service provider can take into account when doing a risk assessment to find out their first aid needs. These include: the needs of service users how likely it is that first aid will be needed what kind of first aid is likely to be needed Publisher: Care Quality Commission Size of Publication: 4p Published: 26/10/2009  Posted in Clinical Governance, First Aid, Governance, Grey Literature, Guidance, Private Sector, Pu... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2930916 Tue, 27 Oct 2009 10:02:47 +0100 2930916 http://www.medworm.com/index.php?rid=2924777&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F10%2F25%2Fprotecting-the-nhs-in-relation-to-patient-mobility-and-cross-border-healthcare-draft-regulations-and-guidance%2F Title: Draft Guidance: Cross Border Healthcare & Patient Mobility Skinny: Case law from the European Court of Justice (ECJ) on patient mobility under Article 49 of the EU Treaty means that patients are able to seek any healthcare (including private care) in another European Economic Area (EEA) Member State, and, as long as they are entitled to the treatment in question under their home healthcare system, they are eligible to have their costs reimbursed. For patients travelling from the UK, this reimbursement can be up to the level of the cost for the same treatment provided in the UK under the NHS. Any additional costs must be met by the individual. The draft regulations and draft accompanying guidance is intended to provide greater clarity to the NHS about the application of case law ... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2924777 Sun, 25 Oct 2009 09:00:43 +0100 2924777 http://www.medworm.com/index.php?rid=2916403&cid=t_167186_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2009%2F10%2F21%2Fendocytes-ec145-produces-significant-anti-tumor-activity-in-advanced-stage-chemoresistant-ovarian-cancer-patients%2F Endocyte, Inc., … presented data from a Phase 2a clinical trial for EC145, … In 49 women with advanced-stage ovarian cancer, EC145 was shown to have anti-tumor activity in a significant percentage of participants in the trial. …[T]he overall disease control rate, defined as stable disease, partial or complete response to therapy, was 40.8 [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=2916403 Thu, 22 Oct 2009 05:00:40 +0100 2916403 http://www.medworm.com/index.php?rid=2862432&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F10%2F05%2Fdosage-of-oseltamivir-in-children-under-one-year-of-age-with-swine-flu-2009%2F Title: Dosage of oseltamivir in children under one year of age with swine flu (2009) Skinny: Letter from Sir Liam Donaldson, Chief Medical Officer for England. Letter highlights the change in dosage of Tamiflu (oseltamivir) in children aged 6 months to 1 year of age during an influenza pandemic outbreak. Up to now, the treatment dose for oseltamivir in children under 1 has been 2mg/kg twice daily for 5 days. The recommended dose for treatmnent of children 6-12 months of age is now 3mg per kg body weight twice daily for 5 days. Outlines the steps that need to be taken to ensure a safe transition to the new dosage. Publisher: DH Size of Publication: 4p Published: 24/09/2009 Posted in Grey Literature, Guidance, Infection Control, Influenza, Paediatrics, Pandemic Tagged: Influenza, Osel... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2862432 Mon, 05 Oct 2009 14:32:02 +0100 2862432 http://www.medworm.com/index.php?rid=2823920&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F09%2F23%2Fmanaging-influenza-like-illnes-ili-in-nursing-and-residential-homes-during-the-current-influenza-pandemic-who-phase-6%2F Title: Managing influenza-like illnes (ILI) in nursing and residential homes during the current influenza pandemic (WHO Phase 6) The Skinny: Guidance which aims to provide advice on the generic management of cases or outbreaks of flu-like illness in nursing and residential homes, and provides specific guidance appropriate to pandemic (H1N1) 2009 influenza. Publisher: DH Size of Publication: 29p Published: 17/09/2009 Posted in Grey Literature, Influenza, Pandemic, Residential Care Tagged: Grey Literature, Guidance, H1N1, Influenza, Pandemic, Residential Care (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2823920 Wed, 23 Sep 2009 09:01:30 +0100 2823920 http://www.medworm.com/index.php?rid=2778349&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F09%2F09%2Finformation-sharing-and-mental-health%2F Title: Information sharing and mental health The Skinny: Guidance establishing some of the issues relating to the exchange of information between mental health trusts and outside organisations and individuals.   It sets out when, why and how information can safely be exchanged for the benefit of the individual and the public. Publisher: DH Size of Publication: 27p Published: 08/09/2009 Posted in Grey Literature, Mental Health, NHS Tagged: Data Protection, Grey Literature, Guidance, Legislation, Mental Health (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2778349 Wed, 09 Sep 2009 11:29:13 +0100 2778349 http://www.medworm.com/index.php?rid=2772674&cid=t_167186_133_f&fid=35129&url=http%3A%2F%2Fwhitterer-autism.blogspot.com%2F2009%2F09%2Fje-mappelle-funny-bear-full-french.html Hosted by "Tracy" at "Mother May I," but the photo-picture below will whizz you right there with one click.Just call me snap happy.I have made a Bakewell Tart and a couple of loaves of fresh bread but I am completely incapable of filling in the rest of the menu for the night as my brain has been numbed by twenty minutes of the sing songy exchange:-“Come to the dark side.”“The health inspectors are here!”I don’t know from whence it has come, but I sincerely I hope that it doesn’t stay too long as the Boris Karloff maniacal laugh that accompanies it, is far too realistic for peace of mind. Frankly I do not consider this an improvement on Axel F sung at 50 decibels in chorus, even though once upon a time I did find the theme song to Beverly Hills Cops quite jolly. I remind myself... Whitterer on Autism blogs http://www.medworm.com/rss/comments.php?id=2772674 Mon, 07 Sep 2009 06:51:00 +0100 2772674 http://www.medworm.com/index.php?rid=2737684&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F08%2F26%2Fmental-health-in-family-medicine-2008-vol-5-no-4%2F Title: What should prompt an urgent referral to a community mental health team? Skinny: Article outlines a set of 12 criteria developed using the Delphi technique to guide what should constitute an ‘urgent’ mental health referral. The criteria was developed after 100 referral letters to a community mental health team were analysed to determine the proportion that were considered urgent by the referrer compared to a consensus panel of psychiatrists. (Print subscription held at Fade Library) Posted in Community Services, Guidance, Journals, Mental Health, Occupational Therapy, Psychology, Social Care, Urgent Care, Vulnerable People Tagged: Community Mental Health Team, Delphi Technique, General Practitioners, Mental Health, Referral, Urgent Care (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2737684 Wed, 26 Aug 2009 23:03:30 +0100 2737684 http://www.medworm.com/index.php?rid=2733997&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F08%2F25%2Fsafer-births-supporting-maternity-services-to-improve-safety-report-of-three-regional-events-held-in-york-london-and-wigan-2009%2F Title: Safer Births: Supporting maternity services to improve safety: Report of three regional events held in York, London and Wigan, 2009 The Skinny: Details the findings of three regional workshops undertaken as part of the King’s Fund’s Safer Births initiative for audience of heads of midwifery, lead obstetricians and risk managers. Publisher: The King’s Fund Size of Publication: 7p Published: 24/08/2009 Posted in Clinical Governance, Health and Safety, Midwifery, Obstetrics, Quality, Standards Tagged: Communication, Education, Grey Literature, Guidance, Health and Safety, Information Systems, Leadership, Midwifery, Obstetrics, Risk Evaluation, Staff Supplu, Teamwork, Training (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2733997 Tue, 25 Aug 2009 14:32:09 +0100 2733997 http://www.medworm.com/index.php?rid=2730358&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F08%2Fno-fda-regulations-would-be-like.html My friend Jonathan Richman asks an interesting question on his blog: "What If There Were No Rules in Pharma Marketing?"“What If There Were No Rules?', asks Richman. "There’s no FDA, no DDMAC, no FTC. Your company guidelines and rules don’t exist and your regulatory and legal teams have been disbanded. It’s a free-for-all and there are no rules. The question is: what would you do?"He includes a nice survey of readers that I encourage you to respond to. But before you do that, have a look at my own parallel survey that may encourage you to think about an analogy to the real world: What if there were no laws against speeding?After the Road Trip with my son (see "I'm Back from My Road Trip South!"), I know that I would not like to live in a world without speed limits!Loading... (Source... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2730358 Mon, 24 Aug 2009 17:33:00 +0100 2730358 http://www.medworm.com/index.php?rid=2730031&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F08%2F24%2F5301%2F Title: Local self-assessment audit for assessing implementation of HTM 01-05: decontamination in primary care dental practices and related infection prevention and control issues The Skinny: Audit tool produced jointly by the Department and the Infection Prevention Society, to allow practices to assess their level of compliance with the HTM 01-05: decontamination in primary care dental practices. It will allow practices to identify areas where they need to improve the quality of the decontamination process to achieve essential quality requirements and best practice, as identified in the guidance document. Publisher: DH Size of Publication: 16p Published: 24/08/2009 Posted in Dental Health, Grey Literature, Infection Control, NHS Tagged: Clinical Audit, Dental Health, Grey Literature, Guid... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2730031 Mon, 24 Aug 2009 15:34:28 +0100 2730031 http://www.medworm.com/index.php?rid=2727068&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F08%2F24%2Fthe-team-around-the-child-tac-and-the-lead-professional-a-guide-for-managers-2%2F Title: The Team Around the Child TAC and the lead professional: A guide for managers The Skinny: Replaces guidance originally published by the DfES in 2006 and reprinted in 2007. It remains non-statutory guidance. The new guidance has been updated and re-titled in order to reflect policy developments and include revisions identified in consultation with practitioners and managers across the children and young people’s workforce. It also seeks to link together the processes and tools, to show how collaboratively they provide a package of support to help practitioners and managers implement integrated working in their practice. Publisher: Every Child Matters Size of Publication: 84p Published: 21/08/2009 Posted in Child Protection Services, Children, Education, Grey Literature, Interagenc... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2727068 Mon, 24 Aug 2009 09:23:10 +0100 2727068 http://www.medworm.com/index.php?rid=2727069&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F08%2F24%2Fthe-team-around-the-child-tac-and-the-lead-professional-a-guide-for-managers%2F Title: Early identification, assessment of needs and intervention – The Common Assessment Framework for children and young people: A guide for managers The Skinny: Replaces guidance originally published by the DfES in 2006 and reprinted in 2007. It remains non-statutory guidance. The new guidance has been updated and re-titled in order to reflect policy developments and include revisions identified in consultation with practitioners and managers across the children and young people’s workforce. It also seeks to link together the processes and tools, to show how collaboratively they provide a package of support to help practitioners and managers implement integrated working in their practice. Publisher: Size of Publication: 68p Published: 21/08/2009 Posted in Children, Education, ... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2727069 Mon, 24 Aug 2009 09:20:35 +0100 2727069 http://www.medworm.com/index.php?rid=2727073&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F08%2F24%2Fearly-identification-assessment-of-needs-and-intervention-the-common-assessment-framework-for-children-and-young-people-a-guide-for-practitioners%2F Title: Early identification, assessment of needs and intervention – The Common Assessment Framework for children and young people: A guide for practitioners The Skinny: Replaces guidance originally published by the DfES in 2006 and reprinted in 2007. It remains non-statutory guidance. The new guidance has been updated and re-titled in order to reflect policy developments and include revisions identified in consultation with practitioners and managers across the children and young people’s workforce. It also seeks to link together the processes and tools, to show how collaboratively they provide a package of support to help practitioners and managers implement integrated working in their practice. Publisher: DSCF Size of Publication: 68p Published: 21/08/2009 Posted in Child Protec... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2727073 Mon, 24 Aug 2009 08:25:53 +0100 2727073 http://www.medworm.com/index.php?rid=2715881&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F08%2F20%2Fmental-capacity-act-2005-deprivation-of-liberty-safeguards-standard-forms-and-guidance-for-best-interests-assessors%2F Title: Guide to standard forms for best interests assessors The Skinny: Document containing all the forms, with guidance, that best interests assessors need in carrying out their responsibilities. Publisher: DH Size of Publication: 5p Published: 14/08/2009 Posted in Grey Literature, Legislation, Mental Health Tagged: Best Interests, Deprivation of Liberty, Forms, Grey Literature, Guidance, Mental Capacity Act 2005, Mental Health, Safeguards (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2715881 Thu, 20 Aug 2009 10:00:38 +0100 2715881 http://www.medworm.com/index.php?rid=2712042&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F08%2F18%2Fmulti-agency-practice-guidelines-handling-cases-of-forced-marriage%2F Title: Multi-agency practice guidelines: Handling Cases of Forced Marriage The Skinny: Revised set of multi-agency practice guidelines for frontline professionals (such as teachers, police officers, social and health care professionals, housing officers) to help them to work more closely together and to better identify and protect children and adults at risk of forced marriage. The revised guidelines replace the existing individual guidelines which were tailored for specific professionals  and now brings these together into one single document. Publisher: DH Size of Publication: 105p Published: 14/08/2009 Posted in Child Abuse, Children, Clinical Guideline, Grey Literature, Guidance, NHS, Social Services, Standards, Vulnerable People, Young People Tagged: Child Protection, Forced Marria... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2712042 Tue, 18 Aug 2009 14:47:44 +0100 2712042 http://www.medworm.com/index.php?rid=2630035&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F07%2F22%2Fdelivering-healthy-ambitions-%25e2%2580%2593-making-our-clinicians-recommendations-a-reality-2009%2F Title: Delivering Healthy Ambitions – making our clinicians’ recommendations a reality (2009)  The skinny: Review of the progress made so far on Healthy Ambitions (2008) NHS Yorkshire and Humber’s contribution to the Darzi Report. This one year on report describes how the SHA began implementation and details feedback from the consultation process. Outlines specific areas which will be focused on over the next 12 months; including improving stroke, maternity and neonatal care, and tackling obesity in Yorkshire and the Humber.    Publisher: NHS Yorkshire and Humber Published: 2009 Size of publication: 85p Posted in Care Pathways, Grey Literature, Guidance in Progress, Neonatology, NHS, Obesity, Outcomes, Primary Care, Quality, Strategic Health Authorities, Stroke Tagged... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2630035 Wed, 22 Jul 2009 23:57:24 +0100 2630035 http://www.medworm.com/index.php?rid=2442761&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F05%2Ffda-rules-are-not-media-agnostic.html FDA has just released a new draft guidance document: "Presenting Risk Information in Prescription Drug and Medical Device Promotion" (find the pdf file here).I haven't read the guidance yet, but according to a Reuters report, the guidance has some specific to TV ads:"Television ads for drugs and medical devices should avoid distracting images and music that can reduce viewers' comprehension of potential side effects, U.S. regulators advised in guidelines proposed on Tuesday."Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the Food and Drug Administration said."It seems to me that contrary to public statements by FDA officials and bloggers (eg, "FDA to Online Marketers: Same Rules Apply"), the same rules do NOT apply to all media.Obvious... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2442761 Tue, 26 May 2009 20:17:00 +0100 2442761 http://www.medworm.com/index.php?rid=2408446&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F05%2F15%2Fh1n1-flu-resource-centre%2F The Lancet’s H1N1 Resource Centre is the result of a collaborative effort by the editors of over 40 Elsevier-published journals and 11 learned societies who have agreed to make freely available on this site any relevant content. Clinical: H1N1 Clinical Medical References & Guidelines @ MDConsult.com Leading medical reference books, journals, clinics, peer-reviewed practice guidelines, and news H1N1 Clinical Nursing References & Guidelines @ MosbysNursingConsult.com Scientific: Search Journal & Book Literature @ ScienceDirect.com Posted in General Practice, Guidance, Influenza, Pandemic, Primary Care, Public Health Tagged: E-Books, E-Journals, Influenza, Pandemic, Primary Care, Public Health, Swine Flu (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2408446 Fri, 15 May 2009 06:16:08 +0100 2408446 http://www.medworm.com/index.php?rid=2398549&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F05%2F05%2Findependent-mental-health-advocates-supplementary-guidance-on-access-to-patient-records-under-section-130b-of-the-mental-health-act-1983%2F Supplementary guidance on access to patient records under section 130B of the Mental Health Act 1983 detailing whether under section 130B of the Mental Health Act 1983 independent mental health advocates (IMHAs) are able to see information in patients’ records which would not be disclosed directly to the patient and, if so, whether IMHAs may share that information with patients. Posted in Grey Literature, Legislation, Mental Health, NHS Tagged: Advocacy, Grey Literature, Guidance, Legislation, Medical Records, Mental Health (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2398549 Tue, 05 May 2009 09:58:19 +0100 2398549 http://www.medworm.com/index.php?rid=2375967&cid=t_167186_87_f&fid=34595&url=http%3A%2F%2Fnhsblogdoc.blogspot.com%2F2009%2F04%2Fswine-flu-news-definitive-guidance-from.html Swine influenza viruses are not transmitted by food. You can not get swine influenza from eating pork or pork products. Eating properly handled and cooked pork and pork products is safe. Cooking pork to an internal temperature of 160°F kills the swine flu virus as it does other bacteria and viruses.Official advice (Source: NHS Blog Doctor) NHS Blog Doctor blogs http://www.medworm.com/rss/comments.php?id=2375967 Wed, 29 Apr 2009 16:55:00 +0100 2375967 http://www.medworm.com/index.php?rid=2367341&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F04%2F25%2Fcombined-bony-and-soft-tissue-reconstruction-for-hip-joint-stabilisation-in-proximal-focal-femoral-deficiency-pffd%2F Title: Combined bony and soft tissue reconstruction for hip joint stabilisation in proximal focal femoral deficiency (PFFD) Source: NICE The Skinny: Children are sometimes born with defects of the hip joint and upper thigh bone, called proximal femoral focal deficiency, often abbreviated to PFFD. Surgical treatment, aiming to produce as functional a leg as possible, may be appropriate. This may also involve a corrective operation on the hip joint (sometimes referred to as the ‘superhip’ procedure). The initial operation may be combined with other surgery to lengthen the leg and treat other problems such as poor knee function at the same time or at a later date. Full guidance to the NHS in England, Wales, Scotland and Northern Ireland on ex-vivo hepatic resection and reimplantation ... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2367341 Sat, 25 Apr 2009 05:56:12 +0100 2367341 http://www.medworm.com/index.php?rid=2367345&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F04%2F25%2Fendoscopic-mastectomy-and-endoscopic-wide-local-excision-for-breast-cancer%2F Title: Endoscopic mastectomy and endoscopic wide local excision for breast cancer Source: NICE The Skinny: Treatment for early breast cancer usually involves surgery to remove all or part of the breast. In this keyhole procedure, part or all of the breast tissue is removed using special instruments inserted through small skin incisions. The skin envelope of the breast and nipple are left intact, ready for an implant that can be inserted during the same operation. Full guidance to the NHS in England, Wales, Scotland and Northern Ireland on ex-vivo hepatic resection and reimplantation for liver cancer. Documents: IPG296 Endoscopic mastectomy and endoscopic wide local excision for breast cancer: guidance (2p,52.69 Kb ) IPG296 Endoscopic mastectomy and endoscopic wide local excision for breas... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2367345 Sat, 25 Apr 2009 05:54:35 +0100 2367345 http://www.medworm.com/index.php?rid=2365442&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fwhat-good-can-come-from-public-fda.html "The reality of that actually happening is very small...""Does the public even want to talk with pharma companies?""If the FDA opened hearings to the public they would get an earful of what they don't want to hear or acknowledge...""Another reason the FDA is not going to get into social media as a marketing tool is that the evolution of social media is continuing at a very fast pace...""...at this time I'm sure the FDA wants to try and head to calmer waters.""With an anemic forecast for pharma sales for 2009 and more layoffs expected I also can't see pharma hiring more people to manage online social media initiatives."Wow! Fellow blogger Rich Meyer really dissed my call for a public hearing hosted by FDA on use of social media (or Internet in general) by pharmaceutical companies in his pos... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2365442 Thu, 23 Apr 2009 13:22:00 +0100 2365442 http://www.medworm.com/index.php?rid=2358889&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fhow-to-do-social-media-pharma-marketing.html That's my re-interpretation of Josh Bernoff's presentation "How to do a social application in life sciences without getting fired" at yesterday's Social Pharmer Boston Unconference organized by @Shwen.Bernoff is the co-author of the book "groundswell - winning in a world transformed by social technologies" and is Vice President and Principal Analyst at Forrester Research.Bernoff's title speaks to corporate politics. My re-interpretation tries to bring in the target audience of marketers -- especially consumers and patients. If not approached correctly, SM denizens can really "blow up" any marketer's carefully laid plans to engage them in conversation.Stuart Foster, an attendee of the SocPharm unconference, summed up Bernoff's presentation in his blog post:"It came down to this: Your custom... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2358889 Wed, 22 Apr 2009 11:50:00 +0100 2358889 http://www.medworm.com/index.php?rid=2349719&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fwww.surveys.pharma-mkting.com%2FFDA-Social.htmhttp%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Ffda-tear-down-this-wall-draft-petition.html FDA, tear down this wall! The wall between pharma and the Internet.For too many years the FDA has neglected to issue guidance to the pharma industry on how it will enforce its regulatory authority over Internet-based promotions. Instead, FDA seems to depend entirely on formulating policy by issuing warning letters. In contrast, FDA has often issued specific guidance with regard to TV and print advertising.The FDA defends its lack of Internet guidance by saying that the same principles apply to the Internet as apply to other media. That argument is not rational nor is it an extension of how the FDA treats other media, such as broadcast TV.The FDA, for example, has long recognized that there are limitations inherent in a 60-second TV commercial that required it to issue guidance on how to co... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2349719 Sun, 19 Apr 2009 14:47:00 +0100 2349719 http://www.medworm.com/index.php?rid=2367380&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F04%2F15%2Fautologous-blood-injection-for-tendinopathy%2F Title: Autologous blood injection for tendinopathy Source: NICE The Skinny: Guidance to the NHS in England, Wales, Scotland and Northern Ireland on autologous blood injection for tendinopathy.  Tendonitis is the inflammation of the tendon - the fibrous tissue that connects muscles to bones - which may occur through overuse. In this treatment, blood is taken from the patient (which is sometimes treated in the laboratory) and then re-injected around the affected tendon to supply growth factors that initiate healing. Documents: IPG279 Autologous blood injection for tendinopathy: guidance (2-p, 35.76 Kb) IPG279 Autologous blood injection for tendinopathy: understanding NICE guidance (4p, 55.16 Kb) IPG279 Autologous blood injection for tendinopathy: understanding NICE guidance (MS Word form... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2367380 Wed, 15 Apr 2009 09:23:27 +0100 2367380 http://www.medworm.com/index.php?rid=2367383&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F04%2F15%2Fultrasound-guided-regional-nerve-block%2F Title: Ultrasound-guided regional nerve block Source: NICE The Skinny: Guidance to the NHS in England, Wales, Scotland and Northern Ireland on ultrasound-guided regional nerve block. There are a number of conditions for which regional anaesthesia to allow surgery is required for a specific part of the body. This technique aims to provide accurate placement of local anaesthetic by using ultrasound guidance to position needles that deliver the local anaesthetic in the correct place next to the nerves. Documents: Ultrasound-guided regional nerve block: guidance (2p, 35.27 Kb) Ultrasound-guided regional nerve block: understanding NICE guidance (4p, 55.79 Kb) Ultrasound-guided regional nerve block: understanding NICE guidance (MS Word format)(4p, 407 Kb) Ultrasound-guided regional nerve block:... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2367383 Wed, 15 Apr 2009 09:22:53 +0100 2367383 http://www.medworm.com/index.php?rid=2367386&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F04%2F15%2Fthoracoscopic-epicardial-radiofrequency-ablation-for-atrial-fibrillation%2F Title: Thoracoscopic epicardial radiofrequency ablation for atrial fibrillation Source: NICE The Skinny: Guidance to the NHS in England, Wales, Scotland and Northern Ireland on thoracoscopic epicardial radiofrequency ablation for atrial fibrillation.  Atrial fibrillation is a condition that affects the heart, causing an irregular pulse. It occurs when the electrical impulses controlling the heartbeat become disorganised, so that the heart beats irregularly and too fast. When this happens, the heart cannot efficiently pump blood around the body. This may cause symptoms such as palpitations, chest pain or discomfort, shortness of breath, dizziness and fainting. Atrial fibrillation increases the risk of blood clots and stroke. In thoracoscopic epicardial radiofrequency ablation, selected are... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2367386 Wed, 15 Apr 2009 09:21:31 +0100 2367386 http://www.medworm.com/index.php?rid=2367389&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F04%2F15%2Finfracoccygeal-sacropexy-using-mesh-for-uterine-prolapse-repair%2F Title: Infracoccygeal sacropexy using mesh for uterine prolapse repair Source: NICE The Skinny: Guidance to the NHS in England, Wales, Scotland and Northern Ireland on infracoccygeal sacropexy using mesh for vaginal vault prolapse repair. Uterine prolapse occurs when the womb (uterus) slips down from its normal position into the vagina. Infracoccygeal sacropexy is an operation that involves the insertion of a piece of material (mesh) with the aim of holding the womb in place. Documents: IPG280 Infracoccygeal sacropexy using mesh for uterine prolapse repair: guidance (2p, 35.03 Kb) IPG280 Infracoccygeal sacropexy using mesh for uterine prolapse repair: understanding NICE guidance (4p, 55.41 Kb) IPG280 Infracoccygeal sacropexy using mesh for uterine prolapse repair: understanding NICE guida... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2367389 Wed, 15 Apr 2009 09:20:07 +0100 2367389 http://www.medworm.com/index.php?rid=2367395&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F04%2F15%2Fmanagement-of-long-term-sickness-and-incapacity-for-work%2F Title: Management of long-term sickness and incapacity for work Source: NICE The Skinny:  This guidance is for all those who manage long-term (or recurring short- or long-term) sickness absence and incapacity, including employers and people working in the NHS. It will also be of interest to workplace representatives and trades unions, employees and those receiving incapacity benefit or employment and support allowance (ESA). Three of the recommendations aim to help employers and employees work together to ensure the right support is available to help someone on sickness absence return to work as soon as they are able. Recommendations for employers include: Identify someone who is suitably trained and impartial to undertake initial enquiries with an employee who is experiencing long-term ... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2367395 Wed, 15 Apr 2009 09:17:36 +0100 2367395 http://www.medworm.com/index.php?rid=2367397&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F04%2F15%2Fneedle-and-syringe-programmes-providing-people-who-inject-drugs-with-injecting-equipment%2F Title: Needle and syringe programmes: providing people who inject drugs with injecting equipment Source: NICE The Skinny: Promotes the optimal provision of needle and syringe programmes (NSPs) among injecting drug users. It is for NHS and other professionals who have a direct or indirect role in, or responsibility for, NSPs. This includes those working in drug (and alcohol) action teams (DAATs), pharmacies, local authorities and the wider public, voluntary and community sectors. It may also be of interest to people who inject illicit substances and non-prescribed drugs, their families and other members of the public. The recommendations relate to people over the age of 18 who inject illicit substances and non-prescribed anabolic steroids. The guidance complements and supports, but does not... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2367397 Wed, 15 Apr 2009 09:16:36 +0100 2367397 http://www.medworm.com/index.php?rid=2301651&cid=t_167186_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Ffda-issues-first-ever-draft-guidance-on.html Discussion of Social Media Guidelines! No More Joking!").I had thought that the phrase "way cool" attributed to Jean-Ah Kang PLUS the links would have given it away.Unfortunately, a few people did not catch those hints. (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2301651 Wed, 01 Apr 2009 12:07:00 +0100 2301651 http://www.medworm.com/index.php?rid=2305906&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F03%2F28%2Fpandemic-flu-guidance-for-businesses-risk-assessment-in-the-occupational-setting%2F explains how businesses can help reduce the spread of flu in the event of a pandemic. It provides information to allow businesses to assess the types of measures that may be used in their particular occupational setting. Posted in Grey Literature, Influenza, Pandemic, Public Health, Strategic Planning Tagged: Business Continuity, Grey Literature, Guidance, Influenza, Pandemic, Strategic Planning (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2305906 Sat, 28 Mar 2009 13:05:07 +0100 2305906 http://www.medworm.com/index.php?rid=2202581&cid=t_167186_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2009%2F02%2F20%2Fendocyte-begins-phase-ii-clinical-trial-of-ec145-for-treatment-of-women-with-platinum-resistant-ovarian-cancer%2F “Endocyte Inc. has announced the initiation of a randomized Phase II clinical study of the company’s investigational drug EC145 in women with platinum-resistant ovarian cancer. The phase II trial, also called the “PRECEDENT study,” will evaluate the efficacy and safety of EC145 when administered in combination with pegylated liposomal doxorubicin (PLD). …The PRECEDENT study will [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=2202581 Fri, 20 Feb 2009 21:35:15 +0100 2202581 http://www.medworm.com/index.php?rid=2110543&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F01%2F16%2Fprotection-of-vulnerable-adults-pova-scheme-in-england-and-wales-for-adult-placement-schemes-domiciliary-care-agencies-and-care-homes-a-practical-guide%2F provides guidance on, and background to, the POVA scheme with FAQs. It supercedes the previous  guidance from 2006. Individuals should be referred to, and included on, the POVA list if they have abused, neglected or otherwise harmed vulnerable adults in their care or placed vulnerable adults in their care at risk of harm. By making statutory checks against the list, providers of care must not offer such individuals employment in care positions. This version of the guidance supersedes the previous guidance published in 2006, as it takes account of two amendments: an important note has been added to the front page of the guidance to draw attention to the POVA transitional arrangements from 20 January 2009, which will be in place until the new vetting and barring scheme is introduced. a... Fade Library blogs http://www.medworm.com/rss/comments.php?id=2110543 Fri, 16 Jan 2009 13:29:51 +0100 2110543 http://www.medworm.com/index.php?rid=2110545&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2009%2F01%2F16%2Fclostridium-difficile-infection-how-to-deal-with-the-problem%2F outlines newer evidence and approaches to delivering good infection control and environmental hygiene and updates the 1994 DH/PHLS guidance (Clostridium difficile infection: Prevention and management). Posted in Evidence Based Practice, Grey Literature, Infection Control, NHS   Tagged: Clostridium Difficile, Evidence Based Practice, Grey Literature, Guidance, Infection Control    (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=2110545 Fri, 16 Jan 2009 09:45:48 +0100 2110545 http://www.medworm.com/index.php?rid=1494402&cid=t_167186_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F06%2Ffda-needs-your-input-on-islet.html The May 22, 2008 Edition of the Federal Register had another announcement that people with type 1 diabetes should be interested in. The U.S. Department of Health and Human Services, Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has issued draft guidance similar to the guidance I announced back in March on diabetes drug and biologic treatments -- the very same guidance that the American Diabetes Association thought was NOT important enough to comment on!(See http://edocket.access.gpo.gov/2008/E8-11516.htm OR the regulations.gov/fdmspublic for the announcement and the guidance documents, search under the docket number, which is FDA-2008-D-0293-0001)"Guidance for Industry "Considerations for Allogeneic Pancreatic Islet Cell Products", Docket #: FDA-2008-D-... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1494402 Wed, 04 Jun 2008 19:25:00 +0100 1494402 http://www.medworm.com/index.php?rid=1439674&cid=t_167186_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F05%2Fadas-silence-is-deafening.html It seems that almost every month, we hear yet another news story about problems at the U.S. Food and Drug Administration. Last December, even an internal report produced by the FDA itself entitled "FDA Science and Mission at Risk" (which can also be found at the Food and Drug Administration's website) concluded that the FDA was desperately short of money and poorly organized, which is putting people's lives at risk. This has Congressional lawmakers finally giving more serious consideration to their oversight (or rather, their lack of oversight) for the FDA, but money won't solve all the Agency's issues, more careful oversight is needed, too.Back in early March 2008, I wrote that the U.S. Food and Drug Administration was soliciting public comments on the Agency's Draft Guidance for Diabetes... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1439674 Tue, 13 May 2008 16:45:00 +0100 1439674 http://www.medworm.com/index.php?rid=1429315&cid=t_167186_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F286169422%2F Five years after the HHS Office of Inspector General issued its compliance guidance for pharma, 92 percent of drugmakers surveyed say the guidelines “significantly impacted” the structure of their medical affairs teams - for instance, have since shifted medical science liasons and thought-leader development teams away from commercial development. Meanwhile, 8 percent indicate the guidelines had caused a complete overhaul, according to Cutting Edge Information. And none of the 14 drugmakers that responded - a group that included Bayer, Glaxo and Novartis - believes the guidelines failed to have a serious impact. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1429315 Thu, 08 May 2008 16:00:55 +0100 1429315 http://www.medworm.com/index.php?rid=1397587&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2008%2F04%2F24%2Fmental-health-act-2007-commencement-no-5-and-transitional-provisions-order-2008-guidance-on-transfers-between-places-of-safety%2F Guidance on transfers between places of safety provides information on the use of SI(2008)800 Mental Health Act 2007 (Commencement No. 5 and Transitional Provisions) Order 2008. Which brings section 44 of the Mental Health Act 2007 (the 2007 Act) on places of safety into effect on 30 April 2008. Under sections 135 and 136 of the Mental Health Act 1983 (the 1983 Act) a police officer may remove a person who is believed or appears to be suffering from a mental disorder to a place of safety. Section 44 of the 2007 Act amends these sections of the 1983 Act to allow a person to be taken from one place of safety to one or more other places of safety during the 72 hour maximum overall period during which they may be detained under either of these two sections. They may be taken between places of ... Fade Library blogs http://www.medworm.com/rss/comments.php?id=1397587 Fri, 25 Apr 2008 04:16:16 +0100 1397587 http://www.medworm.com/index.php?rid=1310946&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2008%2F03%2F18%2Fpersonal-beliefs-and-medical-practice%2F from the GMC is guidance for medical staff that states  doctors must not allow their personal beliefs to compromise patient care. The guidance explores how doctors should deal with a range of dilemmas including abortion, the wearing of face-veils and male circumcision.  It also looks at patients’ own beliefs and how they can affect the doctor/patient relationship.  It aims to balance a doctors’ right to practise in accordance with their views and beliefs, and the patients’ right to receive timely and appropriate medical care. (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=1310946 Tue, 18 Mar 2008 16:18:34 +0100 1310946 http://www.medworm.com/index.php?rid=1297680&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2008%2F03%2F12%2Flocal-pharmaceutical-services-guidance-notes%2F Local Pharmaceutical Services (LPS) - guidance notes provides information on aspects of LPS permanence which allows PCTs to enter into LPS contracts without requiring prior approval of the Secretary of State for Health and provides PCTs with flexibility to make LPS arrangements in response to local needs within timetables of their own choosing. The guidance also details the commissioning process and may be of use to those PCTs that wish to use LPS (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=1297680 Wed, 12 Mar 2008 19:35:55 +0100 1297680 http://www.medworm.com/index.php?rid=1280795&cid=t_167186_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F03%2Ffda-needs-your-input-on-diabetes.html On Tuesday, I wrote about the opportunity for people with diabetes to attend the NIH/NIDDK's jointly-sponsored (along with JDRF) "Artificial Pancreas Workshop" in July. But I also mentioned that it was merely the first opportunity for you as patients to contribute something by representing real-life patient needs to our Government-funded agencies.Another opportunity you should be aware of is that the FDA has just issued a document with Draft Guidance for Industry for Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention, which provides recommendations to industry regarding the development of drugs and more specifically, therapeutic biologics regulated within the Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) for... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1280795 Wed, 05 Mar 2008 17:00:00 +0100 1280795 http://www.medworm.com/index.php?rid=1188510&cid=t_167186_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2008%2F01%2F30%2Fpandemic-influenza-guidance%2F Everyone will be involved in the fight against pandemic influenza (flu) in terms of managing the impact it will have on society and preventing further spread of the infection. These booklets explain how the following groups can, in the course of their daily work, protect themselves, their colleagues and their families, and prevent the spread of flu. Pandemic flu guidance for funeral directors: What you need to know and how to protect yourself and others Pandemic flu guidance for cleaning staff and refuse collectors in non-health care settings: What you need to know and how to protect yourself and others Pandemic flu guidance for the Fire and Rescue Service: What you need to know and how to protect yourself and others Pandemic flu guidance for the Police Service: What you need to kno... Fade Library blogs http://www.medworm.com/rss/comments.php?id=1188510 Wed, 30 Jan 2008 17:57:55 +0100 1188510