International IT Regulations and Compliance. Quality Standards in the Pharmaceutical and Regulated Industries

Research and Markets has announced the addition of John Wiley and Sons Ltd’s new report International IT Regulations and Compliance. Quality Standards in the Pharmaceutical and Regulated Industries to their offering.

After taking part in an EU Leonardo da Vinci project to create a complete curriculum for a Master’s degree in IT Validation, Siri H. Segalstad decided to write this book as she realised there was a need for a comprehensive book that rings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries.

This text allows the readers to acquire not only knowledge but also understanding of quality thinking and to apply this knowledge. It will allow them to use the Quality Management System (QMS) as a tool for further development in their organization and to assess QMS from other companies during a supplier audit.

This book will enable the user to understand the process of validation, how to divide validation into manageable pieces, and what is included in the validation for different types of systems.

Topics covered include:

- Quality standards
- Regulatory requirements for IT systems
- Quality Management Systems-QMS
- Organization for an IT system
- Legal implications of an IT system
- Advanced quality management systems
- Validation process and validation techniques
- Validation of IT systems
- Risk assessment and risk management
- Laboratory Information Management Systems (LIMS) and Building Management Systems (BMS)

This comprehensive text will be useful to those working with quality assurance and validation of IT systems and in regulated industries, regardless of which standards they are using.
For more information visit Research and Markets

Source: John Wiley and Sons Ltd
Business Wire 
Source: Pharmiweb.com

New pharmacovigilance legislation comes into operation

Better protection of public health through strengthened EU system for medicines safety

02/07/2012 - The European Medicines Agency (EMA) welcomes the start of new European Union (EU) legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.

“The progress made in healthcare would not have been possible without medicines and the research and development community behind them. But we need smart regulation for the system to be able to continue to deliver safe and effective medicines,” said the Agency’s Executive Director, Guido Rasi.

“The new pharmacovigilance legislation will help us to make the system more robust for public health and more transparent. It gives regulators a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines. It also increases the efficiency of medicines regulation for the benefit of all stakeholders.”

The new legislation was proposed by the European Commission in 2008 and adopted by the European Parliament and the Member States in December 2010. Highlights of the new legislation include:

  • establishment of a new scientific committee, the Pharmacovigilance Risk Assessment Committee (PRAC);
  • clarification of the roles and responsibilities of all actors involved in the monitoring of the safety and efficacy of medicines in Europe and strengthened coordination, leading to more robust and rapid EU decision-making;
  • engagement of patients and healthcare professionals in the regulatory process, including direct consumer reporting of suspected adverse drug events;
  • improved collection of key information on medicines, e.g. through risk-proportionate, mandatory post-authorisation safety and efficacy studies;
  • more transparency and better communication, including publication of agendas and minutes of the PRAC and the possibility to hold public hearings.

The Agency is ready for the first meeting of the PRAC on 19 and 20 July 2012. All Member States have nominated their members. The European Commission has appointed six independent scientific experts who will also serve as members. The nomination of PRAC members representing patients and healthcare professionals will follow a new public call for expressions of interest.

Information about the roles and the functioning of the PRAC has been published today and can be found on the Agency’s website, together with more information about the new pharmacovigilance legislation.

Notes
1. This press release, together with all related documents, is available on the Agency’s website.
2. More information on the new pharmacovigilance legislation is available here.
3. The status report ‘Countdown to July 2012: the Establishment and Functioning of the PRAC’ is available on the Agency’s website.
4. The new pharmacovigilance legislation is comprised of Directive 2010/84/EU and Regulation (EU) No 1235/2010.
5. More information on the work of the European Medicines Agency can be found on its website

Event: “Cloud and Social Networking in Healthcare: What are the leaders doing?”

9 July 2012, London, United Kingdom.

Friday, June 15th – DocCom, provider of the first cloud-based enterprise social networking platform exclusively for healthcare, today announces that it is partnering with Microsoft to co-host an exclusive event for healthcare professionals that will explore the practical issues, potential pitfalls and transformative opportunities of cloud and social networking for healthcare. The half-day forum, entitled “The Cloud and Social Networking in Healthcare: What are the leaders doing?” is being held on Monday 9th July at Microsoft’s London offices in Cardinal Place. Attendance is encouraged from Medical Directors, CEOs and CIOs from NHS Trusts, and frontline clinicians and healthcare managers are also welcome to attend. Spaces are strictly limited and can be reserved by emailing events@doccom.info to register.
DocCom and Microsoft are hosting this key event to provide healthcare decision-makers with expert analysis of the practical application and benefits of cloud and social technologies in a clinical context, offering clear guidance on how healthcare organisations can harness the future of secure healthcare communication. DocCom will be presenting an overview of its cloud-based enterprise social networking solution for healthcare, which is built on the latest Microsoft Development Stack for enterprise grade security and compliance. The half-day session will feature key user case studies from DocCom’s customers, including Peter Aitken, Lead for Improvement at NIHR CLAHRC Southwest Peninsula, who will talk about the importance of Insight when trying to change human behaviour in healthcare; Kevin Cleary, Medical Director East London NHS Foundation Trust and Former Medical Director NPSA, who will be demonstrating how networks can improve safety by disseminating safety information; and Dr Clare Wedderburn, Associate Dean at Dorset GP, who will be exploring how the new relationships between acute and primary care will impact coordination and communication. With a strong focus on security and information governance issues, Nick Umney, Technical Specialist for Cloud at Microsoft, will give his insight on the opportunity cloud presents for healthcare, while Dr Jonathan Bloor, co-founder and medical director of DocCom and Dr Jonathon Shaw, co-founder and managing director of DocCom, will share their vision of how secure social networking can be used to make healthcare a safer and more efficient place.

Founded by doctors, DocCom is taking the very best social networking technology and applying it to the unique requirements of healthcare professionals – empowering healthcare teams to securely find, collaborate, communicate and share with each other effectively, and giving healthcare organisations the tools and insight to solve specific business problems in safety and efficiency. A 2011 NHS staff survey revealed that only 26 per cent of respondents felt that communication between senior managers and staff is effective, and less than a third (30 per cent) reported that senior managers act on feedback from staff. This backs up research carried out by DocCom which found that 90 per cent of Medical Directors have a problem communicating with their doctors. This frustration, caused by the lack of fit-for-purpose online communication platforms, has led to some staff taking the initiative to engineer their own “workaround” solutions, including use of third-party, non-healthcare-specific software and, in some cases, inappropriate use of social networking platforms such as Facebook – with potentially calamitous implications for data protection and patient confidentiality.

“Social networking and cloud technologies are now a fact of modern life, and innovators in the healthcare industry are now realising that these platforms can deliver immense benefits to healthcare teams, if harnessed in a secure, reliable and responsible way,” comments DocCom co-founder and medical director Dr Jonathan Bloor. He continues: “Effective communication saves lives, time and money. The impact of the human and financial costs associated with the poor organisational and cross-industry communication in healthcare is being clearly felt across all levels of healthcare delivery, from frontline staff to senior management. This event is aimed at helping medical directors and healthcare IT professionals to understand how an enterprise social networking system that is fully standards-compliant – and supported and endorsed by key healthcare management – can significantly improve clinical safety and efficiency within their own organisations.”

About DocCom
DocCom provides the first enterprise networking solution specifically designed to help healthcare professionals to connect, communicate and collaborate. DocCom is combining the best attributes of social and enterprise networking to create secure, cloud-based, healthcare-focused tools that can be accessed anytime, anywhere, and via any device – supporting busy people delivering critical care. DocCom’s secure software solutions are designed by doctors who understand the unique privacy and operational challenges involved – making life easier for healthcare teams and clinical practice safer and more effective.

Language Barriers to Health Care in the United States

This perspective article was written and published back in 2006 by Glenn Flores, M.D. in the New England Journal of Medicine (N Engl J Med 2006; 355:229-231 - July 20, 2006) yet it remains dramatically and sadly true today, 6 years later.

A 12-year-old Latino boy arrived at a Boston emergency department with dizziness and a headache. The patient, whom I’ll call Raul, had limited proficiency in English; his mother spoke no English, and the attending physician spoke little Spanish. No medical interpreter was available, so Raul acted as his own interpreter. His mother described his symptoms:

La semana pasada a el le dio mucho mareo y no tenía fiebre ni nada, y la familia por parte de papá todos padecen de diabetes.”(Last week, he had a lot of dizziness, and he didn’t have fever or anything, and his dad’s family all suffer from diabetes.)

“Uh hum,” replied the physician.

The mother went on. “A mí me da miedo porque el lo que estaba mareado, mareado, mareado y no tenía fiebre ni nada.” (I’m scared because he’s dizzy, dizzy, dizzy, and he didn’t have fever or anything.)

Turning to Raul, the physician asked, “OK, so she’s saying you look kind of yellow, is that what she’s saying?”

Raul interpreted for his mother: “Es que si me vi amarillo?” (Is it that I looked yellow?)

“Estaba como mareado, como pálido” (You were like dizzy, like pale), his mother replied.

Raul turned back to the doctor. “Like I was like paralyzed, something like that,” he said.

If Raul received inappropriate care owing to his misinterpretation, he would not be alone. One interpreter, mistranslating for a nurse practitioner, told the mother of a seven-year-old girl with otitis media to put (oral) amoxicillin “in the ears.” In another case, a Spanish-speaking woman told a resident that her two-year-old had “hit herself” when she fell off her tricycle; the resident misinterpreted two words, understood the fracture to have resulted from abuse, and contacted the Department of Social Services (DSS). DSS sent a worker who, without an interpreter present, had the mother sign over custody of her two children. Clearly, catastrophes can and do result from such miscommunication.

Some 49.6 million Americans (18.7 percent of U.S. residents) speak a language other than English at home; 22.3 million (8.4 percent) have limited English proficiency, speaking English less than “very well,” according to self-ratings. Between 1990 and 2000, the number of Americans who spoke a language other than English at home grew by 15.1 million (a 47 percent increase), and the number with limited English proficiency grew by 7.3 million (a 53 percent increase, see graph). Percentages of Americans Who Speak a Language Other Than English at Home or Who Have Limited English Proficiency.). The numbers are particularly high in some places: in 2000, 40 percent of Californians and 75 percent of Miami residents spoke a language other than English at home, and 20 percent of Californians and 47 percent of Miami residents had limited English proficiency.

Yet many patients who need medical interpreters have no access to them. According to one study, no interpreter was used in 46 percent of emergency department cases involving patients with limited English proficiency. Few clinicians receive training in working with interpreters; only 23 percent of U.S. teaching hospitals provide any such training, and most of these make it optional. Data collection on patients’ primary language and English proficiency is frequently inadequate or nonexistent. Although no federal statutes require the collection of such information, no statute prohibits it, either.

Language barriers can have deleterious effects. Patients who face such barriers are less likely than others to have a usual source of medical care; they receive preventive services at reduced rates; and they have an increased risk of nonadherence to medication. Among patients with psychiatric conditions, those who encounter language barriers are more likely than others to receive a diagnosis of severe psychopathology — but are also more likely to leave the hospital against medical advice. Among children with asthma, those who confront language barriers have an increased risk of intubation. Such patients are less likely than others to return for follow-up appointments after visits to the emergency room, and they have higher rates of hospitalization and drug complications. Greater resources are used in their care, but they have lower levels of patient satisfaction.

Inadequate communication can have tragic consequences: in one case, the misinterpretation of a single word led to a patient’s delayed care and preventable quadriplegia. A Spanish-speaking 18-year-old had stumbled into his girlfriend’s home, told her he was “intoxicado,” and collapsed. When the girlfriend and her mother repeated the term, the non–Spanish-speaking paramedics took it to mean “intoxicated”; the intended meaning was “nauseated.” After more than 36 hours in the hospital being worked up for a drug overdose, the comatose patient was reevaluated and given a diagnosis of intracerebellar hematoma with brain-stem compression and a subdural hematoma secondary to a ruptured artery. (The hospital ended up paying a $71 million malpractice settlement.)

In 1998, the Office for Civil Rights of the Department of Health and Human Services issued a memorandum regarding the prohibition, under Title VI of the Civil Rights Act of 1964, against discrimination on the basis of national origin — which affects persons with limited English proficiency. This memorandum states that the denial or delay of medical care because of language barriers constitutes discrimination and requires that recipients of Medicaid or Medicare funds provide adequate language assistance to patients with limited English proficiency. In 2000, a presidential executive order was issued on improving such persons’ access to services. Thirteen states currently provide third-party reimbursement (through Medicaid and the State Children’s Health Insurance Program) for interpreter services. Unfortunately, most of the states containing the largest numbers of patients with limited English proficiency have not followed suit, sometimes citing concerns about costs. Although the Office for Civil Rights issued guidelines in 2003 that seem to allow health care facilities to opt out of providing language services if their costs are too burdensome, Title VI provides no such exemption.

Ad hoc interpreters, including family members, friends, untrained members of the support staff, and strangers found in waiting rooms or on the street, are commonly used in clinical encounters. But such interpreters are considerably more likely than professional interpreters to commit errors that may have adverse clinical consequences. Ad hoc interpreters are also unlikely to have had training in medical terminology and confidentiality; their priorities sometimes conflict with those of patients; and their presence may inhibit discussions regarding sensitive issues such as domestic violence, substance abuse, psychiatric illness, and sexually transmitted diseases. It is especially risky to have children interpret, since they are unlikely to have a full command of two languages or of medical terminology; they frequently make errors of clinical consequence; and they are particularly likely to avoid sensitive issues. Given the documented risks associated with the use of ad hoc interpreters, it is of concern that the 2003 guidance from the Office for Civil Rights states that such use “may be appropriate.”

Later this year, the California legislature will consider a bill prohibiting state-funded organizations from using children younger than 15 years of age as medical interpreters. Leland Yee, the California speaker pro tempore, proposed the bill, prompted by his experiences interpreting for his mother and, later, as a child psychologist. The bill requires organizations receiving state funding to establish a procedure for “providing competent interpretation services that does not involve the use of children.”

Although this legislation may emerge as a state model, as an unfunded mandate, it will have limited power to improve care. Perhaps the time has come for payers to be required to reimburse providers for interpreter services. The provision of adequate language services results in optimal communication, patient satisfaction, outcomes, resource use, and patient safety. A 2002 report from the Office of Management and Budget estimated that it would cost, on average, only $4.04 (0.5 percent) more per physician visit to provide all U.S. patients who have limited English proficiency with appropriate language services for emergency-department, inpatient, outpatient, and dental visits. This seems like a small price to pay to ensure safe, high-quality health care for 49.6 million Americans.

SOURCE INFORMATION

Dr. Flores is director of the Center for the Advancement of Underserved Children and a professor of pediatrics, epidemiology, and health policy at the Medical College of Wisconsin and the Children’s Research Institute of the Children’s Hospital of Wisconsin, Milwaukee.

Glenn Flores, M.D.- New England Journal of Medicine 2006; 355:229-231 July 20, 2006 - original article: http://www.nejm.org/doi/full/10.1056/NEJMp058316

EMA boosts EU transparency with online publication of suspected side effect reports

 

 

 

Member States and the Agency release data on medicines in compliance with EudraVigilance access policy

31/05/2012 – The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: http://www.adrreports.eu. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency’s continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

The information published today relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing-authorisation holders. These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorised medicines.

A side effect (also known as an adverse drug reaction) includes side effects arising from use of a medicine within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and those associated with occupational exposure.

All information on the website relates to suspected side effects. Suspected side effects may not be related to or caused by the medicine, and as a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful. All users of the website are asked to read and accept a disclaimer explaining how to understand the information before they view a web report.

Medicines are an important part of modern healthcare, providing effective treatments for many diseases and conditions. For a medicine to be authorised for use in the EU the benefits of the medicine must always outweigh the risks.

Today’s launch also highlights the importance of side effect reporting and pharmacovigilance in safeguarding public health within the EU. Side-effect reporting is a key element in ensuring the detection of new or changing safety issues, and the Agency continues to further strengthen its work with partners and stakeholders across Europe to ensure a robust system for safety signal detection.

In June, the Agency will launch the website in the remaining 22 official EU languages.

Press release issued May 31st, 2012 on the EMA website – http://www.ema.europa.eu

European Medicines Agency publishes new versions of controlled vocabularies

The European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines

The European Medicines Agency has published a set of updated versions of Extended EudraVigilance product report message (XEVMPD) controlled vocabularies. These vocabularies support marketing authorisation holder compliance with Article 57(2) of the 2010 pharmacovigilance legislation, which requires marketing-authorisation holders to submit information to the Agency electronically on all medicines for human use authorised in the European Union by 2 July 2012.

The controlled vocabularies will be updated regularly to improve the standardisation of the terminology used in the electronic submission of medicinal product information to the Agency.

A marketing-authorisation holder that has already submitted medicine information to the Agency using the previous version of the controlled vocabularies is not required to resubmit this information. Marketing-authorisation holders are required to use the latest versions of the controlled vocabularies for submissions of medicine information as soon as they are published on the Agency’s website.

The updated controlled vocabularies are available on the EMA website

And the winner is….

It seems The Stinging Nettle totally honored its name. I was amazed at the number of aggressive, sometimes even insulting comments and e-mails we’ve been receiving since the beginning of this action – it’s just fascinating how many people felt personally attacked. Anyway – here’s the promised result ;)

Whoever works in the medical translation field should be aware of the numerous existing standards (DIN/EN/ISO…) in this industry. Often, these standards even state the exact wording of entire segments. We’ve been so far expecting from translators to be able to identify whether a piece of text is subject to a certain standard (or could be) and accordingly conduct a search or contact us and simply ask. In this specific case, the relevant standards to use were DIN EN 980:2008-08 “Symbols for use in the labeling of medical devices; German version” and the draft standard DIN 6877-1:2007-12 “Magnetic resonance equipment for human use – Part 1: Instructions for labeling items within the controlled area”.

“Keller”, though not specialized in medical device texts, submitted a translation that was the closest in line with the rules of these standards and therefore earns the 50€. “S.W” (who’s no medical translator either) and “AL” did realize that those were texts that were probably set in standards but unfortunately did not submit any proposal.  I found “Michael’s” proposal very interesting as well – he is not a translator but his translation was qualitatively not different from many proposals.

You can read all proposals here and here

What did we learn?

None of the translators who participated knew the standards. Some found them as they were researching and translated correctly but most would probably have made a “wrong” translation of the segments. It occurred to us that during our time as freelancers, no agency ever said to us that a given part of the text was subject to a given standard nor ever provided us with these standard existing translations available (though this does not completely apply for pharmaceutical texts as some agencies take the time and provide their translators with all standards). We came therefore to the decision that, in the future, we will be informing our translators when we give them a new project where standards apply and make those standards available to them.

I would like to thank all translators who participated. It was an interesting experience and we did learn something. We hope that translators in the future will also pay more attention to regulatory requirements in the medical technology field, and keep themselves up-to-date with these as well.
The next “translation survey” is already in the oven and we’d be delighted if you decide to participate again, or participate for the first time!

The underestimated importance of medical interpreters…

This video was made by TAHIT (Texas Association of Healthcare Interpreters and Translators) to promote the use of interpreters in a clinical setting.
We just love it. It’s so strong and powerful…

Watch out! A new trend in pharma marketing – GIGO – SEO

In the past few months, we were involved in localizing various websites targeting certain patient populations. These projects were all sponsored/run by big pharma and these websites all claim to provide useful information, e.g. for people interested in participating in clinical studies or supporting patient education on health problems.

After a while it became obvious that most of these websites contain highly SEO optimized content serving only one purpose:  driving traffic to the pharma companies’ websites or their dedicated websites for given products/clinical studies.

Since these sites are extremely SEO optimized, which results in high rankings in the various search tools, they divert traffic from more impartial websites run e.g. by patient organizations.

Some might consider this a highly questionable trend in itself, but this is not my point.

The problem for me lies in the fact that huge parts of these web pages’ content seem to be created by marketing copy writers – it seems they’re given a list of SEO keywords, and they just have to produce page after page after page using these keywords.

Wrong and even dangerous contents

In contrast with what you would expect from a responsible pharma company, nobody seems to check this content, which results in statements such as:

-    The objective in diabetes treatment is to achieve the lowest possible blood glucose level.
This is not only wrong, but also extremely dangerous, as this would cause hypoglycemic coma.

-    The red blood cells transport oxygen to the lungs
This is plain wrong. The red blood cells transport oxygen from the lungs to the tissue.

-    Hemoglobin transports the carbon dioxide to the lungs
I consider this statement as being incorrect too, since only 5-10 percent of the carbon dioxide is transported by hemoglobin.

These examples have been edited so that you can’t identify the respective websites, but their aim is to help you understand my point that these websites don’t even get the most basic medical facts right. Looking at more complex content, e. g. relating to cancer treatment, the situation isn’t any better.

Localization requires more than just translating contents

Another aspect of these websites solely created for SEO purposes, is that they really don’t care about the reader. Quite often you will find that:
-    the only contact option they offer is a toll free phone number in the US (on the localized pages) which you can’t even contact from abroad,
-    they only provide links to English sources such as patient organizations
-    there are no literature references in the target languages.

What this means to the translation industry

As a language service provider, our role is to raise these issues with clients. We should not contribute to multiplying wrong or even dangerous content by translating it. We should also stress the fact that localization requires more than just translating the content.
By doing this we will not only help our clients by preventing costly legal actions if somebody gets harmed after following wrong instructions and by raising the quality of the content and giving the websites a more professional image. Badly localized websites also damage the reputation of our own industry, as many readers might believe it was the translator who introduced these errors.