The Royal Pharmaceutical Society of Great Britain’s Council is pressing the government for an
urgent change in legislation to decriminalise dispensing errors.

Under the Medicines Act 1968, pharmacists automatically commit a criminal offence each time
they make a dispensing error or a labelling error - and the Council has set out to champion the
case to change the law.

Experts on medical safety all agree that a disproportionate response to human errors makes
systems less safe, as accidents become hidden and driven underground, so no one learns
where the system is unsafe, so it cannot be made safer for others.

The Society is currently surveying pharmacists on its register to explore their views on
recording dispensing errors in a dispensing error log. The early results show the recent court
case where a pharmacist received a suspended sentence for a dispensing error has made
pharmacists reluctant to record dispensing errors. The survey showed 42.8 per cent of
pharmacists are now seriously concerned about recording dispensing errors. Pharmacists are
torn between doing the right thing - recording and learning from mistakes - and the risk of
incriminating themselves by making a record of a potential criminal offence.

Last week the Society threw its weight behind an online petition, started by grassroots
pharmacists, calling for decriminalisation of dispensing errors. A message was sent to all
members of the Society, urging them to sign the petition. The petition already has over 10,000
signatures from pharmacists and members of the public.

President Steve Churton said: “The law as it currently stands is outdated, manifestly unjust and
disproportionate. It discourages pharmacists from reporting errors and this plainly does not
serve the public interest.”

Society lay Council member, Alan Kershaw said: “I am not a pharmacist but as a member of
the public, I would expect the profession to be governed by the same principles as those that
apply to other healthcare professionals. Anyone can make an error, especially when under
pressure, and the consequences for a patient can be tragic. But for a pharmacist to
automatically face the prospect of the police on their doorstep, for a single error, is simply not
the best way to secure standards. It must discourage pharmacists from reporting and learning
from such errors. This cannot be in the public interest”.

Notes

The online petition can be viewed here.

1. The Society is an enforcement authority under the Medicines Act 1968 (’the Act’) and it also
has regulatory policies in place regarding dispensing errors. However, other organizations
such as the police and the Medicines and Healthcare products Regulatory Agency (MHRA)
also enforce certain provisions in the Act. The Crown Prosecution Service (CPS), who
prosecute on behalf of the behalf of the police, may institute criminal proceedings for serious
criminal breaches, for example, gross negligence manslaughter. There are therefore instances
where police/CPS involvement is wholly appropriate.

2. The MHRA is currently undertaking a project to consolidate and review the legislation. The
RPSGB has submitted a concept paper to the MHRA as part of their review project, available
on the website: http://www.rpsgb.org/pdfs/consdoc1754.pdf.

In this submission, the RPSGB has urged the MHRA to specifically review section 64 of the
Medicines Act 1968 with a view to exclude dispensing errors made by pharmacists.

Source
Royal Pharmaceutical Society of Great Britain

Medtronic, Inc (NYSE: MDT) announced the launch of the Shock-Less clinical trial. This trial will identify ways physicians can improve the quality of care for patients through optimal application of device-based tools designed to reduce unnecessary shocks in patients with implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices. Specifically, the Shock-Less study aims to create evidence that will increase the use of programming tools that reduce unnecessary shocks including features on Medtronic devices, such as Medtronic’s exclusive Lead Integrity Alert™ (LIA) and Anti-Tachycardia Pacing (ATP) During Charging™.

“Medtronic has pioneered the advances in shock reduction technology, supported by large randomized clinical trials, in the last several years; in fact, with current Medtronic programming and technology, frequency of shocks can be reduced by more than 63 percent,” said Marshall Stanton, M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “We are dedicated to supporting the use of those innovative programming tools with scientific research and education that will help physicians deliver the best possible therapy for their patients.”

While appropriate defibrillation therapy is proven to saves lives, unnecessary shocks can be reduced in several ways:

- Using proprietary device programming for Medtronic’s Anti-Tachycardia Pacing (ATP) During Charging to deliver painless pacing pulses to safely and effectively terminate dangerous ventricular tachyarrhythmias;

- Using Medtronic exclusives Wavelet™ SVT in single chamber ICDs and Medtronic’s PR Logic® in dual chamber ICDs to reduce shocks that may be delivered due to heart rhythms for which therapy is unnecessary (supraventricular tachycardias or non-sustained ventricular tachycardias);

- Using the Medtronic exclusive Lead Integrity Alert, the first continuous ICD monitoring technology that alerts clinicians and makes real-time device changes to reduce the potential of inappropriate therapy that may result from fractured leads.

- Maximizing device programming detection and therapy parameters to reduce shocks for non-sustained arrhythmias in Medtronic devices with short and consistent charge times.

“Despite the evidence, physicians are not maximizing the clinically proven programming tools to help reduce unnecessary shocks for their patients,” said Avi Fischer, M.D., principal trial investigator and assistant professor of Medicine and director of Pacemaker and Defibrillator Therapy at Mount Sinai Medical Center in New York. “Our aim is to document the differences in the way these devices are programmed and understand the barriers to using this proven therapy. We hope to better understand how outcomes and patient management can be improved through shock reduction.”

Physicians in the study will receive customized reports showing the reasons patients received shocks and analysis on how consistently their patient’s devices are programmed using the latest clinical evidence as compared to others in their region, and study-wide. Additionally, the trial is also designed to show how physicians change their device programming practices after shocks are delivered.

About Medtronic’s Shock-Less Trial

The prospective, quality improvement trial will enroll approximately 2,500 subjects at approximately 125 U.S. and Canadian medical centers. Medtronic implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) patients will be followed in the study for at least two years. Data will be gathered from device downloads as well as through Medtronic CareLink® Network transmissions, the industry’s largest remote monitoring network that currently allows more than 350,000 Medtronic patients worldwide to send cardiac device information automatically to more than 3,000 clinics in 20 countries.

Medtronic also will collect performance data on Medtronic’s proprietary shock reduction tool, Lead Integrity Alert™ (LIA); LIA is the exclusive continuous ICD monitoring technology that offers at least three days advanced warning in three out of four defibrillator patients with lead fracture. It safely and automatically increases the number of intervals required to detect VF (following detection of a lead fracture) to avoid treating lead fractures as VF.

LIA is available worldwide on Medtronic ICD and CRT-D devices. The latest LIA version for the newest portfolio of Vision 3D™ devices will be available in the U.S. in the coming months.

Medtronic Shock Reduction Research Medtronic continues to provide the broadest portfolio of scientific research in the area of shock reduction, including:

- ADVANCE III (Avoid Delivering Therapies for Non-Sustained Arrhythmias in ICD Patients III) is an ongoing trial to determine if Medtronic ’s Anti-Tachycardia Pacing (ATP) During Charging and extending the time to detect and treat arrhythmias safely, can reduce the necessity for shock therapy in all ICD-indicated patients.

- ADVANCE CRT-D (ATP Delivery for Painless ICD Therapy in CRT-D) showed that ATP for fast ventricular tachycardias is safe and effective in CRT candidates, and patients with coronary artery disease benefit more from biventricular ATP.

- ADVANCE-D (ATP Delivery for Painless ICD Therapy) is an ongoing trial comparing different ATP therapies to optimize success of painless therapies for ventricular tachyarrhythmias in patients with ICDs.

- COMFORT (Concept of Optimal Management of Ventricular Fibrillation or Very Fast Ventricular Tachycardia) is evaluating the efficacy and safety of ATP and low energy cardioversion for ventricular arrhythmias in patients with ICDs.

- EMPIRIC (Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter-Defibrillators) proved that now standardized Medtronic device settings are as safe and effective as individual, physician-tailored device settings to reduce shocks.

- ENTRUST originally demonstrated the safety and efficacy of ATP During Charging, which delivers painless ATP therapy during capacitor charging and prevents delay of shock therapy when needed.

- PainFREE Rx and PainFREE Rx II (Pacing Fast Ventricular Tachycardia Reduces Shock Therapies) showed that three out of four shocks are eliminated using ATP, thus improving quality of life.

- PREPARE (Proven Shock Reduction for Primary Prevention Patients) showed a 63 percent reduction in unnecessary shocks for primary prevention patients.

- GEM DR showed that Medtronic’s PR Logic® dual chamber rhythm detection resulted in more accurate tachyarrhythmia therapy to help reduce inappropriate shocks.

- RELEVANT (Registry on Left Ventricular Dysfunction and Non-ischemic Ventricular Tachyarrhythmias) showed that extending the time an ICD takes to detect and treat arrhythmias is safe and effective in reducing shocks for non-ischemic primary prevention heart failure patients.

- WAVE (Worldwide Application of Marquis VR Enhancements) showed that the Medtronic exclusive Wavelet™ SVT discrimination feature in single chamber ICDs reduced inappropriate therapy by 78 percent.

- SATISFACTION (Survey on Antitachycardia Pacing Strategy for the Termination of Fast Ventricular Tachycardia in Japanese Implantable Cardioverter-Defibrillator Population) will determine the efficacy of ATP to painlessly terminate ventricular tachycardias in Japanese ICD and CRT-D patients.

Medtronic and the University of Minnesota are hosting an educational session, “Unnecessary Shocks: What Are You Doing?,” on shock reduction during Heart Rhythm 2009, the annual congress of the Heart Rhythm Society at 7 p.m. ET Wednesday, May 13, 2009, at the Boston Marriott Copley Place in Boston. Pre-registration is required.

Source
Medtronic, Inc.

The SNM Clinical Trials Network, an initiative designed to address the need for streamlined drug discovery through the integration of imaging biomarkers into multi-center clinical trials, recently added Genentech, Inc. as a supporter.

SNM, the world’s largest medical and scientific society for molecular imaging professionals, inaugurated the Clinical Trials Network in late 2008 to facilitate more cost-effective drug development through the integration and standardization of imaging biomarkers into Phase 1, 2, 3 and 4 therapeutic clinical trials. As part of this initiative, the society continues to bring together pharmaceutical developers, the imaging community, biomarker manufacturers and regulatory agencies to address critical needs for incorporating imaging biomarkers into multi-center trials. A formal introduction to the Clinical Trials Network was provided at a two-day workshop in Clearwater Beach, Fla. in February 2009 and additional educational sessions about the network are planned for June during SNM’s 56th Annual Meeting in Toronto, Canada.

“We are gratified to have Genentech - a pioneer in the field of developing targeted therapeutics - join us in this important endeavor, which we hope will broaden the scope and effectiveness of today’s medical practice and lead to improved patient care in the near future,” said Peter S. Conti, M.D., Ph.D., co-chair of the SNM Clinical Trials Network and professor of radiology, pharmacy and biomedical engineering at the University of Southern California. “We are pleased that such an innovative corporate leader supports our mission of advancing molecular imaging and therapy.”

The use of imaging in clinical trials can help pharmaceutical developers determine earlier in the development process whether a new product is clinically promising by allowing physicians to see and assess whether it is working as intended for a patient, explained Dr. Conti.

“Molecular imaging is an essential component of such studies since it accelerates the development of promising compounds and eliminates those without apparent patient benefit earlier in the development cycle,” he added. “We hope that Genentech’s collaboration with SNM will help improve patient treatment worldwide.”

Source:
Amy Shaw

Society of Nuclear Medicine