News/Issues

Issues & Legislative Committee Report

February 9, 2006

JCAHO Update

According to the JCAHO, the current Random Unannounced Survey (RUS) process will be discontinued after December 31, 2007. Organizations surveyed, or due for survey, under the new Random Unannounced full survey are exempt from the RUS process. However, random unannounced evidence of standards compliance (ESC) validation surveys will start in January 2006. The Joint Commission will continue to conduct a 5% sample of supplemental unannounced surveys. As the number of RUS' is reduced, the number of ESC validation surveys will be increased to maintain the 5% sample size. For more information, visit www.jcaho.org.

Safety Issues

Materials Management aspects of patient safety include maintaining product integrity, rotating supplies to reduce opportunity for outdates, and focusing on product standardization to reduce variability in treatment where applicable.

Disaster Preparedness

New Funds Dedicated to Influenza Pandemic Preparation

In January 2006, $100 million dollars was apportioned among the states to fund preparations for an influenza pandemic. Initial grants were awarded to all 50 states, 7 territories, Puerto Rico, and Washington D.C. The funds should help accelerate and intensify current planning efforts for preparation and execution of a pandemic plan. To date, none of the funds have been earmarked to help hospitals make capital investments required in a pandemic such as ventilators or beds.

HHS has sought to foster planning by developing checklists for individuals and families as well as well as businesses and health departments to aid in preparedness. Additional information can be found at www.pandemicflu.gov.

Source:http://www.hhs.gov/news/press/2006pres/20060112.html

The President Proposes Pandemic Budget for Flu Vaccine

In a proposed $7.1 billion pandemic budget, President Bush devotes the bulk of the funds to the development and purchase of a flu vaccine, along with stockpiling antiviral medications. At press time, none of the President’s proposals included money specifically for hospital preparedness. A Senate version would funnel money to local communities including money for hospitals.

Source: HHN magazine, January 2006

Planning for Supplies in Possible Bioterrorism Attacks

Supply chain personnel are key to planning for supplies of all types and backup sources, including specific supplies needed for controlling potential biological agents. These supplies include patient, worker, and occupant protection as well as specific supply needs (i.e. masks and gloves). Many organizations are planning for a 90 day supply. The threat may come in the form of bacteria, viruses and poisons.

A good place to start preparing is to become familiar with advice and recommendations developed by organizations such as the CDC, APIC, and/or AHRQ. APIC has a template for healthcare facilities to “guide the development of practical and realistic response plans for their institutions in preparation for a real or suspected bioterrorism attack.”

Source: Healthcare Purchasing News, February 2006.

eCommerce

Reverse Auction, also referred to as "online reverse auction", or "e-sourcing" reverses the roles of buyer and seller. The buyer issues a request for quotes to purchase a particular item. Suppliers then respond with their price. This can also be done with commodity items. May things are taken into consideration other than pricing (i.e. quality, lead-tie, maintenance, or other value added services). Obviously internet technology has made this increasingly popular.

After analysis of savings based on direct and indirect costs, one must determine if a value proposition exists that would warrant participation. Brian Davis has had experience with Reverse Auctions and will possibly assist in submitting a paper regarding this subject in the future. As well, he will submit websites associated to Reverse Auctions.

Quality & Medication Errors

JCAHO Warns of Medication-reconciliation Errors

Medication accuracy when transferring patients and/or sending the patient home. Urges prescribed medications be highly visible on patient’s chart. Compare order with actual medications. Communication failures stem 63% of medication errors in JCAHO database. Half of which could have been avoided by medication reconciliation by Matthew DoBias.

Source: Modern Healthcare Daily Dose, February 1, 2006.

Top Hospitals Continue to Improve Faster

Top 5% of U.S. hospitals are pulling away in terms of improvement in risk adjusted patient mortality and complications rates from 2002 to 2004. Twenty-seven percent lower average risk of dying per health grades. If extrapolated, and if all Medicare patients had been treated comparably to best hospitals, 152,966 lives may have been saved and 21,896 may have avoided major post-op complications.

Source: Joseph Conn, Modern Healthcare Daily Dose, February 6, 2006.

AHQA Sets New Rules

Criticism of Medicare quality improvement organizations from Congress contributed to a decision by the American Health Quality Association (AHQA) to release a new code of conduct. The code raises the bar for several areas: compensation, executive compensation, travel expenses, structure, composition and independence of boards, and conflicts of interest.

Source: Andis Robeznieks, Modern Healthcare, February 6, 2006, page 10.

Radio Frequency Identification (RFID)

The focus of RFID technology in healthcare is currently in the pharmaceutical industry to help protect customers from counterfeit drugs. Most articles in current news discuss huge forecasts in spending to prevent huge loses to counterfeit drugs. With all the discussion and forecasting, progress is slow due largely to cost, fear of early market hype, and legislation being “on hold”.

RFID Heats up Pharma Industry

The pharmaceutical industry is experiencing the implementation of RFID with it being adopted by Pfizer and West Pharmaceutical Services. FDA has already released the guidelines and recommendations for implementing RFID in the U.S. in order to prevent counterfeit drugs. With around 10 billion units being shipped from drug manufacturers to doctors, hospitals and pharmacies in the U.S. and Europe, the potential for application of RFID in the pharmaceutical industry is tremendous. With Pfizer spending $5 million on RFID and other drug companies also investing in implementing it, there is bound to be a drastic drop in counterfeit drugs case.

Source: www.rfidgazette.org/2006/01/rfid_heats_up_p.html

SupplyScape Launches Pharma Industry's First Authentication Service Able to Verify Drug EPCs before Dispensing

Seeking to help protect customers from counterfeit drugs, SupplyScape Corporation announced it has launched the SupplyScape RxAuthentication Service. For the first time, the serial number of each pharmaceutical package, called an Electronic Product Code (EPC), can be verified as authentic before the drugs are dispensed to U.S. consumers. The RxAuthentication Service leverages Radio Frequency Identification (RFID) tags to store the EPC of the drug package, which pharmacies and wholesalers can verify over the Web.

“Drug counterfeiting exceeds $32 billion worldwide each year," said Peter J. Pitts, a former FDA Associate Commissioner and member of the agency's Counterfeit Drug Task Force. "In fact, counterfeit drugs are growing approximately 16% annually, a rate which is much faster than the legitimate pharmaceutical business."

Source: www.genengnews.com

RFID Exploding into Pharma Industry

February 1, 2006 − Adoption of RFID hardware and software throughout the pharma industry is about to explode, spurred on by the push from industry organizations such as the US Food & Drug Administration (FDA) to implement RFID tags to combat sales of fake drugs, according to reports by market research analysts Gartner and Frost & Sullivan. Frost and Sullivan estimates that the revenue from the healthcare and pharmaceutical industries investing in RFID technology will rise almost six fold, from $370 million in 2004 to $2.3 billion in 2011. Over the next couple of years, RFID is likely to see a swift uptake within the healthcare market and several companies in the U.S. and Europe are already conducting pilots on the use of this technology.

"There is a significant focus on using RFID in pharmaceutical manufacturing because of the FDA's interest in using RFID tags to help combat diverting and counterfeiting," said Jeff Woods, research vice president at Gartner.

Source: www.in-pharmatechnologist.com/news/ng.asp?n=64786-gartner-frost-and-sullivan-rfid

Legislation Uncertainty Slows Adoption of Pharmaceutical RFID Tracking

February 6, 2006 − Oyster Bay, NY − A new ABI research study of RFID tracking in the pharmaceutical industry, anticipates that no more than 10 medications will be tagged on a large scale during 2006. This contrasts with the optimism of a year ago, when the evidence suggested a nearly 3.5-fold increase in life sciences RFID transponder shipments between 2005 and 2006.

According to Sara Shah, ABI Research's industry analyst for RFID and M2M research, the slowdown may be attributed to cost, as well as to a retreat from the "irrational exuberance" of early market hype and a desire to execute small-scale pilots before committing to full deployments.

One important inhibitor of this market concerns legislation "on hold". The U.S. Prescription Drug Marketing Act (PDMA) of 1988 requires biotech and pharmaceutical manufacturers to prove they have processes in place to prevent the diversion of drugs. This encompasses the idea of "pedigree", or the ability to trace a shipment's "chain of custody" at all stages from manufacturing to delivery.