Cardinal Health and Ohio State University College of Pharmacy have teamed up to 
curb prescription drug abuse in their communities by developing the Generation Rx 
toolkit, to help pharmacists work with concerned citizens, local schools and civic 
organizations to fight this growing social health problem in their communities. The 
online toolkit contains all of the communications materials needed to educate local 
schools and community organizations about the scope and consequences of 
prescription medication abuse and misuse. It also shares information about how to 
safely store and dispose of prescription medications; how to learn more about this 
problem; and action steps to prevent it. See: www.cardinalhealth.com/generationrx

Poisoning by powerful prescription painkillers, sedatives and tranquilizers; City-
living middle-aged women  particularly vulnerable --  According to Dr. Jeffrey H. 
Coben, West Virginia University School of Medicine, across the country, very 
significant increases in serious overdoses associated with these prescription drugs 
are being seen.  Between 1999 and 2006, US hospital admissions due to poisoning 
by prescription opioids, sedatives and tranquilizers rose from approximately 43,000 
to about 71,000. That increase of 65 percent is about double the increase 
observed in hospitalizations for poisoning by other drugs and medicines, Coben 
and colleagues found.  

Opioids -- examples include morphine, methadone, OxyContin and the active 
ingredient in Percocet -- are powerful narcotic painkillers that can be habit-
forming. Some examples of sedatives or tranquilizers include Valium, Xanax, and 
Ativan. 

Accidental - or unintentional -- poisoning by opioids, sedatives and tranquilizers 
rose by 37 percent during the 7-year study period, while unintentional poisonings 
by other substances increased by just 21 percent.

According to Dr. Coben, unintentional poisoning is now the second leading cause 
of unintentional injury death in the U.S.  Among people 35 to 54 years old, 
unintentional poisoning surpassed motor vehicle crashes as the leading cause of 
unintentional injury death in 2005.   

Even people who take opioid painkillers for legitimate medical reasons are at risk of 
overdosing. In a study reported by Reuters Health earlier this year, researchers 
followed nearly 10,000 adults who had received at least three opioid prescriptions 
within 90 days to treat chronic pain like back pain. Of these, 51 experienced at 
least one overdose, and six died as a result. The researchers also found that the 
higher the painkiller dose, the more likely the patients were to overdose.

In the current study, Coben's  team found that intentional poisonings - suicide, 
self-inflicted poisoning, or poisoning someone else -- from prescription opioids, 
sedatives, and tranquilizers more than doubled, from about 10,000 in 1999 to 
nearly 24,000 in 2006. That compared to just a 53 percent increase in intentional 
poisonings from other substances.  The biggest percent increase in 
hospitalizations for poisoning for a specific drug was a quintupling for methadone, 
according to the team's report published in the American Journal of Preventive 
Medicine. This may be due to the more than 10-fold increase in overall retail sales 
of this drug from 1997 to 2006.  Their findings stem from a comprehensive look at 
the US Nationwide Inpatient Sample, a database that contains records for roughly 
8 million Americans hospitalized annually.

What Needs to Be Done?

According to Dr. Coben, a multifaceted approach is needed to stem the tide in 
poisoning by opioids, sedatives and tranquilizers. "Doctors need to perhaps rethink 
the types and quantities of medications they are prescribing, and we need to get 
better messages out to the public in terms of the dangers associated with these 
medications and combinations of these medications that are being used."   
(SOURCE: American Journal of Preventive Medicine, April 2010)

The U.S. Food and Drug Administration today approved a new formulation of the 
controlled-release drug OxyContin that has been designed to help discourage 
misuse and abuse of the medication. OxyContin is made to slowly release the 
potent opioid oxycodone to treat patients who require a continuous, around-the-
clock opioid analgesic for management of their moderate to severe pain for an 
extended period of time. Because of its controlled-release properties, each 
OxyContin tablet contains a large quantity of oxycodone, which allows patients to 
take their drug less often. However, people intent on abusing the previous 
formulation have been able to release high levels of oxycodone all at once, which 
can result in a fatal overdose and contributes to high rates of OxyContin abuse.

The reformulated OxyContin is intended to prevent the opioid medication from 
being cut, broken, chewed, crushed or dissolved to release more medication. The 
new formulation may be an improvement that may result in less risk of overdose 
due to tampering, and will likely result in less abuse by snorting or injection; but it 
still can be abused or misused by simply ingesting larger doses than are 
recommended.

As with all opioids, safety is an important consideration,” an FDA official 
noted.  “Prescribers and patients need to know that its tamper-resistant 
properties are limited and need to carefully weigh the benefits and risks of using 
this medication to treat pain.”  According to the U.S. Substance Abuse and 
Mental Health Services Administration’s National Survey on Drug Use and Health, 
approximately half a million people used OxyContin non-medically for the first time 
in 2008. 

The manufacturer of OxyContin, Purdue Pharma L.P., will be required to conduct a 
post-market study to collect data on the extent to which the new formulation 
reduces abuse and misuse of this opioid. The FDA is also requiring a REMS (Risk 
Evaluation and Mitigation Strategy) that will include the issuance of a Medication 
Guide to patients and a requirement for prescriber education regarding the 
appropriate use of opioid analgesics in the treatment of pain.

The Drug Enforcement Agency (DEA) is posting in the Federal Register on 
Wednesday an interim final rule that would permit hospitals, healthcare providers, 
and pharmacies to use electronic prescriptions in the dispensing of controlled 
drugs. Comments on the rule will be open for 60 days.

The rule is similar to a regulation proposed by DEA in June 2008 for e-prescribing. 
That provision ran into trouble when federal healthcare providers told DEA that 
the approach proposed for the private sector was inconsistent with their existing 
practices and did not meet the security requirements for federal systems.

Under current regulations, while providers can create prescriptions electronically 
for controlled substances, those prescriptions are either printed out for signatures 
or faxed to a pharmacy. "True electronic prescriptions are transmitted as 
electronic data files to the pharmacy, whose applications import the data file into 
its database," the rule noted.

The new interim rule adds the option of using of biometric identifiers—such as a 
fingerprints, iris scans, or handprints—to help authenticate the identity of the e 
prescribing user. In the new regulation, users of e prescribing systems for 
controlled substances would have to prove their identities by using two out of 
three factors: something you know (passwords), something you have (tokens), or 
something you are (biometrics). In the new rule, DEA said it is allowing the use of 
a biometric as a substitute for a hard token or a password. If a hard token is 
used, it must meet specified security standards for cryptographic devices or one 
time password devices, and it must be stored on a device that is separate from 
the computer in use.

The rule addresses the use of controlled substances that "have a potential for 
abuse and psychological and physical dependence" such as opioids, stimulants, 
depressants, hallucinogens, and anabolic steroids. Controlled substances 
constitute between 10% and 11% of all prescriptions written in the U.S.

(Source: HealthLeaders Media Online) 

Eli Lilly and Company has issued a statement and details regarding the stolen 
company products from its distribution operations in Enfield, Connecticut on 
Sunday, March 14.  Lilly is working with the U.S. Food and Drug Administration and 
other law enforcement officials to recover cases of select lots of pharmaceutical 
products that were stolen from one of Lilly's U.S. distribution centers in Enfield, 
Connecticut, on Sunday, March 14, 2010.  For a list of stolen medicines see the 
above link. 

Product from the affected lots which had been delivered from Lilly to retailers, 
wholesalers or institutions prior to March 14 was approved for its intended use 
and is not affected by this event. Product containing these lot numbers has been 
distributed by Lilly within the United States, Puerto Rico and its territories. 

These medicines require a prescription for purchase. Consumers should purchase 
Lilly products only from well-established and reputable retailers. Lilly recommends 
that consumers always inspect the product and label for signs of tampering before 
opening.  Lilly is advising practitioners, retailers and consumers to check all 
pharmaceutical products for signs of tampering or damage prior to purchase 
and/or use. Pharmacists and other health care professionals should not use the 
product if it has been removed from the sealed bottle or container, if the 
induction seal has been compromised, or in the case of glass vials, if the flip cap 
appears to have been disturbed in any way.