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. 

The Food and Drug Administration added a boxed warning to the anti-blood 
clotting drug Plavix (clopidogrel), alerting patients and health care professionals 
that the drug can be less effective in people who cannot metabolize the drug to 
convert it to its active form. 

Plavix reduces the risk of heart attack, unstable angina, stroke, and 
cardiovascular death in patients with cardiovascular disease by making platelets 
less likely to form blood clots. Plavix does not have its anti-platelet effects until it 
is metabolized into its active form by the liver enzyme, CYP2C19.

People who have reduced functioning of their CYP2C19 liver enzyme 
cannot effectively convert Plavix to its active form. As a result, Plavix may be less 
effective in altering platelet activity in those people. These “poor metabolizers” 
may not receive the full benefit of Plavix treatment and may remain at risk for 
heart attack, stroke, and cardiovascular death. In May 2009, the FDA added this 
warning to the drug’s label. After reviewing more data, the agency felt it was 
important to highlight this risk in a boxed warning.

It is estimated that 2 percent to 14 percent of the U.S. population are poor 
metabolizers. The FDA recommends that health care professionals consider 
alternative dosing of Plavix for these patients, or consider using other anti-
platelet medications. Tests are available to assess CYP2C19 genotype to 
determine if a patient is a poor metabolizer.

According to FDA, patients should not stop taking Plavix unless told to do so by 
their health care professional. They should talk with their health care professional 
if they have any concerns about Plavix.

A small study suggests that older psychiatric inpatients may be a “vulnerable 
target” for polypharmacy and are, in fact, frequently discharged with multiple 
medications that have potentially hazardous interactions, according to data 
reported at the European Psychiatric Association 18th European Congress of 
Psychiatry.

Researchers presented the results of a study that assessed the extent of 
polypharmacy and potential drug interactions in 25 elderly psychiatric inpatients 
at the time they were discharged from the hospital to their home, a nursing home, 
or residential care. Eighty percent of individuals over age 75 years take at least 1 
prescription medication, with 36% taking 4 or 5 medications," according to the 
study director.

Multiple Medications at Discharge

For this study, the researchers identified potential interactions by entering 
information on the patient’s medication prescriptions as documented in their 
medical records on a UK Website known as www.BNF.org. The organization aims 
to provide UK health professionals with authoritative and practical information on 
the selection and clinical use of medicines in a clear, concise, and accessible 
manner.  Overall, 8 patients (32%) had prescriptions for 4 or fewer medications at 
discharge, 10 (40%) had 5 to 8 prescriptions, and 7 (28%) had 9 or more 
prescriptions at discharge. The median number of prescriptions at discharge was 
6.5. The median number of hazardous interactions was 3.1.  A prescription for 6 or 
more medications was more likely to cause drug-drug interactions and hazardous 
drug-drug interactions. 
Preventing Polypharmacy 

To improve patient outcomes, Dr. Kumar the study author echoed prior published 
recommendations: including:  
Know your patient well before starting treatment;
 
Order a treatment package, not just a prescription;
Educate the patient;
 
Choose the right medicine;
 
Ensure that the patient takes the medication;
 
Use as few drugs as possible;
 
Tailor the treatment to the patient’s needs;
 
Familiarize yourself with the drug;
 
Have a high index of suspicion; and
 
Consider the patient’s viewpoint.
The psychiatrist may need to work with nurses and social workers to ensure that 
these recommendations are implemented given that older patients may have 
difficulty in communicating. He also said that a dedicated in-house pharmacist 
may be pivotal in reducing the risk of polypharmacy in elderly psychiatric 
inpatients.

In her latest column, Carolyn M. Clancy, M.D., Director of the Agency for 
Healthcare Research and Quality (AHRQ), highlights for consumers information on 
two common medicines used to treat high blood pressure, and explains the steps 
individuals can take to find the medicine that works best for them.