Pharmacist’s Corresponding Responsibility

The responsibility for the proper prescribing and
dispensing of medications lies primarily with the
prescribing practitioner. However, a corresponding
responsibility rests with the pharmacist who fills
a prescription order. The DEA recommends that a
pharmacist scrutinize each prescription. Some things to
look for are quantities, directions, or dosages that differ
from usual medical usage or practice. Check to see if the
prescription has been presented in a reasonable length
of time since the prescriber wrote it. If the patient is
returning too frequently or refilling the same prescription
on a weekly or even a daily basis, it may be fraudulent.
To prevent diversion, know the patient and his or her
medication history. Get to know your prescribers and
their signatures and DEA registration numbers. If you
see anything that is suspicious, call the prescriber using
the telephone book or your record of his or her telephone
number and not the number on the prescription for
verification or clarification. If you believe that you have
received a forged, altered, or counterfeit prescription, do
not dispense it. Call your local police department.

Source found here

Office Use in Kansas

Office Use Prescriptions
The Board has been asked on occasion whether
an “office use” prescription is valid. The answer is
no. Medications prescribed must be dispensed to a
patient. When medication is sent from a pharmacy to a
practitioner for administration, the transfer is considered
a distribution.
The transfer of a prescription medication is permitted
from one pharmacy to another pharmacy or practitioner.
The transfer must be documented with an invoice record.
The invoice record must have the name, strength, form of
the medication, the name and address of both the seller
and the purchaser, and the date of the sale. This record
should be maintained for five years with your pharmacy
records.
If the transfer is a controlled substance, the invoice
must also include the DEA number of both the seller
and the purchaser. If the medication is a Schedule II
medication, the purchaser must provide a DEA Form 222
to the seller before the transfer is completed.
A retail pharmacy may transfer prescription drugs to
another retail pharmacy to alleviate a temporary shortage,
except that the gross dollar value of these transfers
shall not exceed 5% of the total prescription-only drug
sales revenue of either the transferor or the transferee
pharmacy during any period of 12 consecutive months.
If a pharmacy is selling more than 5% they should be
registered as a wholesale distributor
Source found here

Officials: Nat'l drug shortage having distinct effect in Az

Posted Dec 3, 2012, 8:38 pm

Lorri AllenCronkite News Service

PHOENIX – A national drug shortage is endangering patients’ health and forcing doctors, pharmacists and first responders to scramble to find supplies, according to experts who shared their stories with Cronkite News Service.

“It’s a terrible problem,” said Tom Van Hassel, vice president of theArizona State Board of Pharmacy and director of pharmacy at Yuma Regional Medical Center. “On any given day, there are 15-20 drugs we’re scrambling to find.”

Pharmacists, especially in rural Arizona, are paying more and spending more time to get drug supplies, Van Hassel said.

“These are drugs used every day in our hospital. I don’t think any hospital in the state has escaped this shortage,” he said. “When we’re out, we’re truly out. The nearest hospital is 150 miles away.”

Continue reading here

Legislators to look at drug shortages Doctors, medical administrators testify at hearing

Andrea K. Walker, The Baltimore Sun

6:57 p.m. EST, December 4, 2012

The staff at Anne Arundel Medical Center considered canceling some surgeries on a recent weekend because the hospital was running low on a common drug used to help bring people out from under anesthesia.

It is the kind of problem hospitals and doctors around the country continue to face as drug shortages that began a few years ago threaten the way everyday medicine is practiced.

The problem has persisted even after calls from Congress and President Barack Obama to find a solution and a federal investigation that found widespread abuses in the drug manufacturing and distribution system. Maryland lawmakers are jumping into the fray with plans to introduce legislation to tackle the issue at the state level.

On Tuesday, the Joint Committee on Health Care Delivery and Finance held a hearing to gather insights on what role the state could play.

Dr. Barry Meisenberg, chair of quality improvement and health systems research at Anne Arundel Medical Center, said the shortages force doctors to make tough decisions on how to treat patients. The hospital decided not to cancel surgeries that weekend, but Meisenberg said the issue was real.

"I used this as an example of how serious this has become," Meisenberg said.

State, FDA could have prevented meningitis outbreak, official says

Updated: Tuesday, 04 Dec 2012, 1:14 PM EST
Published : Tuesday, 04 Dec 2012, 1:14 PM EST

• Matt Murphy, State House News Service

BOSTON (State House News Service) - As the state’s pharmacy board considers final regulations to improve oversight of retail and compounding pharmacies, some in the industry believe it was the lack of enforcement of existing rules that led to a deadly fungal meningitis outbreak.

“In retrospect, we feel this situation could have been prevented if either the FDA or the Board of Pharmacy enforced the regulations already on the books,” Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, told the News Service Tuesday after testifying before the board.

Brown and David Miller, of the International Academy of Compounding Pharmacists, offered feedback Tuesday to the Board of Registration in Pharmacy on emergency regulations put in place Nov. 1 following the linkage of the meningitis outbreak to tainted steroids produced by the New England Compounding Center in Framingham.

Only three people testified on the regulations that apply to an industry that has come under scrutiny in Massachusetts and at the federal level in the wake of the outbreak.

Brown called it “ironic” that a Massachusetts pharmacy would be responsible given the relatively strict regulations already in place, and he called NECC an “outlier” that flaunted the state’s regulations and yet their violations went undetected.

Board president James DeVita and counsel Heather Engman alone were on hand to collect public comment on the regulations adopted at the direction of Gov. Deval Patrick in early November. The state at that time also permanently revoked NECC’s pharmacy license and Patrick established a special commission to report back before the end of the year on legislative steps the state could take to improve its oversight and pharmacy licensing laws and regulations.

The board also began periodic, unannounced inspections of compounding labs in the state.

While the regulations governing Massachusetts-based pharmacies are already strong, according to Brown and Miller, both said they had concerns that there was no registration process for out-of-state pharmacies doing business in Massachusetts. Georgia and Pennsylvania are the only other two states that don’t require out-of-state registration.

“It is a concern to us whenever we see a board that doesn’t have the same type of protections for citizens of pharmacies and compounding pharmacies outside its borders,” Miller said.

Brown said he has been in contact with legislators who have agreed to file legislation regarding the registration of out-of-state pharmacies in Massachusetts, though he declined to name lawmakers with whom he has been working.

Continue reading here

Pharmacists request changes in state regulations adopted after meningitis outbreak

Pharmacists request changes in state regulations adopted after meningitis outbreak

Pharmacy representatives slam state’s new emergency regulations

Pharmacy representatives slam state’s new emergency regulations

Reform is Coming: The Purpose of This Blog Has Been Accomplished

When I began this blog in March 2012, I was stunned at the lack of education and knowledge about compounding in the veterinary and medical world.  I have learned so much since beginning this blog. I hope you have to.  In the beginning of this blog, I could foresee a tragic event such as the NECC meningitis outbreak happening.  I hoped it wouldn't.  I hoped the worst of tragedies had already been seen in cases such as Franck's, and Apothecure and similar cases, but I knew the odds were great that something bad would happen based on the way things were done or not done in the compounding world and when it did happen it would be big.  The one good thing that can possibly come out of that big bad thing is reform of the compounding world--better knowledge, better education, better procedures, better practices, better communication, better enforcement, better everything.  It is not enough for organizations to point their finger at the federal government.  All share in the blame. All must take responsibility and all must work together to improve the situation to make sure nothing like the NECC meningitis outbreak happens again.  Whether the federal government passes some sort of legislation and takes over most of the jurisdiction of compounding or the states keep the jurisdiction and strengthen the teeth of the rules and regulations they have, reform is needed and I have no doubt reform is headed our way.  There is much left for many to do.  There is much knowledge to be gained.  There is much education that still  must be accomplish.      

Fungal Meningitis From Injections: Not Even Close To Over

There’s been an extraordinary outbreak going on over the past few months here in the United States: cases of fungal meningitis, a rare illness, primarily caused by Exserohilum rostratum, a plant pathogen that is equally rare as a cause of human infections. Since the beginning of October, 541 people have been made ill by the infection, in 19 states, and 36 have died. The cause has been traced to contamination in steroid injections for pain relief, made by a compounding pharmacy in Massachusetts which — according to federal investigative reports — was operating outside the lines of what compounding pharmacies are allowed to do. More than 14,000 people are believed to have received the shots.

I haven’t been covering the outbreak because I’ve been following other stories, and also because friends in the mainstream media, particularly the excellent health-science team at the Boston Globe, have been covering it well. (Here’s an archive from their paid site and one from their free site.) But last night I happened to get a close and moderately exclusive look at this complex story, so I thought I’d share.

The back-story: I am on the board of the Association of Health Care Journalists. One of the many things AHCJ does is to offer grant-funded training programs and fellowships for writers. This week, our 2012-13 Regional Fellows (who are funded by the Leona M. and Harry B. Helmsley Charitable Trust and this year come from Tennessee, Mississippi, Alabama, Florida, Georgia and South Carolina) are getting an inside look at the operations of the Centers for Disease Control and Prevention here in Atlanta. Last night, the group got a personal briefing on the meningitis outbreak from Dr. John Jernigan, who is the CDC’s director of the Office of Health Associated Infections Prevention Research and Evaluation, and the clinical lead in the meningitis investigation.

When we follow disease investigations in the media, we tend to focus on the detective story: who got sick, how many of them there are, and how the cause was found. Once those questions are answered, for many reporters, the story is over. But what struck me, in Jernigan’s description of this outbreak, is that this story will continue long after most of the reporters covering it have moved on to other issues. These patients, it turns out, are facing unusually lengthy, high-dose, toxic and expensive treatment, with uncertain odds of success. Months after the injections were delivered, he said, it isn’t possible to say that any of these patents are cured; in fact, at this point, no one can say just how “cure” will be defined.

I live-tweeted Jernigan’s chat as it was delivered to our small group, and made a Storify of it afterward to share. Here you go.

Source found here

Malpractice Bills May Impact Meningitis Outbreak Victims

4 Dec, 2012 17:00 CET

In Michigan, a new set of medical malpractice bills before the state legislature may make recovery of damages difficult for victims and increase immunity for healthcare professionals.

The Daily Press and Argus reports that the bills may even limit the damages sought by the victims of the nationwide meningitis outbreak that has sickened 510 people and resulted in 36 deaths. Supporters of the bill deny any such impact on meningitis suits. Michigan has been one of the state’s hardest hit by the outbreak.

The bills have been awaiting approval by the state’s Senate Insurance Committee for several months.

Contaminated steroid shots mixed at the Massachusetts-based New England Compounding Center (NECC) have been linked to the recent meningitis outbreak by federal health officials.

Michigan law provides immunity to pharmaceutical companies from being sued if the product in question is an FDA-approved. But NECC can likely be sued because compounding pharmacies and their products do not come under the FDA’s oversight.

Source found here