October 2005
South Dakota State Board of Pharmacy
4305 S Louise Ave, Suite 104, Sioux Falls, SD 57106
NEW REGISTERED PHARMACISTS
The following candidates recently met licensure requirements and were registered as pharmacists in South Dakota: Stacey Bear, Kari Bitzer, Abigail Bockholt, Thomas Chiu, Rodney Haars, Amber Hanson, Britt Hofer, Dustin Horning, Patrick Huska, Travis LaCore, Chad Panning, Magan Rasmussen, Vicki Riemer, Jennifer Rydell, Levi Sanderson, Beth Sieler, Kristi Walth, Amanda Welsh, Kristi Zeeb.
PHARMACY LICENSES
A pharmacy license was recently issued to: Shane Clarambeau, Brothers Pharmacy d/b/a Northside Pharmacy, Huron.
PHARMACY TECHNICIANS THIS IS A REMINDER THAT PHARMACY TECHNICIANS ARE REQUIRED TO RENEW THEIR REGISTRATION BY OCTOBER 31. FORMS WILL BE SENT TO PHARMACIES TO FACILITATE THE RENEWALS |
A PHARMACIST’S RESPONSIBILITY
A recent article appeared in Pharmacy Practice News July 2005 which was a good reminder of what responsibilities a pharmacist should remember.
Many pharmacists believe that if they fill and label prescriptions correctly, they have done their job. This may have been the case many years ago when the ultimate discretion over the drug’s usage remained the doctor’s call.
Today, pharmacy practice and the courts have extended the pharmacist’s sphere of liability all the way to the ultimate usage of the dispensed drug. This means a pharmacist could be held liable in court for a drug misused by a physician, nurse, or patient because the pharmacist failed to inform or manage how a drug was used, stored or controlled.
One example was in a hospital where a nurse was recently accused of allegedly murdering patients with the neuromuscular blocker mivacurium chloride. The plaintiff’s lawyer accused the pharmacist of negligence because the pharmacist-in-charge had supervisory, management and policy-making duties with respect to overseeing the hospital staff’s use and stocking of drugs on the unit.
Another case involved the misuse of Methylene Blue. To test for CSF leak, the neurosurgeon injected 8 ml of methyene blue into the subarachinoid space to try and determine the leak. The leak was never found. The patient, however developed arachnoiditis, a condition that causes severe neurologic deficits.
Package inserts for methylene blue made by various manufacturers clearly state that methylene blue should not be given by intrathecal (intraspinal) injection as neural damage has occurred, and has been reported as far back as the 1960’s.
Does a pharmacist working in the main pharmacy have a duty to know how a surgeon is going to use the methylene blue? Probably not; however, if methylene blue is ordered by a neurosurgeon--probably yes, especially if the pharmacist is working in a surgery satellite.
The learning point of this message is that whether you are the pharmacist-in-charge or a staff pharmacist working by yourself, today you need to ask questions, talk to patients, doctors, and nurses. Knowing what the medicine is and how it will be used will prevent harm to patients and a possible lawsuit.
Missing medications are every pharmacist’s responsibility. Never provide another dose of a drug when the only information you are given is the medicine is not available or lost. The medication may have been given to the wrong patient or sent to the wrong unit, the drug may have even been stolen. Ignorance won’t limit your liability as far as it relates to safe drug use whether in a hospital or retail pharmacy.
FENTANYL TRANSDERMAL PATCHES
The FDA has been conducting investigations into reports of serious side effects and deaths due to overdoses of fentanyl in patients using fentanyl transdermal patches for pain control.
The FDA is urging everyone who prescribes, dispenses, or administers fentanyl patches to thoroughly review the recent FDA Pubic Health Advisory and an alert from the makers of fentanyl patches (Janssen) at www.ismp.org/MSAarticles/fdasafetyalerts.htm.
The Institute for Safe Medical Practice (IMSP) has long been concerned that transdermal fentanyl is often prescribed and dispensed without proper consideration of patient selection criteria, starting dose recommendations, contraindications, dose adjustment recommendations and safe administration procedures.
Just recently a nurse practitioner reported to IMSP the death of a family member who was using fentanyl patches. The patient was a 77-year-old lady who died in March due to misprescribing, inadequate patient education, and subsequent confusion about how to use a fentanyl patch.
One week prior to her death she was given hydrocodone and acetaminophen 5mg/500mg four times daily for sciatic pain. She took four doses daily for a week, but still was in pain. She contacted a primary care physician who prescribed fentanyl 50 mcg per hour patches to be applied every 48-72 hours. She received a box of five patches. The pharmacist did not provide any education regarding proper use of the patch. Not understanding how the patch actually works, the patch was applied to the buttock with a friend’s help.
When the lady went to bed she used a heating pad on her lower back/buttock area as was her usual practice. After two days of not hearing from the lady, a friend went to her apartment and found her dead in bed. Three patches were left in the box and it was unconfirmed but suspected that she may have used a second patch because of the directions “apply every 48-72 hours”.
Several errors contributed to this fatality. First, the patient was not an appropriate candidate for a fentanyl patch. The manufacturer states that these patches should only be used on patients receiving or who have received opioid therapy and demonstrated tolerance to opioids, and who require a total daily dose at least equivalent to 25 mcg per hour of fentanyl patch.
Patients who are considered opioid tolerant are those who have been taking at least 60 mg of oral morphine daily or 30 mg of oral oxycodone daily, or 8 mg of oral HYDROmorphone daily. Use of this type of drug when this patient was not tolerant led to her death from respiratory depression.
Compounding the problem was the higher than recommended starting dose. The prescribed 48-hour dosing interval was inappropriate for this patient. Only when a patient does not achieve adequate analgesia on the 72-hour regimen and a dose increase to a stronger patch for 72 hours should adjusting dosing intervals be considered.
Unfortunately, the pharmacist did not question the initiation of the fentanyl therapy, the strength prescribed, the dosing interval and did not provide counseling. Neither the physician nor the pharmacist warned the patient about applying heat. Patients who experience an increase in body temperature or are exposed to external heat sources such as hot tubs, heating pads, saunas, or water beds may have a sudden and possible dangerous increase in fentanyl absorption.
Due to the risk of serious or life threatening hypoventilation, fentanyl patches are contraindicated in opioid naïve patients in the management of acute or postoperative pain or mild or intermittent pain.
Prescribers must consider the prescribing information before initiating transdermal fentanyl therapy. Likewise, before dispensing or administering the medication, pharmacists and nurses must ensure that a fentanyl patch is indicated for the patient, that the dosage and dosing interval prescribed are appropriate for the patient, and the caregiver receives complete education regarding safe and proper use of the patch.
IMSP also has received reports of errors due to improper titration of doses. In one case a hospitalized opiate-tolerant patient was started at a 50 mcg per hour dosage; however, the dose was adjusted twice within 72 hours before the patient was discharged on a 100 mcg per hour dosage. At home, he experienced somnolence and confusion, fell and was readmitted to the hospital.
Prescribing information states that, after the initial patch application, evaluation of the maximum analgesic effect cannot be made until the patch is worn for at least 24 hours. The initial dose of supplemental opioid analgesics required by the patient may be increased on the second or third day after the initial application. After increasing the dose, it may take up to six days for the patient to reach equilibrium on the new dose. Therefore, a patient should be maintained at the increased dose through two applications before any further increase in dosage is made.
The South Dakota Board of Pharmacy and Department of Health recommend that each pharmacist review and adopt the manufacturer’s guidelines for the dispensing of NEW orders of fentanyl patches. Pharmacists must determine if the patient meets the criteria for using this potent drug. If the patient does not, the physician should be consulted.
Pharmacists should consult the package insert for all dose conversion guidelines.
Information for this article was reprinted from the August 2005 edition of the Institute for Safe Medical Practice Newsletter.
