Pharmacist sign-off for off-label scrips?

[tkim]

---

Members don't see this ad.

http://www.latimes.com/news/local/la-me-uci7apr07,1,517352.story?coll=la-headlines-california

Hospital Suicide Sparks a Rule

UCI Medical Center tells state regulators that pharmacists will now have to approve doctors' unorthodox use of medications.

By Christian Berthelsen, Times Staff Writer
April 7, 2006

UCI Medical Center has told state health regulators it will require pharmacists to review and approve physicians' unconventional use of drugs to treat patients, as part of a plan to correct deficiencies discovered in the wake of a patient suicide in December.

Last month, the state Department of Health Services found that the Orange hospital treated a psychiatric patient with drugs not approved for his condition and that there was no record of a pharmacist signing off on the therapy plan, as required by law. The drugs are known to increase the risk of suicidal thoughts.

Doctors regularly prescribe medications for uses other than those approved by the U.S. Food and Drug Administration. But in this case, state officials questioned whether this "off-label" usage of one of the drugs had merit.

Under a correction plan the state approved Thursday, pharmacists will make computerized entries in patients' medical records showing they have signed off on the drug therapy.

The patient, an 18-year-old man from Fountain Valley, was admitted to the psychiatric ward in October after being admitted twice previously. He had a history of wrist-cutting and pill overdoses.

The man was diagnosed with schizophrenia and depression. He was treated with Zoloft, an antidepressant, and Strattera, a drug used to treat attention deficit disorder. A state report issued in March said the doctor, who has not been identified, prescribed Strattera because of "cost for the family." Both drugs carry warning labels citing a possible increase in suicidal behavior by adolescents who take them.

UCI disputed the state's findings that the drugs may have been inappropriate for the patient. Warning labels say the greatest risk of suicide occurs when the patient begins taking the drugs. The hospital said the warning label was irrelevant in this case because he already was using the drug when he was admitted. It also defended the use of Strattera, saying there was no other approved medication to treat the patient's symptoms.

The hospital said doctors and family members thought the patient was improving and that he told hospital staff he had no desire to kill himself, even making the statement an hour before the suicide.

The medical center also said it will make other changes, including removing handrails, shower heads and door locks from bathrooms. The patient hanged himself from a bathroom handrail with a bed sheet.

UCI will also tell staffers more explicitly that they must actually see patients during safety check rounds.

A hospital aide knocked on the patient's bathroom door and heard noises suggesting that the patient was "on the toilet," according to the state report, but then left and returned five minutes later.

The aide got no response after knocking again. No key to the bathroom was immediately available, and hospital staff could not open the door until 10 minutes later.

---

The bolded part is the interesting part. I had no idea that CA law requires pharmacists to sign off on rx plans? Is this only for inpatient? Anyone know?

 

[Wyclef]

I've heard plenty of stories about pharmacists disagreeing with doctors and the patient still getting the meds anyway, for better or for worse. I just don't like the idea of limits on the prescribing rights of physicians. If a pharmacist feels strongly enough against a prescription, he/she has the right to refuse to fill the med. Maybe a pharmacist must "sign off" for a script, meaning he reviews the script for any terrible errors, and then signs that he reviewed it, whether or not he agreed with the choice of drug. It does make sense that a pharmacist would review all meds prescribed by a physician. Signing off may just mean the pharmacist reviewed the script. Forgive my rambling... I work in a pharmacy and I know that in that setting the pharmacist must review all scripts before the meds are dispensed. I have no idea about the laws in hospitals or in CA. Peace out.

 

[maxhealth]

Pure speculation here, but perhaps law requires pharmacists to sign off on prescriptions that are written off label. I may be a little ignorant on the subject but it has always seemed somewhat risky to me to prescribe medications for anything other than their intended purpose. There are massive amounts of clinical data and stringent guidlines in place to insure patient safety, that is when the medication is prescribed for what it is proven to treat. It seems to be somewhat of a roll of the dice to prescribe medications off label as there is no clinical information (i.e. phase III clinical trials) to support such use. Who is held responsible when something goes wrong? The doctor, the pharmacist, the drug company??? Just some thoughts to ponder.

 

[Raven Feather]

So, enlighten me...In TX do doctors then write the patients' diagnoses on the scripts, too? How would the pharmacist know what it is being prescribed for otherwise? That doesn't happen in IN.

Viagra's intended use is for erection dysfunction but it appears to work well for pulmonary HTN. I don't think just because something was originally intended for condition X, should then be excluded for condition Y.

To be honest, the above article *appears* (to me, anyway) to possibly be about distraught, grieving parents making accusations.

 

[Raven Feather]

Pure speculation here, but perhaps law requires pharmacists to sign off on prescriptions that are written off label. I may be a little ignorant on the subject but it has always seemed somewhat risky to me to prescribe medications for anything other than their intended purpose. There are massive amounts of clinical data and stringent guidlines in place to insure patient safety, that is when the medication is prescribed for what it is proven to treat. It seems to be somewhat of a roll of the dice to prescribe medications off label as there is no clinical information (i.e. phase III clinical trials) to support such use. Who is held responsible when something goes wrong? The doctor, the pharmacist, the drug company??? Just some thoughts to ponder.

If it is given while in-patient in the hospital, in my state anyway, it is the fault of whoever gave it (ie, nurses)--otherwise, if it is an appropriate dose--probably the physician.

 

[maxhealth]

Viagra's intended use is for erection dysfunction but it appears to work well for pulmonary HTN. I don't think just because something was originally intended for condition X, should then be excluded for condition Y.

To be honest, the above article *appears* (to me, anyway) to possibly be about distraught, grieving parents making accusations.

I agree with you, the article does appear to be about grieving parents and they are going to want to hold someone responsible. As for the case of viagra and pulmonary hypertension, you are absolutely right. Just because a substance is approved to treat one condition does not mean it should be excluded from all others, however these multiple indications need to be researched THOROUGHLY before routinely prescribed. This was the case with Viagra and pulmonary hypertension. PDE 5 inhibitors (active ingredient in viagra) have long been investigated for the treatment of pulmonary hypertension. In this case, clinical trials were carried out with Viagra (Sildenafil) for pulm. hypertension patients and it was found a safe and effective treatment and approved by the FDA. Pfizer reformulated the dosage and now markets the drug as Revatio (which raises a whole 'nother Oprah about the ethics of patent extension). While one active substance is used to treat two different conditions (as is the case with many drugs) this is not off label prescribing. This is prescribing a drug for its indicated use.