Unlabeled indications, drug use for

In this book, we critically review both the formal FDA labeled indications, as well as those indications accepted by experts in the field of psychopharmacotherapy. In terms of the latter, meta-analysis is used when possible to formally assess the size and quality of the database that supports the usefulness of a drug for a clinically accepted, but not formally labeled, indication. These analyses can then aid the clinician in the decision to use a given drug for an unlabeled indication in a specific patient. Cost is considered in terms of price of medicine, as well as to the individual and society. 

Even if the patient suffers injury from the drug, its use for an unlabeled purpose does not in itself constitute "malpractice." Flowever, the courts may consider the package insert labeling as a complete listing of the indications for which the drug is considered safe unless the clinician can show that other use is considered safe by competent expert testimony. 

Trissel LA Handbook on Injectable Drugs, 13th ed. American Society of Hospital Pharmacists, 2005. (With supplements.) Use of approved drugs for unlabeled indications. FDA Drug Bull 1982 12 4. 

With each new prescription or physician order, the pharmacist must decide if the chosen therapy is appropriate for the patient and if there is evidence to support the use of the prescribed drug for the specific indication. How does the pharmacist make this decision when the drug has been prescribed for an unlabeled indication What is the pharmacist s liability Will this affect reimbursement ... 

Additional resources that pharmacists can use for information about unlabeled indications include medical and pharmacy textbooks, handbooks, journals, electronic databases, and the Internet. Although the Internet can be a useful resource for finding information, many sites offer unreferenced information, often with unsubstantiated claims. Drug information services staffed by pharmacists trained in the retrieval, interpretation, and dissemination of medical literature are excellent resources for determining if an unlabeled use of a drug is appropriate. 

Pharmacists are faced with product efficacy, patient safety, liability, and reimbursement issues when medications are used for unlabeled indications. Lack of FDA approval for a specific use should not prevent a pharmacist from dispensing an available drug. Rather, drugs should be used in a manner consistent with good medical practice and in the patient s best interest. It is good pro-... 

Lack of criminal prosecution is not a predictor of future actions or exposure to civil litigation. Therefore, it is important for a pharmacist to be familiar with labeled indications and unlabeled uses of a drug and to be prepared to defend the appropriateness of a drug s use in the event of litigation. Liability will be minimized if the pharmacist, in the exercise of sound professional judgment, concludes that the use is rational, safe, and reasonable. ... 

Epoetin alpha (e.g., Epogen) Epoetin alpha is recombinant human erythropoietin. Erythropoetin, which is synthesized in the kidney in response to hypoxia or anemia, stimulates erythropoiesis. Epoetin alpha is indicated for anemia in patients with chronic renal failure, because these patients are unable to synthesize erythropoetin to correct the anemia. Additional uses include correcting zidovudine (AZT)-induced anemia in HIV-infected patients and chemotherapy-induced anemia in cancer patients (unlabelled use). Several weeks of therapy are required before the hematocrit levels rise, therefore, this drug cannot replace transfusions for the acute treatment of severe anemia. Epoetin alpha should not be used in patients with uncontrolled hypertension because the elevation in hematocrit may exacerbate hypertension. 

As indicated earlier, the selective PDE5 inhibitors developed for the treatment of male erectile dysfunction resulting from organic or mixed organic-psychogenic origin have been the most successful PDE inhibitors. The three marketed drugs are sildenafil, vardenafil, and tadalafil (Fig. 17.2). In addition to the treatment of erectile dysfunction, sildenafil has been indicated for the treatment of pulmonary hypertension and female sexual dysfunction. These latter uses are unlabeled uses. 

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