1. Aschenbrenner, Diane S. MS, APRN-BC


* Until recently, only unapproved PEPs were available to patients lacking three necessary pancreatic enzymes.


* Three PEPs-Creon, Zenpep, and Pancreaze-are now FDA approved.



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When a patient's pancreas can't make the digestive enzymes-amylase, lipase, and protease-it requires, pancreatic enzyme products (PEPs) can make up for the deficiency. PEPs contain the active ingredient pancrelipase, a combination of those three enzymes, but until recently enzyme levels in PEPs weren't uniform-patients and clinicians had no way of knowing whether patients were getting too little or too much.


The Food and Drug Administration (FDA) has been working with drugmakers for several years to ensure that enzyme levels in PEPs are standardized so that the drugs could be approved. But setbacks in manufacturing processes have forced the agency to extend its deadlines for granting approval, allowing the manufacturers to market unapproved medications in the meantime.


In April the deadline arrived, yet only three PEPs managed to satisfy the standards necessary for approval: Creon, Zenpep, and (most recently) Pancreaze. Now that approved products exist, only these can be prescribed-although unapproved drugs still on pharmacy shelves can be sold until supplies run out.


The FDA is working with patient advocacy groups and health care organizations to get the word out, but patients and clinicians may not even know that the approved PEPs are available. These new PEPs are different from the unapproved forms of pancrelipase; nurses should be aware that it can take up to two weeks for a patient to adjust to the new drug and dosage. Patients should also be told to read the new medication guide accompanying the approved PEPs to learn about their safe use.


Although Pancreaze and the other PEPs are not currently approved for administration through gastrostomy tubes, the manufacturers are conducting tests to evaluate the feasibility of administering PEPs in this way. For more on PEPs from the FDA, go to