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| 04-10-02 | IACP Addresses Nicotine Lollipop Concern |
April 10, 2002 - IACP Addresses Nicotine Lollipop Concerns
April 10, 2002
Contact: L.D. King
281-933-8400
IACP Addresses Nicotine Lollipop Concerns
The use of Nicotine Lollipops as a smoking cessation tool has received a great amount of media coverage since the Wall Street Journal carried a story entitled “Some Pharmacies Sell New Nic-Fix — Lollipops Laced With Nicotine” on April 3, 2002 .
Compounded nicotine lollipops may be legally provided under the provisions of the Food and Drug Administration Modernization Act (FDAMA) of 1997. There, Congress has approved procedures for pharmacists to compound for individual patients in response to physician prescriptions subject to regulation by state boards of pharmacy and FDA. Drugs compounded in compliance with the standards of FDAMA and applicable state laws are not subject to the FDA new drug approval process.
IACP advises that all compounding pharmacists require a valid prescription for nicotine lollipops. IACP also recommends that all compounding pharmacists use USP/NF grade chemicals or components of FDA approved products such as Nicotine Polacrilex USP, the same ingredient used in many of the other commercially made nicotine replacement products. Pharmacists should not make claims regarding the effectiveness or safety of compounded medications. Pharmacists should counsel all patients receiving nicotine lollipops by noting possible side effects, adverse reactions, drug interactions, and precautions that should be taken to ensure that the medication is not used by other persons (especially children and or minors) than for whom it was prescribed. Childproof packaging should be used and attractive colors should be avoided when dispensing medicated lollipops. It is important that all medication, especially nicotine lollipops and any other prescription medication be kept out of reach of children. “We are confident that our members will follow the recommendations that IACP has set forth,” said IACP President Mike Leake, R.Ph.
The purpose of nicotine replacement products is to assist smokers to stop smoking, an activity that is responsible for 1 in 5 deaths in the United States , according to the American Cancer Society. The American Cancer Society further states that the health benefits attributed to those who quit smoking include lowering their risk for developing at least seven cancers, decreasing their risk of coronary and cardiovascular disease and regardless of their age, living longer than those who continue to smoke. Obviously there are great health benefits for those patients who are able to quit smoking. Leake said, “As smoking is a great risk, it is imperative that health care professionals including physicians and pharmacists have a full range of tools available to assist those patients who desire to quit smoking.”
Compounding pharmacy is the science and art of preparing prescribed personalized medication to meet the unique medical needs of patients. IACP is a nonprofit association representing nearly 1600 community compounding pharmacists globally. For more information about IACP, please visit the organization’s website at http://www.iacprx.org/.
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