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NEWS AND VIEWS |
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Complimentary Medicine Dr. Timothy Birdsall, vice president for Integrative Medicine at the Cancer Treatment Centers of America in Zion, Ill, reported on the results from their study on the use of complimentary medicines in patients with advanced pancreatic cancer. Thirty-six of fifty patients who were currently undergoing treatment for their cancer were given a variety of complementary remedies including but not limited to green tea extract, melatonin and high potency multivitamins that contained at least 1,000 mg of vitamin C and 400 IU of vitamin E. Assessment of pain and fatigue was measured at the beginning of the trial and six months later. Manageable pain increased from 40% to 67% of the study participants in the 6 month period. Thirty-five percent of patients who were not taking the complimentary medicines had manageable pain levels, but decreased to 22% at the end of 6 months. In regards to fatigue, participants rated their fatigue on a 100 point scale with 0 being no fatigue and 100 being the most debilitating fatigue. Initially, fatigue levels were at 55 points and decreased to 35 points by the end of the study. The control group started out at 45 points and increased to 65 points by the end of the study. This small study indicated that including complimentary medicines into conventional practice can improve the quality of life of patients with pancreatic cancer. Website New Federal Regulations Effective December 19, 2007, the Drug Enforcement finalized a rule that was proposed in September 2006. This rule describes the situation where multiple prescriptions for schedule II drugs may be written. In 21 CFR part 1306.12 (b), it states “An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90 day supply of a Schedule II controlled substance provided the following conditions are met:” |
* there is a legitimate medical reason and it is consistent with the usual course of professional practice * instructions are written on each prescription indicating when the pharmacy can fill the prescription * providing multiple prescriptions does not create an undue risk of diversion or abuse * it is permissible within the practitioner’s individual state * all other rules and regulations regarding scheduled medications are being followed per state law This regulation does not mean that it is now acceptable to provide ‘refills’. A prescription for the patients medication is completed in the usual fashion. The subsequent prescription (s) must contain the actual issue date and on the prescription the additional statement ‘Do not fill before…(insert date)…….’ must be written. This date is when the pharmacy may fill the next prescription. Please note that with this new regulation, the pharmacy cannot change the date via telephone. This also includes changing or adding any patient demographic data on the prescription. If a change needs to be made, it is required that a new prescription be written -- so be aware of issues that impact that date, ie. Pharmacy is closed, holidays, length of month, etc. The following is a review of other regulations pertaining to Schedule II medications. Partial filling of a prescription A pharmacy may provide as much of a drug as possible and complete the prescription within 72 hours. The quantity supplied to the patient must be written on the prescription. If the pharmacy cannot furnish the entire amount within 72, the prescription is void and the prescriber must be contacted by the pharmacy. If the patient is in a long term care facility or is terminally ill, the 72 hours requirement does not apply. In this situation, the pharmacy has 60 days and there are documentation requirements for the pharmacy. |
Emergencies A prescription can be phoned in if it is an emergency. The pharmacist must obtain a written signed prescription from the prescriber within 7 days. ( A postmark is acceptable). The prescription is for the specific amount of the drug required during the emergency period. And the statement “Authorization for Emergency Dispensing” must be written on the prescription. Faxing Prescriptions Faxed schedule II prescriptions are acceptable for patients who are in long term care facilities or for patients on hospice care through a Medicare certified hospice. Other situations allowing a fax to serve as the original prescription are those containing a compounded opioid that will be used for direct administration via the intravenous, intramuscular, subcutaneous, or intraspinal route. Otherwise, a pharmacist must have the written prescription in hand before dispensing the medication. Needless to say, it is important that you as the provider determine, based on documented assessments, the necessity for the patient to be on schedule II medications and that they are appropriate for receiving multiple prescriptions. It is also up to the provider to determine the frequency of patient visits. It is not mandated that a 90-day supply be given at a time. Sixty day or less than 30-day increments may be more appropriate for your patient. References Multiple C-II prescriptions: new federal regulations. Pharmacist’s Letter/Prescriber’s Letter 2008; 24(1): 2401 01. U.S. Department of Justice Drug Enforcement Administration. Office of Diversion Control. Rules-2007. |
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