Brought to you by the International Journal of Pharmaceutical Compounding
February 10, 2006 Volume 3, Issue 6
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Quality Assurance in the Compounding Pharmacy
A Pharmacist's Guide to Providing Veterinary Prescription Services
 
 
 
 
  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.
Editorial: Kudos to IACP and the New Labeling Guidelines

The longest standing, and longest lasting, means of communications pharmacists have had, and continue to have, is the prescription label. In that small space is printed the results of the patient experiencing an illness or injury, the trip to the physician or dentist office, the examination, the prescribing of a medication, transmittal to the pharmacy, the evaluation and filling by the pharmacist and the delivery to the patient with appropriate counseling. After this, the patient drives home, takes the medication out of the sack, and may or may not look at any additional printed materials which may be discarded. A few days later, the only thing remaining for communication purposes is the prescription label.

The prescription label says a lot. We are all familiar with the manufacturers labeling required for prescription drugs and nonprescription drugs. We are more familiar with the labeling required for each prescription that is prepared. For prescriptions that are filled with commercial products, the basic information would be the patient's name; prescribers name; name, address, phone number of the pharmacy; prescription number, name, strength and quantity of medication; directions for use; date prescription filled, expiration/beyond use date, storage instructions, other appropriate auxiliary labels and any other state requirements.

Labels for compounded medications must have all the previously mentioned components and IACP recommends the following statement (or something similar to be added:

"This medicine was specially compounded in our pharmacy for you at the direction of your prescriber."

In addition, a package insert containing more lengthy language can be prepared and placed with each compounded prescription. The text of this can be found at: http://www.iacprx.org/pdf/IACPLabelingGuidelines.pdf

Since compounded medications are somewhat more difficult to identify in the event of an emergency, an emergency contact telephone number should be provided or the telephone number of the pharmacy be tended 24/7 so contact can be made with the pharmacy for identification of the contents of a compounded prescription.

Compounding for office use should have the following on the label:

"This medicine was compounded in our pharmacy for use by a licensed professional only".

In the past, these statements printed on prescription labels, have been sufficient to protect pharmacists from actions by health practitioners who have been misusing medications that were compounded for office use only and intended for administration in the practitioners office; they are NOT for providing to patients for patient administration.

These guidelines have been a long time coming and are greatly needed. In fact, many states and other agencies have discussed implementing requirements for the statement that compounded prescriptions be so labeled. If all pharmacists would adhere to and support these guidelines, there may be no need for legislation as this could become a professional standard that is accepted and implemented. In fact, some entities have even recommended that the statement "This medication has not been FDA-approved", or "This is an unapproved medication" be placed on the labels. This obviously opens up a whole can of worms as there are many preparations/products that technically are not approved by the FDA.

Also, these guidelines should apply to all compounded medications, including those in community pharmacies, nursing homes, hospitals, clinics, mail order pharmacies, nuclear pharmacies, veterinary pharmacies and others. It's great to see IACP taking the bull by the horns and promoting this recommended labeling. Congratulations!


Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

 
CompoundingToday.Com Activity Report

In the last seven days, 2,377 unique visitors have been to CompoundingToday.com. Here is what these visitors accessed most frequently:

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FDA Public Health Advisory

Consumers Filling U.S. Prescriptions Abroad May Get the Wrong Active Ingredient Because of Confusing Drug Names
Some FDA-approved products have the same brand names as drug products that are marketed outside the U.S. but contain completely different active ingredients. The FDA has put together a comprehensive lists of such drugs. Read the article and see the lists here, http://www.fda.gov/oc/opacom/reports/confusingnames.html

 
Networking this Week on the Compounders Network List

This week on IJPC's free list, pharmacists posted email discussing:

  • The need for a formula for mesalamine suspension
  • Marketing compounding services to a variety of physician offices in all practice areas, including dialysis
  • HRT: BHRT, DHEA, facial hair growth and hot flashes due to weight loss
  • Lime-sulfur dip formula needed; commercial product is on manufacturer backorder.

Join at IJPC.com and just read what others have to say or contribute and ask questions. It's easy, free and informative.

 
Baxter Recalls Volumetric Infusion Pumps

There has been a third Class 1 recall of Baxter's Colleague� Volumetric Infusion Pumps. To read more, click here: http://www.fda.gov/cdrh/recalls/recall-121305.html

 
Health Tip for Patients:

Vanquishing Cold Sores
By Larry J. Frieders, RPh

Cold sores, which are caused by a herpes virus, are fluid-filled blisters that develop on the gums and the lips. The primary infection usually occurs in children. Recurrences can be triggered by sun exposure, fever, menstruation, and stress. Cold sore blisters are contagious.

Arginine is required for the herpes virus to replicate. Because lysine competes with arginine for intestinal transport, a diet rich in lysine and low in arginine may have an antiviral effect.

Whether the herpes virus becomes active depends in part on the ratio of lysine to arginine consumed. Arginine triggers the virus into hyperactivity, so taking extra lysine alters that ratio and subdues the virus.

Prevention
Lysine, which is found in brewer's yeast, legumes, dairy, wheat germ, fish, and meat, does not cure a cold sore but instead helps to relieve the symptoms. One thousand milligrams of lysine taken orally in capsule form 3 times daily may be effective as both prevention and treatment for cold sores.

Avoidance
Some experts suggest that avoiding foods high in arginine, such as chocolate, nuts, and gelatin, can help to reduce the incidence of cold sores. Yes, gelatin, so taking lysine in a gelatin capsule is counterproductive to cold sore prevention! However, lysine supplements are also available as tablets and in veggie caps.

A research study in Germany showed that cold sores treated with topically applied lemon balm cream healed in 5 days instead of 10 days if untreated. When applied regularly, lemon balm may also decrease the frequency of cold sore recurrence.

To prevent or treat cold sores:

  • Avoid foods high in arginine
  • Consider taking l-lysine supplements
  • Apply lip balms designed to resolve cold sores

Sources / References

  1. Kagan C. Letter: Lysine therapy for herpes simplex. Lancet 1974; 1(7848): 137.
  2. Balch JF, Balch PA. Prescription for Nutritional Healing. 3rd ed. Garden City Park, NY: Avery Publishing Group; 1997: 434.
  3. Mindell E, Hopkins V. Drugs for herpes and their natural alternatives. In: Prescription Alternatives: Hundreds of Safe, Natural Prescription-Free Remedies to Restore and Maintain Your Health. 3rd ed. New York, NY: Warner Books; 2003: 438.
  4. Koytchev R, Alken RG, Dundarov S. Balm mint extract (Lo-701) for topical treatment of recurring herpes labialis. Phytomedicine 1999; 6(4): 225-230.

 
Press Release

TampAlerT� Liquid Packaging

EPS�, INC. is pleased to announce the latest enhancement to its TampAlerT� liquid packaging line. TampAlerT is now available in larger sizes�60 mL, 100 mL and 120 mL (2, 3 and 4 ounce capacities). These new larger sizes are ideal for larger unit dose meds, controlled substances as well as outpatient and after-hours dispensing.

All TampAlerT bottles (including the smaller 15 and 30 mL sizes) are stocked in either a natural Polyethylene or in a White Ultraviolet-Inhibitant resin. The caps are available in either a regular screw cap or child-resistant styles. Simply screw the cap on the bottle, wait a couple of minutes and then unscrew the cap. A tamper-evident seal will adhere to the top of the bottles.

No outside equipment or accessory heat seals are necessary in order to provide a tamper-evident seal. TampAlerT is tamper-evidence with a twist of the wrist.

For more information, please contact us:
Phone: 800-523-8966, 215-396-8600
Fax: 800-323-8966, 215-396-6662
E-Mail: info@medidose.com
Web Site: www.medidose.com

 
Compounding Tip of the Week

Telephone Solicitors
Don't you love sitting down to dinner after a long, hard day at work and the telephone rings and they are soliciting something? It has been suggested that when such a call comes, immediately say to the caller, "Just a minute!" and set the receiver down and go back to dinner or whatever you were doing. When you hear the telephone company tone that the caller has hung up, simply replace the receiver. Unwanted callers at inappropriate times of the day can be minimized by an action taken to intrude upon their time by their waiting for you to come back and they may give up.

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