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| Clinical Pharmaceutics and Compounding, Part XXV |
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As introduced last week, this week, we will look at the issue of "drawing up for direct administration OR repackaging Avastin."
There is an issue when drawing up for direct administration OR repackaging Avastin in 1-mL polypropylene syringes containing silicone for intravitreal administration. A study has reported that the silicone oil within the syringe is "immediately" mixed with the bevacizumab injection as soon as it is drawn from the original vial and, therefore, can be injected into the eye. This study utilized:
- Ion chromatography
- Size-exclusion chromatography
- Peptide mapping
- 2nd derivative UV and IR spectroscopy
- Turbidimetry
- Diffraction laser spectroscopy
- Thermal denaturation curves
- Microscopic examination
- Image analysis
The authors' summary of that study states that they
�clearly demonstrate that the commercial solution of bevacizumab can be safely repackaged in polypropylene syringes and stored for up to 3 months at 4�C without alteration of its primary, secondary, and tertiary structure. The only difference observed is the contamination of the syringe content by silicone oil microdroplets, which is quite immediate and does not change significantly during the storage in terms of number and size.
(Paul M, Vieillard V, Roumi E et al. Long-term stability of bevacizumab repackaged in 1 mL polypropylene syringes for intravitreal administration. Ann Pharm Fr 2012; 70(3): 139-154.)
Some publications have directed criticism at compounding pharmacists for "contaminating" the Avastin during the repackaging process with silicone oil. However, it is stated in this article that the "contamination" of the Avastin with silicone oil is immediate and results from the action of withdrawing into a syringe containing silicone oil.
As suggested in this newsletter last week, one could consider using only silicone-free syringes when drawing up for direct administration or repackaging bevacizumab (Avastin) injection. The difficulty is that we have found only "1-mL" silicone-free syringes that are commercially available; however, many facilities use "0.5-mL" syringes for repackaging.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
ADHD Drugs Used by Workers to Increase Productivity
Amphetamine-based stimulants prescribed for attention deficit hyperactivity disorder have been abused by many college students and now are graduating into the work force. Reliable data on the extent of misuse does not exist, but, in interviews, dozens of people in a wide spectrum of professions said they and co-workers misused stimulants like Adderall, Vyvanse, and Concerta to improve work performance. "We are definitely seeing more than one year ago, more than two years ago, especially in the age range of 25 to 45," said Dr. Kimberly Dennis, the medical director of Timberline Knolls, a substance-abuse treatment facility for women outside Chicago.
http://www.nytimes.com/2015/04/19/us/workers-seeking-productivity-in-a-pill-are-abusing-adhd-drugs.html?_r=0
A Review of Pediatric Pill-swallowing Interventions
Targeted interventions have shown to improve medication administration and treatment compliance among pediatric patients that have difficulty swallowing solid oral medications. Medication-swallowing difficulties are a barrier that can be overcome with a variety of successful interventions.
http://pediatrics.aappublications.org/content/early/2015/04/14/peds.2014-2114.abstract
Homeopathic Products a New Target of the FDA
Homeopathy has long been a target for controversy, earning a devoted following among patients who insist its remedies are safe and effective, while attracting criticism from many who say homeopathic treatments offer no more help than a placebo. As a result of problems within the industry in recent years, the FDA says it wants to revisit how it oversees homeopathic products, which can be manufactured and marketed without prior approval from regulators.
http://www.washingtonpost.com/national/health-science/for-first-time-in-decades-fda-to-revisit-how-it-regulates-homeopathic-products/2015/04/18/2753315c-e207-11e4-81ea-0649268f729e_story.html
The FDA Warns of Pets Exposed to Flurbiprofen Topical Pain Medications
The FDA is alerting pet owners, veterinarians, healthcare providers, and pharmacists that pets are at risk of illness and death when exposed to topical pain medications containing the nonsteroidal anti-inflammatory drug flurbiprofen. These medications should be used with care in households with pets, as even very small amounts could be dangerous to these animals.
The FDA has provided a list of recommendations that can be taken to prevent pets from being exposed to these medications, even in ways that may seem unlikely to cause problems. Physicians and pharmacists should advise patients with pets to take care to prevent exposure of the pet to the medication.
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm443333.htm
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Did You Know ...
�that The Pharmacist Activist editorial this month is entitled, "Pharmacy's Vision for 2015 (2004-2014) Rest in Peace"? Dr. Hussar details the last 10 years in the movement to move pharmacy to "�be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes."
www.pharmacistactivist.com/2015/PDFs/March_2015.pdf
(Note: This proposed change in pharmacy practice actually started back in the early 1970s (about 45 years ago) leading to the adoption of the PharmD degree, but pharmacists still are not recognized nor are they adequately reimbursed for their efforts.)
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Tip of the Week
Subscribe to the free Pharmacist Activist at: www.pharmacistactivist.com
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Looking Back
A whiskered gent,
At a bazaar,
Paid for a kiss,
But got a jar� of
Burma Shave
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