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Editorial: What is Compounding Pharmacy, Part VIb: Responsibilities of a Compounding Pharmacist

A compounding pharmacist is responsible for the entire scope of activities of routine pharmacy practice plus all the responsibilities associated with compounding, many of which are listed below. To reiterate comments made in Part VIa on this topic, a manufacturer takes months, and even years, to develop a drug formulation, whereas a compounder has a few minutes or hours; a manufacturer has complete departments to handle each of the functions listed below, whereas a compounder is responsible for all of them. The AWP of a drug from a manufacturer includes all the activities and functions in the selling price and people expect them to charge for everything in the price of the product plus a profit, whereas a compounder is expected to base the price on only the cost of the "active ingredient" plus a small dispensing fee. Such discrimination has to be addressed.

The overall/general responsibilities of a compounding pharmacist include aspects associated with:

• Proper formulation of a preparation that is safe and effective
• Determining the complexity of each preparation
• Consultations with healthcare professionals
• The compounding process (methods, techniques, procedures, measuring, weighing)
• Compounding facilities (environmental quality and maintenance)
• Compounding equipment (e.g., acquisition, certification, maintenance, calibration)
• Cleaning and disinfecting
• Component selection (e.g., APIs, excipients, quality standards)
• Component handling (nonhazardous and hazardous)
• Component storage (e.g., temperature, humidity)
• Stability and beyond-use date assignment
• Packaging, repackaging, and drug preparation containers
• Labeling
• Final preparation release checks
• Final preparation handling and storage
• Shipping and delivery
• Compounding documentation
• Quality control/assurance and continuous quality monitoring
• Correction of any deficiencies
• Testing (in-house and outsourced; physical, chemical and microbiological)
• Patient counseling, monitoring, complaints, and adverse-event reporting
• Training, retraining, and assessment
• Patient knowledge (human and/or veterinary)
• Patient or caregiver education and training
• Personnel cleanliness and garb
• Drug/excipient disposal
• Continuing education
• Meeting ever-changing state board of pharmacy requirements
• Many, many, many others too numerous to list

Much can be written about each and every responsibility listed above. The responsibilities of a compounding pharmacist are truly incredible and all-encompassing; and patients depend upon these responsibilities being taken seriously and judiciously.

Black Box Warnings and Teen Suicide
Following up two years later on the FDA's 2004 Black Box warning on antidepressants, there was a 31% decrease in antidepressant use, while attempted suicides increased 21.7%, according to research published in BMJ, formerly the British Medical Journal. Especially notable was that attempted suicides among those ages 18 to 29 increased 33.7%. The study's lead author states there should be better communication by public health professionals. She stated that the drop in antidepressant prescriptions among adolescents and young adults probably means their depression went untreated.
http://www.bloomberg.com/news/2014-06-18/teen-suicide-attempts-rise-as-warning-cuts-medicine-use.html

Apotex India Plant Faked Data for Years
The FDA-banned plant in Bangalore, India, owned by Canadian generic company Apotex, has, among other issues, been deleting data of failed test results and then reporting that the batches passed; this practice dates back about 8 years. "According to laboratory analysts interviewed during the inspection, the common practice was to complete the analysis and to record the sample preparation data only if the results were acceptable," the report reads. "If the results obtained were atypical, a fresh sample was to be prepared and analyzed. The original sample testing was not recorded."
http://www.fiercepharmamanufacturing.com/story/fda-says-apotex-india-plant-has-faked-data-years/2014-06-17

Ranbaxy Problems Cost U.S. Consumers Millions of Dollars
The Indian generic company won the right to market generic copies of Nexium, Divan, and Valcyte. However, the Ranbaxy quality-control problems are costing consumers a lot of money. The reason for this is because the FDA has banned imports of Ranbaxy products from four different facilities in India due to numerous regulatory violations. The brand-name companies, with combined sales of those three drugs of $8 billion last year, stand to continue to profit by this.
http://blogs.wsj.com/pharmalot/2014/06/17/how-much-ranbaxy-problems-cost-u-s-consumers-millions-of-dollars/?KEYWORDS=generics#

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�that the Earth reaches one of its four major way stations this Saturday (June 21; i.e., it will reach its northernmost point in the sky, known as the summer solstice)? It seems to pause briefly before beginning its move southward again, and this marks the longest day of the year. Solstice is derived from the Latin words for "sun stationary." Our summer solstice occurs when the tilt of a planet's semi-axis reaches its maximum axial tilt toward the sun at 23� 26'.

Get ready for the weather! The warmest days of summer are usually a month or two later because it takes the Earth a while to warm up in summer and to cool down in winter. The Earth's seasons lag about six weeks behind the exact dates dictated by the geometry of the Earth's orbit. Of course, our friends in the southern hemisphere should now be looking forward to the coolest part of the year, since their seasons are opposite of ours!

Pedro walked
Back home by golly,
His bristly chin
Was hot-to-Molly!
     Burma Shave

PCAB is proud to announce the accreditation of the following pharmacies:

Key Compounding Pharmacy, Federal Way, Washington; Irene Foo, RPh, irenef@keycompounding.com. Re-Accreditation for Sterile & Nonsterile Compounding

Community Pharmacy, Denton, Texas; Kelly Selby, RPh, kelly@communitypharmacy.com. Re-Accreditation for Sterile & Nonsterile Compounding

Oncology Plus Incorporated, Brandon, Florida; Zachary Scholl, zscholl@oncologyplus.com. Re-Accreditation for Sterile Compounding

Pharmacy Specialties, Inc., Sioux Falls, South Dakota; Cheri Kraemer, RPh, cheri@rxpsi.com. Re-Accreditation for Sterile & Nonsterile Compounding

Shertech Pharmacy Piedmont, Kernersville, North Carolina; Cierra Minus, PharmD, cminus@shertechpharmacy.com. Initial Accreditation for Sterile & Nonsterile Compounding

Wright Specialty Pharmacy & Diabetic Supply, LLC DBA Benevere Pharmacy, Collierville, Tennessee; Amelia Whigham, PharmD, brett@beneverepharmacy.com. Initial Accreditation for Nonsterile Compounding

Home Care Solutions, Maitland, Florida; William Elliott, RPh, welliott@qmedrx.com. Initial Accreditation for Sterile & Nonsterile Compounding