June 5, 2009 Volume 6, Issue 23
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  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.


Editorial: Quality Assurance of Parenteral Preparations

Editor's Note: This is the seventh in a series of brief quality-assurance notes and reminders on different compounded dosage forms. Many of the testing methods can be done in-house and some may need to be outsourced; this is up to the individual pharmacist. However, a program of quality assurance is the responsibility of compounding pharmacists in all aspects of their practice.

Quality-control assessment can include:

  • Weight/volume
  • Physical observation
  • pH
  • Specific gravity
  • Osmolality
  • Assay
  • Color
  • Clarity
  • Particulate matter
  • Sterility
  • Pyrogenicity

The above quality tests can be utilized for all three risk levels of sterile preparation compounding. Sterility and pyrogenicity testing programs are very important for high-risk compounding of sterile preparations.

Sources:
Allen LV Jr. Standard operating procedure for particulate testing for sterile products. IJPC 1998; 2(1): 78.

Allen LV Jr. Standard operating procedure: Quality assessment for injectable solutions. IJPC 1999; 3(5): 406-407.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

 
Other News

NABP Moves to Next Phase of Recommending Mandatory Technician Regulation
The Pharmacy Technician Certification Board (PTCB) announces a new recommendation issued by the NABP Task Force on Standardized Pharmacy Technician Education and Training which encourages state boards of pharmacy to require certification by the PTCB. The recommendation is that boards of pharmacy require pharmacy technicians to be certified by 2015, in accordance with the JCPP Future Vision of Pharmacy Practice.

Melissa Murer Corrigan, RPh, Executive Director and CEO of PTCB, says that "Having consistent requirements for pharmacy technician certification in every state is an important first step towards meeting the high standard of safety that patients expect and deserve." PTCB was established in January 1995 and is governed by five pharmacy organizations: (1) American Pharmacists Association (APhA), (2) American Society of Health-System Pharmacists (ASHP), (3) Illinois Council of Health-System Pharmacists (ICHP), (4) Michigan Pharmacists Association (MPA), and (5) National Association of State Boards of Pharmacy (NABP).
http://www.prweb.com/releases/PTCBTechnicianRegulation/05272009/prweb2464304.htm

FDA to Consider Becoming More Transparent
For years, the FDA has withheld information about drugs and medical devices from the public when their makers cite trade secrecy�even in cases where the agency suspects that the products are causing serious illness or death. The new leadership at FDA may change that as a task force is being established within the agency to recommend ways to reveal more information about FDA decisions, possibly including the disclosure of now secret data about drugs and devices under study.

The task will be complicated but has a timeline of six months. Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act. Still, the goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers.

Trade secrets can include company plans to test experimental medicines, the complete results of most clinical trials, and even the FDA's reasons for rejecting a company's application to market a product. Researchers have long complained that keeping such information secret can harm the public. Whenever possible, the FDA should provide data on which it bases its regulatory decisions.

Editor's Note: Maybe we can learn the basis for the FDA's decision on "estriol."
http://www.nytimes.com/2009/06/02/health/policy/02fda.html?_r=1

Observations and Comments from the Massachusetts and Tennessee Health Plans
"The belief that we should all have health insurance coverage is broadly held," said Alan Weil of the nonpartisan National Academy for State Health Policy. "But there are tremendous differences around the country in beliefs on how to achieve that goal."

A Massachusetts-style requirement for individuals to obtain health insurance is likely to emerge as part of the health overhaul taking shape in Congress, although details remain unsettled.

A variation of Tennessee's practice of charging higher premiums to smokers and those who are overweight also may emerge; some in Congress are discussing a lifestyle tax on alcohol and sugar-sweetened drinks to help finance the national plan.

In Massachusetts, a couple may now pay just $78 a month for state-subsidized insurance that covers doctor visits, prescriptions, and hospital stays. If pregnant, they pay nothing for her checkups, medicine, and vitamins. But pared-down benefits may lie ahead in Massachusetts because of the throngs of the newly insured swelled costs of Commonwealth Care to $628 million last year; the demand for care is outstripping the number of doctors. One in five Massachusetts adults said a doctor's office or clinic told them they weren't taking new patients with their type of insurance, or they weren't accepting new patients at all. Massachusetts covers virtually everyone with high standards for minimum health insurance and decided to deal with costs later. A state commission expects to call for fundamental changes in the way doctors and hospitals are paid in a plan that amounts to putting them on a financial diet.

The Massachusetts approach was "coverage first, then cost control." Tennessee, on the other hand, chose to get just a few more people bare-bones insurance at a budget price with limits on how much plans would pay for hospital stays.

A state program built around Medicaid (TennCare) "got totally out of control. It was growing at 15 percent a year. Tennessee had the most expensive Medicaid program in the country," Governor Bredesen said. "Our experience with trying to do universal coverage ended up being a disaster."

When Bredesen took office in 2003, he inherited soaring state healthcare spending. In 2005, he cut 170,000 adults from TennCare. He reduced benefits for thousands more. His new initiative, CoverTN, takes "baby steps" toward covering more people. It targets workers at small businesses, the self-employed, and the recently unemployed. The cost of monthly premiums is shared by the state, the individual, and employers. No one is forced to participate.

Bredesen said the plan design reflects what uninsured Tennesseans want—primary care, not catastrophic care—in a trimmed-down package. Only eight people have exceeded the annual maximum for inpatient hospital costs since the program began. Bredesen said, "I'm always amazed, however, when you actually charge someone for health insurance, how many fewer people are willing to sign up for it, than are willing to demand affordable health care."
http://ncpa.yellowbrix.com/pages/ncpa/Story.nsp?story_id=130635033&ID=ncpa

 
Book Review

Basic Pharmacokinetics
First Edition

Jambhekar SS, Breen PJ
London, UK: Pharmaceutical Press; 2005

An intuitive approach to pharmaokinetics, this new release uses profiles (sketches of relationships) to aid the learner in understanding pharmacokinetics. Also, excellent graphics throughout the book aid the learner in visualizing the concepts and relationships. Some of the equations show how they are derived, which aids in understanding their application and usage. This text is very well-written and is very easy-to-read. It will be valuable as a textbook in pharmacokinetics as well as for pharmacists who wish to review the material.

 
Did You Know?

From out of the past�"Liquid Lightning"

Essential oil of mustard2 drachms
Aconite2 grains
Glycerine2 ounces
Alcohol4 ounces

Mix and apply by rubbing with the hand. This is useful in rheumatism, neuralgia, headache, toothache, and all nervous pains.

Source: [No author listed.] Secrets of Wise Men, Chemists and Great Physicians; 1902

 
Compounding Tip of the Week

Periodic(al) Marketing
What to do with popular magazines you no longer need? Why not place the name of your store on the label and provide them to barber and beauty shops for their customers while they wait? Or, deliver them to nursing homes, etc�.they will appreciate them and it's good marketing.

RxTriad - The most valuable marketing tool available for compounding pharmacist.
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