ALL Pharmacists Should Read This-- Drug Topic: Pharmacy should be shaken AND stirred

FEB 15, 2013

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Pharmacy badly needs a hero right now. Every story I hear in the national news, on the online blogs, and from my personal grapevine has the same theme. Pharmacy is being demeaned by employers, indifferent pharmacy boards, out-of-touch academicians, and our own loss of mojo. The “Most Trusted Profession” is turning into the “Most Trampled Profession.”
At present, the news media are having a heyday with unauthorized prescription refills, alleged prescription fraud, pharmacies shuttered for excessive narcotic dispensing, and substandard compounding practices causing patient deaths.
Not all of this can be laid at the feet of the practicing pharmacist, but we have allowed it to happen. Emboldened by a surplus of pharmacists for the first time in many years, chain-pharmacy middle management is making all the calls now, and they are mostly bad. Never have I heard so much despair and discontent voiced by pharmacists.

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Drug Topic: Specialization is pharmacy's future

Jan 15, 2013 By: Ernest P. Gates, Jr., RPh, FASCP, FIACP, FACADrug Topics

The future of pharmacy—a healthcare profession in which the role in patient treatment and care is continually growing—is specialization. It is pharmacy specialization that will enable our healthcare system to meet the mandate of controlling cost by improving medical outcomes. This will be accomplished through the provision of more care in community settings, as well as by reducing unnecessary hospital readmissions.
We are already seeing it happen. Where, once, all pharmacy services were provided in one place, specialty pharmacies are currently operating in areas such as oncology, geriatrics, diabetes, fertility, HIV, psychiatry, nuclear medicine, nutrition support, the compounding of specialty medications, and pharmacotherapy. Various pharmacy specialty certifications are granted through organizations such as the American Pharmacists Association, the Board of Pharmacy Specialties, the American Society of Health-System Pharmacists, and the American College of Clinical Pharmacy. 

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Drug Topics: Compounding pharmacy takes an unexpected turn

Jan 15, 2013 By: Ned Milenkovich, PharmD, JDDrug Topics

The deadly outbreak of fungal meningitis has resulted in a public health crisis. More than 500 individuals across 19 states have become infected by contaminated vials of injectable steroid drug from the New England Compounding Center (NECC). Dozens have died.
From a legal and regulatory point of view, the crisis has exposed a void in the world of drug manufacturing versus compounding pharmacy to which few pay attention, although there has been significant litigation in this area even before this latest crisis.
Traditional compounding pharmacy practices involve admixing or altering prescription ingredients to make custom medications that fit the needs of an individual patient, whether sterile or non-sterile products. These pharmacies have historically fallen under the jurisdiction of the state pharmacy boards.
In 1997, Congress attempted to clarify the role of FDA in the oversight of compounding pharmacies as a part of the FDA Modernization Act.
However, before the law was to take effect, seven compounding pharmacies sued to block its enactment. Since then, the law, as well as FDA's existing authority to regulate compounding pharmacies under the federal Food, Drug and Cosmetic Act, became mired in litigation and uncertainty. To attempt to remedy some of the ambiguity, FDA issued guidelines in 2002 to try to draw a line between manufacturing and traditional compounding.
The tragedy has caused legislators to call for Congressional hearings on the issue of pharmacy compounding. Congressman Ed Markey of Massachusetts is quoted as stating: "A state's ability to protect patients is limited only to activities that take place within its borders. Because the new age of compounding pharmacies involves shipping drugs across state lines, the federal government — specifically the FDA — needs the authority to ensure that patients that rely on compounded drugs are kept safe. The FDA has said clearly that it needs new authority to effectively protect patients and oversee these companies. This authority can only be provided by Congress."
Although Markey believes that traditional small compounding pharmacies should continue to operate as they currently do, and should continue to be regulated by the states as long as they use safe drugs, undertake safe practices, and get valid prescriptions for the drugs they make, he is proposing new legislation that is intended to address when a pharmacy should be regulated by FDA when it engages in certain drug preparation activities.
In general, the NECC crisis has federal legislators and regulators calling for greater accountability of certain compounding pharmacies. Some examples include:
1. Registration with FDA as drug manufacturers,
2. FDA inspections of compounding pharmacies at any time,
3. Transparency to the public, with appropriate labeling of compounded drugs, and
4. Mandatory reporting to the FDA when adverse reactions occur so patients aren't given drugs that are known to have caused health problems.
Although it is well known at this time that both federal and state investigation and inquiry have been undertaken against NECC, recent reports indicate that a grand jury has been convened to assess any criminal culpability of individuals associated with NECC.
This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.
Ned Milenkovich is a member at McDonald Hopkins, LLC, and chairs its drug and pharmacy practice group. He is also Vice-Chairman of the Illinois State Board of Pharmacy. Contact Ned at 312-642-1480 or at nmilenkovich@mcdonaldhopkins.com

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