Pharmacists: Partnering with physicians to curb the national prescription drug abuse crisis

September 01, 2013

Editorial for Special Pain Section

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Recent American Medical Association (AMA) resolutions addressing the increase in verification calls received from pharmacists about controlled substances describe such calls as “inappropriate interference with the practice of medicine.” These resolutions additionally call for legislative advocacy to stop pharmacists’ request for patient information when determining prescription legitimacy. While it’s important to note that the AMA is working closely with professional pharmacy organizations, including the American Pharmacists Association, to address concerns, it’s equally imperative that we understand the events leading up to this impasse.

For nearly a decade, Florida has been recognized as the “pill-mill” capital of the United States. Efforts by law enforcement to combat this plague largely failed prior to the establishment of the Florida Prescription Drug Monitoring Program (E-FORCSE). “Pain management” clinics thrived, and millions of doses of the drugs oxycodone, morphine, hydrocodone, hydromorphone, methadone, and alprazolam were prescribed and subsequently dispensed at local pharmacies. As Walgreens is the nation’s largest pharmacy chain, inevitably many of these local pharmacies were units of Walgreens.

In an unprecedented move, DEA in September 2012 halted shipments from the Jupiter, FL–based Walgreens distribution center and suspended registration. DEA cited “failure to maintain effective controls against the diversion of controlled substances into other than legitimate medical, scientific, and industrial channels.” Furthermore, the Settlement and Memorandum of Agreement (MOA) between DEA and Walgreens cited alleged “dispensing … of controlled substances to individuals Walgreens knew or should have known were diverting controlled substances …” Among other stipulations of this MOA, Walgreens agreed to implement numerous policies and programs that ultimately ensure that controlled substances only be dispensed for a legitimate medical purpose or by a practitioner acting within the usual course of medical practice.  

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As Congress addresses compounding pharmacies

M. Keith Hodges, owner of Gloucester Pharmacy and a member of the Virginia House of Delegates, writes in “First, do no further harm”:

As a pharmacist and small business owner, I can tell you for certain that provisions in a well-intended Senate proposal (S. 959) would hinder the ability of independent pharmacists across the country to compound medications for their patients who might not be able to get these vital prescriptions anywhere else.

Additionally, the measure would require pharmacies to report directly to the Food and Drug Administration when they are compounding medications to alleviate a drug shortage. State boards of pharmacy regulate the practice of pharmacy in each state. During the H1NI outbreak several years ago, when Tamiflu was in short supply, independent pharmacies utilized their compounding expertise to fill the void for countless children. As drug shortages continue to skyrocket with no relief in sight, Congress must make certain that patients receive all necessary medications in a timely manner, not create further delays by adding additional federal bureaucracy.

Niels Erik Hansen, president and CEO of Intelligent Hospital Systems in Winnipeg, writes in “Technology can make compounding safer”:

Medication compounding is a common practice in hospitals and pharmacies. Physicians prescribe combinations of medicines that are mixed in a single syringe or IV bag for a specific patient. To make these compounds accurately and safely, pharmacists must measure and combine drugs with meticulous care — for example, diluting a few milliliters of one drug and adding an equally small quantity of another. But despite the best efforts of pharmacy workers to mix medications perfectly, humans are not perfect.

One of the biggest advantages automated pharmacy compounding technology provides is removing the primary source of contamination and error — humans — from the compounding process. And automated compounding systems deliver many more benefits than the ability to make highly precise sterile compounds exactly right every time.

- See more at: http://blogs.roanoke.com/roundtable/2013/09/as-congress-addresses-compounding-pharmacies/#sthash.Si0OI6PO.dpuf

Technology can make compounding safer

Last year’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risks inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened almost 750 people and killed more than 60.

Virginia was one of 20 states impacted, with 54 cases of illness and five deaths. As this paper reported, some of those who became ill continue to struggle with symptoms almost a year later.

Although this outbreak is an egregious example of medication compounding gone awry, it is hardly an isolated incident. In addition to product recalls from compounding pharmacies in Georgia, Florida, Indiana, Nevada, New Jersey and Texas, among others, the Food and Drug Administration continues to investigate adverse patient reactions to steroid injections produced by a compounding pharmacy in Tennessee.

In December, the journal American Health & Drug Benefits reported that medication errors from injectable drugs harm more than 1 million patients annually in U.S. hospitals. Adverse drug events due to injectable medications cost U.S. health care payers between $2.7 billion and $5.1 billion annually, an average of $600,000 per hospital.

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Boundary Violations by Pharmacists--Crossing the Line by having Personal Relationships--Great Reminder by Dale J. Atkinson in Article Entitled Pharmacist Fills More than Just Prescriptions

Legal Briefs: Pharmacist Fills More than Just Prescriptions

August 28, 2013 1:00 pm Topics: Pharmacists

By Dale J. Atkinson 

Originally published in the August 2013 NABP Newsletter 

Many licensed professionals are subject to codes of ethics and other standards of practice that limit and, in some cases, prohibit personal relationships with patients/clients. Indeed, such boundary violations are far too common in many of the mental health professions whereby a personal relationship ripens out of the professional relationship. In most cases, a specified period of time must expire between the termination of the professional relationship and the beginning of the personal one. Under some circumstances, such as a clinical relationship, a personal relationship may be forever prohibited. Of course, violations of boundary parameters subject licensees to administrative prosecution and ultimately to adverse actions against licenses.

Similarly, pharmacists have a unique relationship with patients, including access to confidential and sensitive information. Pharmacists are placed in a position of trust regarding medical conditions and treatments thereof. While apparently not commonplace in the sphere of pharmacy practice as illustrated by the lack of published case law, boundary violations are certainly a possibility.

The full article, which reviews a case involving a pharmacist using patient information to pursue a personal relationship, is available in the August 2013 NABP Newsletter (PDF; pages 148-149).