Thursday, March 28, 2013

SPLITTING THE DIFFERENCE. At Shamrock Medical, we have some past experience with tablet splitting.

To give you some background, in March 2013, the FDA issued a Guidance for Industry that provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). It outlines what criteria should be met when evaluating and labeling tablets that have been scored. Scoring facilitates the practice of tablet splitting. (Just a reminder: Previously, the FDA considered tablet scoring as an issue when determining whether a generic drug product is the same as the reference listed drug [RLD]. One characteristic of a tablet dosage form is that it may be manufactured with a score or scores.) As of this writing, the guidance does not establish legally enforceable responsibilities, but it details current thinking on the topic.

According to the FDA, this characteristic is useful because the score can be used to facilitate the splitting of the tablet into fractions when less than a full tablet is desired for a dose, although, presently, there are no standards or regulatory requirements that specifically address scoring of generic vs. RLD tablets.

The FDA goes on to say that, "Consistent scoring ensures that the patient is able to adjust the dose, by splitting the tablet, in the same manner as the RLD. This enables the patient to switch between products made by different manufacturers without encountering problems related to the dose. In addition, consistent scoring ensures that neither the generic product nor the RLD has an advantage in the marketplace because one is scored and one is not.

This, folks, is a considerable issue to consider.

A SHORT HISTORY CONTEMPLATING DRUG SPLITTINGThe Center for Drug Evaluation and Research (CDER) Drug Safety Oversight Board considered the practice of tablet splitting at its October 2009 and November 2010 meetings. During those meetings, they discussed how insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the patients’ dose or as a cost-saving measure. Because of this, the Agency conducted internal research on tablet splitting and concluded that in some cases, there are possible safety issues, especially when tablets are not scored or evaluated for splitting. The Agency’s concerns with splitting a tablet included variations in the tablet content, weight, disintegration, or dissolution,
which can affect how much drug is present in a split tablet and available for absorption. In addition, there may be stability issues with splitting tablets.

WHERE SHAMROCK MEDICAL STANDS ON THIS ISSUEIf you remember, drug repackagers used to split tabs for the customers, but the FDA said a split tab was a new drug, and required a new drug application, stability studies, etc. So we no longer split tabs. This guidance document may lay the groundwork for allowing drug repackagers to once again split tabs; but there are other outcomes to consider before the drug repackaging industry can feel comfortable with this concept.

These FDA recommendations on are not simply a matter of splitting a tablet. In my next post on this topic, I'll discuss the criteria that the industry would have to follow, and the pros and cons of this proposal by the FDA.


Here's to better solutions, 
Dave Bystrom

Wednesday, March 13, 2013

FAKE DRUGS -- REAL DANGERS

In a previous post I talked about the California Pedigree Law, which will require tracking drugs whenever a change in ownership occurs from the sale of drugs to other trading partners, and how this may inevitably affect every state via a nationally mandated policy. Why? Here are three major reasons:
·    Federal regulators in February 2013 discovered another batch in a string of fake versions of the cancer drug, Avastin.
·    Early in 2013, a doctor in La Jolla pleaded guilty in federal court to treating patients with unapproved drugs.
·    Tainted steroids produced by a Massachusetts compounding pharmacy led to a fungal meningitis outbreak in September 2012 that killed 45 people and sickened more than 650.
As concerned caregivers, we cannot allow this to continue.

The problem of fake, contaminated or prescription drugs that don't meet proper quality standards may be worse in developing countries, but drug security is clearly a concern here, too. And I, like other health officials, believe that as we become more globalized it's more than likely the problem will only increase. So a national mandate may be part of our future.

A 360-page report from the Institute of Medicine and sponsored by the U.S. Food and Drug Administration states that "...quantifying the problem in the United States is difficult, but the trade of adulterated prescription drugs is considered more profitable than that of illicit drugs, like heroin...".

"Many of these fake drugs are the subject of sophisticated criminal networks," said Larry Gostin, professor of health law at Georgetown University, who headed the committee that produced the report.

And the tragedy continues when expired or adulterated prescription drugs often fall into the hands of unwitting health care providers from a secondary wholesaler offering what appears to be a good deal for the medication, because the United States at present has no national system to track and trace drugs through the maze of wholesalers and secondary marketers.

No one system or technology will completely resolve the problem because of its complexity, but the Institute of Medicine report calls for a variety of potential solutions, such as better ways to authenticate packaging so that regulators may be able to identify and detect counterfeit drugs. This could include better inks, holograms or other security features that could outwit counterfeiters.

The report also calls for improved tracking systems for keeping tabs on every time a drug changes hands. This "electronic pedigree," could better secure the supply chain, leaving fewer opportunities for bad drugs to enter the health market.

Bar-coding and wireless radio-frequency identification, or RFID, are some of the technologies being used or considered to better track drugs. Much of the technologies are focused on securing company drug packaging so it is more difficult to counterfeit.

Use of a trusted drug repackager is another step one can take to ensure safety in the drugs you provide for your patients. As a highly regulated drug repackager, Shamrock Medical is required to ensure that the safety, identity, strength, quality, and purity of the drugs we handle are maintained. We take every precaution to verify the identity and legitimacy of suppliers sending us products through the “normal channel of distribution”. Now, and always, we continue to remain vigilant, both with you and for you, our customer.


Here's to better solutions, 
Dave Bystrom