Off label use of medications – cherry picking at its best
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IMG_2313[2]I had a conversation with our local palliative care and pain clinic doctor the other day. As a disclaimer, this physician is open to treating patients with the safety of the patient first in mind and he also has what I refer to as an “open mind” when it comes to doing whatever we can to alleviate pain and suffering. A lot of the time it involves using medications and therapies that most physicians would prescribe. It also involves therapies that are safe and effective but are shunned by other physicians either because of lack of knowledge or experience with them or because they claim it is an off label use or one that lacks either a firm recommendation from a governing body or has not been recommended at a recent conference they attended.

Off label prescription writing is certainly not a stranger to my daily dispensing of drugs. Some reviews put this practice as high as 10% of prescriptions written in Canada. A May 2012 MacLean’s article discusses this as a major issue and a huge gamble for the physicians writing these prescriptions. As a pharmacists, I can assure you that this practice is the norm and for the most part doesn’t land people in the hospital any more often than officially approved writing of any other prescription medication such as NSAIDS, narcotics, blood pressure or heart meds, or antibiotics, to name a few. There are hundreds of examples of off label uses of drugs now being written for. A few common ones listed by the Lexicomp Facts and Comparisons Off Label are:

 

ASA for high risk coronary artery disease

Clonidine for hot flashes

Erythromycin for acne vulgaris

Folic acid for neural tube defects

Gabapentin for diabetic neuropathy

Nifedipine topical for anal fissures

Trazodone for insomnia in the elderly

Amitriptyline (oral or topical) for neuropathic pain

Childhood and adolescent uses of many medications

 

Note the use of the amitriptyline topically. Topical compounds are notoriously listed here although there are studies showing they work for various types of pain when used correctly at the right strength. Granted many of these studies are small but many are well designed and like I always say, nothing beats the experience of the first patient a physician tries and sees the topical preparation working and the lack of side effects compared to oral medications is an added bonus.

Most consider topical pain therapy to be limited to capsaicin, lidocaine and camphor menthol combinations.  There is an entire universe out there of other ingredients used in these preparations. And for those who like a few references here you go.

Dubinsky RM, Kabbani H, El-Chami Z, Boutwell C, Ali H; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: treatment of postherpetic neuralgia: an evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2004;63(6):959-965.[PubMed 15452284]

Ho KY, Huh BK, White WD, Yeh CC, Miller EJ. Topical amitriptyline versus lidocaine in the treatment of neuropathic pain. Clin J Pain. 2008;24(1):51-55.[PubMed 18180637]

Lynch ME, Clark AJ, Sawynok J, Sullivan MJ. Topical 2% amitriptyline and 1% ketamine in neuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005;103(1):140-146.[PubMed 15983466]

Lockhart E. Topical combination of amitriptyline and ketamine for post herpetic neuralgia. Poster presented at: American Pain Society Annual Meeting; May 6-9, 2004; Vancouver, BC. http://www.ampainsoc.org/db2/abstract/view?poster_id=2185#893. Accessed November 4, 2008.

 

-Lexicomp

 

Now a common complaint is that I supply studies that cherry pick what I am trying to prove, although I assume that whomever is asking has plenty of studies to favour something against my side. The point is, when you know something works, and it’s safe, you tend to care more about potential patients and less about converting non believers. Topical pain relief is just one of those “alternative” therapies. Many would consider off label use to be alternative therapy by definition. If alternative therapy is something that wanders past a monograph or official indication, then many practice alternative medicine. If that therapy is “recommended” by a medical group then for most it becomes accepted therapy and therefore not alternative. Although this may make them more comfortable with prescribing choices, alternative therapy’s definition is one that changes based on the one defining it.

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