Prescribing unfamiliar medications. What do you do?

[Guest Paula]

If you are not experienced prescribing an unfamiliar drug and it is one of few options, what do you do?

 

If there is a serious adverse event will we be liable or put ourselves at risk for a lawsuit or some kind of disciplinary procedure by our employers?

 

If we did not consult the SP before prescribing the medication but consulted pharmacy/infectious disease/specialist would that put us at less risk?

 

This question came up in another thread  (Pinworms thread) and stimulated my thought process. 

 

If we consulted the SP and it was agreed to start the new medicine (and we documented the conversation in the chart) will both of us be liable if neither one of us have prescribed the medicine before?

 

I prescribed Invokana this past week and consulted with the SP first.  We both have cared for the same diabetic patient and felt this was the next step.  The patient did have some contraindications...i.e.  uncircumcised and had a case of balanitis in December 2013.  We discussed the patients history and my SP said let's go ahead and prescribe it and keep track of the patient carefully.  Of course, I wrote the script and documented our conversation.

 

What do you do in this situation?

 

Am I over-thinking? 

[ventana]

sounds like the right thing to do

 

I try to not prescribe newer meds (obvious reasons) but at times will have to

Also, make sure you review black box warnings and read about it - I typically will read every tab in Epocrates to make sure I am familiar with it - if need more I go to UpToDate and read of it's use, and lastly, just search internet (ugh I hate that) 

 

The level of involving other providers (sp, and specialists) increases as the risk of the med increases.......   low risk --> a new formulation of Amoxn..... not much needed.......   starting Chemotherapy or a very strange new ABX - yeah better have a consult with a specialists or your SP.

 

 

In the scheme of things..... your SP is where the buck stops so just involve them....  (unless you own your own practice.... then you read read read and if a risky drug I still make sure with my SP - same with procedures)

[jmj11]

I really try not to unless I've had the time to study the drug.

 

Case in point.  We have used methergine for tier 3-4 migraine control when all else has failed.  Due to shortages the price has suddenly gone up to $3,000/ month.  So I had to find an alternative for these patients who have been every where and have tried everything.  I arrived at bromocriptine. I had never prescribed it before. I've spent the last month studying it.  I've read every article ever published (that I could find) and every bit of information I could.  I wrote my first two prescriptions Friday.

[GetMeOuttaThisMess]

Paula, one of the things that I do with medications, even when not necessarily new to me but which carry not insignificant risks (Tamiflu for example), I pull out Epocrates and stand next to the patient and go through the line listing of any black box or significant reaction list with them.  At least that way THEY can't say that they weren't made aware.  Then it becomes a joint decision making process.  I agree with making the SP aware (the more risk sharing, the better).  This was my prior SP's greatest fear in all the world was liability with regard to medications (classic was ....wait for it....STATINS and macrolides).  I did it one time accidentally and I swear I was going to be asked to go take actual possession of the prescription from the patient.  Telling the SP that the patient was informed of the error and noting that they said that they would destroy the written script before even filling it wasn't enough for them.

[Guest Paula]

I use Epocrates and read up on the drug, plus use my medscape resource.  I pretty much ignore the drug reps who visit our clinics altho there are some who do highlight the negative side effects of drugs and the cautions and warnings.  The Invokana rep made sure we were aware of the eGFR and other warnings. 

 

I studied the SGTLs several months ago and listened to a webinar on them too.  Usually I won't prescribe the newer drugs until we see the specialists use them routinely.  

 

@GetMeOutta:  Do  you know how many patients get macrolides and statins????  It's a daily occurrence at my clinic!  Did your SP have a bad outcome once with that combination???   WOW!

 

I will say the more and more research and warnings on common drugs makes me ever so careful on over-use of them, especially ABXs. 

 

Here is a case in point:  We have a diabetic patient who lives off rez and when I did our annual IHS diabetes audit I noticed her last creatinine was 2.1 and her eGFR was at 32.  I panicked as she is on metformin and  ACEI and had normal eGFR and creatinine at a previous visit.  I pulled her chart and thankfully I was not the one who last saw her.  It was the doc and HE DID NOT MAKE ANY CHANGES TO HER MEDICATIONS.  He signed off on the labs.  I called her and asked her to come in for repeat labs and to have a medication discussion and told her that we need to make changes and adjustments.  She is a chronically unreliable patient with multiple co-morbidities.....renal bruits, PAD with severe claudication, smoker, HTN, asthma or COPD.  She has not come in and I will not re-new her medications when she calls for them.  She usually sees the doc.  Quite frankly I forgot about her until now so my AR nature will be pulling her chart tomorrow to see if she came in.  IF not, she will get a call from me and I suppose I need to notify the doc of his oversight?   I documented in her chart our phone call and that she is to come in and discontinue the metformin and possibly the ACEI too.   Goodness gracious grapenuts.  (My grandmothers terminology for swearing). 

[GetMeOuttaThisMess]

^^^  Not that I'm directly aware of but suffice it to say it is examples such as this that I decided it was time to move on (it only took me 8+ years though to figure it out; I'm a slow learner).  It didn't help that the administrator would bring up unhappy clientele because I didn't pucker for them whenever they walked in knowing what they needed and didn't receive it.

[True Anomaly]

Don't forget that using the medications for FDA-approved applications would also help back you up. Go off-label, and you're at higher risk.

[rev ronin]

I use UpToDate, EPIC's drug interaction warnings, and if need be, a clinical pharmacist.  We used to have one sitting in our 12-provider pod, but they centralized her, so now she works ~30 miles away and is available by phone or EPIC message for questions.  Only rarely will I talk to the patient's PCP about a medication question, since I have clinical pharmacists available.

[EMEDPA]

also make sure to check any new rx for interactions with meds the pt is currently taking....

[winterallsummer]

My humble opinion...

 

There are two facets to this issue.

 

1) Do your research.  Consult others, read on-line, etc.

2) Inform the pt of your inexperience with the med, possible ADRs, and commit to a plan to follow up responsibly and monitor for side effects accordingly.

 

There are many drugs once considered safe that today are high risk.  Any many drugs that were new and risky at one point and now are considered standard of care.

 

In medicine we tend to gravitate towards thinking the "best" practitioner is one who adheres most stringently to EBM.  But at the end of the day, that is not enough.  If we consider who we want caring for us or a loved one, it is not someone who just follows the rules completely, but someone invested in our care, who is willing to take calculated risks when necessitated and will do whatever is best to take care of us.  We should strive to do the same for our patients.

 

As long as you keep these things in mind, I think you are doing right by your patient.  You can never predict a good or bad outcome even with a well studied and "safe" drug.  Again just MHO.

[Guest Paula]

I got a note back from a pediatrician today who prescribed off label drug for cradle cap for a baby I referred out to have an umbilical granuloma fixed.  Ketoconazole shampoo for a 2 month old. 

[PACProvider]

In my first job in Primary Care, I inherited a patient from a panel of patients of a former colleague. The patient was a woman with fibromyalgia. She called in a refill request for low dose naltrexone for fibromyalgia. I reviewed her chart and noted that her previous provider found a case report where low dose naltrexone was helpful treating fibromyalgia. I searched UpToDate for any evidence and could find none. Uncertain about the safety of prescribing a drug with little evidence and due to my limited experience, I went to TWO physicians in the clinic. Both of the physicians were responsible to teaching residents in clinic and hospital. My SP only worked two days in the clinic and it was commonly accepted to utilize any available physician for consult. One was an MD/PhD while the other was MD/PharmD. Both of them heard my presentation of the case at the same time and both concluded that they themselves would not write for low-dose naltrexone. They recommended offering treatment with evidence supporting safety and efficacy. I informed the patient who became angry and filed a complaint. She requested a transfer to a different provider. The clinic manager switched her to a Nurse Practitioner in the next office over who happened to be present when I presented the entire case to the two physicians. She ended up writing the prescription because she didn't want to have her employment threatened. When my SP returned, he came to my office and said that I should have written for low-dose naltrexone. 

[Guest Paula]

^^^^^^^ That really stinks.  Your SP and fellow colleague NP stink too. 

[Guest Paula]

Naltrexone for fibromyalgia?  I am guessing the patient became addicted to an opiate that was prescribed for fibromyalgia pain?  This is the type of patient that goes to pain a clinic. 

[primadonna22274]

It's been in the pain medicine literature past few years. Not unheard of...I generally try to avoid fibromyalgia patients whenever possible so haven't tried it :)

http://www.ncbi.nlm.nih.gov/m/pubmed/23359310/

[rcdavis]

I am not so sure..

 

IF This fibromyalgia patient is getting relief from naltrexone ( whether or not she is a closet alcoholic or opioid addict, in which case the pretreatment trial should have shown some withdrawal syndrome...) and for whatever reason she is unable to go to pain management ( who WILL end up with her on methadone), then I find the use of it both intriguing and pretty safe.

 

I would use it.

 

Sometimes this is how off label uses become on label uses.. Family, urgent care docs, EM docs start trying something for difficult diagnoses previously not approved for that drugs use (aka droperidoll or compazine for headaches... I've depacon for headaches.. Septra for lice)

 

I would be very hesitant to classify the SP or NP as " stinks", simply because they are a little more aggressive than the OP.. who may not have as much clinical expertise as they.

 

The conundrum with awaiting all treatments to be evidence based is that only academic centers try avant garde treatments... The rest if us " Sheep" wait for their approval and reported algorhythms.

 

A lot of HIV medicine would never have occurred had this approach been used.

 

I applaud the SP for apparently finding a novel, non dangerous treatment approach to a debilitating condition.

[rev ronin]

The problem with EBM is that it's not a religion, although some people treat it like it is.  EBM *should* give us medicines that are demonstrated to help statistically relevant groups in statistically relevant ways.  But it has blind sides:

 

* Manipulation of published studies for profit

* Some distinct and clinically relevant groups of patients aren't large enough to study and/or not large enough to have been broken out separately.

* Some treatments don't have effective placebos--and I'm thinking mostly of physical or manipulative treatments here--so can't be double-blinded.

* Some conditions don't have enough incidence or prevalence to generate good studies.

* Some things are (or recently have been) considered off-limits due to the severity of outcomes.

 

... but last time I heard, NS was beating both Lidocaine and Amiodarone in the King County ACLS drug study.

 

EBM should get us the right answers to properly and impartially studied questions, but it is the height of arrogance and ignorance to think that only EBM-proven answers can yield good outcomes.  There are a lot of 'right' answers out there that have yet to be discovered.

 

To this specific case, I never have a problem continuing a physician's treatment plan for his or her own patient.  If I have a question, I ask the prescribing doc.  Even if the physician doesn't have as current a knowledge of pharmacology as I might, he or she should have a better understanding of the whole aspect of that particular patient.  One of my preceptors ranted to me once about a newly board-certified hospitalist who was treating a patient of his whom he'd known and treated for 10+ years.  All the first line treatments had been counterproductive, and the patient ended up responding well to an odd combination of pharmaceuticals.  Upon admission, all of those were discontinued and first-line treatments restarted without consulting the patient's physician, my preceptor.  The patient, predictably, reacted badly and was dead inside two weeks. While that outcome could probably be chalked up to poor record keeping (only paper charts at the time), I'm not sure a hospitalist with access to all those years of electronic charts would have bothered to go back through and find out why that patient was on that med regimen, either. 

[Guest Paula]

It's been in the pain medicine literature past few years. Not unheard of...I generally try to avoid fibromyalgia patients whenever possible so haven't tried it :)

http://www.ncbi.nlm.nih.gov/m/pubmed/23359310/

Interesting.  i attended an on-line pain management seminar conducted by University of New Mexico via Indian Health Service free CME.  It covered a wide range of topics including fibromyalgia.  Naltrexone was never mentioned and the speakers were 2 physicians who specialize in pain management.  The course was in the spring/summer 2013.  

 

I still think the SP stinks and so does the NP because they were playing politics.  The SP could have at least defended PACProvider's due diligence and thought process, plus the fact that he did consult with 2 other physicians, and should have given him a promotion instead.  

[db_pavnp]

She ended up writing the prescription because she didn't want to have her employment threatened. When my SP returned, he came to my office and said that I should have written for low-dose naltrexone. 

 

Was it said why you should have written the script?

[GetMeOuttaThisMess]

Let me take a wild guess.....potential loss of $$$ and physician satisfaction rating.

[PACProvider]

I thank all contributors who responded to my case of low dose naltrexone. Rev Ronin's remarks were very interesting. I appreciate hearing alternative views on the exclusive reliance on evidence based medicine. Thank you Mr. Ronin.

[skyblu]

In this scenario, my problem is with the NP writing the prescription stating the reason as "not wanting to threaten her employment." That's not a good reason to write something that you're not familiar with and that is not generally approved as treatment for a condition.

 

I don't have a problem with off-label use of drugs. But the use needs to be thoughtful and researched, and born of a familiarity of the pharmacokinetics and pharmacodynamics as well as the side effect profile of the drug. NOT based on fear of losing your job!