Think Before You Speak

On the advice of her daughter’s psychiatrist, the mother of a severely mentally-disabled patient became her legal conservator for the purpose of managing her medications.  Knowing that her daughter didn’t drive and only had access to one pharmacy in the neighborhood, the mother went to that particular pharmacy requesting that her daughter be prevented from picking up her own prescriptions and instead, asked that all prescriptions be dispensed directly to the mother or one of her designees.  In order for the pharmacy to honor this type of request, it was necessary for the mother to furnish them with the conservatorship agreement.  This was done not once but three times in consecutive years and these instructions were ostensibly placed in the "notes" section of their computer system.  On several occasions when the mother visited the pharmacy, employees assured her that the request was in their computer system and that she had nothing to worry about.  There were even occasions in which the daughter attempted to pick up her own prescriptions and was prevented from doing so by an alert pharmacy staff who queried the computer.

In late 2006, the pharmacy changed computer systems.  Although the prescription data itself automatically migrated to the new system, information contained in the “notes” section (typically allergy information and special instructions) had to be manually transferred from the old system to the new one.  Unfortunately, according to the pharmacist-in-charge at the time of the changeover, this was not done on a consistent basis.  Curiously, right around the time of the computer changeover, signature records inexplicably began showing that the patient was picking up her own medications contrary to instructions.  Despite this, the pharmacy continued to represent to the mother that everything was fine even though it obviously wasn't.

In late, 2007, the patient’s psychiatrist issued the patient two paper prescriptions, one for a hypnotic and another for an anxiolytic, believing that (a) the patient would simply hand the prescriptions over to her mother, and (b) even if she didn’t and attempted to fill them herself, the pharmacy would prevent this from happening just as it had on at least two previous occasions.  To everyone’s surprise and dismay, the patient was not only able to fill both prescriptions at the pharmacy where the so-called “block” was in place, she was able to fill a third prescription for a codeine-based cough suppressant (issued by another physician) at yet a different pharmacy which was not aware of the her “conserved” status.  The patient returned home, ingested the contents of all three prescriptions at the same time and arrested shortly thereafter.  Unfortunately, emergency personnel called to the scene were not able to immediately establish an airway because of aspirated material and although the patient was eventually resuscitated, she is now in a permanent vegetative state. 

There are two important takeaway points regarding the way the pharmacy handled this situation.  First, pharmacy personnel must be extremely careful when making representations to patients (or their conservators).  In this case, personnel made representations to the mother that were not completely accurate with regard to the existence of a “block” in their computer system.  While that information was in their computer system at some point, it appeared not to be in their computer system the day she was able to obtain her last two prescriptions despite the fact that no more than one month prior to the incident, pharmacy personnel assured the mother that it was.  Had pharmacy personnel actually taken the time to accurately investigate the mother’s query, the discrepancy could have easily been reconciled before the mishap occurred.  Second, pharmacies must use extreme caution when migrating information from one computer system to another.  If they are aware that some information does not automatically migrate and has to be manually moved to the new system, written policies and procedures must be put in place and enforced to facilitate this transfer of vital information.  More likely than not, this is where the information got "lost".

When in Doubt, Clarify

A pharmacy vendor for a long-term care facility received an order for potassium chloride (KCl) solution 10 mEq/15 mL with a dose of 10 mEq once daily. KCl solution is commercially available only in a strength of 20 mEq/15 mL. The pharmacy never clarified the order but instead, sent out the 20 mEq/15 mL solution and labeled the bottle "10 mEq=7.5 mL" which would have yielded the desired dose. During their annual visit, the Department of Public Health noted the disconnect between what was written in the physicians' order section, the medication administration record (MAR), and what the pharmacy sent and labeled.  The good news was the disconnect did not result in patient harm because the correct dose was on the label.  The bad news was the error triggered a further investigation which uncovered a number serious, possibly life-threatening, medication issues.  As a result, the facility received an immediate jeopardy (IJ) citation and a significant fine. The pharmacy vendor, who started the chain of events simply by not clarifying the KCl order, was terminated. When in doubt, clarify!

Don't Put a Target on Your Back-Part II

A community pharmacist with a small practice in a strip mall decided to re-invent himself as a "compounding pharmacist".  He took out ads in a number of professional journals and even set up a web site on the internet to advertise his services.  He became particularly fascinated with a product known as Sargenti paste or N2.  Sargenti paste is a dental product that contains paraformaldehyde as the active ingredient and is sometimes used as a sealant in endodontic procedures.  Its use is extremely controversial.  Although some users (mostly general dentists who perform endodontic procedures) claim it is easier and faster to place in root canals than gutta-percha, its detractors (namely board-certified endodontists) have noted that if the active ingredient leaks out of the canal into surrounding tissue, damage to nerves and bone can be quite severe.  Because of extreme opposition by endodontists, there are currently no commercial preparations of the product and although the FDA banned the interstate marketing of the product in 1991, a pharmacist can still legally compound it provided it does not contain heavy metals such as lead and it is not dispensed in quantities > 5 grams at any one time (the amount typically used to perform one procedure).


Because this pharmacist's compounding business was slow and it appeared there might be a market for Sargenti paste, he obtained the precise formula for it from his professional compounding society and actively advertised it to the American Endodontic Society (AES), an organization consisting of general dentists who use the product.  It was there that his problems started.  A group of general dentists in another state saw an advertisement in their professional newsletter and ordered a small supply of Sargenti paste.  He dispensed 25 grams of the product, a quantity sufficient to perform 5 separate procedures.  However, neither his recordkeeping nor product labeling listed the actual names of the patients who would be receiving the product.  Rather, it was simply dispensed in a single bulk container. 

One of the patients who received the product during her root canal experienced severe complications (leak into surrounding tissue) which necessitated extraction of the tooth as well as surrounding tissue.  Her pain became chronic and intractable despite surgery, a very tragic case indeed.  Subsequently she sued the dental group for malpractice (they immediately made an undisclosed settlement and signed a consent decree stating that they had been grossly negligent) and the pharmacist for both negligence and strict liability.  

Normally, compounded prescriptions are not considered "manufactured" products per se, hence they are exempt from claims of strict liability.  However in this particular case, there were some interesting twists.  First, the pharmacist mailed out 25 grams of the product in a bulk container, a practice not consistent with FDA guidelines which require patient-specific dispensing.  Second, the pharmacy did not possess a non-resident pharmacy permit in the state to which it shipped the product.  This is one factor his own state's Board of Pharmacy takes into account when determining whether an act is compounding (acceptable) or manufacturing (unacceptable).  Third, the state where the product was shipped to also required the pharmacy to have a non-resident permit.  Because the FDA did not view the pharmacist's overall performance as being consistent with an unlicensed manufacturer, they did not pursue regulatory action.  Instead, they deferred to the Board of Pharmacy as is customary in cases such as this one.  When the latter also determined that no laws had been broken, the judge threw out the most serious claim, that of strict liability, and the pharmacist made a token settlement on the claim of negligence.  The takeaway point from this most tragic case is that compounding pharmacists should be very careful what they compound and for what reasons.  If there is a reason to question the appropriateness of a particular product, they probably should not compound it in the first place.

Don't Put a Target on Your Back

A young pharmacist decided to open up a small pharmacy inside a medical building.  He ran the pharmacy on a shoestring but was able to generate approximately 75 prescriptions per day in addition to a small but adequate over-the-counter business.  It was certainly enough to house and feed his family of five.  One day, he was approached by two gentlemen purporting to represent a medical provider network.  They asked him if he would provide mail order prescription services to patients belonging to the network.  The arrangement would entail the network faxing or hand-delivering the prescriptions to the pharmacy along with relevant customer information and envelopes with pre-paid postage.  His instructions were to mail out the prescriptions within 48 hours of receipt and he would be reimbursed according to a fee schedule set up by the network.  Without performing any due diligence with regard to the network, the pharmacist signed an agreement and immediately commenced filling prescriptions for them.

Over an 18-month period, the pharmacist filled approximately 7000 prescriptions for the network.  Of note was that the bulk of the prescriptions were written by three different physicians, all of whom were licensed to practice in the same state as the pharmacy, but whose offices were located nowhere near the pharmacy.  Also, very few of the patients resided in the state where the pharmacy and physicians were licensed. Nearly all of the prescriptions were for DEA Schedule III and IV controlled substances although the quantities prescribed were consistent with what a patient might use within a course of therapy as opposed to higher quantities which might be sold on the street.  Most of the prescriptions were restricted to two refills.  On a handful of occasions, the pharmacist called the prescribers for clarification of particular prescriptions but made no other inquiries regarding the nature of the patients being treated.  His margin of profit filling these prescriptions was nominal and significantly less than that generated from non-network prescriptions.  During the 18-month period he was working with the provider network, < 30% of his net profit came from filling these prescriptions.

One day, he was visited by inspectors from the state medical board informing him that at least two of the physicians he was receiving prescriptions from were writing them without performing a good-faith medical examination.  Upon hearing this and now realizing he may have been part of something that was not legal, the pharmacist immediately terminated his relationship with the network.  Unfortunately, it was too late.  Soon afterward, he was visited by inspectors from his state's Board of Pharmacy who asked for, and received, a written statement describing his relationship with the network as well as bank statements, tax records, and telephone records.  The Board later cited him for unprofessional conduct and brought him before an administrative law judge for license revocation.  Although the Board's intent was to revoke both his license AND that of his store, punishment was later negotiated down to 30-day suspensions of both and an order to hire a "preceptor" to guide him in his day-to-day operations until such time that the Board was satisfied he understood the nuances of American pharmacy law and practice (he was born and trained outside the United States).

This is a perfect example of how internet pharmacies work and eventually fail.  Had the pharmacist performed due diligence prior to signing his contract, he would have noticed that this so-called provider network was really nothing more than a handful of physicians conducting sham medical examinations over the telephone for $100 apiece and writing prescriptions for controlled substances.  In some states, administrative fines for filling these types of prescriptions can run into the tens of millions of dollars, not including license suspension or revocation.  There are easier ways for a pharmacist to make a living!

When Money Changes Hands

A compounding pharmacy was presented with a prescription for chloroquine phosphate for a 7-year-old child who was traveling with her parents to Central America.  Shortly after accepting the prescription from the mother, the pharmacist-on-duty noticed he did not have enough on hand to compound the entire order.  Since it would take 48-72 hours to obtain it from his supplier and he had promised the prescription by the next day, he called another compounding pharmacy in the area to see if they had any chloroquine phosphate on hand that he could have.  The owner of the second pharmacy noticed that he had two bottles on his shelf and offered  to sell both at his cost.  In lieu of using a courier, the owner of the second pharmacy simply dropped off the bottles on his way home from work.  The pharmacist-on-duty noticed that one of the bottles he received was sealed but the other one had an "X" on it, denoting that it had already been opened.  For some inexplicable reason, instead of using a combination of his own stock and the contents of the sealed bottle he had just purchased, the pharmacist elected to use his own stock and the contents of the opened bottle.  In the end, it didn't matter.

Shortly after ingesting one of the compounded capsules of what was thought to be chloroquine phosphate, the child complained of "feeling funny" and passed out.  Her father, a pediatric intensivist at a local hospital, recognized that his daughter was either having an allergic reaction to the medication or possibly something worse.  He immediately put her in the car and took her to the emergency room of the hospital where he practiced.  There, he ordered a number of lab tests including a toxic substances screen of her blood and urine and then transferred her to the intensive care unit (ICU) for supportive care with fluids, pressors, and a respirator.  To everyone's surprise, both screens showed toxic, almost lethal, levels of clonidine, an antihypertensive agent.  The child recovered over a period of a week and was discharged without sequelae.  The balance of her prescription was sent to a forensic laboratory for assay.  Not surprisingly, the capsules contained a combination of chloroquine phosphate and clonidine.  The pharmacy that compounded the prescription immediately removed both bottles of the chloroquine phosphate it purchased from the second pharmacy and sent them for assay as well.  The bottle that was used to compound the prescription (the bottle marked with the "X") contained a mixture of chloroquine phosphate and clonidine.  The sealed bottle that was NOT used in the compounding contained pure clonidine.  The most likely explanation was that the second compounding pharmacy purchased two sealed but mislabeled bottles of chloroquine phosphate from its supplier and used a portion of one of them for its own compounding purposes (interestingly, there were no reports of accidental clonidine poisonings associated with prescriptions coming from THAT pharmacy).

The father sued both the pharmacy that compounded the prescription and the manufacturer of purported chloroquine phosphate powder.  A motion for summary judgment was granted to the pharmacy because the judge felt that even though the prescription was incorrectly filled, it was through no fault of the pharmacist.  The manufacturer of the purported chloroquine phosphate, who had a long history of problems with the FDA, made a substantial settlement with the father.  During discovery, when it was noted that a portion of the ingredients used to compound the prescription came from a second pharmacy, that pharmacy was added to the lawsuit as well.  The theory that plaintiff's counsel pursued in the case of the second pharmacy was that since the owner decided to sell the product rather than lend it as is the long-standing custom in pharmacy practice, he was really functioning as a wholesaler (and an unlicensed one at that).  Counsel for the second pharmacy, recognizing the bind they were in with regard to strict liability, also settled with the father.  The takeaway point in this case is that it is always permissible, even laudable, for one pharmacist to come to the aid of another by lending a needed product when time is of the essence.  However, selling the same product, even at acquisition cost, becomes a point of no return if the product is defective and results in a misadventure.

The AMA and Scope of Practice

The American Medical Association (AMA) recently completed a series of position papers entitled AMA Scope of Practice Data Series.  While the series purports to "...serve as a resource for state medical associations, national medical specialty societies and policymakers...", it is, more or less, a shot across the bow of any non-physician health care professional who attempts to provide patient care that could be remotely construed as being "medical" in nature.  The series could easily have been entitled "what I don't like about you".  Regarding the AMA's position on pharmacists, they could not have gotten this more wrong on so many fronts but the one area where the AMA falls well below the threshold for common sense is their position on collaborative drug therapy management (CDTM). CDTM programs are essentially programs in which physicians "download" certain clinical tasks to well-trained pharmacists because (a) they know the pharmacist can perform the task better than they can, or (b) they don't want to be bothered with it.  The best examples of this are the various drug-dosing and management ("per pharmacy") protocols commonly in use in organized healthcare settings.  In the AMA's eyes, CDTM is an unwelcome extension of pharmacists' scope of practice into what has traditionally been the physician's domain.  However, based on their stance on CDTM, it appears they never got the memo on the definition of "collaborative".  In order for something to be "collaborative", there has to be "collaboration", and in order to have "collaboration", both parties must agree to the terms of the collaboration.  Not only do the terms have to be agreed to in advance, the terms are generally determined and enforced by medical staff committees, not pharmacy staff committees.  If anybody is driving CDTM, it is the physicians themselves!  A physician that does not want to participate in CDTM doesn't have to.  Furthermore, a pharmacist who attempts to perform CDTM without the physician's permission runs the risk of not only ceasing to exist as a health professional, but incurs an incredible amount of professional liability should their performance result in a therapeutic misadventure. 


At one time, a series of this type would have been taken as the gospel by physicians and policymakers but the AMA of today is not the AMA of 25 years ago, or even 10 years ago.  Just to show how much things have changed, I contacted just about every physician I am on a friendly basis with in order to obtain the Scope of Practice Data Series in its original form (it is currently accessible only to AMA members).  Guess what?  Not one of them could help me because not one of them even belongs to the AMA!  Each and every one had quit the organization because they no longer saw the organization as relevant to their practice.  Perhaps this is why?

Black Box Warnings and Duty

The Kefauver-Harris amendment to the Federal Food, Drug, and Cosmetic Act requires that drug labeling take into consideration special problems such as those that may lead to death or serious injury and a warning be placed in a "prominently displayed box".  This box has come to be known as a black-box warning because it is generally enclosed in a black border at the top of the package insert.  This type of warning addresses the avoidance of the drug in certain high-risk patients or patient populations, dosing and/or drug interaction issues, the use of the drug in a particular clinical setting, or the need for special training prior to prescribing or administering the drug. It is the most serious warning associated with a particular drug.

Approximately 450 different drugs or drug entities carry black-box warnings.   Most black-box warnings are informational only and address the avoidance or careful use of particular drugs in certain clinical situations (i.e. pregnancy) or in certain patient populations (i.e. patients with renal, cardiovascular, gastrointestinal, neurological, hepatic, bone marrow, or addictive disorders).  However, a subset of drugs with black-box warnings also include well-defined "prerequisites" before they can be ordered, dispensed, and administered.
  
For example, the black-box warning associated with droperidol states that  "the drug should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments...and that patients about to receive droperidol should first undergo a 12-lead electrocardiogram... and those patients with prolonged Q-T intervals should not receive the drug...".  The black-box warning for transdermal fentanyl, among other things, states that the drug shall only be used for persistent moderate to severe chronic pain in opioid-tolerant patients. In California, three institutions received immediate jeopardy (IJ) citations for promoting the use of droperidol as a first-line treatment of post-operative nausea and vomiting without requiring a 12-lead ECG prior to use.  Similarly, three institutions in California received IJ citations for dispensing and administering transdermal fentanyl patches to patients for whom the drug was contraindicated based on its black-box warning.   Other drugs with black-box "prerequisites" being used in the inpatient setting have thus far escaped scrutiny by regulators, although that too may be changing as drug utilization in the inpatient setting is being watched more closely by the Department of Public Health (DPH).

Because these "prerequisites" may be construed as imposing a "duty" on the part of the prescriber or institution, any breach of that duty leading to harm is, by definition, negligence, and exposes both parties to liability for negative outcomes.  An interesting question is, does this duty extend to the pharmacy who dispenses the drug?  We know that from a legal standpoint, inpatient pharmacies are expected to control and distribute drugs and biologicals "...in accordance with applicable standards of practice, consistent with Federal and State law...".  This may include, but not be limited to, guidelines, protocols, policies, procedures, and systems which must be followed before the pharmacy can dispense the drugs.  We also know that accreditation organizations such as JCAHO incorporate State and Federal laws into their accreditation standards and in general, their accreditation standards are nearly always stricter than the interpretive criteria used by the regulatory agencies.  Therefore, since the inpatient pharmacy has to be involved at some point when black-box warning drugs are utilized, a reasonable person would conclude that these prerequisites, and thus a "duty", extend to them as well.

A more interesting question is, does this duty also extend to outpatient pharmacies?  The answer so far is no, but that could change at any time.  California pharmacy law does require both community pharmacies and pharmacies that provide services to long-term care (LTC) facilities "...to review a patient's drug therapy and medication record before each prescription drug is delivered...the review shall include screening for severe potential drug therapy problems...".  Does this mean that a community or LTC pharmacy must, when presented with a prescription for a drug like transdermal fentanyl, question the patient or the patient's agent as to whether or not the patient is opioid-naive?  So far, there is no case law regarding this matter and to date, no regulatory attacks have been made against community or LTC pharmacies who dispense black-box drugs contrary to prerequisites or contraindications.  Will this change in the future?  Attorneys are always on the lookout for new "duties" for healthcare professionals so my advice is, stay tuned.