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.
Wednesday, June 30, 2010
Tuesday, June 29, 2010
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!
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!
Friday, June 18, 2010
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.
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.
Monday, June 7, 2010
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?
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?
Thursday, June 3, 2010
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.
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.
Wednesday, June 2, 2010
Teamwork Is Not an Abstract Idea
Alameda County Medical Center was recently fined $75,000 by the California Department of Public Health (DPH) for a preventable medication error which resulted in a patient's death. The patient, a female with end-stage renal disease requiring thrice-weekly hemodialysis, was admitted to the hospital for sudden shortness of breath and chest pain. During a dialysis session two days after admission, she experienced seizures, hypertension, and acute pulmonary edema necessitating transfer to the ICU. At 1400, shortly before transfer to the ICU her attending physician ordered 1000 mg phenytoin IV over 1 hour (specifically mentioning that the dose should not be "pushed quickly"). According to hospital records, the order was scanned to the pharmacy 45 minutes later. Because IV phenytoin was in the ICU's Pyxis unit, the pharmacy assumed the dose had already been given and took no action on the order.
Approximately 7 hours after the order was written, the patient's ICU nurse, not having the ordered medication, called the pharmacy. According to her, she was told by the pharmacist to remove four-250 mg units of IV phenytoin from the Pyxis unit and "give it". She claimed she was given no other instructions by the pharmacist. During the investigation by the DPH, the pharmacist acknowledged receiving the call but stated that she instructed the nurse to mix the phenytoin in a 250 mL bag of saline and administer it through a 0,22 micron filter but admitted failing to provide an infusion rate. The nurse "gave it" as she believed she had been instructed by the pharmacist. Six minutes after the dose was administered, the patient arrested and was pronounced dead approximately 30 minutes after that.
While on the surface this appears to be a "she said-she said" situation, it should have NEVER come to this. Given that most reasonable pharmacists would have immediately screened such an order and construed it to be "emergent", the pharmacist should have then contacted the nursing unit to see if the dose had, in fact, been administered. If it hadn't, the pharmacist had two options. First, she could have instructed the RN to remove the medication from the Pyxis unit and then given her meticulous instructions on how to administer it. The second option, which would have been the ideal one, would have been to prepare and deliver the IV phenytoin exactly as ordered by the physician.
Teamwork requires that members of a team talk to each other, not AT each other, especially during critical times. What was most troubling in this case was that the nurse in question worked for a nursing registry and probably was not completely knowledgeable about certain policies and procedures relating to medication procurement and administration. Given that she wasn't regular staff, she probably didn't feel totally comfortable questioning what she believes she "heard" the pharmacist tell her. In fact during the DPH investigation, she was quoted as saying "...it shouldn't have happened. I shouldn't have listened to the pharmacist and it didn't sound right to give four vials IV push. I should have refused...". The pharmacist, being a regular staff member, should have taken control of the situation rather than taking a passive approach to an order she had believed had already been carried out. Was it laziness? Was it lack of proper training? Did the pharmacist see herself as a "bystander" rather than a "team member" (unfortunately, pharmacists often feel and perform like bystanders)? None of this was revealed during the DPH investigation. However, removing injectable phenytoin from the Pyxis unit and placing the registry nurse on a "do not return" list are, unfortunately, too little, too late. Hopefully, BOTH departments will use this as a "teachable moment".
Approximately 7 hours after the order was written, the patient's ICU nurse, not having the ordered medication, called the pharmacy. According to her, she was told by the pharmacist to remove four-250 mg units of IV phenytoin from the Pyxis unit and "give it". She claimed she was given no other instructions by the pharmacist. During the investigation by the DPH, the pharmacist acknowledged receiving the call but stated that she instructed the nurse to mix the phenytoin in a 250 mL bag of saline and administer it through a 0,22 micron filter but admitted failing to provide an infusion rate. The nurse "gave it" as she believed she had been instructed by the pharmacist. Six minutes after the dose was administered, the patient arrested and was pronounced dead approximately 30 minutes after that.
While on the surface this appears to be a "she said-she said" situation, it should have NEVER come to this. Given that most reasonable pharmacists would have immediately screened such an order and construed it to be "emergent", the pharmacist should have then contacted the nursing unit to see if the dose had, in fact, been administered. If it hadn't, the pharmacist had two options. First, she could have instructed the RN to remove the medication from the Pyxis unit and then given her meticulous instructions on how to administer it. The second option, which would have been the ideal one, would have been to prepare and deliver the IV phenytoin exactly as ordered by the physician.
Teamwork requires that members of a team talk to each other, not AT each other, especially during critical times. What was most troubling in this case was that the nurse in question worked for a nursing registry and probably was not completely knowledgeable about certain policies and procedures relating to medication procurement and administration. Given that she wasn't regular staff, she probably didn't feel totally comfortable questioning what she believes she "heard" the pharmacist tell her. In fact during the DPH investigation, she was quoted as saying "...it shouldn't have happened. I shouldn't have listened to the pharmacist and it didn't sound right to give four vials IV push. I should have refused...". The pharmacist, being a regular staff member, should have taken control of the situation rather than taking a passive approach to an order she had believed had already been carried out. Was it laziness? Was it lack of proper training? Did the pharmacist see herself as a "bystander" rather than a "team member" (unfortunately, pharmacists often feel and perform like bystanders)? None of this was revealed during the DPH investigation. However, removing injectable phenytoin from the Pyxis unit and placing the registry nurse on a "do not return" list are, unfortunately, too little, too late. Hopefully, BOTH departments will use this as a "teachable moment".
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