Health and Pills » Reviews & Views http://healthandpills.com Guide To Good Health and Drugs: Tablets, Gels, Capsules Tue, 07 Feb 2012 09:49:47 +0000 en hourly 1 http://wordpress.org/?v=3.3.1 Procedure and Substance http://healthandpills.com/reviews-views/procedure-and-substance http://healthandpills.com/reviews-views/procedure-and-substance#comments Sat, 18 Dec 2010 07:01:32 +0000 admin http://healthandpills.com/?p=645
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      One of the most frustrating aspects of litigation is the almost endless procedures and complicated court rules that the parties must endure on the way to seeking justice. Procedures sometimes get in the way of substance, much like misplaced focus on a single tree prevents us from seeing a whole forest. A recent case, Burkes v. Fred’s Stores of Tennessee, demonstrates the problems that can occur when too much emphasis is placed on following court rules and scant attention is paid to the facts at hand.

      A suit that has taken four years to move to trial illustrates the problem of paying more attention to court procedures than the facts of the case itself.

      Facts

      In August 1996, suffering from leg cramps, the plaintiff consulted her physician. He prescribed quinine sulfate. The plaintiff took her prescription to the defendant-pharmacy located in Lexington, Mississippi. Although it is highly disputed, it appears that the pharmacist mistakenly filled the prescription with quinidine. In any event, the label on the container indicated the drug was quinidine, not the quinine that had been prescribed. The plaintiff did not notice the difference in the names. Not knowing that she had the wrong drug, the plaintiff took her medication as directed on the label for two weeks. She began suffering severe stomach cramps and was admitted to a hospital in Jackson with gastritis. During her stay, the error was discovered. She was discharged a few days later with a diagnosis on her chart of “adverse drug reaction to quinidine.”

      Procedures

      She sued the pharmacy corporation and the individual pharmacist in a Mississippi court for negligence in filling her prescription. Her lawsuit was filed on December 4, 1996. The defendants answered the complaint on January 7, 1997, and began discovery by asking the plaintiff to produce all records in support of her claims. As part of the request, the defendants asked the plaintiff to list her expert witnesses and state the basis for their testimony. The plaintiff responded to the discovery requests over a period of time from February 16, 1997 to April 11, 1997. On March 24, 1997, the plaintiff filed documents indicating two expert witnesses, one a Ph.D. and the other a Pharm.D., both employed by the University of Mississippi School of Pharmacy. She also listed the name of her treating physician. She did not, however, designate the subject matter on which the experts were expected to testify, the substance of the facts and opinions they were expected to provide, or a summary of each expert’s opinion.

      In answer to the plaintiff’s discovery requests, the defendants admitted that the pharmacist “mistakenly mislabeled the medicine dispensed to the plaintiff as quinidine sulfate instead of quinine sulfate.” The pharmacist did not, however, admit that he dispensed quinidine instead of quinine. In fact, he never indicated what he dispensed, limiting the admission only to mislabeling the vial. The plaintiff unsuccessfully attempted to employ other discovery methods to pin down the defense. The plaintiff tried to take the deposition of the pharmacist on several occasions but he refused to appear.

      On April 15, 1997, the defendants “removed” the lawsuit from the state court system to the federal district court sitting in Mississippi. Removal is a procedure often employed by corporate defendants that are headquartered outside of the state where the complaint is filed. Right or wrong, this tactic is employed on the belief that the outside corporation will be treated “fairer” by the federal court system where a jury pool consists of residents from a much larger area. In state courts, the jury pool is usually composed of residents from the county where the plaintiff lives. Local residents are presumed to be more sympathetic to the plaintiff than an outside corporation.

      Upon the filing of the motion to remove the case, discovery ceased. This is normal because discovery rules differ between state and federal courts. Discovery is usually postponed until the courts determine where the proper venue is. The federal district court determined on December 12, 1997, that jurisdiction was proper in the state court, not the federal court. Accordingly, the case was “remanded” back to the court where the complaint was originally filed.

      On January 8, 1998 (well over a year after the lawsuit began), the defendants filed a Motion for Summary Judgment, asking the judge to throw out the lawsuit, or in the alternative, to compel more discovery. On April 21, 1998, the state court judge realized that discovery had ceased during the removal proceeding. He then entered an amended scheduling order that extended discovery until August 15, 1998. He held the defendants’ Motion for Summary Judgment in abeyance until after the new discovery deadline. Under the court rules, within a few weeks of the new scheduling order, the plaintiff should have again designated expert witnesses and listed the basis for their testimony. This was not done.

      The defendants filed a renewed motion to either compel discovery or dismiss the case. On June 16, 1998, the judge entered an order compelling the plaintiff to designate experts on or before June 22, 1998. The plaintiff did not comply and on July 6, 1998, the defendants again asked the judge to dismiss the case. On August 24, 1998, the judge entered an order of summary judgment in favor of the defendants. The judge specifically found that the plaintiff had failed to “properly” designate experts as ordered and, as a result, cannot prove her case. The plaintiff asked the judge to reconsider, pointing out that experts were originally named on March 24, 1997. The request for reconsideration was denied on August 27, 1998. A final order of dismissal was entered
      on May 3, 1999. The plaintiff appealed to the Mississippi Court of Appeals.

      Appellate Decision

      On October 3, 2000, nearly four years after the lawsuit started, the Court of Appeals rendered its decision. It reversed the lower court ruling and ordered the case scheduled for trial. It was clear to the appeals court that the plaintiff did designate witnesses in a timely manner as mandated by the scheduling orders and court rules. However, the plaintiff, or more properly, her attorney, did not provide the required details concerning the expert witnesses’ testimony as requested by the defendants pursuant to interrogatories. The opinion of the Court of Appeals speculates, “Perhaps this is what the trial judge was referring to in the order when she said that the plaintiff had ‘failed to properly designate’ her experts.”

      As an excuse for not supplying the additional information about the experts, the plaintiff argued that her attorney was “taking all possible steps to obtain the deposition of the defendants in an effort to obtain information to present to her experts for purposes of evaluating the necessity of expert opinion testimony in this case.” The plaintiff noted that the defendants, especially the pharmacist, were uncooperative and that he refused to be deposed. Although the Court of Appeals did not rule on this particular argument, it did note that the record shows the plaintiff’s attorney made an unsuccessful effort to depose the pharmacist prior to the trial court’s granting summary judgment.

      The Court of Appeals also looked much closer at the evidence in the record. It stated that there is still a question of fact as to whether the pharmacist had misfilled the plaintiff’s prescription. According to the Court of Appeals, “The medical records which were produced by the plaintiff during discovery showed, without contradiction, that upon admission, [the plaintiff] had a serum quinidine level of 0.7. The medical records also showed, without contradiction, that [the plaintiff] had suffered acute gastritis which was quinidine induced. According to the complaint [the plaintiff] ingested quinidine given her by [the pharmacist] who admitted that the medicine prescribed was quinine sulfate. While not identifying the medicine he gave [the plaintiff], the pharmacist contends that the medicine was mislabeled as quinidine sulfate. Whether it was mislabeled or was in fact quinidine sulfate was a genuine issue of material fact. Consequently, there remained material issues of fact when the motion for summary judgment was granted.”

      Insofar as the question of the experts not being properly described, the Court of Appeals stated, “It appears to us that it does not require expert testimony to prove that misfilling a prescription is negligence. It does, however, take a medical expert to prove that [the plaintiff's] injuries were caused by the drug quinidine. In this regard, we note that the medical records produced in discovery clearly conclude that quinidine was the culprit. According to the medical records, that conclusion was reached by [the plaintiff's] treating physician at [the hospital]. His name had been separately disclosed to [the defendants], not as an expert, but as a person having discoverable information about [the plaintiff's] allegations. Of course, it is obvious that a medical doctor possesses special knowledge and expertise in medical matters. It is also obvious, based on the disclosed documents, that [the defendants] were aware of the physician’s final opinion though that opinion had not been disclosed to them in the proper form.”

      In its conclusion, the Court of Appeals took special care to note, “Although we are reversing and remanding this case for trial, we want to be clear that [the plaintiff] had an obligation to supplement her answer, designating her experts, to include the subject matter on which the experts were expected to testify, the substance of the facts and opinions to which each expert was expected to testify, and a summary of the grounds for each expert’s opinion. We do not condone [her] failure to do so, and on remand, the trial judge is free to impose whatever sanctions she determines to be appropriate for [the plaintiff's] actions. In this regard, we only add that the trial court should also consider the role, if any, that [the defendants] had in frustrating or thwarting [the plaintiff's] effort to take the depositions she desired and whether their actions, if any, in that regard impacted [the plaintiff's] ability to timely supplement her answer regarding her designated experts.”

      Analysis

      This case is close to the epitome of elevating form over substance. It has gone in and out of the state court, in and out of the federal court, back to the state court, dismissed from the trial court, up to the Court of Appeals and now back to the trial court. By artful manipulation of the legal system, this case has been pending for over four years since this patient was injured as a result of getting the wrong medication from her pharmacy. If this is not a case of “justice delayed is justice denied,” it is hard to think of what would qualify. Without intense persistence, the plaintiff may have never had her day in court. A trial court judge dismissed the complaint because expert witnesses were not “properly” designated. That would be a harsh sanction indeed. From the pharmacy perspective, this may even seem to be a worthy and appropriate outcome. How badly could she have been hurt, anyway? From the perspective of the corporate pharmacy, maybe it is better to pay the defense lawyers and show that plaintiffs cannot sue it without paying a heavy price. From the trial lawyers’ perspective, the case has to be a gem. Think of the legal fees generated by all
      the procedural wrangling. The amount of paperwork generated by the case to date must be astounding. From the trial court judge’s perspective, the plaintiff’s failure to follow the rules looks like a good excuse to get rid of one more case that is part of what is undoubtedly an overburdened docket. Perhaps people who do not follow the form and substance of the court rules should not have their day in court.

      The Court of Appeals took an entirely different perspective and did the harder but more appropriate work of looking at substance first and procedure second. The record showed that the plaintiff obtained the wrong drug from somewhere, that the pharmacist typed the wrong name of the drug on the label, that the labeled name was not the name of the prescribed drug, that the patient was hospitalized, that laboratory tests showed her blood level of the drug name typed on the pharmacy label was elevated, and that her physician was convinced that her symptoms were caused by a toxic amount of a drug she consumed but that had not been prescribed for her. The record also revealed that the plaintiff did
      designate two experts from a respected pharmacy school and that she had attempted, without any cooperation on the defendants’ part, to take the deposition of the pharmacist. Although not explicitly stated, it is also obvious from this record that the defense is trying to argue that there is no evidence that the pharmacist in fact dispensed the wrong drug, that he only mistyped quinidine instead of the prescribed quinine on the label, that there is no evidence that the elevated blood serum level of quinidine displayed by the plaintiff resulted from quinidine obtained from the pharmacy, and that there is no evidence that the quinidine the patient got from somewhere caused her symptoms. The defense seems to also be asserting that because the plaintiff did not explain the basis for the opinions of her expert witnesses, they should be barred from testifying which, in turn, will make it impossible for her to prove her case. Those are all good and legal arguments that could be credible in the right context. But, as the Court of Appeals found, the arguments are beyond credibility under the facts and circumstances of this case.

      Lawyers are supposed to be zealous in the representation of their clients. Like it or not, we live in a society that allows people to retain the best lawyers and put them to work as hard as they can up to the limits they can afford. Sometimes, in the fervent pursuit of justice, though, we lose perspective of what we should
      be about. Pharmacists are not lawyers. Our job is to help people make the best use of their medications. If we make mistakes, we need to minimize the harm caused to the patient. It does not appear that the profession of pharmacy is well served in this case.

      ]]> http://healthandpills.com/reviews-views/procedure-and-substance/feed 0 Mistake or Wanton Disregard? http://healthandpills.com/reviews-views/mistake-or-wanton-disregard http://healthandpills.com/reviews-views/mistake-or-wanton-disregard#comments Sun, 16 May 2010 08:15:18 +0000 admin http://healthandpills.com/?p=642
      Contents

          The standard for showing wanton disregard is much higher than for a negligent mistake.

          T here should be no doubt that pharmacists and pharmacies will be held liable in a civil lawsuit when a dispensing error causes patients to be harmed. The damages usually awarded to the patient are for compensation of the injuries actually suffered and may include an amount for pain and suffering. In some states, patient-plaintiffs may also seek punitive damages if there is evidence that the defendant did something willful or wanton in reckless disregard for the plaintiff’s safety. Two recent cases demonstrate the distinction.

          Case #1

          The plaintiff entered a weight-loss treatment program in 1995 and was given prescriptions for Verelan (antihypertensive), Profast and Pondamin (commonly called the Fen/Phen diet). At the pharmacy, she agreed to have the prescriptions filled with generic drugs. The pharmacist misread the Pondamin prescription, thinking it called for prednisone, and dispensed Deltasone. The pharmacist testified that because it was during the cold and flu season it would not be unusual for a doctor to prescribe a steroid, which often causes weight gain, along with a diet drug. Although the plaintiff left the prescription with the pharmacist, her physician had also given her a list of the drugs he was prescribing for her. Based on that list, she knew that the pharmacist gave her Deltasone rather than Pondimin, but she did not ask if there was any difference between the two.

          The physician had given her prescriptions for 30 days’ worth of each medication, with refills. When she returned to the pharmacy for refills, all of the prescriptions were correctly filled. Within days after this, she began to experience blurred vision and lethargy. After consulting with her physician, the pharmacy error was detected. She claims to have suffered several physical and mental ailments as a result of the mistake. She sued the pharmacy and the pharmacist for negligence and wantonness. A claim of wanton disregard for the plaintiff’s well-being would, if proven, entitle the plaintiff to seek punitive damages.

          The plaintiff testified that when she stopped taking the steroid and began taking the correct medication, her system went into withdrawal, causing the blurred vision and lethargy. After the mistake in prescriptions was discovered, she was put back on the steroid and gradually weaned off the drug. The plaintiff claimed that as a result of taking the steroid, she had difficulty in concentrating and had memory loss, hair loss, night sweats, joint pain, and swollen glands. She also stated that she became severely depressed and suicidal. Two physicians diagnosed the plaintiff as suffering from depression and Epstein-Barr virus. One mental health professional determined that her depression and anxiety stemmed from steroid use.

          The pharmacy’s expert witnesses contradicted the plaintiff’s experts as to causation and the extent of damages suffered. They testified that the problems experienced by the plaintiff were related to the long-term use of the prescribed diet medications, use of the antidepressant Serzone, and the adenosine injections she received in conjunction with her weight-loss program. These experts also disputed whether the active Epstein-Barr virus was present in her system. According to them, the plaintiff’s test results indicated the presence of the Epstein-Barr antibody in her system, and its presence would indicate that she may have been exposed to the virus at some time in the past. In any event, they claimed that the presence of the Epstein-Barr virus or antibody in her system was not related to her use of the steroid Deltasone.

          A state statute requires that malpractice claims against “healthcare providers” be proven by substantial evidence. The trial court judge ruled that pharmacists are healthcare providers and therefore come within the substantial evidence mandate. The judge ruled that the plaintiff had failed to submit substantial evidence that the pharmacy or pharmacist had acted with wanton disregard and dismissed the claims. The plaintiff agreed and voluntarily dismissed the pharmacist from the law suit. After a jury trial against the pharmacy on the negligence claim, the jury returned a verdict in favor of the pharmacy. The plaintiff appealed to the state’s Supreme Court. This Court upheld the finding that a pharmacist is a healthcare provider because the dispensing of drugs is an integral part of healthcare services. The Court also upheld dismissal of the wantonness claim. The pharmacist’s mistake in reading the prescription does not rise to the level of reckless disregard necessary to sustain a wantonness claim. The Court, however, remanded the case for a new trial on the negligence claim because it found the jury instructions to be confusing.

          Case #2

          The plaintiff was diagnosed with pancreatic cancer in 1995. She underwent radical surgery to remove her stomach, parts of her small intestine and her pancreas. In 1997, after she underwent further surgery, her physician prescribed fluorouracil chemotherapy and radiation. Upon release from this hospitalization, she had prescriptions for Diflucan, Kytril and Pepcid taken to the defendant pharmacy. The prescription for Pepcid 20 mg was erroneously filled with Paxil 20 mg. The normal starting dose for Paxil is 10 mg. She consumed the Paxil as directed, twice daily, for approximately one month. During this time she exhibited increased irritability, weakness, confusion and inattention to hygiene. Approximately two weeks after the prescription was erroneously filled, and without knowing about the error, her physician prescribed Zoloft to address the signs of depression displayed by the patient. However, within five days, the doctor stopped the Zoloft because the patient presented with very low blood pressure. A few days later, she got up to go to the bathroom and she fell, causing her to fracture her leg and foot. Testimony indicated that her loss of equilibrium was due to the Paxil. She was admitted to a nursing home. Her daughter brought all of her medications from home and the nurses continued to administer them, including the Paxil. The error was discovered by a nurse five days after admission to the nursing home. Her physician discontinued the Paxil immediately upon learning of the error. When her daughter told the pharmacy about the mistake, the pharmacy indicated that it would fill out an incident report. No one at the pharmacy discussed any of the side effects associated with Paxil or the dangers of abrupt withdrawal. Ten days after the error was discovered, the patient was to be released from the nursing home. However, she fell, causing injuries to her head, back and pelvis. Testimony indicated this fall was caused by abrupt withdrawal of the Paxil.

          She sued both the pharmacy and the pharmacist. The jury returned a general damages verdict of $100,000 against both defendants and $150,000 in punitive damages against the pharmacy only. The pharmacy appealed the punitive damages award, claiming there was insufficient evidence to submit the claim to the jury. The pharmacy asserted that this was a simple mistake, not willful and wanton disregard for another’s safety. It also disputed the jury instructions on punitive damages and challenged evidentiary rulings allowing the submission of incidence reports and licensee disciplinary proceedings associated with this incident. The Court found that there was enough evidence to submit the punitive damages question to the jury.

          The pharmacist who made the error was on duty alone during the noon rush hour when the mistake occurred. The pharmacist admitted that she had asked for extra technicians to help her during busy times. The evidence showed that during a preceding three-year period, 34 mistakes of a similar nature occurred at this pharmacy. All involved dispensing the wrong drug with the same first alphabetical letter as the prescribed drug. The Supreme Court of Iowa concluded that the jury could have reasoned from this evidence that the pharmacy knew it had a problem and did not take adequate steps to correct it. The Court stated that the pharmacy’s conduct was “particularly egregious” because it failed to warn the plaintiff or her physicians about the adverse consequences of using Paxil or dangers associated with its abrupt withdrawal. The pharmacy knew of the error 12 days before the plaintiff fell in the nursing home, yet, in violation of its own written policy manual, neglected to tell the plaintiff, her family or her physicians what signs or symptoms should be watched for. A jury could have concluded that warnings of this type could have prevented the last fall. Failing to take action after it learned of the error could be taken as evidence of obvious indifference in support of the punitive damage award. Therefore, the trial court did not err in submitting the punitive damages question to the jury. There was also no error in the jury instruction, which indicated “punitive damages are intended to punish the defendant…and protect the public by deterring the defendant and others from doing such wrong in the future.” Nor did the trial court err in admitting evidence of the pharmacy’s financial worth for purposes of calculating the punitive damage award. Likewise, the trial court correctly admitted the reports of 34 other incidents involving misfilled prescriptions as evidence of the existence of a dangerous condition. The fact that 30 of the incidents did not involve the pharmacist who misfilled this prescription is not relevant to the claim for punitive damages against the pharmacy; these incident reports are evidence that the pharmacy corporation knew there was a problem at this particular pharmacy and did not take any corrective action.

          The Supreme Court did, however, find that the trial court committed reversible error in admitting evidence regarding the Board of Pharmacy investigation and administrative proceedings about this incident. The trial court erroneously admitted a stipulation and consent order agreed to by the state and the pharmacy. The consent order specifically stated that the parties entered into it for the purpose of settling the charges without a hearing and that the pharmacy did not admit the charges were true or that it was guilty of any wrongdoing. The charges in the Board of Pharmacy complaint “convey an atmosphere of criminality” against the pharmacy and did carry the threat of criminal penalties. This evidence was not probative and its admission caused harm to the pharmacy’s rights. For this reason, the Supreme Court of Iowa remanded the case for retrial only on the issue of punitive damages against the pharmacy. The compensatory damages award against both the pharmacist and the pharmacy were affirmed.

          One judge dissented, finding there was insufficient evidence of willful misconduct on the part of the pharmacy to submit the issue of punitive damages to a jury. This judge reasoned that the pharmacy justifiably relied on the plaintiff’s treating physician to render appropriate care after the error was discovered. This judge noted the fact that the pharmacy took no action when it learned of the mistake may be “egregious conduct” but believed the lack of action does not amount to willful or wanton misconduct, where the pharmacy could reasonably assume that the physician would take whatever steps were necessary to protect the patient.

          Analysis

          Taken together, these cases show that there is significant controversy in how claims against pharmacies are handled in the courts. In the first case, the evidence showed that the pharmacist made a mistake that resulted in harm to a patient. The Supreme Court of Alabama concluded that this evidence was not sufficient to meet the standards of wantonness to sustain a punitive damage claim. Instead, the mistake should serve as a basis for compensatory damages under an ordinary negligence standard.

          Although the case has to be retried because the Board of Pharmacy proceedings should not have been admitted, on retrial, the 34 incident reports will still be available as proof on the wanton disregard claim. It is almost ironic that this pharmacy may again face punitive damages because its own incident reports will be used against it. Had similar incident reports been available in the first case, a very different result likely would have occurred.

          Pharmacists should take these cases to mean that they are responsible for their work environment. If a simple negligent mistake harms a patient, they will be held accountable for at least compensatory damages. But if they work in situations where errors are continually made and do not take corrective action, they may very well face much greater liabilities.

          ]]> http://healthandpills.com/reviews-views/mistake-or-wanton-disregard/feed 0 Two-Tier Pricing: Unequal Protection http://healthandpills.com/reviews-views/two-tier-pricing-unequal-protection http://healthandpills.com/reviews-views/two-tier-pricing-unequal-protection#comments Wed, 12 May 2010 08:10:53 +0000 admin http://healthandpills.com/?p=640
          Contents

              Many third-party prescription drug benefit programs use two-tier pricing schemes that differentiate between “chain” and “independent” pharmacies. In almost all situations, discounts off the Average Wholesale Price (AWP) of drugs are smaller for the independents and larger for the chains. For example, the independents may be reimbursed using a formula of AWP minus 10% (plus a “dispensing fee” minus any co-pay). The formula for a chain in the same program might be AWP minus 15%. The rationale given for the dichotomy is a belief that the chains have the ability to secure larger discounts from the wholesalers and manufacturers by virtue of volume purchases. Independents are viewed as not having the same leverage. There is, of course, a wide variation in the amount of the discounts and just what constitutes an “independent” or a “chain” pharmacy.

              Wal-mart and Walgreen’s indicated they would withdraw as Medicaid providers if the higher discount rate imposed on chains went into effect.

              As might be imagined, most of the independent pharmacy operators favor this pricing differential as a means of “leveling the playing field.” The chains, for the most part, view the differential as arbitrary and capricious, with little or no actual justification. Many chains assert that the belief that they have market power to demand greater discounts is largely based on anecdotal evidence that is not supported by any credible studies. From the chain perspective, differentiation creates a decidedly unequal playing field.

              Up until recently, however, there has been little success in challenging these reimbursement methodologies. A new case may change that. If this case is not reversed during any appeals, pharmacy benefit programs, at least those supported by various government agencies, will have to modify existing payment plans to pharmacies.

              Facts

              The Arkansas Department of Human Services administers the Medicaid program for that state. On April 24, 2000, the Department adopted a plan that would reimburse independent pharmacies at the rate of AWP minus 10.5% plus a dispensing fee of $5.51. Chain pharmacies would receive the same dispensing fee but the cost of drugs would be reimbursed at AWP minus 17.3%. In separate lawsuits, consolidated for this decision, Wal-Mart and Walgreen’s sued the Department in federal court, claiming that the two-tier scheme violates both the federal Medicaid Act and the Equal Protection clause of the Fourteenth Amendment to the United States Constitution. Both chains sought a permanent injunction to stop implementation of the new program. The plaintiff-chains claimed that the defendant-Department considered factors that are not permitted under federal law when it adopted the plan and that, to the extent that chains are treated differently than independents by the Department, there is unconstitutional discrimination between similarly situated pharmacies without any rational reasoning.

              It is noteworthy that 75% of all pharmacies in Arkansas are considered independent. Nevertheless, Wal-Mart operates 84 pharmacies and Walgreen’s has 13 pharmacies in the state. Both chains indicated to the Court that they would withdraw as Medicaid providers if the higher discount rate imposed on chains went into effect. This would mean an immediate 25% reduction in access to pharmacies providing services to Medicaid patients in that state.

              Federal Medicaid Law

              Medicaid programs are the joint efforts of the federal and each of the state governments. The federal law sets the standards for participating states to administer the benefits provided to indigent patients. Each state is reimbursed by the federal government for a percentage of the benefit paid by the state to providers. There is no mandate that any state provide any of the benefits available under federal law. However, if a state does elect to participate in the Medicaid program, it must follow federal guidelines regarding payment schedules, coverage and access. The Health Care Financing Administration (HCFA) oversees Medicaid at the federal level and adopts regulations designed to implement the various statutes constituting the Medicaid Act. While all state plans and modifications to plans for eligible benefits must be approved by HCFA, the plans are deemed to be approved 90 days after they are submitted unless HCFA objects. In other words, a plan might be deemed approved even if it is never reviewed at the federal level. Insofar as brand-name prescription drug benefits go, the federal program requires states to reimburse pharmacies at the less of either the usual and customary price or by the estimated acquisition cost (EAC). Almost all brand-name drugs are paid for at the EAC level. EAC is defined as the agency’s “best estimate of the price generally and currently paid by providers.” Each state has some flexibility to determine the EAC. However, the states are constrained in setting reimbursement rates by federal law that requires states to enlist enough providers so that services are as equally available to Medicaid recipients and the general public. This aspect of the law is generally referred to as the “equal access” provision. Providers who claim that reimbursement rates are too low in violation of the equal access provision often sue under the anti-discrimination provisions of the civil rights laws.

              Findings

              The district court judge hearing this case ruled that the Arkansas Medicaid program must consider certain statutorily mandated factors, including equal access, efficiency, economy and quality of care, when it sets pharmacy reimbursement rates. The judge found there was no evidence that the Department had followed this requirement. Instead, the Department only considered how other states determined pharmacy reimbursement rates. The Court found that this consideration was not relevant to how an individual state sets the rates.

              The Court noted that the Department did contract with a private firm to survey pharmacy costs and reimbursement rates. That firm had conducted similar surveys in other states and made some of those data available to Arkansas. However, the survey was used primarily to determine the dispensing fee, not the EAC or the discount from AWP. The Department argued that the fairness of the reimbursement rate should be determined by considering both the dispensing fee and the AWP discount together. The Court rejected this position, noting that the federal regulation defines EAC as the best guess of providers’ actual costs. In other words, the dispensing fee amount and how that is determined is separate from the method of determining how to calculate a pharmacy’s actual drug costs.

              In this case, the Arkansas department used the AWP discount to establish the EAC. The Department asserted that the chains regularly receive “secret” discounts of approximately 6.8% that are not available to the independents. However, no evidence was introduced to support this claim. In fact, the report generated by the firm hired by the Department to help set the fees concluded that, based on its surveys of the Arkansas pharmacies, there was no significant difference between the acquisition costs for chains and independents. That firm later recanted this conclusion but replaced it with a statement that the survey it conducted did not establish whether there is any difference between the prices paid for brand-name drugs between chain and independent pharmacies.

              The Department also used surveys done in other states to determine the appropriate discount rate. The judge ruled that this consideration was completely wrong because the federal statutes dictate that each state consider the conditions that affect drug costs within that state.

              The Court was also critical of the Department’s motives in establishing two-tier pricing. The judge observed that this was really a political and economic attempt to save approximately $4 million per year in Medicaid expenditures. The judge stated that it was his “clear impression” the 17.3% discount offered to the chains was really intended as a bargaining chip to induce the chains to come in and negotiate a more reasonable discount. This is wholly inappropriate, given the federal requirements that specific factors be used to objectively determine each pharmacy’s EAC for brand-name drugs.

              The fact that the Department used different rates for independent and chain pharmacies and applied the formula across the board, without regard to the size or type of chain or to the kinds of services offered, was enough to convince the judge that the two-tier system was arbitrary and capricious and without a rational relationship to the federal mandates. Thus, reasoned the judge, there is no basis to differentiate reimbursement rates between chains and independents. Absent evidence that appropriate factors had been considered in determining the EAC, the Court ruled that the Department violated the Medicaid Act and engaged in unconstitutional discrimination.

              Analysis

              Assuming this case is not overturned if or when it is appealed, its implications are significant to the interests of all pharmacies participating in any third-party program that incorporates differential reimbursement plans. Because this case involves Medicaid payments, by its nature, the decision would apply initially to publicly funded plans. However, because most private plans are highly regulated, it is very possible that other state agencies would adopt the rationale of this case to apply to private insurance or managed care plans as well.

              While this might seem like good news, at least to the chain operators, a word of caution is offered to the independents and the rest of the pharmacy world. The evidence in this case suggested to the judge that all pharmacies in Arkansas should be reimbursed at the rate of AWP minus 10.5%. The judge could have concluded that all pharmacies should be compensated at the rate of AWP minus 17.3%. This would have accomplished the same goal of “leveling the playing field” sought by the chains because all pharmacies would be treated equally (perhaps, equally bad, but equally nonetheless). In fact, the survey evidence showed that the average pharmacy in that state, without distinction in type, only paid 82.7% of the AWP. Luckily for both the chains and the independents, the judge discounted the credibility of this survey. While there was no evidence supporting the idea that the 10.5% discount is any more accurate or any less arbitrary, at the very least it is more palatable.

              One of the factors the judge expressed repeated concern over is whether or not pharmacies will remain in the provider network to assure that Medicaid recipients will have access to prescription drugs. The chains made a fairly clear threat to not participate at the 17.3% rate. If they followed through with this threat, the state would have lost 25% of its Medicaid pharmacies. While there might not have been evidence to support the 10.5% discount as any more reasonable, at the very least no one was threatening to pull out of Medicaid. That is, of course, good news for Medicaid-eligible recipients as well as the pharmacies that serve this needy population. Just beware that the next case could result in a verdict that is less pharmacy-friendly.

              ]]> http://healthandpills.com/reviews-views/two-tier-pricing-unequal-protection/feed 0 Refusal to Fill http://healthandpills.com/reviews-views/refusal-to-fill http://healthandpills.com/reviews-views/refusal-to-fill#comments Sat, 08 May 2010 08:07:43 +0000 admin http://healthandpills.com/?p=637
              Contents

                  The Court concluded that the duty to consult with a patient arises only when the pharmacist receives a prescription order—but is it that simple?

                  Should a pharmacist be held liable when a patient is harmed because the pharmacist does not assist the patient in obtaining a prescription? Does it make any difference if the pharmacist has never seen the patient before? These are the questions faced by the court in a recent case.

                  Facts

                  On October 1, 1994, the patient entered a pharmacy that she had never been in before. She had a history of severe asthma and she believed she was suffering an attack when she went to the pharmacy. Her physician had prescribed an albuterol inhaler in the past. She was out of medication and did not have a prescription with her. She asked the pharmacist to provide her with an inhaler or call her doctor or the hospital to verify that the medication had been prescribed. For reasons that are not explained, the pharmacist did not make the call and he refused to provide the requested medication. As a result, the patient was taken to a hospital by ambulance. She claims that she has suffered additional breathing problems from the delay in her treatment caused by the pharmacist’s refusal to assist her.

                  Lawsuit

                  The patient filed a malpractice lawsuit against both the pharmacist and the pharmacy. The defendants asked the trial court to dismiss the case on the grounds that the pharmacist had no duty to supply prescription-only medication without a prescription and that there is no duty for a pharmacist to call a physician for a prescription when there is no current prescription on file for the patient in the pharmacy. The trial court judge agreed and entered judgment for the defendants in February 1999. The patient appealed.

                  Decision

                  The Missouri Court of Appeals was faced with the question of whether a pharmacist has a legal duty to protect a patient by either dispensing the medication without a prescription or by calling the physician and obtaining a prescription. It began with defining “duty” as the obligation to conform to a standard of conduct to protect others from unreasonable and foreseeable risks. The fact that someone asks for help does not give rise to a legally recognized duty to act. The Court noted the general rule in American jurisprudence that there is no legal duty to aid someone in distress unless a special relationship exists between the parties. Using these principles, the Court found that a pharmacist has no legal duty to protect the patient unless an established relationship previously existed. At best, it could only characterize this relationship as one between a pharmacist and a potential customer.

                  The Court also considered state and federal laws dealing with the rights and obligations of pharmacists. The state’s definition of the “practice of pharmacy” includes the “dispensing of drugs pursuant to prescription orders.” The Court interpreted the statute and found that it does “not describe or anticipate the practice of pharmacy to include calling a doctor or hospital to see if a potential customer who does not have a written prescription is entitled to prescription medication when he or she requests prescription medication due to immediate need.” The Court went on to observe that a pharmacist is not a medical doctor, does not prescribe or make prescription orders, and dispenses drugs on the directions of those who are authorized to prescribe. It also noted that the state had amended its Board of Pharmacy regulations to comply with the federal OBRA-90 statute mandating standards regarding pharmacists’ consultations with patients. In part, this regulation states: “Upon receipt of a prescription drug order and following a review of the available patient information, a pharmacist or his/her designee shall personally offer to discuss matters which will enhance or optimize drug therapy with each patient or caregiver of each patient.” The Court concluded that the duty to consult with a patient arises only when the pharmacist receives a prescription order.

                  Considering common law tort principles and the applicable statutes, the Court affirmed dismissal of the case. It concluded that the pharmacist had no legal duty to the patient because she had never had a prescription filled at that pharmacy and did not present the pharmacist with a prescription.

                  Analysis

                  This is a strikingly unusual case because it is rare that anyone sues a pharmacist for not filling a prescription. From an economic standpoint, the reason should be obvious. Pharmacists do not get paid when they refuse to fill prescriptions. Stranger yet, the patient here did not even have a prescription to present to the pharmacist. Odd as it may seem, the patient appears to be arguing that the pharmacist should have supplied a prescription-only drug without a prescription just because she asked for it. It should come as no surprise that the Court ruled as it did. At least, not under these facts.

                  But maybe it is not that simple. Why didn’t the pharmacist call the physician? No explanation is provided. Pharmacists call doctors for new prescriptions for new patients all the time. So this request cannot be considered that unusual. And remember, there is the economic incentive to make the call. Maybe he was busy. Maybe the pharmacy did not take her insurance and she had no money to pay for the inhaler. Maybe he had some other good excuse. Perhaps he did not. Maybe he just did not like the way the patient looked or acted. Either way, it does not matter. According to the Court in this case, the reason or motivation for refusing to call the doctor is not relevant. If there is no prior existing relationship, no duty exists to help another.

                  Does a pharmacist have a legal duty to protect a patient by dispensing medication without a prescription?

                  Perhaps this explanation serves general situations well. Under American law, a simple request for assistance does not create a legal duty on the part of someone else to render help. While there may be a moral or humane obligation to help, absent a “special relationship,” the law does not impose a duty to help others in distress. It may seem odd but, according to what is sometimes called the “rescuer doctrine,” there is no duty on the part of an observer to rescue a drowning child when the observer could do so even without any danger or risk of harm to the observer. The law even provides an incentive not to provide aid when one does not have to. If one who has no duty to assist in the first place voluntarily assumes the duty and offers assistance, that person must render the aid completely and in a non-negligent manner. Failure to due so could result in liability by the rescuer. Using the drowning child analogy, assume an observer on the shore could easily wade out into the water, pick up the child and carry it safely back to shore. Although there may be no initial duty to rescue the child, the observer who starts the rescue must complete it in a non-negligent way. Assume the observer sees the child drowning, starts out to save it but halfway there changes his or her mind and returns to shore. Assume further that the child does drown. It is possible that the would-be rescuer could be sued and held liable for wrongful death if there were evidence that someone else would have saved the child but did not try because he or she saw the other rescuer start out to aid the child.

                  While that doctrine may be well and good for ordinary situations, it does not serve the public or professionals very well. In this case, labeling the patient as nothing more than a “potential customer” left her with no recourse but to take an ambulance to the hospital emergency room for treatment of a full-blown asthma attack. Arguably, had the pharmacist obtained a prescription and filled it, this extra time and expense could have been avoided.

                  Imagine what the outcome might have been had the Court viewed the patient as a patient and not just a “potential customer.” The Court might just as well have concluded that a special relationship exists when a professional holds him or herself out to be a helping professional. Putting a sign out in view to the public that says “pharmacy” and putting on a smock or name badge on that says “pharmacist” is a form of advertising or, at least, informing others that we have healthcare knowledge and ability and are there to help. There is an implication that pharmacists are obligated to help when we can. But, for now, that obligation remains an ethical, not legal one. However, the day may not be far off when the courts turn our ethical principles into legal mandates.

                  ]]> http://healthandpills.com/reviews-views/refusal-to-fill/feed 0 Legal Considerations: 'Drugstore' or 'Pharmacy'? http://healthandpills.com/reviews-views/legal-considerations-drugstore-or-pharmacy http://healthandpills.com/reviews-views/legal-considerations-drugstore-or-pharmacy#comments Tue, 04 May 2010 08:03:15 +0000 admin http://healthandpills.com/?p=634
                  Contents

                      A recent opinion reveals how the words “drugstore” and “pharmacy” may be interpreted in different ways. It also shows just how valuable the terms may be in conducting pharmacy (or drugstore) business.

                      Facts

                      A pharmacy signed a 20-year lease in 1977 with a commercial landlord, for occupancy of a 15,000-square-foot space in a shopping center. The pharmacy negotiated several exclusive rights in the lease, including an obligation by the landlord not to lease space in the shopping center to any other “drugstore” or any other store whose “primary business is the sale of patent medicines, health and beauty aids, cosmetics” or other specific items. A similar clause gave the pharmacy an exclusive right to operate a “photo-finishing business” in the shopping center. The pharmacy lease indicated that the pharmacy would be an anchor tenant and that the landlord would lease another anchor space to a supermarket. The pharmacy lease also indicated that the pharmacy’s exclusive right to sell specific items, including patent medicines, health and beauty aids, and cosmetics, would not apply to the supermarket. The pharmacy lease contained a clause that would obligate the landlord to pay the pharmacy a minimum of $25,000 annually if these provisions were breached.

                      The pharmacy was purchased by a large chainstore operator sometime later. As a successor to the original pharmacy, the chainstore assumed the rights and obligations of the lease. Near the end of the lease term, the lease was renewed.

                      A supermarket did eventually open in the shopping center. It operated for 18 years without a pharmacy or photo-developing service. The supermarket underwent a change of ownership and the new operator remodeled the store with a full-service pharmacy and a photo-developing drop box. The supermarket’s lease indicates that the supermarket is prohibited from operating a pharmacy only to the extent that the chainstore lease prohibits as much.

                      In April 1998, the chainstore notified the landlord that it was aware that the new supermarket owner was planning to open a pharmacy and photo-developing service. It asked the landlord to intervene and enforce the exclusivity portions of the chainstore lease. The landlord failed in its attempts to limit the supermarket’s plans. In June 1998, the supermarket did reopen with the pharmacy and photo-developing service.

                      Within four months after opening, the supermarket averaged approximately $30,000 in monthly sales just from the pharmacy. This represents about 2.3% of the supermarket’s total business. During the same period, the chainstore pharmacy generated an average of $55,000 per month, significantly less than when it operated the only pharmacy in the shopping center.

                      Lawsuits

                      The chainstore stopped paying the rent and the landlord filed a suit against the chainstore and the supermarket, seeking a declaratory judgment on the rights and obligations of all of the parties. The chainstore and the supermarket filed counterclaims against each other and the landlord for breach of contract. In essence, everybody claimed that everybody else breached the leases. Each of the parties also filed motions for summary judgments asking the trial court to declare a winner. The supermarket operator argued that it is not a “drugstore” or a “pharmacy” and that when a pharmacy is operated in a supermarket, the pharmacy is no longer a “drugstore” within the meaning of the chainstore lease.

                      The trial court judge ruled that the supermarket was neither a “drugstore” nor a “pharmacy,” nor engaged in a “photo-finishing business.” Part of the rationale expressed by the judge included the fact that only 2.3% of the supermarket’s income was generated from the pharmacy. The judge concluded that these sales are “incidental” rather than the “primary” source of income. The claims against the landlord and the supermarket were dismissed in January 1999.

                      Appeal

                      The chainstore appealed, claiming the judge made a mistake in interpreting the various provisions in the leases.

                      The Court of Appeals reversed the lower court rulings, taking what it called a “commonsense” approach to defining the relevant terms. The higher court ruled that considering the supermarket’s sales from the pharmacy operation as only “incidental” to the total business is “simply a red herring.” It noted that the supermarket pharmacy was bringing in $30,000 per month in pharmacy business while the chainstore pharmacy generated $55,000 in the same period— hardly incidental, noted the Court of Appeals. These figures qualified the supermarket pharmacy as “exactly the form of competition that the chainstore sought to avoid in its lease.”

                      The Court noted that the dictionary definition of a ‘drugstore’ is ‘a store where prescriptions are filled and drugs and sundries are sold.’

                      The Court of Appeals also found it absurd to not consider the supermarket’s pharmacy to be a “drugstore,” as that term is used in the chainstore lease. Looking at the exclusive rights provisions of the lease in context, this Court concluded that the supermarket is prohibited from selling prescription pharmaceuticals. The fact that the exclusivity clause provided an exception, allowing the supermarket to sell nonprescription patent medicines, health and beauty aids, and other specific items, did not give the supermarket any right to sell prescription-only items. The Court stated, “In other words, when the exclusivity provisions are viewed in context, it is clear that the chainstore’s prohibition of another ‘drugstore’ sought to avoid the competitive sale of prescription medicines in the shopping center.”

                      The Court noted language from another case of controlling precedence, stating that “the academic definition of words is often important, but more important still is the purpose of the [lease]. Has the purpose been kept or broken?” From this, the Court concluded that it is more important to look at the substance of the business than what it is called. The supermarket contended that it would not be in violation of the chainstore lease, as long as the supermarket did less than 50% of its business in prescription drug sales because until that time, it is not a drugstore. The Court rejected this argument, stating, “An approach that permits the label to control substance could surely lead to absurd results.” Further, the Court stated, “A ‘drugstore’ is no less a drugstore merely because it has been incorporated into a structure called a ‘supermarket.’” The Court also noted that the state statutes regulating pharmacists and pharmacies use the terms “drugstore” and “pharmacy” as synonyms. The Court then opened a dictionary and noted the definition of a “drugstore” is “a store where prescriptions are filled and drugs and sundries are sold.”
                      To add muster to its conclusion, the Court reached into an ancient Latin canon of contract construction and interpretation: expressio unius est exclusion alterius (“expression of one thing is the exclusion of another”). Excluding prescription drugs from the list of items that the supermarket could sell without violating the chainstore lease supports the notion that the chainstore has an exclusive right to prescription-only sales in the shopping center. Using similar logic, the Court also concluded that the photo-developing drop box in the supermarket also violates the exclusive right of the chainstore to engage in the photo-developing business.
                      The case will now be sent back to the trial court for further proceedings. Ultimately, a trial will be conducted to determine what damages, if any, have been sustained.

                      Analysis

                      Just as a rose is still a rose by any other name, a drugstore is still a pharmacy, no matter what it is called or where it is located. Because the supermarket relied on a very technical reading of the leases at stake, the Court of Appeals was forced to go beyond the words expressed in the agreements and look at the intent of the parties. As evidenced by the fact that the trial court judge took a radically different approach to interpretation than did the Court of Appeals, the question is not as close as it might seem on first blush.

                      Courts are often reluctant to enforce the kind of restrictive covenants contained in these leases because they do inhibit competition and infringe on the rights of parties to engage in the freedom of conducting appropriate business practices. Restrictive covenants in the form of exclusive rights are contrary to the notion of a free marketplace. Legitimate competition is often the cornerstone of consumer protection and the regulation prices and services. Yet, as important as these concepts are, the right to engage in an exclusive business within a reasonable geographical area can be an important tool for a landlord to attract certain desirable businesses to an area.

                      The Court of Appeals recognized the exclusive right to operate a pharmacy within the shopping center is not overly restrictive.

                      In this case, the Court of Appeals recognized the exclusive right to operate a pharmacy within the shopping center is not overly restrictive. It was also impressed by the fact that the chainstore lease carved out only a small portion of exclusive rights: the ability to conduct pharmacy and photo-developing services. The selling of cosmetics, nonprescription drugs and other sundries typically carried by both pharmacies and supermarkets was not affected. To the Court of Appeals, this seemed
                      to be a reasonable business scheme. A different result might have occurred were it not for these exceptions to the exclusivity parts of the lease.

                      The Court may have also been impressed by the fact that a pharmacy and supermarket co-existed in this shopping center for nearly two decades in relative peace and harmony. Trouble began only when the new supermarket owner went over the bounds of reasonable business practices to seek income from pharmacy operations. While the Court saw this as overreaching, its job of deciding what is fair under the circumstances was made more difficult because of the arguments advanced by the supermarket. But don’t blame the supermarket too much for taking “absurd” positions. It stands to lose over $30,000 per month in prescription sales. Desperation fuels absurdity in legal circles.

                      ]]> http://healthandpills.com/reviews-views/legal-considerations-drugstore-or-pharmacy/feed 0 Off-Label Promotion Approved to Limited Extent http://healthandpills.com/reviews-views/off-label-promotion-approved-to-limited-extent http://healthandpills.com/reviews-views/off-label-promotion-approved-to-limited-extent#comments Sat, 01 May 2010 07:51:24 +0000 admin http://healthandpills.com/?p=631
                      Contents

                          How far will the FDA go in separating promotional activity from free speech?

                          Before marketing any drug in the United States, a manufacturer must obtain permission from the Food and Drug Administration (FDA) in the form of an approved New Drug Application (NDA). As part of this process, the FDA approves the labeling for the new drug. The labeling indicates the purposes for which the drug has been found to be safe and effective. In many situations, after the drug is initially marketed, new indications are discovered that are not referred to in the labeling. In most cases, the manufacturer will seek to amend the labeling by filing a Supplemental New Drug Application (SNDA). However, between the time of the NDA and approval of the SNDA, a gap will occur where the drug may be used for purposes not approved by the FDA.

                          This is usually not a problem because physicians may prescribe and pharmacists may dispense drugs for purposes that are not indicated on the manufacturer’s FDA-approved labeling, so long as the drug is not prescribed for an experimental purpose and the “off-label” use is supported by valid scientific opinion, usually in the form of peer-reviewed literature or some other authoritative text. The FDA has never attempted to restrict drug use to only those described in the FDA-approved labeling developed by a drug manufacturer. A manufacturer, however, is prohibited from promoting a drug for off-label uses. A drug promoted for an off-label use is considered misbranded.

                          The guidelines allow the manufacturer to disseminate off-label information if it first agrees to submit an SNDA.

                          While the law clearly prohibits the express advertising or explicit promotion of a drug for non-approved uses, it has been less clear what role a manufacturer might take in referring health professionals to written materials or education programs developed independent of the manufacturer in which off-label uses are discussed. In the past, the FDA interpreted the Food Drug and Cosmetic Act (FD&CA) to totally ban any references by a manufacturer, including its representatives, to off-label uses. This prohibition prevented a manufacturer from distributing journal articles, texts or other reference material that discussed an off-label use. It also prevented a manufacturer from supporting continuing education programs in which the manufacturer knows off-label uses will be discussed.

                          This situation creates an information void for many practitioners. Often the manufacturer and its representatives know about the sources of literature supporting the off-label use. There are situations in which a patient could benefit from an off-label use of the drug but the practitioner does not know about the literature, and, until very recently, the manufacturer could do nothing to alert the practitioner where to look for useful information.

                          As a means of addressing this situation, in 1996 and 1997 the FDA produced three guidelines that discuss when enforcement action could be taken against a manufacturer that engages in prohibited conduct concerning off-label promotional activities. One guideline deals with the conditions under which a manufacturer might distribute scientific articles written by independent authors that discuss off-label uses. Another addresses distribution of textbooks dealing with the same issue. The third addresses conditions under which a manufacturer might support continuing medical education (CME) programs or seminars at which speakers discuss off-label uses. In essence, the guidelines allow the manufacturer to disseminate off-label information if it first agrees to submit an SNDA. This scheme would permit a manufacturer to discuss off-label uses with practitioners while the SNDA is pending.

                          Lawsuit

                          Soon after the guidelines were issued, the Washington Legal Foundation (WLF), a nonprofit public interest law policy center, sued the FDA, seeking an injunction against enforcement of the guidelines. The lawsuit was premised on the theory that the guidelines violated the free speech rights of a manufacturer to disseminate information about a drug unless and until it filed the SNDA.

                          Ruling 1

                          In a long, detailed analysis, the district court agreed with the WLF and enjoined the FDA from enforcing the guidelines. The Order specifically prohibits the FDA from restricting the ability of a drug manufacturer to disseminate to healthcare practitioners articles published in bona fide peer-reviewed professional journals and reference textbooks published independent of the manufacturer, where the article or text refers to off-label uses of a drug. The Order also prohibits the FDA from restricting the ability of a manufacturer to suggest content or speakers and providing support for independent continuing education programs or other symposiums.

                          Soon after this decision was filed, the Food and Drug Administration Modernization Act of 1997 (FDAMA), an amendment to the FD&CA, became effective. FDAMA contains provisions regarding dissemination of written articles and texts discussing off-label uses, similar to the FDA guidelines discussed in the WLF case. Because of the timing of the Court’s decision and the effective date of FDAMA, there was some confusion, at least in the minds of FDA officials, as to the effect on the Court’s injunction. The FDA went back to court and asked the judge for clarification.

                          Ruling 2

                          All parties agreed that the FDAMA statutes superseded the FDA guidelines on these issues. FDAMA does not address the matter of a manufacturer’s support for CE programs. The FDA contended that the injunction should not apply to the FDAMA provisions. In a subsequent decision, the Court held that the underlying policies embodied in the FDA guidelines are unconstitutional, and the injunction continued. The Court asked the parties to provide additional briefings on whether the FDAMA provisions are also unconstitutional. Not satisfied, the FDA went back to court, seeking to limit the injunction to the guidelines only and not the FDAMA statutes.

                          Ruling 3

                          This resulted in a third decision, which explicitly holds that the FDAMA provisions in question are unconstitutional.8 The injunction was amended to include a prohibition against enforcement of the FDAMA restrictions on dissemination of off-label materials. The injunction against enforcement of the continuing education guidelines also continued.

                          By the time of this third go-round, the judge displayed his disgust with the FDA’s attempts to limit the effects of his rulings. He wrote that the government’s argument that the case did not involve “speech” is nothing more than “preposterous.” He went on to state that the requirement that a manufacturer seek a supplemental new drug application to amend the labeling of a drug before disseminating off-label information amounts to “constitutional blackmail — comply with the statute or sacrifice your First Amendment rights.” He concluded that the FDA’s position could not withstand judicial scrutiny.

                          Appeal

                          The FDA appealed these ruling to the Court of Appeals for the District of Columbia. The higher Court seemed no less flabbergasted with the arguments advanced by the FDA. The judge issuing the Opinion for this Court noted that the FDA took inconsistent positions regarding the intent of FDAMA and the guidelines. At times, the FDA agreed with the WLF that FDAMA does indeed limit free speech, but the limitations are constitutional. Under this position, the FDA would have authority to prosecute a manufacturer that violates the FDAMA provisions or the continuing education guidelines. At other times, the FDA argued that the statute and guidelines establish a “safe harbor.” The FDA asserted that the FDAMA statutes ensure certain forms of conduct cannot be used against a manufacturer in a misbranding enforcement action. This later position would seem to be an abandonment of earlier arguments in which the FDA claimed authority to prosecute a manufacturer that violated any of the FDA’s guidelines or FDAMA provisions.
                          By the time that the case came to oral argument, the FDA firmly embraced the “safe harbor” theory and when pressed, admitted, “neither FDAMA nor the CME guidance independently authorizes the FDA to prohibit or sanction speech.” The Court of Appeals Opinion further characterizes the FDA’s new attitude:

                          “Were a pharmaceutical company to send out reprints of an article devoted to its drug’s off-label uses to thousands of physicians tomorrow, the government agreed — indeed stipulated — that the agency would draw no independent prosecutorial authority from FDAMA to buttress any enforcement proceeding. And the FDA offers a similar view of the CME guidance: If a drug manufacturer wishes to suggest content to a CME program provider in a manner that runs afoul of all the Guidance’s twelve ‘factors,’ that, by itself, is not a violation of law. Although the FDA retains the prerogative to use both types of arguably promotional conduct as evidence in a misbranding or ‘intended use’ enforcement action, the agency insists that nothing in either of the provisions challenged in this case provides the FDA with independent authority to regulate manufacturer speech.” (citations omitted)

                          Appeals Court Ruling

                          Given the FDA’s firm commitment not to use obvious violations of FDAMA or the CME guideline as a basis for prosecuting a manufacturer when exercising “free speech” rights, the Court concluded that there is no constitutional issue in controversy and that “the dispute between the parties has disappeared before our eyes.” This means that the appeal could be dismissed and the district court’s rulings on the unconstitutionality of FDAMA and the CME guideline could be vacated.

                          Analysis

                          There is some concern that the FDA could still use violations of the FDAMA or the CME guideline in the future to prosecute misbranding allegations if a manufacturer either distributes journals or books or supports programming that discusses off-label uses — even though the FDA admitted that it has no authority to do so in the context of this case. The Court of Appeals observed that the position announced in this case constitutes “nothing less than an official interpretation” that the FDA cannot change unless it provides a reasoned explanation for doing so.

                          It would appear that, at least for the time being, the FDA is stuck with the fact that it cannot use evidence of a manufacturer’s behavior in the manner described here to support misbranding allegations. There will, of course, be further questions about how far a manufacturer can push this kind of off-label promotion before sparking the FDA into action. For now, pharmacists and other practitioners should be able to discuss off-label uses of a drug with a manufacturer’s representative and be afforded some guidance in accessing independent expertise in the literature and continuing education symposiums.

                          ]]> http://healthandpills.com/reviews-views/off-label-promotion-approved-to-limited-extent/feed 0 Book: The Facts about Drug Use http://healthandpills.com/reviews-views/book-the-facts-about-drug-use http://healthandpills.com/reviews-views/book-the-facts-about-drug-use#comments Mon, 08 Mar 2010 13:30:18 +0000 admin http://healthandpills.com/?p=584 The Facts about Drug Use

                          Dr Barry Stimmel, The Haworth Medical Press, 10 Alice St, Binghamton, NT 13904-1580, USA, 1993, 366pp

                          Family physicians often see patients who misuse drugs. This widespread problem is the source of much hidden morbidity and mortality for patients and much frustration for doctors.

                          Family doctors are likely to have had little formal training in identifying and intervening in this area. Their attitudes toward problem drug use probably differ little from those held by the public.

                          This book was written “to enable those with little or no background in science or health care to understand the often complex issues of drug use” and “is presented clearly, concisely, and without jargon.” It presents the facts about drug use with authority.

                          The book is divided into three parts: basic concepts, mood-altering drugs, and areas of special concern. Information is based on statistics from the United States. The regulations and laws quoted are American. Treatments discussed are based on the American system of privately funded health care.

                          In part 1 (basic concepts), the chapter titled “Habituation, Dependency and Addiction” is useful for defining terms and distinguishing misuse from abuse and dependency from addiction. This chapter briefly describes the neurophysiological basis for the ability of drugs to produce mood alteration, which can lead to dependency and addiction.

                          Part 2 discusses each different class of mood-altering drugs and provides lots of factual information. However, the chapter on opiates underemphasizes their importance as drugs of abuse in clinical practice while the chapter on heroin and on methadone maintenance is too long. In the chapter on nicotine, the nicotine patch is referred to only briefly.

                          In part 3 (areas of special concern), well written, factual chapters cover such topics as drugs and AIDS, drugs and pregnancy, and drugs and sports. The final chapter is one with a decidedly American slant entitled “Why has the War Against Drugs Failed?”

                          Three appendices covering sources for reporting drug use (American), drug testing technology, and common street names for drugs are followed by almost 400 references. This book is not written for family physicians. It does not develop skills for identifying problems or intervening in this area or even challenge attitudes. However, it would be useful for family doctors interested in the facts on drug use and as an addition to a hospital, school, or public library.

                          ]]>                           http://healthandpills.com/reviews-views/book-the-facts-about-drug-use/feed 0                           Book: A quick reference for drug information http://healthandpills.com/reviews-views/book-a-quick-reference-for-drug-information http://healthandpills.com/reviews-views/book-a-quick-reference-for-drug-information#comments Fri, 05 Mar 2010 13:17:22 +0000 admin http://healthandpills.com/?p=581 Essentials f Drug Therapy

                          Gordon E. Johnson, PHD W.B. Sounders Company, 55 Homer Ave, Toronto, ON M8Z 4X6, 1991, 425 pp

                          Essentials of Drug Therapy is a clearly written book, summarizing information on drugs that are commonly used. It is not a reference text in pharmacology or an exhaustive detailed volume, such as the Compendium of Pharmaceuticals and Specialties, but is a practical source of information for the medical student and practitioner.

                          The chapters are organized according to therapeutic categories and are introduced by a brief overview of the therapeutic rationale for use of pharmacologie agents. Most drug groups are included, even those used for symptomatic relief, such as antitussives and analgesics. It is somewhat surprising that laxatives are not included, but these have never been an attractive group of drugs for pharmacologists.

                          The text is clear and succinct. Paragraph headings facilitate rapid access to information, with paragraphs on mechanism of action and pharmacological effects, therapeutic uses, adverse effects, drug interactions, and doses.

                          The book should be a useful volume for the busy practitioner and the medical student.

                          ]]>                           http://healthandpills.com/reviews-views/book-a-quick-reference-for-drug-information/feed 0                           Drug-induced hepatotoxicity http://healthandpills.com/reviews-views/drug-induced-hepatotoxicity http://healthandpills.com/reviews-views/drug-induced-hepatotoxicity#comments Tue, 02 Mar 2010 11:33:35 +0000 admin http://healthandpills.com/?p=579 Drug-induced hepatotoxicity

                          Ed by RG Cameron, G Feuer, FA de la Iglesia, 681 pp, ISBN 3 540 60201 1, Berlin: Springer Verlag 1996

                          The editors of this splendid volume have invited an international array of contributors to cover its 26 chapters on all aspects of hepatotoxicity due to drugs — adverse effects that mimic acute fulminant hepatitis, chronic active hepatitis, cirrhosis and even malignancy. Turn to one of these chapters for an update on molecular aspects of hepatic drug reactions, in vitro models, cytochrome P450, drug-induced cholestasis, choline deficiency, the fatty liver, immune mechanisms, encephalopathy, pregnancy, Reye syndrome, or hepatotoxicity in infants and the elderly; and, of course, for separate information on each individual drug, including one of the most important, alcohol.

                          This new Canadian text naturally invites comparison with an Australian text, Drug-induced Liver Disease, edited by GC Farrell (Churchill Livingstone), published in 1994. They are both very good and equally helpful when asked to solve a laboratory or clinical problem. Australian Ian Mackay contributes the immune mechanisms of drug hepatotoxicity in both books. To his credit they are in many respects different. In the earlier book he mentions the Th1 and Th2 subclasses of CD4 helper T cells. In the new Canadian book he advances his thoughts and forecasts that tipping towards Th1 or Th2 subsets influences the mode of expression of allergies and autoimmune diseases.

                          Both books will undoubtedly achieve new editions, so that each will leapfrog the other effectively in different segments of the Commonwealth in the long-term future. It is true to say that clinicians and pathologists have combined admirably to cover the whole gamut of adverse reactions in a single volume which is authoritative, academic and readable.

                          ]]>                           http://healthandpills.com/reviews-views/drug-induced-hepatotoxicity/feed 0                           Complete Guide To Women's Health http://healthandpills.com/reviews-views/complete-guide-to-womens-health http://healthandpills.com/reviews-views/complete-guide-to-womens-health#comments Sun, 28 Feb 2010 00:26:06 +0000 admin http://healthandpills.com/?p=570
                          Contents

                                Complete Guide To Women's Health

                                Complete Guide To Women's Health

                                Author: American Medical Association
                                Random House of Canada, Ltd, 1265 Aerowood Dr, Mississauga, ON L4W1B9
                                1996/759 pp

                                Good starter guide to women’s health

                                Strengths

                                Well formatted, easy to read, practical approaches to common problems, focus on wellness and preventive health

                                Audience

                                General public

                                This comprehensive reference volume for women contains common-sense approaches to a number of important health issues. Its target audience is middle-class American women with a moderately high level of literacy. The book aims to provide women with up-to-date medical information to guide decision making and to facilitate communication with their physicians.

                                Its four main sections cover health maintenance, sexual and reproductive health, pregnancy, and the common health concerns of women. It is well laid out with useful summaries, flow charts, sidebars containing helpful hints, questions women often ask, and narrative vignettes that lend a dynamic and personal tone to the main text.

                                I found the chapters on nutrition, fitness, avoiding risky behaviour, and stress management refreshingly frank and practical. The sections on pregnancy and childbirth are well illustrated and cover many of the issues women enquire about in my own practice. Although there are excellent chapters on family violence, sexual assault, and bereavement, the social context of women’s health is not explored in sufficient depth. The short section on sexual abuse, for example, makes only passing mention of the health consequences that an adult survivor of abuse might experience. In contrast, the 19 pages on elective cosmetic surgery seemed excessive.

                                The book is written with a specialty focus, emphasizing early referral. Very little is said about family physicians and their potential for providing comprehensive care and building health partnerships with women over time. There are no references or suggestions for further reading for women who wish to pursue controversial or rapidly changing issues, such as prevention guidelines. It is also unclear how consultants evaluated the evidence behind their recommendations. I found it surprising, for example, to see episiotomy presented as a procedure to prevent excessive tears during childbirth when there is evidence in the literature to the contrary.

                                The overall strength of this publication is its range, its detail, and its attention to the prevention of illness, making it a good starting place for many women to access health information and to consider dialogue with their physicians. In this regard, it fulfils the authors’ objectives. Because of its expense and likelihood of dating quickly, I would recommend it as a resource volume for a public library or community health clinic.

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