Generic Substitutions for Brand-Name Drugs

Staff Report

Everyone’s concerned about the rising cost of healthcare.  You probably hear it whenever you prescribe medications for your patients.  Either the patients or their insurance company keep asking for generic drugs instead of brand-name drugs.  The patient’s cost for brand-name drugs can be much higher for those who have insurance, and overall prices are definitely much higher for those who do not have insurance.  You must be cautious before you consent to those requests for generic drugs.  It is not simply a matter of substitution of a cheaper drug for a more expensive one — they are not always 100% identical.

Physicians and patients often ask about the safety and efficiency of generic drugs, when they are substituted for brand-name drugs.  The USFDA generally approves a generic substitute if it has proven to be “identical, or bioequivalent” within a certain percentile to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.  Pawel Lewek, MD and Przemyslaw Kardas, MD, PhD, in their article on generic drugs in the November 2010 issue of The Journal of Family Practice, recommend that, when in doubt, physicians check the FDA’s Orange Book:  Approved Drug Products with Therapeutic Equivalence Evaluations, online at

Many articles recommend that physicians monitor some generic drug substitutions closely.  In particular, Drs. Lewek and Kardas feel that the most caution should be taken with antiepileptic (anti-seizure) drugs.  Martin Sipkoff, in his article on generic substitution in Modern Medicine magazine dated March 2010, adds immunosuppressants, psychotropic agents (antidepressants), thyroid drugs, antiarrthythmic drugs, and modified-release formulations to the list that needs careful monitoring once a switch is made to generic drugs.

While brand-name drug manufacturers can update their warning labels on brand name drugs if they uncover new evidence of danger, generic makers don’t have the same authority.  A ruling by the US Supreme Court last year limited lawsuits against generic manufacturers for failing to provide updated warnings.

Drs. Lewek and Kardas performed a literature search and the generic drugs are in general less safe or effective then the equivalent brand drug.  There are strict standards that exist to maintain the quality of the generic equivalents. The doctors looked at 47 studies covering nine subclasses of cardiovascular medications with no evidence that the brand drug performed better than the generic.  Plus the generics cost 30% to 60% less than the brand drug in most cases.  Lower co-pays for the generics also improved patient compliance to remain on medication.

In most cases, there is no “evidence-based” reason to choose the brand drug over the generic.  But when in doubt, check the Orange Book at the above link.


Protect Against Negative Online Reviews

Staff Report

Beth Thomas Hertz, in her article “Damage Control,” reported that there is a proliferation of many new online sites for reporting medical experiences and rating doctors, such as,, and  These web sites allow patients to tell the whole world via the Internet about their medical experiences.  Even if most of your reviews were positive, the negative ones can cause damage to your practice.  This article is a quick overview of a few things that you can do to improve your on-line ratings in this new age of instant information.

Many patients are using the Internet to research their healthcare and insurance companies are surveying patients to review their provider network.  Thus, decent reviews from your patients are becoming important.  Many of the negative ratings are usually due to lack of courtesy and professionalism of the office staff.  Ms. Hertz offers ways to reduce and deal with bad reviews. While some review items actually rate the physician; other survey items could refer to indirect issues as lack of parking.  You should use the feedback to determine what you are doing right, determine how you can provide the “extra” value that patients want and what areas in your practice need improvement.

Improvement Steps

Daniel O’Connell, a PhD in psychology, consults with physicians and recommends that doctors pay special attention to whether they clearly explain matters to patients, or whether patients are included in the decision making process.  If you score low on any these issues, ask yourself how you can act differently to show you care.  Ask such open ended questions as “What do you think is causing this problem?” or “Was there something special you wanted me to do today for you?” or “What concerns you most about this problem?”  At the beginning of a visit, ask the patient if they have any other concerns besides the main reason for the visit.  Then you will be able to budget your time during the visit rather than getting surprise concerns at the end of the visit when you are out of time.

Improve patient satisfaction by explaining the medications prescribed, spell the name if they wish to research it, explain why you are prescribing this medication and the dosage and any possible side effects.  Inform the patient how they can determine that the medicine is working.

Ms. Hertz also reported that patients are more satisfied if they are included in the decision-making process.  If applicable, provide a choice of treatments involving the patient and negotiate the best one.

Benefits of Setting up Grievance Procedures

Staff Report

Kathryn Moghadas, a registered nurse, warns that a patient’s unresolved complaint about you or your office could evolve into a lawsuit.  This article summarizes her advice on how physicians can implement a written grievance process that provides patients with a way to get action on a problem before it escalates into a larger issue or becomes a lawsuit.

In an ideal visit, the appointment is on time, the staff is friendly and knowledgeable, and the doctor listens to the patients concerns and then performs the appropriate exam or explains a medical decision, prescribes a treatment, and asks for any questions or additional concerns.  But some visits are not perfect and patients will have complaints.

If a patients leave with an unresolved complaint, they may talk about their “poor” treatment to their friends and relatives directly or express the grievances on a M.D. rating web site which are now common. They may also complain to an insurance carrier or, worst of all, file a malpractice claim.  If a practice has a straightforward policy for handling grievances, it can be used to limit negative outcomes.  This policy can be short and succinct. The goal is to resolve complaints and gather information for corrective action to limit unhappy patients who may leave, denigrate the physician’s reputation or cause litigation.

Make Your Policy Known to Your Patients

Post your grievance policy where your patients can read it.  Provide a visible suggestion box and critique forms and a copy of the policy to patients at the reception window.  The policy should explain that the doctor reviews all complaints, major and minor, as part of the office improvement program.  It’s also important to clearly post how patients can contact appropriate managers at the practice to share their questions or concerns.  This helps to resolve problems early and avoid escalation.

Common Reasons for Grievances

Ms. Moghadas states that most common reasons for patient grievance are:

(1)  Failure to communicate

(2)  Failure to fulfill expectations for examination and treatment

Other complaints arise from prolonged wait time, rudeness of the staff and billing communication issues.  The first two reasons pose a litigation risk whereas all will cause the patient to leave the practice.

Basic Grievance Process Template

A basic grievance policy’s objective states that all complaints related to care or services are handled as courteously and quickly as possible.

    • 1.) The policy should designate the individual to contact for complaints or grievances
    • 2.) Train all staff members on the policy and the process
    • 3.) Provide an easily obtainable complaint form for patients
    • 4.) Staff must document verbal complaints
    • 5.) Investigate the underlying cause for complaint.
    • 6.) Develop corrective actions that eliminates the cause
    • 7.) Communicate the corrections to the patient


Reduce Primary Care Malpractice Risk due to Diagnosis Errors

Staff Report

Suraj Achar, MD and Wiggin Wu, in their article in the July/August 2012 issue of Family Practice Management, report that recognizing warning signs and careful documentation are two keys to reduce the risk of malpractice lawsuits.  They report that approximately 5% of family physicians and 7% of all physicians are sued for malpractice in the USA each year.  The occurrence of lawsuits is much greater in some surgical specialties (approaching 20% for neurosurgery and cardiothoracic surgery).

In a malpractice suit, the plaintiff must prove that the physician neglected the “owed duty of care” and that the physician’s action or inaction led to damage causing the plaintiff to suffer harm as a result of the breach of duty.  Malpractice is proven by presenting convincing evidence showing its probable truth or accuracy. This is a lower standard than in criminal cases requiring proof of guilt beyond a reasonable doubt.

In the following diagnosis errors section, we summarized the recommendations that help reduce a physician’s malpractice risk.

Diagnosis Errors:

The five most common malpractice lawsuits for primary care physicians involve errors in diagnosis for myocardial infarction, breast cancer, appendicitis, lung cancer and colon cancer.  Lung, breast and colon cancer cases usually involve delayed diagnosis.  Appendicitis cases are the result of not addressing the possibility of appendicitis if initial symptoms worsen plus lacking a documented follow-up plan.  Misdiagnosing heart conditions comprise 50% of diagnosis error cases.  These lawsuits are filed by patients that are most likely to be misdiagnosed because they are younger, have atypical histories or don’t exhibit many of the risk factors.

Dr. Anchar and Mr. Wu state that careful chart documentation can help get a case dismissed.  If there is failure to report a differential diagnosis and there is absence of contrary evidence, you can expect jurors to assume the worst.

Also, physicians need to be sure their notes reflect shared decision-making with patients.  Documentation should explain alternatives to patients including the associated risks and benefits, the agreement on a treatment plan, and the follow-up plans if symptoms continue or worsen.

Goals, expectations, and progressive effects of treatments should also be part of the physician’s documentation.  Any warnings given or risks discussed should be included in the chart notes on file.  Use the patient’s opinion of the treatment to determine his understanding of the plan and document when the “patient understands and agrees”.  Be sure the documentation reports an “after visit summary” was provided that included the diagnosis, orders given (including phone numbers for consultations and/or testing) and patient instructions.  Good documentation is critical for a good defense.


Demotech Assigns Financial Stability Rating® to Lancet Indemnity Risk Retention Group, Inc.

Lancet Indemnity Risk Retention Group, Inc. has earned a Financial Stability Rating® (FSR) of A, Exceptional, from Demotech, Inc.  This level of FSR is assigned to insurers who possess exceptional financial stability related to maintaining positive surplus as regards policyholders, liquidity of invested assets, an acceptable level of financial leverage, reasonable loss and loss adjustment expense reserves (L&LAE) and realistic pricing.

FSRs summarize Demotech’s opinion of the financial stability of an insurer regardless of general economic conditions or the phase of the underwriting cycle.  FSRs utilize statutory financial data based on insurance accounting principles prescribed or permitted by the National Association of Insurance Commissioners (NAIC).  Since 1989, FSRs of A or better have been accepted by the major participants in the secondary mortgage marketplace.

About Lancet Indemnity Risk Retention Group, Inc.
Lancet Indemnity Risk Retention Group, Inc. was formed in 2007 by a group of Florida physicians to provide medical professional liability insurance.  Lancet is a Nevada domiciled corporation with its corporate offices in Tampa, Florida. Lancet currently writes business in 14 states and insures all medical specialties.

Lancet Indemnity is a unique collaboration of ideas: a Physician Owned and Directed Professional Liability Insurance carrier specifically created to protect its policyholders. Lancet Indemnity provides traditional and innovative coverages for individual physicians, groups, captives and associations in an effort to manage today’s assets and tomorrow’s realities.

About Demotech, Inc.
Demotech, Inc. is a financial analysis firm specializing in evaluating the financial stability of regional and specialty insurers.  Since 1985, Demotech has served the insurance industry by assigning accurate, reliable and proven Financial Stability Ratings® (FSRs) for Property & Casualty insurers and Title underwriters.  FSRs are a leading indicator of financial stability, providing an objective baseline of the future solvency of an insurer.  Demotech’s philosophy is to review and evaluate insurers based on their area of focus and execution of their business model rather than solely on financial size.  This philosophy was the catalyst for the Demotech Company Classification System, which was published in Insurance Journal, in order to stratify and categorize insurers into operational categories.

Visit for more information.

Should There Be Caps on Pain and Suffering in Malpractice Lawsuits?

The odds of being sued approach 99%1 for physicians that practice in the five most-sued specialties, which are neurosurgery, thoracic cardiovascular surgery, general surgery, orthopaedic surgery, and plastic surgery. More than half of the states place limits for medical liability awards. But most of the award payments come from “pain and suffering” with no legal limits to the amount that can be awarded by a jury.

To be fair, we have looked at capitation arguments on both sides of this issue.

Those in favor of capitation of pain and suffering for malpractice awards point out that capitation would fight out of control health care costs. Excessively unfair verdicts would not be determined by overly emotional cases. At this point there is still no limit on damages for lost wages and medical bills which affects the cost of medical liability insurance. With caps, patients may be discouraged from filing a frivolous complaint because it is expensive and time consuming. If a substantial verdict is not possible, many lawyers will be more selective when taking cases on a contingency basis. Thus, any type of damage cap may reduce a percentage of frivolous filings. Actually, many cases are settled out of court at a lower settlement to avoid cost and time of both parties. Plaintiffs want to avoid a long trial and the possibility of losing. Capitation would also help lower these settlement amounts.

Some doctors are leaving their practices, retiring early, or eliminating higher risk procedures due to rising malpractice insurance costs. Physicians are caught between stagnant or lower reimbursements from insurers and rapidly rising practice overhead expenses. Mistakes by others are penalizing good doctors. Perhaps the greatest concern of many doctors is that they have to practice defensive medicine. Their focus is on not making mistakes rather than providing the quality of care they learned in their training. Some doctors order unnecessary additional diagnostic tests to verify the accuracy of their diagnosis. Some doctors feel the need to work in large impersonal hospitals rather than be part of a small, responsive private practice because of the increasing overhead costs.

Those in opposition to capping pain and suffering argue that every case is different and that a jury should determine damage amounts. They state that a cap would leave very little negotiating room for settlements. They say not capping encourages hospitals to oversee strong safety procedures so that doctors exercise the greatest possible level of care. A study at Harvard University’s Kennedy School of Government found that only 2.4 percent2 of health expenditures on average arise from medical liability including legal costs, verdicts, settlements and the use of “defensive” medical testing. Damage caps affect only large cases with merit; these caps do nothing to limit so-called “frivolous” medical malpractice lawsuits. Those in opposition to caps declare that there are adequate filters to eliminate claims that have no merit: our judges. Also, they state that personal injury lawyers need to choose cases with merit before incurring large expenses they may have to eat.

Avoiding Malpractice Litigation

In our ever growing litigious society, bewildered physicians are desperately looking for an answer to the question “How can I prevent a malpractice suit”? This a rather tall order when juries are no longer asking the question what did the doctor do wrong, but rather can the doctor prove that he did everything right? Is there not a sure fired way to not face the dreaded malpractice suit? Dr. George Thomas, a physicist and medical doctor, has studied this concern in great detail and asserts that physicians who follow his recommendations “to the letter” can greatly reduce their malpractice exposure.

Dr. Thomas focuses his treatise from the knowledge that most physicians are sued for failing to properly diagnose an ailment or failing to make a referral in a timely manner. Following is a summary of his do’s and don’ts to reduce the chances of a malpractice lawsuit.

When a doctor recommends that a diagnostic test be taken and the patient refuses, the patient/doctor relationship should be terminated immediately. In court, juries have felt that a physician was not forceful enough in suggesting a particular test. Also, forget your ego and recommend that, after your diagnosis, the patient see a specialist in an appropriate field. Again, discontinue the patient as a client if he/she refuses. If a patient or family member requests a particular test, order the test and refer to an appropriate specialist.

The telephone may have many very useful purposes; however giving medical advice over the phone is not one of them. Physicians should try to not give medical advice over the phone. Recent laws and good sense prohibit prescribing new medication without an examination. It goes without saying that every prescription involving the central nervous system should be accompanied by a warning about driving or operating machinery. Experienced practitioners recommend that doctors officially discontinue care for the patient with written notice because the patient is non-compliant. It is also recommended that the primary care physician should probe to see if the patient is suicidal or has suicidal thoughts.

Dr. Thomas admits, and most of us would agree, that neither he nor the great majority of physicians practice medicine following every one of these issues to the letter. It is, however, critical that the consequences of not following them are present every time there is contact with a patient. He recognizes that good doctoring is a combination of skills, intuition, and art. Insurance companies and juries should not be able to dictate the practices of medical professions, but the realities of present day societal influences cannot be ignored.

Improving the Doctor’s Odds in a Malpractice Lawsuit

Medical malpractice lawsuits are certainly a part of our litigious times and nearly every healthcare professional has, to some degree, been affected by this phenomena. If not directly involved in a court action, at the least, practitioners have dealt with the rising costs of insuring against negative litigation. Many common questions from physicians include how to win a malpractice lawsuit and what are the components of an actual lawsuit. Mark E. Crane, a freelance writer from Brick, New Jersey, has interviewed a number of health care professionals and compiled a summary of the salient points of this issue. Following is a summary of the intricacies of this timely subject.

Every physician is abhorred by the thought of being accused of and brought to court in a malpractice lawsuit. The fact that nearly half of all physicians have been sued during their professional careers provides little relief for men and women in the field. Crane’s statistics from a 2010 American Medical Association survey reveals that over 42% of physicians have been sued, with OB/GYN’s leading the field, and ninety percent of general surgeons over the age of 55 have been sued. The average defense cost ranges from a low of $22,000 to more than $100,000 for cases that go to trial. Awards to plaintiffs average $200,000 for settled claims, and $375,000 for claims that go to trial.

Should a physician be contacted by a patient’s attorney seeking medical records, or to gather information, or if there is suspicion that a patient may seek legal assistance, it is strongly recommended that the physician immediately contact his or her malpractice insurance carrier. The claim representative can be an advocate for the physician and coordinate all aspects of the litigation.

If a case that is filed goes into litigation, and a good number of them never make it that far, interrogatories and depositions will occur. During this process, the attorneys for both sides have the opportunity to gather background information and determine, under oath, relevant facts in the case.
During this phase it is extremely important for the physician to keep emotions under control, as stressful as the situation may be, and to work very closely with the malpractice attorney in preparing responses for the various sessions. Being truthful in all matter is crucial, but never provide more information than is required. Again, the attorney will guide the client on giving testimony in a deposition or in front of a jury. The facts of the case, well represented, will be the best defense of any practitioner.

In the case of a malpractice accusation, it is good to remember that most claims, nearly 65%, are dropped or dismissed without going to trial. Twenty-five percent of claims are settled, and in the very small percentage that goes to trial, the physician prevails in nearly 90% of the cases. In any event, it should be pointed out that malpractice suits can take four years to resolve and the trial may not take place for two years after the suit is filed. The trial itself may only take a few days, but there is always the possibility of an appeal from either side. Medical malpractice representatives can be a tremendous resource to the practice of every health professional. Seek out their knowledge.

Do’s and Don’ts for a Witness in a Deposition

One of the most frightening events experienced by thousands of individuals each year is being subpoenaed to give testimony in a deposition. This is true for people in all walks of life and professions. It is not uncommon for health care professionals to be called upon to testify in a lawsuit. As with the Boy Scouts, being prepared and knowing what to expect are the best ways to handle this dreaded ordeal. The goal of a deposition is not just to find facts in a case, but a strategy by opposing attorneys to find faults in a person’s testimony. Emory Healthcare in Atlanta, Georgia has developed a lengthy list of do’s and don’ts for a person scheduled to give testimony in a deposition. Following is a summary of those points.

As for being prepared, discuss the upcoming deposition thoroughly with your attorney. Ask all questions that will help you to be prepared. While it is imperative to be truthful in answering every question, your attorney can give you information that will be helpful in letting you know the direction desired by the opposing attorney. Be wary of loaded questions that contain inaccurate information. Don’t let the attorney put words in your mouth or provide a summary of your statements that is wrong. Questions that begin with “don’t you agree” or “isn’t it true” may very well be intended to skew the truth in your response. Your attorney is your advocate, but he cannot coach you how to answer a question once the deposition has begun. Listen carefully to any objections he makes as these may help you better understand the relevance of a question and alert you to a possible strategy.

It is normal for a person being questioned to be somewhat defensive but is never advisable to attempt to argue with the attorney questioning you. You may be asked the same question throughout the deposition. The attorney may be trying to see if your answers vary. Be alert and indicate that it is a repeated question and that your answer is the same. You are not being argumentative, but you can show that you are willing to stand your ground.

Fatigue is likely to occur during a lengthy deposition. This can cause a lapse in your ability to remain alert. Ask for a break when needed and refresh yourself. You may speak with your attorney, but comments heard by the opposing attorney can be used for questioning during the deposition.

Finally, when you think the deposition is over, it isn’t really over. You should take the opportunity to read and sign the deposition before it is filed in court. While original answers cannot be deleted from the transcript, you can correct mistakes or incomplete answers. Again, it is advised that you consult with your attorney before completing an errata sheet.