The Medico-Legal Advisor ®
HEPATITIS-B VACCINE ... A BARGAIN AT ANY PRICE
Hepatitis-B virus infection is a major cause of acute and chronic hepatitis, cirrhosis and primary hepatocellular carcinoma. The onset of the illness is generally insidious. Clinical signs and symptoms include various combinations of anorexia, malaise, nausea, vomiting, abdominal pain and jaundice. Skin rashes, arthralgia, and arthritis can also occur. Overall fatality rates generally do not exceed 2 percent in the acute phase of the disease, but chronic active hepatitis leads to cirrhosis in 25 percent of carriers and these carriers have a risk of developing liver cancer that is 12 to 300 times higher than that of other persons. Many people die from hepatitis-B related cirrhosis each year in this country and others die from hepatitis-B related liver cancer. A person who is infected or is a carrier of the virus has high concentrations of hepatitis-B virus in the blood and serous fluid; less is present in other body fluids such as saliva and semen. Transmission occurs when infected secretions penetrate the skin or mucous membranes of a new host. The following groups of people have been identified as being at high risk for contracting the hepatitis-B virus: -Health care workers who have frequent and direct blood contact; -Clients and staff of institutions for the mentally deficient; -Hemodialysis patients; -Homosexual males; -Users of illicit injectable drugs; -Recipients of factor Vill or IX; -Household and sexual contacts of HBV carriers; -inmates of long-term correctional facilities; -Heterosexually active persons with multiple sex partners. As you can see, health care workers lead the pack of those at highest risk of becoming infected with hepatitis-B. As a sub-group of this category, surgeons, anesthesiologists, emergency department physicians, dentists, pathologists, blood bank personnel, phlebotomists, and I.V. therapy nurses stand the greatest chance of infection. Health care workers that are at slightly less risk of exposure and infection are clinical laboratory staff, respiratory therapists, nurses in emergency departments and critical care units. Persons with moderate exposure include housekeeping personnel who handle needles or sharp instruments and nonsurgical and medical house staff. Since hepatitis-B infection is a risk for health care workers, the employers of these workers have some obligation, we postulate, to provide immunization for them ... just as they provide rubber gloves for protection against the secretions that crawl with the virus. A plasma-derived hepatitis-B vaccine has been widely available since 1981 and in 1986 a recombinant hepatitis-B vaccine (Recombivax HB) was licensed for use. Initial efforts by hospitals to provide the plasma-derived vaccine to its staff were thwarted by the AIDS scare, since the plasma pool used to manufacture the 1981 vaccine included sera of homosexual men (a population with a high incidence of HBV antigenemia). Follow-up data from the Center for Disease Control (CDC) assured us that the hepatitis-B vaccine was safe, but health care workers were still reticent to be vaccinated, even if their institutions provided the immunizations free. Statistics derived from surveys conducted by the CDC show that as many as 68 percent of the U.S. hospitals have instituted hepatitis B vaccination programs. On the other hand, the surveys have also disclosed that perhaps as few as 24 percent of physicians have received the vaccine, and only 36 percent of high-risk workers in hospitals with programs have been vaccinated. Apparently the AIDS concern frightens health care workers away from taking advantage of the vaccination programs. Yet by 1986, all fears related to the use of the vaccine should have been laid to rest. The recombinant hepatitis-8 vaccine carries NO RISK of transmitting the AIDS virus. With the AIDS scare eliminated, there should be no excuse for health care workers not to take advantage of free hospital vaccination programs, but the ever-cautious health care worker has become concerned about the reports of side effects and adverse reactions to the vaccine. The most common side effect reported has been soreness at the injection site (the deltoid muscle is the preferred site for reasons of absorption). Among an estimated 750,000 vaccinees, approximately 100 episodes of severe illness have been reported, after receipt of the vaccine. These have included arthraigias, neurologic reactions (such as Guillian-Barré syndrome), and other illnesses. The rate of Guillian-Barré syndrome following vaccination doesn't appear to be significantly increased above that observed in normal adults. Such temporally associated illnesses are not considered to be etiologically related to hepatitis-B vaccine. Health care facilities and health care workers need to cooperate in immunization programs, since the potential for litigation exists from several perspectives. The employer has an obligation to provide a safe working environment for its employees. If an employee contracts hepatitis-B without benefit of an immunization program offered by the hospital, it is reasonable to expect that such an employee could take action against the hospital. Another viewpoint is illustrated by the following scenario: A surgeon (at highest risk) has a subclinical hepatitis-B infection which he probably contracted in the operating room from direct blood contact; his institution does not provide immunization; he gets sicker and dies of complications of the hepatitis-B infection and before the ink on the death certificate is dry, lawyers are going through the records of his patients in search of hepatitis-B victims. Other consequences for a surgeon who is labeled a "carrier" are that he might be required to get informed consent of his patients prior to treatment; or he might be removed from the operating room ... his livelihood. A case such as this has been reported. This is a gray area, indeed, but the legal community views it as a fertile field. The possibilities for litigation seem endless. Health care workers could sue hospitals, patients could sue nurses, physicians, and hospitals. Now, considering that the estimated cost of HBV infection in this country is about $1 million per day (never mind the potential for litigation) and that the recommended 3 dose immunization series costs about $100, it seems reasonable that hospitals would rush to provide the necessary immunizations at no cost to employees and that these same employees would eagerly line up to get them. |