Document 6bmkj94qK4jOzqLav6nEr6mY3

pneumovax (Pneumococcal Vaccine, Polyvulent|MSD) INDICATIONS: PNEUMOVAX is indicted Tor immunbuiuon against lobar pneumonia and bacteremia, caused bv those types of pneumococci included in the vaccine, in all person* t*o years of a*e or older in whom there is an increased risk of morbidity and mortality from pneumo coccal pneumonia. These include' (I)'person* having chronic phystc.il conditions such js chronic neart disease oT any etiology. chronic brotichopulmonarv diseases, chrome renal failure, and diabetes mcllitus or other chronic metabolic disorders: {2) persons in chronic care facilities: (3) persons convalescing from severe disease: (4) persons 50 years of aae or older. When PNEUMOVAX and FLUA.X (Influenza Virus Vaccine. MSD) were given simultaneously m separate extremities, antibody response and adverse effects uers comparable to those which followed administration of the vaccine* at different times. Before administering see full prescribing information for FLUAX, NOTE: Revjccinauon with PNEUMOVAX should not be carried out at intervals of less than three years CONTRAINDICATIONS: Hvperaensiuvity to anv com ponent ol'the vaccine. Epinephrine injection (1:1000) must be immediately available should an acute anaphylactoid reaction occur due to anv component of the vaccine. Do not sive PNEUMOVAX to preenam females: the possible effects of the vaccine on fetal development are unknown. Children less than two years of ase do not resoond satisfactorily to the capsular types of PNEUMOVAX that are most otten the cause of pneumococcal dLsetuse m this age 2roup, Accordingly. PNEUMOVAX is not reeommended in this age group PNEUMOVAX is not recommended for patients who have received extensive chemotherapv and/or nodal irra diation for Hodwtns disease. WARNINGS: PNEUMOVAX *'ill not immunize against capsular types ofpneumococcus other than those contained m the vaccine (see table heinvc). 14 PflgunuKKCJl Ofouiar Tvfxj Included in PNEUMOVAX VuiTitfrcdjjiiife PntfufTuxrtth'dl Tvfws I*cI'S i ; i 4 li J 9 i; U W y 25 Jl <6 Dsflish t ' j 4 HA J 4N I2F 14 IVf ;jf 25 TF If the vaccine is used in persons receiving tmmunoMip* pressive therapy, the expected scrum antiBody response mav not be ootamed lniradermal administration nuv cause severe local reactions. In patients who require penicillin for other antibiotic) prophviaxis against pneumococcal infection, such propnv- laxi* should riot be discontinued after immunisation with PNEUMOVAX. PRECAUTIONS: Any febrile respiratorv illness or other ac tive infection is reason for delaying use of PNEUMOVAX. except when, in the opinion of the physician, withholding the agent emails even greater risk;. Caution and appropriate care should be exercised in administering PN'CUMOVAX to individuals with severely eomprot!iise"d cardiac and/or pulmonary function ?h whom a systemic reaction would pose a sisniYicant risk jnd also to patients who have had episodes of pneumococcal pneumonia or other pneumococcal infection in (he pre* ceding three years and may have high levels of preexisting pneumococcal antibodies which mav result in mcrejsed reactions, mostly local but occasionally systemic. Available data suggest tHat revaccination before' three years mav result in more frequent and severe local reactions at ;ne site of injection, especially m persons who have retained hieh antibodv levels. Children under two years of age mav not obtain a satisfactory jnnbody response to'some'pneumococcal capuiiar types Therefore, the vaccine should not be used m this age group PNEUMOVAX mav not be effective m preventing infection resulting from basilar skull fracture or from external cornmuniciiion with cerebrosOinal fluid ADVERSE REACTIONS: Local eruhenu'jnd sorenevs at the injection <itc. usually of less than ajj hours'duration. occurs commonlv; local induration occurs less commonly In u studv of PNEUMOVAX (containing 14 capsular types) in 26 adults, 24192%) showed local reaction charac terized principally by local soreness and/or induration at the injection site w ithin 2 days alter vaccination. Low.grade fever (less than 100.9*10 occurs occasionally and is u*u,iik confined to the 24-hour period following vaccination. Although rare, fever over Uj2*F ha* oecn remaned. Reactions of greater seventy, duration, or extent are unusual Rarely, anaphylactoid reaction* have been reported. NO IT- Administer subcutuneousW or intramuscularly. DO MOT GIVE IMTR WF.MQlSL) DO MOT OlVT tSTRADCR WALLY STORAGE AND USE: Store single-dove ^refilled svrmses and unopened jnd opened vials jt 2-.vC 135.6- 44T). The vaccine is used directlv as supplied No dilution or reconstitution is necessary Phenol 0-5% added a.* preserv alive. I've a separate heal-sterili/ed syringe and needle for each mdiviuual patient to prevent transmission of hepatitis U and other infectious agents from one person to another. Alt vaccine must be discarded alter the expiration date. Single-Dose ITefilled Syrtnge Inject content-* of syringe to effect a single dose, Sin^lo-Dovt and 5-Duse Vials lurSmnffe (jse: Withdraw 0 5 ml from vial using a sterile needle and syringe free of preservatives'! antiseptic*, jnd detefgeiiLs, HOW SUPPLIED: PNEUMOVAX is supplied in 5-Jovr yiais of liquid vascme. for use wiin syringe only, in a box ol 5 mdividu.il cartons, each containing a single-dose vul of vacemc; and in 5 single-dose pretillaJ svnnges MSD J9PX15 (DC 701480-1) SHARK COHME t`( f more detailed Hit.'f itulion consult sitnr NtSr> fcprcscnuiisc or ,*e lull prc^r.isi/n: mlorri'(,,() Merit Sham A (h-rime, ()i\,-n>n -`I M. S < I',. |. ' W-M I' tr, R&S 020190 Letters to the Editor Readers are invited to submit letters tor publica tion in this department. Submit to Dons Flournoy, Executive Editor, journal oi Occupational Medicine. 750 M Wacker Drive. Chicago, li 60606 Letters should be typewritten, double spaced and should be designated "For Publica tion." Dose-Response and Immortality in SMR Studies To the Editor: Because doseresponse is an important criterion in the determination of causality, in dustrial epidemiologists often ex amine their standardized mortality ratio (SMR) results by level of ex posure. Classification of workers into high and low categories based upon their highest exposure job is a method commonly used (see the acrylonitrile study in the April 1980, JOM for a recent example). Unfor tunately, investigators using this "highest exposure job" method often make the mistake of a,ltoGajng all of the person-years at risk for each worker to just one exposure category, a ' procedure" (Fiat can negate or reverse what might actually be a positive dose-response gradient. The problem has received little attention to date, and consequently misallocation of person-years is rather com mon. For instance, three of nine SMR studies of vinyl chloride-exposed workers have made this error.1 2 1 An example will help to illustrate the problem. Suppose there is a plant at which all workers start at the same time in low-exposure jobs, and 20 years later the process changes such that all jobs for those still working are considered high ex posure (no workers enter or leave the work force, except for deaths). When the workers are subsequently classified into low and high catego ries on the basis of highest exposure job ever held, one finds in the lowexposure category that the number of observed deaths is much greater than the expected number, in fact all of the workers in the low ex posure category are dead. How ever, in the high-exposure category the mortality is much less than ex pected, in fact nobody in the high- exposure category dies in the first 20 years after initial employment. One would conclude from such an analysis that low exposures are quite dangerous but that high- ex posures are somehow protective. This fictitious example is ex treme, but it serves to show that workers who move from low- to high-exposure jobs will bias results if they (and all their person-years) are classified by highest exposure job. The problem is that, for such workers, low-exposure person-years are included in the high-exposure category. These low-exposure per son-years are immortal in the high category because if workers die while in low-exposure jobs, their deaths are put into the low catego ry. The high category, therefore, contains too many person-years at risk and overestimates the expected number of deaths. The opposite oc curs in the low category. The result for the high category is conser vative mortality ratios and the result for the low category is in flated mortality ratios. . Openings are available throughout the U.S. for physicians seeking choice positions with industry for occupational medicine, pharmaceutical firms, and hospitals, and in solo and group practice. Absolute confidentiality is assured. Call or mail your C.V. to: Duse Van den Bosch Q DAVIS-OMEGA 2 West 45 Street New York, N.Y. 10036 212-840-0899 SB 574 ft I 8 I 9 I01S | R&S 020191 Letters continued ries. and not to lump all of a worker's person-years into one category. . A solution is to allocate person- years to the low-exposure category until workers switch to high-exposure jobs. Only when they make the job change should their person-years be allocated to the high-exposure cate gory. This principle has previously been termed "concurrent classifica tion" by Waxweiler* Workers who start in high-exposure ]oEs~~~~and~ change to low-exposure jobs do not" require special handling, because ' with the highest exposure job method, all of their person-years are- considered high . exposure. (The , method assumes that the highest ex posure determines excess disease risk.) ---- The correct data processing re quires selection of certain workers and control over the beginning and ending of person-years calculations for each worker. For the "low" com puter run, workers who began work in a low-exposure job are selected. Those selected who changed to a high-exposure job have their person- years stop accumulating on the date of the job change, and the remainder (those who stayed in low-exposure jobs) are processed as usual. For the "high" computer run, all workers who were ever in a high-exposure job are selected. Those selected whose first job was a low-exposure job have their person-years start on the date of the switch to the first high-exposure job, and again the remainder (those who started in high-exposure jobs) are processed as usual. If three or more categories are desired, e.g., low, medium, and high, the analysis is more complex but is still feasible. A final comment is that the highest exposure job method does not take into account the length of time ex posed. To account for time, an alter nate method of assessing dose- response is to analyze by length of exposure and to weight the time by a dose factor relating to the actual ex posure level of the job (the resultant variable can be called "cumulative exposure"). But regardless of whether the "highest exposure job" or "cumulative exposure" method is used, care needs to be taken to allocate a worker's person-years at risk to appropriate exposure catego lames J Beaumont, Ph.D. Epidemiologist, Biometry Section NlOSH Division of Surveillance, Hazard Evaluations and Field Studies Cincinnati, OH 45226 References 1 Fox A|, and Collier PF: Mortality ex perience or workers exposed to vinyl chloride monomer in the manufacture of polyvinyl chloride in Great Britain. Br / Ind Med 34:1-10, 1977. 2. Equitable Environmental Health, Inc.: Epidemiologic study of vinyl chloride workers. Final report submitted to Manufac turing Chemists Association, 1978. 3. Ott MC, Langner RR, and Holder SB: Vinyl chloride exposure in a controlled in dustrial environment. Arch Environ Health 30.333-339. 1975. 4. Waxweiler R|: Methodologic considera tions in occupational cohort mortality studies. Presented at the Annual Meeting of the Society for Epidemiologic Research, 1979. Bladder Cancer and Dairy Farming To the Editor: A recent occupa tional survey from Roswell Park Memorial Institute' reported an association between bladder cancer and dairy farming. Although this association was not evident in other mortality surveys of farmers,2'5 the wide range of potentially hazardous exposures (i.e,, pesticides, fuels and oils, solvents, paints, and fertilizers) used in farming plus the large population-at-risk underscores the need to further evaluate this new lead. Concern about pesticide ex posure was also raised by the recent report of an excess risk of bladder cancer among pesticide applicators. Through a quick and inexpensive case-control study, we examined the occupational statements on a large number of death certificates from Wisconsin, a state with a large dairy industry. Between 1968 and 1976 there were 1,386 deaths from bladder cancer among white males 30 years or older. For each death certificate givjn bladder cancer as the underlying cause, a control certificate, matche on race, sex, age and year of deat , and county of residence was chosen from other causes of death. Occupy tion, as recorded on the death certi 1fi9c6a0te,Cweanssucso7 dOedddsaccraotriodsing(OtRoethaes calculated by the McNemar test,* s'S nificance tests, and 95% confident I '2 l* ! t 4 ) 4 ,.,.>** % 576 818191 OiS Letters-to-the-ditor