Originally Posted by MeepyCat
Catmom, my concern is that the article you linked is out of date. Rhogam hasn't changed (aside from the removal of thimerosal), but procedures for administering it and for making sure it's appropriately offered continue to evolve.
So if Wickham's opposition to routine prenatal Rhogam is that we could avoid the theoretical risk of blood-borne disease (there's never been a Rhogam-related case of blood borne illness) if we just tightened up procedures for better practices for non-routine administration - is it possible that those steps have already been taken? A quick Google search reveals that the NHS updated their recommendations for Anti-D administration in 2008 (www.nice.org.uk/nicemedia/pdf/ta156guidance.pdf). Did these updates adequately address Wickham's concerns? (Wickham's concerns seem a touch vague to me, so I can't really answer this.) There has not been research comparing routine Anti-D administration to Rh- pregnant to Anti-D offered to those women only in cases where maternal-feto hemorrhage is known or suspected to have occurred - it strikes me as probably impossible to get ethics board approval for such a study.
Hospitals can and do update standard operating procedures, and professional best practices undergo frequent review and revision - but these things are not research and are not published in the same way. In 2007, when I had a baby at a teaching hospital of a major university, I was tested for Rh factors at my pregnancy intake appointment, and those records were referred to every time my blood type came up throughout the pregnancy. In 2009, a different teaching hospital of the same university insisted on retesting my blood on each admission, to assure that lab errors weren't left mouldering in my file, and "I know it seems dumb, but the system helps us make sure we're giving Rhogam to everyone who needs it." The ED kicked all pregnant women upstairs to L&D as a matter of course, and the newer procedures required the L&D department to test all admitted patients for Rh factors, and document consideration of Rhogam for each case. The options were "patient is Rh+," "patient is Rh-, administered Rhogam," or the incredibly time-consuming "patient declined", which required extensive discussion of risks and benefits, and documentation of patient's understanding of all key points.
IMO, Wickham's concerns about the failure of NHS personnel to appropriately offer bloodtyping and Rhogam in cases of abdominal trauma, etc., are solid arguments for making those things routine parts of pregnancy care, rather then arguments for demanding that emergency room personnel step up their games (or however Wickham would like to address it). It's a lot easier to say that OB should routinely give Rh- pregnant women Rhogam then it is to say that when a pregnant woman presents at the ED, part of her evaluation and treatment should include an additional blood test and results-dependent administration of Rhogam - that means a pregnant woman is going to occupy space in the ED for additional hours (however long it takes to get the blood test back, keeping in mind that not all hospitals have 24/7 on-site lab facilities for this testing). Rhogam is cheap compared to the costs of a sensitized pregnancy, and Rhogam is extremely safe in absolute terms, and even more so when compared with the risks of treatment for sensitized infants (which can involve transfusions in utero, which have a 2% risk of pregnancy loss, and involve far less rigorously screened blood products). Rhogam is also cheap compared to the costs of having a patient taking up space (that might be needed by another patient) so that you can hold her until the labs come back.
Because Rhogam is in somewhat short supply, worldwide, there has been some research on the benefits of targeting administration using non-invasive testing for fetal blood types. In this way, we can limit Rhogam administration to Rh- pregnant women carrying Rh+ babies. The initial results of this appear quite promising. (http://www.plosone.org/article/info:doi/10.1371/journal.pone.0070984)
"Rhogam hasn't changed (aside from the removal of thimerosal), but procedures for administering it and for making sure it's appropriately offered continue to evolve. "
The procedures for administering it, for my situation isn't what I am concerned about. What hasn't changed is the fact of the risks of Rhogam which are clearly written up to date on Rhogam.com which are: RhoGAM® and MICRhoGAM® Ultra-Filtered PLUS Rho(D) Immune Globulin (Human) are made from human plasma. Since all plasma-derived products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. RhoGAM® and MICRhoGAM® are intended for maternal administration. Do not inject the newborn infant. Local adverse reactions may include redness, swelling, and mild pain at the site of injection and a small number of patients have noted a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. RhoGAM® and MICRhoGAM® contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Patients who receive RhoGAM® and MICRhoGAM® for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.
Giving Rhogam while you are pregnant does affect the fetus by 10%. If something where to happen to the mother or baby after administering Rhogam, it couldn't be "proven" off 1 case as a result of the Rhogam. Could you prove a still born was a result of Rhogam? probably not. Could you prove your child with neurological problems/birth defects/immune deficiencies was a result of Rhogam, probably not. But yet the risks are clearly given that it may carry a risk of transmitting infections agents along with a lot of other risks. That to me doesn't make me feel confident in the product itself, either though the risk is "small". Its enough they issued a warning on the label about it.
"So if Wickham's opposition to routine prenatal Rhogam is that we could avoid the theoretical risk of blood-borne disease (there's never been a Rhogam-related case of blood borne illness) if we just tightened up procedures for better practices for non-routine administration "
In Wickham's book there have been cases of viruses being passed through
During the 1970's the anti-D projected faced other problems, not least of which was the issues of virus transmission to women receiving anti-D. During 1978 and 1979, a single-source outbreak of hepatitis C occurred in 2,533 Irish women who had received contaminate anti-D. This episode was followed by a handful of studies that followed up groups of women to assess whether hepatitis C and other viruses were being contracted from batches of the product. Unfortunately, there is no central source of data on virus transmissions, and it is impossible to determine the rate of viral transmission from anti-D because of the difficulty in tracing these data. Women are reassured by various sources that their risk of receiving virally-contaminated anti-D is low, but, although this may well be the case, the same women are not offered specific data so they can judge the risk for themselves, and decide whether it is one they are willing to take.
In 1994 a national screening program was set up in Ireland in response to another cluster of hepatitis C cases and reported the identification of a number of "suspect batches' of anti-D. clearly the 1978 outbreak was not an isolated episode, even for one country. The problem of virus transmission is not unique to anti-D; The Irish Blood Transfusion Board conducted a tribunal of inquiry into the cases, and found 'many other transmission episodes of hepatitis C virus by immunoglobulin preparations (Yap, 1997) Anti-D is, however, the only immunogloblulin preparation routinely administered to healthy women of childbearing age.
Other forms of hepatitis of also been transmitted via anti-D in the former East Germany there were cases of hepatitis B and non-A non-B hepatitis contracted through contaminated anti-D (Kircheber et al., 1994) This group of researchers along with a number of others, sought to assess the extent of the problem by testing the blood of a group of randomly chosen women who had received anti-D since its introduction. They compared the presences of viruses in this group with those found in a group of rhesus-[positive women, concluding that the fact that they found no statistically significant differences between the groups confirmed the viral safety of the products. However, this may be considered is less convincing upon funding that the conclusion was mad e on the basis of blood tests on just 520 rhesus-negative women. Thus far, nobody has suggestion that virus contaminated anti-D is the norm; merely that batches of contaminated anti-D have been identified and that there is an occasional or potential risk of infection. With thousands of women receiving anti-D every year in any given country, the real surprise would be if a random sample of 520 women showed an incidence of viral transmission from any blood product. We need much better ways of measuring the incidence of viral transmission through anti-D or other, products, and of storing these data in a way that is easily accessible to women and their caregivers. In this way, women could be given more accurate information regarding the risks of anti-D or similar products, and those responsible for monitoring such outbreaks toud be able to identify contaminated product more quickly and remove it from use. (makes sense to me)
The HIV antibody has also been transmitted through anti-D in some countries. (Dumasia et al., 1989 Malvivya et al., 1989). Since it became understood that the HIV virus can be transmitted in plasma, routine screening of blood products has been undertaken in most countries. In the case o the UK, this was implemented in 1985. However, other countries were not so fast to react to developments in this area. Dumasia et al. 1989 confirmed that "batches produced in India in late 1988 would have been administered to several RhD negative women before the product was banned. In fact, four contaminated batches found to be HIV antibody positive, and two batches were described as "indeterminate". Where transmission of HIV in Anti-D has occurred, it is quite possible that this contamination form one blood donor; several batches may be contaminated because blood donations are pooled in order to make anti-D. This raises the question of whether pooling blood to make anti-D is truly essential to the manufacturing process, if this increases the chance of more Women being infected.
Other risks of anti-D
Other aspects of the safety of anti-D have also been questions; Inamay Gaskin, an American midwife, was one of the first to raise concerns about the effects of anti-D. she noticed the correlation between the issues in this area and the work of Durandy et al. 1981, who studied the effects of the administration of gamma globulin to children between the ages of 4 and 10 years. While the children did not show negative effects of this immediately, the researchers found that their immune systems where compromised for up to 5 months after receiving the gamma globulin.
Penni Harmon, another American midwife, looked at the risks and benefits of anti-D around the them that the American College of Obstetricians and Gynecologists were promoting the use of this in the antenental period. While stressing the importance of maternal choice, she noted that "the long-term risks of anti=d are not known, and there is controversy as to the safety of this application (Harmon, 1987)
Whether or not issues happened years ago, or its outdated information, doesn't change what has happened. Even if it isn't in the USA, even if it was back in 1979. Again we relied on the medical industry and were given Rhogam which contained Thermosal before 2001. Why did the US and other countries decide to remove the Thermosol from Rhogam if it wasn't a concern? The concerns were mercury linking to autism and neurological problems. What about the mothers/children that had gotten the shot and their doctors told them it was Okay back before 2001? Its not a shock why I am questioning the risks of Rhogam. The truth is we don't know. The only thing we can do is research to decide if something is best for our particular situation or not.
Having reading this, doesn't matter when or what year it happened, doesn't matter what country. It has happened and could happen. The fact the country I am in the USA to this present date Rhogam states the warning on the label "Since all plasma-derived products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent."
What it comes down to is that it carries risks, and you can't ever prove it came from Rhogam as the research seems to be not there to prove it. Proving it really wouldn't matter at that point when you are clearly warned about the risks.