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[Basis for a hospital registry of acute myocardial infarction in Spain. The PRIAMO study. Project of a Hospital Registry of Acute Myocardial Infarction].

BACKGROUND AND OBJECTIVES: Information on the management of myocardial infarction in Spain in scarce. PRIAMHO (Proyecto de Registro de Infarto Agudo de Miocardio Hospitalario) study is aimed at developing standardized methods to allow the registration of characteristics and management of patients discharged with a diagnosis of myocardial infarction. Methods and results of the pilot study are presented. METHODS: In the present collaborative study with one-year follow-up, all patients diagnosed with myocardial infarction discharged from 33 Spanish hospitals are registered for one year including their demographic, clinical and outcome characteristics, as well as details on their management when admitted to a coronary care unit. Standardized definitions of diagnosis and measurements are used. Confidentiality of patients' identity and anonymous participation of each center are also warranted. RESULTS: The 33 participant coronary care units, covering some 10,000,000 people, admitted on average 83.9% of myocardial infarction patients of their hospital. In 16 participating centers there is a laboratory of hemodynamics and in 11 coronary surgery. During the pilot study, 606 patients were discharged from the participating coronary care units where the case-fatality, rate was 10.3%. While 19.8% of patients developed left heart failure, 44.1% received thrombolytic therapy. The delay between onset of symptoms and first monitoring was approximately 6 hours, and thereafter admission to the coronary unit about 3 hours. CONCLUSION: PRIAMHO study will allow to establish of the fundamentals for developing a nation-wide myocardial infarction register and will provide an accurate perspective of the characteristics and management of this disease in Spain.

Aged↗

Report from the International Bone Marrow Transplant Registry and Autologous Blood and Marrow Transplant Registry - North America.

Allogeneic and autologous bone marrow and blood cell transplants are increasingly used treatments for cancer and disorders of bone marrow and immune function. This is largely due to use of autotransplants to treat common diseases such as breast cancer. The use of blood cells alone for autotransplants was also a significant change in the past 5 years. The IBMTR and ABMTR continue to provide a unique resource for studying outcomes and trends in allogeneic and autologous bone marrow and blood cell transplants.

Adolescent↗

[Reporting of induced abortions in 1994. A comparison between the data in the Registry of Legally Induced Abortions and the National Patient Registry].

Up to 31st December 1994 all cases of legally induced abortions were notified by the physician responsible for the operation to the National Board of Health and recorded in the Register of Induced Abortions. Following this data, abortion statistics will rely on data concerning induced abortions in the Danish National Patient Register, which includes information based upon the unique personal number of all patients admitted to hospitals. The completeness of the Register of Induced Abortions and the National Patient Register as to induced abortions in 1994 was assessed to evaluate the impact of the change in method of monitoring on trends in the national and regional abortion rate. The complete number of induced abortions was estimated to be the sum of the number recorded in both registers, cases recorded only in the Register of Induced Abortions, cases recorded only in the National Patient Register, and the missing number of registration of induced abortions calculated by capture-recapture methods. Of these 18,429 abortions 96.4% were registered in the National Patient Register and 93.5% in the Register of Induced Abortions. There were some regional variations. In some counties more abortions were registered in the Register of Induced Abortions and in others in the National Patient Register. Considering the change from 1995 in sources of the statistics of induced abortions, analyses of trends in the abortion rate in the early 1990s in Denmark must be evaluated with prudence.

Abortion, Legal↗

Mortality following non-ST elevation acute coronary syndrome: 4 years follow-up of the PRAIS UK Registry (Prospective Registry of Acute Ischaemic Syndromes in the UK).

AIM: To present information on long-term prognosis and risk factors following an admission with non-ST elevation acute coronary syndrome. METHODS: A cohort of 653 patients was followed for mortality and causes of death using data from the UK Office of National Statistics (ONS). Cox proportional hazards model was used to identify the prognostic factors. RESULTS: Overall survival at a maximum follow-up of 45 months was 77.8% (95% CI 74.1-81.1%). Seventy-three per cent of the deaths were clearly due to a cardiovascular cause. Age, male gender, heart failure, ST depression or bundle branch block were all associated with higher short- and long-term risk. Taking aspirin or having a revascularization procedure, over the period of six months following initial hospitalisation were both associated with a lower long-term risk. CONCLUSION: Non-ST elevation acute coronary syndromes carry a high risk of death over a 4-year period. Conventional risk factors can predict both short- and long-term risk. More invasive management and the use of evidence-based therapies appear to be associated with a lower risk.

Adult↗

Support for immunization registries among parents of vaccinated and unvaccinated school-aged children: a case control study.

BACKGROUND: Immunizations have reduced childhood vaccine preventable disease incidence by 98-100%. Continued vaccine preventable disease control depends on high immunization coverage. Immunization registries help ensure high coverage by recording childhood immunizations administered, generating reminders when immunizations are due, calculating immunization coverage and identifying pockets needing immunization services, and improving vaccine safety by reducing over-immunization and providing data for post-licensure vaccine safety studies. Despite substantial resources directed towards registry development in the U.S., only 48% of children were enrolled in a registry in 2004. Parental attitudes likely impact child participation. Consequently, the purpose of this study was to assess the attitudes of parents of vaccinated and unvaccinated school-aged children regarding: support for immunization registries; laws authorizing registries and mandating provider reporting; opt-in versus opt-out registry participation; and financial worth and responsibility of registry development and implementation. METHODS: A case control study of parents of 815 children exempt from school vaccination requirements and 1630 fully vaccinated children was conducted. Children were recruited from 112 elementary schools in Colorado, Massachusetts, Missouri, and Washington. Surveys administered to the parents, asked about views on registries and perceived utility and safety of vaccines. Parental views were summarized and logistic regression models compared differences between parents of exempt and vaccinated children. RESULTS: Surveys were completed by 56.1% of respondents. Fewer than 10% of parents were aware of immunization registries in their communities. Among parents aware of registries, exempt children were more likely to be enrolled (65.0%) than vaccinated children (26.5%) (p value = 0.01). A substantial proportion of parents of exempt children support immunization registries, particularly if registries offer choice for participation. Few parents of vaccinated (6.8%) and exempt children (6.7%) were aware of laws authorizing immunization registries. Support for laws authorizing registries and requiring health care providers to report to registries was more common among parents of vaccinated than exempt children. Most parents believed that the government, vaccine companies or insurance companies should pay for registries. CONCLUSION: Parental support for registries was relatively high. Parental support for immunization registries may increase with greater parental awareness of the risks of vaccine preventable diseases and utility of vaccination.

Adult↗

A new Swedish twin registry containing environmental and medical base line data from about 14,000 same-sexed pairs born 1926-58.

Since the beginning of the 1960's the Department of Environmental Hygiene of the Karolinska Institute and of the National Swedish Environment Protection Board has maintained a registry on about 10.000 same-sexed twin-pairs born 1886-1925. The registry has been used for studies of morbidity and mortality against the background of certain external risk factors, especially smoking. Supported by the Research Committee of the National Swedish Environment Protection Board, the establishment of a new twin registry covering younger age cohorts was initiated in 1970. The main purposes of this registry are to evaluate individuals' adaptation to changes in the environment and to study the effects of the environment on human health. Moreover, the registry is intended to be usable in obtaining specific target groups with a certain exposure. The main reason for the establishment of a twin registry instead of using a representative sample from the entire population is that a twin population offers some additional analytical possibilities. With twins composing the study group, it is possible to assess the role of the genetic factor for different variables. In addition, the twin approach provides opportunities of analyzing the subjects as matched pairs--the twin control method. This method involves the evaluation of the effect of one factor, to which one twin in the pair is exposed and the other not, while other variables are kept constant in a far-reaching way, e.g. sex, age, genetic composition, childhood, environment, etc. A twin registry can also be employed as a general epidemiological base line registry. For such purposes, the twin methodology is ignored, and the effects of some agent, for example having to do with environmental hygiene, are studied on all of the individuals, independently of their twin pair qualities. The registry is then in many regards comparable with a registry of non-twins. The first step in creating the Swedish twin registry was to compile information on names and addresses. By means of searches in birth records for the years 1926-1949 and birth notices for the years 1950-1967, registration was made of ca 110 000 twin individuals, which constitute virtually all twins accounted for in official statistics. Of these, ca 13 800 were stillbirths or infant deaths. Before the search for the twins' current addresses was begun, all pairs in which at least one individual was dead were eliminated. Such was the case in ca 10 250 pairs. The address search hence covered about 89 500 individuals and was carried out with the assistance of two location procedures. The first was applied to those born between 1926 and 1949 and the second to those born between 1950 and 1967. The result was that in ca 96% of the pairs both members (37 590 pairs) or one member (4 853 pairs) could be found. It could be anticipated that of the latter pairs 1 450 would not be useable due to the death of one of the twins. The data collection has been carried out via a mail questionnaire which consists of the following main areas of inquiry: medication, annoyance experienced because of factors in the general and occupational environments, smoking and drinking habits, physical activity, food habits, psychosocial status, occupational and educational history, conditions of place of dwelling and certain background data. Before the questionnaire was sent out to the twin population, it was tested in a pilot investigation, which purported to study the effectiveness of the data collection procedure and to elucidate the validity of some of the individual questions. The pilot investigation showed an external nonresponse rate of 18%. Regarding the ability of the subjects to answer the questions, it was revealed that only a few of the question categories presented problems which gave rise to minor changes in the questionnaire. Comparison between the answers on the questionnaire and a parallel interview showed a high degree of agreement. Thus the questionnaire was considered satisfactory. The principal data collection was carried out during the period January - May 1973 and during the period December 1973 - February 1974. Of the 42 294 individuals included in the data collection, 3 339 could not be contacted because of death, illness etc. Responses have been received from 32 374 individuals, which corresponds to 83% of the subjects who could be contacted. Regarded as a population of twin pairs, 3 262 pairs have not been utilizable for similar reasons. The total number of pairs in which both have answered the questionnaire is 13 811, corresponding to a little over 77%. There are three versions of the twin registry; a birth registry, an address registry and a questionnaire registry. The birth registry contains birth data from about 110,000 twin individuals. The address registry contains in addition current information as to name and address as well as current and past census registration. The questionnaire registry, which comprises twins born 1926-1958, moreover contains information obtained on the basis of the mail questionnaire.

Adolescent↗

Evaluation of institutional cancer registries in Colombia.

The four primary objectives of this descriptive study were to: 1) design a quality-measurement instrument for institutional cancer registries (ICRs), 2) evaluate the existing ICRs in Colombia with the designed instrument, 3) categorize the different registries according to their quality and prioritize efforts that will efficiently promote better registries with the limited resources available, and 4) determine the institution with the greatest likelihood of successfully establishing Colombia's second population-based cancer registry. In 1990 the National Cancer Institute of Colombia developed 13 institution-based cancer registries in different Colombian cities in order to promote the collection of data from a large group of cancer diagnostic and treatment centers. During the first half of 1997, this evaluation reviewed 12 registries; one of the original 13 no longer existed. All of the Colombian institutions (hospitals) that maintain institution-based cancer registries were included in the study. At each institution, a brief survey was administered to the hospital director, the registry coordinator, and the registrar (data manager). Researchers investigated the institutions by looking at six domains that are in standard use internationally. Within each domain, questions were developed and selected through the Delphi method. Each domain and each question were assigned weights through a consensus process. In most cases, two interviewers went to each site to collect the information. The university hospitals in Cali, Pereira, and Medellín had substantially higher scores, reflecting a good level of performance. Four of the 12 institutions had almost no cancer registry work going on. Five of the 12 hospital directors considered that the information provided by the cancer registries influenced their administrative decisions. Three of the registries had patient survival data. Four of the institutions allocated specific resources to operate their cancer registries; in the other 8 hospitals there was no clear budget allocation. Seven of the hospital directors could not identify five or more objectives of a cancer registry. Data management was usually poor and resources insufficient at most of the institutions. In summary, the cancer registry system in Colombia varies greatly from institution to institution. A few of the hospitals do a good job while others have neglected the registries. The high, identical total scores for Pereira and Medellín suggest they would be good locations to establish new population-based cancer registries similar to the existing one in Cali. However, the overall characteristics in Pereira may provide a more appropriate environment for the second registry, with Medellín as an alternative.

Colombia↗

Private provider participation in statewide immunization registries.

BACKGROUND: Population-based registries have been promoted as an effective method to improve childhood immunization rates, yet rates of registry participation in the private sector are low. We sought to describe, through a national overview, the perspectives of childhood immunization providers in private practice regarding factors associated with participation or non-participation in immunization registries. METHODS: Two mailed surveys, one for 264 private practices identified as registry non-participants and the other for 971 identified as registry participants, from 15 of the 31 states with population-based statewide immunization registries. Frequency distributions were calculated separately for non-participants and participants regarding the physician-reported factors that influenced decisions related to registry participation. Pearson chi-square tests of independence were used to assess associations among categorical variables. RESULTS: Overall response rate was 62% (N = 756). Among non-participants, easy access to records of vaccines provided at other sites (N = 101, 68%) and printable immunization records (N = 82, 55%) were most often cited as "very important" potential benefits of a registry, while the most commonly cited barriers to participation were too much cost/staff time (N = 36, 38%) and that the practice has its own system for recording and monitoring immunizations (N = 35, 37%). Among registry participants, most reported using the registry to input data on vaccines administered (N = 326, 87%) and to review immunization records of individual patients (N = 302, 81%). A minority reported using it to assess their practice's immunization coverage (N = 110, 29%) or generate reminder/recall notices (N = 54, 14%). Few participants reported experiencing "significant" problems with the registry; the most often cited was cost/staff time to use the registry (N = 71, 20%). CONCLUSION: Most registry participants report active participation with few problems. The problems they report are generally consistent with the barriers anticipated by non-participants, but did not impede participation. Recruitment efforts should focus on demonstrating the benefits of the registry to providers. In addition, many participants are not utilizing the full range of registry features; further study is needed to determine how best to increase use of these features.

Attitude of Health Personnel↗

Use of registry employees can pose legal problems.

In view of the potential legal liability to which a recipient entity can be exposed when using registry employees, some care must be taken in drafting registry contract services and in modulating the recipient entity's behavior towards the registry personnel. The following steps should generally be taken by health care establishments purchasing registry services to minimize such exposure: (1) Ensure that the registry treats its personnel as employees and complies with all applicable employment law obligations, including state and federal employment tax requirements, workers' compensation laws, and any state law wage and hour requirements in the recipient's state. (2) If using an out-of-state registry, make sure that the registry also has workers' compensation insurance in the recipient's state and complies with that state workers' compensation laws. (3) Make sure that termination decisions regarding registry employees are not made for reasons that violate any federal anti-discrimination laws. (4) Provide in the registry agreement for full indemnification by the registry to the recipient. (5) Ensure that the registry is solvent and has adequate insurance to honor its indemnification obligation. (6) Obtain a warranty from the registry that it carefully screens all of its employees before hiring them. (7) Expressly state in the registry agreement that the registry has the right to discipline and supervise the personnel it refers. (8) Do not reject registry personnel for reasons that would be improper with respect to the facility's own employees, e.g., race, sex, age, religion, disability, etc.

Contract Services↗

Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment.

OBJECTIVE: Glaxo Wellcome becomes aware of prenatal exposures to its medications as early as the clinical trial phase of development. An international process for monitoring prenatal exposure to all Glaxo Wellcome medicines has been developed. For specific products there are prospective pregnancy registries. STUDY DESIGN: The registries are observational, case-registration, and follow-up studies designed to detect evidence of teratogenicity associated with specific medications. After prenatal exposure to the registry medication, pregnancies are registered prospectively, through voluntary reports by health care providers. An advisory committee of independent scientists for each registry reviews data and advises in dissemination of information. Risk of birth defects, as defined by the Centers for Disease Control and Prevention, is compared with published risks both in women in the general population and in women with the underlying condition being treated, if available. RESULTS: The following data show results from the prospective first-trimester exposures registered since establishment of each registry. The published risk of birth defects in the general population range is 3% to 5%, and the risk in women with epilepsy is 6% to 9%. The proportions of outcomes with birth defects are as follows: in the Acyclovir (antiviral medication) Pregnancy Registry (1984-1998) (19/581), 3.3% (95% confidence interval, 2.0%-5.2%); in the Lamotrigine (monotherapy and polytherapy antiepileptic medication) Pregnancy Registry (1992-September 1998) (8/123), 6.5% (95% confidence interval, 3.1%-12.8%); in the Sumatriptan (migraine medication) Pregnancy Registry (1996-October 1998) (7/183), 3.8% (95% confidence interval, 1.7%-8.0%). The Valacyclovir, Bupropion, and Naratriptan registries have insufficient data for analysis. CONCLUSION: None of the registries has provided a risk estimate exceeding that expected in the disorder treated, and no pattern of defects has been observed. Whereas information from the larger registries is reassuring regarding risk, these studies cannot rule out possible small excess risks from use of these drugs in pregnancy. Data obtained through these registries are shared with the medical community as a supplement to animal toxicology studies to assist in weighing potential risks and benefits of treatment for individual patients. The success of the registries depends on the continued willingness of the obstetrics and gynecology community to notify the registries of prenatal exposures.

Abnormalities, Drug-Induced↗

Measuring immunization registry costs: promises and pitfalls.

INTRODUCTION: The medical and public health communities advocate the use of immunization registries as one tool to achieve national goals for immunization. Despite the considerable investment of resources into registry development, little information is available about the costs of developing or maintaining a registry. METHODS: The objective of this study was to measure the direct costs of maintaining one immunization registry. Cost and resource-use data were collected by interviewing registry personnel and staff at participating pediatric practices, collecting available financial records, and direct observation. RESULTS: The estimated direct cost for maintaining the registry during the 3 calendar years 1995 through 1997 was $439,232. In 1997, this represented an annual cost of $5.26 per child immunized whose record was entered into the registry. In all years, personnel expenses represented at least three fourths of the total costs, with the majority of administrative effort donated. Yearly costs increased over time largely because of growing administrative personnel requirements as the registry became fully operational. CONCLUSION: Considerable resources are required to establish and maintain immunization registries. Because personnel costs, particularly nontechnical personnel, represent a large portion of total registry costs, it is important to accurately account for donated effort. Recommendations for future registry cost studies include prospective data collection and focusing upon the costs of providing specific outreach or surveillance functions rather than overall registry costs. In addition, registry effectiveness evaluations are needed to translate registry costs into cost-effectiveness ratios.

Child↗

Qualitative study of clinic staff members' experiences using an immunization registry.

OBJECTIVES: To examine individual clinic staff members' experiences with using an immunization registry and to compare staff members' perceptions of immunization registries across different provider sites. DESIGN: Cross-sectional survey using in-depth interviews and direct observation. SETTINGS: The pediatric department of an urban community health center and 2 urban hospital-based pediatric primary care clinics. PARTICIPANTS: Twenty-five subjects were recruited using maximum variation sampling at each site. The subjects included clerks, clinic assistants, licensed practical nurses, a nurse practitioner, and registered nurses. MAIN OUTCOME MEASURES: Clinic staff members' perceptions of an immunization registry and frequency of registry use. RESULTS: Differences were observed in subjects' perceptions of an immunization registry across provider sites. Although most subjects had positive attitudes toward the registry, they did not necessarily believe that the registry decreased their workload. The ability to access immunization registry data and actual use of the registry seem to be related to training of clinic personnel, location of the registry terminal, and helpfulness and availability of registry staff. CONCLUSION: Obtaining the opinions of immunization registry users is an important strategy to evaluate the usefulness of a registry in a site and target possible areas for improvement.

Attitude to Health↗

How complete are immunization registries? The Philadelphia story.

OBJECTIVE: To assess accuracy and completeness of Philadelphia, Pa, registry data among children served by providers in areas at risk for underimmunization. METHODS: Philadelphia's Department of Public Health selected a simple random sample of 45 children age 19-35 months (or all children age 19-35 months if there were <45 children in the practice) from each of 30 private practices receiving government-funded vaccine and located in zip codes where children are at risk for underimmunization. Chart and registry data were compared with determine the proportion of children missing from the registry and assess differences in immunization coverage. RESULTS: Of 620 children reviewed, 567 (92%) were in the registry. Significant differences (P < .05) were observed in immunization coverage for 4 diphtheria-tetanus-acellular pertussis vaccinations, 3 polio vaccinations, 1 measles-mumps-rubella vaccination, and 3 Haemophilus influenzae type b vaccinations between the chart (80% coverage) and registry (62% coverage). Providers submitting electronic medical records or directly transferring electronic data to the registry had significantly more children in the registry and higher registry-reported immunization coverage than those whose data were entered from billing records or log forms. All practice types experienced difficulties in transferring complete data to the registry. CONCLUSIONS: Although 92% of study children were in the registry, immunization coverage was significantly lower when registry data were compared with chart data. Because electronic medical records and direct electronic data transfer resulted in more complete registry data, these methods should be encouraged in linking providers with immunization registries.

Child↗

Reporting cutaneous melanoma to cancer registries in the United States.

BACKGROUND: Central cancer registries provide data to monitor incidence rates of cutaneous melanoma. OBJECTIVE: The aim of this study was to assess the completeness of melanoma reporting in the United States. METHODS: Data provided by central cancer registries were used to calculate age-adjusted, average annual incidence rates and were compared by time period (1992-1994, 1995-1997), stage, and program (Surveillance Epidemiology and End Results [SEER] and National Program of Cancer Registries [NPCR]). Completeness was measured with incidence/mortality ratio. RESULTS: Incidence rates among whites for 1995-1997 from SEER registries ranged from 11.8 to 33.9 per 100,000 population; 18 of 40 NPCR registries were within this range. For 1992-1994, 8 of 30 NPCR registries were within the range of SEER incidence rates. NPCR registry incidence rates were generally higher for 1995-1997 than 1992-1994. The percentage of cases of localized melanoma did not increase substantially in most SEER registries over the study period, but some NPCR registries had substantial increases. Among NPCR registries that had incidence rates comparable with those of SEER in 1995-1997, the incidence/mortality ratios were generally lower among NPCR registries than SEER registries. CONCLUSION: Although melanoma incidence rates are generally increasing, part of the increases in incidence rates reported by NPCR registries over the study time period are likely due to increased case ascertainment and reporting.

Humans↗

Rheumatoid arthritis registries in Sweden.

Patient registries provide valuable contributions to the field of rheumatology for both quality control and scientific purposes. With respect to the latter, patient registries are among the most important datasets used for longitudinal observational studies in rheumatic diseases, which are in turn an essential complement to data obtained from randomized, controlled trials. In Sweden a number of registries are available for such studies, ranging from general medical registries such as the in-patient registry, to rheumatoid arthritis (RA)-specific inception cohorts and biologics registries focusing on a specific patient population defined by a group of treatments. In recent years it has become particularly clear that questions regarding new therapies, their use in practice and their long-term safety, as well as aspects such as pharmacoeconomics, cannot fully be assessed using the data from clinical trials, and that registries are indispensible to obtain accurate answers to such questions. In this review we describe the Swedish rheumatology registries, including the Swedish RA registry and the Swedish biologics registries ARTIS (Antirheumatic Therapies Iin Sweden), SSATG (Southern Sweden Antirheumatic Therapy Group), and STURE (Stockholm Tumor Necrosis Factor-a Follow-up Registry). Data obtained from analyses based on these registries are reviewed. It is concluded that rheumatology registries are excellent tools for improving our knowledge base regarding rheumatic diseases.

Antirheumatic Agents↗

Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment.

Objectives: Glaxo Wellcome (G.W.) becomes aware of prenatal exposures to its medications from as early as the clinical trial phase of development. An international process for monitoring prenatal exposure to all G.W. medicines has been developed utilizing a passive surveillance system and, for specific products, pregnancy registries. Additionally, G.W. jointly sponsors the multi-company Antiretroviral and North American Antiepileptic Drug (AED) Pregnancy Registries.Study Design: The registries are observational, case-registration and follow-up studies designed to detect evidence of teratogenicity associated with specific medications. Pregnancies are registered prospectively following prenatal exposure to the registry medication. An advisory committee for each registry reviews data and assists in dissemination of information. Committee members include independent scientists with expertise in fields such as obstetrics, teratology, epidemiology, pediatrics, and the relevant therapeutic areas.Results: The following data are from the prospective first-trimester exposures in each registry. Through December 1996, the proportion of outcomes in the Acyclovir Pregnancy Registry with birth defects (n = 17/505) is 3.4% (95% CI 2.0%, 5.4%). Through March 1997, the proportion of outcomes in the Lamotrigine Pregnancy Registry with birth defects (n = 4/76) is 5.3% (95% CI 1.7%, 13.6%). Through April 1997, the proportion of outcomes in the Sumatriptan Pregnancy Registry with birth defects (n = 5/148) is 3.4% (95% CI 1.3%, 8.1%). The newer Valacyclovir and Bupropion Pregnancy Registries have insufficient data for analysis. None of the registries have provided a risk estimate exceeding that expected in the general population, and no pattern of defects has been observed.Conclusions: The outcomes accumulated to date represent a sample of insufficient size for reaching conclusions regarding the possible teratogenic risk of using these drugs in pregnancy. Data obtained through these registries are shared with the medical community as a supplement to animal toxicology studies and to assist in weighing potential risks and benefits of treatment for individual patients. The success of the registries depends on the continued willingness of the OB/GYN community to notify the registries of prenatal exposures.

Journal Article↗