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PubMed2006

Medical contraindications to implant therapy: part I: absolute contraindications.

In order to ensure implant success, it is essential to select patients who do not possess local or systemic contraindications to therapy. Hence, it is the purpose of this paper to review the medical diseases that reportedly preclude conventional dental implant treatment. Absolute contraindications to implant rehabilitation include recent myocardial infarction and cerebrovascular accident, valvular prosthesis surgery, immunosuppression, bleeding issues, active treatment of malignancy, drug abuse, psychiatric illness, as well as intravenous bisphosphonate use. Any of these conditions bar elective oral surgery, and require judicious monitoring by the physician as well as the dental provider. Noncompliance to the suggested protocol may, in the worst possible case, result in patient mortality.

Bone Density Conservation Agents↗
PubMed1976

Symposium: contraindications to tympanoplasty. IV. Contraindications to tympanoplasty.

Aural and non-aural disorders that are relative or are absolute contraindications to tympanoplasty surgery are discussed. Particular attention is focused on non-aural convert general medical conditions that may escape the otologist's attention as he is not daily concerned in the management of such conditions. The aural contra-indications are dealt with briefly because of the obvious and well known disorders that are familiar to all otologists.

Age Factors↗
PubMed2006

Contraindication labelling changes in the United States and Germany.

OBJECTIVE: Communication of a drug's benefits and risks through drug labelling is an important tool in the risk management of prescription drugs. Contraindication labelling provides the strongest safety-based guidance for the health care practitioner. In this study, the labelling of new contraindications between the United States (US) and Germany was compared. METHODS: We assessed whether contraindications that were newly labelled in the US between January 2003 and May 2005 had been incorporated into the German Summary of Product Characteristics (SPC) by October 2005 (end of the study period). We classified the results of our comparison as no difference, a slight difference (more detailed contraindication in one country or the other) or as a relevant difference (new US contraindication not contraindicated in the German SPC). We assessed the time difference between the date of the labelling change in the US and October 2005. RESULTS: During the study period, 66 new contraindications were evaluable for analysis. We found no difference in labelling between the US and Germany with regard to 30 contraindications (45.5%) and slight differences with regard to 14 contraindications (21.2%). In 22 instances (33.3%), the new contraindication in the US had not been incorporated into the German SPC. The median delay between the date of labelling in the US and October 2005 was 14 months and ranged between 5 and 31 months. In 77.3% of the relevant differences in contraindication labelling, the pharmaceutical manufacturer was the same in the US and Germany. CONCLUSION: Our study shows a remarkable discrepancy in the labelling of new contraindications between the US and Germany. The underlying reasons for this discrepancy were discussed, but need to be explored further.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

A retrospective study to determine the impact of medical- and lifestyle-based contraindications to a prescribed HAART regimen on clinical outcomes and adherence.

OBJECTIVE: To determine whether patients who are prescribed a highly active antiretroviral therapy regimen, that minimizes medical and lifestyle contraindications, will be better able to adhere to their drug regimens and will have better clinical outcomes, than patients who do not have such a regimen. METHODS: A retrospective chart review of patients' prescription renewals and changes in viral load and CD4(+) count and a comparison of these changes with patients' self-identified contraindications. Contraindications were identified by a questionnaire with 35 questions relating to medical history/concurrently prescribed medication and 16 questions on lifestyle. Main outcome measures are adherence assessed by prescription renewals, change in plasma HIV-1 RNA viral loads, and change in CD4(+) T-lymphocyte counts. Logistic and linear regression and student t-test were used to identify associations between outcome measurements and number of contraindications. RESULTS: A total of 203 patients (72% male, 74% African-American, 7% Hispanic) completed the questionnaire. Seventy-four per cent of the patients had at least one medical/drug contraindication and 78% had at least one lifestyle contraindication. Increases in CD4 counts were reduced by an average of 13 cells/mm(3) (P = 0.033) for each medical/drug contraindication and viral load decreases was significant even with one medical contraindication vs. none (P = 0.042). Patients with fewer lifestyle contraindications were more likely to have at least a 1 log drop in viral load (P = 0.036). For each increase in the number of contraindications, there was a corresponding 2% decrease in the rate of adherence (P = 0.048). CONCLUSIONS: The results suggest that using a patient administered questionnaire it is possible to identify contraindications in prescribed regimens that impact on adherence and on treatment effects on viral load and CD4 counts.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Can contraindications compromise evidence-based, patient-centered clinical practice?

BACKGROUND: Despite their often weak evidence base, contraindications convey the unequivocally adverse risk-benefit profile of an intervention in a specific clinical context. However, some patients in that context may nonetheless prefer the contraindicated intervention (with its potential benefits and risks) to the available alternatives. The impact of contraindications on treatment decisions remains unexplored. OBJECTIVE: To provide an estimate of the impact of the "contraindication" label on treatment decisions. METHODS: We conducted an international 6-wave email/internet and fax survey of practicing clinicians who were members of the American Diabetes Association or the College of Physicians and Surgeons of Ontario and had available email addresses and fax numbers. Each participant considered one of two patient scenarios. In each scenario, the patient expressed a strong preference for use of a medication that carried a "contraindication" label despite weak evidence of harm. We designed these scenarios so that respondents who placed greater weight on patient preferences and research evidence than on the label "contraindication" would be ready to prescribe the contraindicated medication. We determined the frequency with which the label "contraindication" dominated participants' treatment decisions despite patient preferences and weak evidence of harm. RESULTS: 466 participants responded (22% response rate). Depending on the group and scenario, contraindications dominated the decisions of 47% to 89% of surveyed clinicians, superseding patient preferences and research evidence. CONCLUSIONS: The label "contraindication" may often dominate clinicians' decisions about treatment and may compromise evidence-based, patient-centered clinical practice. Further research should elucidate the process that leads to the formulation of contraindications and its impact on treatment decision-making.

Attitude of Health Personnel↗
PubMed2004

The prevalence of contraindications to total disc replacement in a cohort of lumbar surgical patients.

STUDY DESIGN: This is a retrospective review of the epidemiology of contraindications to lumbar total disc replacement (TDR). OBJECTIVE: To define the prevalence of contraindications to lumbar total disc replacement in a cohort of patients undergoing lumbar surgery in the senior author's (F.P.C.) practice. SUMMARY OF BACKGROUND DATA: No published reports have documented the prevalence of contraindications to lumbar total disc replacement. METHODS: We performed a retrospective review of 100 consecutive patients who had lumbar surgery by one surgeon between September and December 2002. Procedures performed and contraindications to TDR were recorded. Contraindications to TDR included central or lateral recess stenosis, facet arthrosis, spondylolysis or spondylolisthesis, herniated nucleus pulposus with radiculopathy, scoliosis, osteoporosis, and postsurgical pseudarthrosis or deficiency of posterior elements. Patients were divided into fusion and nonfusion groups. The percentage of patients without contraindications to TDR was calculated. RESULTS: Of 100 patients, 56 had fusions and 44 had nonfusion surgery. In the fusion group, 56 of 56 patients had contraindications to TDR. In the nonfusion group, 11% (5 of 44) were candidates for TDR. Overall, 5% of patients in this series were candidates for TDR. The average number of contraindications to TDR was 2.48 (range, 0-5). CONCLUSIONS: Predictions that TDR will replace fusion are premature. A small percentage (5%) of the patients currently indicated for lumbar surgery at our institution have no contraindications to TDR. Future growth in TDR implantation will result from the indication of patients for surgery who would not be indicated today or from the elimination of current contraindications.

Adult↗
PubMed2006

Co-dispensing of contraindicated medications in patients using cisapride in Italy.

PURPOSE: To investigate the co-dispensing of contraindicated medications in patients using cisapride in an Italian population. METHODS: The study included patients who had at least one cisapride prescription dispensed between 1 April 1997 and 30 September 2000. The proportion of cisapride users with concomitant medications, the proportion of prescriptions of cisapride with an overlapping dispensing of a contraindicated medication and the proportion of person-days of cisapride use concomitant with contraindicated medications, were calculated. RESULTS: In the 4-year study period, 249,740 total cisapride prescriptions, which corresponded to 382,835 packages, were dispensed to 91,204 users (52,442 female, 57.5%). Concomitant use of contraindicated drugs was identified in 4403 cisapride users (4.83%). Throughout the study period, there was an increase in the proportion of cisapride users with contraindicated co-prescriptions: 4.29% in 1997, 4.99% in 1998, 5.15% in 1999, but a decline to 3.34% in 2000. In each year, this figure was higher in males, with the highest proportion reported in 1999 (5.50%). A total of 7215 cisapride prescriptions (2.85%) were concomitant with contraindicated drugs, ranging from 2.27% in September 1998 to 3.55% in January 1999. Cisapride prescriptions were most frequently associated with macrolide antibiotics (1.14%) and class III antiarrhythmics (1.03%). CONCLUSIONS: In the period 1997-2000, a substantial proportion of cisapride prescriptions were concomitant with contraindicated medications. In Italy in 1998, the National Health Authority issued a bulletin warning about the risk of serious arrhythmias after concomitant use of contraindicated drugs. Despite this warning, there was no reduction in contraindicated drug uses.

Adolescent↗
PubMed2003

Breastfeeding practices in a cohort of inner-city women: the role of contraindications.

BACKGROUND: Little is known about the role of breastfeeding contraindications in breastfeeding practices. Our objectives were to 1) identify predictors of breastfeeding initiation and duration among a cohort of predominantly low-income, inner-city women, and 2) evaluate the contribution of breastfeeding contraindications to breastfeeding practices. METHODS: Mother-infant dyads were systematically selected from 3 District of Columbia hospitals between 1995 and 1996. Breastfeeding contraindications and potential predictors of breastfeeding practices were identified through medical record reviews and interviews conducted after delivery (baseline). Interviews were conducted at 3-7 months postpartum and again at 7-12 months postpartum to determine breastfeeding initiation rates and duration. Multivariable logistic regression analysis was used to identify baseline factors associated with initiation of breastfeeding. Cox proportional hazards models were generated to identify baseline factors associated with duration of breastfeeding. RESULTS: Of 393 study participants, 201 (51%) initiated breastfeeding. A total of 61 women (16%) had at lease one documented contraindication to breastfeeding; 94% of these had a history of HIV infection and/or cocaine use. Of the 332 women with no documented contraindications, 58% initiated breastfeeding, vs. 13% of women with a contraindication. In adjusted analysis, factors most strongly associated with breastfeeding initiation were presence of a contraindication (adjusted odds ratio [AOR], 0.19; 95% confidence interval [CI], 0.08-0.47), and mother foreign-born (AOR, 4.90; 95% CI, 2.38-10.10). Twenty-five percent of study participants who did not initiate breastfeeding cited concern about passing dangerous things to their infants through breast milk. Factors associated with discontinuation of breastfeeding (all protective) included mother foreign-born (hazard ratio [HR], 0.55; 95% CI 0.39-0.77) increasing maternal age (HR for 5-year increments, 0.80; 95% CI, 0.69-0.92), and infant birth weight > or = 2500 grams (HR, 0.45; 95% CI, 0.26-0.80). CONCLUSIONS: Breastfeeding initiation rates and duration were suboptimal in this inner-city population. Many women who did not breastfeed had contraindications and/or were concerned about passing dangerous things to their infants through breast milk. It is important to consider the prevalence of contraindications to breastfeeding when evaluating breastfeeding practices in high-risk communities.

Adult↗
PubMed2000

Contraindicated use of cisapride: impact of food and drug administration regulatory action.

CONTEXT: Cisapride, a gastrointestinal tract promotility agent, can cause life-threatening cardiac arrhythmias in patients susceptible either because of concurrent use of medications that interfere with cisapride metabolism or prolong the QT interval or because of the presence of other diseases that predispose to such arrhythmias. In June 1998, the US Food and Drug Administration (FDA) determined that use of cisapride was contraindicated in such patients and informed practitioners through additions to the boxed warning in the label and a "Dear Health Care Professional" letter sent by the drug's manufacturer. OBJECTIVE: To evaluate the impact of the FDA's 1998 regulatory action regarding contraindicated use of cisapride. DESIGN AND SETTING: Analysis of data for the 1-year periods before (July 1997-June 1998) and after (July 1998-June 1999) the regulatory action from the population-based, pharmacoepidemiology research databases of 2 managed care organizations (sites A and B) and a state Medicaid program (site C). PARTICIPANTS: Patients with at least 180 days of prior enrollment in 1 of the 3 sites who were prescribed cisapride at least once in the period before (n = 24 840) or after (n = 22 459) regulatory action. Patients could be included in both cohorts. MAIN OUTCOME MEASURES: Proportion of cisapride users in each period for whom cisapride use was contraindicated by the product label, based on computerized patient medical encounter records. RESULTS: In the year prior to regulatory action, cisapride use was contraindicated for 26%, 30%, and 60% of users in study sites A, B, and C, respectively. In the year after regulatory action, use was contraindicated for 24%, 28%, and 58% of users, a reduction in contraindicated use of approximately 2 per 100 cisapride users at each site. When the analysis was restricted to new users of cisapride after regulatory action, only minor reductions in contraindicated use were found. CONCLUSION: The FDA's 1998 regulatory action regarding cisapride use had no material effect on contraindicated cisapride use. More effective ways to communicate new information about drug safety are needed.

Cisapride↗
PubMed2003

Prescription of topical antiglaucoma agents for patients with contraindications to beta-blockers.

BACKGROUND: In Canada, public drug plans may restrict the use of newer topical antiglaucoma agents. The goals of this retrospective study were to estimate the proportion of patients who, at the initiation of topical glaucoma therapy, had contraindications to the use of topical beta-blockers and to identify whether changes in formulary listing status (from restricted-drug list to generally available drug list) influenced the use of topical glaucoma agents in patients with contraindications to beta-blockers. METHODS: Claims databases administered by the Régie de l'assurance maladie du Quebec were used to identify incident users of beta-blockers (betaxolol and timolol) and newer antiglaucoma agents (brimonidine, dorzolamide and latanoprost) among patients aged 35 years or older. Drug claims and physician diagnoses were used to determine the prevalence of the following contraindications to the use of beta-blockers (including warnings and precautions): asthma or chronic bronchitis, diabetes, dysrhythmia and heart failure, all in the year preceding the initiation of therapy; or use of systemic beta-blockers at the time glaucoma therapy was started. The observation period was divided into 2 phases: the time during which newer agents were on the restricted-drug list (first-line use being limited to patients with contraindications to the use of beta-blockers; January 1997 to March 1999) and the time during which these agents were on the generally available drug list (that is, after reimbursement restrictions were relaxed; April 1999 to June 2000). RESULTS: Of the 20 309 eligible patients, 59.8% were female, and the mean age was 72 years. Contraindications to topical beta-blocker therapy were significantly more frequent among the patients using newer antiglaucoma agents than among those using beta-blockers (71.5% vs. 55.5%, p < 0.0001). Asthma and chronic bronchitis were also more frequent among the patients using the newer agents than among those using beta-blockers (43.1% vs. 22.5%, p < 0.0001). Among the patients without contraindications to topical beta-blocker therapy, the overall proportions started on therapy with a newer agent were 22.7% when there were reimbursement restrictions and 30.0% when the restrictions were relaxed (p < 0.0001). CONCLUSIONS: Among patients with contraindications to the use of beta-blockers, newer topical antiglaucoma agents were used more often than beta-blockers. Among patients without such contraindications, the use of the newer agents increased modestly when reimbursement restrictions were relaxed.

Administration, Topical↗
PubMed2001

Contraindications to metformin therapy in patients with Type 2 diabetes--a population-based study of adherence to prescribing guidelines.

AIMS: To define the number of people in Tayside, Scotland (population 349 303) with Type 2 diabetes who use metformin, the incidence of contraindications to its continued use in these people and the proportion that discontinued metformin treatment following the development of a contraindication. METHODS: Retrospective cohort study of the incidence of contraindications to metformin in all patients with Type 2 diabetes using metformin from January 1993 to June 1995. The contraindications of acute myocardial infarction, cardiac failure, renal impairment and chronic liver disease were identified by: the regional diabetes information system, biochemistry database and hospital admissions database and a database of all encashed community prescriptions. RESULTS: One thousand eight hundred and forty seven subjects (26.3% of those with Type 2 diabetes) redeemed prescriptions for metformin. Of these, 3.5% were admitted with an acute myocardial infarction (71 episodes); 4.2% were admitted with cardiac failure (114 episodes); 21.0% received metformin and loop diuretics for cardiac failure concurrently; 4.8% developed renal impairment; and 2.8% developed chronic liver disease. The development of contraindications rarely resulted in discontinuation of metformin, for example only 17.5% and 25% stopped metformin after admission with acute myocardial infarction and development of renal impairment, respectively. In total, 24.5% of subjects receiving metformin, 6.4% of all people with Type 2 diabetes, had contraindications to its use. There was one episode of lactic acidosis in 4600 patient years. CONCLUSIONS: This population-based study shows that 24.5% of patients prescribed metformin have contraindications to its use. Development of contraindications rarely results in discontinuation of metformin therapy. Despite this, lactic acidosis remains rare. Diabet. Med. 18, 483-488 (2001)

Cohort Studies↗
PubMed2004

The effect of contraindications and patient preference on dialysis modality selection in ESRD patients in The Netherlands.

BACKGROUND: Patients with end-stage renal disease (ESRD) who are about to start long-term dialysis therapy are faced with the question of modality choice. The aim of the current study is to determine the influence of different factors on long-term dialysis modality choice. METHODS: As part of a large Dutch prospective multicenter study, the Netherlands Cooperative Study on the Adequacy of Dialysis, we consecutively included all new patients with ESRD. Nephrologists indicated the most important reason for the modality selection. RESULTS: Of 1,347 included patients, 36% (n = 483) had a contraindication to either peritoneal dialysis (PD) or hemodialysis (HD) therapy. Eighty percent (n = 386) of all contraindications were directed to PD therapy. The most frequently mentioned contraindication was a social one; ie, the expected incapability of patients to perform PD exchanges themselves. Patients with contraindications were older, had more comorbidity, and lived alone more often compared with patients without contraindications. In patients without contraindications (64%), modality choice was based on patient preference. Older age increased the odds of choosing HD, whereas receipt of predialysis care was associated with a lower preference for HD. CONCLUSION: Older age was associated with more contraindications to PD therapy and stronger patient preference for HD therapy. An elderly patient therefore was more likely to start with HD therapy. Results from the current study suggest that an increase in provision of predialysis care, in combination with a reduction in social contraindications to PD therapy, may be associated with an increase in likelihood of starting with PD therapy. In a time of an aging population, increasing demand on dialysis capacity, and limited amount of financial supplies, we may reconsider current strategies to provide future patients with ESRD the possibility to start with the dialysis modality they prefer.

Adult↗
PubMed1996

Outcome of different reperfusion strategies in patients with former contraindications to thrombolytic therapy: a comparison of primary angioplasty and tissue plasminogen activator. Primary Angioplasty in Myocardial Infarction (PAMI) Investigators.

High-risk patients have been excluded from most thrombolytic trials because of concern over hemorrhagic complications or lack of efficacy. However, based on several recent studies suggesting that patients with relative thrombolytic contraindications may also benefit from reperfusion, recommendations have been made to broadly expand the eligibility criteria for thrombolytic therapy, despite higher absolute complication rates. Primary percutaneous transluminal coronary angioplasty (PTCA) may be an attractive alternative for patients presenting at appropriately equipped hospitals who would otherwise remain at high risk after thrombolytic therapy. In the Primary Angioplasty in Myocardial Infarction (PAMI) trial, 395 patients with acute myocardial infarction were randomized to tissue plasminogen activator (t-PA) or primary PTCA. Conditions were present in 151 patients (38%) which formerly would have contraindicated thrombolytic therapy (age > 70 yr, symptom duration > 4 hr, or prior bypass surgery). In-hospital mortality was 4.3-fold higher in patients with former thrombolytic contraindications compared to lytic-eligible patients (8.6% vs. 2.0%, P = .002). Lytic-eligible patients treated with t-PA and PTCA had similar in-hospital mortality (1.7% vs. 2.4%, P = NS). In contrast, both in-hospital (2.9% vs. 13.2%, P = .025) and 6-mo mortality (2.9% vs. 15.7%, P = .009) were significantly reduced in patients with former thrombolytic contraindications treated by primary PTCA compared to t-PA. By logistic regression analysis, treatment by PTCA rather than t-PA was the strongest predictor of survival in patients with former thrombolytic contraindications. We conclude that patients with conditions formerly contraindicating thrombolytic therapy constitute a high-risk group with significant morbidity and mortality after lytic reperfusion. Our data suggest that patients with former contraindications to thrombolytic therapy may benefit by preferential management with primary PTCA without antecedent thrombolysis.

Aged↗
PubMed2003

Impact of cisapride label changes on codispensing of contraindicated medications.

OBJECTIVE: To quantify the impact of the first three label changes and 'Dear Doctor' letters as sole interventions, sent to prescribers and pharmacists, on the prescribing and dispensing of cisapride and contraindicated drugs. METHODS: Using a managed care claims database, a total of 38,757 patients with cisapride prescriptions (July 1993-December 1998) were selected. An interrupted time series analysis and an exponentially weighted moving average analysis (EWMA) were conducted to determine whether there were changes in the proportion of contraindicated codispensing following each intervention. RESULTS: 3.6% of cisapride dispensing overlapped with contraindicated drug dispensing. Beginning in 1994, the overlapped proportions declined slowly from 4.5% ending at 3.2% in 1998. The interrupted time series analysis showed that there was a statistically significant abrupt permanent decrease in the proportion of contraindicated dispensing following the June 1998 label change (coefficient -1.0094, p = 0.045), meaning that the proportion of contraindicated dispensing dropped nearly one percentage point after the third intervention. The 1995 label changes did not have statistically significant effects. The EWMA analysis showed that the proportion of contraindicated dispensing was lower than 3 standard deviations below average during the period after the June 1998 intervention, with no significant effects following the two earlier interventions. CONCLUSIONS: The June 1998 cisapride label change and accompanying 'Dear Doctor' letter had a downward impact on the proportion of dispensing of contraindicated drugs with cisapride. The other two label changes did not have independent significant impacts.

Adolescent↗