OBJECTIVES: To evaluate the changes in types of medications prescribed for pain before and after withdrawal of certain selective cyclooxygenase 2 (COX-2) inhibitors in 2004 and to determine whether there was an association with fall events in elderly adults with a diagnosis of osteoarthritis (OA). DESIGN: A nested case-control design using electronic medical records compiled between 2001 and 2009. SETTING: Electronic medical records for care provided in an integrated health system in rural Pennsylvania over a 9-year period (2001-09), the midpoint of which rofecoxib and valdecoxib were pulled from the market. PARTICIPANTS: Thirteen thousand three hundred fifty-four individuals aged 65 to 89 with a diagnosis of OA. MEASUREMENTS: The incidence of falls and fractures was examined in relation to analgesics prescribed: narcotics, COX-2 inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs). The comparison sample of individuals who did not fall was matched 3:1 with those who fell according to age, sex, and comorbidity. RESULTS: Narcotic analgesic prescriptions were associated with a significantly greater risk of falls and fractures. The likelihood of experiencing a fall/fracture was higher in participants prescribed narcotic analgesics than those prescribed a COX-2 inhibitor (odds ratio (OR) = 3.3, 95% confidence interval (CI) = 2.5-4.3) or NSAID (OR = 4.1, 95% CI = 3.7-4.5). CONCLUSION: Use of narcotic analgesics is associated with risk of falls and fractures in elderly adults with OA, an observation that suggests that the current guidelines for the treatment of pain, which include first-line prescription of narcotics, should be reevaluated.
"P<0.001) or NSAID (OR 4.1, 95% CI 3.7–4.5; P<0.001).31 For older adult patients with chronic pain at higher risk for NSAID-related adverse effects, such as those who have gastrointestinal or cardiovascular disease, diabetes mellitus, or who are taking low-dose aspirin, narcotics are recommended instead.32 "
[Show abstract][Hide abstract] ABSTRACT: Background
Falls among the elderly are an issue internationally and a public health problem that brings substantial economic and quality-of-life burdens to individuals and society. Falls prevention is an important measure of nursing quality and patient safety. Numerous studies have evaluated the association of medication use with fall risk in elderly patients. However, an up-to-date review has not been available to summarize the multifaceted pharmaceutical concerns in the prevention of medication-related falls.
Materials and methods
Relevant literature was identified by performing searches in PubMed, Web of Science, and the Cochrane Library, covering the period until February 2014. We included studies that described an association between medications and falls, and effects of drug pharmacokinetic/pharmacodynamic properties, characteristics of medication use, and pharmacological interventions on fall risk in elderly patients. The full text of each included article was critically reviewed, and data interpretation was performed.
Fall-risk-increasing drugs (FRIDs) include central nervous system-acting agents, cough preparations, nonsteroidal anti-inflammatory drugs, anti-Alzheimer’s agents, antiplatelet agents, calcium antagonists, diuretics, α-blockers, digoxin, hypoglycemic drugs, neurotoxic chemotherapeutic agents, nasal preparations, and antiglaucoma ophthalmic preparations. The degree of medication-related fall risk was dependent on one or some of the following factors: drug pharmacokinetic/pharmacodynamic properties (eg, elimination half-life, metabolic pathway, genetic polymorphism, risk rating of medications despite belonging to the same therapeutic class) and/or characteristics of medication use (eg, number of medications and drug–drug interactions, dose strength, duration of medication use and time since stopping, medication change, prescribing appropriateness, and medication adherence). Pharmacological interventions, including withdrawal of FRIDs, pharmacist-conducted clinical medication review, and computerized drug alerts, were effective in reducing fall risk.
Based on the literature review, clear practical recommendations for clinicians to prevent falls in the elderly included making a list of FRIDs, establishing a computerized alert system for when to e-prescribe FRIDs, seeking an alternative drug with lower fall risk, withdrawing FRIDs if clinically indicated, taking pertinent cautions when the use of FRIDs cannot be avoidable, paying attention to prescribing appropriateness, simplifying the medication regimen, strengthening pharmacist-conducted clinical medication review, ensuring the label of each FRID dispensed contains a corresponding warning sign, being careful when medication change occurs, enhancing medication adherence, and mandating for periodic reassessment of potential risk associated with the patient’s medication regimen. Further studies should be conducted in this area, such as investigating whether medication reconciliation and improving medication adherence could decrease the rate of falls.
[Show abstract][Hide abstract] ABSTRACT: Cyclooxygenase type 2 (COX-2)-selective nonsteroidal anti-inflammatory drugs (NSAIDs) (c2sNSAIDs) have been scrutinized relative to the less costly nonselective NSAIDs (nsNSAIDs). The conclusions reached were not always consistent with the data, and best treatment choices for patients were not always recommended.
The data that were used to criticize the c2sNSAIDs are reexamined in a controversial light, demonstrating that the presence of reverse bias was often, but not always, present.
A review of both Pubmed and news media articles relating to nsNSAIDs and c2sNSAIDs was conducted. References were selected on the basis of relevance to the controversies.
The initial claims for the c2sNSAIDs of reduced gastrointestinal (GI) injury and preservation of platelet function were soon dwarfed by concerns regarding increased cardiovascular (CV) risk with publication of the Vioxx Gastrointestinal Outcomes Research trial for rofecoxib. Initial prothrombotic theories had a poor basis for explaining these concerns and have since largely been replaced with more credible explanations, including blood pressure elevations known to occur with all NSAIDs. Between data suggesting increased CV risk and under political pressure and public outcry, rofecoxib was withdrawn from the market in 2004. Soon, all c2sNSAIDs were under scrutiny. The Food and Drug Administration has since grouped all NSAIDs, whether c2sNSAID or nsNSAID, into one class with similar warnings regarding skin, CV, renal, and GI side effects.
The entire "COX-2 debacle" is reminiscent of past events with NSAIDs. Amid this public, media, and political hysteria, it is not clear if we will see any more NSAIDs (selective or otherwise) approved in the near future.
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