Abstract：
BACKGROUND:During the past 5 years, there has been much concern about the safety of and ease of access to drugs that are unavailable without a prescription in the United States but are manufactured and can be purchased over the counter (OTC) in Mexico. However, based on a literature search, studies have not been performed to determine whether such drugs meet the US Pharmacopoeia (USP) standards for percent of labeled amount. OBJECTIVE:The aim of this study was to determine whether 5 drugs commonly prescribed in the United States and manufactured and purchased in Mexico met USP standards for stated concentration, were properly packaged and sealed, and had properly labeled expiration dates and lot numbers. METHODS:For the study, we purchased acetaminophen, carbamazepine, diazepam, digoxin, and phenytoin from 2 to 4 pharmacies in Ciudad Acuna, Mexico. Samples of each drug, each with a different lot number, were purchased OTC or with a prescription. None of the pharmacists had knowledge of the study. Brand-name or generic drugs manufactured and obtained in the United States were also analyzed for comparative purposes. Each drug was analyzed by high-performance liquid chromatography using USP guidelines established for the analysis of each drug. In addition, we visually examined the packaging, seals, color, and appearance of the drugs, and observed whether the packages contained lot numbers and whether the drugs were within the stated expiration dates. RESULTS:For all 5 drugs, the 95% CIs fell within the USP-defined acceptable ranges for percent of labeled amount. This was found to be true for drugs obtained at different pharmacies, for different drug manufacturers, and for drugs with different lot numbers. All of the drugs were found to be properly packaged and sealed, had lot numbers listed on the packages, and were sold before the stated expiration dates. CONCLUSION:Although health care practitioners should be aware that patients might be using drugs manufactured and purchased in Mexico, the results of this study of a small sample of such drugs suggest they meet the USP standards for percent of labeled amount.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Schwertner HA,Storrow ABdoi
10.1016/j.clinthera.2005.05.007subject
Has Abstractpub_date
2005-05-01 00:00:00pages
609-15issue
5eissn
0149-2918issn
1879-114Xpii
S0149-2918(05)00083-4journal_volume
27pub_type
杂志文章abstract：:The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) may be the most significant piece of legislation affecting the practice of pharmacy since the Durham-Humphrey amendments to the Food, Drug and Cosmetic Act. As part of the OBRA-90 legislation, the Health Care Financing Administration (HCFA) was required to publis...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1993-05-01 00:00:00
abstract：:Pregnancy creates a climate favorable to the growth of Candida albicans, and this yeast often is difficult to eradicate in pregnant women. Miconazole nitrate administered intravaginally has been found to achieve comparable therapeutic and mycological cure rates in both pregnant and nonpregnant women. A number of clini...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1986-01-01 00:00:00
abstract：:The effect of leuprorelin acetate depot on the endocrine system and on lipid metabolism was evaluated in a multicentre, noncomparative study. During the first month of treatment, suppression of serum oestradiol levels to below 20 pg/ml was achieved and luteinising hormone and follicle-stimulating hormone levels were r...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究
doi：
更新日期：1992-01-01 00:00:00
abstract：:Coexisting diseases may have unforeseen yet clinically significant effects on patients' well-being. Both generic and disease-specific measures are frequently used to assess health-related quality of life (QOL). The present study assessed the effects of comorbidity on the results of QOL measures through an analysis of ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/S0149-2918(00)88295-8
更新日期：1999-02-01 00:00:00
abstract：BACKGROUND:Treatment of infections caused by gram-negative bacilli is increasingly challenging because of emerging resistance. Current surveillance data are informative, but may not discern differences by infection site and clinical setting, and do not incorporate pharmacodynamic (PD) characteristics when determining s...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究
doi：10.1016/j.clinthera.2009.11.021
更新日期：2009-11-01 00:00:00
abstract：PURPOSE:Selumetinib (AZD6244, ARRY-142886), an oral, potent, and highly selective mitogen-activated protein kinase 1/2 inhibitor with a short half-life, has shown activity across various tumor types. Before initiation of Phase III trials, the site, scale, and color (hypromellose shell from white [Phase II] to blue [Pha...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2017.08.022
更新日期：2017-11-01 00:00:00
abstract：BACKGROUND:Nearly half of all US patients with type 2 diabetes mellitus (T2DM) are unable to maintain adequate glycosylated hemoglobin (HbA₁(c)) control (ie, <7.0%). OBJECTIVE:The aim of this work was to determine the long-term cost-effectiveness of incretin-based therapy with once-daily liraglutide (vs twice-daily ex...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2010.08.010
更新日期：2010-09-01 00:00:00
abstract：:Recent pharmacotherapeutic advances in the treatment of depression have included the development of selective serotonin re-uptake inhibitors (SSRIs). The present study was designed to contrast direct health service expenditures for the treatment of depression among patients enrolled in a health maintenance organizatio...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0011-393x(05)80275-9
更新日期：1994-07-01 00:00:00
abstract：PURPOSE:The complex and varied presentation of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has made it difficult to diagnose, study, and treat. Its symptoms and likely etiology involve multiple components of endocrine and immune regulation, including the hypothalamic-pituitary-adrenal axis, the hypothal...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2019.03.002
更新日期：2019-04-01 00:00:00
abstract：BACKGROUND:Impaired mineral homeostasis affecting calcium, phosphate, and magnesium is a result of parathyroid hormone (PTH) deficiency in hypoparathyroidism. The current standard of treatment with active vitamin D and oral calcium does not control levels of these major minerals. Recombinant full-length human PTH 1-84 ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2014.04.001
更新日期：2014-05-01 00:00:00
abstract：:To determine the cost relative to efficacy and tolerability of two antimicrobial regimens, a prospective, multicenter study compared imipenem-cilastatin (I-C) monotherapy with clindamycin+aminoglycoside (C+A) in the treatment of serious lower respiratory, intra-abdominal, gynecologic, and urinary tract infections. The...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：
更新日期：1992-01-01 00:00:00
abstract：BACKGROUND:Terazosin is an alpha1-selective adrenoceptor blocking agent that has been reported in many clinical trials to be an effective choice for the treatment of benign prostatic hyperplasia (BPH). To improve cost-effectiveness, the development of an effective and well-tolerated generic formulation is needed. OBJE...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2007.04.013
更新日期：2007-04-01 00:00:00
abstract：:The in vitro activity of Ro 09-1428, a new parenteral cephalosporin, was compared with that of other beta-lactams and aminoglycosides in 1230 clinical isolates from 1028 consecutive patients. Using an agar dilution method, the drugs were tested against 625 isolates of Enterobacteriaceae, 68 Pseudomonas aeruginosa, 36 ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1992-07-01 00:00:00
abstract：BACKGROUND:In the United States, patients with high-risk stage II or III melanoma are often treated with adjuvant interferon (IFN) therapy for 1 year after surgery. Adverse events associated with IFN alfa-2b use are primarily constitutional symptoms. However, hypertriglyceridemia requiring treatment has been reported. ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2005.12.002
更新日期：2005-12-01 00:00:00
abstract：:Flecainide, a new antiarrhythmic agent, was given to eight healthy men to ascertain plasma drug levels and to assess tolerance for the drug. Each subject received a single intravenous (IV) dose (0.5, 1, 1.5, or 2 mg/kg) of flecainide, and plasma levels of unchanged flecainide were measured by gas-liquid chromatography...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1984-01-01 00:00:00
abstract：:Two groups of patients with idiopathic Parkinson's disease underwent quantified electroencephalography (EEGq) using fast Fourier transfer to assess the effects of treatment with citicholine. Evidence of cortical cognitive impairment was seen in one group but not in the other. Certain parameters were established which ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1992-09-01 00:00:00
abstract：:The field of rheumatology has made major contributions to medicine through the identification of cellular and molecular targets and with the development of therapies for the treatment of an impressive range of immune-mediated rheumatic diseases. In recent years new milestones have been achieved. These include the reco...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2019.04.014
更新日期：2019-07-01 00:00:00
abstract：BACKGROUND:High incidences of cardiovascular events coincide with a surge in blood pressure (BP) that occurs in the early morning hours at the time of arousal. Thus, control of BP at this time of day, using oral fixed-dose combinations (FDCs) as required, is important in reducing cardiovascular risk in hypertensive pat...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析
doi：10.1016/j.clinthera.2005.11.014
更新日期：2005-11-01 00:00:00
abstract：:Despite the fact that reflux esophagitis is a multifactorial disease, inhibition of gastric acid secretion is the mainstay of medical treatment, both for moderate and severe cases. Antisecretory agents lower the acidity of the refluxate, thus decreasing its aggressive effect, which favors the mucosal healing process. ...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：
更新日期：1993-01-01 00:00:00
abstract：:The effects of treatment with epalrestat, an aldose reductase inhibitor, on peripheral neuropathy were studied in 45 patients with non-insulin-dependent diabetes mellitus (NIDDM). Epalrestat 150 mg three times daily was given for 24 weeks. Subjective symptoms, such as spontaneous pain in the lower extremities and numb...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/0149-2918(95)80111-1
更新日期：1995-05-01 00:00:00
abstract：:In a double-blind study, 59 patients with chronic erosive gastritis received 50 mg of pirenzepine twice daily and 55 patients received 400 mg of cimetidine twice daily for six weeks. In both groups, days of pain, of heartburn, and of nausea per week were significantly reduced during treatment (P less than 0.01). After...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1989-11-01 00:00:00
abstract：:A total of 128 corticosteroid-independent adults with chronic allergic asthma were treated for six weeks with 400 micrograms/day of beclomethasone dipropionate aerosol. Most patients (114 or 89%) had a good to excellent response, characterized by a marked improvement in the signs and symptoms of asthma. Substantial im...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：PURPOSE:We conducted a retrospective cohort study to compare medication use patterns of a long-acting extended-release methylphenidate (Osmotic Release Oral System [OROS(®)] methylphenidate, CONCERTA(®)) and Teva-methylphenidate (methylphenidate ER-C), a generic drug determined by the Canadian regulatory authority, Hea...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2016.07.001
更新日期：2016-08-01 00:00:00
abstract：BACKGROUND:Postoperative emetic symptoms (nausea, retching, and vomiting) are common following total joint replacement, with an incidence as high as 83% when no prophylactic antiemetic is provided. However, most antiemetics currently used in Japan, such as antihistamines (eg, hydroxyzine), butyrophenones (eg, droperido...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验,收录出版
doi：10.1016/j.clinthera.2005.05.011
更新日期：2005-06-01 00:00:00
abstract：BACKGROUND:In patients with type 2 diabetes, published data suggest that glycemic control can be achieved as effectively with an inhaled insulin regimen (preprandial inhaled intrapulmonary insulin plus a single bedtime Ultralente injection) as with a conventional subcutaneous insulin regimen involving 2 to 3 injections...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0149-2918(02)85131-1
更新日期：2002-04-01 00:00:00
abstract：BACKGROUND:Dementia is a cerebral disorder resulting in a progressive deterioration of intellectual function that compromises the patient's ability to function. The diagnostic criteria for dementia are primarily clinical and are based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. The Hac...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/S0149-2918(00)80056-9
更新日期：2000-07-01 00:00:00
abstract：:Macrolide and beta-lactam antimicrobial agents are frequently used for the treatment of upper and lower respiratory tract infections and skin or skin structure infections. To evaluate the relative in vitro activity of these antimicrobial drugs against organisms commonly involved in these infections, we tested clarithr...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1993-01-01 00:00:00
abstract：OBJECTIVES:This study evaluated adherence to anti-inflammatory controller medication for asthma in a French population. METHODS:This was an observational cohort study that employed data from the health insurance database for the Aquitaine region of France. Eligible subjects were aged between 15 and 45 years and had > ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2008.06.011
更新日期：2008-01-01 00:00:00
abstract：:The efficacy and safety of transferring 76 patients with poorly controlled type II diabetes mellitus from various self-mixed human insulin regimens to a premixed insulin regimen (Novolin 70/30, 70% NPH and 30% Regular insulin, semisynthetic) were evaluated in a 24-week, multicenter, open-label study. During the initia...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究
doi：
更新日期：1994-01-01 00:00:00
abstract：BACKGROUND:The role of folate in pregnancy is well established, with most prenatal vitamins (PNVs) on the market containing at least 800 μg of folic acid. Folic acid must be converted in the body to L-methylfolate, the natural and biologically active form of folate. The role of vitamin B(12) in pregnancy is less charac...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究
doi：10.1016/j.clinthera.2011.02.010
更新日期：2011-02-01 00:00:00
