A Nationwide Drug Surveillance Network

2018 ◽  
pp. 171-189
Author(s):  
Thaddeus H. Grasela
Keyword(s):  
Drug Surveillance ◽  
Surveillance Network

A Clinical Pharmacy-Oriented Drug Surveillance Network: Results of a Nationwide Antibiotic Utilization Review of Bacterial Pneumonia–1987

DICP ◽  
1989 ◽  
Vol 23 (2) ◽  
pp. 162-170
Author(s):  
Thaddeus H. Grasela ◽  
Jerome J. Schentag ◽  
Steven J. Boekenoogen ◽  
Kenneth D. Crist ◽  
William L. Lowes ◽  
...  
Keyword(s):  
Bacterial Pneumonia ◽  
Prescribing Patterns ◽  
Oral Drug ◽  
Utilization Review ◽  
Antibiotic Prescribing ◽  
Drug Surveillance ◽  
Surveillance Network ◽  
Gram Negative ◽  
Days Of Therapy ◽  
Culture Positive

One hundred eighteen pharmacists enrolled in the Drug Surveillance Network completed a survey of antibiotic prescribing patterns for bacterial infections. A total of 319 hospitalized patients being treated for suspected or documented bacterial pneumonia were monitored, and this paper summarizes the data collected on this specific subpopulation. Two hundred three patients (64 percent) were treated for community-acquired pneumonia and 116 patients (36 percent) were treated for nosocomial pneumonia. Seventy-three percent of the nosocomial pneumonias were culture-positive, with a gram-negative microorganism as the predominant isolate. Forty-eight percent of the community-acquired pneumonias were culture-positive with a mixture of gram-positive and gram-negative organisms. Fifty percent of patients were treated with a single agent, 33 percent with two antibiotics, and the remaining 17 percent with a combination of three or more antibiotics. A satisfactory response was noted for 62 and 76 percent of the patients with nosocomial and community-acquired pneumonias, respectively. Twenty percent of the pneumonia patients were switched to oral drug after an average of five days of therapy and discharged from the hospital. Twenty-five adverse events that were possibly or probably related to the antibiotic regimen were reported in 23 of the 350 patients for an overall incidence of 6.5 percent. The results of this survey provide a cross-sectional view of antibiotic prescribing patterns for the treatment of bacterial pneumonia and the outcome of therapy under actual clinical conditions of use.

A Nationwide Investigation of a Possible Protamine Drug-Product Defect

1992 ◽  
Vol 26 (5) ◽  
pp. 643-644 ◽  
Author(s):  
Carlos R. Herrera ◽  
Thaddeus H. Grasela ◽  
Cynthia A. Walawander
Keyword(s):  
Coronary Artery ◽  
Adverse Events ◽  
Coronary Artery Bypass ◽  
Response Rate ◽  
Artery Bypass ◽  
Drug Surveillance ◽  
Surveillance Network ◽  
Serious Adverse Events ◽  
Telephone Interviews

OBJECTIVE: To follow-up a report submitted to FDA Spontaneous Reporting System, we investigated the hypothesis that there was not a striking increase in unexpected deaths within four hours after elective coronary artery bypass surgery associated with protamine sulfate use. DESIGN: Surveys were mailed to clinical pharmacists at 521 hospitals participating in the Drug Surveillance Network. Questionnaires were to be completed with the assistance of cardiac surgeons and anesthesiologists. Hospitals responding with a suspected problem with protamine were contacted via telephone. RESULTS: Surveys were received from clinical pharmacists at 380 hospitals (73 percent response rate) and 29 hospitals reported the occurrence of potential problems associated with protamine during coronary artery bypass graft surgery. Telephone interviews of the positive responders yielded six cases of possible myocardial decomposition potentially associated with protamine. There was no association with a specific distributor, however, and none of the hospitals reported a dramatic increase in serious adverse events around the time of index cases. CONCLUSIONS: There was no evidence of a widespread public health problem with protamine and a product recall was not necessary. The high response rate and the ability to follow-up with telephone interviews suggests that the Drug Surveillance Network is an effective mechanism for investigating possible outbreaks of serious adverse events in the hospital setting.

A Clinical Pharmacy-Oriented Drug Surveillance Network: II. Results of a Pilot Project

1987 ◽  
Vol 21 (11) ◽  
pp. 909-914 ◽  
Author(s):  
Thaddeus H. Grasela ◽  
Blake A. Edwards ◽  
Marsha A. Raebel ◽  
Thomas S. Sisca ◽  
Barbara J. Zarowitz ◽  
...  
Keyword(s):  
Antimicrobial Agents ◽  
Clinical Care ◽  
Pilot Project ◽  
Drug Surveillance ◽  
Drug Experience ◽  
Surveillance Network ◽  
Cross Sectional ◽  
Clinical Pharmacists ◽  
Link Information ◽  
Promising Source

A nationwide network of clinical pharmacists has been organized for the purpose of collecting drug experience data generated during the routine clinical care of patients. In order to assess the utility of this network a pilot project was performed to obtain a cross-sectional view of antibiotic utilization in the U.S. and to identify potential problems with a more widespread implementation of this program. One hundred eleven pharmacists enrolled in the drug surveillance network participated in this survey and collected information on more than 2000 patients treated with antimicrobial agents over approximately a three-month period (February-April 1987). The most common sites of infection were the lung, genitourinary tract, skin and soft tissue, and the abdomen, and accounted for approximately 75 percent of infections. Overall, the aminoglycosides, the first-generation cephalosporins, and the aminopenicillins remain the most commonly used antibiotics and represent approximately 50 percent of antimicrobials used in the surveyed population. The results of this pilot project suggest that the use of a nationwide network of clinical pharmacists is a promising source of clinically relevant drug experience data. The ability to concurrently evaluate patients and link information regarding patient demographics, drug therapy regimens, diagnosis, and clinical outcomes fills an important gap in our knowledge of clinical drug utilization.

Food Safety Security: A new Concept for Enhancing Food Safety Measures

2012 ◽  
Vol 82 (3) ◽  
pp. 216-222 ◽  
Author(s):  
Venkatesh Iyengar ◽  
Ibrahim Elmadfa
Keyword(s):  
Food Safety ◽  
Hazard Analysis ◽  
Warning System ◽  
Shared Responsibility ◽  
Fine Tuning ◽  
Strategic Action ◽  
Surveillance Network ◽  
Measurement Systems ◽  
Critical Control Points ◽  
The Impact

The food safety security (FSS) concept is perceived as an early warning system for minimizing food safety (FS) breaches, and it functions in conjunction with existing FS measures. Essentially, the function of FS and FSS measures can be visualized in two parts: (i) the FS preventive measures as actions taken at the stem level, and (ii) the FSS interventions as actions taken at the root level, to enhance the impact of the implemented safety steps. In practice, along with FS, FSS also draws its support from (i) legislative directives and regulatory measures for enforcing verifiable, timely, and effective compliance; (ii) measurement systems in place for sustained quality assurance; and (iii) shared responsibility to ensure cohesion among all the stakeholders namely, policy makers, regulators, food producers, processors and distributors, and consumers. However, the functional framework of FSS differs from that of FS by way of: (i) retooling the vulnerable segments of the preventive features of existing FS measures; (ii) fine-tuning response systems to efficiently preempt the FS breaches; (iii) building a long-term nutrient and toxicant surveillance network based on validated measurement systems functioning in real time; (iv) focusing on crisp, clear, and correct communication that resonates among all the stakeholders; and (v) developing inter-disciplinary human resources to meet ever-increasing FS challenges. Important determinants of FSS include: (i) strengthening international dialogue for refining regulatory reforms and addressing emerging risks; (ii) developing innovative and strategic action points for intervention {in addition to Hazard Analysis and Critical Control Points (HACCP) procedures]; and (iii) introducing additional science-based tools such as metrology-based measurement systems.

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