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Biomedical subjects

W N Kelly

Publications and source records attributed to W N Kelly.

At least 19 recordsLinked to original sources

Potential risks and prevention, Part 3: Drug-induced threats to life.

Potential risk factors for and the preventability of drug-induced threats to life were studied. Case reports of adverse drug events (ADEs) published in Clin-Alert during 1977-97 were the source of information on drug-induced life threats. Patient, drug, and event variables were identified, and the causality, predictability, and preventability of each case were assessed. Data were entered into a relational database for analysis. The data indicated 846 drug-induced life threats. Seventy-four percent of the cases were assessed as definite or probable. Patients received usual or below-usual dosages in 89% of the cases. Patients tended to be middle-aged and only moderately ill. The drug categories most frequently associated with life threats were antimicrobials and central-nervous-system agents. Plasma drug level monitoring should have been performed in 127 cases but occurred only in 31 cases (24%). Event types were distributed as adverse drug reactions (50%), allergic reactions (35%), drug interactions (11%), and medication errors (4%). A commercial reference classified almost half of the drug interactions associated with a life threat as posing minimal or no potential risk to the patient. Half of the life-threatening events were judged to have been preventable; about half of these could have been prevented by a pharmacist. Litigation was reported for only 1% of the cases of drug-induced threats to life; judgments and settlements averaged $1.2 million. A review of published case reports of ADEs for 1977-97 yielded information on possible risk factors for drug-induced life threats and on which events may have been preventable.

Adverse Drug Reaction Reporting Systems↗

Potential risks and prevention, Part 4: Reports of significant adverse drug events.

A summary analysis of three descriptive studies of significant adverse drug events (ADEs) was conducted. Case reports of ADEs published in Clin-Alert during 1976-97 were the source of information on ADEs, including drug-induced deaths, disabilities, and threats to life. The results of the three studies were compared, and recommendations were made. During the 21-year period, 1520 significant ADEs were reported (29% resulting in death, 15% in permanent disability, and 56% in life threats). Event types were distributed as adverse drug reactions (52%), allergic drug reactions (25%), medication errors (15%), and drug interactions (8%). Only 12% of the drug interactions were classified as having highest significance by one drug information reference, while 32% of the drug interactions were unclassified. Typically, patients were 40-69 years old and relatively healthy or only moderately ill and had received usual dosages. However, 29% of the patients with a drug-induced permanent disability were less than 10 years old. Only 17% of the drugs that could have been monitored by blood level tests were so monitored. The drug categories most commonly involved in ADEs were central-nervous-system agents, antimicrobials, antineoplastics, and cardiovascular agents. The nervous, hematopoietic, cardiovascular, and respiratory systems were affected the most. Faulty prescribing was the most common reason for medication error, and wrong dosage was the most common type of error. A lawsuit was reported in 13% of the cases. Overall, 52% of the cases were judged to have been preventable; of these, 50% could have been prevented by a pharmacist. Litigation was reported for 13% of the cases; settlements and judgments averaged $3.1 million. A summary analysis of more than 1500 published case reports of ADEs for 1976-97 yielded information on possible risk factors for drug-related deaths, disabilities, and life threats and on which events may have been preventable.

Adverse Drug Reaction Reporting Systems↗

Potential risks and prevention, Part 1: Fatal adverse drug events.

Potential risk factors for and the preventability of fatal adverse drug events (ADEs) were studied. Case reports of ADEs published in Clin-Alert during 1976-95 were the source of information on fatal ADEs, Patient, drug, and event variables were identified, and the causality, predictability, and preventability of each case were assessed. Data were entered into a relational database for analysis. The data indicated 447 cases involving a fatal ADE. Ten percent of the fatal ADEs were assessed as definite, 46% as probable, and 44% as possible. Fatal-ADE frequency increased with age. Forty-five percent of the patients were 40-69 years of age, and 40% were healthy. Central-nervous-system agents, antineoplastics, antimicrobials, and cardiovascular agents accounted for 69% of the deaths. Only 33% of patients received more than the usual dosage. Many of the suspected drugs could have been monitored with blood level tests but were not, and baseline testing of critical blood count and liver and renal function was often not performed. The most common causes of death were hepatitis, hepatic failure, cardiopulmonary arrest, overdose, and agranulocytosis. ADE types were distributed as adverse drug reactions (58%), allergic reactions (19%), medication errors (17%), and drug interactions (6%). Sixty-eight percent of the fatal ADEs were judged to have been preventable; of these, a pharmacist could have prevented 57%. Litigation was reported for 14% of the fatal-ADE cases; judgments and settlements averaged $1.1 million. A review of published case reports of ADEs for 1976-95 yielded information on possible risk factors for fatal ADEs and on which events may have been preventable.

Adverse Drug Reaction Reporting Systems↗

Potential risks and prevention, Part 2: Drug-induced permanent disabilities.

Potential risk factors for and the preventability of drug-induced permanent disabilities were studied. Case reports of adverse drug events (ADEs) published in Clin-Alert during 1978-97 were the source of information on drug-induced permanent disabilities. Patient, drug, and event variables were identified, and the causality, predictability, and preventability of each case were assessed. Data were entered into a relational database for analysis. The data indicated 227 cases of drug-induced permanent disabilities. Twenty-three percent of the cases were assessed as definite, 47% as probable, and 30% as possible. Twenty-nine percent of the patients were less than 10 years old, and 36% were considered healthy. The drug categories most commonly associated with a drug-induced permanent disability were antimicrobials, vaccines, central-nervous-system agents, and antineoplastics. About half of the patients received more than the usual dosage. The most common permanent disabilities were brain damage, blindness, tardive dyskinesia, deafness, quadriplegia, and hearing loss. Event types were distributed as medication errors (55%), adverse drug reactions (43%), and drug interactions (2%). Eighty-four percent of the drug-induced permanent disabilities were judged to have been preventable; of these, a pharmacist could have prevented 40%. Litigation was reported for 56% of the cases of drug-induced permanent disability; judgments and settlements averaged $4.3 million. A review of published case reports of ADEs for 1978-97 yielded information on possible risk factors for drug-induced permanent disabilities and on which events may have been preventable.

Adverse Drug Reaction Reporting Systems↗

Can the frequency and risks of fatal adverse drug events be determined?

Death is the ultimate adverse drug event. Despite its importance, the frequency of fatal adverse drug events is unknown. Estimates in the United States are as high as 140,000/year, although this number is heavily disputed. Potential reasons and risks for fatal adverse drug events, as well as epidemiologic designs for studying this important public health issue, are discussed and issues are raised to promote further thought.

Adverse Drug Reaction Reporting Systems↗

Calcium-channel blocker withdrawal in a pregnant woman.

We present a case report of a woman for whom a topical mucosal ulcer drug was prescribed and the pharmacist erroneously dispensed a calcium channel blocker (CCB), resulting in toxicities from the drug and withdrawal symptoms when attempts were made to stop the CCB. The pharmacology and toxicology of CCBs are discussed, particularly in relation to the adverse experiences of the case.

Adult↗

Target drug monitoring: a cost-effective service provided by staff pharmacists.

A concurrent drug use evaluation program that improves patient care while meeting JCAHO requirements was designed and implemented. Integration of staff pharmacists into the program has been an important component. The net annual savings of the program for H2 antagonists and cephalosporins was $16,756. The net annual cost of the program if all drugs were studied throughout each quarter would be $1,336. The program essentially pays for itself, meets medication use standards for JCAHO, and may save significant healthcare costs if potential drug misadventures are avoided.

Concurrent Review↗

National survey of ethical issues presented to drug information centers.

Whether and how drug information centers respond to calls from the public that involve ethical issues was studied. A survey describing six ethical dilemmas typical of those presented by calls from the public was mailed to pharmacists in 154 drug information centers to see how the questions would be handled. Centers that had written policies governing responses to questions with ethical implications were asked to submit those policies. One hundred twenty-six centers (82%) responded to the survey; of these, 81 (64.3%) answered questions from the public. There were no significant differences in characteristics between centers that did and did not respond to public calls. The case analyses, completed only by pharmacists in centers that responded to public calls, covered such issues as invasion of privacy, social responsibility, personal liability, and interference with the patient-physician relationship. Respondents exercised a wide degree of discretion in determining if they would answer a question; for example, while only 4% would not answer a question concerning the efficacy of a weight-loss diet patch, 77% reported they would not respond to a caller asking for information on drugs that could interfere with the results of a polygraph test. Although respondents often cited institutional policy as the reason for failing to respond to a question, none submitted a copy of such a policy. The pharmacists' responses indicated a high degree of moral and social sensitivity; nonetheless, written policies should be developed to assist drug information center staff members in handling questions that have ethical implications.

Adrenergic beta-Antagonists↗

Clinical career ladders: Hamot Medical Center.

The clinical career ladder program for pharmacists at Hamot Medical Center (HMC), a 500-bed not-for-profit community teaching hospital, is described. Between 1980 and 1989 a career ladder at HMC evolved from an idea to an established program with parallel administrative, business, and clinical tracks. The development of the career ladder mirrored the growth of clinical programs and the diversification of pharmaceutical services. A formal plan for a clinical ladder was developed when the first satellite pharmacy opened in 1984. An entry-level pharmacist at HMC starts with a six-month period during which he or she learns the drug distribution system and prepares for several certification tests. The employee is then promoted to staff pharmacist. Staff pharmacists are promoted to clinical pharmacist II (CP II) upon meeting requirements for competence in a broad range of clinical skills and knowledge. Candidates for the position of clinical pharmacist specialist (CP I) must have either a minimum of three years of experience as a CP II or a Pharm.D. degree and have established an area of clinical expertise. A CP I can progress to assistant and associate director positions as vacancies occur. The clinical ladder has enhanced job satisfaction and encouraged the development of clinical practitioners who provide improved care. Problems have included time constraints, competition for positions, and management of incentives. A parallel career ladder program with a clinical track has enhanced the growth of pharmacy practice at HMC and improved the quality of pharmaceutical care.

Career Mobility↗

A financial evaluation of the Becton Dickinson 360 infuser system.

The cost effectiveness of a new syringe infuser system for intermittent delivery of drugs was compared to current methods (69% minibags, 30% frozen commercially available minibags, and 1% premixed minibags) of delivery. All costs including labor, equipment, raw drug, labeling, supplies, and wasted drug were compared. Personnel costs were calculated using time and motion studies performed by a third party. There were minimal problems associated with using the new infuser system, all of which were corrected as the system was implemented. Eighty-two percent (82%) of intermittent drugs (remaining was 17.4% minibags; 0.6% pre-mix) could be converted to this system. Initially, more time was associated with preparing syringes versus minibags, but after a short learning curve, time differences were insignificant. The time to prepare commercially available pre-mixed i.v.'s and frozen minibags (retrieve and label) was 1.02 minutes compared to 1.61 minutes to prepare a traditional minibag and 1.62 minutes to prepare a syringe. There was a $0.98 savings/dose preparing 82% of our intermittent doses in syringes versus our current system. This extrapolated to an annual savings after the first year of $74,230, which was 28.0% of our i.v. admixture system costs. The BD 360 Infuser System is a significant cost savings device for intermittent drug delivery.

Cost-Benefit Analysis↗

Cost analysis of a satellite pharmacy.

The cost-effectiveness of a satellite pharmacy that serves 100 beds in a 550-bed community teaching institution was determined. On one day six months before and one day six months after the satellite pharmacy was implemented, 30 patients were randomly selected for study from the 50-bed surgical-trauma unit and the 50-bed medical oncology unit served by the satellite. Data for the cost analysis were collected from the medical charts of these 60 patients; each patient's entire hospital stay was used for all calculations. Data collected included costs per patient day for drugs, i.v. therapy, and laboratory tests; total hospital costs per patient day; number of doses per patient day; and length of hospital stay. There were no significant differences in patient age or sex, length of hospital stay, or patient mix among patients studied before and after the satellite pharmacy was implemented. The cost per patient day for drugs was significantly less after the satellite pharmacy was implemented. A cost analysis based on this decrease in drug costs per patient day of $5.77 showed that an annual savings of $134,927 could be realized as a result of satellite pharmacy implementation. Implementation of a pharmacy satellite proved to be cost-effective, largely because of decreased drug costs.

Cost-Benefit Analysis↗

Strategic planning for clinical services: Hamot Medical Center.

As a result of a two-day strategic-planning program, a hospital pharmacy department developed a five-year plan for addressing seven critical issues facing the department. The pharmacy department at a large nonprofit community hospital began a formal planning process in 1981 after concluding that the existing clinical services had been implemented in a haphazard fashion and had mixed results. The planning process began with a two-day planning program aimed at identifying issues facing the department, followed by the development of consensus about the most important issues and the development of action plans for dealing with these. The planning program consisted of four parts: presentations by hospital administrators, nurses, and the medical staff on future directions in their respective areas and pharmacy's potential input; presentations on the future of pharmacy from the perspectives of the pharmacy director and the responsible hospital administrator; preliminary recommendations related to drug distribution services and clinical services by two pharmacy consultants; and discussions of departmental management issues and key points identified in previous sessions. The department's progress in addressing each of the seven critical issues is described; most of the action plan has been completed. The consensus-building planning process allowed the department to focus on the most important issues, identify support and possible conflicts from others, and obtain administrative approval of the department's focus on patient-oriented services.

Cost-Benefit Analysis↗