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REVIEW ARTICLE |
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Year : 2008 | Volume
: 52
| Issue : 4 | Page : 373 |
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Pharmacovigilance in Intensive Care Unit - An Overview
Bimla Sharma1, Abhijit Bhattacharya2, Ranju Gandhi3, Jayshree Sood4, BK Rao5
1 Senior Consultant, Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India 2 Professor & Ex Senior Consultant, Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India 3 Clinical Assistant, Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India 4 Senior Consultant and Chairperson, Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India 5 Senior Consultant and Chairperson, Department of Critical Care Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India
Date of Acceptance | 14-Mar-2008 |
Date of Web Publication | 19-Mar-2010 |
Correspondence Address: Bimla Sharma Department of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060 India
 Source of Support: None, Conflict of Interest: None  | Check |

The drug related complications are on the rise warranting special attention towards patient safety in Intensive Care Unit (ICU) setup. Pharmacovigilance is the science about the detection, assessment and prevention of drug related problems. This review is aimed to highlight significant problems arising from medication errors with emphasis on special drugs used in ICU (oxygen, antibiotics, sedatives, analgesics and neuromuscular blocking drugs) and their risk reduction strategies in ICU utilizing practice of pharmacovigilance. Human error, lack of communication among various health providers, inadequate knowledge about drugs, failure to follow protocols or recommended guidelines are important causes of drug related problems in ICU. It is imperative that ICU administrators and medical directors of hospitals consider adverse drug events (ADEs) as system failures. Pharmacovigilance, an observational science is the need of the hour for patients admitted in ICUs. We need to give more emphasis on prevention rather than treating the potentially fatal complications arising from ADEs. Eternal vigilance is the key. Protocol based management, improvement of medication system, frequent audits, improved communication, good team work, a blame free environment, inclusion of a pharmacist, leadership involvement and use of information technology in the ICU are possible solutions. Keywords: Pharmacovigilance, Oxygen, Antimicrobial agents, Sedatives, Analgesics, Neuromuscular blocking agents, Medication errors in ICU.
How to cite this article: Sharma B, Bhattacharya A, Gandhi R, Sood J, Rao B K. Pharmacovigilance in Intensive Care Unit - An Overview. Indian J Anaesth 2008;52:373 |
How to cite this URL: Sharma B, Bhattacharya A, Gandhi R, Sood J, Rao B K. Pharmacovigilance in Intensive Care Unit - An Overview. Indian J Anaesth [serial online] 2008 [cited 2021 Jan 18];52:373. Available from: https://www.ijaweb.org/text.asp?2008/52/4/373/60651 |
Introduction | |  |
Need for Pharmacovigilance in ICU
Intensive Care Units (ICUs) came into existence for patients with special needs and represent a milestone in the development of medicine. [1] The ICU environment is proactive, interventional, complicated, and hostile, making it prone to potential problems. [1] The chances of drug related complications are high here, requiring special attention towards patient safety. Pharmacovigilance, an observational science about drug safety is the study of the drug related injuries. [2] The WHO defines pharmacovigilance (WHO 2002) as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It helps us in warning or withdrawal of offending pharmaceutical product. The scope of pharmacovigilance has since been broadened to cover areas such as medical errors and medical devices.
An adverse event (AE) is an untoward medical occurrence, which may or may not have a causal relationship with the treatment while medication errors, adverse drug events (ADEs) and adverse drug reactions (ADR) are related to the drug use. [3] ADE is defined as an injury resulting from medical intervention related to a drug. [4] It can be ameliorable or nonameliorable. ADEs associated with medication error at any stage are considered preventable. Non-preventable ADEs are those not due to medication errors and are also known as ADRs. The International Conference on Harmonisation defines ADR as any noxious unintended, and undesired effects of a drug, that occur at doses used in humans for prophylaxis, diagnosis, or therapy of disease or for the modification of physiological function. [3] The objective of the practice of pharmacovigilance in ICU is to highlight:
A. Significant problems resulting from medication errors.
B. Various risk reduction strategies and their potential impact on improving the patient outcome.
C. The research in the field of ADEs and medication errors in ICU.
This overview aims to underline the importance of pharmacovigilance in day-to-day practice in ICU set up. The critically ill and/or injured patients frequently need oxygen, antimicrobial agents, sedatives, analgesics and neuromuscular blocking agents (NMBAs). Therefore, emphasis has been given to the problems associated with the sustained use of these drugs in ICUs. The current risk reduction strategies as a part of pharmacovigilance and their potential impact on improving patient outcome in the ICU is also delineated.
Data was obtained from peer-reviewed journals, textbooks, cross references, abstracts, conferences and symposia proceedings, expert informants, journal hand searching and Medline generated reference material (19702007) mainly in the English language. The keywords used for Medline search were pharmacovigilance, oxygen, antimicrobial agents, sedatives, analgesics, neuromuscular blocking agents (NMBAs), medication errors and their risk reduction strategies in ICU.
Magnitude of the problem | |  |
Medical injuries account for 44,000-98,000 deaths per year in the United States and over 7000 of the deaths are attributed to medication errors alone. [5] The data may be reported under various headings such as ADRs, ADEs, medication errors and adverse events (AEs). ADEs account for up to 7.5% of hospital admissions, 28% of all emergency department visits and 5% of hospital deaths. [6],[7],[8] In a comparative study of intensive care and general care units, Cullen et al. reported that the preventable and potential ADEs in ICUs to be nearly twice that of non-ICUs. [9] [Table 1] shows incidence of ADEs in ICUs by various authors. [9],[10],[11],[12],[13],[14],[15],[16]
Epidemiology | |  |
The various factors contributing to ADEs and necessitating the need for pharmacovigilance in an ICU are:
A. Human error | |  |
Human error accounted for two thirds of ICU complications in one study while it was 73% in another study and 92% of these were avoidable. [17],[18] Other studies have concluded that errors are influenced by:
1. Staff characteristics: staff shortages, overwork, distractions, break in the continuity of the care, inexperienced staff, new residents, introduction of new medical techniques. [19],[20]
2. Communication breakdown among health professionals. [21],[22]
3. Errors by doctors: inappropriate indication, dosing and frequency of drug administration; choosing the wrong drug, prescribing incorrect dose and failure to recognize drug allergy in patients. [12],[21],[23]
B. Co-morbidity and age | |  |
The patients most likely to experience ICU complications are at the extremes of age, the sick and patients with two or more organ system failure. [24],[25] Length of stay, gender, altered renal and hepatic functions and drug exposure are other important factors affecting ADEs. [26],[27],[28] Children comprise a special group where the drug dosage has to be calculated on a weight basis and neonates, in particular, have limited room for errors. [29] Fortescue et al reported that medication errors occur at similar rates in paediatric age group as in adults but with thrice the potential to cause harm. [30] The rate of potential ADEs is significantly higher in neonates in the neonatal-ICUs. [30] Elderly patients experience higher incidence of ADEs because they are exposed to a greater number of medications, making them vulnerable to medication errors and drug interactions. The low therapeutic index of certain drugs narrows their safety margin in critically ill patients owing to altered pharmacodynamics and pharmacokinetic secondary to illness which may predispose to drug toxicity. [31]
C. Drugs (number and class) | |  |
The potential for medication-related error increases as the average number of administered drugs increases. [32] Cullen et al, found that although ICU patients had significantly higher rates of potential ADEs than non-ICU patients, after adjusting for the number of administered drugs, the rate was similar in both sectors. [9] Darchy reported that cardiovascular drugs accounted for 31%, anti-inflammatory and analgesics for 20% and antibiotics for 11% of ADRs. [33]
D. Staging of errors in drug administration | |  |
Bates et al reported that preventable drug errors occurred in 28% of cases with physician ordering accounting for 56% and nurse administration for 34% cases. Dispensing (4%) and transcription (6%) errors resulted in a small fraction of preventable errors. [11] In another study, 57.9% of ADEs were avoidable and most of these were associated with inappropriate administration, drug-drug interactions, dosage error, drug not stopped despite the onset of ADEs. [34]
Problems with commonly used drugs in ICU | |  |
Pharmacy accounts for about 10-23% of ICU budget, since ICU patients require more drugs than their non-ICU peers. [35] The drugs most likely to create problems are oxygen, antibiotics, sedatives, analgesics and neuromuscular blocking agents. The implications of using these agents in ICUs are different from those seen in the immediate perioperative period. [36] The specific problems related to the drug are discussed with the drug itself, followed by discussion on the general preventive measures.
A. Oxygen | |  |
Oxygen is considered to be the commonest drug used in the ICU. There are indications, contraindications and certain guidelines for rational use of inhaled oxygen therapy. The efficacy of the inspired oxygen should be monitored to avoid its toxicity. [37] When oxygen is delivered to the airway in concentrations exceeding the usual 21%, the lung is the first organ to be exposed to it. When breathed in excess of 50-60% or for prolonged periods, secondary physiological changes and toxic effects can occur. There are only a few prospective studies detailing this problem in ICU patients. [38],[39]
Pulmonary oxygen toxicity can present as absorption atelectasis, tracheobronchitis, bronchopulmonary dysplasia, and acute respiratory distress syndrome (ARDS). The earliest adverse changes in pulmonary function or structure are; reduced oxygen-dependent respiratory drive (within minutes), substernal discomfort from acute tracheobronchitis (up to four hours) secondary to breathing pure oxygen and decreased tracheal mucus velocity from consequent loss of ciliated epithelium. Moreover, an oxygen rich environment is a fire hazard. Extra pulmonary targets for O 2 toxicity include:
Retina. Angiogenesis leading to reatrolental fibroplasia occurs when a newborn is exposed to increased oxygen tension. Latest Cochrane Reviews do not provide strong evidence for either the benefits or harms of early oxygen weaning in preterm/ low birth weight infants. [40] Future research and studies should be directed toward addressing the question of defining the most appropriate target levels of oxygenation in this particular clinical setting.
Central nervous system: Hyperbaric oxygen therapy where pressure exceeds 200 kPa (2 atm) can result in CNS toxicity. Symptoms are seizures and visual changes, which resolve when oxygen tension returns to normal values.
B. Antimicrobial Agents | |  |
Majority of patients in ICU receive one or a combination of antimicrobial agents either empirically or based on evidence. The treating clinician should send cultures of blood and other body fluids before starting the drug therapy based on a presumptive bacteriological diagnosis. However, any empirical treatment has to be reevaluated after 48-72 hours. [41] Excessive use, misuse, inappropriate therapy and the development of resistance with antibiotics are global problems and add to the economic burden on health care system. Complying with current WHO or Centers for Disease Control and Prevention (CDC) Hand Hygiene Guidelines are important tools to tackle the problems with antimicrobial agents in an ICU. [42]
1. Misuse and Excessive use | |  |
Inadequate treatment of nosocomial infections is associated with empiric use of certain antibiotics. [43] The other end of the spectrum is an overzealous and inappropriate use of antimicrobials. Certain non-pharmacological factors including cultural and economic factors take the upper hand in dictating the antibiotic use. [44] According to the WHO report (2000) on infectious diseases, practicing physicians are the main culprits as the widespread use of antibiotics is of the major determinants in the shift toward resistant strains.
2. Antimicrobial resistance | |  |
Antimicrobial resistance is several folds higher in ICU patients and the incidence of nosocomial infections is high (25 to 33%) here. [41] However, resistance patterns vary widely among institutions, and make empirical choice of antibiotics increasingly problematic. Active surveillance programs, aggressive invasive diagnostic techniques, use of agents in combination, antimicrobial cycling, follow up of practice guidelines and evaluation of the effectiveness of the practiced polices are some of the recommended measures for prevention of antibiotic resistance. [41],[45],[46],[47] The use of information technology can result in major reductions in the rate of complications associated with antibiotics, and can decrease costs and the rate of nosocomial infections. [47]
C. Sedatives and Analgesics | |  |
Anxiety, delirium, agitation and pain are common in ICU. Sun et al reported that in the surgical ICU, roughly 97% intubated patients and 92% nonintubated patients need analgesia and 87% patients are sedated with a benzodiazepine. [48] About 50% of seriously ill medical patients report pain. [49]
Benzodiazepines, praopofol, opioids, dexmedetomidine, barbiturates, butyrophenones, clonidine, haloperidol and isoflurane have been utilized for sedation in ICU. Opioids like morphine and fentanyl and nonsteroidal anti-inflammatory drugs (NSAIDs) with opioid sparing actions are the commonly used drugs for acute pain. Sedatives and narcotics may precipitate cardiovascular instability and respiratory depression. Benzodiazepines should be administered intermittently rather than by continuous infusion as there is risk of accumulation and prolonged sedation with infusions. [50]
Continual monitoring of the respiratory rate and pattern may improve patient safety in those receiving neuraxial/ intravenous opiates. Gastrointestinal hypomotility, masking of signs and symptoms of head injury, central depression, suppression of adrenal cortical axis, post paralysis myopathy, neuropathy in mechanically ventilated patients are other undesirable effects seen with opioids. [51] Progressive metabolic acidosis, rhabdomyolysis, hyperlipidemia, hepatomegaly, bradyarrhythmia, and unresponsive myocardial failure has been reported in children and adult head-injured patients receiving propofol infusion. [52],[53] Propofol is not approved for continuous sedation of paediatric patients in the ICU. Dexmedetomidine, alpha 2 adrenergic agonist in a dose of 0.2 - 0.7 mg kg -1 hr -1 causes less respiratory depression than opioids. Infusions lasting more than 24 hours are not recommended to prevent rebound hypertension. NSAIDs inhibit platelet aggregation, prolong bleeding time and may lead to renal toxicity or gastrointestinal tract ulceration with bleeding and perforation with long-term administration. Induction of hepatic enzymes, drug interactions, and negative immunologic effects have also been reported. [54] Antipsychotic agents like droperidol have unique deleterious effects such as tardive dyskinesias or the neuroleptic malignant syndrome. [55]
Excessive sedation can lead to venous stasis, pressure ulceration, aspiration pneumonia, delayed weaning from ventilator and increased ICU stay and cost. [50],[56] The effects of sedative and analgesic drugs must be measured using a pharmacodynamic end point such as sedation score. The Joint Task Force of the American College of the Critical Care Medicine along with the American Society of Health -System Pharmacists clinical practice guidelines (2002) for the optimal use of sedative and analgesics recommend use of Numerical rating scale or the Visual analogue scale to asses pain and response to analgesia in the ICU. [36] Ramsay scale, Riker sedation-agitation scale, Bispectral Index Sedation Score (BIS, Aspect Medical Systems, Newton, Mass) and bispectral analysis have also been used in ICU. [57],[58],[59] Delirium, an incredibly common problem in 50% to 80% of ventilated, severely ill patients and 20% to 50% of other ICU patients has multifactorial etiology which should be recognized and treated. [60],[61]
D. Neuromuscular Blocking Agents (NMBAs) | |  |
NMBAs in the ICU are used to facilitate intubation, reduce oxygen consumption, control harmful muscle activity in conjunction with sedation, permitting mechanical ventilation in patients undergoing permissive hypercapnia. [62] The use of neuromuscular monitoring to monitor the effect of NMBAs is desirable and may prevent the delivery of excessive drug dosages and may avoid long-term problems such as prolonged weakness or myopathies, polyneuropathy and drug interactions. [63],[64] Majority of adverse effects have been associated with the use of steroidal muscle relaxants (vecuronium, pancuronium) but the benzylisoquinolinium muscle relaxant, atracurium, has also been implicated. Awareness, unrecognized extubation, decubitus ulcers, nerve injury, corneal abrasions, venous stasis and venous thrombi are the other common problems seen with the use of NMBAs. The signs of cardiac ischemia, seizures, CNS abnormalities and abdominal pathologies may go unrecognized in patients receiving NMBAs. The Joint Task Force (2002) clinical practice guidelines for the use of NMBAs in ICU recommend that the patients must receive sedation and analgesia before the institution of NMBAs. [65]
Risk reduction strategies and possible solutions | |  |
Pharmacovigilance by preventing errors, enhances the quality of care in ICU patients. Improvement of the accuracy of patient identification, the effectiveness of communication among caregivers, the safety of using medications and reduction of the risk of health careassociated infections are some of the several approved goals of the Year 2008 National Patient Safety Goals by the Joint Commission's Board of Commissioners. [42]
Epidemiologic approach | |  |
Rigorous epidemiological approach to identify and prevent the problems by reactive as well as proactive means may be one of the best risk reduction strategies. Proactive methods like failure mode and effect analysis (FMEA) anticipate and preemptively implement changes to prevent errors. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) adopted a new leadership standard in 2001 that requires department heads in health care organizations to perform at least one FMEA every year. [66] Reactive or retrospective error analysis begins with the recognition of a serious, avoidable adverse event that has occurred and may happen again. Causes of a specific error of interest and preventive strategies can be identified after the fact by the process of root cause analysis.
A. Identification of the problem | |  |
A vital step which can be implented by passive and active surveillance and audits.
1. Passive surveillance | |  |
Self-reporting by health professionals especially about incidents in inpatient settings is very useful. [11] However, the fear of punitive actions or the medico legal concerns are deterrents to self-reporting of the true incidence of the problem. Harris et al recently reported a voluntary anonymous card-based event reporting system among healthcare workers across ICUs increased reporting significantly compared with pre-intervention web-based reporting. [67] Knowledge discovery in databases along with use of data mining techniques are more likely to detect signals earlier than the current methods. [68]
2. Active surveillance | |  |
This can be done by reviewing medical records, bedside charts or interviewing patients and/ or physicians in a sample of sentinel sites. Direct observation approach can detect a large number of medication errors and is highly reliable for in the inpatient and longterm care settings. Computerized monitoring using triggers by automatic detection of abnormal laboratory values from computerized laboratory reports and drug event monitoring provide an efficient active surveillance system. Simpson et al have developed a checklist of care issues that must be addressed daily for every patient in the intensive care unit to deter from omission and mistakes. [69]
3. Frequent audits | |  |
Audit and retrospective analysis are simple ways to estimate the frequency and cost of ADEs. Morimoto et al have devised methods to collect incidents. [70] In one study, real time safety audits performed in ICU during routine work could detect a broad range of errors leading to rapid changes in policy and practice. [71]
Following detection, subsequent classification should be done to find out the type and severity of errors to help in preventability and improvement of patient safety. Regulatory authorities such as the FDA and the WHO maintain databases of adverse events and evaluate them for new safety signals. The problems of screening have been highlighted by Sanzaro and Mills. [72] Statistics have been used to address the problem of inter observer variability and a kappa score of 0.8 is considered near ideal. Despite the poor predictive value, the ICD-9 coding of medication errors and ADEs including drug and laboratory data may also be used. [73]
B. Human factor engineering approach and non technical skills | |  |
An adverse event becomes an opportunity for improvement once it is recognized that a significant problem exists and needs remedial measures. Prevention includes system approach or human factor engineering approach where emphasis is laid on having foolproof systems and to the factors which can help in eliminating human errors such as; decreased work hours, better working conditions, use of information technology and the designing of tasks so that errors are difficult to make. [74] A recent review of contributory factors underlying critical incidents in ICU stresses the need for nontechnical skill competencies like good teamwork, situation awareness, task management and decision-making skills for safe practice in ICU. [75] Further research is necessary on the non technical skill proficiencies for teaching and reliable assessment.
1. Improvement of medication system | |  |
Prevention strategies should aim at improving medication systems [26] by paying attention to the following factors.
a. Storage | |  |
Drugs should be kept free from contamination (blood, organic matter). Solvents and carriers are required for lipophilic drugs may pose problems. The Anaesthesia Patient Safety Foundation has published guidelines for safe handling of parenteral medications used for anaesthesia and sedation. In the service areas, maintain a list of high alert medications e.g. narcotics, NMBAs. Store them at one place and remove them from patient care areas. A separate register can be kept where entries are made each time the drugs are used and signed by the consultant using them.
b. Drug administration | |  |
Increased vigilance is required for delivery and monitoring of medication. [76] Correct identification before administration is essential. Colour coding, proper labeling of syringes to avoid syringe swapping and proper packaging may check errors in drug administration. There can be chemical, bacterial or glass particles contamination of the drug during administration. This can be avoided by changing the packaging in the case of glass ampoules. All solutions for infusions should be carefully labeled with the date of preparation, the concentration, and the amount of drug, the route of administration and the name of the individual who prepared the infusion. Similar tube connections for different drugs should be discouraged. Standardize the abbreviations, acronyms, and symbols used in an organization, as this is one of the National Patient Safety Goals recommended by the Institute of medicine. [42]
Simple measures as the use of Electronic Medication Administration Records, use of a zero before the decimal point (0.4) and no use of zero after decimal point (4.0) are helpful to prevent ten fold overdose. [22]
Regarding the use of central neuraxial blocks in patients in ICU, there should be standardization and monitoring of the cleaning, wrapping, autoclaving and storing steps, and of sterile material distribution. [77] Routine use of a 0.2 mm bacterial filter for aspirating drugs is recommended.
Careful marking of epidural or spinal catheters with legible and visible labels may reduce the likelihood of these catheters being mistaken for intravenous lines by anaesthesia/nursing personnel. In our hospital, we routinely label the catheters and follow a policy of keeping the central and the neuraxial catheters on opposite side of the patient.
c. Drug and electrolytes monitoring | |  |
The effectiveness of antibacterials using pharmacokinetic/pharmacodynamic relationships for drug monitoring are important predictors of successful outcomes for quinolone and aminoglycoside. Monitoring of serum levels of certain drugs along with electrolytes may help prevent certain drug interactions and adverse effects.
2. Training, education and communication | |  |
Lack of knowledge (29-30%) about the drug and inadequate communication among health care givers are important causes of medication error. [78] Education, a simple and inexpensive modality should target all levels of organization. It is important that educational efforts should be ongoing and must provide continual feedback on safety and quality improvement projects. After confirmation of the relationship of the drug and the adverse event, the information should be shared with other clinicians through various platforms. [79] Communication is cited as one of the major contributor to the quality of patient care. Improving communication between physicians, nurses and pharmacists is a relatively cost effective and easy to implement strategy to reduce medication error rates. [80]
3. Involvement of pharmacist | |  |
A pharmacist can bring down the prescribing errors and monitor the transcription process. With the help of computerized pharmacy systems, the pharmacists can screen for duplicate drug therapies, potential allergies, drug interactions, drug/laboratory interactions and dose range. Nurses can be helped and supervised in monitoring of the drug preparation, distribution and storage systems. They may be engaged in various education programmes as well as actively participate in developing drug protocols. Individualized pharmacotherapeutic care can be provided in addition to significant reductions in the drug costs. [81]
4. Protocol based management | |  |
Effort should be made to standardize and limit the number of drug concentrations in an organization. More stringent safeguards, such as, protocol driven ordering, dosing tables, independent versus professional double checks of the syringe pump settings and the dose/ volume/concentration to be administered are indicated for high risk medications. A clearly defined system must be in place to alert clinicians to patient's allergies and this information must be readily available to the ICU staff. Though the use of selected guidelines and protocol based management, very helpful, but these are not alternatives to vigilance or knowledge. It has been found that physicians and nurses do not always follow the guidelines and may be reluctant to use them. [82] Patients medicated according to drug guidelines have significantly shorter lengths of stay in the ICU, have improved sense of well-being and mechanically ventilated patients have lower rates of self-extubation. [22],[36] It is cost effective and helps in cutting down the excessive use of drugs.
5. Use of information technology | |  |
Computerized physician order entry, clinical decision support systems, automated dispensing, bar coding of drugs and patients, smart intravenous devices for performing dilutions; automated bedside dispensing devices; and unit-based dosing and computerization of the medical records and of discharge prescriptions and instructions are the different ways in which information technology can be used. Information technology prevents and decreases errors by improving communication thereby making knowledge more accessible, and assists with calculations and clinical decision-making. Smart monitors highlight signals, which indicate the early detection and aid in taking timely corrective measures. [83] Computer systems to detect critical conditions and automatically notify the responsible physician via the hospital's paging system has also been used. [84] Various studies have shown that the application of information technology can prevent up to 95 percent of ADEs. [4],[19],[28],[34] The specificity of the computer monitoring system can be improved by the implementation of 'trend monitoring' in laboratory values (delta ALS). [85] Information systems to display drug and patient data may also produce long-term reduction in errors. [86]
Conclusion | |  |
A patient admitted in an ICU needs continuous monitoring, oxygen therapy, multiple diagnostic or therapeutic interventions, and is dependent upon complex pharmacological regimens using sophisticated delivery and other organ support systems. Multidisciplinary strategies involving physicians, pharmacists, and other health care professionals with a special focus on communication and education should be targeted. Pharmacovigilance incorporating information technology can be of great help in improving the patient care in the ICU. Pharmacovigilance must be integrated into public health programmes as recommended by the WHO for promotion of safe and rational use of medicines. However its application should not be limited to ICU alone rather quality and safety should become second nature to all health care professionals.
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[Table 1]
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