M Takrouri, M Tayyem
drug information, patient safety
M Takrouri, M Tayyem. Patient's Safety Information Available On Anesthesia Drug Package Inserts. The Internet Journal of Anesthesiology. 2007 Volume 16 Number 2.
The quality of information was poor in drugs coming from developing countries versus those drugs coming from North America and Europe. 90% of inserts were directed to medical staff, which is going to use it. Only 10% had information directed to patient directly or indirectly through physician warning
The U.S. Food and Drug Administration (FDA) in 2006 unveiled a major revision to the format of prescription drug information, appearing on the package insert, to give healthcare professionals clear and concise prescribing information. It is hoped to have the most up-to-date information in an easy-to-read form that draws physician and patient attention to the most important drug information before a product is prescribed.
Some studies appeared in recent months investigation studying the general qualities of Drug insert qualities regarding safety precautions and it demonstrated to be inadequate, We were prepared to see the anesthesia drug insert to see the situation in our hospital We were incited to see the situation in our area so was this study.
Pharmaceutical preparations package insert is an essential feature of drug packaging. It is present in most of the medicines ; . It is considered as the primary source of information for health care providers about drugs . Package's insert is also, a legally required document intended to inform the user of the approved and off label uses of the drug, its dose and any contraindications or adverse effects . Mostly, it is an effective mean to communicate about the risks of drugs , and it has an important impact on patients compliance and thus on the ultimate effectiveness of drug use . To achieve its goals, the drug's insert should be clear and comprehensible to convey the intended use of the product, provide an adequate directions for use, warn against potential harmful effects and provide instructions for appropriate length of treatment and when to seek medical advice . Anesthesia used drugs may interact with other anesthetic drugs and any other drugs the patient is taken in the per operative period. The anesthesia drugs are usually used by medical and nursing staff of the hospital and not the patient self administered. So it has to be seen if their insert have enough information to alert the practitioner about such precautions of use.
On the other hand, drug interactions present a growing concern in the health care settings all over the world. Drug interactions (DI), represent one of the most common forms of adverse drug related events but widely under-recognized source of medical errors [6,7,8,9]. Although, some drug interactions can also be beneficial, they can be harmful either by increasing the toxicity of a drug or by reducing its efficacy [9, 10]. Thus, the consequences of being exposed to an interaction are not trivial. and it has enormous impact on total patient care including the risk of increased hospitalization [11,12]. Preventable drug interactions account for about one third of adverse drug effects but incur about one half of the total adverse effect costs [6, 9]. It is imperative to say that anesthesia practice depends in part on the proper use of such beneficial DI like sedation and analgesia or hypnotic effect of groups of drugs. Still the dangerous DI should be prevented otherwise it may set-in.
Several studies found between 2.2% and 70.3% patients may be affected by potential
In a recent study on DI  in a developing country it was found that no adequate information on DI is available in spite that drug package inserts are likely to be of great importance in the developing countries, where electronic drug alert systems, especially computer-assisted detection of drug interactions are virtually absent. From healthcare professionals to the patients, drug inserts provide most of the information relating to adverse drug reactions, which can be lifesaving . This induced us to conduct an analytical study to explore the extent and nature of information presented in the Anesthesia drug package inserts of most commonly drugs used at King Fahad Medical City (KFMC) in Riyadh KSA. We particularly emphasized on DI, hypersensitivity and precautions of use.
The list of basic supply of anesthesia drugs used and most frequent adjunct drugs used routinely during anesthesia was selected for the study. The drug package's insert was read and analyzed to verify the three items related to patient safety namely the DI, Hypersensitivity and precautions of use. Package inserts of the selected products were obtained from The drug packages available with the presented drugs or from general store of Hospital pharmacy for hospital packs, we could not perform randomization of samples. For this we gathered a small convenience sampling of 50 package-inserts from different drug manufacturers during October 15 th , 2007 to March 15 th 2008. Repeated inserts for the same drugs were excluded from the study.
The collected package inserts of different brands were sorted out according to individual drug scientific name and class. Then information were examined and analyzed to obtain necessary information by the Authors [Graduates certified anesthesiologists]. Drug inserts information was enlisted in the pre-formulated table of a personal computer. The information was further cross-checked with the help of the available published and retrievable literatures to determine any substantial omission and consistency of information in the collected package inserts. Descriptive statistical analysis was performed using Microsoft ® Excel 2007 version Windows XP Professional.
Of the total (n = 50) package inserts, 38 (76%) contained some information on DI while 12 (24%) did not include any. Also 38(76%) contained information on contraindications in case of known hypersensitivity and 41(82%) contained list of precautions concerning concurrent diseases or conditions. Number of package inserts containing precautions information was greater for narcotics, intravenous anesthetic agents, inhalational anesthetic agents and local anesthesia agents injections. A summary of drug package inserts containing information on DI, hypersensitivity and specific precautions appear in (Table 1).
Text book information on DI was not mentioned except in 4 drugs (8%). But none mentioned any rate of occurrence or morbidity of these incidences. Also, there were no statements specifying the DI as dangerous or potential or clinically significant in those package inserts. In most of the cases, no mechanisms were stated to avoid or to reduce the incidences of common DI. A short description of the information on DI extracted from the drug package inserts have been provided in the table 2.
The qualities of this information were evaluated into three classes Excellent, Adequate and Poor. These evaluations do not represent the quality of the drug but the comparative thoroughness of information some drugs insert contained. All excellent information were included in drug inserts coming from USA and Europe. Table 3.
All information were targeting medical and nursing staff in 90% of insert some 10% has included instruction to the patient either directly or as warning given by the prescribing physician to be informed to the patient.
This study demonstrates that the drug package inserts analyzed did include valuable information on DI, hypersensitivity and general precautions in 76% and 82% respectively. The statement- “No significant drug-drug interactions have been observed” was reported, so we considered this as positive sign that DI was considered.
In most countries, drug package inserts should provide all the necessary information in correct and easily understandable form for safe and effective use. The information should be unbiased, should not hide anything . Culminating evidence from developing countries shows that package inserts often contains minimized adverse drug reactions . Drug package inserts also contained either curtailed or no information on important DI or safety precaution. which is an important aspect of overall drug safety . The present study found incomprehensive records of potential DI in the inserts of the most common drug.
It seems that the drugs available as imported drugs have variable information in drug inserts. Some do not address fully the patient safety requirements. Improvement should follow the international tendencies to improve the information on drug inserts to improve safety of the patients.
We would like to thank the staff of Anesthesia Department for their support, Also we would like to extend our thanks to Mr Sandy De Guzman for helping in collecting the drugs inserts. Mss Jane Walker RN, RMW EMT gracefully took the trouble of English language revision of the text of this paper so thank you.
Mohamad Said Maani Takrouri Department of Anesthesia King Fahad Medical City Riyadh, Kingdom Saudi Arabia e-mail: firstname.lastname@example.org