Introduction

In 2006, U.S.A.’s Food and Drug Administration (FDA) 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 intended 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.

Pharmaceutical preparations package insert is an essential feature of drug packaging. It is present in most of the medicines; [₁]. It is considered as the primary source of information for health care providers about drugs [₂]. 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 [₁]. Mostly, it is an effective mean to communicate about the risks of drugs [₃], and it has an important impact on patients compliance and thus on the ultimate effectiveness of drug use [₄]. 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 [₅]. Neuroanesthesia used drugs may interact with other anesthetic drugs and any other drugs the patient is taken in the perioperative period. The neuroanesthesia 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.

Some studies appeared in recent months’ investigation studying the general qualities of drug insert qualities regarding safety precautions and it demonstrated to be inadequate. Recently a publication from our department prepared to examine the anesthesia drug insert’s qualities of information in our hospital [₆]. In this paper a report on the quality of patient safety information contained in drugs inserts used in Neuroanesthesia.

Drug interactions (DI), represent one of the most common forms of adverse drug related events but widely under-recognized source of medical errors [₇₈₉₁₀]. 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 [₁₀₁₁]. 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 [₁₂₁₃]. Preventable drug interactions account for about one third of adverse drug effects but incur about one half of the total adverse effect costs [₇₁₀]. 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 DI [₁₁]. Other studies have reported that the incidence of DI ranges from 3% to 30% [₈]. Again, a number of studies have also estimated the incidence of potential DI in 20-30% of patients with clinically relevant interactions at 4-10% [₈₁₄₁₅]. Although, not all drug interactions are clinically significant, it is important to be alert for those that are. But, it is impossible to remember all the known important drug interactions; however, knowledge of the main types of DI will act as a useful alert when prescribing [₁₁]. To treat patients in a competent and safe manner, some awareness of the DI issue and some means of detecting DI are essential [₁₃]..

In a recent study on DI [₁₅] 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 [₁₇]. This study conducted an analytical study to explore the extent and nature of information presented in neuroanesthesia drug package inserts of most commonly drugs used at King Fahad Medical City (KFMC) in Riyadh KSA. We particularly emphasized on DI, hypersensitivity and neurological precautions of use.

Methods

Sample selection

Data Analysis

Results

Of the total (n = 48) package inserts, 37 (77%) contained some information on DI while 11 (23%) did not include any. Also 37 (77%) contained information on contraindications in case of known hypersensitivity and 29 (60%) 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).

Figure 1

Table 1: Breakdown number of package inserts information [N 50 (100%)]

Textbook’s 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.

Figure 2

Table 2: Types of precautions for drug actions presented in the package inserts. Characteristics of Precautions concerning CNS in (29 ubsert 60%) Anesthetic Drugs Package Inserts

The qualities of the 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.

Figure 3

Table 3: Qualities of information and the country of origin of the drugs presented in the package inserts.

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.

Discussion

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 [₁]. Culminating evidence from developing countries shows that package inserts often contains minimized adverse drug reactions [₁₈]. 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 [₁₉]. The present study found incomprehensive records of potential DI in the inserts of the most common drug.

Conclusion

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.

Acknowledgement

Correspondence to

Maher Mohammad Tayyem MD, MS Anesthesia. CJBA Department of Anaesthesia King Fahad Medical City, Riyadh, Saudi Arabia e-mail: dr_mahertay@hotmail.com