Adverse Reaction Monitoring System

Sweden s National Adverse Reaction Monitoring System called the attention of physicians to a case in which a 73-year-old woman developed anaphylactic shock after taking only a single tablet of Moduretic (7). The National System had received three other reports on anaphylactic reactions to this combination, and by 1988 the WHO center in Uppsala had received eight others from other countries. Except for mild skin reactions, hypersensitivity reactions to hydrochlorothiazide alone are highly unusual and not of this type. 

Sachs RM, Bortnichak EA. An evaluation of spontaneous adverse drug reactions monitoring systems. Am ] Med 1986 81 49-55. 

The Special Nutritionals Adverse Event Monitoring System (SN/AEMS) of the U.S. Food and Drug Administration (FDA), a database of consumer reactions to nutritional supplements and substances, has had 31 reports of adverse reactions to products containing creatine between 1993-1998. Reported symptoms include (but were not limited to) ... 

Reported adverse events after immunization in New Zealand from 1990 to 1995 have been presented (24). Reactions at the injection site following adult tetanus + diphtheria vaccine were the most commonly reported (68 reports per 100 000 immunizations). The authors concluded that the picture confirmed the overall safety of vaccines and the value of an adverse events monitoring system. 

Monitoring, violation and sanction spheres For post-marketing surveillance of product safety, ADR monitoring systems exist in all the countries, with the exception of Uganda. But it is difficult to evaluate the effectiveness of these systems in monitoring product safety. Only the Adverse Dmg Reactions Advisory Committee in Australia... 

Vaccine safety is monitored by the FDA and CDC through a passive reporting system that allows anyone, health professionals or lay public, to report any event. Health care professionals are bound by federal regulation to report certain adverse events (Table 83-2). Additionally, any serious, life-threatening or unusual reactions should also be reported. The Vaccine Adverse Event Reporting System (VAERS) can be found at http //vaers.hhs.gov. 

In response to the National Childhood Vaccine Injury Act of 1988, which required health workers to report vaccine adverse events, the CDC and the FDA collaborated in 1990 to implement the Vaccine Adverse Event Reporting System (VAERS) to monitor the safety of vaccines in both sectors. Health care professionals and parent or other caretakers are encouraged to report all clinically significant vaccine adverse events. Narrative diagnostic reports are reviewed and assigned standard codes using Coding Symbols for a Thesaurus of Adverse Reaction Terms. The source of the vaccines (public versus private provider) is recorded on the form. 

American Society of Hospital Pharmacy (1995). ASHP Guidelines on adverse drug reaction monitoring and reporting. Am. J. Health Systems Pharm. 52 417—419. 

This chapter begins by discussing how consumer perceptions of risks associated with food additives compare to other food-related health risks. It then addresses the US government s system for monitoring adverse reactions from food additives. The bulk of the chapter focuses on additives that have been blamed for causing health problems and which have generated controversy in the US and other countries. Finally, there is a brief discussion of future trends and additional sources of information are provided. 

Although the US is one of the few countries to have a formal system for monitoring adverse reactions from food additives as part of its regulatory structure, other countries also periodically review additives. In addition, the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) also monitors food additives. Since 1956, the Joint FAO/WHO Expert Committee on Food Additives has developed specifications for the purity of additives, evaluated toxicological data, and recommended safe levels of use. 

The United States is one of the only countries that has established a formal surveillance system for post-approval monitoring of adverse reactions to food additives. Despite the obvious limitations of a passive surveillance system, ARMS provides an important venue for the public and others to report health problems perceived to be related to food additives. It provides a means of spotting potential longer-term problems with additives which can then be investigated further. 

Experience with PRP-D derives from Finland and Iceland. In Finland, 14.1 adverse reactions per 100 000 doses were reported in aU, consisting respectively of 5.3, 6.3, 4.4, and 2.9 per 100 000 doses of local reactions, fever, rash, and irritability. These rates probably underestimate the true rate. In Iceland, adverse effects have not been monitored, but no serious events have been reported. For PRP-CRM, there were 17.8 per 100 000 doses in aU, of which 7.7 per 100 000 doses were due to local reactions, 8.9 to fever, and 8.3 to rash. PRP-T currently enjoys the largest use in Scandinavia, being the routine choice in three countries. Of 115 reactions reported in Denmark, none was of serious concern most were local reactions, fever, or rash. In Norway, the incidence of systemic reactions was 1 in 550 doses fever and other symptoms and signs similar to those after DTP vaccination were the most common complaints. However, two findings were characteristic of Norway, where local reactions were reported with an overall frequency of 1/1500 doses ... 

The combination of pyrazinamide plus levofloxacin is first-line treatment for multidrug-resistant latent tuberculosis. In 17 Canadian patients there were important adverse reactions affecting the musculoskeletal and central nervous systems hyperuricemia, gastrointestinal effects, and dermatological effects were also common (3). This combination may be used with careful monitoring for adverse effects. 

Side effects should be monitored after the initiation of lidocaine. The most common adverse reactions are drowsiness, dizziness, paresthesia, and euphoria. Patients also may experience serious central nervous system (CNS) side effects such as confusion, agitation, psychosis, seizures, and coma, but usually only at supratherapeutic levels. The active metabolites of lidocaine are responsible for most of the CNS toxicities. Cardiovascular side effects, including atrioventricular block, hypotension, and circulatory collapse, are not as well correlated to lidocaine levels. 

American Society of Health-System Pharmacists. ASHP Guidelines on Adverse Drag Reaction Monitoring and Reporting. Am. J. Health-Syst. Pharm. 1995, 52, 417-419. 

In the UK the present yellow card system had its origins in 1965, when Witts,who was then a member of the Committee on Safety of Drugs (the precursor to the Committee on Safety of Medicines), published a method for the collection of suspected adverse reactions to drugs. The thalidomide tragedy was a powerful stimulus for the setting up of an effective system of adverse event monitoring. An excellent early publication which set out many of the basic principles and definitions of terms and procedures is that of Finney. ... 

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