Suspected Adverse Reactions

Observing the adverse reactions. The frequency of these observations will depend on die drug administered. The nurse must record all suspected adverse reactions and report them to die primary care provider. The nurse must immediately report serious adverse reactions to the primary care provider. 

MTX is potentially toxic. Therefore, the nurse observes closely for development of adverse reactions, such as thrombocytopenia (see Nursing Alert in Gold Compounds section) and leukopenia (see discussion of adverse reactions associated with hydroxychloroquine). Hematology, liver, and renal function studies are monitored every 1 to 3 months with MTX therapy. The primary care provider is notified of abnormal hematology, liver function, or kidney function finding. The nurse immediately brings all adverse reactions or suspected adverse reactions to the attention of the primary health care provider. 

In the United Kingdom, 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 CSM), published a method for the collection of suspected adverse reactions to drugs. 

Venning GR. Identification of adverse reactions to new drugs. IV verification of suspected adverse reactions. BMJ 1983 286 544-7. 

The Yellow Card Scheme, at first restricted to receive reports from doctors, dentists and coroners, has been gradually expanded to receive reports from other sources. From October 1996, the Scheme was extended to include reporting of suspected adverse reactions to unlicensed herbal remedies. In April 1997, the Yellow Card Scheme was further extended to include hospital pharmacists as recognised reporters of suspected ADRs. In addition, there are specially targeted extensions of the Scheme such as adverse reactions to HIV medicines and adverse reactions in children. Over the period, the Scheme has been gradually extended further to receive reports from community pharmacists and in October 2002, from nurses, midwives and health visitors. 

The establishment and maintenance (recently changed to manage ) of a system for collection, evaluation and collation of aU suspected adverse reaction information so that it maybe accessed at a single point in the Community ... 

As the company s representative you have an important role to play in the process of collecting information on possible adverse reactions and quality defects to the products we market. You will often be the only contact that a healthcare professional has with the company, and it is known that some healthcare staff report suspected adverse reactions only to the representative. 

If neoplasia is the suspected adverse reaction, is the time relationship plausible. 

The applicant should also describe any proposed postmarketing clinical studies and the reasons for doing such studies, e.g., to study further a suspected adverse reaction, or studies in children if there is a potential for use in this group. 

The degrees of causal relationship between a drug and a suspected adverse reaction are defined as follows ... 

All suspected adverse reactions should be reported, especially tliose tliat are ... 

Given the perceived failure of spontaneous reporting systems and the paucity of ADR reports/ some institutions have instituted more active methods of ADR detection to supplement spontaneous reports. Medication order screening has become a common practice in U.S. hospitals. Manual chart reviews and audits and computer programs are used for retrospective/ concurrent/ and prospective medication utilization evaluation. Certain events often prompt an evaluation of a suspected adverse reaction. These include abrupt discontinuation of a medication/ abrupt dosage reduction/ orders for antidotes and emergency medications/ orders for special tests or serum drug concentration measurements/ and abnormal results from laboratory tests and medical procedures. 

Voluntary reporting. Doctors, nurses and pharmacists are supplied with cards on which to record suspected adverse reaction to drugs. In the UK, this is called the Yellow Card system and the Committee on Safety of Medicines collates the results and advises the government s Medicines Control Agency. It is recommended that for ... 

Ransford RA, Langman MJ. Sulphasalazine and mesalazine serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines. Gut 2002 51(4) 536-9. 

Routledge PA, Lindquist M, Edwards IR. Spontaneous reporting of suspected adverse reactions to antihistamines a national and international perspective. Clin Exp Allergy 1999 29(Suppl 3) 240-6. 

The basis for this anaphylactic reaction was hypersensitivity to Echinacea, confirmed by skin prick and RAST testing. However, others have challenged the notion of a causal relation in this case (28). Nevertheless, the author affirmed his belief that Echinacea was the causal agent and reported that at that time Echinacea accounted for 22 of 266 suspected adverse reactions to complementary medicines reported to the Australian Adverse Drug Reaction Advisory Committee (28). 

Smith I. Suspected adverse reaction to essential oils. Aromatherapy World 2000 September 7. 

A report from the Uppsala Monitoring Centre of the WHO has summarized aU suspected adverse reactions to herbal medicaments reported from 55 countries worldwide over 20 years (31). A total of 8985 case reports were on record. Most originated from Germany (20%), followed by France (17%), the USA (17%), and the UK (12%). Allergic reactions were the most frequent serious adverse events and there were 21 deaths. The authors pointed out that adverse reactions to herbal medicaments constitute only about 0.5% of all adverse reactions on record. 

In one inconclusive case report acantholytic dermatosis (Grover s disease) was described as a suspected adverse reaction to penicillamine (253). This is a papulovesicular eruption in elderly people, characterized histologically by focal acantholytic dyskeratosis. 

There have been two reports of Sjogren s sjmdrome (keratoconjunctivitis sicca, xerostomia, swelling of the parotids) in suspected association with penicillamine (372,373). In one study, reference was made to a patient with a Henoch-Schonlein-like syndrome as a suspected adverse reaction to penicillamine, but no details were given (374). 

Positive merthiolate tests were found in eight of 30 patients with suspected adverse reactions to tetanus or tick-borne encephalitis vaccine (local inflammatory reactions at the injection site, fever, lymphadenopathy, urticarial or lichenoid exanthemas) (1). 

Receive all relevant information about suspected adverse reactions to medicinal products authorized by the centralized procedure. 

ADRAC utilizes a spontaneous, voluntary reporting system to identify suspected adverse reactions to drugs... 

Medical sales representatives must be given adequate training and must have SPCs available for the products they promote at all visits to medical practitioners. They are also under an obligation to pass on information they receive with regard to the use of the product, and in particular suspected adverse reactions, to their employers. 

To improve its ability to surveil marketed drugs, the FDA has recently conducted a successful educational demonstration program in Rhode Island to encourage physicians voluntarily to report suspected adverse reactions directly to the FDA or to the manufacturer. At the end of the 2-year project, adverse drug reports from this State were 17 times greater than the national average (374). 

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