Adverse drug reactions systems

In a review of definite or probable drug-associated pancreatitis spontaneously reported to the Dutch adverse drug reactions system during 1977-98, azathioprine was the suspected drug in four of 34 patients, two of whom had positive rechallenge (37). Although most of the carefully described reports of azathioprine-induced pancreatitis were found in patients with inflammatory bowel disease, transplant recipients can also suffer this complication. 

A definite case of pancreatitis proven by positive rechallenge was also briefly cited in a review of drug-associated pancreatitis spontaneously reported to the Dutch adverse drug reactions system (261). 

Discuss ways to promote an optimal response to drug therapy, how to manage common adverse drug reactions, and important points to keep in mind when educating patients about the use of central nervous system stimulants. 

ASSESSMENT OF THE HOSPITALIZED PATIENT The hospitalized patient receiving a female hormone requires careful monitoring. The nurse takes the vital signs daily or more often, depending on the patient s physical condition and the reason for drug use. The nurse observes the patient for adverse drug reactions, especially those related to the liver (the development of jaundice) or the cardiovascular system (thromboembolism). The nurse weighs the patient weekly or as ordered by the primary health care provider. The nurse... 

Establishing and maintaining a pharmacovigilance system to capture and evaluate all reports of suspected adverse drug reactions. 

It is important to review the patient s medication history for potential drug-drug and drug-glaucoma interactions, adherence, presence of systemic and ocular adverse drug reactions, and ability to use ophthalmic preparations. 

Evaluate the patient for systemic and ocular adverse drug reactions and drug allergies. 

There have been several attempts over the years to classify adverse drug reactions, primarily based on the perception of what can and what cannot be predicted given knowledge of the pharmacology and toxicology of the drug. For example, Edwards and Aronson [13] proposed what is probably the most extensive classification system ... 

Drug-related problems can be defined as Any undesirable event experienced by the patient that involves or is suspected to involve drug therapy and that actually or potentially interferes with a desired patient outcome (Strand et al. 1990). This is a vital component of Pharmaceutical Care and Clinical Pharmacy and will be described more in detail in another chapter. It should however be noted that there are several definitions and classification systems for DRPs. A literature review (van Mil et al. 2004) identified fourteen classifications and their critical elements. In the presented definition a potential problem is a DRP but this is not the case in all definitions and classifications. This is also the case for unavoidable adverse drug reactions (e.g. with cytotoxic agents). 

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

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

Article 102 includes a provision that requires Member States to share information collected through their pharmacovigilance system with other Member States and the EMEA. The central database EudraVigilance has been developed to allow Member States and the EMEA to share information on adverse drug reactions once all Member States have populated it. 

The ABPI Code of Practice, in line with European Directive 75/319/EEC, calls for an efficient transfer of information on adverse drug reactions. In the case of defective medicines, an ABPI Batch Recall of Pharmaceutical Products system is in operation. In the ABPI Expanded Syllabus, batch recall is referred to in the Pharmaceutical Technology section and adverse drug reactions in the Pharmacology and Classification of Medicines and the Pharmaceutical Industry and the NHS sections. 

Lack of access to medicines and inappropriate doses result in serious morbidity and mortality, particularly for childhood infections and chronic diseases, such as hypertension, diabetes, epilepsy and mental disorders. Inappropriate use and over-use of medicines waste resources - often out-of-pocket payments by patients - and result in significant patient harm in terms of poor patient outcomes and adverse drug reactions. Furthermore, over-use of antimicrobials is leading to increased antimicrobial resistance and non-sterile injections to the transmission of hepatitis, HIV/AIDS and other blood-borne diseases. Finally, irrational over-use of medicines can stimulate inappropriate patient demand, and lead to reduced access and attendance rates due to medicine stock-outs and loss of patient confidence in the health system. 

Davie s Textbook of Adverse Drug Reactions. Chapters on organ systems and their possible adverse reactions, including mechanisms and clinical advice. 

Memantine is the first in a novel class of Alzheimer s disease medications acting a.o. on the NMDA receptor of the glutamatergic system. It also acts as an uncompetitive antagonist at different neuronal nicotinic receptors at potencies possibly similar to the NMDA receptor. Memantine is approved for treatment of moderate to severe Alzheimer s disease and its use is associated with a moderate decrease in clinical deterioration of the disease. Common adverse drug reactions (>1% of patients) include confusion, dizziness, drowsiness, headache, insomnia, agitation, and/or hallucinations. 

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