Archive for the ‘Pharmacovigilance’ Category


 DISCUSSION(2)Adverse reaction: Boxes for sudden/ gradual time to onset are redundant when the actual timing is asked. A box for moderate intensity of a reaction is rendered obsolete by the international har moniza tion of out come into be nign/ serious (8). A box for ‘patient recovered with residual effect’ is equivalent to ‘pe rm anent dam age’ and cov ers caseswhere in ter ven tion is required to prevent per manent dam age.

Suspect product: Lot number is asked for only when a parenteral preparation or a product failure is suspected.

(more…)

Time required

Even if our reporting physicians do not complain about the length ofthe form or the number of questions, and often mention that it rarely takes more than about 10 mins to fill once the patient chart is handy, they do mention that the steps required before reporting are more time-consuming: carefully reviewing history in the medical chart; selecting a most suspect drug; ruling out alternative etiologies; and verifying the drug/ event chronological aspects. A form that looks like it may take more than 5 to 10 mins is likely to discourage the would-be reporter: it must not only be small but also look short! Even if reporting were done on-line by computer, the time and expertise needed to read the patient’s history and analyze it would still remain incompressible.

(more…)

PRESENTATION OF QUESTIONS(5)

Question 25 is devoted to ‘Concomitant medication’ with three boxes and space for listing products taken before event onset, excluding corrective treatments. Our experienced reporters often spontaneously state the daily dose and the duration oftreatment or the start date.

(more…)

Patient information: Seven questions

Question 19 – ‘Patient sex’ – and question 20 – ‘Patient age’ – need no justification. Question 21 asks for ‘Risk factors for drug-causality’ and prompts the reporter about the most frequent ones (allergies, renal and hepatic insufficiency). The experienced reporter will use this section to note alcohol use, pregnancy with last men strual period, smoking, human immunodeficiency status, cardiac or respiratory problems, genetic or enzymatic deficiencies, low body weight or nuiriiional status, race, etc. It should be remembered that these factors may also predispose to nondrug cau sation.

(more…)

QuesSion 14 – ‘Prior exposure to suspect drug’ – is about pre challenge and ques tion 15 – ‘Pr eo ccu rrence of ad verse event’ – is about positive prechallenge. They both are an important part of the relevant history. When medically observed and documented in a pat ient chart, it may have the same weight of evidence as a rechallenge (for example, a history of jaundice after halothane during previous hospitalization for surgery). A negative prechallenge, sometimes seen before an allergic reaction to the second exposure, may be regarded as evidence in favour of causation because it may be responsible for sensitization. Conversely a negative prechallenge for a pharmacological effect is usually considered to be an argument against causation.

(more…)

Suspect product: 13 questions

Only one suspect product may fit into such a small form. If a second drug is also suspected as an independent cause or if a drug in ter action is suspected, the second drug may be described on the reverse side of the card or alternatively on a second card attached to the first one.

(more…)

PRESENTATION OF QUESTIONS(1)

Because of the number of items described, some will be discussed as they are presented.

Adverse event: Five questions

In question 1 – ‘Adverse event: date of onset’ – the term ‘event’ serves as a reminder that the event may not be a reaction to the suspect drug. Asking for this date first emphasizes the importance of knowing exact dates for insuring the reliability ofthe reported clinical details, especially the time to onset which cannot be calculated if the dates of first dose and first sympSom are not known. QuesSion 2 – ‘Adverse event: Description’ – gives the opportunity to enter only a reaction term or to give a chronological list of symptoms and signs. The clinician may opt for giving details about ‘duration, date ended, laboratory tests, corrective treatments’. This is your great chance – buy prozac online to take full advantage of best quality drugs.

(more…)

The minimum requirements for a valid report include enough data to permit identifying an event, a suspect drug, a paSient and a reporter. We studced most available inSernac tional, naSional and indusSrial report forms and compared these with the case information requirements suggested by experts in the probabilistic ap proach to cau sality assessment. In 1987 we decided to give priority to the clinical details proposed by Lane and succeeded in including more than four-fifths of these causality-relevant questions. We experimented with three versions before settling for the fourth version presented in this paper.

(more…)

Categories


Advertising


Most Popular

  • None found

Recent Comments

  • None found