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Training Manual for Preventive Malaria - Ministry of Health

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WHO SHOULD REPORT ADRS IN GHANA FOR SP IN IPT<br />

• The patient (usually to the CBS/CHO/MCH Centre/<strong>Health</strong> Centre/ Hospital).<br />

• Community Based Supports (CBSs)<br />

• <strong>Health</strong> care workers (e.g. Clinic attendants)<br />

<strong>Health</strong> pr<strong>of</strong>essionals should fill the SP/IPT reporting <strong>for</strong>m on behalf <strong>of</strong> patients and submit it<br />

to the next level.<br />

WHAT SHOULD BE REPORTED?<br />

All suspected reactions to SP on SP/IPT <strong>for</strong>ms and all drugs on National Reporting Form – blue<br />

colour, including minor ones.<br />

In addition, drug-drug, drug-food, or drug-food supplements interactions (including herbal and<br />

complementary products) should also be reported.<br />

The following should also be reported;<br />

• Overdose or medication error<br />

• Lack <strong>of</strong> efficacy or when the drug is suspected to be defective, substandard, counterfeit or<br />

not giving the “expected” response.<br />

• Any other reaction that the patient is sufficiently concerned about to report to the health<br />

pr<strong>of</strong>essional. Remember “if the patient is concerned enough to report a reaction to you, you<br />

must also be concerned to report to the NMCP/NCPv.<br />

ADVERSE EVENT REPORTING FORM (specimen at the appendix)<br />

A copy <strong>of</strong> the National Spontaneous Reporting Form is shown in Appendix. The <strong>for</strong>m consists<br />

four main parts as follows:<br />

Patient Details<br />

Name<br />

Age, Weight<br />

Address<br />

Reaction Details<br />

What happened – description <strong>of</strong> the event or problem<br />

When – date <strong>of</strong> event<br />

What was done – treatment given to the patient or whether the drug was withdrawn<br />

(dechallenge) and/or reintroduced (rechallenge)<br />

What was the outcome – outcomes attributed to adverse event i.e. was the patient<br />

hospitalized? If so, <strong>for</strong> how long? Did the patient die? How long did the reaction last?<br />

Drug Details<br />

o Suspected agent (brand names if known or else generic name)<br />

o Lot/batch number, expiry date etc. if known<br />

o Dose, frequency and route used<br />

o Date <strong>of</strong> intake<br />

o Was patient on SP <strong>for</strong> IPT?<br />

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