Dear Provider:
In an effort to ensure high-quality care to our users, we aim to collect information on any
problems that may be associated with drugs and medical devices. We hope you will use the
Suspected Adverse Event Report for Contraceptive Implant Users (enclosed) to report
pregnancies, complications with insertions or removals, illnesses, or other adverse events that
follow use of any contraceptive implants.
To make the process easy, we have provided a simple instructional guideline to help you
complete the report form. Please review the brief guidelines that follow prior to completing
the form.
If you are not sure how to answer any item on the form, kindly record as much information as
you can. If you need clarification on any of the items, please contact us at Pharm Access Africa
Ltd (PAAL) by phone or email. In addition, we may contact you if we need further information
to help us understand the events you report.
Protecting the confidentiality of you and the users of any implant is our priority, and the
information you submit will be kept in the strictest of confidence. Information will be reported
to the manufacturer and to other service delivery groups in order to help ensure product safety
and quality. The implant user will never be identified in any of those reports.
Once the form is completed please send to Pharm Access Africa Ltd. The information can be
reported to PAAL in three ways: a mailed hard-copy form; a fax to +254 20 374 1734; or the
form can be scanned and sent to PAAL by email at the address: info@pharmaccessafrica.com.
Alternatively, you can call the PAAL office to file a report. We ask that you report all serious
adverse events (SAEs; see form) to PAAL within 2 business days of notification of the event. We
ask that you report less serious events to us within 5 business days of notification of the event.
Thank you again for your attention to this issue. And regards from Pharm Access Africa Ltd.
Pharm Access Africa Ltd
P.O. Box 21 507, 00505 Nairobi
Telephone: + 254 20 3743294/5/6
Fax: +254 20 3741 734
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General Instructions for completing the form
Suspected Adverse Event Report for Contraceptive Implant Users
Important note: Only adverse events occurring in users of Sino-implant (II) (with
brand names including Femplant, Zarin or Trust) should be reported to PAAL.
Adverse events among women using a different hormonal implant should be
reported to the manufacturer and/or distributor of that implant. Adverse events
should also be reported to your national drug regulatory authority (DRA), regardless
of the type of implant used.
General Instructions
Please complete all entries in either black or blue ink. Kindly make entries as legible as possible.
Please complete all sections that apply to your report.
Dates should be entered as dd/mm/yyyy (example: 23 March 2011 or 23/03/2011). If exact dates are
unknown please provide the best estimate (example: March 2011).
If the fields do not provide adequate space, attach additional pages as needed. Identify all attached
pages as Page _of_, indicating the appropriate section (example: “additional clinical information”).
User Details
Please provide the user’s initials or some other type of identifier that will allow you to readily locate the
case file if you are contacted for more information. Please do not record user’s name. Please provide
the user’s age, weight in kg, and height in cm. The type of hormonal implant is important: only adverse
events occurring in users of Sino-implant (II) should be reported to PAAL. Brand names for Sino-implant
(II) include Femplant, Zarin or Trust.
Batch/Lot number is generally printed on the side of the box. For Sino-implant (II), it is an 8-digit
number.
Suspected Reaction
An adverse reaction is any incident in which the use of a medication at any dose is followed by an
adverse clinical event or complication in the user. We are not, however, collecting information on the
common, mild side effects of 2-rod contraceptive implants, particularly menstrual changes such as
irregular bleeding or amenorrhea. You should not submit a Suspected Adverse Event Report for those
expected side effects.
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See below for the list of common mild side effects that should not be reported:
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Changes in bleeding patterns such as no monthly bleeding, infrequent bleeding, lighter bleeding,
irregular bleeding, and heavy or prolonged bleeding (unless a serious underlying condition is
suspected)
Headaches
Abdominal pain
Acne
Weight changes
Breast tenderness
Dizziness
Mood changes
Nausea
However, if any side effect is moderate to life-threatening in severity (see below), or if the side effect
results in a Serious Adverse Event (SAE; see definitions below), you should report that reaction.
For reporting purposes, it is not necessary to be certain of a cause-and-effect relationship between the
adverse reaction and the use of the medical product in question. Suspicion of an association is sufficient
reason to report.
Submission of a report does not constitute confirmation that medical personnel or the product caused
or contributed to the event.
For the date that the adverse reaction started, please indicate the date when the user first became
aware of the event or reaction.
Guide to scale of severity of the reaction
Mild
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The adverse drug reaction (ADR) requires no treatment or change in product use
No increase in length of stay (if hospitalized)
Moderate
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The ADR requires treatment or management, but does not require that the product be
withheld, discontinued or otherwise changed
The ADR requires that the suspected drug be withheld, discontinued or otherwise changed,
and/or an antidote or other treatment is required
Increases length of stay by at least one day (if hospitalized)
The ADR is the reason for admission (if hospitalized)
Severe
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The ADR requires intensive medical care
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The ADR causes permanent harm to the patient
Life-threatening
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The patient was at substantial risk of dying at the time of the adverse event
Use or continued use of the medical product might have resulted in the death of the patient
Guide to seriousness of the reaction
A serious adverse event, or SAE, is a special sub-set of adverse reactions. For an adverse reaction to be
considered serious, it must involve one or more of the following:
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Death
Life-threatening condition
Hospitalization, or prolongation of hospitalization
Persistent or significant disability
Congenital anomaly or birth defect
Pregnancy
Please provide the basic facts about the pregnancy (including whether a pre-insertion pregnancy test
was done, what the outcome of the pregnancy was, etc).
Concomitant Medications
Provide the names, including trade and brand names, of all drugs used at the time of the suspected
reaction. If the trade/ brand names are not known, use the generic product name. Also include overthe-counter drugs and traditional drugs used, if known. If more than 3 drugs were used, list additional
drugs on a supplemental sheet and attach to the report.
Dosage – provide the dosage being taken for this drug. For example, 500 mg QID/BD.
Route – indicate route of administration of the drug. For example, IV for intravenous, IM for
intramuscular,etc.
Indication – write down what the drug was prescribed for. For example, hypertension management,
diabetes, etc.
Treatment of Reaction
Describe the treatment(s) provided in as much detail as is available.
Outcome of Reaction
Indicate the current medical status of the user here.
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Additional Clinical Information
In this section, please provide information not otherwise covered on the form. Knowledge of other risk
factors can help in the evaluation of a suspected adverse reaction. Please provide information on the
user’s medical history, for example hypertension, diabetes mellitus, liver or kidney problems. Known
allergies should be specified. Laboratory tests performed should be included. Include any other data
that might be useful in understanding the sequence of events.
Reporter details
Confidentiality is an important concern in the context of adverse reaction reporting. The user’s identity
should not be reported on the form.
The reporter’s identity is needed to allow for timely follow-up in serious cases. The provider or the
physician who is completing the report should provide his/her name, mailing address, phone number,
fax number and email address. Also, please include the name of your institution or organization.
Finally, please indicate if the suspected adverse event was reported to your national drug regulatory
authority (DRA).
OFFICE USE
Pharm Access Africa Limited will confirm if the local service provider has informed the national drug
regulatory authority.
Pharm Access Africa Limited will also confirm if Shanghai Dahua Pharmaceutical Company Limited has
been informed.
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