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RISK MANAGEMENT PLAN.

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STANDARD OPERATING
Document No. MM- 025-2017
PROCEDURE
Effective Date: July 8, 2017
PHARMACY Revision No:00
RISK MANAGEMENT
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HOSPITAL
REVISION HISTORY
Rev. Prepared by: Reviewed by Approved by

RHODORA M.
VIRGINIA C. LEONARDO AZER M. VILLAMAYOR, MD
BENIPAYO, RN. MAN.
Chief Pharmacist Medical Director
Chief Nurse/ QA Officer
REFERENCES
Document No.: Title

PURPOSE:

 This policy is intended to propose a standard concept for “Pharmacovigilance


Plan” and “Risk Minimization Plan” in order to deal with “Important identified
risks”, “ Important potential risks” and “Important missing information” in
accordance to Pharmacovigilance Planning.
 This policy should be used as a guideline when AMH considers further
surveillances and studies regarding the safety of the product and additional
actions to mitigate risks in the time of approval review of any product in the
pharmacy.
 This policy is intended to improve safety measures based on the assured safety
guidelines, the benefit/risk assessment and the review of them.

SCOPE

 The products which are subject to “Risk Management Plan (RMP)” and the time
when the Plan is applied are described below:
1. In the time of approval review of new drugs (include new additional indication
and dosage, revised/additional dosage and administration, new combination
drug, additional dosage form: the same shall apply hereinafter), and when Safety
Specification is newly submitted during the re-examination period.

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RISK MANAGEMENT PLAN.……

2. When Safety Specification is newly submitted for generic drugs and drugs for
which the re-examination was completed.
3. At the time of approval of the generic, in the case that its reference drug has
already obligated to develop an additional risk minimization activity.

POLICY:

Safety Specification

1. AMH should present “ Important identified risks”, “ Important potential risks”


and “ Important missing information” as Safety Specification in order to review
whether additional actions are needed in Pharmacovigirance Plan and risk
minimization activity for the appropriate benefit-risk balance with taking into
account of the characteristics of the treatment population, disease and
administration.
2. Safety Specification should be a summary of the following important potential
risks which may affect the benefit/risk balance. As to preparing the Safety
Specification, AMH should refer to the revised“Medication Management Policy”.

DEFINITION OF TERMS:
a. “Important identified risks”:severe or frequent adverse drug
reactions (ADRs) (includes drug interaction): ADRs which are fully
verified in non-clinical studies as well as in clinical data. ADRs which are
suggested causal relationships to a drug by studies including clinical
trials. ADRs which are strongly suggested causal relationships to a drug
based on the ADR reports.

b. “Important potential risks”:adverse events (AEs) that are required


further collecting information because of safety concerns such as cases
(includes drug interaction).
 Severe and frequent AEs which occurred in clinical trials or other
clinical use (the causal relationships unclear).
 Potential serious ADRs which occurred in clinical trials and other
clinical use.

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 AEs which are identified in non-clinical studies but not identified in


clinical trials.
 AEs which are not identified in clinical studies but
pharmacologically predictable.
 AEs which are identified in another drug of the same class but not
identified in the drug.
 Accumulated the ADR reports with unclear causal relationship to
the drug.

c. “Important missing information”: information which was not


acquired at the time of submission of Risk Management Plan and
suggests that it has a limitation in the estimation of the drug safety in the
post-marketing setting. e.g.) The safety information essential for a
certain patient population that is excluded from the clinical trials but need
to be considered about the drug safety, due to high frequency of the
drug use in a practical clinical setting.

3. AMH must identify the safety issues as Safety Specification in the time of
approval review of any drug to be included in the Formulary. The RMP which is
included in the "Basic plans of the Phamacovigilance Management System"
should be developed by identifying Safety Specification as the starting point, as
with described in the Medication Management Guideline.

Risk Management Plan (RMP)

1. Based on the “Important identified risks”, “Important potential risks” and


“Important missing information” which are identified as Safety Specifications,
AMH should develop the “Pharmacovigilance Plan” and “Risk Minimization Plan”,
the whole plan should be submitted as RMP.
2. RMP should be reviewed for consistency with its review report. Depending on the
Safety Specification, AMH should clarify whether an additional action should be
implemented besides the regular pharmacovigirance plan and risk minimization
activity. And the Pharmacy should also clarify the reason of that.

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3. Even if it is not considered that the drug needs to be taken an additional action
in safety specifications, the Pharmacy is required to submit Adverse Drug
Reaction (ADR) under the provision of the FDA. In principle, pharmacovigilance is
required to be conducted for all new drugs.
4. Even if it is not considered that the drug needs an additional action in safety
specifications, information provision by the package insert is required as routine
risk minimization activity. The Pharmacy should provide information based on the
drug formulary using additional materials for new drugs.
5. If it is considered that the drug needs additional pharmacovigilance and that use-
cases surveillance including specified use-cases surveillance should be
implemented, the pharmacy should clarify the objectives of the survey and pays
attention to implement the RMP in an appropriate manner.
6. The pharmacy should also make a point to utilize methods of
pharmacoepidemiology as use- cases surveillance.
7. In the "Pharmacovigilance Plan" and "Risk Minimization Plan", when the
pharmacy reviews the need for additional actions, the following should be
considered.
a. The impact of ADRs, the severity, frequency, reversibility and
preventability on severe ADRs
b. The severity of disease included in drug indications, the severity and the
background incidence rate of complications
c. Estimated number of patient exposure
d. Identified risk populations
e. Expected benefits by conducting risk minimization activity
f. Treatment duration
g. World-wide market authorization status
h. Results of overseas surveillance and studies (if it is changed, the points
which should be taken into account)
i. The difference in safety profiles between Japan and overseas
j. Safety measures which was taken in overseas

8. If an additional action is required in pharmacovigilance plan and/or risk


minimization activity, AMH should clarify the reason and the method of the

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action. In the case that it is not considered the drug needs an additional action,
AMH should clarify the reason.

Important potential risks

 -Safety review of long-term administration


 -Review of increased risk of possible AE
 -Review of AEs which may occur in the natural course of the underlying disease
or complication, and are difficult to distinguish from ADRs
 -Review whether the frequency of ADR is potentially higher than that of the
other drug long-term administration surveillance/studies, Pharmacoepidemiology
studies including a cohort study and case-control study

Important missing information

 -Review of the drug safety in the case that safety information obtained from
clinical practice by the time of approval was extremely limited due to the
inefficient number of patients
 -Review of the drug safety in the case that the drug may be used in sub-groups
including pregnant women. Information gathering by registry, other active
surveillances, use-cases surveillances

END OF DOCUMENT

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