ALAMINOS DOCTOR’S HOSPITAL, Inc.

Bolaney, Alaminos City, Pangasinan

Risk Management Plan

I. Rationale

This Risk Management Plan is to implement economical applications of resources to

minimize, monitor, and control the probability the impact of risks of drug products
with regards to safety, efficacy, and quality as per FDA requirement based on
Republic Act 9711 Sec.4 and Sec.5, Article VII, Section 4 (h) of IRR of RA 9711, Article
II, A, Section 2 (l) of IRR of RA 9711, FDA Circular No. 2013-004 Section V, (2),
Administrative Order No. 2014-0034 Section V, D.

II. Objective

This is to comply to the requirements for the issuance of LTO of Pharmacy in the
Alaminos Docators Hospital.. This guidance is intended to propose a standard
concept for “Pharmacovigilance Plan” and Risk Minimization Plan” by Market
Authorization Holders (MAHs) in order to deal with Important identified risks, and
important missing information and must always be available for inspection. This
guidance is also intended to aid to improve safety measures based in the assured
safety, benefit/risk assessment and the review of them.

III. Scope

The Purpose of this guideline is to propose a structure for a Pharmacovigilance Plan

and Safety Specification that summarises the identified and potential risks of the
medicines and products in the hospital. The plan could be used as the basis for
discussion of pharmacovigilance activities. During the course of implementating the
various components of the Plan, any important emerging benefit or risk information
should be discussed and used to revise the Plan.

IV. Implementing Details

Alaminos Doctors Hospital has a Vision to provide promt, adequate and quality
health care service to all patients inWestern Pangsinan and beyond and to
continuous maintenance and upgrading of hospital facilities and ancillary services in
consonance with the Department of Health standards.
The Alaminos Doctors Hospital Pharmacy provides an adequate supply of safe,
effective and good quality drugs to ensure genuine patient care and customer
satisfaction through dependable pharmacy services.
V. Risk Management Objective

Alaminos Doctor Hospital pharmacy has the general risk management objective is to
ensure the safety, efficacy, and quality of drug products, and ensure compliance
with regulatory requirements, to GPS, to ethical business practices, and regular
updating to advisories and policies.

VI. Safety Specifications

- The MAH should present Important identified risks, Important risks, as Safety
Specification in order to review whether additional actions are needed in
Pharmcovigilance 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.
- Important identified risks- severe or frequent adverse drug reactions (ADRs)
(includes drug reaction).
- ADR which are strongly suggested causal relationships to a drug based on the
ADR reports.
- Important potential risks- adverse events (AEs) that are required further
collecting information because of safety concerns such as cases (include drug
reaction).
- AEs which are identified in another drug of the same class but not identified in
the drug.
- For Safety issues for which were not able to be identified at the time of application
of the drug product, the MAH should describe in RMP that the potential issues were
pointed out in the review process.

VII. Risk Management Plan

1. RMP should be reviewed for consistency with its review report. Depending on
the Safety Specification, the MAH should clarify whether an additional action
should be implemented besides the regular pharmacovigilance plan and risk
minimization activity and the MAH should also clarify the reason of that.
2. Even if it is not considered that the drug needs to be taken an additional action
in safety specifications, information provision by the package insert is required
as routine risk minimization activity.
3. If it is considered that the drug needs additional pharmacovigilance and that use-
cases surveillance including specified use-cases surveillance should be
implemented, the MAH should clarify the objectives of the survey and pays
attention to implement the RMP in an appropriate manner.
4. In the Pharmacovigilance. Plan and Risk Minimization Plan, when the MAH
reviews the need of additional actions, the following should be considered.
a. The impact of ADRs, 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. Expected benefits by conducting risk minimization activity.
e. Treatment duration.
f. World-wide market authorization status.
g. Results of overseas surveillance and studies.
 If an additional action is required in pharmacovigilance plan and/or minimization
activity, the MAH should clarify the reason and the method of the action.

VIII. Pharmacovigilancae Plan

1. The MAH should describe the summary of the necessity of additional

Pharmacovigilance Plan and the reason for that, and a method of
Pharmcovigilance Plan. When the MAH considers a method of additional actions,
the MAH should choose a method with considering how to utilize it and what
kind of result you can expect.
2. If an important Safety Specification was newly identified, the MAH may required
to take an additional action on risk minimization as well as conducting an
additional pharmacovigilance practice to evaluate implementation of the action.
When the AE with high background incidence rate due to the natural course of
the primary disease and complication is difficult to distinguish from the ADR, in
the treatment population, the MAH may be required to conduct an additional
pharmacovigilance practice.

IX. Risk Minimization Plan

1. Overview of the Risk Minimization Activity

Risk Minimization plan is the overall individual activities for risk minimization.
The MAH should contribute to mitigate risks, while maintaining a favorable
benefit-risk balance, based on the drug safety information obtained by the time
of approval of the drug.
2. Routine risk minimization activity involves all medicines and medical supplies in
the pharmacy includes preparation and dissemination of a package insert as well
as establishment of “indications”, “Dosage and Administration”, and
“Precaution”. Monthly checking of expiration dates, proper stocking of pharmacy
items which are in alphabetical order to ease confusion of the medicines are
some of the minimization activities that are done by the pharmacy staff.
3. In case of brownouts, the hospital has the generator ready at all times.
4. The MAH is establishing the following conditions of the drug use to ensure
proper and safety use of the drug according to the property of the drug of the
mature of the disease. These conditions include a description in a package insert
and a setting as an approval condition or a part of the safety control procedure.
5. The MAH should set up some conditions that healthcare professionals should
thoroughly inform patients of the drug efficacy and safety and that they should
obtain the patients’ consent before starting therapy, regarding (a) drug that has
relative high risk of a fatal adverse reaction, patients need to be aware of the
risk, so that they can find the adverse reaction in early phase and contact their
physician promptly; (b) a drug that seems to have potential risk as specified
biological products, MAH may provide an educational program for patients to
avoid a certain serious adverse reaction, help patients thoroughly understand of
the therapy and encourage to be more careful for the risk.
6. The MAH should ask healthcare professionals to educate patients of the way of
drug use and precautions to avoid certain adverse reaction, regarding a therapy
with drug for a self injection.
 7. The MAH should ask healthcare professionals to perform a pregnancy test
before starting therapy with a strongly teratogenic drug.
8. The MAH should take an appropriate measure about a labeling or
container/package in the light of avoiding a human error.

X. Risk Communitcation

1. For the communication system of the hospital pharmacy internally, memo and
formal letter are the means of communication.
2. In cases of recall from FDA, inform records management team to review
distribution records immediately and communicate through phone, formal
letter, and personal appearance in their office.
3. For the consumers and other stakeholders we use formal letter, phone, and the
Therapeutic Committee is conducting monthly meeting to utilize therapeutic
issues.

XI. Time of Review

It is important that the MAH should review the RMP in an appropriate manner at
proper time. The RMP will be reviewed and revised as the end of the data lock point,
2 months before the expiration of the validity of the LTO.. RMP shall be reviewed in
instances theidentified risks occur which needed additional risk management.

XII. Effectivity

Alaminos Doctors Hospital is a licensed hospital pharmacy with license number 01-
011-18-42-H1-2 located at Bolaney, Alaminos City, Pangasinan.

Alaminos Doctors Hospital is licensed to sell registered drug products, medical

supplies, and temperature-sensitive products , specifically vaccines to the in-patients
and out-patients on a retail basis.