Pharmacy Risk Management Plan.docx

Mabama Doctors’ Hospital

Title: PHARMACY RISK MANAGEMENT PLAN

No. Page Page::

Adm. 2018-11-001

1 of 6

Effective Date ( After approval by FDA) Retires Policy Dated: None Previous Versions Date None Approval Date:

Pharmacy Risk Management Plan INTRIDUCTION

Risk is defined as an event that has a probability of occurring, and could have either a  positive or negative impact to the lifecycle of a medicinal product. A risk may have one or more causes and, if it occurs, one or more impacts either in cost, schedule or  performance, for example. Risk management means managing a wide spectrum of risks that could affect the  practice of pharmacy. It involves protection of the patient, protection of the pharmacists pharmacists and technicians, and protection of the pharmacy itself. It goes beyond merely putting the right tablets in the bottle with the correct directions on the label. It is even broader than protecting the patient from harm, although that must remain the primary focus of all.

SCOPE

This Plan applies to MDH Pharmacy, and ALL Drug products available.

OBJECTIVE

This guidance is intended to propose propo se to FDA a standard concept for MDH Pharmacy Risk Management Plan ( RMP) in order to deal with “Important identified risks” both risks” both Pharmacovigilance and Risk Minimization Plan. The whole plan is called “Risk Management Plan (RMP).” - This guidance should be used as a guideline when the MDH Pharmacy considers further surveillances and studies regarding the safety of the drug products available at the Pharmacy and additional actions to mitigate risks at anytime when the need is identified. This guidance is intended to aid and improve safety measures based on the MDH Pharmacy protocols.

Mabama Doctors’ Hospital

Title: PHARMACY RISK MANAGEMENT PLAN

No. Page:

Adm. 2018-11-001

2 of 6

Effective Date ( After approval by FDA) Retires Policy Dated: None Previous Versions Date None Approval Date:

Definition of Terms:

Risk - a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions. Risk Identification / Assessment - is a term used to describe the overall process or method where you: 

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Identify hazards and risk factors that have the potential to cause harm (hazard identification). Analyze and evaluate the risk associated with that hazard (risk analysis, and risk evaluation). Determine appropriate ways to eliminate the hazard, or control the risk when the hazard cannot be eliminated (risk control).

Risk Minimization - is the process of doing everything possible to reduce the  probability and/or impact of a risk  towards zero. Risk Communication –   Exchange of information and opinions, and establishments of an effective dialogue, among those responsible for assessing, minimizing, and regulating risks, and those who maybe affected by the outcome of those risk. SAFETY SPECIFICATION

The Mabama Doctors’ Hospital Pharmacy, is a licensed hospital Pharmacy located at Bonifacio Road, Pobalcion 2, Bansalan, Davao del Sur, owned by Mr. William Lowell C. Bragat, and as owner, my responsibilities are below; 1. As a licensed hospital Pharmacy, our general risk management objective is to ensure the safety, efficacy, and quality of drug products, and ensure compliance with regulatory requirements Specifically,  –  Ensure compliance to regulatory action  –  Ensure compliance to GSP  –  Ensure compliance to ethical business practices 2. To ensure that the data lock point  is observed, 3. Ensure that all healthcare professionals such as Physicians, Nurses and Pharmacists are medically qualified and competent,

Mabama Doctors’ Hospital

Title: PHARMACY RISK MANAGEMENT PLAN

No. Page:

Adm. 2018-11-001

3 of 6

Effective Date ( After approval by FDA) Retires Policy Dated: None Previous Versions Date None Approval Date:

4. That all Adverse Drug Reactions (ADR) and Adverse Event (AE) will be reported to the Pharmacovigilance Center using the MDH Adverse Drug Reaction ( ADR) Report Form, 5. To recall all Drug products that has an Adverse Drug Reactions from the Pharmacy and general store room. Make report and return the product to the distributor, 6. To update this MDH Pharmacy RMP when the need is identified and based on the FDA guidelines and Circulars.

The MDH Risk Management Officer

To address the need of a Risk Management Plan in the MDH Pharmacy, the Hospital Administrator appoint the Medical Director, Dr. Sylvia P. Bragat, FPPS as the MDH Risk Management Officer. Under her, are the Chief Nurse and the Chief Pharmacist. The term of reference of the MDH Risk Management Officer as follows; 1. Review and approve the risk policies and any material changes made to these; 2. To review and recommend to the Leadership and Management Committee standards for the RMP which require their approval; and 3. Monitor compliance with the GSP ( cold-chain protocol ) and other policy in MDH Pharmacy RMP

Risk Identification

1. Compliance to Regulatory Action Objectives: To be fully compliant with the FDA regulations and to have a complete list of advisories and documentation of recall products.

Mabama Doctors’ Hospital

Title: PHARMACY RISK MANAGEMENT PLAN

No. Page:

Adm. 2018-11-001

4 of 6

Effective Date ( After approval by FDA) Retires Policy Dated: None Previous Versions Date None Approval Date:

Mitigation Plan Process: Risk Description

Level of Severity

Action to be Taken

Time / Schedule

Responsible Person

1. Compliance to regulatory Action 1.1.

1.2.

1.3.

Lack of Time to Check at the FDA website Poor Internet Connection

Other Risk unidentified  but may occur

Medium 1. Update at FDA website

Every Morning

Pharmacist on duty

Monday –  Friday

Low

Low

1. Contact the IT Every time maintenance  problem exist Technician

Pharmacist on duty

1. To update the MRP and make report to FDA ( data lack point)

Risk Management Officer

Upon Identification

2. Compliance to Good Storage Practice ( GSP) Objectives: To be compliant with the protocol on Cold Chain, “that all products are stored and maintained in correct temperature and to have a consistent temperature on the monitoring charts.” Mitigation Plan Process: Risk Description

2. Compliance to Good Storage Practice 2.1. Cold Chain Irregular Checking

Level of Severity

Medium

Action to be Taken

1.To Check the Refrigerator if  power is on 2.To Check the temperature of refrigerator and record to chart

Time /Schedule

Responsible Person

Every Morning Mondays to Sundays

Pharmacist on Duty

Mabama Doctors’ Hospital

Title: PHARMACY RISK MANAGEMENT PLAN

No. Page:

Adm. 2018-11-001

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Effective Date ( After approval by FDA) Retires Policy Dated: None Previous Versions Date None Approval Date:

2.2. Power Outage

2.3. Malfunctioning Monitoring Equipment

2.4. Malfunctioning Refrigerator

Note: Refer to 1.Contingency Plan for Both Mechanical and Power failure 2. Maintenance and care of the Bio Ref. 3. Monitoring and Adjusting of Temp. of Bio Ref.

Low

Medium

Low

1. Start up the Generator Set

Within 20 minutes from the time of  power interruption

Maintenance Technician On duty

1. To Replace the monitoring equipment

Upon detection of malfunctioning 1. Prepare Purchase Request

Pharmacist on Duty

1. Request repair of the Refrigerator 2. Transfer the drugs to another refrigerator

1. Upon detection of malfunctioni ng

Pharmacist on Duty

Risk Minimization: Standards:

In order to minimize the Risks, the above step by step mitigation planned activities shall be followed. The Risk Management Officer shall review and monitor compliance to the above standards. If upon review, the Risk Management Officer found that the above planned activities were routinely performed by the responsible  persons and still not sufficient to manage the risks, then a supplemental policy shall be formulated to address the current and the newly identified risks.

Mabama Doctors’ Hospital

Title: PHARMACY RISK MANAGEMENT PLAN

No. Page:

Adm. 2018-11-001

6 of 6

Effective Date ( After approval by FDA) Retires Policy Dated: None Previous Versions Date None Approval Date:

Risk Monitoring and Management Evaluation

Standards:

1. The MDH Pharmacy RMP will be reviewed and revised at the end of t he data lock  point or after six (6) months after FDA approval, 2. Review shall follow SOP of the Pharmacovigilance, and 3. RMP shall be reviewed in instances the identified risks occur which needed additional risk management.

Annex: The Standard Operating Procedures of Pharmacovigilance

EFFECTIVITY:

This MDH Pharmacy Risk Management Plan (RMP) will take effect after approval  by the Food and Drug Administrations ( FDA ).

MR. WILLIAM LOWELL C. BRAGAT Hospital Administrator