Guidelines for Patient Engagement in the Activities of the Philippine National Formulary System

August 9, 2017

DOH ADMINISTRATIVE ORDER NO. 2017-0013

 

I. RATIONALE

Patients play a critical role in developing a responsive healthcare system as they are the main recipients of health services provided by the government. As part of good governance, the agency values the importance of stakeholders' participation in planning, prioritization, policy development, allocation of resources and implementation so that they will have a sense of co-ownership of the programs and projects of the government. This is further strengthened by the Philippine Health Agenda, which aims to promote health and deliver healthcare through means that respect, value, and empower clients and patients as they interact with the health system. HTcADC

Recognizing that medicines are essential in the attainment of optimal health outcomes, the development of the Philippine National Formulary (PNF) is a good venue for a two-way interaction between the government and the citizens as this serves as the county's essential medicines list and the basis for medicines procurement by the government as well as the reimbursements made by the Philippine Health Insurance Corporation. The PNF rests on its two-fold objectives: (1) the promotion of rational, responsible use of medicines and (2) the wise and efficient utilization of finite funds of the government and the individual to benefit all Filipinos especially the poor. Through the active engagement of the public, participatory governance can be realized and can be ensured when the Formulary adequately responds to the healthcare needs of the majority of the population.

II. OBJECTIVES

This Order shall provide guidelines on the extent of patient/public engagement on the processes of the Philippine National Formulary.

III. SCOPE AND COVERAGE

This Order shall be applicable to all civil society organizations (CSOs), which include among others non-governmental organizations, patient groups, faith-based organizations, indigenous peoples movement and other institutions that promote the interests of the citizens.

IV. GENERAL GUIDELINES

A. The Philippine National Formulary Executive Council (PNFEC) upholds its commitment to openness and transparency, and as such, recognizes that the CSOs and the public can provide valuable contributions in the development of the PNF.

B. The health authorities must progressively contribute to the patient's right to health and access to quality public health care, which include among others the provision of essential medicines.

C. The patients have a societal right to participate in policy decisions relating to patient's right to health at the community and national level.

D. The involvement of the CSOs and the public in the process of health technology assessment (HTA) shall be guided by the following principles: relevance, fairness, equity, legitimacy and capacity building.

E. The PNF shall contain the list of essential medicines that can be procured by the government and reimbursed by PhilHealth.

F. The CSOs shall be allowed to submit application for inclusion into and deletion from the PNF using the prescribed forms. CAIHTE

G. The schedule of submission of application as stipulated in Administrative Order No. 2016-0034 or The New Implementing Guidelines of the Philippine National Formulary System, Section VI.E.1.b, shall still be observed.

H. Declaration of conflict of interest shall be mandatory to all proponents of the PNF.

I. The CSOs are encouraged to actively report any untoward reaction experienced related to the use of a medicine.

J. Capacity building on HTA shall be provided to the CSOs based on the methods manual of the PNFS.

V. SPECIFIC GUIDELINES

A. Qualification of CSOs

In order to preserve the integrity of the PNFS, only those that satisfy the following criteria shall be allowed to participate in the process:

1. Member organization of the Philippine Alliance of Patient Organizations (PAPO); or

2. Registered with the Securities and Exchange Commission.

B. Filing of application for medicine inclusion

1. The CSO shall accomplish the proposal form prescribed by the PNFEC (Annex A).

2. A letter of request together with the accomplished proposal form shall be submitted to the Pharmaceutical Division, which acts as the technical secretariat of the PNF.

3. All applications shall be submitted on or before the last day of January of each year.

4. Only submissions with duly accomplished proposal form shall be discussed by the Philippine National Formulary Executive Council for prioritization using the criteria set in A.O. 2016-0034. Incomplete submissions shall not be processed. aScITE

C. Conflict of Interest

1. The proponent CSO shall declare any support received from pharmaceutical companies or other private organizations. Failure to do so shall forfeit the application submitted.

D. Participation in meetings

1. CSOs shall be invited to the public consultation of medicines and vaccines prioritized for evaluation, which is scheduled in March of each year.

2. Representatives of CSOs may be invited to the meetings of the PNFEC, as deemed necessary, to act as resource persons. During the meeting, questions will be asked relating to their experience with the condition and/or therapy.

3. The CSO representative shall act solely as resource person and shall not be allowed to vote. They shall, however, be allowed after the meeting to submit comments on the recommendation of the PNFEC.

VI. ROLES AND RESPONSIBILITIES

A. Pharmaceutical Division

The Pharmaceutical Division through its Policy, Planning, Program Development and Research Unit shall act as the technical secretariat of the Philippine National Formulary and shall be responsible in disseminating all PNF-related information to all stakeholders. It shall likewise be responsible in convening the meetings of the PNFEC and coordinating with the concerned CSOs.

B. Philippine National Formulary Executive Council

The PNFEC shall review all applications submitted for inclusion in or deletion from the PNF and make appropriate recommendations to the Secretary of Health thru the concerned Undersecretary or Assistant Secretary.

C. Evidence Review Groups

The ERG shall prepare the evidence summaries and perform facilitated/rapid reviews or cost-effectiveness analysis pertaining to the medicines under deliberation as requested by PNFEC.

D. Pool of specialty experts

The specialty experts on various disciplines shall provide inputs during the deliberations when called upon by the PNFEC.

E. Civil Society Organizations

The CSOs shall ensure the completeness of submissions and shall be responsible in disseminating PNF-related information to their members. They shall also report to the Pharmaceutical Division and Food and Drug Administration any adverse events related to the administration of a medicine. DETACa

F. Food and Drug Administration

The FDA shall provide immediate action to any issues related to the safety, efficacy and quality of medicines as reported by the CSOs.

VII. SEPARABILITY CLAUSE

If any provision in these Guidelines, or application of such provision to any circumstance, is held invalid, the remainder of these Guidelines shall not be affected thereby.

VIII. EFFECTIVITY

This Order shall be effective within fifteen (15) days from publication in the Official Gazette.

 

(SGD.) PAULYN JEAN B. ROSELL-UBIAL, MD, MPH, CESO IISecretary of Health

ANNEX A

 

Patient Group Submission Template for HTA of Medicines

Health Technology Assessment (HTA) on

1. Purpose of this form

We recognize that patients have unique knowledge about what it's like to live with a specific disease or medical condition. They can describe advantages and disadvantages of therapies, which may not be reported in published literature. They can tell us what they would most value from a new treatment.

This submission form has been created to help patient groups provide information for the assessment of a particular medicine. It provides prompts to draw out the unique patient knowledge that has the greatest potential to influence the decisions made by HTA staff and appraisal committees.

Section 2 provides guidance to patient groups on how to complete this submission form.

Section 3 asks you for some background information about your patient group.

Sections 4-8 are the main part of the form for you to complete, describing the views and experiences of patients and their caregivers/carers.

We recognise that completing this form requires substantial resources and so we commit to making all patient submissions available to all involved in the appraisal process, particularly HTA reviewers and committee members. Furthermore, our assessment reports and/or HTA advice/recommendations will document how the information from patients was considered in developing our conclusions/recommendations. HEITAD

If requested, we will provide you with further feedback about how the submission from your patient group was used and influenced decision-making.

2. How to complete this form

In the main sections of this form, you are asked to describe the challenges patients face in living with the condition being studied, experiences of using current therapies, expectations from the new medicine and, if you are aware, the potential benefit or drawbacks from the new medicine being assessed.

Each question has a series of prompts in a box that are intended to assist you in providing the information that will be helpful to HTA reviewers and committees in understanding the impact of the condition and its treatment. Please address any of the prompts that your group feels is important and describe any other relevant issues that are not captured in the list of prompts.

In all parts of this form the term "patient" refers to anyone living with, or who has lived with, the condition for which the new medicine is indicated.

Please provide clear facts, information and summaries of experiences to give a concise, accurate and balanced overview of a range of patients' and care-givers' (carers') perspectives/views. State the source of your information (e.g., web survey, helpline analysis, social networking, focus group, patients' records, one-to-one conversations with those in clinical trials, patient stories) and provide clear references where they are available.

There is no need to send us published scientific papers, as we already have access to those. However, if you have views about the interpretation of a paper about a particular clinical trial, we would be happy to hear them.

For any of the sections in the form, if there are groups that should have special consideration, please indicate the specific needs/issues of that group (e.g., children, women/men, ethnic groups, those living in a particular location, those with other disabilities, disease sub-types).

If you require help in understanding HTA related terms, please refer to the HTAi glossary for patients or visit the training resources on the HTAi website (www.htai.org).

If you have any questions when completing this form, please contact the PNF Secretariat at telephone number 6517800 extension 2555 or email at [email protected] and [email protected]

3. Information about your group

Name of group:

Key contact name:

Role:

Email:

Phone:

Postal address:

Type of group (tick all that apply):

Registered charity	[ ]
Fellowship	[ ]
Informal self-help group	[ ]
Unincorporated organisation	[ ]
Other

Please state _________________________________________________

Purposes of group (tick all that apply):

Advocacy	[ ]
Education	[ ]
Campaigning	[ ]
Service	[ ]
Research	[ ]
Other

 

Please specify ______________________________________________

Describe your membership (number and type of members, region that your group represents, demographics, etc)? aDSIHc

In line with how we treat other stakeholders, we ask you to complete our declaration of interests.

Did anyone help you prepare this submission? YES/NO

If yes — who helped you and in what way?

Are you willing for this submission to be shared on our website after removal of financial information and personal information that could identify patients? YES/NO

We may invite you to meetings where this HTA is to be discussed. Would a member of your group be willing to attend such meetings? YES/NO

4. Impact of condition

How does the condition or disease for which the medicine is being assessed, affect patients' quality of life?

Issues to consider in your response

• Aspects of the condition that are most challenging (e.g., symptoms, loss of ability to work, loss of confidence to go out, inability to drive, social exclusion).

• Activities that patients find difficult or are unable to do.

• Aspects of the condition that are the most important to control (e.g., symptoms that limit social interaction or ability to work such as difficulty breathing, pain, fatigue, incontinence, anxiety). ATICcS

• Support required for daily living (physical or emotional).

• Types of patients that are most affected by the condition (e.g., men/women, children, ethnic groups).

• Challenges in managing this condition when patients also have other medical conditions.

• What patients would most like to see from a new treatment (e.g., halting of disease progression, improvement in a particular symptom).

How does the condition or disease affect carers/unpaid caregivers?

Issues to consider in your response

• Challenges faced by family and friends who support a patient to manage the condition.

• Pressures on carers/care-givers daily life (e.g., emotional/psychological effects, fatigue, stress, depression, physical challenges).

5. Experience with current therapies

How well are patients managing their condition with currently available therapies?

(Currently available therapies may include any form of medical intervention such as medicines, rehabilitation, counselling, hospital interventions etc. If no specific therapy is available that should be stated.)

Issues to consider in your response

• Main therapies currently used by patients for this condition and how they are given (tablet, injection, physiotherapy, hospital check-ups, etc., at home, in hospital; dose and frequency, ease of access)

• Extent to which current therapies control or reduce the most challenging aspects of the condition.

• The most important benefits of current therapies.

• The burden of therapy on daily life (e.g., impact at different stages of disease, interruption to work, stigma, clinic visits to receive infused medicines, need for weekly blood tests or describe a typical episode of therapy over a week or period of treatment). ETHIDa

• Side effects from the therapies that are difficult to tolerate.

• Concerns about long-term use of current therapy.

• If the current therapy is a medicine:

o Challenges in taking it as prescribed (e.g., swallowing the pill, self-injecting, use of a device to deliver the medicine, taking after food, not being able to lie down for 30 minutes after taking medicine).

o Ways in which the dosing is modified compared to what is prescribed (e.g., dividing the dose to avoid unwanted side effects, missing doses to fit into daily life).

6. Experiences with new medicine being assessed

For those with experience using the new medicine, what difference did it make to their lives?

Issues to consider in your response

• Advantages and disadvantages of the new medicine compared with current therapy.

• Ease of use.

• Symptoms that were improved with the new medicine and impact on quality of life.

• Impact of the new medicine on the use of healthcare services (e.g., fewer visits to hospital).

• Financial implications (e.g., cost of medicine, travelling costs, medicine administration supplies, days off work).

• Explain whether the full prescribed dose of the new medicine is generally taken and what factors have led patients to miss doses.

• Side effects from the new medicine that are difficult to tolerate.

• Extent to which the new medicine addresses patients' needs.

For those without experience using the new medicine, but who are aware of the results of clinical trials about the new medicine, what are the expectations/limitations of it?

Issues to consider in your response

• Perceived advantages and disadvantages of the new medicine.

• Whether the clinical studies have reported outcomes that are important to patients.

• Level of improvement patients would like to see.

• Impact the new medicine might have on use of healthcare services (e.g., fewer visits to hospital).

• Financial implications (e.g., cost of medicine, travelling costs, medicine administration supplies, days off work). TIADCc

• The level of side effects that patients would tolerate for a given benefit.

• Groups of patients who might particularly benefit or who might benefit less from the new medicine than others.

• Aspects of patients' needs or expectations that it is hoped the new medicine will address (explaining specific issues for particular stages of disease).

7. Additional information

Please include any additional information you believe would be helpful to the HTA reviewers and committee (e.g., ethical or social issues).

8. Key messages

In no more than five statements, please list the most important points of your submission.

For example:

• The biggest challenges of living with this condition are. . .

• Current therapies are inadequate because. . .

• This new medicine will be important for patients because. . .