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Introduction
Good Pharmacy Practice (GPP) is at the very                             authorities and other relevant bodies
heart of the profession of Pharmacy; indeed it                          responsible for drawing up relevant
is the very essence of the profession. Moreover,                        documentation and related laws and
it expresses our covenant with the patient not                          regulations in their individual countries.
only to ‘do no harm’ but also to facilitate good                        It does not establish national standards by
therapeutic outcomes with medicines.                                    itself but provides guidance on specific
                                                                        achievable roles, functions and activities that
It is recognized that pharmacy practice varies                          fulfill the mission of pharmacy practice in the
enormously from one country to another and                              new millennium.
from one continent to another, incorporating
developing, transitional and developed                                  Professional concerns and attitudes are
countries. The applicability of the 2011 update                         emphasized throughout these guidelines
of the joint WHO/FIP guidelines on Good                                 and the patient’s welfare and well-being are
Pharmacy Practice: Standard for quality of                              of paramount importance. However it will
pharmacy services is intended to take these                             be noted that legal, workforce and economic
variations in practice in to account.                                   frameworks are also introduced for the first
                                                                        time in the context of GPP and this is aptly
The pharmacy profession is currently                                    timed, given the considerable worldwide
advancing at a considerable pace and new                                debate on the economics of medicines, access
roles are being proposed and promulgated,                               to quality medical products, access to trained
not only by the profession itself but also by                           health professionals, global health workforce
other healthcare professions and by national                            shortages, escalating cost of healthcare and
and international authorities and agencies.                             application of new collaborative pharmacy
These guidelines on GPP are intended to be                              practice models.
far reaching and sufficiently flexible in its
approach that it should remain relevant as                              In conclusion, both WHO and FIP define GPP as
these new roles become established.                                     the practice of pharmacy that responds to the
                                                                        needs of the people who use the pharmacists’
Both WHO and FIP emphasize that these                                   services to provide optimal, evidence-based
guidelines on GPP are for the use of national                           care. To support this practice it is essential that
pharmacy professional associations, together                            there be an established national framework of
with their national                                                     quality standards and guidelines.

                                                                        Dr Michel Buchmann,
                                                                        President, FIP



The following content refers to:
Annex 8: Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services from the WHO technical report series,
No. 961, 45th report of the WHO Expert Committee on specifications for pharmaceutical preparations © World Health Organization 2011

Reprinted with permission from WHO.


Available online at: http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf
Annex 8


Joint FIP/WHO
guidelines on good
pharmacy practice:
standards for
quality of pharmacy
services


Background
1. Introduction
2. Underlying philosophy
3. Definition of good pharmacy practice
4. Requirements of good pharmacy practice
5. Setting standards for good pharmacy practice
6. Conclusions
Background
Under the World Health Organization (WHO)’s Revised Drug Strategy adopted by
the World Health Assembly in 1986, WHO organized two meetings on the role of the
pharmacist, in Delhi, India in 1988 and in Tokyo, Japan in 1993. This was followed by the
adoption, in May 1994, of the World Health Assembly Resolution WHA47.12 on the role
of the pharmacist, in support of the WHO Revised Drug Strategy.

In 1992 the International Pharmaceutical Federation (FIP) developed standards for
pharmacy services under the heading “Good pharmacy practice in community and
hospital pharmacy settings”. The text on good pharmacy practice was also submitted
to the WHO Expert Committee on Specifications for Pharmaceutical Preparations
in 1994. Following the recommendations of the WHO Expert Committee and the
endorsement of the FIP Council in 1997, the FIP/WHO joint document on good
pharmacy practice (GPP) was published in 1999 in the thirty-fifth report of the WHO
Expert Committee on Specifi cations for Pharmaceutical Preparations (WHO Technical
Report Series, No. 885).

Subsequently WHO organized two more meetings on the role of the pharmacist, in
Vancouver, Canada in 1997 and in the Hague, the Netherlands in 1998. These meetings
reinforced the need for pharmacy curricular reform and the added value of the
pharmacist in self-care and self-medication.

In collaboration with WHO, the fi rst edition of a practical handbook Developing
pharmacy practice — a focus on patient care was launched in 2006. This handbook is
designed to meet the changing needs of pharmacists, setting out a new paradigm for
pharmacy practice and presenting a step-by-step approach to pharmaceutical care.

With the overall aim of improving standards and practice of distribution and use
of medicines, using the FIP/WHO guidelines for GPP as the framework, FIP took the
initiative to explore the possibilities for providing technical assistance to its Member
Organizations in Cambodia, Moldova, Mongolia, Paraguay, Thailand, Uruguay and
Viet Nam, in developing national standards for GPP in a pilot study from 2005 to
2007. In 2007 the “Bangkok declaration on good pharmacy practice in the community
pharmacy settings” in the South-East Asia Region was adopted by the FIP South-East
Asia Pharmaceutical Forum and set out the commitment of its Member Associations
towards raising standards of pharmacy services and professional practice.

Since the adoption of the GPP guidelines in community and hospital settings,
significant changes in practice, applied science and technology and pharmaceutical
policy have occurred, including the relevance of more recent World Health Assembly
resolutions: WHA54.11 (WHO Medicines Strategy), WHA54.13 (Strengthening health
systems in developing countries), WHA55.14 (Ensuring accessibility of essential
medicines), WHA55.18 (Quality of care: patient safety), WHA57.16 (Health promotion)
and WHA60.16 (Rational use of medicines).

Furthermore, in 2007 FIP established an initiative to investigate the need to update the
guidelines on GPP to reflect contemporary standards of practice and thinking. An FIP
working group on GPP first met on 15 October 2007 to identify key issues that needed
to be considered in the revision of the guidelines.

In 2008 FIP organized an expert consultation in Basel, Switzerland during its 68th World
Congress. Fifty participants attended the meeting, including the FIP Working Group
(WG) on GPP, WHO staff from headquarters, representatives from the WHO Regional
Office for the Eastern Mediterranean, country medicines advisers from Ghana, Nigeria
and the United Republic of Tanzania, Presidents and Secretaries of the six FIP Regional
Pharmaceutical Forums, FIP Member Organizations and several invited experts.

Following this consultation, the FIP WG on GPP undertook an extensive review of the
existing national standards on GPP in at least 37 countries and established a time
frame that would allow sufficient consultation with all of FIP’s 120 national Member
Associations, relevant experts and WHO. A proposal for this initiative was presented
to the forty-third meeting of the WHO Expert Committee on Specifi cations for
Pharmaceutical Preparations in October 2008 and an updated report was provided to
the Expert Committee at its forty-fourth meeting in October 2009.

1. Introduction
The health of the public is fundamental to the happiness and welfare of all people.
Barriers to good health include poor access to quality medical products, lack of access
to trained health professionals and care, an inadequate health workforce, unaffordable
cost of care and poor standards of education of health-care professionals.

Medicines are an essential and critical part of health-care services in all cultures
and societies. When accessed, medicines are often an essential component of
many disease prevention programmes and virtually all disease treatment plans.
The potential benefit of medicines is often not realized — there is a gap between
the proven efficacy of medicines demonstrated in clinical trials and their actual
effectiveness in practice. The reasons for this gap include problems with medicine
selection and dosages, improper administration of medicines and lack of adherence by
patients to prescribed treatment, medicine–medicine and medicine–food interactions,
and adverse medicine events. Besides clinical problems associated with medicine-
related problems, there are cost implications. It has been estimated that the cost
of problems with the use of medicines is equal to or greater than the cost of the
medicines themselves.

Medicines are also increasingly expensive and their cost is compromising the
affordability of health care. Managing the costs of medicines is critical to making the
best use of limited resources to maximize health care for as many people as possible.
Substandard, adulterated, unlicensed and spurious/falsely-labelled/falsified/
counterfeit medicines are a growing problem that compromise health. There is a need
for a system of assuring the integrity of the medicine supply chain to assure the value
of medicines used for the prevention of disease and the treatment of patients.

Pharmacists 1 are specifically educated and trained health professionals who are
charged by their national or other appropriate (e.g. state or provincial) authorities
with the management of the distribution of medicines to consumers and to engage
in appropriate efforts to assure their safe and efficacious use. There is also increasing
recognition that providing consumers with medicines alone is not suffi cient to
achieve the treatment goals. To address these medication-related needs, pharmacists
are accepting greater responsibility for the outcomes of medicines use and are
evolving their practices to provide patients with enhanced medicines-use services.

As health-care professionals, pharmacists play an important role in improving access
to health care and in closing the gap between the potential benefit of medicines and
the actual value realized and should be part of any comprehensive health system.
In addition, the increasingly complex and diverse nature of pharmacists’ roles in the
health-care system and public health demands a continuous maintenance of the
competence of pharmacists as health-care professionals who have up-to-date skills
and expertise.

National pharmacy professional associations need to work together with their
governing bodies and other health-care professional associations to support
pharmacists in their countries through provision of continuing professional
development activities, including distance-learning programmes, and establishing
national standards of pharmacy services and practice objectives.

These guidelines are intended to provide a description of ways in which pharmacists
can improve access to health care, health promotion and the use of medicines on
behalf of the patients they serve. The role of FIP is to provide leadership for national

1 Pharmacists are health-care professionals whose professional responsibilities and accountabilities include seeking to ensure that people derive maximum thera-
peutic benefit from their treatments with medicines. This requires them to keep abreast of developments in pharmacy practice and the pharmaceutical sciences,
professional standards and requirements, the laws governing pharmacy and medicines and advances in knowledge and technology relating to use of medicines.
pharmacy professional organizations, which in turn provide the impetus for setting
national standards.2 The vital element is the commitment of the pharmacy profession
worldwide to promoting excellence in practice for the benefit of those served. The
public and other professions will judge the pharmacy profession on how its members
translate that commitment into practice in all settings, especially community and
hospital pharmacy settings.

It is the policy of FIP and WHO to provide guidance to national pharmacy professional
organizations regarding the development of their national GPP guidelines. The
conditions of practice vary widely from country to country and each national
pharmacy professional organization is best able to decide what can be achieved and
within what time-scale.

2. Underlying philosophy
The mission of pharmacy practice is to contribute to health improvement and to help
patients with health problems to make the best use of their medicines.

There are six components to this mission:
• being readily available to patients with or without an appointment;
• identifying and managing or triaging health-related problems;
• health promotion;
• assuring effectiveness of medicines;
• preventing harm from medicines; and
• making responsible use of limited health-care resources.

In the community setting, pharmacists should be acknowledged as health-care
professionals whom patients can consult for health-related problems. Because
health-care products and services are available from the pharmacist, some problems
can be managed at this point of care. Problems that require additional diagnostic
skill or treatments not available from a pharmacist can be referred to an appropriate
health-care professional or site of care, such as a hospital. This should be done in good
collaboration between the health-care providers.

To improve the use of medicines, pharmacists have responsibilities for many aspects
of the process of medicines use, each of which is important to achieve good outcomes
from treatment. This begins with assuring the integrity of the medicine supply chain,
including detecting spurious/falsely-labelled/falsified/counterfeit medicines, ensuring
proper storage of medicines and quality preparation of medicines when needed. It
also includes assuring the proper prescribing of medicines so that dose regimens and
2 Throughout this document, the term “national standards” includes laws, regulations, standards, ordinances or other requirements enacted or promulgated by an
official body at any level of government, as well as guidelines, recommendations or other pronouncements of professional organizations of pharmacy.
dosage forms are appropriate; instructions for use are clear; medicine–medicine and
medicine–food interactions are prevented; known and predictable adverse medicine
reactions, including allergies and other contraindications, are avoided; unnecessary
treatments are minimized and the cost of medicines is considered.

Another important component of this mission is assisting patients and those
administering medicines to understand the importance of taking medicines properly,
including the correct timing of doses, foods or other medicines to avoid when taking
a dose and what to expect after taking the medicine. Monitoring treatment to verify
effectiveness and adverse medicine events is also an important part of the process of
use of medicines.

3. Definition of good pharmacy practice
GPP is the practice of pharmacy that responds to the needs of the people who use the
pharmacists’ services to provide optimal, evidence-based care. To support this practice
it is essential that there be an established national framework of quality standards and
guidelines.

4. Requirements of good pharmacy practice
• GPP requires that a pharmacist’s first concern in all settings is the welfare of patients.
• GPP requires that the core of the pharmacy activity is to help patients make the best
  use of medicines. Fundamental functions include the supply of medication and other
  health-care products of assured quality, the provision of appropriate information
  and advice to the patient, administration of medication, when required, and the
  monitoring of the effects of medication use.
• GPP requires that an integral part of the pharmacist’s contribution is the promotion
  of rational and economic prescribing, as well as dispensing.
• GPP requires that the objective of each element of pharmacy service is relevant to
  the patient, is clearly defined and is effectively communicated to all those involved.
  Multidisciplinary collaboration among health-care professionals is the key factor for
  successfully improving patient safety.

In satisfying these requirements, the following conditions are necessary:

• the well-being of patients should be the main philosophy underlying practice, even
  though it is accepted that ethical and economic factors are also important;
• pharmacists should have input into decisions about the use of medicines. A system
  should exist that enables pharmacists to report and to obtain feedback about
  adverse events, medicine-related problems, medication errors, misuse or medicine
  abuse, defects in product quality or detection of counterfeit products. This reporting
may include information about medicine use supplied by patients or health
  professionals, either directly or through pharmacists;
• the relationship with other health professionals, particularly physicians, should be
  established as a therapeutic collaborative partnership that involves mutual trust and
  confidence in all matters relating to pharmacotherapy;
• the relationship between pharmacists should be one of colleagues seeking to
  improve pharmacy service, rather than acting as competitors;
• in reality, organizations, group practices and pharmacy managers should accept a
  share of responsibility for the definition, evaluation and improvement of quality;
• the pharmacist should be aware of essential medical and pharmaceutical
  information (i.e. diagnosis, laboratory test results and medical history) about each
  patient. Obtaining such information is made easier if the patient chooses to use only
  one pharmacy or if the patient’s medication profile is available;
• the pharmacist needs evidence-based, unbiased, comprehensive, objective and
  current information about therapeutics, medicines and other health-care products in
  use, including potential environmental hazard caused by disposal of medicines’ waste;
• pharmacists in each practice setting should accept personal responsibility for
  maintaining and assessing their own competence throughout their professional
  working lives. While self-monitoring is important, an element of assessment and
  monitoring by the national pharmacy professional organizations would also
  be relevant in ensuring that pharmacists maintain standards and comply with
  requirements for continuous professional development;
• educational programmes for entry into the profession should appropriately address
  both current and foreseeable changes in pharmacy practice; and
• national standards of GPP should be specified and should be adhered to by
  practitioners.

At the national or appropriate (e.g. state or provincial) level, it is necessary to establish:

• A legal framework that:
- defines who can practice pharmacy;
- defines the scope of pharmacy practice;
- ensures the integrity of the supply chain and the quality of medicines.

• A workforce framework that:
- ensures the competence of pharmacy staff through continuing professional
  development (CPD or continuing education (CE)) programmes;
- defines the personnel resources needed to provide GPP.
• An economic framework that:
- provides sufficient resources and incentives that are effectively used to ensure the
  activities undertaken in GPP.

5. Setting standards for good pharmacy practice
GPP includes standards that often exceed those laid down by national legislation.
Furthermore, legislation seldom gives precise instructions about how the services
should be produced to meet the requirements. Therefore, national pharmacy
professional associations have a role in setting standards required for GPP, which
includes a quality management framework and a strategic plan for developing
services. It is also recognized that in developing national standards for GPP, attention
must be paid to both the needs of the users of health-care services and the capacity of
national health-care systems to support these services.

Just as pharmacy practice will vary among nations, it will also vary among practice
locations. Therefore, standards should recognize the uniqueness of different
pharmacy practice settings (e.g. community and hospital pharmacy). In addition, as
medicines and needs change, the standards should acknowledge evolving practice
settings and provide these developing services with guidance without negatively
affecting the evolutionary nature of practice. At the same time, a baseline should be
established for practice below which the activity cannot be considered “pharmacy
practice” at all and, therefore, should not be condoned.

When establishing minimum standards on GPP, FIP emphasizes the importance of
first defining the roles played by pharmacists, as expected by patients and society.
Secondly, relevant functions for which pharmacists have direct responsibility and
accountability need to be determined within each role. Thirdly, minimum national
standards should then be established, based upon the need to demonstrate
competency in a set of activities supporting each function and role.

The minimum national standards for each activity are based on processes that need
to be relevant and defined appropriately according to the local needs of the pharmacy
practice environment and national profession aspirations. All national pharmacy
professional associations should also adapt these roles and functions in accordance
to their own requirements. The activities listed below can be further defined and
measured by setting indicators of good practice within a national context and can be
weighted by actual practice-setting priorities.

It is recommended that national pharmacy professional associations consider the
following roles, functions and activities for pharmacists, where appropriate:
Role 1: Prepare, obtain, store, secure, distribute, administer,
dispense and dispose of medical products
• Function A: Prepare extemporaneous medicine preparations and medical products
  Minimum national standards should be established for these activities.
- Pharmacists should ensure that medicine preparation areas are appropriately
  designed to permit ease of extemporaneous preparations and are maintained
  in a manner that minimizes the potential for medication errors and assures the
  cleanliness and safety of medical products.

- Pharmacists should ensure that compounded medicines are consistently prepared
  to comply with written formulas and quality standards for raw materials, equipment
  and preparation processes, including sterility where appropriate.

• Function B: Obtain, store and secure medicine preparations and medical products
  Minimum national standards should be established for these activities.
- Pharmacists who are responsible for procurement should ensure that the
  procurement process is transparent, professional and ethical so as to promote equity
  and access and to ensure accountability to relevant governing and legal entities.

- Pharmacists who are responsible for procurement should ensure that procurement
  is supported by strong quality assurance principles to assure that substandard,
  adulterated, unlicensed and spurious/falsely-labelled/falsified/counterfeit medicines
  are not procured or allowed into the system.

- Pharmacists who are responsible for procurement should ensure that procurement
  is supported by a reliable information system which provides accurate, timely and
  accessible information.

- Pharmacists should establish contingency plans for shortages of medicines and for
  purchases in emergencies.

- Pharmacists should assure that proper storage conditions are provided for all
  medicines, especially for controlled substances, used in the pharmacy or health-care
  facility.

• Function C: Distribute medicine preparations and medical products
  Minimum national standards should be established for these activities.
- Pharmacists should ensure that all medical products, including medicine samples,
  are handled and distributed in a manner that assures reliability and safety of the
  medicine supply.
- Pharmacists should establish an effective distribution system which includes a
  written procedure, to recall promptly and effectively medical products known or
  suspected to be defective or spurious/falsely-labelled/falsified/counterfeit, with a
  designated person(s) responsible for recalls.

- Pharmacists should develop with manufacturers, wholesalers and government
  agencies (where appropriate) an access plan for uninterrupted supply of essential
  medicines as part of a disaster or pandemic preparedness strategy.

- As part of a disaster or pandemic preparedness strategy, national medicines
  regulatory agencies may introduce new medicines which are authorized for
  marketing with limited safety data; pharmacists have a responsibility to be aware of
  the safety issues and to institute necessary mechanisms for monitoring occurrence
  of adverse events.

• Function D: Administration of medicines, vaccines and other injectable medications
  Minimum national standards should be established for these activities.
- Pharmacists should have a role in the preparation and administration of medicines,
  in establishing procedures in their work settings with respect to the administration,
  and in monitoring the outcomes of medication administration.

- Pharmacists should have an educator, facilitator and immunizer role, thus
  contributing to the prevention of diseases through participation in vaccination
  programmes, by ensuring vaccination coverage and by also ensuring vaccine safety.

- Pharmacists should participate in directly observed therapy (DOT) programmes in
  areas such as the management of drug addiction, HIV/AIDS, tuberculosis and sexually
  transmitted diseases, where applicable.

• Function E: Dispensing of medical products
  Minimum national standards should be established for these activities.
- Pharmacists should ensure that appropriate facilities, trained personnel, standard
  dispensing practices and documentation procedures are in place in the pharmacy for
  the supply and dispensing of prescribed medicines and other health-care products.

- Pharmacists should assess and evaluate all paper or electronic prescriptions
  received, considering the therapeutic, social, economic and legal aspects of the
  prescribed indication(s) before supplying medical products to the patient. Where
  possible, generic substitution is recommended.
- Pharmacists should ensure patient confi dentiality at the point of dispensing
  medical products and should provide advice to ensure that the patient receives and
  understands suffi cient written and oral information to derive maximum benefit for
  the treatment.

• Function F: Dispose of medicine preparations and medical products
  Minimum national standards should be established for these activities.
- Pharmacists should ensure that regular monitoring of the medicines inventory is
  conducted and should always include medicines samples in the process of periodic
  inspection for expiration dates and removal of outdated stock.

- Pharmacists should ensure that recalled medical products, including medicines
  samples, are immediately stored separately for subsequent disposal and prevented
  from being available for further dispensing or distribution.

- Pharmacists should establish a safe way of medicines waste disposal at the hospital
  and/or community pharmacy so that patients and the public can be encouraged
  to return their expired or unwanted medicines and medical devices. Alternatively,
  pharmacists should provide appropriate information to patients on how to safely
  dispose of expired or unwanted medicines.

Role 2: Provide effective medication therapy management 3
• Function A: Assess patient health status and needs
  Minimum national standards should be established for these activities.
- Pharmacists should ensure that health management, disease prevention and healthy
  lifestyle behaviour are incorporated into the patient assessment and care process.

- Pharmacists should acknowledge unique patient considerations such as education
  level, cultural beliefs, literacy, native language and physical and mental capacity in all
  individual patient assessments.

• Function B: Manage patient medication therapy
  Minimum national standards should be established for these activities.
- Pharmacists should maintain access to an appropriate evidence base relating to
  the safe, rational and cost-effective use of medicines such as reference books on
  medicines, journals, national essential medicines lists and standard treatment
  guidelines.


3 Medication therapy management is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication therapy man-
agement services are independent of, but can occur in conjunction with, the provision of a medication product.
- Pharmacists should ensure that medicine formulary system(s) (local, regional and/
  or national) are linked to standard treatment guidelines, protocols and treatment
  pathways based on the best available evidence.

- Pharmacists should have a key role in educating prescribers on the access to and
  evidence for optimal and appropriate use of medicines including the required
  monitoring parameters and prescribing adjustments. Where appropriate,
  pharmacists should provide advice or recommendations to the prescriber on
  medicine therapy, including the selection of the appropriate medication or dosage.

- Pharmacists should have access to, contribute to and use all necessary clinical and
  patient data to coordinate effective medication therapy management, especially
  when multiple health-care practitioners are involved in the patient’s medication
  therapy, and intervene if necessary.

- Pharmacists should establish a standard operating procedure for referrals to
  physicians, specialists or other health-care providers, where appropriate.

- Pharmacists should provide continuity of care by transferring information on
  patients’ medicines as patients move between sectors of care.

• Function C: Monitor patient progress and outcomes
  Minimum national standards should be established for these activities.
- Pharmacists should consider patient diagnosis and patient-specific needs when
  assessing patient response to medicine therapy and intervene if necessary.

- Pharmacists should document necessary clinical and patient data to assess and
  monitor medication therapy and to track patients’ therapeutic outcomes.

- Pharmacists should perform point-of-care testing for patients in order to monitor
  and adjust therapy, when needed.

• Function D: Provide information about medicines and health-related issues
  Minimum national standards should be established for these activities.
- Pharmacists should ensure that in every pharmacy there is a suitable place for
  discussing confi dential information with the customers and patients.

- Pharmacists should provide sufficient health, disease and medicinespecific
  information to patients for their participation in their decision-making process
regarding a comprehensive care management plan. This information should aim at
  supporting adherence to treatment and empowerment of the patient.

- Pharmacists should be proactive in reducing antimicrobial resistance by providing
  information about the appropriate use of antimicrobials to consumers and prescribers.

Role 3: Maintain and improve professional performance
• Function A: Plan and implement continuing professional development 4 strategies
  to improve current and future performance
  Minimum national standards should be established for these activities.
- Pharmacists should perceive continuing education as being lifelong and be able
  to demonstrate evidence of continuing education or continuing professional
  development to improve clinical knowledge, skills and performance.

- Pharmacists should take steps to update their knowledge and skills about
  complementary and alternative therapies such as traditional Chinese medicines,
  health supplements, acupuncture, homeopathy and naturopathy.

- Pharmacists should take steps to update their knowledge and be engaged in
  implementation of new technology and automation in pharmacy practice, where
  feasible.

- Pharmacists should take steps to become informed and update their knowledge on
  changes to information on medical products.

Role 4: Contribute to improve effectiveness of the health-care system
and public health
• Function A: Disseminate evaluated information about medicines and various aspects
  of self-care
  Minimum national standards should be established for these activities.
- Pharmacists should ensure that the information provided to patients, other health-
  care professionals and the public is evidence-based, objective, understandable, non-
  promotional, accurate and appropriate.

- Pharmacists should develop and/or use educational materials for health management,
  health promotion and disease prevention programmes that are applicable to a wide
  range of patient populations, age groups and health literacy levels.


4 The concept of continuing professional development (CPD) can be defined as “the responsibility of individual pharmacists for systematic maintenance, develop-
   ment and broadening of knowledge, skills and attitudes, to ensure continuing competence as a professional, throughout their careers.”
- Pharmacists should educate patients on how to evaluate and use web-based or other
  forms of health-care information (including medicines information) and strongly
  encourage them to be advised by a pharmacist regarding the information they fi nd,
  particularly if obtained from the Internet.

- Pharmacists should assist patients and their care providers to obtain and critically
  analyse information to meet their individual needs.

• Function B: Engage in preventive care activities and services
  Minimum national standards should be established for these activities.
- Pharmacists should engage in preventive care activities that promote public health
  and prevent disease, i.e. in areas such as smoking cessation, infectious and sexually
  transmitted diseases.

- Pharmacists should provide point-of-care testing, where applicable, and other health
  screening activities for patients at higher risk of disease.

• Function C: Comply with national professional obligations, guidelines and
  legislations
  Minimum national standards should be established for these activities.
- Pharmacists should take steps to ensure that they comply with the provisions of a
  national code of ethics for pharmacists.

• Function D: Advocate and support national policies that promote improved health
  outcomes
  Minimum national standards should be established for these activities.
- Pharmacists should contribute to public and professional groups to promote,
  evaluate and improve health in the community

- Pharmacists should collaborate with other health-care professionals in their efforts
  to improve health outcomes.
6. Conclusions
There are four main roles where pharmacists’ involvement or supervision is expected
by society and the individuals they serve:

1. Prepare, obtain, store, secure, distribute, administer, dispense and dispose of
   medical products.
2. Provide effective medication therapy management.
3. Maintain and improve professional performance.
4. Contribute to improve effectiveness of the health-care
   system and public health.

These roles may vary for each individual pharmacist depending on their practice
responsibilities.

Specific standards of GPP can be developed only within a national pharmacy
professional organization framework.

This guidance is recommended as a set of professional goals to be met in the interest
of the patients and other key stakeholders in the pharmaceutical sector. Responsibility
for moving the project forward will rest with each national pharmacy professional
association. Achieving specific standards of GPP for each nation within these
recommendations may require considerable time and effort. As health professionals,
pharmacists have a duty to begin the process without delay.
GPP guidelines fip publication final
GPP guidelines fip publication final

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การประเมินโอกาสเสี่ยงต่อโรคหัวใจและหลอดเลือดในผู้ป่วยเบาหวานและความดันโลหิตสูงการประเมินโอกาสเสี่ยงต่อโรคหัวใจและหลอดเลือดในผู้ป่วยเบาหวานและความดันโลหิตสูง
การประเมินโอกาสเสี่ยงต่อโรคหัวใจและหลอดเลือดในผู้ป่วยเบาหวานและความดันโลหิตสูง
 
ความรู้เรื่องโรคไต
ความรู้เรื่องโรคไตความรู้เรื่องโรคไต
ความรู้เรื่องโรคไต
 
แนวทางการพัฒนาการตรวจรักษาโรคจมูกอักเสบภูมิแพ้ในคนไทย (ฉบับปรับปรุง พ.ศ. ๒๕๕๔)
แนวทางการพัฒนาการตรวจรักษาโรคจมูกอักเสบภูมิแพ้ในคนไทย (ฉบับปรับปรุง พ.ศ. ๒๕๕๔)แนวทางการพัฒนาการตรวจรักษาโรคจมูกอักเสบภูมิแพ้ในคนไทย (ฉบับปรับปรุง พ.ศ. ๒๕๕๔)
แนวทางการพัฒนาการตรวจรักษาโรคจมูกอักเสบภูมิแพ้ในคนไทย (ฉบับปรับปรุง พ.ศ. ๒๕๕๔)
 
พระราชบัญญัติว่าด้วยราคาสินค้าและบริการ
พระราชบัญญัติว่าด้วยราคาสินค้าและบริการพระราชบัญญัติว่าด้วยราคาสินค้าและบริการ
พระราชบัญญัติว่าด้วยราคาสินค้าและบริการ
 
ข้อเท็จจริงเรื่องยาคุมฉุกเฉิน
ข้อเท็จจริงเรื่องยาคุมฉุกเฉินข้อเท็จจริงเรื่องยาคุมฉุกเฉิน
ข้อเท็จจริงเรื่องยาคุมฉุกเฉิน
 

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GPP guidelines fip publication final

  • 1.
  • 2.
  • 3. Introduction Good Pharmacy Practice (GPP) is at the very authorities and other relevant bodies heart of the profession of Pharmacy; indeed it responsible for drawing up relevant is the very essence of the profession. Moreover, documentation and related laws and it expresses our covenant with the patient not regulations in their individual countries. only to ‘do no harm’ but also to facilitate good It does not establish national standards by therapeutic outcomes with medicines. itself but provides guidance on specific achievable roles, functions and activities that It is recognized that pharmacy practice varies fulfill the mission of pharmacy practice in the enormously from one country to another and new millennium. from one continent to another, incorporating developing, transitional and developed Professional concerns and attitudes are countries. The applicability of the 2011 update emphasized throughout these guidelines of the joint WHO/FIP guidelines on Good and the patient’s welfare and well-being are Pharmacy Practice: Standard for quality of of paramount importance. However it will pharmacy services is intended to take these be noted that legal, workforce and economic variations in practice in to account. frameworks are also introduced for the first time in the context of GPP and this is aptly The pharmacy profession is currently timed, given the considerable worldwide advancing at a considerable pace and new debate on the economics of medicines, access roles are being proposed and promulgated, to quality medical products, access to trained not only by the profession itself but also by health professionals, global health workforce other healthcare professions and by national shortages, escalating cost of healthcare and and international authorities and agencies. application of new collaborative pharmacy These guidelines on GPP are intended to be practice models. far reaching and sufficiently flexible in its approach that it should remain relevant as In conclusion, both WHO and FIP define GPP as these new roles become established. the practice of pharmacy that responds to the needs of the people who use the pharmacists’ Both WHO and FIP emphasize that these services to provide optimal, evidence-based guidelines on GPP are for the use of national care. To support this practice it is essential that pharmacy professional associations, together there be an established national framework of with their national quality standards and guidelines. Dr Michel Buchmann, President, FIP The following content refers to: Annex 8: Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services from the WHO technical report series, No. 961, 45th report of the WHO Expert Committee on specifications for pharmaceutical preparations © World Health Organization 2011 Reprinted with permission from WHO. Available online at: http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf
  • 4. Annex 8 Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services Background 1. Introduction 2. Underlying philosophy 3. Definition of good pharmacy practice 4. Requirements of good pharmacy practice 5. Setting standards for good pharmacy practice 6. Conclusions
  • 5. Background Under the World Health Organization (WHO)’s Revised Drug Strategy adopted by the World Health Assembly in 1986, WHO organized two meetings on the role of the pharmacist, in Delhi, India in 1988 and in Tokyo, Japan in 1993. This was followed by the adoption, in May 1994, of the World Health Assembly Resolution WHA47.12 on the role of the pharmacist, in support of the WHO Revised Drug Strategy. In 1992 the International Pharmaceutical Federation (FIP) developed standards for pharmacy services under the heading “Good pharmacy practice in community and hospital pharmacy settings”. The text on good pharmacy practice was also submitted to the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 1994. Following the recommendations of the WHO Expert Committee and the endorsement of the FIP Council in 1997, the FIP/WHO joint document on good pharmacy practice (GPP) was published in 1999 in the thirty-fifth report of the WHO Expert Committee on Specifi cations for Pharmaceutical Preparations (WHO Technical Report Series, No. 885). Subsequently WHO organized two more meetings on the role of the pharmacist, in Vancouver, Canada in 1997 and in the Hague, the Netherlands in 1998. These meetings reinforced the need for pharmacy curricular reform and the added value of the pharmacist in self-care and self-medication. In collaboration with WHO, the fi rst edition of a practical handbook Developing pharmacy practice — a focus on patient care was launched in 2006. This handbook is designed to meet the changing needs of pharmacists, setting out a new paradigm for pharmacy practice and presenting a step-by-step approach to pharmaceutical care. With the overall aim of improving standards and practice of distribution and use of medicines, using the FIP/WHO guidelines for GPP as the framework, FIP took the initiative to explore the possibilities for providing technical assistance to its Member Organizations in Cambodia, Moldova, Mongolia, Paraguay, Thailand, Uruguay and Viet Nam, in developing national standards for GPP in a pilot study from 2005 to 2007. In 2007 the “Bangkok declaration on good pharmacy practice in the community pharmacy settings” in the South-East Asia Region was adopted by the FIP South-East Asia Pharmaceutical Forum and set out the commitment of its Member Associations towards raising standards of pharmacy services and professional practice. Since the adoption of the GPP guidelines in community and hospital settings, significant changes in practice, applied science and technology and pharmaceutical policy have occurred, including the relevance of more recent World Health Assembly
  • 6. resolutions: WHA54.11 (WHO Medicines Strategy), WHA54.13 (Strengthening health systems in developing countries), WHA55.14 (Ensuring accessibility of essential medicines), WHA55.18 (Quality of care: patient safety), WHA57.16 (Health promotion) and WHA60.16 (Rational use of medicines). Furthermore, in 2007 FIP established an initiative to investigate the need to update the guidelines on GPP to reflect contemporary standards of practice and thinking. An FIP working group on GPP first met on 15 October 2007 to identify key issues that needed to be considered in the revision of the guidelines. In 2008 FIP organized an expert consultation in Basel, Switzerland during its 68th World Congress. Fifty participants attended the meeting, including the FIP Working Group (WG) on GPP, WHO staff from headquarters, representatives from the WHO Regional Office for the Eastern Mediterranean, country medicines advisers from Ghana, Nigeria and the United Republic of Tanzania, Presidents and Secretaries of the six FIP Regional Pharmaceutical Forums, FIP Member Organizations and several invited experts. Following this consultation, the FIP WG on GPP undertook an extensive review of the existing national standards on GPP in at least 37 countries and established a time frame that would allow sufficient consultation with all of FIP’s 120 national Member Associations, relevant experts and WHO. A proposal for this initiative was presented to the forty-third meeting of the WHO Expert Committee on Specifi cations for Pharmaceutical Preparations in October 2008 and an updated report was provided to the Expert Committee at its forty-fourth meeting in October 2009. 1. Introduction The health of the public is fundamental to the happiness and welfare of all people. Barriers to good health include poor access to quality medical products, lack of access to trained health professionals and care, an inadequate health workforce, unaffordable cost of care and poor standards of education of health-care professionals. Medicines are an essential and critical part of health-care services in all cultures and societies. When accessed, medicines are often an essential component of many disease prevention programmes and virtually all disease treatment plans. The potential benefit of medicines is often not realized — there is a gap between the proven efficacy of medicines demonstrated in clinical trials and their actual effectiveness in practice. The reasons for this gap include problems with medicine selection and dosages, improper administration of medicines and lack of adherence by patients to prescribed treatment, medicine–medicine and medicine–food interactions, and adverse medicine events. Besides clinical problems associated with medicine-
  • 7. related problems, there are cost implications. It has been estimated that the cost of problems with the use of medicines is equal to or greater than the cost of the medicines themselves. Medicines are also increasingly expensive and their cost is compromising the affordability of health care. Managing the costs of medicines is critical to making the best use of limited resources to maximize health care for as many people as possible. Substandard, adulterated, unlicensed and spurious/falsely-labelled/falsified/ counterfeit medicines are a growing problem that compromise health. There is a need for a system of assuring the integrity of the medicine supply chain to assure the value of medicines used for the prevention of disease and the treatment of patients. Pharmacists 1 are specifically educated and trained health professionals who are charged by their national or other appropriate (e.g. state or provincial) authorities with the management of the distribution of medicines to consumers and to engage in appropriate efforts to assure their safe and efficacious use. There is also increasing recognition that providing consumers with medicines alone is not suffi cient to achieve the treatment goals. To address these medication-related needs, pharmacists are accepting greater responsibility for the outcomes of medicines use and are evolving their practices to provide patients with enhanced medicines-use services. As health-care professionals, pharmacists play an important role in improving access to health care and in closing the gap between the potential benefit of medicines and the actual value realized and should be part of any comprehensive health system. In addition, the increasingly complex and diverse nature of pharmacists’ roles in the health-care system and public health demands a continuous maintenance of the competence of pharmacists as health-care professionals who have up-to-date skills and expertise. National pharmacy professional associations need to work together with their governing bodies and other health-care professional associations to support pharmacists in their countries through provision of continuing professional development activities, including distance-learning programmes, and establishing national standards of pharmacy services and practice objectives. These guidelines are intended to provide a description of ways in which pharmacists can improve access to health care, health promotion and the use of medicines on behalf of the patients they serve. The role of FIP is to provide leadership for national 1 Pharmacists are health-care professionals whose professional responsibilities and accountabilities include seeking to ensure that people derive maximum thera- peutic benefit from their treatments with medicines. This requires them to keep abreast of developments in pharmacy practice and the pharmaceutical sciences, professional standards and requirements, the laws governing pharmacy and medicines and advances in knowledge and technology relating to use of medicines.
  • 8. pharmacy professional organizations, which in turn provide the impetus for setting national standards.2 The vital element is the commitment of the pharmacy profession worldwide to promoting excellence in practice for the benefit of those served. The public and other professions will judge the pharmacy profession on how its members translate that commitment into practice in all settings, especially community and hospital pharmacy settings. It is the policy of FIP and WHO to provide guidance to national pharmacy professional organizations regarding the development of their national GPP guidelines. The conditions of practice vary widely from country to country and each national pharmacy professional organization is best able to decide what can be achieved and within what time-scale. 2. Underlying philosophy The mission of pharmacy practice is to contribute to health improvement and to help patients with health problems to make the best use of their medicines. There are six components to this mission: • being readily available to patients with or without an appointment; • identifying and managing or triaging health-related problems; • health promotion; • assuring effectiveness of medicines; • preventing harm from medicines; and • making responsible use of limited health-care resources. In the community setting, pharmacists should be acknowledged as health-care professionals whom patients can consult for health-related problems. Because health-care products and services are available from the pharmacist, some problems can be managed at this point of care. Problems that require additional diagnostic skill or treatments not available from a pharmacist can be referred to an appropriate health-care professional or site of care, such as a hospital. This should be done in good collaboration between the health-care providers. To improve the use of medicines, pharmacists have responsibilities for many aspects of the process of medicines use, each of which is important to achieve good outcomes from treatment. This begins with assuring the integrity of the medicine supply chain, including detecting spurious/falsely-labelled/falsified/counterfeit medicines, ensuring proper storage of medicines and quality preparation of medicines when needed. It also includes assuring the proper prescribing of medicines so that dose regimens and 2 Throughout this document, the term “national standards” includes laws, regulations, standards, ordinances or other requirements enacted or promulgated by an official body at any level of government, as well as guidelines, recommendations or other pronouncements of professional organizations of pharmacy.
  • 9. dosage forms are appropriate; instructions for use are clear; medicine–medicine and medicine–food interactions are prevented; known and predictable adverse medicine reactions, including allergies and other contraindications, are avoided; unnecessary treatments are minimized and the cost of medicines is considered. Another important component of this mission is assisting patients and those administering medicines to understand the importance of taking medicines properly, including the correct timing of doses, foods or other medicines to avoid when taking a dose and what to expect after taking the medicine. Monitoring treatment to verify effectiveness and adverse medicine events is also an important part of the process of use of medicines. 3. Definition of good pharmacy practice GPP is the practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal, evidence-based care. To support this practice it is essential that there be an established national framework of quality standards and guidelines. 4. Requirements of good pharmacy practice • GPP requires that a pharmacist’s first concern in all settings is the welfare of patients. • GPP requires that the core of the pharmacy activity is to help patients make the best use of medicines. Fundamental functions include the supply of medication and other health-care products of assured quality, the provision of appropriate information and advice to the patient, administration of medication, when required, and the monitoring of the effects of medication use. • GPP requires that an integral part of the pharmacist’s contribution is the promotion of rational and economic prescribing, as well as dispensing. • GPP requires that the objective of each element of pharmacy service is relevant to the patient, is clearly defined and is effectively communicated to all those involved. Multidisciplinary collaboration among health-care professionals is the key factor for successfully improving patient safety. In satisfying these requirements, the following conditions are necessary: • the well-being of patients should be the main philosophy underlying practice, even though it is accepted that ethical and economic factors are also important; • pharmacists should have input into decisions about the use of medicines. A system should exist that enables pharmacists to report and to obtain feedback about adverse events, medicine-related problems, medication errors, misuse or medicine abuse, defects in product quality or detection of counterfeit products. This reporting
  • 10. may include information about medicine use supplied by patients or health professionals, either directly or through pharmacists; • the relationship with other health professionals, particularly physicians, should be established as a therapeutic collaborative partnership that involves mutual trust and confidence in all matters relating to pharmacotherapy; • the relationship between pharmacists should be one of colleagues seeking to improve pharmacy service, rather than acting as competitors; • in reality, organizations, group practices and pharmacy managers should accept a share of responsibility for the definition, evaluation and improvement of quality; • the pharmacist should be aware of essential medical and pharmaceutical information (i.e. diagnosis, laboratory test results and medical history) about each patient. Obtaining such information is made easier if the patient chooses to use only one pharmacy or if the patient’s medication profile is available; • the pharmacist needs evidence-based, unbiased, comprehensive, objective and current information about therapeutics, medicines and other health-care products in use, including potential environmental hazard caused by disposal of medicines’ waste; • pharmacists in each practice setting should accept personal responsibility for maintaining and assessing their own competence throughout their professional working lives. While self-monitoring is important, an element of assessment and monitoring by the national pharmacy professional organizations would also be relevant in ensuring that pharmacists maintain standards and comply with requirements for continuous professional development; • educational programmes for entry into the profession should appropriately address both current and foreseeable changes in pharmacy practice; and • national standards of GPP should be specified and should be adhered to by practitioners. At the national or appropriate (e.g. state or provincial) level, it is necessary to establish: • A legal framework that: - defines who can practice pharmacy; - defines the scope of pharmacy practice; - ensures the integrity of the supply chain and the quality of medicines. • A workforce framework that: - ensures the competence of pharmacy staff through continuing professional development (CPD or continuing education (CE)) programmes; - defines the personnel resources needed to provide GPP.
  • 11. • An economic framework that: - provides sufficient resources and incentives that are effectively used to ensure the activities undertaken in GPP. 5. Setting standards for good pharmacy practice GPP includes standards that often exceed those laid down by national legislation. Furthermore, legislation seldom gives precise instructions about how the services should be produced to meet the requirements. Therefore, national pharmacy professional associations have a role in setting standards required for GPP, which includes a quality management framework and a strategic plan for developing services. It is also recognized that in developing national standards for GPP, attention must be paid to both the needs of the users of health-care services and the capacity of national health-care systems to support these services. Just as pharmacy practice will vary among nations, it will also vary among practice locations. Therefore, standards should recognize the uniqueness of different pharmacy practice settings (e.g. community and hospital pharmacy). In addition, as medicines and needs change, the standards should acknowledge evolving practice settings and provide these developing services with guidance without negatively affecting the evolutionary nature of practice. At the same time, a baseline should be established for practice below which the activity cannot be considered “pharmacy practice” at all and, therefore, should not be condoned. When establishing minimum standards on GPP, FIP emphasizes the importance of first defining the roles played by pharmacists, as expected by patients and society. Secondly, relevant functions for which pharmacists have direct responsibility and accountability need to be determined within each role. Thirdly, minimum national standards should then be established, based upon the need to demonstrate competency in a set of activities supporting each function and role. The minimum national standards for each activity are based on processes that need to be relevant and defined appropriately according to the local needs of the pharmacy practice environment and national profession aspirations. All national pharmacy professional associations should also adapt these roles and functions in accordance to their own requirements. The activities listed below can be further defined and measured by setting indicators of good practice within a national context and can be weighted by actual practice-setting priorities. It is recommended that national pharmacy professional associations consider the following roles, functions and activities for pharmacists, where appropriate:
  • 12. Role 1: Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medical products • Function A: Prepare extemporaneous medicine preparations and medical products Minimum national standards should be established for these activities. - Pharmacists should ensure that medicine preparation areas are appropriately designed to permit ease of extemporaneous preparations and are maintained in a manner that minimizes the potential for medication errors and assures the cleanliness and safety of medical products. - Pharmacists should ensure that compounded medicines are consistently prepared to comply with written formulas and quality standards for raw materials, equipment and preparation processes, including sterility where appropriate. • Function B: Obtain, store and secure medicine preparations and medical products Minimum national standards should be established for these activities. - Pharmacists who are responsible for procurement should ensure that the procurement process is transparent, professional and ethical so as to promote equity and access and to ensure accountability to relevant governing and legal entities. - Pharmacists who are responsible for procurement should ensure that procurement is supported by strong quality assurance principles to assure that substandard, adulterated, unlicensed and spurious/falsely-labelled/falsified/counterfeit medicines are not procured or allowed into the system. - Pharmacists who are responsible for procurement should ensure that procurement is supported by a reliable information system which provides accurate, timely and accessible information. - Pharmacists should establish contingency plans for shortages of medicines and for purchases in emergencies. - Pharmacists should assure that proper storage conditions are provided for all medicines, especially for controlled substances, used in the pharmacy or health-care facility. • Function C: Distribute medicine preparations and medical products Minimum national standards should be established for these activities. - Pharmacists should ensure that all medical products, including medicine samples, are handled and distributed in a manner that assures reliability and safety of the medicine supply.
  • 13. - Pharmacists should establish an effective distribution system which includes a written procedure, to recall promptly and effectively medical products known or suspected to be defective or spurious/falsely-labelled/falsified/counterfeit, with a designated person(s) responsible for recalls. - Pharmacists should develop with manufacturers, wholesalers and government agencies (where appropriate) an access plan for uninterrupted supply of essential medicines as part of a disaster or pandemic preparedness strategy. - As part of a disaster or pandemic preparedness strategy, national medicines regulatory agencies may introduce new medicines which are authorized for marketing with limited safety data; pharmacists have a responsibility to be aware of the safety issues and to institute necessary mechanisms for monitoring occurrence of adverse events. • Function D: Administration of medicines, vaccines and other injectable medications Minimum national standards should be established for these activities. - Pharmacists should have a role in the preparation and administration of medicines, in establishing procedures in their work settings with respect to the administration, and in monitoring the outcomes of medication administration. - Pharmacists should have an educator, facilitator and immunizer role, thus contributing to the prevention of diseases through participation in vaccination programmes, by ensuring vaccination coverage and by also ensuring vaccine safety. - Pharmacists should participate in directly observed therapy (DOT) programmes in areas such as the management of drug addiction, HIV/AIDS, tuberculosis and sexually transmitted diseases, where applicable. • Function E: Dispensing of medical products Minimum national standards should be established for these activities. - Pharmacists should ensure that appropriate facilities, trained personnel, standard dispensing practices and documentation procedures are in place in the pharmacy for the supply and dispensing of prescribed medicines and other health-care products. - Pharmacists should assess and evaluate all paper or electronic prescriptions received, considering the therapeutic, social, economic and legal aspects of the prescribed indication(s) before supplying medical products to the patient. Where possible, generic substitution is recommended.
  • 14. - Pharmacists should ensure patient confi dentiality at the point of dispensing medical products and should provide advice to ensure that the patient receives and understands suffi cient written and oral information to derive maximum benefit for the treatment. • Function F: Dispose of medicine preparations and medical products Minimum national standards should be established for these activities. - Pharmacists should ensure that regular monitoring of the medicines inventory is conducted and should always include medicines samples in the process of periodic inspection for expiration dates and removal of outdated stock. - Pharmacists should ensure that recalled medical products, including medicines samples, are immediately stored separately for subsequent disposal and prevented from being available for further dispensing or distribution. - Pharmacists should establish a safe way of medicines waste disposal at the hospital and/or community pharmacy so that patients and the public can be encouraged to return their expired or unwanted medicines and medical devices. Alternatively, pharmacists should provide appropriate information to patients on how to safely dispose of expired or unwanted medicines. Role 2: Provide effective medication therapy management 3 • Function A: Assess patient health status and needs Minimum national standards should be established for these activities. - Pharmacists should ensure that health management, disease prevention and healthy lifestyle behaviour are incorporated into the patient assessment and care process. - Pharmacists should acknowledge unique patient considerations such as education level, cultural beliefs, literacy, native language and physical and mental capacity in all individual patient assessments. • Function B: Manage patient medication therapy Minimum national standards should be established for these activities. - Pharmacists should maintain access to an appropriate evidence base relating to the safe, rational and cost-effective use of medicines such as reference books on medicines, journals, national essential medicines lists and standard treatment guidelines. 3 Medication therapy management is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication therapy man- agement services are independent of, but can occur in conjunction with, the provision of a medication product.
  • 15. - Pharmacists should ensure that medicine formulary system(s) (local, regional and/ or national) are linked to standard treatment guidelines, protocols and treatment pathways based on the best available evidence. - Pharmacists should have a key role in educating prescribers on the access to and evidence for optimal and appropriate use of medicines including the required monitoring parameters and prescribing adjustments. Where appropriate, pharmacists should provide advice or recommendations to the prescriber on medicine therapy, including the selection of the appropriate medication or dosage. - Pharmacists should have access to, contribute to and use all necessary clinical and patient data to coordinate effective medication therapy management, especially when multiple health-care practitioners are involved in the patient’s medication therapy, and intervene if necessary. - Pharmacists should establish a standard operating procedure for referrals to physicians, specialists or other health-care providers, where appropriate. - Pharmacists should provide continuity of care by transferring information on patients’ medicines as patients move between sectors of care. • Function C: Monitor patient progress and outcomes Minimum national standards should be established for these activities. - Pharmacists should consider patient diagnosis and patient-specific needs when assessing patient response to medicine therapy and intervene if necessary. - Pharmacists should document necessary clinical and patient data to assess and monitor medication therapy and to track patients’ therapeutic outcomes. - Pharmacists should perform point-of-care testing for patients in order to monitor and adjust therapy, when needed. • Function D: Provide information about medicines and health-related issues Minimum national standards should be established for these activities. - Pharmacists should ensure that in every pharmacy there is a suitable place for discussing confi dential information with the customers and patients. - Pharmacists should provide sufficient health, disease and medicinespecific information to patients for their participation in their decision-making process
  • 16. regarding a comprehensive care management plan. This information should aim at supporting adherence to treatment and empowerment of the patient. - Pharmacists should be proactive in reducing antimicrobial resistance by providing information about the appropriate use of antimicrobials to consumers and prescribers. Role 3: Maintain and improve professional performance • Function A: Plan and implement continuing professional development 4 strategies to improve current and future performance Minimum national standards should be established for these activities. - Pharmacists should perceive continuing education as being lifelong and be able to demonstrate evidence of continuing education or continuing professional development to improve clinical knowledge, skills and performance. - Pharmacists should take steps to update their knowledge and skills about complementary and alternative therapies such as traditional Chinese medicines, health supplements, acupuncture, homeopathy and naturopathy. - Pharmacists should take steps to update their knowledge and be engaged in implementation of new technology and automation in pharmacy practice, where feasible. - Pharmacists should take steps to become informed and update their knowledge on changes to information on medical products. Role 4: Contribute to improve effectiveness of the health-care system and public health • Function A: Disseminate evaluated information about medicines and various aspects of self-care Minimum national standards should be established for these activities. - Pharmacists should ensure that the information provided to patients, other health- care professionals and the public is evidence-based, objective, understandable, non- promotional, accurate and appropriate. - Pharmacists should develop and/or use educational materials for health management, health promotion and disease prevention programmes that are applicable to a wide range of patient populations, age groups and health literacy levels. 4 The concept of continuing professional development (CPD) can be defined as “the responsibility of individual pharmacists for systematic maintenance, develop- ment and broadening of knowledge, skills and attitudes, to ensure continuing competence as a professional, throughout their careers.”
  • 17. - Pharmacists should educate patients on how to evaluate and use web-based or other forms of health-care information (including medicines information) and strongly encourage them to be advised by a pharmacist regarding the information they fi nd, particularly if obtained from the Internet. - Pharmacists should assist patients and their care providers to obtain and critically analyse information to meet their individual needs. • Function B: Engage in preventive care activities and services Minimum national standards should be established for these activities. - Pharmacists should engage in preventive care activities that promote public health and prevent disease, i.e. in areas such as smoking cessation, infectious and sexually transmitted diseases. - Pharmacists should provide point-of-care testing, where applicable, and other health screening activities for patients at higher risk of disease. • Function C: Comply with national professional obligations, guidelines and legislations Minimum national standards should be established for these activities. - Pharmacists should take steps to ensure that they comply with the provisions of a national code of ethics for pharmacists. • Function D: Advocate and support national policies that promote improved health outcomes Minimum national standards should be established for these activities. - Pharmacists should contribute to public and professional groups to promote, evaluate and improve health in the community - Pharmacists should collaborate with other health-care professionals in their efforts to improve health outcomes.
  • 18. 6. Conclusions There are four main roles where pharmacists’ involvement or supervision is expected by society and the individuals they serve: 1. Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medical products. 2. Provide effective medication therapy management. 3. Maintain and improve professional performance. 4. Contribute to improve effectiveness of the health-care system and public health. These roles may vary for each individual pharmacist depending on their practice responsibilities. Specific standards of GPP can be developed only within a national pharmacy professional organization framework. This guidance is recommended as a set of professional goals to be met in the interest of the patients and other key stakeholders in the pharmaceutical sector. Responsibility for moving the project forward will rest with each national pharmacy professional association. Achieving specific standards of GPP for each nation within these recommendations may require considerable time and effort. As health professionals, pharmacists have a duty to begin the process without delay.