Compiled Pharmacist Ethics Resources

8/14/2019 Compiled Pharmacist Ethics Resources

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CODE OF ETHICS

Preamble

The Code deals with the ethics rather than the laws governing pharmacy practice. Laws and ethics

of health care necessarily overlap considerably, since both share the concern that the conduct of

health care professionals reflects respect for the well-being, dignity and self determination of

patients. The two domains of law and ethics remain distinct, and the Code, while prepared with

awareness of the law, is addressed to ethical obligations.

The pharmacist, by entering the profession, is committed to moral norms of conduct and assumes a

professional commitment to the health and well-being of patients. As citizens, pharmacists continue

to be bound by the moral and legal norms shared by all other participants in society. As individuals,

pharmacists have a right to choose to live by their own values as long as those values do not

compromise pharmacy care.

Adoption of the Code represents a conscious undertaking on the part of the members of the College

of Pharmacists of British Columbia to be responsible for practising in accordance with the expressed

principles (values and obligations). The Code defines and seeks to clarify the obligations of

pharmacists to use their knowledge and skills for the benefit of others, to minimize harm, to respect

patient autonomy and to provide fair and just pharmacy care for their patients.

!

For those entering the profession, the Code identifies the basic moral commitments ofpharmacy care and serves as a source for education and reflection.

! For those within the profession, the Code serves as a basis for self-evaluation and peer review.

! For those outside the profession, the Code provides public identification of the professional

ethical expectation of its members.

Therefore the Code of Ethics is educational, guides behaviour, and expresses to the larger

community the values and ideals that we espouse by reason of trust and commitment.

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Elements of the Code

The Code contains different elements designed to help the pharmacist in its interpretation. The

values and obligations are presented by topic and not in order of importance.

! Values express broad ideals of pharmacy practice. They establish correct directions for

pharmacy practice. In the absence of a conflict of ethics, the fact that a particular action

promotes a value of pharmacy practice may be decisive in some specific instances. Pharmacist

behaviour can always be appraised in terms of values; How closely did the behaviour approach

the value? How widely did it deviate from the value? The values expressed in the Code must be

adhered to by all pharmacists in their practice. Because they are so broad, however, values

may not give specific guidance in difficult instances.

!

Obligations provide more specific direction for conduct than do values; obligations spell outwhat a value requires under particular circumstances.

It is also important to emphasize that even when a value or obligation must be limited, it nonetheless

carries moral weight. For example, a pharmacist who is compelled to testify in a court of law on

confidential matters is still subject to the values and obligations of confidentiality. While the

requirement to testify is a justified limitation upon confidentiality, in other respects confidentiality

must be observed. The pharmacist must only reveal that confidential information that is pertinent to

the case at hand, and such revelation must take place within the appropriate context.


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Value 1 - Pharmacists respect the professional relationship with the patient and acts with

honesty, integrity and compassion.

Obligations

1. The patient-pharmacist relationship is a covenant, meaning that a pharmacist has moral

obligations in response to the trust received from society. In return for this, a pharmacistpromises to help patients achieve optimum benefit from their medications, to be committed to

their welfare, and to maintain their trust.

2. A pharmacist has a duty to tell the truth, to act with conviction of conscience, and to avoid

discriminatory practices and behaviour.

Value 2 - Pharmacists honour the individual needs, values and dignity of the patient.

Obligations

1. A pharmacist assists patients to make informed choices about their own best interests.

2. A pharmacist aids patients in their expression of needs and values, and recognizes their right to

live at risk.3. A pharmacist's commitment to the patient's care must be sensitive to, but not prejudiced by,

factors such as the patient's race, religion, ethnic origin, social or marital status, gender, sexual

orientation, age, or health status.

4. A pharmacist recognizes the patient's membership in a family of choice, and, with the patient's

consent, attempts to facilitate, where appropriate, the participation of significant others in the

care of the patient.

5. A pharmacist's conduct at all times acknowledges the patient as a person. Discussion of care in

the presence of the patient should, whenever possible, actively include the patient.

Value 3 - Pharmacists support the right of the patient to make personal choices about

pharmacy care.

Obligations

1. A pharmacist has the primary responsibility to inform the patient about available pharmacy care.

Consent is an essential precondition to the provision of care.

2. A pharmacist owes a duty to disclose material risks associated with medication therapy.

Adequate disclosure is normally achieved by highlighting the more frequent and serious side

effects, as well the probability of their occurrence.

3. Valid consent, usually verbal, represents the free and informed choice of the competent patient

to undergo pharmacy care.

4. A pharmacist should aid patients in becoming an active participant in their care to the maximum

extent that circumstances permit.5. A pharmacist provides information to the patient in an understandable and sensitive way.

6. A pharmacist does not withhold pertinent medication information or use deceptive tactics in

obtaining consent. When the patient's questions require information beyond that available to a

pharmacist, the patient will be referred to an appropriate health care professional.


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Value 4 - Pharmacists provide competent care to the patient and actively supports the

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Obligations

1. A pharmacist places concern for the well-being of the patient at the centre of professional

practice, providing the best care that circumstances, experience and education permit.2. A pharmacist who suspects incompetence or unethical conduct by a health care professional

will first consider the welfare of the patient. Subject to that principle, the following will apply:

A pharmacist should engage in direct discussion with the health care professional involved, if

a situation can be resolved without peril to the patient.

A pharmacist shall not participate in efforts to deceive or mislead patients about the cause of

alleged harm or injury resulting from unethical or incompetent conduct.

3. A pharmacist commits to lifelong learning designed to maintain relevant knowledge and skills.

Value 5 - Pharmacist protect the patient's right of confidentiality.

Obligations

1. A pharmacist provides pharmacy care with consideration for the personal privacy of patients.

2. An affirmative duty exists to institute and maintain practices that protect patient confidentiality.

3. A pharmacist, where appropriate, reveals to the patient the boundaries of professional

confidentiality. Pharmacy care may require that other health care personnel have access to or

be provided with the relevant information. Whenever possible, the patient should be informed,

and generally, it is up to the patient to determine who should be informed and what personal

information should be released.

4. When a pharmacist is confronted with the necessity to disclose, confidentiality should bepreserved as much as possible. Both the amount of information disclosed and those to whom

disclosure is made should be restricted to that which is necessary.

5. A pharmacist may breach confidentiality when the failure to disclose information will place other

persons or the patient in serious danger. A pharmacist will, whenever possible, consult with

other health professionals involved with the patient before breaching confidentiality.

Value 6 - Pharmacist respect the values and abilities of colleagues and other health

professionals.

Obligations

1. A pharmacist accepts responsibility to work with colleagues and other health care professionals

and with public interest pharmacy organizations and patient advocacy groups, to promote safe

and effective pharmacy care.

2. A pharmacist, when appropriate, asks for the consultation of colleagues or other health

professionals or refers the patient.


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Value 7 - Pharmacists endeavour to ensure that the practice environment contributes to safe

and effective pharmacy care.

Obligations

1. A pharmacist manager has a responsibility to foster an optimal practice environment and to

ensure the provision of required resources.

2. If there is a conflict between professional activities and management policies, professional

responsibilities will take precedence.

3. A pharmacist will challenge employment conditions that are inconsistent with professional

practice as described in this code.

Value 8 - Pharmacists ensure continuity of care in the event of job action, pharmacy closure

or conflict with moral beliefs.

Obligations1. A pharmacist has a duty through coordination and communication to ensure the provision of

essential pharmacy care throughout the duration of any job action or pharmacy closure.

Patients who require ongoing or emergency pharmacy care are entitled to have those needs

satisfied.

2. A pharmacist is not ethically obliged to provide requested pharmacy care when compliance

would involve a violation of his or her moral beliefs. When that request falls within recognized

forms of pharmacy care, however, there is a professional obligation to refer the patient to a

pharmacist who is willing to provide the service. The pharmacist shall provide the requested

pharmacy care if there is no other pharmacist within a reasonable distance or available within a

reasonable time willing to provide the service.


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Commentary

Ethical Problems

Situations often arise that present ethical problems for pharmacists in their practice. These situations

tend to fall into three categories:

(a) Ethical violations involve the neglect of moral obligation; for example, a pharmacist who

neglects to provide competent pharmacy care to a patient because of personal inconvenience

has ethically failed the patient.

(b) Ethical dilemmas arise where ethical reasons both for and against a particular course of action

are present and one option must be selected. A patient who is likely to refuse some appropriate

form of pharmacy care presents the pharmacist with an ethical dilemma. For example, a patient

might refuse to take medication to treat their cancer if there is a likelihood of hair loss. In this

case, substantial moral reasons may be offered on behalf of several opposing options.

(c) Ethical distress occurs when pharmacists experience the imposition of practices that provoke

feelings of guilt, concern or distaste. Such feelings may occur when pharmacists are ethically

obliged to provide particular types of pharmacy care despite their personal disagreement or

discomfort with the course of treatment prescribed. For example, the sale of injection devices

for nonmedical use has been shown to reduce the HIV infection rate, but a pharmacist may hold

a personal belief against facilitating the use of illicit drugs.

The Code provide clear direction for avoiding ethical violations. When a course of action is

mandated by the Code, and there exists no opposing ethical principle, ethical conduct requires that

course of action.

The Code cannot serve the same function for all ethical dilemmas or for ethical distress. There is

room within the profession of pharmacy for conscientious disagreement among pharmacists. The

resolution of any dilemma often depends upon the specific circumstances of the case in question,

and no particular resolution may be definitive of good pharmacy practice. Resolution may also

depend upon the relative weight of the opposing principles, a matter about which reasonable people

may disagree.

The Code cannot relieve ethical distress but it may serve as a guide for pharmacists to weigh and

consider their responsibilities in the particular situation, Inevitably, pharmacists must reconcile their

actions with their consciences in providing pharmacy care to patients.

The Code tries to provide guidance for those pharmacists who face ethical problems. Proper

consideration of the Code should lead to better decision-making when ethical problems are

encountered.

It should be noted that many problems or situations seen as ethical in nature are problems of

miscommunication, failure of trust or management dilemmas in disguise. There is, therefore, a

distinct need to clarify whether the problem is an ethical one or one of another sort.


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The revised Code of Ethicsfor Pharmacists and Pharmacy Technicians:Questions & Answers

Q Why was the Code reviewed?

A In 2005 the Society committed to undertake a fundamental review of theexisting Code of Ethics and Standards for pharmacists and Code of Ethics forpharmacy technicians in response to the changing roles, responsibilities, andworking practice of the pharmacy profession. The new Code has beendesigned to promote and support the use of professional judgement andreflects the professional considerations facing modern pharmacy.

Q What was the review process?

A A working group was formed to oversee the review process. This group

contained representatives from each sector of pharmacy as well as patientand public interest representatives.

Council stated from the outset that it wished to engage the profession andpublic throughout the review process and a series of consultations were held.Responses to these consultations were vital in shaping the revised Code.

Q What has changed?

A The structure of the revised Code of Ethics is very different from the existingCodes. The fundamental changes include:

The revised Code of Ethics is based on a set of principles that will inform theconduct, practice and performance of pharmacists and pharmacy technicians

The principles are intended to be applicable to all sectors of the profession,irrespective of whether an individual is involved in direct patient care

The revised Code applies to both pharmacists and pharmacy technicians.This is based on the fact that the same ethical principles should be applicableto all sectors of the profession, even though how they are applied will dependon an individuals role and circumstances

The revised Code is designed to promote and support a culture ofaccountability and professional judgement

The revised Code does not contain detailed technical guidance, but acts as

the core document from which further standards and guidance can bedeveloped

The requirements of the revised code reflect key issues for modern pharmacypractice, such as encouraging patients to be involved in decisions about theircare, respecting patient choice and working in partnership with otherhealthcare professionals.

Q What are the principles that the Code is based on?

A The revised Code of Ethics is based on seven principles. Each principle issupported by requirements that explain the types of actions and behavioursexpected of pharmacists and pharmacy technicians when applying theprinciples in practice. The seven principles are:


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1. Make the care of patients your first concern2. Exercise your professional judgement in the interests of patients and the

public3. Show respect for others4. Encourage patients to participate in decisions about their care5. Develop your professional knowledge and competence6. Be honest and trustworthy7. Take responsibility for your working practices

Q If the revised Code does not include detailed technical guidance, wherecan I obtain this information?

A Unlike previous versions, detailed standards and guidance will be producedseparately from the Code.

Seven professional standards and guidance documents have been developedto support and expand on the principles of the new Code of Ethics in thefollowing areas:

Patient consent Patient confidentiality Sale and supply of medicines Pharmacist prescribers Pharmacists and pharmacy technicians in positions of authority Advertising Internet pharmacy

Q When does the revised Code come in to effect?

A The revised Code comes in to force on 1 August 2007. The supportingprofessional standards and guidance documents will also come into effect onthis date. The requirements of the existing Code will still apply until 1 August.You can get a preview of the revised Code and its supporting documents onthe Societys website www.rpsgb.org.

Q When will I receive my revised copy of the Code?

A Printed copies of the new Code and its supporting documents will be

distributed to all registrants with The Pharmaceutical Journalon 21 July 2007.

Q Who should I contact if I have any questions?

A Further information about the revised Code of Ethics and the review processcan be obtained by contacting Lynsey Cleland, Head of Professional Ethicson tel: 020 7572 2519, email: [email protected].

Advice on the Code and other professional or legal obligations can beobtained by contacting the Societys Legal and Ethical Advisory Service ontel: 020 7572 2308, email: [email protected].
http://www.rpsgb.org/mailto:[email protected]:[email protected]://www.rpsgb.org/mailto:[email protected]:[email protected]


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12 Pharmacy Student September/October 2002

Pharmacy has experienced many

changes in the 150 years since a group of

creative, innovative, and proud pharma-

cists first gathered in Philadelphia to cre-ate a national professional society of

pharmacists. It was the goal of these phar-

macists to maintain the viability of, and

address the issues facing, the profession.

Since that time, the profession has

changed from one focused on managing

the production of drugs to one primarily concerned with the

safe, effective, and appropriate use of medications and the pro-

vision of enhanced pharmacy services to patients. Although the

practice of pharmacy has changed, the fact that pharmacists are

professionals has remained the same.

Pharmacy, like many other professions, is continuously evolv-ing to meet the needs of the public it serves. Pharmacists are and

will always remain professionals and they must work to instill

the professions attitudes and values in students who, as pharma-

cists, will be responsible for maintaining the continuity of phar-

macy as a profession.

A profession, notjust an occupation

The importance of pharmacy students professional develop-

ment has been long recognized as a key issue in pharmacy edu-

cation. A 5-year commitment by the Task Force on Professional-

ism resulted in publication of the White Paper on Pharmacy

Student Professionalism, in the January/February 2000 issue ofJournal of the American Pharmaceutical Association. Drafted by

APhAASP and the American Association of Colleges of Phar-

macy Council of Deans, the white paper focuses on raising

awareness and leading action on developing professionalism

among pharmacy students. This paper looks at the definitions of

professionalism and challenges in professional development and

makes recommendations for students, educators, and practition-

ers. The white paper calls for the profession to recommit itself to

enhancing the professional development of students.

The white paper defines professional socialization as the

process of inculcating a professions attitudes, values, and

behaviors in a professional. It goes on to state that the goal o

professional socialization is to develop professionalism.Professional socialization begins when students first apply to

one of the nations 84 colleges of pharmacy. It is at this time that

they make the decision to become a professional. Students reaf-

firm their commitment on the first day of orientation when they

dedicate themselves to acquiring the knowledge and skills neces

sary to practice pharmacy. Throughout their education, students

commit to constantly improving their knowledge for the benefit

of their patients.

Pharmacists devote themselves to providing service to their

communities. When providing these ser-

vices, they are expected to make consci-

entious, ethical decisions and to beresponsible for their work. Students must

take the initiative to learn and understand

the characteristics that make pharmacy a

profession and not merely an occupation

Professionalism is a lifelong commitment

that pharmacists must continually practice

and develop.

Hasthe pharmacistshortage weakened

pro fession alism?

Throughout the country, print and television media have

drawn attention to the pharmacist shortage. When students applyto pharmacy school, what are their intentions? Today, most stu

dents enter pharmacy school hoping to serve the public and

improve health care outcomes, but each student has at least one

classmate who entered pharmacy school with the intention to

strike it rich. A pharmacist shortage means big money, but this

money has the potential to distract students from their true rea

son for choosing pharmacy as a profession.

The pharmacist shortage has also increased the workload of

practicing pharmacists. Increased workloads for pharmacists

ProfessionalismisalifelongcommitmentAPhAASP seeks to increase awareness

By Andrew P.Traynor and Heather R.Ferguson

COVER STORY

Ferguson

Traynor


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September/October 2002 Pharmacy Student 13

serving as preceptors and men-

tors have the potential to reduce

the time they can give and

lower the quality of the guid-

ance they offer. So, students,

excited about the opportunity to

implement innovative services

as they begin rotations, oftenencounter resistance from these

overburdened pharmacists.

Some of these pharmacists have

developed a jaded perception of

professionalism due to the cur-

rent stresses in their practice

environment.

This is something pharmacy

students may encounter as they

make the transition from the

classroom to practice. Only

through the continuous development of professional attitudes willstudents acquire the skills necessary to overcome these challenges.

Profession alism activities encouraged

Keeping in mind the white papers assertion that the goal of

professional socialization is to develop professionalism, the

20022003 APhAASP Executive Committee renewed its

efforts to increase the awareness of professionalism in phar-

macy and actively promote professional development for

Academy members.

The Executive Committee encourages activities such as theformation of professionalism committees consisting of pharmacy

students and faculty members devoted solely to the professional

ization of pharmacy students. The Executive Committee also

encourages the planning and organizing of white coat cere-

monies, pinning ceremonies, and mentoring opportunities, as

well as promoting classroom civility, honor codes, and conduc

that fosters professionalism in schools and colleges of pharmacy

It is our hope that the results of these professionalism initiative

will spread to both students and practitioners.

Examples of pro fession alism

At the University of Georgia College of Pharmacy, theincoming class participates in a white coat ceremony tha

excites and encourages them as they begin their professiona

journey in pharmacy. Before they begin their fourth profes

sional year and embark on rotations, students attend a pinning

ceremony that signifies the last step that they must take before

they become practitioners.

Recently, the University of Washington School of Pharmacy

implemented a new program in which the incoming class is

required to develop its own oath of professionalism. This oath

will inform and guide their activities throughout their years o

pharmacy school. As a reminder of their commitment, this oath

of professionalism will be read at their graduation.Students and faculty members at University of Minnesota

College of Pharmacy have banded together to address profes-

sionalism issues. The group applied to the University Central

Council to form an Ad Hoc Committee on Professionalism

The committee consists of four faculty members and four

pharmacy students, one student representative from each class

The committee has held luncheons with a random selection of

Graduates of the 2002 APhA Summer Leadership Institute pose in white labcoats.PHOTO

BY

MI

TCH

ROTHHOLZ

Definingprofessional

Professional: A member of a profession who displays the

following 10 traits:

1. Knowledge and skills of a profession.

2. Commitment to self-improvement of skills and

knowledge.

3. Service orientation.

4. Pride in the profession.

5. Covenantal relationship with the client.

6. Creativity and innovation.

7. Conscience and trustworthiness.

8. Accountability for his or her work.9. Ethically sound decision making.

10. Leadership.

Professionalism: The active demonstration of the traits of

a professional.

Professional socialization (professionalization): The pro-

cess of inculcating a professions attitudes, values, and

behaviors in a professional. The goal of professional social-

ization is to develop professionalism, as defined by the 10

character traits above. Professionalism continued on page 14


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students to talk about issues and discuss proposed courses of

action. One proposal being seriously considered is holding

professional development colloquia in combination with the

curriculum. Recognizing that the development of professional-

ism as an evolutionary process, these colloquia will addressspecific areas of professionalism, such as civility, professional

organizations, the recognition of colleagues, professional

responsibilities, professional awareness, contemporary issues

in pharmacy literature, expectations during externships and

rotations, maintaining professionalism, and mentoring, for

each class. This committee will explore other options for addi-

tional programming in the near future.

University of Minnesota Associate Dean Ron Hadsall stated:

As pharmacy educators, we should focus on knowledge, prac-

tices, and attitudes in pharmacy. Right now, we place the major-

ity of our efforts on knowledge and practice. We need to place

emphasis on attitudes toward pharmacy.

Active role required

Pharmacy professionals are people who take the initiative to

develop their skills and dedicate themselves to learning from

and communicating with their peers. They join professional

associations and actively participate in advocacy for their pro-

fession. Professionals strive to be creative and innovative in

their profession. They take on leadership roles in both the pro-

fession of pharmacy and the provision of care to patients.

Above all, professionals take pride in their profession. It is the

obligation of pharmacy educators and pharmacy students to

develop the characteristics and values necessary to becomeprofessionals and help instill them into others.

APhAASP has always worked to supplement these obliga-

tions and foster student development and will continue to do so

in the years to come. Together, pharmacy students must take an

active role in changing the attitudes of their peers who have yet

to embrace professionalism.

Andrew P. Traynor is a third-year PharmD candidate at the

University of Minnesota College of Pharmacy and 20022003

APhAASP president-elect. Heather R. Ferguson, is a fourth-year

PharmD candidate at the University of Georgia College of Pharmacy

and 20022003 APhAASP Speaker of the House.

14 Pharmacy Student September/October 2002

The Pledge of Professionalism

As a student of pharmacy, I believe there is a need to build

and reinforce a professional identity founded on integrity, ethi-

cal behavior, and honor. This development, a vital process in

my education, will help to ensure that I am true to the profes-

sional relationship I establish between myself and society as I

become a member of the pharmacy community. Integrity willbe an essential part of my everyday life, and I will pursue all

academic and professional endeavors with honesty and com-

mitment to service.

To accomplish this goal of professional development, as a

student of pharmacy I will:

A. DEVELOP a sense of loyalty and duty to the profes-

sion by contributing to the well-being of others and by enthu-

siastically accepting responsibility and accountability for

membership in the profession.

B. FOSTER professional competency through lifelong

learning. I will strive for high ideals, teamwork, and unity

within the profession in order to provide optimal patient care.

C. SUPPORT my colleagues by actively encouraging per-

sonal commitment to the Oath of a Pharmacist and the Code

of Ethics for Pharmacists as set forth by the profession.

D. DEDICATE my life and practice to excellence. This

will require an ongoing reassessment of personal and profes-

sional values.

E. MAINTAIN the highest ideals and professional

attributes to ensure and facilitate the covenantal relationship

required of the pharmaceutical caregiver.

The profession of pharmacy is one that demands adherence

to a set of ethical principles. These high ideals are necessary to

ensure the quality of care extended to the patients I serve. As a

student of pharmacy, I believe this does not start with gradua-

tion; rather, it begins with my membership in this professional

college community. Therefore, I will strive to uphold this

pledge as I advance toward full membership in the profession.

I voluntarily make this pledge of professionalism.

Adapted from the University of Illinois College of Pharmacys

Pledge of Professionalism, 1993. Developed and adopted by

APhAASP and the American Association of Colleges of Pharmacy

Council of Deans Task Force on Professionalism on June 26, 1994.

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Professionalism continued from page 13


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Professional Standards and

Guidance for Responsible Pharmacists

About this document

The Code of Ethics sets out seven principles of ethical practice that youmust follow as a pharmacist. It is your responsibility to apply theprinciples to your daily work, using your judgement in light of theprinciples.

The Code of Ethics says that you must Make the care of patients yourfirst concern. In meeting this principle you are expected to:

Provide a proper standard of practice and care to those for whom youprovide professional services.

Be satisfied as to the integrity and quality of products to be suppliedto patients.

Maintain timely, accurate and adequate records and include all

relevant information in a clear and legible form. Undertake regular reviews, audits and risk assessments to improve

the quality of services and minimise risks to patient and public safety.

As the responsible pharmacist for a registered pharmacy, you have botha professional and a legal duty to comply with the requirements of theMedicines Act 1968 and the regulations made under the Act, TheMedicines (Pharmacies) (Responsible Pharmacist) Regulations 2008.This document expands on the principles of the Code of Ethics to

explain your professional responsibilities when acting in your capacityas the responsible pharmacist. It is designed to meet the Societysobligations under the Pharmacists and Pharmacy Technicians Order2007 and other relevant legislation.


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Professional Standards and Guidance for Responsible Pharmacists

From 2010 the current regulatory responsibilities of the Royal

Pharmaceutical Society will, be transferred to the GeneralPharmaceutical Council, the arrangements for which are currentlyunder discussion at the time of writing. The regulatory role of thePharmaceutical Society of Northern Ireland is similarly underdiscussion.

This document does not give detailed guidance on the legalrequirements, but you must ensure you comply with relevant legislativerequirements. The UK Health Departments have produced factualguidance on the Health Act 2006 amendments to the Medicines Act1968, and the responsible pharmacist regulations made under section72A of the 1968 Act.

Where this document refers to the Act this is the Medicines Act 1968 asamended by the Health Act 2006. Where this document refers to theregulations these are The Medicines (Pharmacies) (ResponsiblePharmacist) Regulations 2008. This document does not detail all therequirements of the Act or the regulations, but will reference thesewhere appropriate.

Status of this document

Principle 6.6 of the Code of Ethics states that you must comply withlegal requirements, mandatory professional standards and acceptedbest practice guidance.

This document contains:

Mandatory professional standards (indicated by the word must) forall registered pharmacists; and

Guidance on good practice (indicated by the word should) which youshould follow in all normal circumstances.

If a complaint is made against you the Societys fitness to practisecommittees will take account of the requirements of the Code of Ethicsand underpinning documents, including this one. You will be expectedto justify any decision to act outside its terms.


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1. THE RESPONSIBLE PHARMACIST

The responsible pharmacist is the pharmacist appointed to secure the

safe and effective running of the pharmacy in relation to the sale and

supply of medicines. At any one time there can only be one responsible

pharmacist for a registered pharmacy premises.

STANDARDS

The Act requires each registered pharmacy premises to have a

responsible pharmacist in order to operate lawfully. As the responsible

pharmacist, the Act requires you to secure the safe and effective runningof the pharmacy. In complying with this legal duty and exercising your

professional judgement, you must:

1.1 establish the scope of your role and responsibilities and takeall reasonable steps to clarify any ambiguities or uncertainties

with the pharmacist in a position of authority or other

delegated person.

1.2 not undertake work that is outside of your competency.

2. PHARMACY PROCEDURES

To comply with the Act, the responsible pharmacist is required to

establish, if not already established, maintain and review pharmacy

procedures. Appendix A lists the minimum information to be included in

pharmacy procedures that must be in place, as required in the

regulations.

Where this document refers to pharmacy procedures, these are

currently known as standard operating procedures. The standards in

this section apply to those procedures detailed in Appendix A.

In this section, reference to an amendment to a procedure is intended to

mean a temporary change to the procedure due to a change in the

pharmacys circumstances, for example a member of staff is off sick or a

power failure. Where amended, the procedure must revert to its original

content once the change in circumstance is resolved.

In this section, a review is where you revaluate the content of the

current procedure to ensure that it is still applicable and workable.Review must be in accordance with the standards below, or following an

incident in the pharmacy which indicates that it may no longer be


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STANDARDS

The pharmacy procedures form part of the quality framework for thesafe and effective running of the pharmacy. Pharmacy procedures mustbe fit for purpose, and reflect the day to day running of the specificpharmacy premises. The regulations set out the minimum areasinformation required in the pharmacy procedures that must be in place.

In addition, you ensure that:

2.1 the procedures are being operated in the pharmacy and therequirement for amendment or review is assessed by you.

2.2 it is clear to staff on duty which procedures are in operation onthe day.

2.3 adequate back ups of the content of pharmacy procedures aremaintained.

2.4 pharmacy procedures must be applicable at all times undernormal circumstances;

Establishing the pharmacy procedures2.5 if you are the responsible pharmacist who is responsible forestablishing the pharmacy procedure(s), these are:

2.5.1 marked with the date of preparation.2.5.2 marked with the date it is due for review.

The amendment of pharmacy procedures

2.6 in the event that you make a temporary amendment to thepharmacy procedure, an audit trail is maintained to identify:

2.6.1 what procedures are currently in place;2.6.2 what procedures were previously in place;2.6.3 the responsible pharmacist who amended or reviewed the

procedures and date on which any changes were made.


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The review of pharmacy procedures

2.7 the procedures are reviewed at least once every two years, andat any time that an incident or event occurs which indicates that

the pharmacy is not running safely and effectively

2.8 any changes to the procedures, following their review, arenotified to the person in position of authority as soon as it is

reasonably practicable.

2.9 an audit trail is maintained to identify:2.9.1

what procedures are currently in place;2.9.2 what procedures were previously in place;2.9.3 the responsible pharmacist who reviewed the procedures

and date on which any changes were made.

Good practice

All members of staff involved in the sale and supply of medicines

should read and comply with the pharmacy procedures

Pharmacy procedures should not be dependant on the presence

and ways of working of the responsible pharmacist under whose

authority they were established

You should record the reason for the review or amendment

3. PHARMACY RECORD

STANDARDS

Failure to complete the pharmacy record, as required in the Act, is a

criminal offence that could result in prosecution. Appendix B sets out

the minimum information to be included in the pharmacy record, as

required by the regulations. In addition, you must:

3.1 ensure the record is accurate and contemporaneous3.2 make appropriate back-ups of an electronic record to ensure

the record is available at the premises

3.3 safeguard a paper based record by initialling and dating anyamendments to an entry made in the record



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4. ABSENCE FROM THE PHARMACY

The regulations enable the pharmacy to continue to operate for the sale

and supply of medicines for a maximum of two hours during the

operational hours of the pharmacy between midnight and midnight

without the presence of a responsible pharmacist, subject to specified

conditions. The regulations require you to remain contactable with

pharmacy staff where this is practical. You must also be able to return

with reasonable promptness. You must return with reasonable

promptness, where in your opinion this is necessary to secure the safe

and effective running of the pharmacy. If you cannot remain contactable,you must arrange for another pharmacist to provide advice throughout

the period of absence or for any time during that period that you are out

of contact. You must exercise your professional judgment in deciding

whether to be absent from the pharmacy.

Good practice

You should record your reason for absence.

You should wherever possible, plan your absence in advance of

leaving the pharmacy.

You should consider the length of time it will take for you to travel

to and from the pharmacy to the alternative destination, in

considering your ability to return with reasonable promptness.

You should consider what would be the most appropriate means to

remain contactable with the pharmacy, for example a pager or

mobile telephone and any risks in being able to remain contactable,

for example where travelling through areas with poor mobile phonereception.


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APPENDIX A

The regulations require that the pharmacy procedures must provide

information on the following:

Arrangements to ensure that medicinal products are:-

- ordered

- stored

- prepared

- sold by retail

- supplied in circumstances corresponding to retail sale

- delivered outside the pharmacy and

- disposed of

in a safe and effective manner.

The circumstances in which a member of pharmacy staff who is not a

pharmacist may give advice about medicinal products The identification of members of pharmacy staff who are, in the view

of the responsible pharmacist, competent to perform specified tasks

relating to the pharmacy business;

The keeping of records about the matters mentioned above

Arrangements which are to apply during the absence of the

responsible pharmacist from the premises

Steps to be taken when there is a change of responsible pharmacist atthe premises

The procedure which is followed if a complaint is made about the

pharmacy business

The procedure which is to be followed if an incident occurs which may

indicate that the pharmacy business is not running in a safe and

effective manner and

The manner in which changes to the pharmacy procedures are to be

notified to the staff



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APPENDIX B

The regulations require the following details to be included in thepharmacy record:

The responsible pharmacists name

Their registration number

The date and time at which the responsib]le pharmacist became theresponsible pharmacist

The date and time at which the responsible pharmacist ceased to be theresponsible pharmacist

In relation to absence from the premises by the responsible pharmacist:

- The date of absence

- The time at which the absence commenced

- The time at which they returned

- If they have been responsible pharmacist for more than one premises,

this fact1

1 At this time a responsible pharmacist cannot be responsible for morethan one pharmacy premises.

Guidance that supports this document

We have produced documents or guidance bulletins on the followingwhich should be considered in conjunction with these standards:

Code of ethics for pharmacists and pharmacy technicians

Professional standards and guidance for pharmacists and pharmacytechnicians in positions of authority

You can download these documents and more copies of this documentfrom our website (www.rpsgb.org) or you can telephone us on020 7735 9141.

Other sources of Society advice

Further information or advice on the professional or legal obligations ofthe pharmacy profession can be obtained by contacting the Societys legaland ethical advisory service on 020 7572 2308 or email


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Professional Standards and Guidance for the Sale and

Supply of Medicines

About this document

The Code of Ethics sets out seven principles of ethical practice that you

must follow as a pharmacist or pharmacy technician. It is your

responsibility to apply the principles to your daily work, using your

judgement in light of the principles.

The Code of Ethics says that you must Make the care of patients yourfirst concern.

In meeting this principle you are expected to:

Provide a proper standard of practice and care to those for whom you

provide professional services.

Seek all relevant information required to assess an individuals needs

and provide appropriate treatment and care. Where necessary, refer

patients to other health or social care professionals or other relevantorganisations.

Seek to ensure safe and timely access to medicines and take steps to

be satisfied of the clinical appropriateness of medicines supplied to

individual patients.

Encourage the effective use of medicines and be satisfied that

patients, or those who care for them, know how to use their

medicines.


Ensure that you have access to the facilities, equipment and materials

necessary to provide services to professionally accepted standards.

This document expands on the principles of the Code of Ethics to set out

your professional responsibilities if you are involved in the sale and

supply of medicines. It is designed to meet Societys obligations under

the Pharmacists and Pharmacy Technicians Order 2007 and other

relevant legislation.This document does not detail legislative requirements, but when


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Professional Standards and Guidance for the Sale and Supply of Medicines




Mandatory professional standards (indicated by the word must) forall registered pharmacists and pharmacy technicians; and



1. PHARMACEUTICAL STOCK

STANDARDSPatients, members of the public and other healthcare professionals areentitled to expect that medicines sold or supplied within the course ofprofessional pharmacy practice are obtained from a reputable sourceand fit for the intended purpose. You must ensure that:

1.1 if you suspect you have been offered or supplied a counterfeit ordefective medicine, this is reported to the Medicines andHealthcare products Regulatory Agency, the Royal

Pharmaceutical Society, the Veterinary Medicines Directorate orthe marketing authorisation holder as appropriate to theindividual situation. Any such stock must be segregated fromother pharmacy stock and must not be sold or supplied for thetreatment of any person(s).

1.2 pharmaceutical stock is stored under suitable conditions, takinginto consideration the stability of the drug.

1.3 particular attention is paid to protection of pharmaceutical stock

from contamination, sunlight, atmospheric moisture and adversetemperatures. You must ensure that where you have concerns


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about the stability of a medicine, it is segregated from the rest of

the stock and not sold or supplied for patient use.1.4 refrigerators used for pharmaceutical stock are capable of storing

products between 2C and 8C. They must be equipped with amaximum/minimum thermometer, or other suitable alternative,which is checked on each day the pharmacy is open and themaximum and minimum temperatures recorded. Steps must betaken to rectify discrepancies in temperatures.

1.5 all stocks of medicines in the pharmacy have batch and expiry

details. Medicines must be removed from blister or foil packsonly at the time of dispensing to assist an individual patient.

1.6 date expired stock is segregated from the rest of the pharmacystock and appropriately disposed of. Procedures must be in placeto reduce the risk of short dated or out-of-date stock beingaccidentally supplied to a patient or member of the public. In theevent of a pandemic flu, Level 6, date expired medicines may besupplied to patients, where this is in line with guidance issued by

the Government and/or the RPSGB.1.7 products that may be injurious to a persons health, for example

tobacco products, alcoholic beverages and products intended tomask the signs of alcohol or drug consumption are not sold orsupplied from registered pharmacy premises.

1.8 medicines returned to the pharmacy from a patients home, acare home or a similar institution are not supplied to anotherpatient. While awaiting disposal, these medicines must be clearly

marked and segregated from other stock.1 In the event of apandemic flu, Level 6, patient returned medicines may besupplied to patients, where this is in line with guidance issued bythe Government and/or the RPSGB.

1.9 within the hospital setting, all medicines returned to thepharmacy department from a ward or other hospital departmentare examined under the direction of a pharmacist to assess theirsuitability for being returned to stock. Patients own drugs

brought into hospital with them must not be returned topharmacy stock or be supplied to another patient.1


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2. SUPPLY OF OVER THE COUNTER (OTC) MEDICINES

STANDARDS

When purchasing medicines from pharmacies patients expect to beprovided with high quality, relevant information in a manner they caneasily understand. You must ensure that:

2.1 procedures for sales of OTC medicines enable intervention andprofessional advice to be given whenever this can assist the safeand effective use of medicines. Pharmacy medicines must not beaccessible to the public by self-selection.

2.2 when a patient or their carer requests advice on treatment,sufficient information is obtained to enable an assessment to bemade of whether self-care is appropriate, and to enable asuitable product(s) to be recommended.

2.3 if a sale is not considered suitable, the reasons for this areexplained to the patient and they are referred to anotherhealthcare professional where appropriate.

2.4 when an OTC medicine is supplied, sufficient advice to ensure thesafe and effective use of the medicine is provided. You must takeinto account any other specific information such as safe storage, orshort expiry dates that the patient may need to be counselled on.

2.5 all staff involved in the sale or supply of an OTC medicine aretrained, or are undertaking the training required for their duties,and are aware of situations where referral to the pharmacist orother registered healthcare professional may be necessary.

Consideration must be given to the types of OTC medicines thatmay require the personal intervention of a pharmacist e.g. thosethat have recently become available without prescription, thosethat may be subject to abuse or misuse, or where the marketingauthorisation for non-prescription use is restricted to certainconditions and circumstances.


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2.6 all persons involved in the sale of OTC products are aware of the

abuse potential of certain OTC medicines and other products. Youmust be alert to requests for large quantities and abnormally

frequent requests and refuse to make a supply where there are

reasonable grounds for suspecting misuse.

2.7 particular care is exercised when supplying products for children,

the elderly and other special groups or individuals, or where the

product is for animal use.

2.8 requests for certain medicines such as emergency hormonal

contraception are handled sensitively and the patients right toprivacy and confidentiality is respected.

2.9 any information provided about OTC medicines is up to date,

accurate and reliable.

2.10 you keep up to date with developments regarding new products

and policies for health promotion and are aware of local and

major national and topical health promotion initiatives.

3. SUPPLY OF PRESCRIBED MEDICINES

STANDARDS

Patients are entitled to expect the dispensing service provided to be

accurate, accessible and reasonably prompt. Appropriate standard

operating procedures must be in place for the dispensing services you

provide, or are responsible for and you must ensure that:

3.1 you seek to maintain adequate stock holdings.3.2 every prescription is clinically assessed by a pharmacist to

determine its suitability for the patient.

3.3 the patient receives sufficient information and advice to enable

the safe and effective use of the prescribed medicine.

3.4 appropriate records of clinical interventions are maintained.

3.5 patients or their carers are informed if you are unable to dispense

their prescription in its entirety and given the opportunity to taketheir prescription to another pharmacy.


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3.6 when medication is outstanding, the patient, carer or their

representative is provided with a legible note detailing the nameand quantity of medicine outstanding and, where possible,informed when the balance will be available for collection. Arecord of the medicine owed must be kept in the pharmacy.

3.7 a product with a marketing authorisation is supplied where sucha product exists in a suitable formulation and is available, inpreference to an unlicensed product or food supplement.2

3.8 except in an emergency, a specifically named product is not

substituted for any other product without the approval of thepatient or carer and the prescriber, a hospital drug andtherapeutics committee, or other similar locally agreed protocols.

3.9 when providing services for drug misusers you do not deviatefrom the instructions given on the prescription. Sugar and/orcolour-free products have a greater potential for abuse thansyrup based and coloured products and must not be dispensedunless specifically prescribed.

3.10 all solid dose and all oral and external liquid preparations aredispensed in suitable reclosable child resistant containersunless:

the medicine is in an original pack or patient pack such as tomake this inadvisable;

the patient has difficulty in opening a child resistant container;

a specific request is made by the patient, their carer or

representative that the product is not dispensed in a childresistant container;

no suitable child resistant container exists for a particularliquid preparation, or

the patient has been assessed as requiring a compliance aid.

3.11 labelling of dispensed products is clear and legible and whereappropriate includes any cautionary and advisory labellingrecommended by the current British National Formulary.

3.12 appropriate systems and procedures are in place if you prepare


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GOOD PRACTICE GUIDANCE

Where verbal information is provided about a prescribed medicine

necessary records of this should be maintained, when clinically

appropriate.

3.13 reimbursement claims for NHS or other professional services are

honest and accurate.3.14 procedures are in place to minimise the risk of dispensing errors

or contamination of medicines. A record of errors or near miss

incidents must be made and practices reviewed in light of such

incidents.

4. EXTEMPORANEOUS PREPARATION OR COMPOUNDING

STANDARDS

This standard is not intended to cover the reconstitution of dry powders

with water or other diluents.

Patients are entitled to expect that products extemporaneously

prepared in a pharmacy are prepared accurately and are suitable for

use. If you wish to be involved in extemporaneous preparation you must

ensure that:

4.1 a product is extemporaneously prepared only when there is no

product with a marketing authorisation available3 and where you

are able to prepare the product in compliance with accepted

standards.

4.2 you and any other staff involved are competent to undertake the

tasks to be performed.

4.3 the requisite facilities and equipment are available. Equipment

must be maintained in good order to ensure that performance is

unimpaired, and must be fit for the intended purpose.

4.4 you are satisfied as to the safety and appropriateness of the

formula of the product.


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Where possible, all calculations and measurements should be

double checked by a second appropriately trained member of

staff.

4.5 ingredients are sourced from recognised pharmaceutical

manufacturers and are of a quality accepted for use in thepreparation and manufacture of pharmaceutical products.

Where appropriate, relevant legislation must be complied with.

4.6 particular attention and care is paid to substances which may be

hazardous and require special handling techniques.

4.7 the product is labelled with the necessary particulars, including

an expiry date and any special requirements for the safe handling

or storage of the product.

4.8 if you are undertaking large scale preparation of medicinal

products, all relevant standards and guidance are adhered to.

4.9 records are kept for a minimum of two years. The records must

include:

the formula,

the ingredients,

the quantities used, their source,

the batch number,

the expiry date,

where the preparation is dispensed in response to a

prescription, the patient's and prescription details and the date

of dispensing,

the personnel involved, including the identity of the pharmacisttaking overall responsibility.


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5. REPEAT MEDICATION SERVICES

STANDARDS

A repeat medication service is a service operated in co-operation with

local prescribers, in which pharmacists will provide professional support

to assist in the rational, safe, effective and economic use of medicines.

In order to provide a repeat medication service, you must:

5.1 ensure the pharmacy operates a patient medication record

system notified to the Information Commissioners Office.

5.2 ensure that an audit trail exists to identify each request and supply.

5.3 establish, at the time of each request, which items the patient or

carer considers are required and ensure that unnecessary

supplies are not made. At this stage pharmacists must also use

their professional judgement to decide whether concordance or

other problems encountered by the patient may require early

reference to the prescriber.

5.4 not request a repeat prescription from a surgery before obtaining

the patients or carers consent. You may however institute apatient reminder system.

5.5 record all interventions in order to be able to deal with any

queries that may arise.

6. DELIVERY SERVICES

STANDARDSA delivery service is where the medicine is handed to the patient, their

carer or other designated person other than on registered pharmacy

premises. When providing medicines via a delivery service you still have

a professional responsibility to ensure that patients or their carers know

how to use the medication safely, effectively and appropriately and

check that they are not experiencing adverse effects or compliance

difficulties. You must ensure that:

6.1 on each occasion a delivery service is provided you use yourprofessional judgement to determine whether direct face-to-face

i h h i h i i


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Wherever possible a signature should be obtained to indicate safereceipt of the medicines.

Systems should be in place to inform a patient who is not at homethat delivery was attempted.

6.2 you obtain consent from the patient or their carer to provide the

delivery service on a single occasion or for a set period of time.6.3 delivery to a person other than the patient or carer is undertaken

only where they have been specifically designated by the patientor their carer.

6.4 you maintain appropriate records of requests for the service.

6.5 the delivery mechanism used:

enables the medicine to be delivered securely and promptly to

the intended recipient with any necessary information toenable safe and effective use of their medicine;

caters for any special security/storage requirements of themedicine;

incorporates a verifiable audit trail for the medicine from thepoint at which it leaves the pharmacy to the point at which it ishanded to the patient, their carer or other designated person,or returned to the pharmacy in the event of a delivery failure;

safeguards confidential information about the medication thata patient is taking.


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7. PRESCRIPTION COLLECTION SERVICE

STANDARDS

A prescription collection service encompasses any scheme where apharmacy receives prescriptions other than directly from the patient,their carer or their representative. When providing such a service youmust:

7.1 obtain consent to receive patients prescriptions. The request forthe ongoing service must be from the patient or their carer andprocedures must exist for maintaining records of the initialrequest for the service.

7.2 explain fully to patients, or their carers, what the service involves,including the time period required to collect/receive anddispense their prescription.

7.3 ensure that any members of staff who collect prescriptions areacting in accordance with your directions.

7.4 take all reasonable steps to ensure patient confidentiality and

the security of prescriptions.

7.5 make sure that requests for repeat prescriptions are initiated bythe patient or their carer. A reminder system may be institutedbut a prescription must not be requested from a surgery beforeobtaining the patients or their carers consent.

7.6 on receipt of prescriptions, including electronic prescriptions, besatisfied that you are authorised to receive and dispense them.Any prescription received for which you do not have the authority,

must be returned to the surgery for collection by the patient orcarer, or be directed to the pharmacy authorised to receive it.


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8. COMPLEMENTARY THERAPIES AND MEDICINES

STANDARDS

You must ensure that you are competent in any area in which you offer

advice on treatment or medicines. If you sell or supply homoeopathic or

herbal medicines, or other complementary therapies, you must:

8.1 assist patients in making informed decisions by providing them

with necessary and relevant information.

8.2 ensure any stock is obtained from a reputable source.

8.3 recommend a remedy only where you can be satisfied of its

safety and quality, taking into account the Medicines and

Healthcare products Regulatory Agency registration schemes for

homoeopathic and herbal remedies.

9. EMERGENCIES

STANDARDS

There may be occasions when you are required to assist members of the

public or patients in an emergency. In such situations you must:

9.1 where appropriate, consider using the exemption in legislation

that allows pharmacists to make an emergency supply of

medicines if a patient has an urgent need for them. You must

consider the medical consequences, if any, of not making the

supply and be satisfied that your decision will not lead to patient

care being compromised.

9.2 advise the patient on how to obtain essential medical care where

you do not consider an emergency supply to be appropriate.

9.3 assist persons in need of emergency first aid or medical

treatment whether by administering first aid within your

competence or by summoning assistance.


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10. PATIENT GROUP DIRECTIONS

STANDARDS

If you are involved in the supply and/or administration of a medicineunder a patient group direction (PGD) you must:

10.1 be satisfied that the PGD is legally valid and that it has beenapproved by the relevant authorising body.

10.2 ensure that when supplies are made the agreed protocol isfollowed and the information specified in the PGD is recorded.

These records must include the identity of the pharmacistassuming responsibility for each supply.

10.3 ensure you have up-to-date knowledge relating to the clinicalsituation covered by the PGD, the medicine and its use for theindications specified.

10.4 ensure that you have undertaken any training required foroperation of the PGD.

If you are involved in writing and/or approving patient group directions(PGD) you are accountable for their content and must ensure that:

10.5 you are familiar with your role and responsibilities and thegovernment advice set out in relevant guidance.

10.6 only PGDs which comply with legal requirements are approved.

10.7 the staff training specified will enable safe operation of the PGD.

10.8 the appropriate people have been involved in the drafting,

approval and signing of the PGD.10.9 you have up-to-date knowledge relating to the clinical situation

being covered by the PGD, the medicine and its use forindications specified in the PGD.


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Guidance that supports this document

We have produced documents or guidance bulletins on the following whichshould be considered in conjunction with these standards:

Code of ethics for pharmacists and pharmacy technicians

Professional standards and guidance for patient consent

Professional standards and guidance for patient confidentiality

Emergency first aid; guidance for pharmacists

Patient group directions: a resource pack for pharmacists

The safe and secure handling of medicines: a team approach (The DuthieReport)

Emergency supplies guidance (Law and Ethics Bulletin)

Safe storage of medicines in patients homes (Law and Ethics Bulletin)

You can download these documents and more copies of this document from ourwebsite (www.rpsgb.org) or you can telephone us on 020 7735 9141.

Other sources of Society advice

Further information or advice on the professional or legal obligations of thepharmacy profession can be obtained by contacting the Societys legal andethical advisory service on 020 7572 2308 or e-mail [email protected].



34/318

Appendix 1

EXTEMPORANEOUS PREPARATION OF METHADONE MIXTURE

You must supply a product with a marketing authorisation, where such aproduct exists in a suitable formulation and is available, in preference toan unlicensed product or food supplement. You must only prepare aproduct extemporaneously if there is no product with a marketingauthorisation available and where you are able to prepare the product incompliance with accepted standards.

An exception to these requirements, to permit the extemporaneouspreparation of methadone mixture in circumstances where a licensed

product is available, will be granted provided the followingrequirements are adhered to:

STANDARDS

(a) If a licensed product is available, methadone mixture may only beprepared extemporaneously if the quantity of methadone dispensed ona regular basis is large enough to preclude storage of sufficientquantities of the licensed product within the pharmacy, in accordancewith the safe custody requirements of the Misuse of Drugs legislation.

(b) In addition to the standard operating procedures (SOPs) required fordispensing, a SOP must be in place for the extemporaneous preparationof methadone. The SOP must ensure safe systems and provide averifiable audit trail. Adherence to the SOP must be ensured.

(c) Extemporaneous preparation must only be carried out by personswho are appropriately trained and competent to do so.

(d) All quantities of methadone powder and diluent, and any colourings,

flavourings and stabilisers, must be accurately measured. You must notrely on the accuracy of the quantities of powder, diluent etc stated onthe manufacturers packs.

(e) The equipment used to measure and prepare extemporaneousmethadone products must be appropriate and be maintained in goodorder to ensure that performance is unimpaired.

(f) Equipment must be properly cleaned between each batch ofextemporaneously prepared product to ensure that no residue from

previous batches remains.

(g) Visual checks must be made to ensure the methadone powder has


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Running balances of methadone powder and the resultingextemporaneously prepared methadone mixture should bemaintained.

The prescriber and the patient should be informed that themethadone product being supplied does not have a marketingauthorisation.

Wh ibl ll t h ld b h k d b

(h) Stock bottles must not be reused.

(i) The product must be labelled with the necessary particulars,including:

The name and strength of the product

The quantity of medicinal product in the container

Any special handling and storage requirements (eg, store in safecustody)

The batch expiry date

A batch reference number(j) For each batch of extemporaneous methadone mixture prepared arecord must be maintained for a minimum of two years of:

The formula

The ingredients and quantities used

The source, batch number and expiry date of the ingredients

The batch number and expiry date of the extemporaneously preparedmixture

The persons involved in preparing the product, including the identityof the pharmacist assuming overall responsibility

(k) Extemporaneously prepared methadone mixture must be stored in acabinet, cupboard or room that meets the requirements of the Misuse ofDrugs (Safe Custody) Regulations 1973.

(l) Extemporaneous preparation of methadone mixture, when a licensedproduct is available, carries increased liability and must be covered by

indemnity insurance arrangements.


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Professional Standards and Guidance for the Sale and

Supply of Medicines

About this document

The Code of Ethics sets out seven principles of ethical practice that you

must follow as a pharmacist or pharmacy technician. It is your

responsibility to apply the principles to your daily work, using your

judgement in light of the principles.

The Code of Ethics says that you must Make the care of patients yourfirst concern.

In meeting this principle you are expected to:

Provide a proper standard of practice and care to those for whom you

provide professional services.

Seek all relevant information required to assess an individuals needs

and provide appropriate treatment and care. Where necessary, refer

patients to other health or social care professionals or other relevantorganisations.

Seek to ensure safe and timely access to medicines and take steps to

be satisfied of the clinical appropriateness of medicines supplied to

individual patients.

Encourage the effective use of medicines and be satisfied that

patients, or those who care for them, know how to use their

medicines.


Ensure that you have access to the facilities, equipment and materials

necessary to provide services to professionally accepted standards.

This document expands on the principles of the Code of Ethics to set out

your professional responsibilities if you are involved in the sale and

supply of medicines. It is designed to meet Societys obligations under

the Pharmacists and Pharmacy Technicians Order 2007 and other

relevant legislation.This document does not detail legislative requirements, but when


37/318





Mandatory professional standards (indicated by the word must) forall registered pharmacists and pharmacy technicians; and



1. PHARMACEUTICAL STOCK

STANDARDSPatients, members of the public and other healthcare professionals areentitled to expect that medicines sold or supplied within the course ofprofessional pharmacy practice are obtained from a reputable sourceand fit for the intended purpose. You must ensure that:

1.1 if you suspect you have been offered or supplied a counterfeit ordefective medicine, this is reported to the Medicines andHealthcare products Regulatory Agency, the Royal

Pharmaceutical Society, the Veterinary Medicines Directorate orthe marketing authorisation holder as appropriate to theindividual situation. Any such stock must be segregated fromother pharmacy stock and must not be sold or supplied for thetreatment of any person(s).

1.2 pharmaceutical stock is stored under suitable conditions, takinginto consideration the stability of the drug.

1.3 particular attention is paid to protection of pharmaceutical stock

from contamination, sunlight, atmospheric moisture and adversetemperatures. You must ensure that where you have concerns


38/318

about the stability of a medicine, it is segregated from the rest of

the stock and not sold or supplied for patient use.1.4 refrigerators used for pharmaceutical stock are capable of storing

products between 2C and 8C. They must be equipped with amaximum/minimum thermometer, or other suitable alternative,which is checked on each day the pharmacy is open and themaximum and minimum temperatures recorded. Steps must betaken to rectify discrepancies in temperatures.

1.5 all stocks of medicines in the pharmacy have batch and expiry

details. Medicines must be removed from blister or foil packsonly at the time of dispensing to assist an individual patient.

1.6 date expired stock is segregated from the rest of the pharmacystock and appropriately disposed of. Procedures must be in placeto reduce the risk of short dated or out-of-date stock beingaccidentally supplied to a patient or member of the public. In theevent of a pandemic flu, Level 6, date expired medicines may besupplied to patients, where this is in line with guidance issued by

the Government and/or the RPSGB.1.7 products that may be injurious to a persons health, for example

tobacco products, alcoholic beverages and products intended tomask the signs of alcohol or drug consumption are not sold orsupplied from registered pharmacy premises.

1.8 medicines returned to the pharmacy from a patients home, acare home or a similar institution are not supplied to anotherpatient. While awaiting disposal, these medicines must be clearly

marked and segregated from other stock.1 In the event of apandemic flu, Level 6, patient returned medicines may besupplied to patients, where this is in line with guidance issued bythe Government and/or the RPSGB.

1.9 within the hospital setting, all medicines returned to thepharmacy department from a ward or other hospital departmentare examined under the direction of a pharmacist to assess theirsuitability for being returned to stock. Patients own drugs

brought into hospital with them must not be returned topharmacy stock or be supplied to another patient.1


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2. SUPPLY OF OVER THE COUNTER (OTC) MEDICINES

STANDARDS

When purchasing medicines from pharmacies patients expect to beprovided with high quality, relevant information in a manner they caneasily understand. You must ensure that:

2.1 procedures for sales of OTC medicines enable intervention andprofessional advice to be given whenever this can assist the safeand effective use of medicines. Pharmacy medicines must not beaccessible to the public by self-selection.

2.2 when a patient or their carer requests advice on treatment,sufficient information is obtained to enable an assessment to bemade of whether self-care is appropriate, and to enable asuitable product(s) to be recommended.

2.3 if a sale is not considered suitable, the reasons for this areexplained to the patient and they are referred to anotherhealthcare professional where appropriate.

2.4 when an OTC medicine is supplied, sufficient advice to ensure thesafe and effective use of the medicine is provided. You must takeinto account any other specific information such as safe storage, orshort expiry dates that the patient may need to be counselled on.

2.5 all staff involved in the sale or supply of an OTC medicine aretrained, or are undertaking the training required for their duties,and are aware of situations where referral to the pharmacist orother registered healthcare professional may be necessary.

Consideration must be given to the types of OTC medicines thatmay require the personal intervention of a pharmacist e.g. thosethat have recently become available without prescription, thosethat may be subject to abuse or misuse, or where the marketingauthorisation for non-prescription use is restricted to certainconditions and circumstances.


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2.6 all persons involved in the sale of OTC products are aware of the

abuse potential of certain OTC medicines and other products. Youmust be alert to requests for large quantities and abnormally

frequent requests and refuse to make a supply where there are

reasonable grounds for suspecting misuse.

2.7 particular care is exercised when supplying products for children,

the elderly and other special groups or individuals, or where the

product is for animal use.

2.8 requests for certain medicines such as emergency hormonal

contraception are handled sensitively and the patients right toprivacy and confidentiality is respected.

2.9 any information provided about OTC medicines is up to date,

accurate and reliable.

2.10 you keep up to date with developments regarding new products

and policies for health promotion and are aware of local and

major national and topical health promotion initiatives.

3. SUPPLY OF PRESCRIBED MEDICINES

STANDARDS

Patients are entitled to expect the dispensing service provided to be

accurate, accessible and reasonably prompt. Appropriate standard

operating procedures must be in place for the dispensing services you

provide, or are responsible for and you must ensure that:

3.1 you seek to maintain adequate stock holdings.3.2 every prescription is clinically assessed by a pharmacist to

determine its suitability for the patient.

3.3 the patient receives sufficient information and advice to enable

the safe and effective use of the prescribed medicine.

3.4 appropriate records of clinical interventions are maintained.

3.5 patients or their carers are informed if you are unable to dispense

their prescription in its entirety and given the opportunity to taketheir prescription to another pharmacy.


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3.6 when medication is outstanding, the patient, carer or their

representative is provided with a legible note detailing the nameand quantity of medicine outstanding and, where possible,informed when the balance will be available for collection. Arecord of the medicine owed must be kept in the pharmacy.

3.7 a product with a marketing authorisation is supplied where sucha product exists in a suitable formulation and is available, inpreference to an unlicensed product or food supplement.2

3.8 except in an emergency, a specifically named product is not

substituted for any other product without the approval of thepatient or carer and the prescriber, a hospital drug andtherapeutics committee, or other similar locally agreed protocols.

3.9 when providing services for drug misusers you do not deviatefrom the instructions given on the prescription. Sugar and/orcolour-free products have a greater potential for abuse thansyrup based and coloured products and must not be dispensedunless specifically prescribed.

3.10 all solid dose and all oral and external liquid preparations aredispensed in suitable reclosable child resistant containersunless:

the medicine is in an original pack or patient pack such as tomake this inadvisable;

the patient has difficulty in opening a child resistant container;

a specific request is made by the patient, their carer or

representative that the product is not dispensed in a childresistant container;

no suitable child resistant container exists for a particularliquid preparation, or

the patient has been assessed as requiring a compliance aid.

3.11 labelling of dispensed products is clear and legible and whereappropriate includes any cautionary and advisory labellingrecommended by the current British National Formulary.

3.12 appropriate systems and procedures are in place if you prepare


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Where verbal information is provided about a prescribed medicine

necessary records of this should be maintained, when clinically

appropriate.

3.13 reimbursement claims for NHS or other professional services are

honest and accurate.3.14 procedures are in place to minimise the risk of dispensing errors

or contamination of medicines. A record of errors or near miss

incidents must be made and practices reviewed in light of such

incidents.

4. EXTEMPORANEOUS PREPARATION OR COMPOUNDING

STANDARDS

This standard is not intended to cover the reconstitution of dry powders

with water or other diluents.

Patients are entitled to expect that products extemporaneously

prepared in a pharmacy are prepared accurately and are suitable for

use. If you wish to be involved in extemporaneous preparation you must

ensure that:

4.1 a product is extemporaneously prepared only when there is no

product with a marketing authorisation available3 and where you

are able to prepare the product in compliance with accepted

standards.

4.2 you and any other staff involved are competent to undertake the

tasks to be performed.

4.3 the requisite facilities and equipment are available. Equipment

must be maintained in good order to ensure that performance is

unimpaired, and must be fit for the intended purpose.

4.4 you are satisfied as to the

Compiled Pharmacist Ethics Resources

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Transcript of Compiled Pharmacist Ethics Resources