ASSIGMENT NAME: Pharmaceutical Ethics

COURSE NAME: Forensic Pharmacy

COURSE NO: 712-T
LECTURER NAME: Ms.Faryal
GROUP NO: 03
GROUP MEMBERS:
 Eman Ehsan
 Ayesha Khan
 Kainat Khalid
 Laraib Khalid
 Laiba Khan
 Fatima Syed
 Malaika Gulzar
 Mehak Noor

A. PATENT AND GENERICS:

PHARMACEUTICAL ETHICS:
Pharmacy is an honorable profession that is devoted to
providing good healthcare services to human beings. The
pharmacist is an important connection between the doctor and
the patient.

Pharmaceutical Ethics encircle the code of moral principles or

the science of morals which is worried about human character.
The pharmacist of today is a multitasker like he is a drug
dispenser, drug maker, patient counselor, drug custodian, drug
researcher, and drug educator above all honest and patriotic
citizen.
Government limits the practice of Pharmacy to those who are
qualified under the regulatory requirements and gives them
advantages that necessarily disprove others. In return for this
benefit government only expects the Pharmacist to recognize his duties and
responsibilities to fulfill his professional obligations
PRINCIPLES OF PHARMACEUTICAL ETHICS:
Some principles of pharmaceutical ethics are:
  The pharmacist should be a law-abiding and good citizen, familiar with Acts
and Rules managing his/her profession.
 He/She should be always ready to sacrifice for both patient and the public.
 Must be able of upholding the dignity and honor of the profession & and not
get involved in action that brings disrespect to the profession.
 He/She should never reveal any information about the patient or his family
which is considered a part of professional activities, unless & until required to
do so by the law.
 Never get involved in unethical work under pressure.
 Pharmacists should possess good communication skills and must be able to
work closely with other healthcare professionals.

PATENT & GENERIC:

A patent is a complete right for an invention or discovery which can be a medicinal

product, drug, or process that is used to invent or find that thing and also offers a new
technical solution to a problem. If you want to get a patent, then you must need to
disclose the technical information about the invention to get a patent application.
When any pharmaceutical company develops a new drug for the first time that is
used for the disease conditions, initially it is sold under a brand name for the patient
prescribed by the doctors. The drug must be patent protected which means that the
company that holds the patent has the right to manufacture, sell and market the drug
to make a profit.

We have three types of patents: design patents, utility patents, and plant patents.
If the patent of the drug has expired, then that drug can be sold and manufactured by
other companies. So, at this point, that drug is sold as a generic drug. According to
FDA guidelines, generic drugs must be identical to branded drugs in several terms
like safety, usage, efficacy, pharmacokinetics, pharmacodynamics, and route of
administration.
A drug can be manufactured as a generic drug if:
 Patent of the drug has expired.
 There is no patent on the drug before.
 If a drug has no patent protection.
 Company that manufactured the generic drug guarantee that the patent of that
drug is invalid or unenforceable.
After the marketing of the patent drug, the ownership of the patent holder is removed.
All this thing encouraged the competition and as a result drop in drug costs.
The company that holds the initial patent can renew the patent again by forming a
new version of the drug that is compared to the original compound. All these things
required re-application and new clinical trials.

How to Obtain Patent Protection

The patent can only be obtained by first filing an application with the United States
Patent and Trademark Office (USPTO). We have both non-provisional and
provisional applications for patents for patent-seekers.

Applicants filed the application for provisional patent by providing them more time to
find out the specifics or qualities of discovery and invention while protecting them
from being patented by others. An applicant that files the provisional patent
application only has one year from the date of filing a file an analogous non-
provisional application.

Application for a non-provisional patent begins the process of official examination for
the USPTO to determine if the discovery or invention is appropriate to receive patent
protection. All the information that must be included in the patent application must
depend upon the type of patent that is being looked for, Application for a non-
provisional patent includes a claim and description of the discovery and invention,
declaration, fees, and an oath. As per PTC (patent cooperation treaty), a person can
also file an international patent.

(Malaika Gulzar)

ETHICS IN SALE:
Pharmaceutical ethics in sales refers to the ethical
principles and values that guide the behavior of
pharmaceutical sales representatives when promoting
and selling their company's drugs to healthcare
professionals. The pharmaceutical industry is highly
regulated, and pharmaceutical sales representatives are expected to adhere to strict
ethical standards when conducting business.

Key Aspects of Pharmaceutical Ethics in Sales:

Here are some key aspects of pharmaceutical ethics in sales

1) Truthfulness:
Pharmaceutical sales representatives must be truthful and accurate in their
communications with healthcare professionals. They should not mislead or
deceive healthcare professionals by making false claims or misrepresenting the
safety or efficacy of their drugs.

2) Transparency:
Pharmaceutical sales representatives should be transparent about the drugs they
are promoting. They should provide complete and accurate information about the
drug's benefits, risks, and limitations, and disclose any conflicts of interest.

3) Professionalism:
Pharmaceutical sales representatives should conduct themselves in a professional
manner at all times. They should be knowledgeable about their company's drugs
and provide excellent customer service to healthcare professionals.

4) Respect:
Pharmaceutical sales representatives should respect the autonomy and expertise
of healthcare professionals. They should not pressure or coerce healthcare
professionals into prescribing their drugs, or use gifts or other incentives to
influence their prescribing behavior.

5) Compliance:
Pharmaceutical sales representatives should comply with all applicable laws and
regulations, including those related to the promotion and sale of drugs. They
should not engage in any unethical practices, such as off-label marketing or
kickbacks to healthcare professionals.

6) Social Responsibility:
Pharmaceutical sales representatives should be aware of the impact of their
company's drugs on society and the environment. They should promote
sustainable and ethical business practices, and avoid selling drugs that are harmful
or unethical.

7) Confidentiality:
 Pharmaceutical sales representatives should maintain the confidentiality of patient
and healthcare professional information, including personal and financial data.

PROFESSIONAL CODE OF ETHICS FOR

PHARMACISTS
The code consists of eight points originated from principles of bioethics and
professionalism in pharmacy

Respect for Patient’s Dignity and Autonomy:

While patients typically rely on physicians for information about their disease and
medications, physicians may not always be able to fulfill all of their needs. Patients
often seek more information about their medications and prefer to discuss drug-
related issues with their primary healthcare provider. In such cases, pharmacists can
play a critical role in filling the information gap, given their expertise and abilities.
Although it is the pharmacist's responsibility to do so, patients may not always be
aware of pharmacist’s capacities.

Beneficence:
Providing benefit to the patients with the aim of optimizing drug therapy according to
their interests. To provide the best healthcare services, efficient pharmacist-patient
relationships is very important. This includes confirming the accuracy of prescriptions
and documenting every professional function carried out in the pharmacy. One of the
most significant responsibilities of pharmacists is to sell every drug, including
supplements, herbal products, and OTC medications.

Non-Maleicence:
In this code, it has been emphasized that a pharmacist should not cause harm to the
patient. The article also provides guidance to pharmacists on how to delegate their
tasks to a technician if they are unable to perform them. Additionally, this code also
highlights the responsibility of pharmacists to ensure the quality of drugs and the
proper dispensing of medication in the pharmacy. It also addresses how pharmacists
should handle medical errors, serious adverse drug reactions, and drug abuse

Justice:
The fourth code focuses on justice, which requires fair allocation of resources in
pharmacies, especially during drug shortages. It also examines the conflicts of interest
that pharmacists may face. Pharmacists should take an active role in reducing the cost
of treatment and improving the quality of healthcare, despite market forces and
financial constraints.

Empathy and Excellence:

The sixth and seventh code highlight the importance of empathy and collaboration
with physicians and other healthcare providers in providing optimal patient care.
Building a strong therapeutic relationship with patients requires empathy, kindness,
and compassion, which can lead to better health outcomes.
Honesty:
The following article emphasizes the value of honesty, particularly in situations where
gifts are offered to pharmacists. Much stress has been put on pharmacists' attendance
on workdays, prohibiting the sale of questionable products that may compromise the
profession's integrity. A pharmacist should not allow his name to be used in
connection with advertisements for promotion of unworthy products.

Cooperation:
The final code of ethics for pharmacists emphasizes the importance of respect for
colleagues and other healthcare providers. Pharmacists are encouraged to increase
their visibility within the healthcare team and provide high-quality, rational care while
building positive relationships with other healthcare providers.
Pharmaceutical ethics in sales is important for building trust and long-term
relationships with healthcare professionals. Sales representatives who adhere to
ethical standards are more likely to gain the respect and loyalty of healthcare
professionals, as well as their colleagues and competitors. In addition, ethical sales
practices contribute to a positive reputation for the company and the industry as a
whole.
(Mehak Noor, Ayesha khan)
ETHICS IN INDUSTRY

Definitions of right and wrong, good and bad, and the justification of actions and
character traits based on some rational system are all part of the field of ethics.
Professional ethics pertain to the moral appropriateness of our work activities and the
proper treatment of all those with and for whom we work, including employees,
clients, client organisations and their various stakeholders, interns, students, and
professional colleagues. This is how professional ethics are applied to the practise of
industrial-organizational psychology. Many of the moral principles that govern such
ethical behaviour are deontological, or rule-based, in origin and have to do with
concepts like upholding one's commitments, performing duties and obligations, and
respecting others' autonomy and dignity.
The majority of secular ethicists do not hold to the notions that there are moral truths
that can be objectively verified to serve as our guidelines or that morality is only a
matter of one person's subjective judgement versus another. According to ethical
reasoning, the decision that is best supported by the available evidence is the ethically
right one. It is advisable to be familiar with some general principles from moral
philosophy as well as applicable ethical standards, such as the American
Psychological Association's (APA) Code of Conduct, that can provide guidance when
needed because it is impossible to specify in advance or to anticipate all of the
potential ethical dilemmas one might face.

THE DOMAIN OF MORAL ACTION:

If a situation has the potential to violate one or more fundamental moral or ethical
principles, such as those outlined in formal ethical codes like the APA's, then it is
often considered to be an ethical dilemma. These are what they are:

1. Respect For People:

Deontological moral theories place a strong emphasis on people's rights to respect,
privacy or confidentiality, autonomy, independence, and the ability to express
themselves. As these rights are universalizable (available to everyone), they do not go
too far and interfere with the rights of others.

2. Beneficence:

One is obliged to act morally and improve human happiness when it is practically
possible to do so, according to this principle, which derives from the "ethics of
caring" in moral philosophy that is founded on empathy. This idea is particularly
relevant when it comes to others, such as coworkers, clients, students, and research
subjects, to whom one owes a particular duty or responsibility or who enhance one's
own interests. Additionally, it is particularly suited for professionals who are
presumed to have societal obligations that extend beyond servicing solely their paying
clients because of the authority, influence, and rights society bestows on their
profession.

3. Nonmaleficence:
The moral principle that moral philosophers agree on the most is the prohibition
against intentionally harming others. It extends to protecting against the potential
misuse of one's labour by others and is especially appropriate with regard to
individuals in vulnerable circumstances (e.g., misuse of personnel assessments or
survey findings). Conflicts between competing commitments must be resolved "in a
responsible manner that avoids or minimises harm," according to the APA code.

4. Fairness and justice:

In a Kantian sense, justice can be described as a balance between rights and

obligations. The fairness with which the advantages and disadvantages of a social
structure, such as an organisation, are allocated among its members is the general
definition of social justice. The empirical microlevel question of perceived justice has
received more attention in industrial/organizational psychology than the explanation
of normative principles of distributive social justice.

5. Moral virtue or character:

The importance of character traits in the manifestation of ethical behaviour is

highlighted by this subdomain. It involves matters like being aware of potential
ethical conflicts and driven to avoid or fairly resolve them, being trustworthy with
coworkers, taking ownership of one's conduct, keeping commitments, and promoting
the veracity, legitimacy, and integrity of professional work.
(Laiba Khan, Laraib Khalid)
ETHICS IN RESEARCH

Guidelines for conducting research responsibly are provided by research ethics. In

order to achieve a high ethical standard, it also instructs and oversees scientists
performing research. A broad outline of various ethical precepts is provided here.

1. Honesty:

Honestly describe the information, findings, techniques, and status of publications.

Don't make up, falsify, or represent data incorrectly.

2. Objectivity:

Avoid bias in all aspects of research, including grant writing, peer review, personnel
decisions, data processing, data interpretation, and expert testimony.

3. Integrity:

Hold your word and uphold commitments; be sincere in your conduct; and strive for
coherence in all that you say and do.

4. Carefulness:

Avoid making thoughtless mistakes and being negligent; thoroughly and critically
evaluate both your own and your colleagues' work. Record your research activities
thoroughly.

5. Openness:

Share information, findings, concepts, and tools. Be receptive to fresh concepts and
criticism.

6. Respect for Intellectual Property:

Respect copyrights, patents, and other types of intellectual property. Without

authorization, never use unpublished data, techniques, or outcomes. Where credit is
due, give it. Never use plagiarism.

7. Confidentiality:

Safeguard private correspondence, including papers or grants that have been

submitted for publication, employee records, commercial or military trade secrets, and
patient records.
8. Responsible Publication:

Publishing should be done to further scholarship and research, not only your personal
career. Avoid wasting resources and publishing twice.
9. Responsible Mentoring:

Assist in educating, mentoring, and counselling pupils. Encourage their welfare and
give them the freedom to decide for themselves.

10. Non-Discrimination:

Avoid treating colleagues or students differently because of their gender, race,

ethnicity, or other characteristics unrelated to their scientific integrity and expertise.

11. Competence:

By engaging in lifelong learning and education, you can uphold and enhance your
own professional competence and knowledge. You can also take actions to advance
scientific competency in general.
(Kainat Khalid)

DRUG CONTROL ADMINISTRATION AT FEDERAL AND

PROVINCIAL LEVEL:

The management of medications is a complicated process that is multidisciplinary in

nature, necessitating careful coordination between patients and healthcare workers
such as doctors, pharmacists, nurses, and other medical staff. Given the importance of
communication channels in the avoidance of medication errors, contact between
healthcare professionals is the key to a successful partnership.
Medication mistakes are sustained by the lack of adequate and effective
multidisciplinary cooperation between healthcare workers engaged in the medication
process, which is evidenced by ambiguous orders, incorrect order interpretation, and
inappropriate drug tracking.
The interdisciplinary healthcare team can optimise drug administration by reducing
polypharmacy, enhancing medication adherence, and balancing the risks and benefits
of medications.
Errors can be prevented by routinely assessing and tracking the prescription process,
along with any associated side effects and adverse drug reactions (ADRs). If the joint
strategy is cohesive and is used in accordance with duties and responsibilities that are
clearly defined, it has a tremendous potential to increase medication safety. When
pharmacists, doctors, and nurses play their roles as designated and work together to
ensure clinical drug safety, the medication process has the best possible result.

Various variables, such as physician decisions, rules and laws, guidelines, and
marketing strategies for the pharmaceutical business, have an impact on how ethically
conscientious pharmacists should be when providing pharmaceutical treatment. The
interplay of consumption, commercialism, and the pharmaceutical industry has also
led to ethics. Because of this, all roles and positions of pharmacists as suppliers of
pharmacological services are required to uphold ethical standards, and these standards
must be used to assess each pharmacist's professional performance.
There have been five major ethical systems created throughout history, including the
utilitarian system, the deontological system, the normative system, and the
consequentialist system.
In addition, deontological method detailed obligations for non-maleficent behavior,
charity, justice, and gratitude. A deontological framework was used, and how
objectives were attained was valued more highly than what was done. As a result,
despite gradually rising illegal drug production, use, fatalities, disease, crime, and
official misconduct, the world still regarded drug ban as being the right policy.
Consequentialist methods to drugs started to gain more and more favour in the final
decades of the 20th century. Now, drug policy was deemed ethically sound if it
primarily had positive effects.

THE ETHICAL BASIS OF DRUG POICY:

Systematizing, defending, and advising ideas of appropriate and inappropriate

conduct are all part of ethics. Typically, it is broken down into three categories: meta-
ethics, normative ethics, and practical ethics. "Meta-ethics" is the study of the
meaning and context of ethical principles, including how they may have developed
through societal construction or as a result of personal feelings. "Normative ethics"
seeks to define moral principles that govern right and incorrect behaviour.

LEGAL ASPECTS OF DRUG POICY:

Malum in se and Malum prohibitum laws, both of which are considered to be "wrong
by statute," are two categories of criminal laws.
Malum in se laws frequently involve violence, are typically very consistent from one
state to another, frequently have easily accessible witnesses (making punishment
simpler), are reasonably steady, and are typically not contentious.
Contrarily, malum prohibitum rules are very inconsistent with one another and
frequently involve consenting and non-violent behaviour.
(Eman Ehsan, Fatima Syed)

REFERENCE:
 Himanshu Gupta, Suresh Kumar, Saroj Kumar Roy, and R. S. Gaud, Patent
protection strategies, Journal of pharmacy & bioallied sciences, 2(1), 2–7.
 Research Ethics and Patent, Nationmal Research Ethics Committees,
Foeskningsetikk, 2nd Jan 20126.
 Patent Attorneys David Pressman and David E. Blau, Introduction to Patent
and Other Intellactual Property (patent), Patent It Yourself: Your Step-by-Step
Guide to Filing at the U.S. Patent Office, October 2022, 20th Edition, Pg no
10-19.
 American Medical Association. (2018). Ethical guidelines for gifts to
physicians from industry.
 Pharmaceutical Research and Manufacturers of America. (2020). PhRMA
code on interactions with healthcare professionals.
 World Health Organization. (2009). Ethical criteria for medicinal drug
promotion
 https://psychology.iresearchnet.com/industrial-organizational-psychology/
corporate-ethics/ethics-in-industrial-organizational-practice/
 https://libguides.library.cityu.edu.hk/researchmethods/ethics
 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8552074/#:~:text=PRN
%20medicines%20management%20is%20mainly,patients%20to%20prevent
%20unethical%20practice.
 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7466816/
 https://www.sciencedirect.com/science/article/abs/pii/
S147617930700002X#:~:text=The%20ethical%20basis%20of
%20drug,normative%20ethics%20and%20applied%20ethics.