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Professional, legal and ethical
issues relevant to prescribing
Megala.M
M.Sc (N)
It is a fundamental component of safe prescribing practice.
Changes with regard
-to education and training,
-professional regulations and
-country’s legislations related to drugs and prescribing,
-supply and administration of medicines influence the
prescribing practice and
-the professional accountability
Professional Issues
Professional regulatory bodies guide the nonmedical
prescribing by setting regulations for practice.
How
-set standards of education, training, conduct and
performance and approve educational programs
Who is the regulator
The professional regulators are Indian Nursing Council
and State Nursing Council.
Cont…
Nurse practitioners must work within the boundaries of
professional codes of conduct given by INC
Why - the intention of providing high quality standards of
healthcare, safeguarding the public and promoting professional
credibility.
Additional qualification and training are required for prescribing.
NPs must be able to assume personal accountability and
responsibility.
Safe prescription standards by regulatory body should guide the
NPs in their decision-making and writing prescription.
Legal issues
 Knowledge about India’s legislation is essential for NPs in their practice
 Who provides rules and regulations
The Drugs and Cosmetics Act (1940) and Rules (1945), related to
drugs, control, license, governance, and import.
 Who all are regulators
Regulatory councils/Commissions for Nursing, Medical and pharmacy
 Central Drugs Standard Control Organization (CDSCO) is a central
drug authority for discharging functions
CDSCO serves as a regulatory control over
-import of drugs,
-approval of new drugs and clinical trials,
-approval of licenses as central license approving
authority and
-consists of a technical advisory board to advise on
amendments to rules and regulations.
National Formulary of India, FDA and Acts of
professional organizations guide prescribers in their safe
and competent practice.
Ethical Issues
As prescribers, ethical dilemmas occur in their daily
practice.
must draw combination of personal, group and
philosophical ethics to assist in the decision- making.
Ethical decisions must be guided by
-personal beliefs and values,
-professional code of conduct and
-the knowledge and analysis of ethical theories.
The most essential ethical theories that guide
decision-making are consequentialism, deontology
and virtue ethics.
Consequentialism - Decisions made consequences
are guided by this theory
Deontologists fundamental rules and consider duty
and obligation are central to their decisions.
Virtue ethics that involve compassion, honesty,
loyalty, kindness and benevolence guide the
prescribers to prescribe safely and effectively
Ethical principles such as autonomy, beneficence,
non-maleficence and justice should also guide ethical
decision-making.
Professional integrity is an important element to be
integrated in making ethical decisions.
Nurse practitioners must work within their
professional codes of conduct and reflect on
professional responsibility and accountability.
Legal knowledge is essential for safe practice. They
must apply moral and ethical theories in making
ethical decisions while prescribing for their patients.
Laws governing drug control in India
The Pharmacy Act, 1948.
The Drugs and Magic Remedies (Objectionable
Advertisement) Act, 1954.
 The Narcotic Drugs and Psychotropic Substances Act, 1985.
The Medicinal and Toilet Preparations (Excise Duties) Act,
1956.
Regulation relevant to drugs in India
The Central Drugs Standard Control Organization
(CDSCO) is the Central Drug Authority for discharging
functions assigned to the Central Government under the
Drugs and Cosmetics Act.
CDSCO has six zonal offices, four sub-zonal offices, 13
port offices, and seven laboratories under its control.
Act governs various aspects of drug
prescribing in India
The Drugs and Cosmetics Act, 1940, as amended by the
Drugs (Amendment) Act, 1955,
the Drugs (Amendment) Act, 1960,
the Drugs (Amendment) Act, 1962,
the Drugs and Cosmetics (Amendment) Act,1964,
the Drugs and Cosmetics (Amendment) Act, 1972,
the Drugs and Cosmetics (Amendment) Act, 1982
Rules for drug prescription in India
Clause 1.5 of the Indian Medical Council (Professional
Conduct, Etiquette and Ethics) Regulations, 2002
prescribes that every physician should prescribe drugs
with generic names legibly and preferably in capital
letters and he/she shall ensure that there is rational
prescription and use of drug
rights of prescribing
the right patient,
the right drug,
the right time,
the right dose,
the right route and
The right to refuse

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PRESCRIBING II - FUNDAMENTALS OF PRESCRIBING MODULE Part II.pptx

  • 1. Professional, legal and ethical issues relevant to prescribing Megala.M M.Sc (N)
  • 2. It is a fundamental component of safe prescribing practice. Changes with regard -to education and training, -professional regulations and -country’s legislations related to drugs and prescribing, -supply and administration of medicines influence the prescribing practice and -the professional accountability
  • 3. Professional Issues Professional regulatory bodies guide the nonmedical prescribing by setting regulations for practice. How -set standards of education, training, conduct and performance and approve educational programs Who is the regulator The professional regulators are Indian Nursing Council and State Nursing Council.
  • 4. Cont… Nurse practitioners must work within the boundaries of professional codes of conduct given by INC Why - the intention of providing high quality standards of healthcare, safeguarding the public and promoting professional credibility. Additional qualification and training are required for prescribing. NPs must be able to assume personal accountability and responsibility. Safe prescription standards by regulatory body should guide the NPs in their decision-making and writing prescription.
  • 5. Legal issues  Knowledge about India’s legislation is essential for NPs in their practice  Who provides rules and regulations The Drugs and Cosmetics Act (1940) and Rules (1945), related to drugs, control, license, governance, and import.  Who all are regulators Regulatory councils/Commissions for Nursing, Medical and pharmacy  Central Drugs Standard Control Organization (CDSCO) is a central drug authority for discharging functions
  • 6. CDSCO serves as a regulatory control over -import of drugs, -approval of new drugs and clinical trials, -approval of licenses as central license approving authority and -consists of a technical advisory board to advise on amendments to rules and regulations. National Formulary of India, FDA and Acts of professional organizations guide prescribers in their safe and competent practice.
  • 7. Ethical Issues As prescribers, ethical dilemmas occur in their daily practice. must draw combination of personal, group and philosophical ethics to assist in the decision- making. Ethical decisions must be guided by -personal beliefs and values, -professional code of conduct and -the knowledge and analysis of ethical theories.
  • 8. The most essential ethical theories that guide decision-making are consequentialism, deontology and virtue ethics. Consequentialism - Decisions made consequences are guided by this theory Deontologists fundamental rules and consider duty and obligation are central to their decisions. Virtue ethics that involve compassion, honesty, loyalty, kindness and benevolence guide the prescribers to prescribe safely and effectively
  • 9. Ethical principles such as autonomy, beneficence, non-maleficence and justice should also guide ethical decision-making. Professional integrity is an important element to be integrated in making ethical decisions. Nurse practitioners must work within their professional codes of conduct and reflect on professional responsibility and accountability. Legal knowledge is essential for safe practice. They must apply moral and ethical theories in making ethical decisions while prescribing for their patients.
  • 10. Laws governing drug control in India The Pharmacy Act, 1948. The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.  The Narcotic Drugs and Psychotropic Substances Act, 1985. The Medicinal and Toilet Preparations (Excise Duties) Act, 1956.
  • 11. Regulation relevant to drugs in India The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices, and seven laboratories under its control.
  • 12. Act governs various aspects of drug prescribing in India The Drugs and Cosmetics Act, 1940, as amended by the Drugs (Amendment) Act, 1955, the Drugs (Amendment) Act, 1960, the Drugs (Amendment) Act, 1962, the Drugs and Cosmetics (Amendment) Act,1964, the Drugs and Cosmetics (Amendment) Act, 1972, the Drugs and Cosmetics (Amendment) Act, 1982
  • 13. Rules for drug prescription in India Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 prescribes that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is rational prescription and use of drug
  • 14. rights of prescribing the right patient, the right drug, the right time, the right dose, the right route and The right to refuse