Pharmacy
Practice Regulations, 2015
[Pharmacy
Practice Regulations, 2015][1]
[15th January, 2015]
In exercise of the powers
conferred by Sections 10 and 18 of the Pharmacy Act, 1948 (8 of 1948), the
Pharmacy Council of India, with the approval of the Central Government hereby
makes the following regulations, namely:
CHAPTER 1
Regulation - 1. Short title and commencement.
(a) These regulations may be
called the Pharmacy Practice
Regulations, 2015.
(b) They shall come into force
from the date of their publication in the Official Gazette.
Regulation - 2. Definitions:
(a) “Act” means the Pharmacy
Act, 1948 (8 of 1948).
(b) “Practice of Pharmacy”
means
(i) Interpretation, evaluation
and implementation of medical orders, dispensing of prescriptions, drug orders;
(ii) Participation in drug and
device selection, drug administration, drug regimen reviews and drug or drug
related research,
(iii) Provisions of patient
counselling and the provision of those acts or services necessary to provide
pharmaceutical care in all areas of patient care including primary care; and
(iv) responsibility for
Compounding and labelling of drugs and devices (except labelling by a
manufacturer, re-packer or distributor of non-prescription drugs and
commercially packaged legend drugs and devices) proper and safe storage of
drugs and devices and maintenance of proper records for them.
(c) “Compounding” means the
preparation, mixing, assembling, packing or labelling of a drug or device
(i) as the result of a
practitioner's prescription drug order (or) initiative based on the
practitioner/patient/pharmacist relationship in the course of professional
practice, or
(ii) for the purpose of, or as
an incident to research, manufacturing, teaching, clinical trial or chemical
analysis including drug analysis and not for sale or dispensing.
Note. Compounding also includes
the preparation of drugs or devices in anticipation of prescription, observed
prescribing patterns.
(d) “Dispensing” means the
interpretation, evaluation, supply and implementation of a prescription, drug
order, including the preparation and delivery of a drug or device to a patient
or patient's agent in a suitable container appropriately labelled for
subsequent administration to, or use by, a patient.
(e) “Distribute” means the
delivery of a drug or device other than by administering or dispensing.
(f) “Patient counselling” means
the oral communication by the pharmacist of information to the patient or
caregiver, in order to ensure proper use of drugs and devices.
(g) “Pharmaceutical care” means
the provision of drug therapy and other patient care services intended to
achieve outcomes related to the care or prevention of a disease, elimination or
reduction of a patient's symptoms, or arresting or slowing of a disease
process, as defined by the Pharmacy Council of India.
(h) “Pharmacy Practitioner”
means an individual (Community Pharmacist/Hospital Pharmacist/Clinical
Pharmacist/Drug information Pharmacist) currently licensed, registered or
otherwise authorised under the Act to counsel or otherwise and administer drugs
in the course of professional practice.
(i) “Community pharmacist”
means an individual currently registered and who works according to legal and
ethical guidelines to ensure the correct and safe supply of medical products to
the general public. They are involved in maintaining and improving people's
health by providing advice and information as well as supplying prescription
medicines.
(ii) “Hospital Pharmacist” means
an individual currently registered and who works in a hospital pharmacy
service, primarily within the public/private sector. They are responsible for
ensuring the safe, appropriate and cost-effective use of medicines. Hospital
pharmacists use their specialist knowledge to dispense drugs and advise
patients about the medicines which have been prescribed. They work
collaboratively with other health care professionals to devise the most
appropriate drug treatment for patients. Some pharmacists are also involved in
manufacturing required drug treatments.
(iii) “Drug Information
Pharmacist” means an individual currently registered who works in a community
pharmacy/hospital Pharmacy/teaching hospital/other health care settings and
provides information and advice regarding drug interactions, side effects,
dosage and proper medication storage to patients/physicians/dentists/other
health care professionals.
(iv) “Clinical Pharmacist” means
an individual currently registered and who provides patient care that optimizes
the use of medication and promotes health, wellness and disease prevention.
Clinical pharmacists care for patients in all health care settings. Clinical
pharmacists often collaborate with physicians and other healthcare
professionals.
(i) “Registered Pharmacist”
means a person whose name is for the time being entered in the register of the
State in which he is for the time being residing or carrying on his profession
or business of pharmacy under the Pharmacy Act, 1948.
(j) “Prescription” means a
written or electronic direction from a Registered Medical Practitioner or other
properly licensed practitioners such as Dentist, Veterinarian, etc. to a
Pharmacist to compound and dispense a specific type and quantity of preparation
or prefabricated drug to a patient.
Note. Types of prescriptions
and content of prescription are given below
Types
of Prescription:
(i) Prescription for Extemporaneous
preparations.
(ii) Prescription for Official
preparations.
(iii) Prescription for Patent
preparations
Contents
of the Prescription:
(i) Prescribers
office information[Name,
qualification, address and Regn. No.]
(ii) Patient
information[Name
and address, Age, Sex, Ref. No.]
(iii) Date
(iv) Rx Symbol or superscription
(v) Medication prescribed or
inscription
(vi) Dispensing directions to
Pharmacist (or) subscription
(vii) Directions for patient [to
be placed on label]
(viii) Refill, special labelling
and/or other instructions
(ix) Prescriber's signature and
licence (or) Drug Enforcement Agency (DEA) number as required.
CHAPTER 2
Regulation - 3. Code of Pharmacy Ethics:
(1) Declaration. Each applicant, at the
time of making an application for registration under the provisions of the Act,
shall be provided a copy of the declaration as specified in Appendix I along
with copies of Code of Pharmaceutical Ethics and Pharmacist's oath by the state
pharmacy council, who shall submit it duly signed.
(2) Privileges
of persons registered as a pharmacist on the register of State Pharmacy Council. Subject to the conditions
and restrictions laid down in these regulations regarding practice of
profession of pharmacy by persons possessing approved pharmacy qualifications,
every person whose name is for the time being entered in the register of the
state in which he is for the time being residing or carrying on his profession
or business of pharmacy shall be entitled to practice as “registered
pharmacist” and engage in the practice of profession of pharmacy and to recover
in due course of law in respect of such practice of pharmacy any expenses,
charges or any fee to which he/she is entitled in lieu of his/her discharging
duties as defined by the PCI from time to time.
(3) Displaying
name of owner and registered pharmacist:
(a) Name of the owner of
pharmacy business shall be displayed at or near the main entrance of each
premises in which the business is carried on.
(b) Name of the registered
pharmacist along with his registration number and qualification along with his/her
photograph shall be displayed adjacent to the area where dispensing is carried
on in the pharmacy. Registered Pharmacist shall also comply with a dress code
of being dressed formally and wearing clean transparent overall (coat/apron) with a
badge displaying the name and registration number.
(c) Registered Pharmacists
shall display as suffix to their names only recognized pharmacy
qualification/degrees or such certificates/diplomas and memberships/honours
which confer professional knowledge or recognizes any exemplary
qualification/achievements.
(4) Owner to appoint registered pharmacist:
(a) The owner of a pharmacy
business to which this clause applies shall appoint a registered pharmacist to
be responsible for Regulations 3.3. There must be such an appointment in force
at all times; otherwise the owner of the pharmacy business shall be deemed
contravening the provisions of Section 42 of the Act.
(b) To be effective the notice
of appointment must be accompanied by a notice of acceptance of the appointment
signed by the appointed person.
(c) An appointment may be
revoked by notice given either by the owner of the pharmacy business or by or
on behalf of the appointed person. The appointment shall be automatically
revoked if the person appointed ceases to be a registered pharmacist.
Regulation - 4. Duties and responsibilities of the registered pharmacist in general:
(1) Character
of registered pharmacist:
(a) The prime object of the
pharmacy profession is to render service to humanity; reward or financial gain
is a subordinate consideration. Whosoever chooses his profession, assumes the
obligation to conduct himself in accordance with its ideals. A registered pharmacist
should be an upright man, instructed in the art of medicines. He shall keep
himself pure in character and be diligent in caring for the sick; he should be
modest, sober, patient, prompt in discharging his duty without anxiety;
conducting himself with propriety in his profession and in all the actions of
his life.
(b) A person having
qualification in any other system of pharmacy is not allowed to practice modern
system of pharmacy in any form.
(c) A registered pharmacist
shall uphold the dignity and honour of his profession.
(2) Renewal
of Registration. For
renewal of registration the pharmacist shall attend minimum 2 refresher courses
in pharmacy of minimum one day duration each in a span of 5 years organized by
any one of the following body.
(i) Pharmacy Council of India.
(ii) State Pharmacy Councils.
(iii) Central Government/State
Governments.
(iv) Professional bodies
recognized by the Council.
(3) Dispensing
against prescription of Registered Medical Practitioner only. Every registered
pharmacist shall dispense only those medicines as prescribed by the Registered
Medical Practitioner and shall not substitute the prescription.
(4) Practical training to student pharmacists:
(a) The owner of the pharmacy
shall seek prior approval of the PCI for approval of the pharmacy for the purpose
of imparting practical teaching to student of Diploma in Pharmacy. In the
absence of approval from the PCI, the student pharmacists shall not be treated
to have completed their Diploma in Pharmacy (Part III) to make them eligible
for registration as a pharmacist under the Act.
(b) The registered pharmacist
shall impart practical training to student pharmacists as prescribed from time
to time under Education Regulations framed under Section 10 of the Act under
intimation to the examining authority.
(c) While imparting such
practical training, the registered pharmacists shall comply with the prescribed
norms relating to number of students pharmacists to be trained, nature of
practical training, duration of practical etc. as laid down under the Education
Regulations from time to time.
Regulation - 5. Pharmacy Inspectors to inspect pharmacies.
(a) The owner/registered
pharmacist shall allow and co-operate with the inspectors appointed under the
Drugs and Cosmetics Act, 1940 and Section 26-A of the Pharmacy Act, 1948 by the
State Pharmacy Council to inspect premises where drugs are compounded or
dispensed.
(b) Any Inspector may
(i) inspect any premises where
drugs are compounded or dispensed and submit a written report to the Registrar;
(ii) enquire whether a person
who is engaged in compounding or dispensing of drugs is a registered
pharmacist;
(iii) investigate any complaint
made in writing in respect of any contravention of the Act and report to the
Registrar;
(iv) institute prosecution under
the order of the Executive Committee of the State Pharmacy Council;
(v) exercise such other powers
as may be necessary for carrying out the purposes of Chapters III, IV and V of
the Pharmacy Act or any rules made thereunder.
Regulation - 6. Maintaining good pharmacy practice:
(1) Membership
in Association:
For the advancement of his profession, a registered pharmacist shall affiliate
with associations and societies of allopathic pharmacy professions and involve
actively in the functioning of such bodies. A registered pharmacist shall
participate in professional meetings as part of Continuing Pharmacy Education
programmes, organized by reputed professional academic bodies or any other
authorised associations/organisations. The compliance of this requirement shall
be informed regularly to Pharmacy Council of India or the State Pharmacy
Councils as the case may be.
(2) Maintenance
of patient records:
(a) Every registered pharmacist
shall maintain the medical/prescription records pertaining to his/her patients
for a period of 5 years from the date of commencement of the treatment as laid
down by the Pharmacy Council of India in Appendix II.
(b) If any request is made for
medical records either by the patients/authorised attendant or legal
authorities involved, the same may be duly acknowledged and documents shall be
issued within the period of 72 hours.
(c) Efforts shall be made to
computerize medical/prescription records for quick retrieval.
(3) Highest
Quality Assurance in patient care. Every registered pharmacist shall aid in
safeguarding the profession against admission to it of those who are deficient
in moral character or education. Registered pharmacist shall not employ in
connection with his professional practice any attendant who is neither
registered nor enlisted under the Pharmacy Act in force and shall not permit such
persons to attend, to patients wherever professional discretion or skill is
required.
(4) Exposure
of Unethical Conduct. A
registered pharmacist should expose, without fear or favour, incompetent or
corrupt, dishonest or unethical conduct on the part of members of the
profession.
(5) Payment
of Professional Services. The
registered pharmacist, engaged in the practice of pharmacy profession shall
give priority to the interests of patients. The personal financial interests of
a registered pharmacist shall not conflict with the medical interests of
patients. A registered pharmacist shall announce his fees before rendering
service and not after. Remuneration received for such services shall be in the
form and amount specifically announced to the patient at the time the service
is rendered. It is unethical to enter into a contract of “no cure no payment”.
Registered Pharmacist rendering service on behalf of the state shall refrain
from anticipating or accepting any consideration.
Regulation - 7. Application of other laws not barred.
The registered pharmacist
shall observe the laws of the country in regulating the practice of pharmacy
and shall also not assist others to evade such laws. He shall be cooperative in
observance and enforcement of sanitary laws and regulations in the interest of
public health. A registered pharmacist shall have regard to the provisions of
the Acts like Drugs and Cosmetics Act, 1940; Indian Medical Council Act, 1956;
Narcotic Drugs and Psychotropic Substances Act, 1985; Drugs and Magic Remedies
(Objectionable Advertisement) Act, 1954.
CHAPTER 3
Regulation - 8. Duties of registered pharmacists to their patients:
(1) Obligations
to the Sick:
(a) Though a registered
pharmacist is not bound to attend each and every person asking his services, he
shall not only be ever ready to respond to the calls of the sick and the
injured, but shall be mindful of the high character of his mission and the
responsibility he discharges in the course of his professional duties. He shall
never forget that the health and the lives of those entrusted to his care
depend on his skill and attention.
(b) Registered pharmacist
having any incapacity detrimental to the patient or which can affect his
performance vis-à-vis the patient shall not be permitted to practice his
profession.
(c) Pharmaceutical care (in
addition to the provisions of Drugs and Cosmetics Rules, 1945 and Schedule N of
the said rules) the following provisions shall be included
(d) No person other than a
registered pharmacist shall compound, prepare, mix, dispense or supply of any
medicine on the prescription of a Registered Medical Practitioner (Schedule H
& X drugs);
(e) A registered pharmacist
shall review the patient record and each prescription presented for supply for
the purpose of promoting therapeutic appropriateness by identifying
(i) Over utilization or under
utilization
(ii) Therapeutic duplication
(iii) Drug-disease interactions
(iv) Drug-drug interactions
(v) Incorrect drug dosage or
duration of drug treatment
(vi) Drug-allergy interactions
(vii) Correlation of availability
of drugs (to avoid artificial shortage of drugs)
(viii) Clinical abuse/misuse
Note. Upon recognizing any of
the above, the registered pharmacist shall take appropriate steps to avoid or
resolve the problem that shall, if necessary, include consultation with the
Registered Medical Practitioner.
(2) Patience,
Delicacy and Secrecy:
Patience and delicacy shall characterize the registered pharmacist. Confidences
concerning individual or domestic life entrusted by patients to a registered
pharmacist and defects in the disposition or character of patients observed
during medical attendance shall never be revealed unless their revelation is
required by the laws of the State. Sometimes, however, a registered pharmacist
shall determine whether his duty to society requires him to employ knowledge,
obtained through confidence as a registered pharmacist, to protect a healthy
person against a communicable disease to which he is about to be exposed. In
such instance, the registered pharmacist shall act as he would wish another to
act toward one of his own family in like circumstances.
(3) Prognosis: The registered pharmacist
shall neither exaggerate nor minimize the gravity of a patient's condition. He
shall ensure himself that the patient, his relatives or his responsible friends
have such knowledge of the patient's condition as will serve the best interests
of the patient and the family.
(4) The
patient must not be neglected: A registered pharmacist is free to choose whom he will serve.
However, he shall respond to any request for his assistance in an emergency.
Registered Pharmacist shall not wilfully commit an act of negligence that may
deprive his patient or patients from necessary medical care.
CHAPTER 4
Regulation - 9. Duties of registered pharmacist:
(1) Dispensing/Supply
of Drugs:
(a) The various activities of
dispensing (prescription assembly) like removal of drugs from the packing,
filling the prescription etc. may be performed under the supervision of a
registered pharmacist by any person who has been trained to perform these
activities. However, the actual dispensing of drugs to patients shall only be
performed by the registered pharmacist after due verification of the
prescription filled by others.
(b) A registered pharmacist
shall undertake a pharmaceutical assessment of every prescription presented for
dispensing. For the purpose of the act, pharmaceutical assessment is defined as
the point at which registered pharmacist applies his knowledge to establish the
safety, quality, efficacy and rational use of drugs treatments specified by a
prescriber.
(c) Patient confidentiality
shall be maintained at all times.
(d) Appropriate information
shall be provided to the patient or the care giver and, where possible,
understanding of this information should be checked.
(e) For all prescriptions
handled by the pharmacy
(i) Patient details shall be
checked and confirmed;
(ii) Pharmaceutical assessment
shall be made;
(iii) Proper documentation shall
be maintained.
(f) Assessment of the
prescription should include but not be limited to assessment of whether
(i) The prescription is legally
valid.
(ii) The prescription includes
an appropriate dosage form and appropriate route of administration.
(iii) Prescription is appropriate
to the patient's condition.
(iv) Duration of treatment is
correct.
(v) Prescription is appropriate
according to patient's para-meters (age, weight etc.) and previous medication.
(vi) Prescription is compatible
with other medications.
(vii) Prescription is consistent
with formulary and guidelines, if any.
(viii) Possibility of side effects
and adverse drug reactions exist.
(ix) Contra-indicated.
(x) Potential for misuse and inappropriate
use of the medicines in prescription by patient exists.
(xi) Prescription is complying
with labelling requirements.
(g) Compounding, dispensing and
labelling of required drug products should ensure that
(i) The drug product matches
the prescription.
(ii) The drug product has not
expired.
(iii) The drug product is
appropriately compounded (if necessary), packed and labelled appropriately.
(iv) The accuracy of dispensing
is checked by registered pharmacist.
(v) Proper documentation is
made.
(h) Delivery of the drug
product to the patient/carer is done in such a way as to ensure that
(i) The registered pharmacist
hands over the drug to the patient/carer.
(ii) Appropriate information on
drugs is provided to the patient/carer.
(2) Pharmacist
for promotion of rational drug use. To promote rational use of drugs, the
pharmacist shall involve himself in activities such as
(i) Preparation of formularies
both at the hospital level and at state/national levels.
(ii) Critical assessment of
promotional materials prepared by the drug companies.
(iii) Dissemination of evaluated
information through authorised sources.
(iv) Updating the knowledge of
drugs through continuing education programmmes and also to organize educational
programmes for health professionals.
(v) Preparation and
dissemination of patient information leaflets.
(3) Patient counselling:
(a) Upon receipt of a
prescription (prescription drug order) and following a review of the patient's
record, a registered pharmacist shall personally initiate discussion of matters
that will enhance or optimize drug therapy with each patient or care given of
such patient. Such discussion shall be in person, whenever practicable or by
telephone and shall include appropriate elements of patient counselling. Such
elements may include the following:
(i) Name and description of the
drugs
(ii) The dosage form, dose,
route of administration, and duration of drug therapy
(iii) Intended use of the drug
and expected action
(iv) Special directions and
precautions for the drug
(v) Common severe side effects
or adverse effects or interactions and therapeutic contra indications that may
be encountered, including their avoidance, and the action required if they
occur;
(vi) Techniques for
self-monitoring drug therapy
(vii) Proper storage of the drugs
(viii) Prescription refill
information
(ix) Action to be taken in the
event of a missed dose
(x) To ensure rational use of
drugs
Note. The pharmacist shall not
be required to counsel a patient or caregiver when the patient or caregiver
refuses such consultations.
(b) The pharmacist shall
maintain the records pertaining to drugs administered to the patients (drug
card) that may be utilized for the evaluation of the drug therapy
(c) The pharmacist is
authorised (as a Health care professional) to undertake process and outcome
research, health promotion and education and provide health information. Also
to undertake the Pharmacoepidemiologic studies.
(d) Pharmacies providing
patient counselling shall have regard to the following
(i) Only registered pharmacists
are involved in counselling.
(ii) Facilities are provided for
confidential conversation and patient confidentiality is maintained.
(iii) Patient information
leaflets are provided.
(iv) Proper documentation is
made.
(v) Unnecessary counselling
should be avoided.
(vi) Counselling
for Patient's Benefit:
In every consultation, the benefit to the patient is of foremost importance.
All registered pharmacists engaged in the case should be frank with the patient
and his attendants.
(vii) Punctuality
in counselling:
Utmost punctuality should be observed by a registered pharmacist in making
themselves available for counselling.
CHAPTER 5
Regulation - 10. Responsibilities of registered pharmacists to each other.
A registered pharmacist
shall consider it as a pleasure and privilege to render gratuitous service to
all registered pharmacists and their immediate family dependants.
(1) Conduct
in Counselling:
In counselling, no insincerity, rivalry or envy shall be indulged in. All due
respect shall be observed towards the registered pharmacist in-charge of the
case and no statement or remark be made, which would impair the confidence
reposed in him. For this purpose no discussion shall be carried on in the
presence of the patient or his representatives.
(2) Appointment
of substitute:
Whenever a registered pharmacist requests another registered pharmacist to
attend his patients during his temporary absence from his practice,
professional courtesy requires the acceptance of such appointment only when he
has the capacity to discharge the additional responsibility along with his
other duties. The registered pharmacist acting under such an appointment shall
give the utmost consideration to the interests and reputation of the absent
registered pharmacist and all such patients shall be restored to the care of
the latter upon his return.
CHAPTER 6
Regulation - 11. Duties of registered pharmacist to the Public and to the Profession:
(1) Registered
pharmacists as citizens:
Registered pharmacists, as good citizens, possessed of special training shall
disseminate advice on public health issues. They should play their part in
enforcing the laws of the community and in sustaining the institutions that
advance the interests of humanity. They shall particularly co-operate with the
authorities in the administration of sanitary/public health laws and
regulations.
(2) Public
and Community Health:
Registered Pharmacists, especially those engaged in public health work, shall
enlighten the public concerning quarantine regulations and measures for the
prevention of epidemic and communicable diseases. At all times the registered
pharmacist shall notify the constituted public health authorities of every case
of communicable disease under his care, in accordance with the laws, rules and
regulations of the health authorities. When an epidemic occurs a registered
pharmacist shall not abandon his duty for fear of contracting the disease
himself.
(3) Physician/Nurses: Registered Pharmacists
shall seek cooperation from physicians, dentists and nurses wherever required.
CHAPTER 7
Regulation - 12. Unethical Acts.
A registered pharmacist
shall not aid or abet or commit any of the following acts which shall be
construed as unethical
(1) Advertising:
(a) Soliciting of patients
directly or indirectly, by a registered pharmacist, by a group of registered
pharmacists or by institutions or organisations is unethical. A registered
pharmacist shall not make use of him (or his name) as subject of any form or
manner of advertising or publicity through any mode either alone or in
conjunction with others which is of such a character as to invite attention to
him or to his professional position, skill, qualification, achievements,
attainments, specialities, appointments, associations, affiliations or honours
and/or of such character as would ordinarily result in his self-aggrandizement.
A registered pharmacist shall not give to any person, whether for compensation
or otherwise, any approval, recommendation, endorsement, certificate, report or
statement with respect of any drug, medicine, nostrum remedy, surgical, or
therapeutic article, apparatus or appliance or any commercial product or
article with respect of any property, quality or use thereof or any test,
demonstration or trial thereof, for use in connection with his name, signature,
or photograph in any form or manner of advertising through any mode nor shall
he boast of cases, cures or remedies or permit the publication of report
thereof through any mode. A registered pharmacist, however, shall be permitted
to make a formal announcement in press regarding the following
(i) on starting practice;
(ii) on changing address.
(b) Printing of
self-photograph, or any such material of publicity in the letter head or on
sign board of the Pharmacy or any such establishment shall be regarded as acts
of self-advertisement and unethical conduct on the part of the registered
pharmacist. However, printing of sketches, diagrams, picture of medicines shall
not be treated as unethical.
(2) Rebates
and Commission. A
registered pharmacist/Pharmacy shall not give, solicit, or receive nor shall he
offer to give solicit or receive, any gift, gratuity, commission or bonus in
consideration of or return for the referring, recommending or procuring of any
patient for sale/dispensing of medicines. A registered pharmacist shall not
directly or indirectly, participate in or be a party to act of division,
transference, assignment, subordination, rebating, splitting or refunding of
any fee for dispensing/sale of medicines.
(3) Secret
Remedies:
The prescribing or dispensing by a registered pharmacist of secret remedial
agents of which he does not know the composition, or the manufacture or
promotion of their use is unethical and as such prohibited. All the drugs
dispensed by a registered pharmacist shall carry a proprietary formula and
clear name.
(4) Human
Rights:
The registered pharmacist shall not aid or abet torture nor shall he be a party
to either infliction of mental or physical trauma or concealment of torture
inflicted by some other person or agency in clear violation of human rights.
CHAPTER 8
Regulation - 13. Misconduct.
The following acts of commission
or omission on the part of a registered pharmacist shall constitute
professional misconduct rendering him/her liable for disciplinary action.
(a) Violation of the
regulations framed under the Act.
(b) Dispensing medicines
without the prescription of the Registered Medical Practitioner which are
required to be dispensed on prescription only.
(c) Substitution of the
prescription without approval/consent of the Registered Medical Practitioner.
(d) Allowing the owner of the
pharmacy to use his pharmacist registration certificate without attending the
pharmacy.
(e) Giving his pharmacist
registration certificate at more than one pharmacies.
(f) Not maintaining the
prescription/dispensing records of his patients for a period of five years as
per Regulation 6.2-a and refuses to provide the same within 72 hours when the
patient or his authorised representative makes a request for it.
(g) Not displaying the
registration certificate accorded to him by the State Pharmacy Council in his
pharmacy.
(h) Wilfully obstructing an
inspector appointed under the Drugs and Cosmetics Act, 1940 and/or Pharmacy
Act, 1948 for inspecting/enquiring/investigating.
(i) Committing adultery or
improper conduct with a patient or by maintaining an improper association with
a patient abusing his professional position. This will render a registered
pharmacist liable for disciplinary action as provided under Section 36 of the
Pharmacy Act, 1948.
(j) Conviction by a Court of
Law for offences involving moral turpitude/Criminal acts.
(k) Signing
Professional Certificates, Reports and other Documents: Registered Pharmacist may
be in certain cases bound by law to give, or may from time to time be called
upon or requested to give certificates, notification, reports and other
documents of similar character signed by them in their professional capacity
for subsequent use in the courts or for administrative purposes etc. Any
registered pharmacist who is shown to have signed or given under his name and
authority any such certificate, notification, report or document of a similar
character which is untrue, misleading or improper.
(l) Issuing of certificates of
efficiency in modern medicine to unqualified person.
(Note. The foregoing does not restrict the proper training and
instruction of bona fide student pharmacists under the personal supervision of
registered pharmacists.)
(m) Contributing to the lay
press articles and giving interviews regarding diseases and treatments which
may have the effect of advertising himself or soliciting practices; but is open
to write to the lay press under his own name on matters of public health,
hygienic living or to deliver public lectures, give talks on the
radio/TV/internet chat for the same purpose and send announcement of the same
to lay press.
(n) Disclosing the secrets of a
patient that have been learnt in the exercise of his profession except.
(i) in a court of law under
orders of the presiding judicial officer;
(ii) in circumstances where
there is a serious and identified risk to a specific person and/or community;
and
(iii) notifiable diseases.
(o) Refusing on religious
grounds alone to dispense medicines on the prescription of Registered Medical
Practitioner.
(p) Publishing photographs or
case reports of his patients without their permission, in any medical or other
journal in a manner by which their identity could be made out. However, if the
identity is not to be disclosed, the consent is not needed.
(q) In the case of running of pharmacy
by a registered pharmacist and employing registered pharmacists to help him,
the ultimate responsibility rests on the registered pharmacist.
(r) Using touts or agents for
procuring patients.
(s) Claiming himself to be
specialist.
(t) If a registered pharmacist
posted in rural area is found absent on more than two occasions during
inspection by the Head of the District Health Authority or the Chairman, Zila
Parishad without information, the same shall be construed as a misconduct.
(u) If a registered pharmacist
working in pharmacy is also found working in another pharmacy/pharmacy
college/institution/industry/any other organization as a teaching faculty or
otherwise, shall be construed as misconduct.
CHAPTER 9
Regulation - 14. Punishment and disciplinary action.
(a) It must be clearly
understood that the instances of offences and of professional misconduct which
are given above do not constitute and are not intended to constitute a complete
list of the infamous acts which calls for disciplinary action, and that by
issuing this notice the Pharmacy Council of India and or State Pharmacy
Councils are in no way precluded from considering and dealing with any other
form of professional misconduct on the part of a registered pharmacist.
Circumstances may and do arise from time to time in relation to which there may
occur questions of professional misconduct which do not come within any of
these categories. Every care should be taken that the code is not violated in
letter or spirit. In such instances as in all others, the Pharmacy Council of
India and/or State Pharmacy Councils have to consider and decide upon the facts
brought before the Pharmacy Council of India and/or State Pharmacy Councils.
(b) Any complaint with regard
to professional misconduct can be brought before the Pharmacy Council of
India/concerned State Pharmacy Council for disciplinary action. Upon receipt of
any complaint of professional misconduct, the Pharmacy Council of
India/concerned State Pharmacy Council would hold an enquiry and give
opportunity to the registered pharmacist to be heard in person or by pleader.
If the registered pharmacist is found to be guilty of committing professional
misconduct, the Pharmacy Council of India/concerned State Pharmacy Council may
award such punishment as deemed necessary or may direct the removal altogether
or for a specified period, from the register of the name of the delinquent
registered practitioner. Deletion from the register shall be widely publicized
in local press as well as in the publications of different Pharmacy
Associations/Societies/Bodies.
(c) In case the punishment of
removal from the register is for a limited period, the concerned State Pharmacy
Council may also direct that the name so removed shall be restored in the
register after the expiry of the period for which the name was ordered to be
removed.
(d) Decision on complaint
against delinquent registered pharmacist shall be taken within a time limit of
6 months.
(e) During the pendency of the
complaint the concerned State Pharmacy Council may restrain the registered
pharmacist from performing the procedure or practice which is under scrutiny.
(f) Professional incompetence
shall be judged by peer group as per guidelines prescribed by Pharmacy Council
of India.
(g) For wilful obstruction of
an inspector appointed under the Drugs and Cosmetics Act, 1940 and Pharmacy
Act, 1948, offence is punishable as provided under the respective Acts.
APPENDIX
I
Declaration
(See Regulation 3.1)
(To be submitted at the time of
application to the state pharmacy council for registration of name in the
register of pharmacists) |
|
1. |
I solemnly pledge myself to
consecrate my life to service of humanity. |
2. |
Even under threat, I will not use my
pharmacy knowledge contrary to the laws of Humanity. |
3. |
I will maintain the utmost respect
for human life from the time of conception. |
4. |
I will not permit considerations of
religion, nationality, race, party politics or social standing to intervene
between my duty and my patient. |
5. |
I will practice my profession with
conscience and dignity. |
6. |
The health of my patient will be my
first consideration. |
7. |
I will respect the secrets which are
confined in me. |
8. |
I will give to my teachers the
respect and gratitude which is their due. |
9. |
I will maintain by all means in my
power, the honour and noble traditions of pharmacy profession. |
10. |
I will treat my colleagues with all
respect and dignity. |
11. |
I shall abide by the code of ethics
as laid down by the Pharmacy Council of India. |
I certify that I have read and agree
to abide by the declarations made above. |
|
I make these promises solemnly,
freely and upon my honour. |
|
Signature |
……………………………………………………… |
Name |
……………………………………………………… |
Place |
……………………………………………………… |
Address: |
|
……………………………………………… |
|
Date……………………… |
APPENDIX
II
Format
for Prescription Record
[See Regulation 6.2]
Name of the patient: |
Age: |
Sex: |
Address: |
Occupation: |
Date of 1st visit: |
Diagnosis: |
Prescription: |
Follow up |
Date: |
Observations: |
Signature in full …………………………. |
Name of registered pharmacist and
Registration No. |
APPENDIX
III
Details of Position Title and job
responsibilities of Pharmacist at Hospital Pharmacy practice site: |
||
1. |
JOB IDENTIFICATION: |
|
|
1.1 |
Position
Title:
Pharmacist |
|
1.2 |
Job
Location (As appropriate): |
|
|
Ministry: Health; |
|
|
Department: Medical Services; |
|
|
Division: Health Care and
Diagnostic Services; |
|
|
Section: Pharmaceutical
Services; |
|
|
Unit: Hospital
Pharmacy/dispensary/Warehouse |
|
1.3 |
Title of
First Level Supervisor (Official title of the Supervisor): Dy. Chief/Sr.
Pharmacist |
2. |
PURPOSE, DUTIES AND RESPONSIBILITIES: |
|
|
Purpose: Provide technical
services and logistics support for effective delivery of pharmaceutical care
and services. |
Duties and responsibilities |
Percentage of time |
|
In Hospital: |
|
|
▪ |
Dispense medicines to patients on the
prescription of the Registered Medical practitioner |
35 |
▪ |
Provide counselling and health
education to the patient |
10 |
▪ |
Assist in the management of pharmacy department |
10 |
▪ |
Maintain records of ADR |
5 |
▪ |
Provide pharmaceutical services to the
inpatients |
5 |
▪ |
Formulate extemporaneous preparation
and specialized products |
5 |
▪ |
Discuss with clinician/health
professional to provide better patient care |
5 |
▪ |
Conduct prescription surveys and
propose changes on the Essential Drug List |
5 |
▪ |
Attend emergency duty as and when
required |
5 |
▪ |
Indent and check the drugs and
non-drugs |
5 |
▪ |
Maintain records of the equipments
and other supplies of the unit |
5 |
▪ |
Documentation of records and
literature |
5 |
Essential Drugs and vaccines |
|
|
▪ |
Review of quantification of annual drug
requirements of the country/state |
20 |
▪ |
Verification of the annual indents
received from storekeepers of different hospitals |
20 |
▪ |
To visit the hospitals for inventory
monitoring, physical verification and analysis |
15 |
▪ |
To correspond with suppliers on the
supply of drugs and non-drugs |
15 |
▪ |
To discuss issues related to the
Pharmaceutical supplies with the other health staff of the department to
improve quality of service |
10 |
▪ |
To correspond with the different
hospitals and mobilize the shortly expiring drugs |
10 |
▪ |
Miscellaneous work |
10 |
3. |
KNOWLEDGE AND SKILLS REQUIREMENTS
(Minimum requirements for performance of work described (Level of Education,
Knowledge, Skill and Ability) |
||
|
3.1 |
Education: Diploma in
Pharmacy/Bachelor in Pharmacy. |
|
|
3.2 |
Training: None. |
|
|
3.3 |
Length and
type of practical experience required: New recruit. |
|
|
3.4 |
Knowledge
of language(s) and other specialized requirement: Should be fluent
in English and regional language |
|
4. |
COMPLEXITY OF WORK (details of the
intricacy of tasks, steps, processes or methods involved in work, difficulty
and originality involved in work) |
||
|
The responsibilities involve
monitoring the patient and providing health education which will have direct
impact on the overall health of the population and disease management. Its
jurisdiction encompasses a wide range of pharmaceutical services be it in a
dispensary or a hospital. The laid out procedures and techniques needs to be
carried out in precise technical efficacy and accuracy. The working process
involves scrutinizing every step to prevent any mistakes in the work as it
deals with human life. The management of life saving drugs is very important
and involves many steps so as to ensure timely supply of drugs to the needy
patients. |
||
5. |
SCOPE AND EFFECT OF WORK (Details of
the breadth of work performance, and the effect the work has on the work of
others or the functions of the organization): |
||
|
Drugs are the lifelines of the health
system. The success of the health care system depends on how various factors
like patient compliance to the medicines, cost, and supply, rational
utilization of resources, minimization of wastages and rational prescribing.
Pharmacist is fully involved in carrying out and promoting them, thus
contributing to the overall economy of the nation. The pharmacist is directly
involved in counselling the patients, advising the prescribers on rational
selection of drugs and therefore it has a direct impact on the overall
patient care. |
||
6. |
INSTRUCTIONS AND GUIDELINES AVAILABLE: |
||
|
6.1 |
Instructions (Details of the controls
exercised over the work by the Superior; how work is assigned, reviewed and
evaluated): |
|
|
|
Work is carried out based on the
annual work plan and regular supervision from the senior pharmacists. |
|
|
6.2 |
Guidelines (written or unwritten
guidelines that are available, and the extent to which the employees may
interpret, adapt or devise new guidelines): |
|
|
|
▪ |
Annual work plan |
|
|
▪ |
Standard Operating
Procedures/hospital guidelines on pharmaceutical care and services |
|
|
▪ |
Standard Manufacturing Instructions |
|
|
▪ |
Pharmacy Act and other laws as
specified above in the regulations. |
7. |
WORK RELATIONSHIPS (The frequency,
nature and purpose of contacts with others within and outside the assigned organization
(other than contacts with superiors): |
||
|
A pharmaceutical service requires
constant interaction with patients and other professionals to monitor, advise
and follow-up on drug efficacy, any side effects and complications. The
profession also requires constant interaction with different health
professionals at various levels to provide the best patient care. |
||
8. |
SUPERVISION OVER OTHERS (the
responsibility that this position has for supervision of other employees,
including the nature of supervisory responsibilities and categories and
number of subordinates, both directly and indirectly supervised are): |
||
|
Supervises the technicians and other
health workers in the Basic Health Unit on the proper storage management,
distribution and proper utilization of medicines. |
||
9. |
JOB ENVIRONMENT (the physical demands
that are required, such as walking, standing, lifting heavy objects, etc.,
and/or any risks or discomforts like exposure to hazards such as exposure to
chemicals infections, radiation, extreme weather and other hostile working
conditions): |
||
|
Compounding involves the use of
chemicals and it is risky to have contact or inhale certain substances and
may give rise to chronic diseases in the long run. The contact with patients
increases the risk of contacting communicable diseases and other profession
related work hazards such as risk of needle pricks exposing him/her to
diseases like HIV and Hepatitis. |
||
Details of Position Title and job
responsibilities of Senior Pharmacist at Hospital Pharmacy practice site: |
|||
1. |
JOB IDENTIFICATION: |
||
|
1.1 |
Position
Title:
Sr. Pharmacist |
|
|
1.2 |
Job Location (Complete as
appropriate): |
|
|
|
Ministry: Health; |
|
|
|
Department: Medical Services; |
|
|
|
Division: Health Care and
Diagnostic Services; |
|
|
|
Section: Pharmaceutical
Services; |
|
|
|
Unit: Hospital
Pharmacy/dispensary/warehouse |
|
|
1.3 |
Title of
First Level Supervisor (Official title of the Supervisor): Chief/Deputy
Chief of the respective fields. |
|
2. |
PURPOSE, DUTIES AND RESPONSIBILITIES
(the purpose, duties and responsibilities, indicating what is done how it is
done. Purpose should be a short statement linking the position to the mission
and goals of the organization and specifying outputs of the position. Duties
should be presented in decreasing order of percentage of time spent on them,
or in order of relative importance): |
||
|
Purpose: Provide technical
services and logistics support for effective delivery of pharmaceutical
services, efficient production and supply management; enforce regulation and
promote quality assurance of the drugs and other medical supplies; and
manages the pharmacy services at a hospital. |
Duties and responsibilities |
Percentage of time |
|
In Hospital: |
|
|
▪ |
Develop plans on pharmaceutical
supplies and mobilize necessary funds. |
15 |
▪ |
Plan and coordinate the departmental
activities. |
15 |
▪ |
Manage pharmaceutical services at a
hospital |
10 |
▪ |
Monitor and provide supervision to
the staff including student trainees |
10 |
▪ |
Supervise and monitor the ADR of
inpatients |
10 |
▪ |
Participate in educational and research
programs |
10 |
▪ |
Conduct the Antibiotic Resistance
studies |
10 |
▪ |
Go ward round and Provide inpatient
pharmaceutical services |
10 |
▪ |
Interact with the specialist and
prescribing clinicians to discuss on pharmaco-therapeutics |
05 |
▪ |
Provide continuing education and
assist superiors |
05 |
▪ |
Supervise and train subordinates (Pharmacists and
pharmacy technician and other health workers) |
20 |
In Supplies Management |
|
|
▪ |
Monitor quantification, procurement
and distribution of medical supplies |
20 |
▪ |
Monitor indents and suppliers |
20 |
▪ |
Supervise subordinates and train
other staff |
20 |
▪ |
Prepare plans and budget |
20 |
▪ |
Provide continuing education to the
health workers |
20 |
▪ |
Assist superiors as and when required |
20 |
3. |
KNOWLEDGE AND SKILLS REQUIREMENTS
(Minimum requirements for performance of work described (Level of Education,
Knowledge, Skill and Ability): |
||
|
3.1 |
Education: Diploma in
Pharmacy/Bachelor in Pharmacy/Doctor of Pharmacy (Pharm.D). |
|
|
3.2 |
Training: Short courses in
Drug Administration, Pharmaco-economics, and Pharmaco-Epidemiology,
Toxicology, Research and Project design. |
|
|
3.3 |
Length and type of practical
experience required: |
|
|
|
D.Pharm. Minimum of 4 years experience as a
Pharmacist. |
|
|
|
B.Pharm./Pharm.D direct recruitment |
|
|
3.4 |
Knowledge of language(s) and other
specialized requirement: |
|
|
|
Should be fluent in regional
languages and English and ability to converse in other dialects is a good
asset. |
|
4. |
COMPLEXITY OF WORK (the intricacy of
tasks, steps, processes or methods involved in work, difficulty and
originality involved in work): |
||
|
Pharmaceutical services are a very
technical profession and it requires self-motivation and professional ethics;
its jurisdiction encompasses a wide range of services. Under general
supervision, senior pharmacist performs duties of broad scope, which requires
extensive experience, and application of knowledge of the total pharmacy
services in a 60 bedded hospital or in relevant pharmaceutical fields. The
position also requires management of life saving drugs involving many steps
so as to ensure timely supply of drugs to the needy patients. |
||
5. |
SCOPE AND EFFECT OF WORK (the breadth
of work performance, and the effect the work has on the work of others or the
functions of the organization): |
||
|
The position is a hospital−wide
recognized professional authority in such areas such as Pharmacokinetics,
infectious disease therapy, adverse reactions, pharmaco-vigilance, provide
authoritative professional guidance to the staff of the hospital and related
organizations. The work consists of execution of specific rules, regulations
or procedures effecting the accuracy, reliability or acceptability of other
processes and services having direct bearing on the patients. |
||
6. |
INSTRUCTIONS AND GUIDELINES
AVAILABLE: |
||
|
6.1 |
Instructions (controls exercised over
the work by the Superior; how work is assigned, reviewed and evaluated): |
|
|
|
Assignment of work is based on the
annual work plan. The work requires evaluation by self and the supervisors in
order to monitor the work efficiency and maintain progress. |
|
|
6.2 |
Guidelines (Indicate which written or
unwritten guidelines are available, and the extent to which the employees may
interpret, adapt or devise new guidelines): |
|
|
|
▪ Financial Manual |
|
|
|
▪ Pharmacy Act and
other legislations mentioned in these regulations |
|
|
|
▪ Policy documents |
|
|
|
▪ Five-year plan
document |
|
7. |
WORK RELATIONSHIPS [the frequency,
nature and purpose of contacts with others within and outside the assigned
organization (other than contacts with superiors)]: |
||
|
A pharmaceutical service requires
constant interaction with patients and other professionals to monitor, advise
and follow-up on drug efficacy, any side effects and complications. Besides
above, the position needs to interact with agencies such as state/central
government, Pharmacy retailers, international pharmaceutical firms to prevent
drug related problems, legalize retailers, monitor drug quality and
compliance of retailers to standard practices and for supply of drugs with
pharmaceutical firms. |
||
8. |
SUPERVISION OVER OTHERS
(responsibility of this position has for supervision of other employees,
including the nature of supervisory responsibilities and categories and
number of subordinates, both directly and indirectly supervised): |
||
|
Supervises the pharmacists, trainees
and other related professionals in the hospitals and the Basic Health Units
on the proper utilization of the medicines and proper store management of the
medicines. |
||
9. |
JOB ENVIRONMENT (physical demands
required, such as walking, standing, lifting heavy objects, etc., and/or any
risks or discomforts like exposure to hazards such as exposure to chemicals
infections, radiation, extreme weather and other hostile working conditions): |
||
|
The pharmaceutical services in all
the area of work need long hour duties with constant standing and frequent
exposure to chemicals and other toxins. The contact with patients increases
the risk of contacting communicable diseases and other profession related
work hazards. The position is also required to travel frequently to the
districts to monitor the pharmaceutical activities, to conduct research and
assure quality of drugs and supplies. |
||
Details of Position Title and job
responsibilities of Chief Pharmacist at Hospital Pharmacy practice site: |
|||
1. |
JOB IDENTIFICATION: |
||
|
1.1 |
Position
Title:
Chief Pharmacist |
|
|
1.2 |
Job Location (Complete as
appropriate): |
|
|
|
Ministry: Health; |
|
|
|
Department: Medical Services; |
|
|
|
Division: Pharmaceutical
services |
|
|
|
Section: Pharmaceutical Services; |
|
|
|
Unit:
Hospital/dispensary/warehouse |
|
|
1.3 |
Title of
First Level Supervisor (Official title of the Supervisor): Head of the
Department/hospital |
|
2. |
PURPOSE, DUTIES AND RESPONSIBILITIES
(Describe the purpose, duties and responsibilities, indicating what is done
how it is done. Purpose should be a short statement linking the position to
the mission and goals of the organization and specifying outputs of the
position. Duties should be presented in decreasing order of percentage of
time spent on them, or in order of relative importance): |
||
|
Purpose: Provide advanced technical
services and logistics support for effective delivery of clinical services,
efficient production and supply management; and ensure regulation and quality
assurance of the drugs and other medical supplies; and manages the pharmacy
department of the hospital. |
||
|
Duties and responsibilities (for all categories) |
Percentage of time |
|
|
▪ |
Coordinate planning and
implementation of relevant activities including mobilization of resources. |
40 |
|
▪ |
Conduct research activities and
facilitates international networking. |
20 |
|
▪ |
Conduct supervision and training for
subordinates and health workers. |
15 |
|
▪ |
Manage the pharmacy department of a
hospital |
10 |
|
▪ |
Monitor and evaluates relevant
activities. |
10 |
|
▪ |
Carry out any other duties assigned by superiors. |
05 |
3. |
KNOWLEDGE AND SKILLS REQUIREMENTS
(Minimum requirements for performance of work described (Level of Education,
Knowledge, Skill and Ability): |
||||
|
3.1 |
Education: |
|||
|
|
By promotion failing which by Direct
Recruitment |
: |
Diploma in Pharmacy with 10 years of
experience. |
|
|
|
|
|
|
OR |
|
|
|
|
Bachelor of Pharmacy with 5 years
experience. |
|
|
|
|
|
OR |
|
|
|
|
|
Master in Pharmacy/Pharm.D. |
|
|
3.2 |
Training: Short course in organizational
management, human resource development and management, and financial
management and policies, research and specialization in pharmaceutical
related fields. |
|||
|
3.3 |
Length and type of practical
experience required: Minimum of 4 years experience as a Sr. Pharmacist or
equivalent experience. |
|||
|
3.4 |
Knowledge of language(s) and other
specialized requirement: |
|||
|
|
Fluent in regional languages and
English. Should be also conversant in government policies, rules and
regulations. |
|||
4. |
COMPLEXITY OF WORK (Describe the
intricacy of tasks, steps, processes or methods involved in work, difficulty
and originality involved in work): |
||||
|
The position needs a competent person
with in-depth technical knowledge and policy issues and must be capable of
executing responsibilities independently. The position is required to fulfil
the professional and administrative responsibilities for the department that
provides comprehensive pharmaceutical services through large number of
professional and technical personnel. It involves advising the technical
bodies and commissions (National Drug Committee, Drug Advisory Committee,
National HIV/AIDS Commission) on embarking right policy decisions. The
position is also required to give constant feedback and assistance to the higher
authorities. |
||||
5. |
SCOPE AND EFFECT OF WORK (Describe
the breadth of work performance, and the effect the work has on the work of
others or the functions of the organization): |
||||
|
The success and image of the health
system is directly influenced by the clinical care provided to the patients.
The pharmaceutical service is the backbone of the clinical services and has
direct impact on the overall health care. The quality of the pharmaceutical
services will entirely depend on how they are planned and implemented and
this position category play a vital role in extending the services to the
public. |
||||
6. |
INSTRUCTIONS AND GUIDELINES
AVAILABLE: |
||||
|
6.1 |
Instructions (Describe controls
exercised over the work by the Superior; how work is assigned, reviewed and
evaluated): |
|||
|
|
The work output will be reviewed
through meetings, reports, publications and successful implementation of the
planned activities. However, supervision is received from the head of the
department on policy and management issues, and from the specialists on
technical areas as and when required. |
|||
|
6.2 |
Guidelines (Indicate which written or
unwritten guidelines are available, and the extent to which the employees may
interpret, adapt or devise new guidelines): |
|||
|
|
▪ |
Indian Civil Service Rules and
Regulations |
||
|
|
▪ |
Financial Manual |
||
|
|
▪ |
Indian legislations relating to
health |
||
7. |
WORK RELATIONSHIPS (Indicate the
frequency, nature and purpose of contacts with others within and outside the
assigned organization (other than contacts with superiors): |
||||
|
The position is required to
collaborate with various international agencies and intergovernmental
organizations for constant upgrading of the policies and programs relating to
matters of pharmaceutical services. The position is required to co-ordinate
in-puts from relevant professional groups and agencies in order to promote
the professional integrity and for better developmental goals and better
patient care. |
||||
8. |
SUPERVISION OVER OTHERS (Describe
responsibility this position has for supervision of other employees,
including the nature of supervisory responsibilities and categories and
number of subordinates, both directly and indirectly supervised): |
||||
|
Supervises the Deputy Chief
Pharmacists and Pharmacists; and oversees the private pharmaceutical dealers
to improve the quality of work and to ensure the quality, efficacy and safety
of medicinal products to safeguard the public health. |
||||
9. |
JOB ENVIRONMENT (Describe physical
demands required, such as walking, standing, lifting heavy objects, etc.,
and/or any risks or discomforts like exposure to hazards such as exposure to
chemicals infections, radiation, extreme weather and other hostile working
conditions): |
||||
|
The work involves frequent exposure
to chemicals and other toxins. The contact with patients through research
works also increase the risk of contacting communicable diseases and other
profession related work hazards. |
||||
|
The position is also required to travel
frequently to the districts to monitor the pharmaceutical activities, to
conduct research and assure quality of drugs and supplies. |
||||
Details of Position Title and job
responsibilities of Community Pharmacist at community Pharmacy practice site
(Drug Store/Pharmacy) |
|||||
1. |
JOB IDENTIFICATION: |
||||
|
1.1 |
Position
Title:
Community Pharmacist |
|||
|
1.2 |
Job Location (As appropriate): |
|||
|
|
Section: Private sector |
|||
|
|
Unit: Community
Pharmacy/Dispensary/Drug Warehouse |
|||
2. |
PURPOSE, DUTIES AND RESPONSIBILITIES |
||||
|
Purpose: Provide technical
services and logistics support for effective delivery of pharmaceutical care
and services. |
||||
|
Typical work activities include: |
||||
|
▪ |
dispensing prescription medicines to
the public; |
|||
|
▪ |
ensuring that different treatments
are compatible; |
|||
|
▪ |
checking dosage and ensuring that
medicines are correctly and safely supplied and labelled (pharmacists are
legally responsible for any dispensing errors); |
|||
|
▪ |
supervising the preparation of any
medicines (not all are supplied ready made-up by the manufacturer); |
|||
|
▪ |
keeping a register of controlled
drugs for legal and stock control purposes; |
|||
|
▪ |
liaising with doctors about
prescriptions; |
|||
|
▪ |
selling over the counter medicines; |
|||
|
▪ |
counselling and advising the public
on the treatment of minor ailments; |
|||
|
▪ |
advising patients of any adverse
side-effects of medicines or potential interactions with other
medicines/treatments; |
|||
|
▪ |
preparing dosette and cassette boxes,
usually for the elderly but also for those with memory/learning difficulties,
where tablets are placed in compartments for specified days of the week; |
|||
|
▪ |
undertaking Medicine Use Reviews
(MUR), an advanced service to help patients understand how their medicines
work and why they have to take them; |
|||
|
▪ |
providing a prescription intervention
service; |
|||
|
▪ |
managing a needle and syringe
exchange; |
|||
|
▪ |
dispensing emergency hormonal
contraception; |
|||
|
▪ |
measuring and fitting compression hosiery; |
|||
|
▪ |
monitoring blood pressure and
cholesterol levels; |
|||
|
▪ |
offering a diabetes screening
service; |
|||
|
▪ |
providing pregnancy testing; |
|||
|
▪ |
arranging the delivery of
prescription medicines to patients; |
|||
|
▪ |
overseeing the ordering and safe
storage of medical products; |
|||
|
▪ |
maintaining computerised records; |
|||
|
▪ |
managing, supervising and training
pharmacy support staff; |
|||
|
▪ |
selling healthcare and other
products, such as toiletries, cosmetics and photographic items; |
|||
|
▪ |
budgeting and financial management; |
|||
|
▪ |
promoting sales and developing the
business; |
|||
|
▪ |
keeping up to date with current
pharmacy practice, new drugs and their uses. |
|||
3. |
KNOWLEDGE AND SKILLS REQUIREMENTS
(Minimum requirements for performance of work described (Level of Education,
Knowledge, Skill and Ability): |
||||
|
3.1 |
Education: Diploma in
Pharmacy/Bachelor in Pharmacy. |
|||
|
3.2 |
Training: None. |
|||
|
3.3 |
Length and
type of practical experience required: New recruit. |
|||
|
3.4 |
Knowledge
of language(s) and other specialized requirement: Should be fluent
in English and regional language. |
|||
4. |
COMPLEXITY OF WORK (details of the
intricacy of tasks, steps, processes or methods involved in work, difficulty
and originality involved in work): |
||||
|
The responsibilities involve monitoring
the patient and providing health education which will have direct impact on
the overall health of the population and disease management. Its jurisdiction
encompasses a wide range of pharmaceutical services be it in a dispensary or
a hospital. The laid out procedures and techniques needs to be carried out in
precise technical efficacy and accuracy. The working process involves
scrutinizing every step to prevent any mistakes in the work as it deals with
human life. The management of life saving drugs is very important and
involves many steps so as to ensure timely supply of drugs to the needy
patients. |
||||
5. |
SCOPE AND EFFECT OF WORK (Details of
the breadth of work performance, and the effect the work has on the work of
others or the functions of the organization): |
||||
|
Drugs are the lifelines of the health
system. The success of the health care system depends on how various factors
like patient compliance to the medicines, cost, and supply, rational
utilization of resources, minimization of wastages and rational prescribing.
Pharmacist is fully involved in carrying out and promoting them, thus
contributing to the overall economy of the nation. The pharmacist is directly
involved in counselling the patients, advising the prescribers on rational
selection of drugs and therefore it has a direct impact on the overall
patient care. |
||||
6. |
INSTRUCTIONS AND GUIDELINES
AVAILABLE: |
||||
|
6.1 |
Instructions (Details of the controls
exercised over the work by the Superior; how work is assigned, reviewed and
evaluated): |
|||
|
|
Work is carried out based on the
annual work plan and regular supervision from the senior pharmacists. |
|||
|
6.2 |
Guidelines (written or unwritten
guidelines that are available, and the extent to which the employees may
interpret, adapt or devise new guidelines): |
|||
|
|
▪ |
Annual work plan |
||
|
|
▪ |
Standard Operating
Procedures/guidelines on pharmaceutical care and services |
||
|
|
▪ |
Pharmacy Act and other laws as
specified above in the regulations. |
||
7. |
WORK RELATIONSHIPS (The frequency,
nature and purpose of contacts with others within and outside the assigned
organization (other than contacts with superiors): |
||||
|
A pharmaceutical service requires
constant interaction with patients and other professionals to monitor, advise
and follow-up on drug efficacy, any side effects and complications. The
profession also requires constant interaction with different health
professionals at various levels to provide the best patient care. |
||||
8. |
SUPERVISION OVER OTHERS (the
responsibility that this position has for supervision of other employees,
including the nature of supervisory responsibilities and categories and
number of subordinates, both directly and indirectly supervised are) |
||||
|
Supervises the technicians and other
health workers in the community Pharmacy on the proper storage management,
distribution and proper utilization of medicines. |
||||
9. |
JOB ENVIRONMENT (the physical demands
that are required, such as walking, standing, lifting heavy objects, etc.,
and/or any risks or discomforts like exposure to hazards such as exposure to
chemicals infections, radiation, extreme weather and other hostile working
conditions): |
||||
|
Compounding involves the use of
chemicals and it is risky to have contact or inhale certain substances and
may give rise to chronic diseases in the long run. The contact with patients
increases the risk of contacting communicable diseases and other profession
related work hazards such as risk of needle pricks exposing him/her to
diseases like HIV and Hepatitis. |
||||
Details of Position Title and job
responsibilities of Drug Information Pharmacist at Pharmacy practice site in
a health care setting (Drug Store/Pharmacy) |
|||||
1. |
JOB IDENTIFICATION: |
||||
|
1.1 |
Position
Title:
Drug Information Pharmacist |
|||
|
1.2 |
Job Location (As appropriate): |
|||
|
|
Unit: Hospital Pharmacy/dispensary/teaching
hospital/other health care setting |
|||
2. |
PURPOSE, DUTIES AND RESPONSIBILITIES |
||||
|
Purpose: Provide patient
care that optimizes the use of medication and promotes health, wellness and
disease prevention. |
||||
|
Core
Responsibilities and Activities: |
||||
|
▪ |
Provide drug information services |
|||
|
▪ |
Supervise pharmacy/Pharm.D students
during the drug information rotation. |
|||
|
▪ |
Participate in the administrative
activities of the drug information centre along with other faculty/health
care providers. |
|||
|
▪ |
Develop and assist in developing drug
monographs and reviews for the Pharmacy and Therapeutics Committee. |
|||
|
▪ |
Write and edit drug information
centre publications such as newsletters and other publications. |
|||
|
▪ |
Contribute to continuous quality
improvement efforts related to drug information services. |
|||
|
▪ |
Contribute to didactic drug
information courses. |
|||
|
▪ |
Complete at least 1 major research
project related to drug information or other area of interest that is
suitable for publication. |
|||
|
▪ |
Present research activity at various
forum. |
|||
Other Responsibilities and
Activities: |
|||||
|
▪ |
Participate in Pharmacy and
Therapeutics Committee meetings |
|||
|
▪ |
Contribute to drug use management
activities (DUE/DUR) |
|||
|
▪ |
Work with other faculty on drug
information service-related projects as needed |
|||
|
▪ |
Attend a major/national pharmacy
meeting. |
|||
|
▪ |
Participate in entrepreneurial
activities of the drug information centre. |
|||
3. |
KNOWLEDGE AND SKILLS REQUIREMENTS
(Minimum requirements for performance of work described (Level of Education,
Knowledge, Skill and Ability): |
||||
|
3.1 |
Education: Bachelor in
Pharmacy/Pharm.D |
|||
|
3.2 |
Training: Drug information
residency |
|||
|
3.3 |
Length and
type of practical experience required: New recruit. |
|||
|
3.4 |
Knowledge
of language(s) and other specialized requirement: Should be fluent
in English and regional language |
|||
4. |
COMPLEXITY OF WORK (details of the
intricacy of tasks, steps, processes or methods involved in work, difficulty
and originality involved in work): |
||||
|
The responsibilities involve
monitoring the patient and providing health education which will have direct
impact on the overall health of the population and disease management. Its
jurisdiction encompasses a wide range of pharmaceutical services be it in a
dispensary or a hospital. |
||||
5. |
SCOPE AND EFFECT OF WORK (Details of
the breadth of work performance, and the effect the work has on the work of
others or the functions of the organization): |
||||
|
Drugs are the lifelines of the health
system. The success of the health care system depends on how various factors
like patient compliance to the medicines, cost, and supply, rational
utilization of resources, minimization of wastages and rational prescribing.
Pharmacist is fully involved in carrying out and promoting them, thus
contributing to the overall economy of the nation. The pharmacist is directly
involved in counselling the patients, advising the prescribers on rational
selection of drugs and therefore it has a direct impact on the overall
patient care. |
||||
6. |
INSTRUCTIONS AND GUIDELINES
AVAILABLE: |
||||
|
6.1 |
Instructions (Details of the controls
exercised over the work by the Superior; how work is assigned, reviewed and
evaluated): |
|||
|
|
Work is carried out based on the
annual work plan and regular supervision from the senior pharmacists. |
|||
|
6.2 |
Guidelines (written or unwritten
guidelines that are available, and the extent to which the employees may
interpret, adapt or devise new guidelines): |
|||
|
|
▪ |
Annual work plan |
||
|
|
▪ |
Standard Operating
Procedures/hospital guidelines on pharmaceutical care and services |
||
|
|
▪ |
Pharmacy Act and other laws as
specified above in the regulations. |
||
7. |
WORK RELATIONSHIPS (The frequency,
nature and purpose of contacts with others within and outside the assigned
organization (other than contacts with superiors): |
||||
|
A pharmaceutical service requires
constant interaction with patients and other professionals to monitor, advise
and follow-up on drug efficacy, any side effects and complications. The
profession also requires constant interaction with different health
professionals at various levels to provide the best patient care. |
||||
[2][7-A. |
The duty
of the Drug Information Pharmacist in the Drug Information Centre in
Hospitals.The
Drug Information Pharmacist shall |
||||
a) |
provide information and advice
regarding drug interactions, side effects, dosage and proper medication
storage to patients, physicians, dentists and other health care
professionals; |
||||
(i) |
provide drug information to patients,
caregivers, and health care professionals; |
||||
(ii) |
create and maintain currency of a
variety of print and online educational resources for patients, namely, tip
sheets, pamphlets and health care material such as in-service documents,
newsletters on topics namely, optimal medication use, general health, or
select clinical questions; |
||||
(iii) |
educate health care professionals on
safe and effective medication-use, policies and processes, including
development of resources to communicate these informations; |
||||
(iv) |
lead or participate in continuing
education services for health care professionals; |
||||
(v) |
precept and educate pharmacy students
and residents; |
||||
(vi) |
participate in quality improvement
research projects and drug cost analysis; |
||||
(vii) |
contribute to the biomedical
literature, and |
||||
(viii) |
provide peer review for other
contributors.] |
||||
[3][7-B. |
Details of Position, Title and job
responsibilities of Clinical Pharmacist |
||||
1. |
Job
Identification: |
||||
1.1 |
Position Title
: Clinical Pharmacist |
||||
1.2 |
Job Location (As appropriate)
: Hospitals |
||||
2. |
Purpose,
duties and responsibilities.The Clinical Pharmacist shall |
||||
(a) |
provide patient care which optimises
the use of medication and promotes health, wellness and disease prevention in
collaboration with physicians and other health care professionals; |
||||
(b) |
evaluate all medicare coverage
requirement requests; |
||||
(c) |
ensure compliance to all clinical
procedures; |
||||
(d) |
coordinate with pharmacy and medical
staff to perform regular interventions according to present drugs; |
||||
(e) |
perform regular evaluation on all
usage and dosage of drugs; |
||||
(f) |
ensure absence of all reactions; |
||||
(g) |
assist all patients with assessment
of patient orders; |
||||
(h) |
assist prescription infusion and
ensure adherence to all laws and regulations; |
||||
(i) |
gather, maintain and analyze all
laboratory data; |
||||
(j) |
record all required patient information; |
||||
(k) |
make recommendations to change dosage
if required; |
||||
(l) |
administer and complete all pharmacy
care plans; |
||||
(m) |
perform reconciliation of all
medications and supervise all sterile mixing processes; |
||||
(n) |
review all medications and equipments
and ensure accuracy and effective functioning; |
||||
(o) |
manage all communications with
physicians and patients; |
||||
(p) |
assist to resolve all patients within
required timeframe; |
||||
(q) |
maintain record of all medications
for patients; |
||||
(r) |
ensure absence of all discrepancies; |
||||
(s) |
analyse all side effects and drug
interactions; |
||||
(t) |
retrieve clinical information for
monitoring; |
||||
(u) |
revision of the medication use
process; |
||||
(v) |
coordinate with all medical case
managers; |
||||
(w) |
evaluate all high risk members to
prevent all risks; |
||||
(x) |
participate in all patient associated
meetings; |
||||
(y) |
prepare all clinical documents; |
||||
(z) |
participate in all on call activities
for pharmacy; |
||||
(za) |
evaluate all pharmacy claim data and
identify all clinical savings; |
||||
(zb) |
attend all therapeutic and pharmacy
committee meetings; |
||||
(zc) |
design and maintain all medication
protocols for all clinical pharmacists; |
||||
(zd) |
coordinate with all clinical team
members to ensure optimal services; |
||||
(ze) |
provide support to all clinical
programs; |
||||
(zf) |
ensure compliance to all medication
process; |
||||
(zg) |
evaluate all data to administer all
drug utilization patterns; |
||||
(zh) |
monitor all departmental activities; |
||||
(zi) |
analyse all quality improvement
activities; |
||||
(zj) |
present all annual studies for
management; |
||||
(zk) |
serve as a drug information resource; |
||||
(zl) |
contribute to drug use management
activities; |
||||
(zm) |
work with other faculty on drug
information service-related projects as needed; |
||||
(zn) |
attend a major and national pharmacy
meeting. |
||||
3. |
Qualification
and skill for clinical pharmacist requirements for performance of work. |
||||
The Clinical Pharmacist |
|||||
(i) |
should possess Pharm.D from an
institution approved by the Pharmacy Council of India; |
||||
(ii) |
should have undergone training in |
||||
(a) involvement in formulary development, drug use evaluation,
and quality assurance activities; |
|||||
(b) ambulatory care experience; |
|||||
(iii) |
should have the ability to research
and analyse the medical literature including drug information, disease
states, and clinical practice guidelines; |
||||
(iv) |
should have extensive knowledge of
pharmacy and its related subdisciplines (therapeutics, pharmacology, physical
pharmacy), formulary development, drug use review, quality assurance, legal,
regulatory, and standards of practice; |
||||
(v) |
should have such length and type of
practical experience for new recruits as specified by the Pharmacy Council of
India; |
||||
(vi) |
should be fluent in English and
regional language of the place in which the Clinical Pharmacist works. |
||||
4. |
Complexity
of Work.The
Clinical pharmacist shall monitor the patient and provide health education
which may have direct impact on the overall health of the population and
disease management. Its jurisdiction encompasses a wide range of
pharmaceutical services. |
||||
5. |
Scope and
effect of work.While
discharging his duties, the Clinical pharmacist shall have regard to
following matters, namely |
||||
(a) |
the factors like patient compliance
to the medicines, cost, and supply, rational utilization of resources,
minimization of wastages and rational prescribing; |
||||
(b) |
carry out and perform his duty, thus
contributing to the overall economy of the nation; |
||||
(c) |
counseling the patients, advising the
prescribers on rational selection of drugs and, therefore, it has a direct
impact on the overall patient care. |
||||
6. |
Instructions
and guidelines.The
Clinical pharmacist shall |
||||
(a) |
comply with the instructions issued
by the superior officers regarding how the work is to be discharged and the
review and evaluation of the same; |
||||
(b) |
carry out the annual work plan and
regular supervision from the senior pharmacists; |
||||
(c) |
issue guidelines and the extent to
which the employees may adapt or devise guidelines on |
||||
(i) annual work plan; |
|||||
(ii) standard operating procedures and hospital guidelines on
pharmaceutical care and services; |
|||||
(iii) provisions of Pharmacy Act, 1948 (8 of 1948) and other
statutory provisions as specified in the regulations. |
|||||
7. |
Work
relationship.The
clinical pharmacist shall, while discharging his duty shall have regard to |
||||
(a) |
constant interaction with patients
and other professionals to monitor, advise and follow-up on drug efficacy,
any side effects and complications; |
||||
(b) |
constant interaction with different
health professionals at various levels to provide the best patient care.] |
||||
OBJECTIVES FOR MAKING PRACTICE
REGULATIONS |
|||||
Professions exist to serve society.
The mission of the pharmacy profession is to render service to humanity with
full respect for the dignity of profession and man, besides addressing the
needs of society and of individual patients. The public places great trust in
the knowledge, skills and professional judgments of pharmacists. This trust
requires the pharmacists to ensure and maintain throughout their career high
standards of personal and professional conduct, up-to date knowledge and
professional competence relevant to their domain of practice. The registered
pharmacist should merit the confidence of patients entrusted to their care,
rendering to each a full measure of service and devotion. For which the
registered pharmacist should try continuously to improve his knowledge and
skills and should make available to their patients and colleagues the
benefits of their professional attainments. |
|||||
The registered pharmacist should
practice methods of practice founded on scientific basis and should not
associate professionally with anyone who violates this principle. The
honoured ideals of the pharmacy profession imply that the responsibilities of
the registered pharmacist extend not only to individuals but also to society. |
|||||
This calls for framing of the
regulations for practice of pharmacy laying down responsibilities of
pharmacist towards patient, another registered pharmacist and the public in
general. Primary reasons to regulate pharmacy profession are: |
|||||
✓ |
To improve quality of health care |
||||
✓ |
To ensure that Pharmacists maintain
high standards in their duty |
||||
✓ |
To reduce cost of health care |
||||
✓ |
To inhibit criminal abuse of medicines |
||||
It is also a call for laying down the
activities which may be construed as misconduct and provision for taking
disciplinary action. |
|||||
[1]
Pharmacy Council of India (Pharmacy Practice Regulations, 2015), Noti. No.
14-148/2012-PCI, dated January 15, 2015, published in the Gazette of India,
Extra., Part III, Section 4, dated 16th January, 2015, pp. 27-52, No. 17.
[2]
Ins. by Noti. No. 14-148/2020-PCI, dated 30-6-2021 (w.e.f. 5-7-2021).
[3]
Ins. by Noti. No. 14-148/2020-PCI, dated 30-6-2021 (w.e.f. 5-7-2021).