PHARMACY COUNCIL OF INDIA
New Delhi, the 30th June, 2021
No. 14-148/2020-PCI.—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 further to amend the Pharmacy Practice Regulations, 2015, namely:—
(1) These regulations may be called the Pharmacy Practice (Amendment) Regulations, 2021.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Pharmacy Practice Regulations, 2015, in Appendix III,-
(i) under the heading – “Details of Position Title and job responsibilities of Drug Information Pharmacist at Pharmacy practice site in a health care setting (Drug store / Pharmacy)”,-
(A) after Para 7- “Work Relationships”, the following para shall be inserted, namely:—
“7A. “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.
(B) Under the heading – Details of Position Title and job responsibilities of Drug Information Pharmacist at Pharmacy practice site in a health care setting (Drug Store/ Pharmacy) after para 7A, and before the heading –
OBJECTIVES FOR MAKING PRACTICE REGULATIONS, the following shall be inserted, namely:-
“7B. 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 optimizes the use of medication and promotes health, wellness and disease prevention in collaboration with physicians and other health care professionals;
(b) evaluate all medicate 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) analyze 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.
ARCHNA MUDGAL, Registrar-cum-Secy.
Note. – The principal regulations, namely, the Pharmacy Practice Regulations, 2015 were published in the Gazette of India, Extraordinary Part III, Section 4, No.17 on 16 January, 2015.
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