Okay, I will generate the policy analysis report based on the provided government policy text, following the specified structure and focusing on the text itself.
**Policy Analysis Report: Pharmacy Practice Amendment Regulations, 2021**
**1. Executive Summary:**
This report analyzes the Pharmacy Practice Amendment Regulations, 2021, which amends the Pharmacy Practice Regulations, 2015. The core purpose of this amendment is to integrate and define the roles of Drug Information Pharmacists and Clinical Pharmacists within healthcare settings, specifically hospitals and drug stores. Key findings include the establishment of Drug Information Centers, the detailed outlining of Clinical Pharmacist roles and responsibilities, and the emphasis on optimal medication use and patient care. The amendment appears to address the need for specialized pharmaceutical services and better integration of pharmacists in patient care teams.
**2. Introduction:**
The purpose of this report is to provide an informative analysis of the Pharmacy Practice Amendment Regulations, 2021, based solely on the content of the official notification provided. The report aims to outline the key changes introduced by this amendment and its potential impact on the pharmacy profession and healthcare delivery.
**3. Policy Overview:**
* This regulation is an amendment to the Pharmacy Practice Regulations, 2015, published in the Gazette of India on January 16, 2015.
* **Core Objective(s):** The core objective, inferred from the text, is to enhance the role of pharmacists in healthcare by:
* Formalizing the establishment of Drug Information Centers within hospitals.
* Defining the specific roles, responsibilities, and qualifications of Clinical Pharmacists, focusing on patient care, medication management, and collaboration with other healthcare professionals.
* Promoting optimal medication use and contributing to overall patient health and wellness.
**4. Background and Rationale:**
This amendment likely addresses a need to:
* **Clarify and expand the roles of pharmacists:** The detailed descriptions of the roles of Drug Information Pharmacists and Clinical Pharmacists suggest a move to more clearly define and standardize these positions within healthcare settings.
* **Improve medication management and patient care:** The emphasis on medication reconciliation, dosage optimization, and patient counseling indicates a desire to enhance the quality and safety of medication use.
* **Integrate pharmacists into the healthcare team:** The focus on collaboration with physicians and other healthcare professionals implies a drive to better integrate pharmacists into the patient care process.
* **Enhance patient safety**: The emphasis on drug interactions, side effects and adverse reactions signals a focus on patient safety and reducing medication-related harm.
**5. Key Provisions / Changes:**
This amendment introduces the following key changes to the Pharmacy Practice Regulations, 2015:
* **Establishment of Drug Information Centers:**
* A Drug Information Center is to be established in all hospitals, led by a Drug Information Pharmacist.
* This Pharmacist's role includes providing information and advice on drug interactions, side effects, dosage, and storage to patients and healthcare professionals. They are also tasked with creating educational resources and training healthcare professionals.
* **Introduction of the Clinical Pharmacist Role:**
* Defines the position of a Clinical Pharmacist within hospitals.
* Specifies the Clinical Pharmacist's duties and responsibilities, which include:
* Providing patient care to optimize medication use and promote health.
* Evaluating medicare coverage requirement requests.
* Ensuring compliance with clinical procedures.
* Coordinating with medical staff on drug interventions.
* Evaluating drug usage and dosage.
* Assessing patient orders and prescriptions.
* Recommending dosage changes.
* Performing medication reconciliation and supervising sterile mixing.
* Managing communication with physicians and patients.
* Analyzing data and identifying clinical savings.
* Attending meetings and designing medication protocols.
* Contributing to drug use management and research.
* **Qualifications for Clinical Pharmacists:**
* Requires a Pharm.D. degree from an institution approved by the Pharmacy Council of India.
* Specifies training requirements in areas like formulary development, drug use evaluation, and quality assurance.
* Requires the ability to research and analyze medical literature.
* Mandates proficiency in English and the regional language of the workplace.
* **Amendment effect:** These ammendments seek to expand pharmaceutical services and improve their delivery. It accomplishes this by specifying Clinical Pharmacist roles and responsibilities along with their qualifications.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders directly affected by this amendment include:
* **Pharmacists:** Specifically, those working or seeking to work as Drug Information Pharmacists or Clinical Pharmacists in hospitals and drug stores.
* **Hospitals and Healthcare Institutions:** As they are required to establish Drug Information Centers and potentially hire Clinical Pharmacists.
* **Patients:** Who will benefit from improved medication management and access to drug information.
* **Physicians, Dentists, and other Healthcare Professionals:** Who will collaborate with pharmacists and receive drug information support.
* **Pharmacy Council of India:** The responsible body for ensuring compliance and updating pharmacy standards.
* **Pharm.D students:** Who will be guided and trained by Clinical Pharmacists
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Pharmacy Council of India (PCI) is the primary body responsible for implementing and enforcing these regulations. The Central Government also has an oversight role, as their approval was required for the amendment.
* **Timelines/Procedures:** The amendment states that it comes into force on the date of publication in the Official Gazette (July 5, 2021), implying immediate effect. However, specific timelines for hospitals to establish Drug Information Centers or hire Clinical Pharmacists are not mentioned in the provided text. Procedures for monitoring and evaluating the implementation of these changes are also not detailed.
* The ammendments also imply the creation of a standard system for data gathering and analysis (lab data, patient information, clinical savings, departmental activities).
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of these changes include:
* **Improved Medication Safety:** By providing better drug information and medication management.
* **Enhanced Patient Care:** Through closer collaboration between pharmacists and other healthcare professionals.
* **More Efficient Healthcare Delivery:** By optimizing medication use and reducing medication-related costs.
* **Standardization of Pharmacist Roles:** By clearly defining the responsibilities and qualifications of Drug Information Pharmacists and Clinical Pharmacists.
* **Increased Value of Pharmacists:** By increasing their involvement and recognition within the healthcare team.
* **Contribution to the Overall Economy of the Nation:** By contributing to the rational utilization of resources and waste minimization.
**9. Conclusion:**
The Pharmacy Practice Amendment Regulations, 2021, represent a significant step towards enhancing the role of pharmacists in healthcare in India. By formalizing Drug Information Centers and defining the Clinical Pharmacist role, the amendment aims to improve medication safety, patient care, and healthcare efficiency. The successful implementation of these changes will require the active participation of pharmacists, healthcare institutions, and the Pharmacy Council of India. The amendment has the potential to significantly improve the role of pharmacists and the services they provide.
Key Entities Referenced
NEW DELHI: Capital of India; place of publication of the notification.
Pharmacy Act, 1948: An act of the Indian Parliament concerning the regulation of pharmacy profession and education in India.
Pharmacy Council of India: A statutory body under the Ministry of Health and Family Welfare, Government of India, responsible for regulating pharmacy education and profession in India.
Central Government: The executive authority of the Union of India.
Pharmacy Practice Regulations, 2015: Regulations pertaining to the practice of pharmacy in India, amended by this notification.
Pharmacy Practice Amendment Regulations, 2021: The amendment to the Pharmacy Practice Regulations, 2015, as per this notification.
Official Gazette: A public journal and an official legal document of the government.
Drug Information Pharmacist: A pharmacist specializing in providing drug information.
Clinical Pharmacist: A pharmacist who provides patient care that optimizes the use of medication and promotes health, wellness and disease prevention in collaboration with physicians and other health care professionals.
Pharm.D: Doctor of Pharmacy degree; qualification for clinical pharmacist.
English: Language in which the Clinical Pharmacist works
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-05072021-228119
xxxGIDHxxx
CG-DL-E-05072021-228119
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग III—खण्ड
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 276] नई दिल्ली, सोमवार, िलु ाई 5, 2021 /आषाढ़ 14, 1943
N0. 276] NEW DELHI, MONDAY, JULY 5, 2021/ASHADHA 14, 1943
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la[;k 14-148@2020&Hkk-Hks-ifj-—QkesZlh vf/kfu;e] 1948 ¼1948 dk 8½ dh /kkjk 10 vkSj 18 }kjk
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3714 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
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¼K[k½ vkS"kf/k mi;ksx Áca/ku xfrfof/k;ksa esa ;ksxnku djuk ;4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
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O;kid Kku ;
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(vi) ftl LFkku ij fDyfudy QkekZflLV dke djrk gS ogka vaxzsth rFkk LFkkuh; Hkk"kk esa fuiq.k gksuk
pkfg,A
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tuleqnk; ds lexz LokLF; rFkk chekjh Áca/ku ij lh/kk ÁHkko gksxkA blds dk;Z {ks=kf/kdkj esa
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ekeyksa ds laca/kksa esa%—
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vFkZO;oLFkk esa ;ksxnku nsrk gSA
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lykg nsrk gS] vr% lexz jksxh ns[kHkky ij bldk lh/kk ÁHkko gksrk gSA
6- vuqns'k ,oa fn'kkfunsZ'k & fDyfudy QkekZflLV %—
¼d½ ofj"B vf/kdkfj;ksa }kjk tkjh funZs’kksa dk vuqikyu] dk;kZsa dk fuoZgu] leh{kk vkSj ewY;kadu dSls fd;k
tk,A
¼[k½ dk;Z dk fu"iknu okf"kZd dk;Z ;kstuk rFkk ofj"B QkekZflLV ls fu;fer i;Zos{k.k ds vk/kkj ij fd;k
tkuk gSA
¼x½ fn'kkfunsZ'k ¼fyf[kr vFkok vfyf[kr fn'kkfunsZ'k tks miyC/k gSa] rFkk ftlds vk/kkj ij deZpkjhx.k
bldh O;k[;k] vuqdwyu dj ldsa vFkok ubZ fn'kkfunsZ'k rS;kj dj ldsa½%
(i) okf"kZd dk;Z ;kstuk
(ii) QkekZL;qfVdy ns[kHkky ,oa los kvksa ij ekud ifjpkyu ÁfØ;k,a@vLirky fn'kkfunsZ'k
(iii) QkesZlh vf/kfu;e 1948 (1948 dk 8) rFkk vU; oS/kkfud izko/kkuksa tSlk fd fofu;eksa esa fofufnZ"V
fd;k x;k gksA
7- dk;Z laca/k & fDyfudy QkekZflLV vius drZO;ksa dk fuoZgu djrs le; &[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5
¼d½ vkS"kf/k ÁHkkodkfjrk fdUgha vuqfØ;kvksa vkSj tfVyrkvksa ds laca/k esa vuqJo.k djus] ml ij lykg nsus
vkSj vuqorhZ dk;Zokgh djus ds fy,] jksfx;ksa vkSj vU; is'ksojksa ds lkFk fujarj fopkj vknku&Ánku
djsxkA
¼[k½ jksfx;ksa dks loksZRre ns[kHkky miyC/k djkus ds fy, fofHkUu Lrjksa ij fofHkUu LokLF; is'ksojksa ds lkFk
fujarj fopkjksa dk vknku&Ánku djsxkA
[जवज्ञापन-III/4/असा./129/2021-22]
vpZuk eqn~xy] fucU/kd&,oa&lfpo
uksV% Á/kku fofu;eksa (Hks"kth vH;kl ¼la'kks/ku½ fofu;e] 2015) dks Hkkjr ds jkti=] vlk/kkj.k Hkkx III & [kaM
4] la[;k 17 fnukad 15 tuojh 2015 dks Ádkf'kr fd;k x;k FkkA
PHARMACY COUNCIL OF INDIA
NOTIFICATION
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. (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:-6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
“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 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;[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 7
(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.
[ADVT.-III/4/Exty./129/2021-22]
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.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.