Pharmacists cannot open clinics to diagnose disease & prescribe medicine; clarifies PCI

Clearing the doubts on pharmacists can open pharma clinics to treat common disease and prescribe medicine, Pharmacy Council of India (PCI) has recently notified that the pharmacists cannot open clinics to diagnose the disease and prescribe the medicines.

PCI has clarified that there is no provision in the Pharmacy Practice Regulations (PPR), 2015 which allows the pharmacists to practice medicine. Under the said Regulations, the registered pharmacist is required to dispense medicines on the prescription of a registered medical practitioner and can counsel the patient or care giver on medicine to enhance or optimise drug therapy.

The elements of patient counselling includes, name and description of the drugs;the dosage form, dose, route of administration, and duration of drug therapy; intended use of the drug and expected action; special directions and precautions for the drug; common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; techniques for self monitoring drug therapy; proper storage of the drugs; prescription refill information; action to be taken in the event of a missed dose and to ensure rational use of drugs.

Dr. B Suresh, president of PCI informed that there are few groups of pharmacists who are claiming that they are doctors and there are various messages being circulated on social media, e-mails, WhatsApp etc. that pharmacists are empowered under PPR, 2015 to open pharma clinics to diagnose the disease and prescribe medicines.

We would like to clarify that there are no such provision under PPR, 2015 which allows pharmacists to diagnose and prescribe medicine. PPR, 2015 only allows the pharmacists to practice pharmacy and not medicine, they can counsel the patient or care giver and dispense medicines on the prescription of a registered medical practitioner but cannot prescribe medicines to the patients

He further adds, “Under no circumstances, the registered pharmacist is empowered under the Pharmacy Act, 1948 and PPR, 2015 to practice medicines or open clinics to provide medical care.

BUT, My query is : Can a registered pharmacist(PHARM D) approved with Clinical Pharmacy Council give PHARMA CARE in his PHARMACY? Services like prior authorization and refill authorization for prescription drugs is permitted?

Medicotherapeutic approach vs Pharmacotherapeutic approach

Therapeutics: In medicine, the branch that deals specifically with the treatment of disease and the art and science of healing. In pharmacology, therapeutics accordingly refers to the use of drugs and the method of their administration in the treatment of disease.

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PHARMACEUTICAL ERRORS

Pharmceutical Errors are different from Medical Errors.

Manufacturing Errors
Compounding Errors 

Dispensing Errors

Storage Errors

Accounting Errors
Clerical errors
Inventory errors
computer entry errors
Data entry in sheet errors
Pharmceutical Calculation Errors

Pharmaceutical Formulation Errors (Research & Development Errors)

Pharmaceutical Analysis Errors

Method of administration Errors

Drug Dose Titration Errors

Adverse Drug Reaction Reporting Errors (Pharmacovigilance Errors)

Drug Drug Interaction Reporting Errors

Ward Round Errors

NUTRACEUTICALS

Chia is grown commercially for its seeds rich in α-linolenic acid.

A Nutraceutical is a pharmaceutical-grade and standardized nutrient.^[1] In the US, "nutraceuticals" do not exist as a regulatory category; they are regulated as dietary supplements and food additives by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.

Regulation[edit]

Nutraceuticals are treated differently in different jurisdictions.

Canada[edit]

Under Canadian law, a nutraceutical can either be marketed as a food or as a drug; the terms "nutraceutical" and "functional food" have no legal distinction,^[3] referring to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food [and] is demonstrated to have a physiological benefit or provide protection against chronic disease."

United States[edit]

The term "nutraceutical" is not defined by US law.^[4] Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, dietary supplement, food ingredient, or food.^[5][6]

International sources[edit]

In the global market, there are significant product quality issues.^[7] Nutraceuticals from the international market may claim to use organic or exotic ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide profit margin may create unregulated products overseas with low-quality or ineffective ingredients.

Market[edit]

A market research report produced in 2012 projected that the worldwide nutraceuticals market would reach US$250 billion by 2018,^[8] defining that market as "Dietary Supplements (Vitamins, Minerals, Herbals, Non-Herbals, & Others), and Functional Foods & Beverages"^[9]

Classification of nutraceuticals[edit]

Nutraceuticals are products derived from food sources that are purported to provide extra health benefits, in addition to the basic nutritional value found in foods. Depending on the jurisdiction, products may claim to prevent chronic diseases, improve health, delay the aging process, increase life expectancy, or support the structure or function of the body.^[10]

Dietary supplements[edit]

Dietary supplements, such as the vitamin B supplement shown above, are typically sold in pill form.

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term: “A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”^[11]

Dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing, but companies must register their manufacturing facilities with the FDA and follow current good manufacturing practices (cGMPs). With a few well-defined exceptions, dietary supplements may only be marketed to support the structure or function of the body, and may not claim to treat a disease or condition, and must include a label that says: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The exceptions are when the FDA has reviewed and approved a health claim. In those situations the FDA also stipulates the exact wording allowed.

Functional foods[edit]

Considered a father of Western medicine, Hippocrates advocated the healing effects of food.

Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as vitamin D to milk.

Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiologicalbenefit, other than a purely nutritional effect.”^[12] In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.^[13]

History[edit]

The word "nutraceutical" is a portmanteau of the words "nutrition" and "pharmaceutical", was coined in 1989 by Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine.^[14] Indians, Egyptians, Chinese, and Sumerians are just a few civilizations that have used food as medicine.^[15] “Let food be thy medicine.” is a common misquotation ^[16] attributed to Hippocrates, who is considered by some to be the father of Western medicine.

The modern nutraceutical market began to develop in Japan during the 1980s. In contrast to the natural herbs and spices used as folk medicine for centuries throughout Asia, the nutraceutical industry has grown alongside the expansion and exploration of modern technology.^[

pharmaceutical and biopharmaceutical

The primary difference between biopharmaceuticals and traditional pharmaceuticals is the method by which the drugs are produced: The former are manufactured in living organisms such as bacteria, yeast and mammalian cells, whereas the latter are manufactured through a series of chemical synthesis.

Drug & Medicine

Medicine, however, is our term for a drug when that drug is used to cure, mitigate, treat, or prevent a disease. Many people become addicted to drugs even when used as medicine. ... Here is where the lines of addiction and medicine become blurry and begin to come together until the medication is the addiction

Medicotherapeutic approach vs Pharmacotherapeutic approach

Therapeutics: In medicine, the branch that deals specifically with the treatment of disease and the art and science of healing. In pharmacology, therapeutics accordingly refers to the use of drugs and the method of their administration in the treatment of disease.