Tuesday, March 22, 2016

Community Pharmacy

Community Pharmacy may be defined as that area of Pharmacy Practice in which medicines and other related products are sold or provided directly to the public from a retail (or other commercial) outlet designed primarily for the purpose of providing medicines. The sale or provision of the medicine may be either on the order or prescription of a doctor or "over the counter" (OTC). In addition to supplying medicines, the community pharmacist is expected to act as a primary health care professional and play a substantial role in health promotion and consumer health information. With the enforcement of the Drugs and Cosmetics Act, 1940, the sale of drugs in India has become a restricted practice and only those persons who have been granted licences by the licensing authorities of the States, can engage themselves in the wholesale, retail, compounding or dispensing of drugs. According to the Drugs and Cosmetics Act, the premises for the retail sale of drugs have been categorised as Drug Store : These retail shops do not require the services of a "Qualified Person" and can sell only such drugs where the sale does not require any technical supervision. Chemists and Druggists : These retail shops have to employ the services of a "Registered Pharmacist" and can sell all types of drugs except those drugs which have to be compounded against prescriptions. Pharmacy or Dispensing Chemist : These retail shops employ "Qualified Person" and engage in the compounding of drugs. These are required to maintain equipments and space as laid down in Schedule N to the Drugs and Cosmetics Act.

TYPES OF DRUG STORES AND DESIGN
Based on their layout design, drug stores may be categorised as

1. Traditional Drug Stores :
These types of drug stores are designed in such a manner that the entire area of drug store is exposed to customers. Such a design has pleasing and professional appearance and is convenient for both workers and customers. It provides opportunity for maximum sales but there are good chances of theft in such design.

2. Personal Service Drug Stores :
 In this type of design, the whole of the area is not exposed to the customer but the customer is required to interact with the drug store personnel at the service ii counter. During the purchasing process, the customer &glands an article and the personnel provides the article. This service and design facilitate maximum interaction between drug store employee area where the customer • expected to wait while his prescription is processed. In this type of of the personnel at the service counter. and the customers. The success of drug store depends upon the convenience and friendly service

3. Prescription Oriented Drug Stores :
These types of drug stores provide a comfortable waiting design, health related items, drugs and prescription accessories are displayed in the vicinity orthopaedic and surgical appliances are kept in a separate room. Cosmetics and gifts are arranged in a suitable area in the store.

4. Pharmaceutical Centres 
: These type of centres sell medicines, convenience articles, orthopaedic and surgical appliances. The store has sufficient floor space and is properly decorated. Orthopaedic and surgical appliances are kept in a separate room.

5. Super Drug Stores:
Such type of drug stores have a huge floor area, ranging from 5,000 to 10,000 sq. ft. with a square design. The customers have access to almost all the area in the drug store and can inspect, handle and select articles themselves. The design is on self-service pattern except for the Prescription department where self service is not possible.

SITE SELECTION
The selection of the exact site or piece of land on which the Drug Store is proposed to be established is of prime importance. The following are some of the factors which should be considered during selection of the appropriate site
1. Population Density :
 The drug store should ideally be located in a thickly populated area since this will ensure more number of customers.
2. Number of Physicians in the area :
More is the number of physicians in the area, more will be the prescription leading to more number of customers for the drug store.
3. Proximity to Physicians and other Health care Facilities:
 The drug store should preferably be located near a Hospital or a nursing home or a practising physician since this will tremendously boost up the sale of drugs as well as surgical and other accessory items.
4. Number of already existing Drug Stores :
This is an important criteria for selection of the site because more number of drug stores in an area will cause a reduction in the business of each.
5. Nearness to Market 
A drug store that is located near a market has better chances of attracting the customers.
6. Nearness to a Parking Facility
 A drug store should not be located at a place where parking becomes a problem since this will reduce the number of customers visiting the place.
7. Traffic Count :
A drug store should preferably be situated on that side of the road which falls on the route of maximum number of people returning from their work place.
8. Income Group of the People in the Area :
A drug store located in an affluent area will have better chances of doing good business because of the good purchasing capacity of the people and also because of better awareness towards their health.
9. Age group of People in the Area :
 A drug store located in an area having a large number of aged persons and infants is likely to do better business in comparison to a drug store located in an area having maximum number of young people.
10. Scope for expansion:
The site selected for a drug store should have a scope for expansion in case the need arises in future.
11. Economic factors :
The guiding principle in the selection of a site for a drug store is that it must result in the lowest unit cost in dispensing and distributing a product. The elements of total cost include cost of land and building, transportation costs of material, power and water rates, taxes and labor and administrative costs.

 LAYOUT DESIGN

Objectives of a Good layout Design :
A good layout design aims at achieving the following objectives :
(1) To ensure compliance with the legal requirements.
(ii) To ensure maximum utilization of the available space.
(iii) To reduce the running cost of the drug store.
(iv) To ensure better supervision of the store thereby reducing chances of pilferage, breakage, etc.
(v) To ensure adequate protection to the medicines against deleterious effects of light, heat and moisture.
(vi) To attract maximum number of customers into the drug store.
(vii) To increase the amount of total purchase of each person entering the drug store.
(viii) To improve the general and professional image of the store.

 Features of a Good Layout Design good stores layout design should have the following features:

(i) There should be proper ventilation facilities in the drug store to project a sense of cleanliness.
(ii) There should be proper illumination inside the drug store by using tube lights (Neon or fluorescent). Lighting by bulbs should be avoided since it presents a gloomy picture.
(iii) The walls and roof should be painted with washable paint for easy cleaning. White or light shades of colour should be used since light colours bring a feeling of cleanliness.
(iv) Sufficient number of wooden or steel racks should be provided. These should be painted hite from inside and should be fitted with glass doors.
(v) The counters should be made from wood having sunmica on top.
vi) The show windows should be tastefully decorated and should be made very attractive.
(vii) Office furniture such as table and sufficient number of chairs should be provided.
(viii) Sufficient waiting space with comfortable chairs should be provided for the customers.
(ix) All the medicines and accessories should be placed on the shelves and there should be efficient use of space and height in arranging the items. The movement of men and materials should be minimized thus saving on time, cost and surveillance.
(x) Fast moving items should he kept handy near the counter while slow moving ones may be kept at the back on upper shelves. Bulky items should be stored on bottom shelves.
(xi) Accessories and equipments such as surgical instruments, gloves, sutures, etc. should be store in separate racks specially reserved for the purpose.
(xii) Cash counter and wrapping counter should be located near the gate.
(xiii) The medicines may either be stored alphabetically or according to their therapeutic categories or according to their manufacturers.

LEGAL REQUIREMENTS FOR STARTING A DRUG STORE

The sale of drugs is quite different from the sale of other goods. In case of ordinary goods, the consumer can select the goods according to his choice but in case of drugs, the choice is in the hands of a physician. Moreover, the sale of drugs is a technical job and must be performed by a qualified person. Before opening a drug store (whether retail or whole sale), there are certain legal requirements which must be fulfilled.

1. Minimum Qualifications
 A person who wishes to start a retail drug store should either be a registered pharmacist himself or should engage the services of a registered pharmacist. In order to become a Registered Pharmacist, a person should fulfil the requirements laid down in the Pharmacy Act which include the following:

(i) The person should have attained at least 18 years of age.
(ii) He should be a resident of the state or should be carrying out his business or profession of pharmacy in the state.
(iii) Should possess a degree of diploma in Pharmacy or any other approved qualification.

A person who wishes to start a wholesale drug store may not be a registered pharmacist but must have passed at least matriculation examination and must possess at least four years experience in handling of drugs.

 2. Minimum Space:
A minimum area of 10 square meters is required for running a retail or wholesale drug store. The tow ch area should be equipped with proper storage facility for preserving the properties of drugs to the licence applies. For the storage of thermolabile substances such as vaccines, sera, enzymatic  preparations, antibiotics, vitamins, etc, a refrigerator is required in order to store these drugs at a temperature be V between 2°C and C. There should be sufficient number of storage racks for storing the drugs and Pharmaceuticalssin case of a Pnarmacy, the requirements as specified in Schedule N to the Drugs and Cosmetics Act should be fulfilled.

3. Application for Grant of Licence categories:
For the purpose of granting sale licences, the drugs have been divided into the following
(I) Drugs specified in. Schedule C and C1 to the Drugs & Cosmetics Act.
(ii) Drugs specified in Schedule X to the Drugs & Cosmetics Act.
(iii) Drugs other than those specified in Schedule C, C1 and X. The retail and wholesale licences are granted with respect to all the above three categories. Any person desirous of getting a licence to sell, stock, exhibit or offer for sale or distribute the drugs should apply to the licensing authorities appointed by the respective State Governments along with the following documents:

(i) Application Form No. 19 (for drugs other than those specified in Schedule X) and/or Form No. 19C (for drugs specified in Schedule X), duly filled in and in duplicate.
 (ii) A fee receipt of Rs 40/- for each category of licence required, to be attached with the application form.
(iii) The following documents as proof of age and qualification of the person
(a) An attested copy of proof of passing the Diploma or Degree course in Pharmacy from an institution recognised by the Pharmacy Council of India.
(b) An attested copy of proof of undergoing 750 hours of practical training in any Hospital. Dispensary or Chemist shop as recommended by Pharmacy Council of India.
(c) An attested copy of the Registration certificate issued by the State Pharmacy Council as proof of being registered.
(d) An attested copy of matriculation certificate as a proof of date of birth.
(e) In case the proprietor of the drug store is not qualified, then an affidavit from a qualified person is to be attached with the application form. In case the licence is required for wholesale of drugs, then a proof of passing the matriculation examination or its equivalent with four years experience in dealing with drugs is to be attached with the application. 
(iv) A layout plan of the drug store duly signed by the proprietor /partners of the firm.
(v) In case two or more persons are partners for starting the drug store. then a Copy of the partnership deed is to be attached with the application.
(vi) If the applicant is the owner of the premises where the drug store is to be started then the legal documents as a proof of ownership or if the premise is on rent, then a copy of rent receipt  or rent deed is to be attached with the application form.
(vii) An affidavit of non-conviction under Drugs and Cosmetics Act, by the proprietor or partners on Rs 3/- non-judicial stamp paper. duly attested by a first class magistrate is to be attached.

After scrutinizing the application form and all documents and if all the requirements are fulfilled. then the drug control authorities will personally visit the premises for which the license is required.. lf the authorities are satisfied, then the licence for the sale of drugs may be issued on the following forms as the case may be : 
(i ) For Retail Sale : 
(a) Form 20 for drugs other than those specified in Schedule C, Cl and X. 
(b) Form 21 for drugs specified in Schedule C and C1 and excluding X. 
(c) Form 20F for drugs specified in Schedule X.

ii) For Whole Sale : 
(a) Form 20B for drugs other than those specified in Schedule C, Ciand X.
(b) Form 21B lor drugs specified in Schedule C and Ci and excluding X. 
(c) Form 20G for drugs specified in Schedule X. 

4. Conditions of Licence 

The licence for the sale of drugs are granted based on certain conditions including the following : 
(i) The licence shall be displayed in a prominent place in a part of the premises open to the public. 
(ii) The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 190 and Rules there under for the time being in force. 
(iii) No drug, shall be sold unless such drug is purchased under cash or credit memo from a duly licensed dealer or a duly licenced manufacturer.
(iv) No Physician's Sample (not for sale) or expired drugs will be stocked on the sale premises. 
However. expired drugs may be kept in separate packages or carton, the top of which shall display prominently the words 'Not for Sale'. 
(v) No drug belonging to ESI, CGHS, Armed Forces Medical store or a Government Hospital shall be present in the licensed premises. 
(vi) In case of Pharmacy, the compounding of the prescription would be done under the personal supervision of a Qualified Person. 
(vii) All registers and records required to be maintained under the Act would be preserved for a period of at least 2 years from the date of the last entry therein. 
viii) The licence will be renewed as and when required.
 (ix) Any change in ownership or "Qualified person" shall be notified to the licensing authority within  three months.

 6. Duration of Licence:
A licence for the sale of drugs remains valid upto 31st December of the year following the year  ill which the licence is  granted or renewed.

7, Renewal of Licence : 
 Application for the renewal of the licence may be made before the expiry or within six months of the date of its expiry, along with late fees. The licence shall be deemed to have expired if the application for renewal of licence is not made within six months after its expiry. In the event of do change in constitution of a licensed firm, the licensee shall inform the licensing of change unless in the authority. Licences of such firms are deemed to be valid for a period of three months from the date meantime a fresh licence has been obtained. 

STORAGE OF DRUGS 

Drugs should be stored in a manner that preserves their potency for the desired period of time. with. The manufacturers instruction on the label regarding the storage of the product should be complied 

Storage of Schedule X Drugs and Drugs with Expiry Dates:
Substances specified in Schedule X should be stored under lock and key in cupboard or drawer reserved solely for the storage of these substances; or in a part of the premises separate from the remainder of the premises and for which only responsible persons have_ access. Other drugs with an expiry date should be stored in a separate cupboard. 

Storage of Veterinary Drugs:
Veterinary drugs should be stored in a cupboard or drawer reserved for the storage of veterinary drugs in a portion of the premises separated from the remainder of the premises to which customers are not permitted to have access. 


DISPENSING OF PROPRIETARY PRODUCTS 
Prescriptions, now-a-days are usually written for preformulated proprietary medicines and the pharmacist has only to dispense them in a proper manner. However, all dispensing of Proprietary products is required to be done either by the Registered Pharmacist himself or under his direct supervision. The following procedure may be adopted during dispensing of such products 

1. Receiving the Prescription: 
The prescription should be received by the pharmacist himself, wherever possible or a person trained properly to do so in a professional manner. The patient should be informed about the approximate time required for filling the prescription. 
2. Reading and Checking the Prescription : 
On receiving the prescription, the pharmacist should first read the prescription completely and carefully. He should verify that the name and address of the patient are correct, the prescription is legally valid and is written correctly. He should not express any doubt regarding the contents of the prescription ether to to the patient or to his messenger, in manner which questions the wisdom of the prescribing physician.  
 The pharmacist should not add, omit or substitute any content of the prescription without the consent of the physician.

 3. Dispensing, Packing and Labelling
 The medicine should he selected from the stock and if in unit dosage form such as tablets or capsules, the correct number should be counted and filled into previously selected containers, The labels of all containers of stock drugs should he checked when selected from and replaced in stock, as well as at the time of actual dispensing, making three checks in total. Any subsidiary label required should be properly affixed to the container. The container must be thoroughly polished to remove any finger prints.

 4. Finishing :
 The final product, the prescription and the labels should be rechecked before handing over to the patient. All records must be completed including those required by legislation. The patient or his representative should be explained about the proper mode of administration and storage of the medicine. preferably in their local language. Dispensing of Schedule H and X Drugs Substances specified in Schedule H and X to the Drugs and Cosmetics Act should not be sold by retail except on the prescription of a Registered Medical Practitioner and in case of substances specified in Schedule X, prescriptions should be in duplicate, one copy of which shall be retained b‘ the licensee for a period of 2 years. A prescription for Schedule H and X drugs should be : 
(i) In writing and signed by the prescriber and dated by him.
(ii) Specify the name and address of the patient or the owner of the animal if the drug is meant for veterinary use.
(iii) Indicate the total amount of medicine to be supplied and the dose to be given. 

The prescriptions for Schedule H and X drugs must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once; however it may be dispensed at stated number of times or at stated intervals of time in accordance with the directions of the prescriber. At the time of dispensing there must be noted on the prescription above the signature of prescribe. the name and address of the seller and the date of dispensing. 

MAINTENANCE OF RECORDS OF  RETAIL AND WHOLE SALE DRUG STORES

Records of Purchase of Drugs : 
The records Pertaining to the purchase of all drugs whether intended to he sold by retail or by wholesale should be maintained under the following headings
 (i) Date of purchase. 
(ii) Name and address of the licensee front whom  
(iii) Name and quantity of the dru purchased and his licence numhet, g and its batch number. 
(iv) Name of the manufacturer of the drug. Purchase bills including cash or credit memos should be kept as records.

 Records of Sale of Drugs : 

Sale of Drugs other than those specified in Schedule X:
 Sale of any drug other than those specified in Schedule X is required to be recorded at the time of supply in a prescribed register maintained for the purpose or in a cash or credit memo book. 
The following particulars are required to be entered 
(i) Serial number of the entry. 
(ii) Date of supply. 
(iii) Name and address of the prescriber. 
(iv) Name and address of the patient or the name and address of the owner of the animal f the drug is supplied for the veterinary use. 
(vi) Names along with the quantities of drugs supplied. 
(vii) In case of Schedule H and C drugs, the name of the manufacturer, its batch number and the expiry date, if any. 
(viii) Signature of the registered pharmacist under whose supervision the medicine was made or supplied.

Sale of Drugs specified in Schedule X:
Supply of Schedule X drugs should be recorded at the time of supply in a bound and serial numbered register maintained for this purpose and separate pages should be allotted for each drugs. 
The following particulars should he entered in the said register 
(1) Date of Purchase. supplier
(ii) Quantity received, if any, the name and address of supplier and the licence number of the .
(iii) Name and quantity of the drug supplied. 
(iv) Manufacturer's name, batch or lot number. 
(v) Name and address of the patient/purchaser. 
(vi) Reference number of the prescription against which supplies were made. 
(vii) Bill number and date of receipt of purchase and supply made by him. 
(viii) Signature of the person under whose supervision the drugs have been supplied. 

ROLE OF PHARMACIST IN HEALTH CARE AND PATIENT EDUCATION
Patient Education, as it relates to pharmacy practice, may he defined as an intervention designed to improve the patient's knowledge about drugs, his compliance with the dosage regimen and outcome of the therapy. In addition to improving knowledge, patient education must motivate patients to recognize the importance of the prescribed therapy. Patient education may be verbal, written or audio-visual. Verbal education may be provided to individual patients or to small groups of patients. Written information can include special labels for different dosage forms, patient package inserts, special information leaflets designed by individual pharmacists or organizations and booklets. Audio-visual programmes may include slides or video programs. A combination of verbal and written counselling or a combination of verbal counselling with audiovisual aids is generally better than the use of traditional written matter only. 

PATIENT COUNSELLING 
Patient Counselling may be defined as a one-on-one, interactive session between a pharmacist and the patient, designed to modify the patient's knowledge and behaviour. Patient Counselling typically provides extensive individualised information in order to overcome barriers to appropriate therapy. Patient Counselling is most effective when the patient actively participates in the session. After receipt of a new prescription and following a review.of the patient's record, a pharmacist should initiate the discussion with the patient or care-giver of a patient. 
When conducting the session, the pharmacist must always be aware of the patient's verbal and nonverbal message and barriers to effective communication. The discussion may include the following elements 
(i) The name and description of the drug. 
ii) The dosage form, dose, route of administration, dosing schedule and duration of drug therapy. 
(iii) Intended use of the drug and expected action. 
(iv) Special directions and precautions for preparation, administration, and use by the patient.
 v) Common severe side or adverse effects or interactions and therapeutic contraindications 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 drugs. 
(viii ) Prescription refill information. 
( ix ) Action to be taken in the event of a missed dose. Pharmacist comments relevant to the individual's drug therapy, including any other information specific to the patient or drug. 

Alternative forms of video programs, etc. patient information such as written information, pictogram labels, may also he used, when deemed necessary in the the pharmacist to supplement the patient counselling, sessions. 


ROLE OF THE PHARMACIST IN COMMUNITY HEALTH CARE 
The role of Pharmacist is to act in an important and responsible manner for the propagation of national health programmes. Many of our health programmes need intervention 01 all heaithcare professionals from all areas for its successful implementation. The pharmacist has a number of roles to play as outlined below :

 1. As a Quality Drug Supplier : 
(i) The pharmacist must ensure that the products he/she purchases are from reputable sources and of good quality. 
(ii) The pharmacist must ensure the proper storage of these products. 
(iii) The pharmacist should dispense the medication •in a professional manner. 

2. As a Communicator:
(i) The pharmacist should initiate dialogue with the patient (and the patient's physician, when necessary) to obtain a sufficiently detailed medication history. 
(ii) In order to address the condition of the patient appropriately the pharmacist must ask the patient key questions and pass on relevant information to him or her. 
(iii) The pharmacist must provide objective information about medicines to the patient. 
(iv) The pharmacist must be able to use and interpret additional sources of information to satisfy the needs of the patient. 
(v) The pharmacist should be able to help the patient undertake appropriate and responsible self-medication or.. when necessary, refer the patient for medical advice. 
(vi) The pharmacist must ensure confidentiality concerning details of the patient's condition..

3. As a Trainer and Supervisor 
(i) To ensure up-to-date quality service, the pharmacist must participate in continuing professional development activities such as continuing education. 
(ii) The pharmacist must ensure that the services rendered by his subordinate staff correspond to established standards of practice. 
(iii) The pharmacist must also promote the training and supervise the work of non-pharmacist staff.





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