VOLUME 5 SECTION 8 POLICIES AND PROCEDURES OF THE PHARMACY COUNCIL OF JAMAICA

Transcription

1 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 1 VOLUME 5 SECTION 8 POLICIES AND PROCEDURES OF THE PHARMACY COUNCIL OF JAMAICA For the Regstraton of Pharmaceutcal Students, Pharmacsts, Pharmacy Owners and Shops/Pharmaces The Responsblty of The Pharmacy Councl of Jamaca 3rd Floor ICWI Buldng 2 St. Luca Avenue Kngston 5

2 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 2 TABLE OF CONTENT CHAPTER PHARMACEUTICAL COUNCIL OF JAMAICA CHAPTER APPLICATION PROCEDURES FOR SETTING UP SHOPS AS PHARMACIES CHAPTER CHANGE OF OWNERSHIP OF PHARMACY / RELOCATION OF A PHARMACY CHAPTER ESTABLISHMENT AND MAINTENANCE OF SHOPS AS PHARMACIES CHAPTER CODES OF CONDUCT CHAPTER CONTINUING EDUCATION AND CLASSIFICATION OF DRUGS APPENDICES

3 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 1 CHAPTER 1 PHARMACEUTICAL COUNCIL OF JAMAICA 1.0 BACKGROUND The Pharmacy Councl of Jamaca was establshed n August 1975 as an agency of the Mnstry of Health, wth responsblty for the regulaton of pharmacsts, pharmaceutcal students, pharmacy owners and authorzed sellers of posons n accordance wth The Pharmacy Act and Regulatons (1975). The Councl mantans the Regsters for all these persons and sets standards for pharmacsts educaton, scopes of practce and conduct. The councl conssts of ten members, sx of whom are nomnated by the Pharmaceutcal Socety of Jamaca and the remanng four by the Mnster of Health.The Mnster apponts all 10 persons for a perod of three years. The Regstrar s the secretary employed to the Councl.The Councl meets on the last Thursday of each month except the months of August and December. The Councl has an nspectorate whch montors pharmaces to ensure complance wth the Pharmacy Act and Regulatons. 1.1 MISSION OF THE PHARMACY COUNCIL The msson of the Pharmacy Councl s to maxmze pharmacy s contrbuton to the protecton of the health and welfare of the Jamacan people. In accordance wth the authorty unted n the Councl under the Pharmacy Act and Regulatons, the councl ams to ensure the mantenance of the hghest standards of conduct and practce. The Councl s dedcated to the advancement of Pharmacy and promotes the pursut of excellence n lfe-long learnng and research. Guded by a sprt of commtment to ntegrty, honesty and cooperaton, the Councl wll acheve ts goals. 1.2 REGISTRATION The Pharmacy Councl of Jamaca regsters pharmaceutcal students, pharmacsts, 1

4 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 2 pharmacy owners and authorzed sellers of Posons Authorzed Sellers of Posons The followng are the requrements for applcants to become authorsed sellers of posons: Pharmaceutcal Students Must be 21 years and older Submt two testmonals Submt two copes of a recent photograph of the applcant certfed by a Justce of the Peace Apply to the Councl usng form set out as Form F (See Appendx 1) The followng are the requrements for applcants who wsh to become pharmaceutcal students: Pharmacy Owners/Shop Be 16 years and over Be accepted n an approved college of Pharmacy Apply to the Councl usng Form A (See Appendx 2) The followng are the requrements for persons wshng to establsh a pharmacy: Pharmacsts Be 21 years and over Satsfy the Councl that the proposed shop meets the requrements to operate as a pharmacy (Retal, Professonal, Manufacturng, Dstrbutng) Apply to the Councl on Form D (Appendx 3) Pay the requste ownershp fee of $15, (one fee) Fees for shops vary accordng to type The followng are the requrements for new pharmacsts to be requested: New Pharmacsts Be 21 years and over 2

5 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 3 Have successfully completed a course of Study n Pharmacy and passed the fnal examnaton to obtan a Bachelor s degree Have undergone vocatonal tranng Apply to the Councl on Form B (See Appendx 4) Pay the requste fee of $ RENEWAL OF REGISTRATION OF PHARMACISTS The requrement for the annual renewal of regstraton came nto effect n Aprl All regstraton therefore expres each year on the 31st of March. Regstraton s renewed f the requste twelve Contnung Educaton (CE) credts have been obtaned and the pharmacst: Renstatement Apples to the Councl n form set out as Form C1 (See Appendx) Pay the requste fee of $ For pharmacsts who do not reman on the regster; renstatement requrements are as follows: Number of years off the regster Requrements 1 Satsfy the CE requrements for that year Pay the annual regstraton fee Pay late regstraton fee 2-5 Satsfy CE requrements for that year Pay renstatement fee that s 75% of annual regstraton fee Pay regular annual regstraton fee Undergo assessment on a case by case by case bass > 5 Assessment done on a case by case bass St and pass competency exam Pay renstatement fee that s 75% of annual regstraton fee Pay regular annual regstraton fee 3

6 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page REGISTRATION OF FOREIGN PHARMACISTS Foregn traned pharmacsts are requred to provde the followng for regstraton as a pharmacst n Jamaca:- v v v v CERTIFIED COPY OF BIRTH CERTIFICATE THREE (3) LETTERS OF RECOMMENDATION CERTIFIED COPY OF CURRENT STATE LICENCE(S)(If applcable) CERTIFIED COPY OF PHARMACY DEGREE CURRICULUM VITAE EXAMINATION FEE OF US$ OR EQUIVALENT IN JAMAICAN DOLLARS - Payable one (1) month before the date of the exam (non-refundable and subject to change wthout notce) TRANSCRIPT (To be sent drectly from the Unversty to the Pharmacy Councl of Jamaca) Documents are checked wth ssung nsttutons and embasses before the Councl responds. If the applcaton s approved, the canddate s requred to st and pass a Foregn Pharmacsts Examnaton (FPQE).Canddates may have three (3) opportuntes at sttng the examnaton. 1.5 EXAMINATION INFORMATION/INSTRUCTIONS The followng nformaton on Examnatons / Instructons s: The examnaton s dvded nto four(4) broad subject areas: Comprehensve multple choce/objectve type examnaton whch tests pharmaceutcal knowledge base and ablty to dspense drug products safely and legally Forensc Pharmacy Examnaton whch tests knowledge of the Jamacan Laws and Regulatons. Prescrptons fllng secton where several prescrptons are gven and the canddate should apply all the rules n the proper fllng of same. 4

7 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 5 v Oral Examnaton The canddate s presented wth practcal, job-related questons to assess hs/her understandng and applcaton of mportant knowledge, sklls and abltes used n the profcent practce of pharmacy (maxmum 30 mns) The followng addtonal nformaton should be noted: v v All sectons of the wrtten examnaton wll be completed on the same day. There s a scheduled break for lunch. All nstructons should be carefully followed and answers clearly stated on the answer sheets. Answer sheet/booklets should be returned to the examnaton nvglator promptly at the end of each secton. The canddate wll be notfed of the examnaton results wthn eght (8) weeks of the date of the examnaton. N/B Falure of the examnaton wll necesstate a re-examnaton at a future date v The examnaton s admnstered twce each year at the scheduled tmes: Last Frday n January Last Frday n July v Canddates should apply to the Councl n wrtng at least one (1) month before the date of the exam Orentaton Perod It s recommended that canddates be n the country at least sx (6) months before the exam and be assgned to a communty pharmacy for a specfed perod of orentaton under the supervson of a Regstered Pharmacst.The exposure over the perod s ntended to enable the canddate to become competent n counsellng patents and communcatng wth members of the 5

8 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 6 health team. Language barrers and cultural norms would also be addressed. 1.6 SPECIAL EXAMINATION INSTRUCTIONS Multple Choce Questons The test s dvded nto fve(5) parts and covers the followng subject areas:- Pharmaceutcal Calculatons Medcnal Chemstry Pharmacology General Pharmacy Pharmacy Practce For multple choce questons, crcle the approprate answer n the queston booklet. For matchng questons, wrte the matchng letters besde the approprate statement Forensc v Answer the prescrbed number of questons. Unless specfcally requested, answer should nclude more than a lstng of tems, that s; concepts should be clearly explaned or dscussed wherever possble. Begn each answer on a separate page and leave space for assgnng grades or for comments. The forensc component comprses questons on: The Pharmacy Act & Regulatons The Dangerous Drug Act & Regulatons The Food & Drug Act & Regulatons The Precursor Act Varous amendments to the Pharmacy Act and Regulatons 6

9 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page Prescrpton Fllng For the examnaton on prescrpton fllng the canddate should: Dspense prescrptons genercally unless otherwse nstructed. Carry out all the prescrbed rules for fllng prescrptons n the test. Prepare labels for all tems dspensed. The use of reference texts s allowed for ths secton of the test Oral Examnaton For the oral examnaton the followng should be noted: Practcal scenaros are rased to test how the canddate s ablty to handle smlar stuatons n the practce settng. Tests the canddates ablty to manage unque stuatons, such as requests for prescrpton drugs wthout prescrptons and other breaches of the act. Tests the canddate s ablty to advse clents on the proper use of medcal devces and correct admnstraton of varous dosage forms such as eye, ear and nose drops, Metered Dose Inhalers etc. 7

10 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 8 CHAPTER 2 APPLICATION PROCEDURES FOR SETTING UP SHOPS AS PHARMACIES 2.0 REGISTRATION OF SHOPS AS PHARMACIES One of the requrements under the Pharmacy Act 1966, for the regstraton of a shop as a pharmacy, s that the Councl must be satsfed that the shop, n whch the busness of a pharmacy s proposed to be carred out, s sutable for the purpose. 2.1 REGISTRATION PROCEDURES All persons wshng to establsh shops as pharmaces are requred to submt the necessary proposals n detal to the Pharmacy Councl for acceptance before embarkng on any expendture to prepare the premses for the purpose of a pharmacy. The Pharmacy Councl s not oblged to approve every applcaton t receves for the regstraton of a pharmacy. The applcaton, however, must satsfy the requrements as prescrbed n the Regulatons / Gudelnes before The councl gves partcular attenton to the name of the proposed pharmacy whch should be approprate and n accordance wth the standards related to the practce of the professon e.g. a busness name should not gve the mpresson or mply that a pharmacy can offer specal feature, commercal or professonal, over and above the servces offered by another pharmacy. 2.2 ACCEPTANCE OF PROPOSALS When a proposal s accepted by the Councl, a letter s sent to the proposed owner that the shop should be prepared for the purposes of a pharmacy n accordance wth the provsons of the Pharmacy Act 1966, ts Regulatons, and the gudelnes. As soon as the premsed are prepared, the proposed owner should nform the Councl n wrtng nvtng an nspecton of the premses.the Councl s Inspectors wll nspect the prepared premses, and f they are found to be satsfactory, the applcant can then apply to the Councl for Regstraton under the Pharmacy Act. If the applcaton s approved n accordance wth Secton 13 () of the Pharmacy Act, the Regstrar wll then ssue a certfcate of regstraton. The owner must apply to the Councl on the prescrbed form (See Appendx 3 for Form D) for 8

11 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 9 regstraton of the shop as a pharmacy and for the Regstraton of the owner of the busness. 2.3 REVIEW OF PHARMACY PROPOSALS BY COUNCIL The revews of applcaton proposals for pharmaces by the councl takes place n January,Aprl, July, and October each year on the fourth (4th) Thursday of each of these months. The fnal date for receval of proposals s 2 weeks before each of these proposal meetng. 2.4 PROCEDURE FOR OPENING A SHOP AS A PHARMACY (RETAIL/PROFESSIONAL) The followng are the requrements and procedures to open a shop as a pharmacy: Apply n wrtng to the Pharmacy Councl ndcatng and submttng the followng:- v v v v v Name of Pharmacy Locaton and type of Pharmacy (Professonal /Retal) Name and Address of Regstered Pharmacst Openng hours Name(s) of pharmacst(s) who wll cover openng hours Name, address and occupaton of each owner/partner/shareholder (NB: Professonal Pharmacy can only be owned by a pharmacst(s) and spouse) If the shop s stuated n a resdental area an approval from the KSAC, the Parsh, the Natonal Envronment and Plannng Agency or the Town and Country Plannng Authorty wll be needed Lst of tems to be stored for sale Provde: Brth Certfcate and Photograph of each owner/partner/shareholder Artcles of Incorporaton f applcable Polce report for all shareholders. v Letter of commtment from a Regstered Pharmacst sgned n the presence of a Justce of the Peace (J.P.), ndcatng wllngness to be the Regstered Pharmacst for not less than one (1) year (Ths pharmacst should not be currently that s n the process of regsterng a pharmacy; f however that s the case but he/she ntends to resgn from that pharmacy, a letter of ntent to resgn 9

12 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 10 should be submtted along wth the commtment letter.) Physcal Features of the Pharmaces A physcal floor plan and layout of proposed pharmacy should be submtted. (It s advsed that professonal assstance be sought n the layout of the pharmacy) ndcatng:- v v v v v x x x x Measurement of entre shop whch should not be less than [640sq. ft. (60m2): RETAIL/ 400sq. ft: PROFESSIONAL] Measurement of the dspensary area. Ths should not be less than 130sq. ft. (12m2) Confdental area (to accommodate 2 chars and a small desk/table) for counsellng. In specal crcumstances wthn a retal pharmacy; a prvate alcove or wndow s acceptable. (The Confdental Corner should not be consdered as an entrance to the dspensng area and should be contguous wth the dspensng area.) Watng area wth chars Dsplay area n dspensary for Lst 2 products Snk (potable water) Narcotc Control Substances Cupboard wth lock (f requred) Refrgerator Work area ncludng compoundng area (counter top) adjonng the snk wth potable water. Two dstnct entrances are requred for the pharmacy area. Adequate storage area Antbotc cupboard The layout should be such that the establshment s separated from and not be part of another busness. Proper parttons should be n place wth an ndependent 10

13 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 11 entrance f the establshment s assocated wth a supermarket or other busness. NB:No tolet faclty should be n the dspensng area. 2.5 PROCEDURE FOR OPENING A SHOP AS A PHARMACY (WHOLESALE) The followng are the requrements to open a wholesale pharmacy: Apply n wrtng to the Pharmacy Councl ndcatng and submttng the followng: v v v v Name of Pharmacy Locaton and type of Pharmacy (Dstrbutng pharmaces must be n a commercal area) Name and Address of Regstered Pharmacst Openng hours Name(s) of pharmacst(s) who wll cover openng hours Name, address and occupaton of each owner/partner/shareholder Lst of tems to be stored for sale Provde the followng: Brth Certfcate and Photograph of each owner/partner/shareholder v Artcles of Incorporaton f applcable Polce report requred for all shareholders. Letter of commtment from a Regstered Pharmacst sgned n the presence of a Justce of the Peace (J.P)., ndcatng wllngness to be the Regstered Pharmacst for not less than one (1) year (Ths pharmacst should not be currently that s n the process of regsterng a pharmacy; f however that s the case but he/she ntends to resgn from that pharmacy, a letter of ntent to resgn should be submtted along wth the commtment letter.) 11

14 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page Physcal Features of the Wholesale Pharmacy The followng must be submtted along wth the applcaton for regstraton: Floor Plan ndcatng Customer Servce Receval and Delvery Storage areas (nternal and external products should be stored n separate rooms) Cold Room and/or Refrgerator (for Bologcals/Injectables) Customer Servce/Offces Specal storage areas for certan for certan tems (e.g. Controlled substances, pestcdes, Insectcdes, antcorrosves etc.) Bathroom (Should not be n the warehouse area) Suffcent space for the purpose of further expanson of the plant Incnerator or access to an ncnerator for the proper dsposal of waste Post Approval of Plan Requrements After the approval of the Proposals are obtaned, the faclty should be prepared n accordance wth the approved plan ensurng that the followng are n place before nspecton: Lghts must be flush wth the celng materal must be easly cleanable Cupboards must lamnated Benches and tables must be made of materal that can be easly cleaned and scrubbed Pallets and shelves for the storage of goods All shelves (sdes, under, top, bottom) must be lamnated for easy cleanng Stanless Steel Snks 12

15 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 13 Corners should be curved/coved to facltate cleanng Floor, walls and celng of smooth, hard surfaces that are easly cleanable, preferable rendered concrete (Epoxy Surface) no dry wall Temperature and humdty Controls All outsde openngs protected aganst entrance of nsects, dust and arborne contamnaton GENERAL MANUFACTURING PRACTICE (G.M.P) INSPECTION MUST BE DONE BY THE PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, AND APPROVED AFTER THE PLAN HAS BEEN APPROVED BY THE PHARMACY COUNCIL AND BEFORE INSPECTION FOR REGISTRATION 2.6 PROCEDURE FOR OPENING A SHOP AS A PHARMACY (MANUFACTURING) The followng are the procedures for openng a shop as a pharmacy (manufacturng): Apply n wrtng to the Pharmacy Councl ndcatng and submttng the followng: v v v v v Name of Pharmacy Locaton and type of Pharmacy (Manufacturng) Name and Address of Regstered Pharmacst(s) Openng hours Name(s) of pharmacst(s) who wll cover openng hours Name, address and occupaton of each owner/partner/shareholder If stuated n a resdental area an approval from the Town Plannng Department of NEPA wll be needed Lst of tems to be stored for sale Provde the followng: Brth Certfcate and Photograph of each owner/partner/shareholder Artcles of Incorporaton f applcable 13

16 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 14 v Polce report requred for all shareholders. Letter of commtment from a Regstered Pharmacst sgned n the presence of a Justce of the Peace (J.P).,ndcatng wllngness to be Regstered Pharmacst for not less than one (1) year. (Ths pharmacst should not be currently that s n the process of regsterng a pharmacy; f however that s the case but he/she ntends to resgn from that pharmacy, a letter of ntent to resgn should be submtted along wth the commtment letter.) Physcal Features The Applcaton Proposal should nclude: Floor plan outlnng: Specfc areas for the manufacturng of dfferent products that allow for proper separaton across product lnes Storage areas (nternal and external product ngredents should be stored n separate rooms) Cold Room and/or Refrgerator (for Bologcals/Injectables) Packagng areas Receval/Delvery area Customer Servce/Offces (separate from general Manufacturng area) Suffcent space for the purpose of further expanson of the plant Specal storage areas for certan tems e.g. Controlled substances Bathrooms (whch should not be n the manufacturng area) Snk 14

17 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page Techncal Features The applcaton should also nclude the followng: An outlne of systems ndcatng: Temperature and humdty controls (Ar Condton) Ar supply whch can be fltered through hgh-effcency partculate ar flters under postve pressure regardless of whether flow s lamnar or non-lamnar Montorng of envronmental condtons Proper Ar Handlng Methods Provson for proper storage of waste Cleanng and dsnfectng of rooms and equpment to produce aseptc condtons Waste dsposal Approprate methods for proper waste dsposal ncludng an ncnerator or access to an ncnerator Approval of Plan Requrements After the approval of Proposals has been obtaned the faclty should be prepared n accordance wth the approved plan ensurng that the followng are n place before nspecton: Lghts must be flush wth the celng materal must be easly cleanable Cupboards must be lamnated Benches and tables must be made of materal that can be easly cleaned and scrubbed Pallets and shelves for the storage of goods 15

18 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 16 All shelves (sdes, under, top, bottom) must be lamnated for easy cleanng Stanless Steel Snks Corners should be curved/coved to facltate cleanng All outsde openngs are protected aganst entrance of nsects, dust and arborne contamnaton Floor, walls and celng of smooth, hard surfaces that are easly cleanable, preferable rendered concrete (Epoxy Surface) dry walls are not allowed. GENERAL MANUFACTURING PRACTICE (G.M.P) INSPECTION MUST BE DONE BY THE PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH AND APPROVED, AFTER THE PLAN HAS BEEN APPROVED BY THE PHARMACY COUNCIL AND BEFORE INSPECTION FOR REGISTRATION 16

19 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 17 CHAPTER 3 CHANGE OF OWNERSHIP OF A PHARMACY/ RELOCATION OF A PHARMACY 3.0 The Pharmacy Councl mantans regsters for pharmaces and owners of pharmaces.the operaton, relocaton or acquston of a pharmacy therefore shall be wth the Councl s pror approval.the provsons of paragraph (c) of subsecton (5) of Secton 13 of the Pharmacy Act states that, the regstraton of every shop as a pharmacy shall become vod on the expraton of one month from the date of any change n the ownershp of the busness carred on n such pharmacy. The Councl s not oblged to approve every applcaton t receves for the regstraton of a pharmacy and other ndvdual (s) as owners(s) of the sad pharmacy therefore t s of paramount mportance that the acton as stated below take place pror to any transactons. 3.1 SELLING A PHARMACY Every owner of a pharmacy who proposes to sell hs busness shall: nform the Councl of ths ntenton at least THREE MONTHS before the sale s concluded nform the Councl as to the name, address and occupaton of the proposed purchaser of the busness. 3.2 BUYING OR RELOCATING A PHARMACY Every person who proposes to acqure an exstng pharmacy shall fle wth the Regstrar of the Councl, at least THIRTY (30) DAYS before he/she acqures or relocates the pharmacy, a sgned statement settng out: v v v The full name and address of the proposed owner of the pharmacy The name by whch the pharmacy wll be known to the publc The locaton of the pharmacy The proposed date of acqurng or relocatng the pharmacy and the the proposed date for commencng the operaton of the pharmacy The name and address of the proposed manager of the pharmacy The name and address of the regstered pharmacst who wll be n control of the drugs n the pharmacy 17

20 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page CHANGE OF OWNERSHIP The Councl must be advsed of any changes to the regstered ownershp of the busness (sole-trader to partnershp). 3.4 RELOCATION OF PHARMACY Any relocaton of an exstng establshment s requred to have the new proposal and the floor plan approved by the Councl BEFORE the move s made. The Councl s NOT oblged to approve any applcaton for the transfer of regstraton, ownershp or locaton of the busness 18

21 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 19 CHAPTER 4 GUIDELINES FOR THE ESTABLISHMENT AND MAINTENANCE OF SHOPS AS PHARMACIES 4.0 REGISTRATION OF A SHOP AS A PHARMACY The Pharmacy Act 1966 requres for the regstraton of a shop as a pharmacy that the Councl must be satsfed that the shop n whch the busness of a pharmacy s proposed to be carred on s sutable for the purpose. Upon the acceptance of the proposal for a shop to be set up as a pharmacy, the shop should be prepared for the purposes of a pharmacy n accordance wth the provsons of the Pharmacy Act 1966 and ts Regulatons.The followng gudelnes are set out below. 4.1 SETTING UP In order to satsfy the Councl that the requred preparatons have been made for the shop to be set up as a pharmacy; every such shop shall be so constructed that: It contans an enclosed dspensng area whch can be locked n a defned area havng a floor area adequate for the effcent operaton of the pharmacy but not less than 130 square feet; (12 square meters) It s free from any condton that may: Be dangerous to health, Injurously affect the drugs prepared, compounded dspensed or stored theren, Floors and floor coverngs (double glazed tle) that s of materal that may be easly cleaned n rooms where: Drugs are prepared, compounded, dspensed or stored Equpment s washed Washng fxtures and tolet fxtures are located, v The walls and celng of rooms and passage-way may be readly cleaned and pantng or decoratng mantaned n good condton. 19

22 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 20 v v All rooms and passage-ways are well lghted and ventlated. Sutable areas are provded for the storage and controlled sale of drugs by the pharmacst or under hs/her supervson. 4.2 OTHER REQUIREMENTS The shop shall also be provded wth: v v A supply of potable water for the suffcent operaton of the pharmacy, A hot plate or other heatng devce to provde heat process and hot water when necessary, facltes for washng utensls used n the preparaton or storage of drugs, and also hand washng facltes, preferable separate, located n a convenent area n the shop, A system for flng prescrptons A prescrpton counter (lamnated) adequate for the effcent operaton of the pharmacst wth not less than 12 sq ft (1 square metre) of free workng space v A refrgerator for the storage of drugs requrng refrgeraton, * v v x x x Suffcent contaners for storng refuse n a santary manner, Lamnated dspensng counter or cubcle for handng n/handng out prescrptons Lamnated shelves n the pharmacy, Antbotc cupboard wth lock, (f applcable) Cupboard for narcotcs and controlled substances wth lock, (f applcable) 20

23 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 21 x The compoundng and dspensng equpment and materals set out below: One prescrpton balance * One set metrc weghts Graduated measure glasses, (mls/varous szes) (at least three) * Mortars & Pestle (varous szes) (at least one set)* Spatulas (stanless steel) small, medum, and large Funnels (glass or plastc) Ontment Tle (glass or plastc not less than 0.5 cm square)* Strrng Rods (glass or plastc) Tablets Counters Bottles and Caps Tablets Vals (glass or plastc) Labels Flter Papers Ontment Jars Dstlled or de-onzed water Dropper Bottles 4.3 LIBRARY FOR THE PHARMACY The shop / pharmacy s requred to have a lbrary whch must nclude:- Current Edton Martndale * Pharmacy Act and Regulatons * Food and Drug Act and Regulatons * v Dangerous Drug and Regulatons* v The Precursor Chemcal Act v Code of Ethcs 4.4 MAINTENANCE All drugs stored n a pharmacy shall be stored on, or n shelves, drawers, cupboards of fxtures provded for that purpose Pharmacy Equpment and condton Every pharmacy shall mantan:- Furnture, equpment and applance used n the nteror of the pharmacy so that thorough cleanng of all areas s possble 21

24 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 22 (lamnated shelves). In a clean and santary condton, all furnture, equpment and applances, and, All rooms n the pharmacy used for the storage, compoundng or dspensng of drugs or not The pantng and decoratng of the nteror and exteror of the pharmacy n good condton. 4.5 STORAGE Every room where drugs are prepared, compounded, dspensed or stored n a pharmacy shall be kept free from materals and equpment not regularly used n the room Refrgerators Refrgerators for the storage of drugs n a pharmacy shall: Be mantaned at a temperature between 1.3 Celsus, 4.5 Celsus or 34 Fah and 40 Fah, Be kept clean and n santary condton, and, Be located n an area not accessble to Publc 4.6 DISPOSAL OF WASTE All refuse and waste materals n a pharmacy:- Shall be removed from the premses at least twce weekly and more often f necessary to mantan a santary condton and, Flled contaners of waste shall be removed from any room n whch drugs are prepared, compounded, dspensed or stored. 4.7 PHYSICAL REQUIREMENTS The followng are the physcal requrements of a pharmacy: It must be establshed n a COMMERCIAL area The measurement of the total area of a pharmacy must not be less than 650 square feet 22

25 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 23 A confdental Area * v A watng Area wth chars v A generc sgn to be dsplayed as requred by Law * When all of the above requrements have been put n place, the owner may then apply to the councl on the prescrbed form for regstraton of the shop as a pharmacy. (A sample form s at Appendx 3) THE ABOVE STATED ITEMS MUST BE IN PLACE PRIOR TO ALL INSPECTIONS WHETHER FOR NEW OR ESTABLISHED PHARMACIES FOR REGISTRATION PURPOSES 4.8 REDESIGN & REFURBISHING OF A PHARMACY Every owner of a pharmaceutcal establshment who wshes to redesgn or refurbsh such establshment must submt to the Councl, a floor plan and layout showng the proposed changes to be made. The new desgn must be approved by the Councl before mplementaton. Ths wll be treated as a new proposal whch wll attract the necessary fees. 23

26 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 24 CHAPTER 5 CODES OF CONDUCT 5.0 PHARMACY PROFESSION The practce of the Pharmacy Professon operates wthn the ambt of the prescrbed Regulatons. The Councl montors and enforces complance wth these Regulatons n order to safeguard the publc s nterest and to mantan the ntegrty of the professon. For further nformaton please relevant repetton under the Pharmacy Act. 5.1 REGISTERED PHARMACISTS The Regstered Pharmacst s expected to: v v v Conform to the requred standards of practce Control all actvtes relatng to the delvery of the pharmaceutcal servce. Observe the standard dress code whle on the job. Observe all the provsons of the Pharmacy Act. Comply wth the Code of Ethcs. Must dsplay hs/her certfcate of regstraton whle on duty at a conspcuous place 5.2 DISPENSING OF PRESCRIPTIONS Pharmacsts are requred to observe the requrements of the Pharmacy Act Regulatons as they relate to the dspensng of prescrptons, such as: Ascertanng the bona fde of the prescrber. Sgnng and datng of prescrptons. Approprate documentaton on prescrptons, etc. v Retenton of the prescrptons for the prescrbed perod of two (2) years. 24

27 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page LETTER OF COMMITMENT Pharmacsts who have gven a letter of commtment have the followng responsbltes: To ensure that the pharmacy s lad out n accordance wth the approved floor plan. To ndcate to the Councl any devaton wth the approved plan promptly, and wthdraw the commtment f the owner perssts. To ensure that the non-pharmaceutcal tems also sold n pharmaces are compatble wth the pharmaceutcal tems. In partcular, the followng tems are prohbted from beng sold n the pharmacy: Meats, Fruts, Vegetables Cheeses Alcoholc beverages Tobacco Grocery tems Yogurt Ground provsons Falure to comply may result n dscplnary acton beng taken by the Councl 5.4 OWNERS OF PHARMACIES The Pharmacy Owner s requred to: Ensure that the dspensary s locked and that no Lsts #4 or Lst #2 drugs are dspensed or sold n the absence of the pharmacst Comply wth the professonal decsons of the pharmacst as t relates to: Dspensng of prescrptons Recommendng of Lsts # 1 and #2 drugs and approprate patent counsellng Ensure that pharmacsts who are wthn ther employment are regstered 25

28 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 26 wth the Pharmacy Councl of Jamaca Ensure that good conduct and decorum are observed by all members of staff n ther employment Cooperate wth the pharmacst to ensure that all relevant reference materals and equpment are n place Cooperate wth the pharmacst to ensure that all other stpulated requrements are met Ensure that Lsts # 4 and #2 drugs are stored n the dspensary and sold under the supervson of a regstered pharmacst Ensure that the dspensng area s properly supervsed n accordance wth the Pharmacy Act and Regulatons Ensure that the pharmacy s operated as a separate and ndependent entty from any other commercal actvty Comply wth all other relevant requrements of the Pharmacy Act. Falure to comply wth the above consttutes a breach by the owner that s punshable by prosecuton and the loss of the lcence to operate a pharmacy. 5.5 PHARMACY INTERNS,PHARMACEUTICAL STUDENTS AND PHARMACY TECHNICIANS Pharmacy Interns, Pharmaceutcal Students and Pharmacy Techncans must operate under the control of a regstered pharmacst 26

29 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 27 CHAPTER 6 CONTINUING EDUCATION AND CLASSIFICATION OF DRUGS 6.0 SUB-COMMITTEES There are four sub-commttees of the Pharmacy Councl of Jamaca.These are: v Educaton Commttee Fnance Commttee Lst Commttee Standards 6.1 CONTINUING EDUCATION The Educaton Commttee sts on the second Tuesday n each month. responsblty for: Its has Contnung Educaton Accredtaton Montorng of Internshp programme Contnung Educaton (CE) Accredtaton Provders of Contnung Educaton are requred to: Apply to the Councl on the requste form one month n pror to the Contnung Educaton (CE) (see Appendx) Pay the requste fee(s) as follows: One hour presentaton - $ Weekday/Weekend 1 day presentaton - $ Weekend presentaton - $ One Week presentatons - $20, CLASSIFICATION OF DRUGS The classfcaton of drugs n Jamaca falls nto four categores.these are: Lst 1 Can be sold n any shop Lst 2 Sold n pharmaces only (Ths requres the nterventon of 27

30 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 28 v the pharmacst) Lst 3 Posons Lst 4 Prescrpton only medcnes The Lst Commttee meets the forth Monday of every other month and s responsble for the classfcaton of Lst 1 and 2 products as well as the reclassfcaton of Lst 4 drugs. 6.3 PROCEDURES FOR CLASSIFICATION OF DRUGS The regstraton of drugs s done by the Pharmaceutcal Regulatory Dvson of the Mnstry of Health n accordance wth The Food & Drug Act and Regulaton (1975) The Dvson havng regstered the drugs would then submt to the Councl the products, whch they consder should not be gven Lst 3 or 4 status for them to be classfed as Lst 1 or RE-CLASSIFICATION OF DRUGS Companes requrng re-classfcaton of products from Lst 4 to Lst 1 or 2 should drect the regstered pharmacsts wthn ther employ to apply n wrtng to the Lst Commttee, Pharmacy Councl ndcatng so and submttng the followng: Evdence for re-classfcaton such as Post-Marketng Survellance results or any other studes deemed to be relevant to the applcaton. Labelng changes n accordance wth secton 21 subsecton (1) whch states: Any person who dspenses, compounds, retals or supples any drug other than n accordance wth the prescrpton of a regstered medcal practtoner, regstered dentst or regstered veternary surgeon or veternary practtoner shall delver such drug n a contaner labeled wth- The name of the drug Adequate drecton for use words of cauton respectng the drug, f necessary Itnerary for tranng of pharmacsts (pendng approval) 28

31 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page APPROVAL Applcatons whch are approved by the Councl for re-classfcaton wll be sent to the Mnster for endorsement. The Mnster s not oblged to endorse every approved applcaton from the Councl. On endorsement of the product, the Councl wll respond n wrtng to the Company s pharmacst and approval gven for marketng the product n ts new status. NB. Marketng of products, by any means, as Lst 1 or 2 should not be done pror to recevng the wrtten statement from the Councl that such can be done.all new classfcatons of pharmaceutcal products must be gazetted, by law, before they can be put on the market for sale to publc. 29

32 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page 30 CONTACT INFORMATION For further nformaton please contact: The Pharmacy Councl of Jamaca 3rd Floor ICWI Buldng 2 St. Luca Avenue Kngston 5 Tel: (876) / Fax: (876) Emal pharmacycouncl@cwjamaca.com 30

33 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page Appendx 1

34 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page Appendx 2

35 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page Appendx 3

36 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page Appendx 4

37 Pharmacy Councl of Jamaca.qxp 22/02/ :31 PM Page Appendx