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  2. Outline  Introduction  Issues in community pharmacy practice  Organization of a community pharmacy  Services of the community pharmacy  Other professional service 2
  3. 1. Introduction  A community pharmacy is a premise registered and licensed by an appropriate government agency for the provision of pharmaceutical services to the general public.  Community pharmacist is the professional who would be in direct access to the public and whose duties are widely sought after by the public and patients. 3
  4. Introduction  Community pharmacies are very frequently the first contact with the health system • Local • Ease of access • Convenient • Extended opening hours • Availability of medicines 4
  5. Introduction  Considerable proportions of pharmacists work in this sector (FIP, 2006; B/Mariam, 2010) • Overall = 57 % • Western Pacific/SE Asia = 51 % • Europe = 71 % • Pan America = 66 % • Africa / Eastern Mediterranean = 66 % • Ethiopia = 19 % 5
  6. Country Total number of community pharmacies Community pharmacy per inhabitant Australia 4926 3980 England 9872 5000 Estonia 523 2486 Germany 21,400 3900 Japan 49,956 2600 Kenya 611 55647 Peru 10,000 2722 United States 55,400 5380 Ethiopia 377 (FMOH, 2011) 212,202* 6 Table: Number of community pharmacies and their per capita distribution in selected countries
  7. 2. Issues in community pharmacy practice o Useful additional business courses: • management (personnel, supply chain, finance, marketing), • entrepreneurship • economics Ownership issues: • pharmacist vs. non-pharmacist • independent/chain 7
  8. Issues in community … Independent: a single Opportunities exist to be:  an owner and run the pharmacy,  an employee working for the owner/manager.  a part-time employee 8
  9. Issues in community … Ethiopia: approx. 300 independent outlets Chain (multiple) pharmacy: 12 to hundreds and up to thousands of pharmacies Are usually for profit/business corporations with opportunities for multiple jobs:  distribution,  marketing, and  operations 9
  10. Issues in community … Chain pharmacy……  Organizational charts with the hierarchy defined by position titles  Ethiopian scenario: ◦ Kenema Pharmacies (under the AA City Administration): > 20 outlets in Addis Ababa ◦ Red Cross Pharmacies (under the ERCS): outlets all over the country 10
  11. Issues in community …  Globally: Example is Rite Aid in the US ◦ 3rd largest drug store in the US ◦ ranked #100 on Fortune among 500 Largest U.S. Corporations in 2011 ◦ reported revenue of $26.3 billion in 2009 ◦ 4703 locations all over the US and 54,600 employees 11
  12. Issues in community … Products sold:  human pharmaceuticals (POM, NP/OTC),  veterinary pharmaceuticals  herbal/alternative medicines,  Cosmetics and sanitary products  food items  others Ethiopian setting: different types of retail outlets  community pharmacies/drug stores/rural drug vendors ( outlets guideline.doc) 12
  13. 3. Organization of a community pharmacy  Human resource ◦ Pharmacists (chief/manager and others) ◦ Pharmacy technicians, ◦ Other support staff (cashier, accountant, cleaner, guard). ◦ Pharmacist(s) and other staff on duty must wear a name tag or badge indicating his/her name and designation. 13
  14. Minimum standards for pharmacy premises, facilities and equipment Appearance of pharmacy premises  Design and layout: ◦ Permit logical flow of work, effective communication and supervision and ensure effective cleaning and maintenance ◦ Minimize the risk of errors, cross- contamination and anything else which would have an adverse effect on the quality of products. 14
  15. Minimum standards… ◦ All parts of the premises must be maintained in an orderly and tidy condition. ◦ The external appearance of the pharmacy must depict a professional image. ◦ Entrances, dispensing counters and doorways must be accessible to disabled persons. . 15
  16. Minimum standards…. Security in pharmacy premises  Careful consideration must be given to the overall security of the pharmacy. ◦ Access to a pharmacy when it is locked ◦ Control of access to medicine Safety of pharmacy premises ◦ Working conditions ◦ Fire extinguisher ◦ Electrical equipment → safe and maintained regularly. ◦ A safety procedure 16
  17. Minimum standards Condition of pharmacy premises  The walls, floors, windows, ceiling, and all other parts of the premises →clean and good order, repair and condition.  Countertops, shelves and walls →finished in a smooth, washable and impermeable material.  Site of premises ◦ Far from areas or premises that can cause contamination to the products and affect health in general (e.g. public toilets, waste 17
  18. Minimum standards…. Construction of pharmacy premises  Prevent: ◦ floods ◦ entry of insects, animals or birds  Easily cleaned and disinfected  Allows adequate lighting and air movement  Ceiling: ◦ Should minimizes effects of high temperatures ◦ Adequate height 18
  19. Minimum standards Environment in pharmacy premises  Products stored according to recommended conditions  Levels of heat, light, noise, ventilation, etc., must exert no adverse effects on pharmaceutical stock as well as personnel.  Suitable and effective means of heating 19
  20. Minimum standards… Hygiene in pharmacy premises  Regular program for cleaning premises  Area for washing equipment and other utensils (hot and cold tap water).  Toilet facilities must be kept clean and in good order.  Hand-washing facilities 20
  21. Minimum standards… Premises Dispensary The size of the dispensary:  allow a safe and efficient flow of work and  effective communication and supervision  arrangement of available space and  space available elsewhere for storage of stock. Waiting area  Comfortable seating must be provided.  Appropriate health-related literature must be provided 21
  22. Minimum standards….  Ethiopian guideline: 25m² minimum for dispensary and waiting area with shortest side not less than 4 m.  South African guideline: a clear working surface area of at least 90 cm by 1 m for each pharmacist or other registered pharmacy personnel. 22
  23. Minimum standards….  Suitability of dispensary  The dispensary, its fittings and equipment must be adequate and suitable for the purpose of dispensing.  The temperature in the dispensing area must be maintained below 25°C. 23
  24. Minimum standards…. Counseling area  The area(s) must ◦ Be easily accessible and, where possible, be close to the dispensary. ◦ Ensure reasonable privacy to the patient at all times and eliminate background noise as far as possible. ◦ Have sufficient space →appropriate counseling and demonstration of the correct and safe use of medicines. 24
  25. Minimum standards….  Three types of areas may be considered for the pharmacy, depending on the: ◦ services offered by the pharmacy and ◦ degree of privacy required.  The models are: ◦ semi-private area ◦ separate private area and ◦ consultation area for the provision of screening and monitoring services 25
  26. Minimum standards  Semi-private area ◦ This area is for the provision of information and/or advice that may occur in an area visible to other patients. ◦ In such an area, patient counseling may take place in a professional manner regarding medicine use and other relevant information, ◦ Does not provide the privacy required 26
  27. Counseling area Semi-private area 27
  28. Counseling area: Semi-private area 28
  29. 29
  30. Environmental factors  The general appearance of the pharmacy  Physical characteristics of pharmacy employees 30
  31. Minimum standards…  Separate private area ◦ a small private room within the pharmacy, which is in close proximity to the dispensary. ◦ the area should be professionally planned, tastefully and professionally furnished and equipped, ◦ allows the pharmacist to counsel patients on: 31
  32. Minimum standards…  Consultation area for the provision of screening and monitoring services ◦ an isolated area within which the pharmacist can  consult in private with a patient and/or  perform certain screening and monitoring services, e.g. cholesterol tests or blood pressure monitoring ( Not allowed in Ethiopia) 32
  33. Minimum standards…  Storage areas in pharmacy premises ◦ independent and secure ◦ Large enough → orderly arrangement and proper stock rotation ◦ Separate storage area for stocking veterinary pharmaceuticals ◦ Sufficient shelving  Ethiopian guideline: 16 m² minimum for storage with shortest side not less than 3 m. 33
  34. Minimum standards….  Compounding room ◦ Must be of suitable size (Ethiopian guideline minimum of 9 m² size and shortest side not less than 2.5 m. ◦ Must have a suitable bench, shelves, washing sink ◦ Appropriate references ◦ Equipments, apparatuses, chemicals and appropriate materials 34
  35. Minimum standards…  Office ◦ secretarial and managerial activities with appropriate furniture and equipments ◦ stock recording and other relevant documents (if applicable) ◦ Telephone and other communications technology  Staff room ◦ Cloak room ◦ Tea room 35
  36. Minimum standards… Other issues  Waste disposal → SOPs ◦ Suitable and adequate means in written form  Dispensing equipment and materials ◦ Adequate, suitable dispensing equipment. ◦ Maintained clean, in good repair and of suitable material.  Common ones include: ◦ Tablets and capsules counting equipments/apparatuses.  For compounding purposes 36
  37. Minimum standards… Technology: specialized software:  manage the stock of pharmaceuticals and other supplies  fills and labels each prescription,  processes the sales transaction  checks for medication errors, for the management of patients with particular disease states such as diabetes Electronic prescribing Additionally :  automated dispensing machines,  specialized compounding and mixing equipment 37
  38. Minimum standards…  Reference sources  Current editions recommended: ◦ Martindale; ◦ Drug interactions reference source; ◦ a comprehensive textbook on pharmacology/pharmacotherapy; ◦ Standard Treatment Guidelines and Essential Drug List for the appropriate level of care. ◦ A pediatric dosing reference guide (where applicable); ◦ A medical dictionary; 38
  39. Minimum standards ◦ the latest copy of the pharmacy legislation; ◦ Code of ethics ◦ Good dispensing practice manual; ◦ Pharmacopoeia (BP, USP) (where applicable); ◦ Others as applicable and appropriate;  Electronic access to the required references is also acceptable in some countries. 39
  40. 4. SERVICES OF THE COMMUNITY PHARMACY  The major work of community pharmacists involves supplying medicines to the public: Dispensing prescriptions ◦ The supply of medicines according to: Good dispensing practices, Good compounding practices Maintaining records and 40
  41. SERVICES/dispensing Good dispensing practices The dispensing process is divided into three phases, namely: Phase 1: Interpretation and evaluation of the prescription. Phase 2: Labeling and preparation of the 41
  42. SERVICES/dispensing Phase 1: Interpretation and evaluation of the prescription  Receipt of the prescription and confirmation of the integrity of the communication. ◦ identifying the patient, the prescriber, ◦ legality/authenticity of the 42
  43. SERVICES/dispensing Assessment of the prescription to ensure the optimal use of medicine. ◦ therapeutic aspects ◦ appropriateness for the individual ◦ social, legal and economic aspects Pharmacist interventions 43
  44. SERVICES/dispensing Phase 2: Labeling and preparation of the prescribed medicine Labeling of item(s) Selecting or preparing the medicine ◦ patient-ready packs/pre-packed medicines ◦ extemporaneous preparations ◦ pharmaceutical containers  Checking 44
  45. SERVICES/dispensing Phase 3: Hand to the patient and Counseling Supply to the patient Counseling to be done by a pharmacist  Patient information leaflet Monitoring patient outcomes  assess the patient for signs of compliance, effectiveness and safety of the therapy  identify areas for interventions, intervene, revise the patient record and record the action taken Read: Ethiopian Good Dispensing 45
  46. SERVICES/patient information Patient information and advice  Patient information and advice is of vital importance in the correct use of medicines  It must respect patient autonomy, improve health and enhance the outcome of medical treatment by: ◦ empowering consumers to make informed decisions about their treatments and take responsibility for their own health care; ◦ improving communication between patients and health care providers; and ◦ aiding and encouraging effective use of 46
  47. SERVICES/patient information Supplementary written information must be used (as appropriate). The pharmacist must assess each patient's ability to understand the information imparted. Confidentiality of the patient must be respected. 47
  48. SERVICES/patient information Steps for counseling a patient on a new prescription Introduce yourself and identify the patient. Ask patient to talk with you about the medication. Assess the patient's understanding of his/her disease and expected outcomes of therapy. Assess patient’s knowledge about the newly 48
  49. SERVICES/patient information COUNSELING PATIENTS ON THE USE OF REFILL PRESCRIPTIONS A refill counseling session should concentrate on the following three areas: ◦ Confirm that the patient has been taking the correct medication and knows the indication for its use. ◦ Ask how the patient has been taking 49
  50. SERVICES/compounding GOOD COMPOUNDING PRACTICE (GCP) Definition  Compounding is the preparation of a customized prescription medication to meet the individual patient needs in response to a licensed practitioner's prescription. 50
  51. SERVICES/compounding Problem Solving… ◦Unavailable Strength/Dosage ◦Unavailable Medications (limited use, short shelf life, etc.) 51
  52. SERVICES/compounding  Basic components of GCP ◦ Personnel ◦ Facilities ◦ Equipment ◦ Ingredients ◦ The compounding process ◦ Packaging and labeling ◦ Stability and beyond-use date ◦ Records and reports 52
  53. SERVICES/compounding PERSONNEL Pharmacists Pharmacy technicians Supportive staff Appropriate education, training, and proficiency. Proper maintenance, cleanliness, and use of all equipment Inspection and approval/rejection of all components and 53
  54. SERVICES/compounding FACILITIES Site  Appropriate for the purpose of preparing quality product.  Isolated from potential interruptions, sources of contaminants of any type.  Located sufficiently away from dispensing and counseling functions and high traffic areas. Service and utilities  Water (acceptable quality); electricity; drainage system; 54
  55. SERVICES/compounding EQUIPMENT Appropriate design, adequate size, and suitably located to facilitate operations. Non-interacting, non-additive and non-absorbing. SOPs should be followed for storage, inspection, calibration, use, maintenance and cleaning55
  56. SERVICES/compounding INGREDIENTS  Stored according to the manufacturers’ directions or the specifications on official monographs  Should meet official compendial requirements 56
  57. SERVICES/compounding THE COMPOUNDING PROCESS Validate the prescription Check that the ingredients are available in desired quality and quantity Perform calculations Identify the equipment needed Wear the proper clothing and wash hands. Clean the compounding area and the equipment Only one prescription is compounded at a time 57
  58. SERVICES/compounding SOPs shall be followed for the following operations:  Weighing/measuring  Mixing of ingredients  Labeling the preparation  Entering information in the compounding log  Cleaning (room, equipment, containers) Finally check before the preparation is being dispensed  Physical characteristics  Quality tests, when appropriate  The beyond-use date 58
  59. SERVICES/compounding PACKAGING AND LABELING Standard type of packaging material to maintain the stability of the product Patient-friendly package Containers and closures cleaned according to SOPs The label on bulk preparations:  Name, strength and quantity of the product  Date of preparation  Control number  Storage condition 59
  60. SERVICES/compounding  The label on compounded preparations for individual patient: ◦ Name and address of the patient ◦ Name, strength and total quantity of the preparation ◦ Control number/batch number of the prod ◦ Beyond-use date ◦ Directions for use ◦ Storage condition 60
  61. SERVICES/compounding STABILITY AND BEYOND-USE DATE Compounded drug preparations are used immediately or stored for a very limited time.  Stability evaluation and expiration dating are different from manufactured drug products 61
  62. SERVICES/compounding The beyond-use date is defined as that date after which a dispensed product should no longer be used by a patient All the available stability information should be consulted and a conservative estimate be made for the product Source of information: expiry date of similar commercial products manufacturer’s literature contacting the manufacturer 62
  63. SERVICES/compounding In the absence of stability information, the following general guideline can be used:  Solids and non-aqueous liquids prepared from commercially available dosage forms - 25% of the remaining expiration date of the commercial product, or 6 months, whichever is earlier  Solids and non-aqueous liquids prepared from bulk ingredients - up to 6 months  Water-containing formulations (prepared from ingredients in solid form) - up to 14 days 63
  64. SERVICES/Record keeping Record keeping Must be both accurate and up- to-date. ◦ Compounding record ◦ Prescription Registration ◦ Patient medication records ◦ Stock records ◦ Health-screening related 64
  65. SERVICES/Record keeping Compounding record The compounding information is recorded on the compounding log/compounding sheet Content of compounding records for products prepared on individual prescription:  Date of preparation.  Control number  Source, batch number and expiration date of all components 65
  66. SERVICES/Record keeping ◦ Beyond-use date ◦ Signature or initials of pharmacist or supportive person performing the compounding function  Recording of the compounding prescription ◦ Patient identifiers ◦ Diagnosis or ICD code number ◦ Description of the preparation ◦ Control number 66
  67. SERVICES/Record keeping Patient medication records Patient medication records must be developed, preferably using computer technology. Patient medication records must respect the patient's privacy. The following information must be captured in a patient medication record: the full name of the patient; the address and telephone number 67
  68. Patient medication Record….. ◦ the patient's sex; ◦ Current weight of the patient; ◦ the name of the prescriber and date of consultation; ◦ any known allergies of the patient; ◦ idiosyncrasies or negative reactions of the patient towards medicine; ◦ family history; ◦ the presence of other factors, e.g. smoking, drinking, etc. ◦ chronic conditions, disease states or 68
  69. SERVICES/Record keeping •a list of all medicines obtained (prescription as well as non- prescription) by the patient at the point of supply during the twelve-month period immediately preceding the69
  70. Patient medication record date prepared:________________ name:______________________sex: ______ date of birth: _____________ weight______ pharmacist name: _____________________________ phone: __________________ primary physician name: ______________________ phone: ____________________ adrs (if known):_______________________________________________________ medication allergies (if known):___________________________________________ medical conditions (if any): ______________________________________________ social history: smoking : ______________alcohol drinking : ____________________ caffeinated beverages : ____________________others: :_______________________ family medical history:___________________________________________________ list of medications (including non-prescription and herbal products): ___________________________________________________________________ _________________________ 70 MEDICATION NAME DOSE DIREC- TIONS PURPOSE FOR USE PRESC- RIBER START DATE STOP DATE REMARKS
  71. SERVICES/SOPs Standard operating procedures (SOPs) A SOP is a written document that specifies what should be done, when, where and by whom. help to assure the quality of the service help to ensure that good practice is achieved consistently 71
  72. Sops…… help to avoid confusion over who does what and clarify roles within the pharmacy provide advice and guidance to locums and part-time staff provide useful training tools for new members of staff 72
  73. SERVICES/sops General principles for SOPs: ◦Specificity to a pharmacy ◦Consideration of the competence of staff 73
  74. SERVICES/sops an outline or summary of SOPs: the aim or purpose of the overall SOP objectives – what is the procedure trying to achieve?  scope – what areas of work are to be covered by the procedure?  risks – are there any risks associated with the task?  review date – to ensure that the procedure continues to be useful 74
  75. SERVICES/sops  The main part of the document includes: ◦ stages of the process – describe how the task is to be carried out step by step ◦ responsibility – who is responsible for carrying out each stage of the process ◦ other useful information – is there 75
  76. SERVICES/public health  Public health is part of the community pharmacist’s roles: ◦ Disease prevention ◦ Health promotion  Promoting healthy lifestyles consists of two separate areas: ◦ prescription-linked intervention ◦ involvement in public health campaigns.  Prescription-linked intervention involves offering opportunistic advice on public health topics to patients that present a prescription. 76
  77. SERVICES/public health  Promotion of healthy lifestyles will include offering advice in the following areas: ◦ STDs and HIV/AIDS ◦ Infectious diseases such as malaria, URTIs and diarrheal diseases ◦ FP and child care ◦ Antimicrobial resistance ◦ CVDs, Cancer, Diabetes  Health issues: stopping smoking, alcohol intake, nutrition advice and77
  78. SERVICES/responding to symptoms Responding to symptoms and referral Advice on appropriate OTC medicines for symptomatic relief in the case of self- limiting minor illnesses and common complaints. The sales of OTC medicines account for between 8 and 30% of total pharmaceutical sales in the majority of world regions. Members of the public sometimes expect 78
  79. SERVICES/responding… The patient's need to ask for a particular OTC medicine/self-medication may arise due to several factors:  Influence of advertisements or the media.  Recommendations by friends or relatives.  Prior use for similar conditions. Inability to go to a physician for various reasons such as Cost factor. Lack of time. Unavailability of a doctor. The feeling that their condition is simple enough to be treated with OTC79
  80. SERVICES/responding…  Skills required may be: ◦ Communication skills ◦ Clinical skills ◦ Knowledge of current OTC medication ◦ Directing/referral  What the pharmacist can do: ◦ Enquire whether the patient knows the correct use of the medicine. ◦ Get into a conversation so that you can ask the patient to tell you the symptoms for which he/she wants 80
  81. SERVICES/responding… ◦ Enquire whether the client is taking any other medicines. ◦ Enquire whether the client suffers from any other illness/conditions. ◦ Assist the patient in selecting an OTC medicine suitable to his symptoms and also check that it is not contraindicated for the illness/condition of81
  82. SERVICES/responding…  Inform the patient: ◦ How to take. ◦ How much to take (maximum permissible daily dose). ◦ When to take; for how long to take ◦ Any adverse drug reactions observed. ◦ Any side effects likely to occur. ◦ Any precautions to be taken. ◦ To see a physician if the condition 82
  83. SERVICES/responding… Further reading  Blenkinsopp A, Paxton P, Blenkinsopp J (2009). Symptoms in the Pharmacy: A Guide to the Management of Common Illness, 6th Edition, Blackwell Publishing 83
  84. 5. Other professional services Retailing  Remuneration/methods of payment: ◦ Markups on individual items and income derived solely from the sale of medicines, ◦ Fixed dispensing fees  Managerial skills  Financial strategy and planning  Marketing 84
  85. Other professional services Emergency hormonal contraceptives (‘morning- after-pill’). Emergency contraception (EC) refers to contraceptive methods that may be used in the first few days after unprotected sexual intercourse, to prevent 85
  86. Other professional services… Pharmacies are ideally placed to provide this service and increase access to the service. Effectiveness of ECs (within 72 hrs) C/I: Confirmed pregnancy Counseling Appropriate use of EC Effective, ongoing contraceptive86
  87. Other professional services Health screening: ◦ Body weight and height; ◦ Blood pressure; ◦ Blood glucose; ◦ Pregnancy; ◦ Cholesterol; ◦ Peak flow test; ◦ HIV  Requirements: facilities and training  Appropriate public health education and counseling 87
  88. Other professional services First aid provision  Emergency treatment of wounds; bone fractures; burns; bleeding; foreign objects in nose, ear, eye and respiratory system; severe diarrhea; high fever; poisoning and snake bite; etc. Adverse drug reaction reporting  Report suspected adverse drug reactions (ADRs) to the regulatory body (e.g. Food, Medicines and Healthcare Administration and Control Authority, FMHACA)  For new drugs that have received market authorization in the last 2 years) for which any 88
  89. Other professional services Nutrition advice (diabetes, hypertension, pregnancy, etc.) Site for training of pharmacy interns Drug information services ◦ General public ◦ Healthcare providers Immunization services ◦ travel, ◦ childhood, ◦ tetanus, etc. 89
  90. Other professional services Smoking cessation clinics  Pharmacies are recognized as being well placed to offer a smoking- cessation service as they are readily accessed by the public and have a resident healthcare professional.  Pharmacists are involved routinely in brief interventions as part of the 90
  91. Other professional services  Initial and follow up consultations ◦ Nicotine replacement therapy (NRT) ◦ NRT delivers nicotine in a clean form and helps smokers to overcome withdrawal symptoms such as irritability and craving while avoiding the many harmful chemicals in tobacco and the carbon monoxide that cause serious damage. 91
  92. Other professional services Medication therapy management (MTM) Medication Therapy Management (MTM) officially recognized by the US Congress in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA 2003). 92
  93. Medication therapy management (MTM….  Requirements for MTM Programs are “designed” to “optimize therapeutic outcomes through improved medication use” and “reduce the risk of adverse events, including adverse drug reactions.”  Objectives are to increase patient adherence, prevent drug complications, 93
  94. MTM…. ◦ MTM programs are designed to improve medication use, enhance patient safety, and increase patient adherence to their medication regimens ◦ A MTM program established for targeted beneficiaries such as those  who have multiple chronic disease 94
  95. MTM….. Core elements for MTM services ◦ Medication therapy review, ◦ Personal medication record, ◦ Medication-related action plan, ◦ Intervention and/or referral, and ◦ Documentation and follow-up 95