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متطلبات معايير الصيدلية

ملتقى الجودة وسلامة المرضى
عدد المعجبين  4معجبون
  • 2 أضيفت بواسطة الكفاح
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  #1  
قديم 10-13-2012, 04:16 PM
الصورة الرمزية الكفاح
 


الكفاح will become famous soon enoughالكفاح will become famous soon enough


المعيار الأول
The hospital has a pharmacy service department and headed by a qualified pharmacist with appropriate experiences.
PH.1.1 The Pharmacy has a clear organization structure.
PH.1.2 Pharmacy head holds Pharm.D, Master, or Bachelor of Science degree in Pharmacy.
PH.1.3 Pharmacy head has signed an updated job description.
PH.1.4 Evidence of valid Saudi Council of Health Specialties license to practice in Saudi Arabia.
PH.1.5 The Pharmacy head has an updated curriculum vitae.
PH.1.6 Evidence of work experience in hospital setting
المستشفى لديه قسم خدمات صيدلية يرأسها صيدلي مؤهل مع الخبرات المناسبة

PH.1.1 والصيدلة لديها هيكل تنظيمي واضح.
PH.1.2 رئيس الصيدلية دكتور صيدلة يحمل، ماجستير، أو درجة البكالوريوس في العلوم في الصيدلة.
PH.1.3 رئيس صيدلية لديه الوصف الوظيفي تم تحديثه ووقع عليه بالعلم
PH.1.4 رخصة من الهيئة السعودية للتخصصات الصحية سارية المفعول لممارسة العمل في المملكة العربية السعودية.
PH.1.5 رئيس الصيدلية لديه السيرة الذاتية محدثة.
PH.1.6 مايثبت ان لديه الخبرة في العمل في المستشفيات.
Recommendation

There is qualification (Bachelor of pharmacy or higher degree), experience and licensed by the Saudi Council of Health Specialties

Current job description of Pharmacy director
هناك التأهيل (بكالوريوس في الصيدلة أو درجة أعلى)، والخبرة ومرخصة من قبل الهيئة السعودية للتخصصات الصحية



وصف الوظيفة لمدير الصيدليةمحدث
المعيار الثاني
The pharmacy has a clear mission, vision, and values.
PH.2.1 Mission is clearly written, posted, and verbalized by pharmacy staff.
PH.2.2 Vision is clearly written, posted, and verbalized by pharmacy staff.
PH.2.3 Values are clearly written, posted, and verbalized by pharmacy staff


الصيدلية لديها مهمة واضحة ( الرسالة)، والرؤيا، والقيم.

الرسالة والرؤيا والقيم مكتوبة بوضوح وتم النشر( ملصقة في اللوح بالصيدلية)، ومفعلة من قبل موظفي الصيدلية.

Recommendation
Pharmacy mission, vision, and values are clearly written

Pharmacy mission, vision, and values are posted.


Pharmacy mission, vision, and values are verbalized
المعيار الثالث
The pharmacy space is adequate. Hours of operation are determined, announced and followed.
PH.3.1 The space provided for pharmacy services allows the principal functions to be carried out in efficient and effective manner.
PH.3.2 Hours of operation of each pharmacy section are clearly defined in the policy and procedure, announced within the hospital and posted at the pharmacy entrance.
PH.3.3 Monthly work schedule is written and announced
مساحة الصيدلية كافية. ويتم تحديد ساعات العمل، ومعلن الجدول لاتباعه.
PH.3.1 المكان المخصص للخدمات الصيدلية يسمح بانجاز المهام الرئيسية فيه بكفاءة وفعالية.
PH.3.2 ساعات العمل كل أقسام الصيدلة محددة بوضوح في السياسات والإجراءات، معلنة في المستشفى وملصقة في مدخل الصيدلية.
PH.3.3 مكتوب جدول العمل شهرياً، ومعلن للجميع
Recommendation
Pharmacy has adequate space to efficiently operate

Pharmacy monthly work schedule is available and posted

Pharmacy operation hours are known and posted
المعيار الرابع
The pharmacy has qualified and licensed staffing.
PH.4.1 All Pharmacy staff has valid licenses from the Saudi Council of health Specialties to practice in Saudi Arabia.
PH.4.2. All staff have a current job description.
PH.4.3. Each staff signed his/her job description
الموظفين الصيادلة مؤهلين ومرخصين بــ .
PH.4.1 جميع الموظفين لديهم تراخيص صيدلية صالحة من الهيئة السعودية للتخصصات الصحية لممارسة المهنة في المملكة العربية السعودية.
PH.4.2. جميع الموظفين لديهم وصف الوظيفة محدث.
PH.4.3. يوقع بالعلم كل الموظفين على الوصف الوظيفي
Recommendation
All pharmacy staff are qualified and licensed by the Saudi Council of Health Specialties

All pharmacy staff have current and signed job description
المعيار الخامس
The pharmacy actively participates in all relevant hospital committees as evidenced by meeting minutes.
PH.5.1 The pharmacy actively participates in the Pharmacy and Therapeutics committee.
PH.5.2 The pharmacy actively participates in the hospital QM/TQM committee.
PH.5.3 The pharmacy actively participates in the hospital Infection Control committee.
PH.5.4 The pharmacy actively participates in the hospital Fire and Safety committee
الصيدلية تشارك بنشاط في جميع اللجان ذات الصلة المستشفى كما يتضح من محضر اجتماع.
PH.5.1 والصيدلة تشارك بنشاط في لجنة الصيدلة والعلاجيات الصيدلانية.
PH.5.2 والصيدلة تشارك بنشاط في لجنة QM / إدارة الجودة الشاملة في المستشفى.
PH.5.3 والصيدلة تشارك بنشاط في لجنة مكافحة العدوى بالمستشفى.
PH.5.4 والصيدلة تشارك بنشاط في لجنة مكافحة الحريق و السلامة
Recommendation
Actively participates in the Pharmacy and Therapeutics committee (as per meeting minutes).

Actively participates in the Hospital Quality Management committee (as per meeting minutes

Actively participates in the Infection Control committee (as per meeting minutes).


Actively participates in the Fire and Safety committee (as per meeting minutes
المعيار السادس
The pharmacy has updated internal policy and procedures for all available services (IPPs.)
PH.6.1 All approved IPPs are written according to standard hospital format & updated every 2 years.
PH.6.2 All multidisciplinary IPPs are established by the combined effort of pharmacy, medical, nursing, and hospital administration.
PH.6.3 IPPs are made accessible to all pharmacy staff all the time and staff is familiar with IPPs
استكملت الصيدلية السياسات والإجراءات الداخلية لكافة الخدمات المتاحة IPPs
.)
PH.6.1 يتم كتابة كافة IPPs السياسات والإجراءات الداخلية ويتم اعتمادها وفقا للنموذج الخاص بالمستشفى ويتم التحديث كل سنة 2.
PH.6.2 يتم كتابة السياسات المشتركة مع فريق متعدد التخصصات كل من الصيدلية، الطاقم الطبي والتمريض، وإدارة المستشفى.
PH.6.3 تكون في متناول جميع الموظفين بالصيدلية في كل وقت والموظفين على دراية IPPs بالسياسات والاجراءات الداخلية
Recommendation
Pharmacy internal policy and procedures are complete, updated (every 2 years) and approved

Multidisciplinary policies are established when necessary

Pharmacy policies are accessible to all pharmacy staff and staff are familiar with it
المعيار السابع
The Pharmacy Director reports workload statistics to the appropriate committee and leadership. Number of FTE (full-time equivalent staff) and actual workload are published.
PH.7.1 Standard time for each function/task is determined.
PH.7.2 Monthly workload is reported for inpatient pharmacy (Unit dose and/or IV admixture).
PH.7.3 Monthly workload is reported for Chemotherapy.
PH.7.4 Monthly workload is reported for pharmacy storeroom.
PH.7.5 Monthly workload is reported for extemporaneous compounding.
PH.7.6 Monthly workload is reported for outpatient pharmacy.
PH.7.7 Monthly workload is reported for clinical pharmacy services.
PH.7.8 Monthly manpower (staffing, FTE) is reported
PH.7.9 Monthly workload is reported for other activities (e.g. meetings, in-services, floor inspections, etc.).
PH.7.10 Workload statistics are reported monthly to the appropriate committee and the leadership for future planning and pharmacy staffing.
PH.7.11 The pharmacy has the necessary manpower to operate the available service as evidenced by the workload statistics
مدير الصيدلية يعمل تقارير إحصاءات عن حجم العمل إلى لجنة الصيدلة والعلاعلاجات الصيدلانية ثم ترفع التقارير الى لجنة ادارة الجودة الشاملة. وتنشر عدد من حجم العمل الفعلي FTE (الموظفين بدوام كامل ما يعادلها) .


يتم تحديد وقت قياسي PH.7.1 لكل وظيفة / مهمة.
وتفيد التقارير PH.7.2 عبء العمل الشهري للصيدلية من المرضى الداخليين (جرعة وحدة و / أو خليط IV).
وتفيد التقارير PH.7.3 عبء العمل الشهري للعلاج الكيميائي.
وتفيد التقارير PH.7.4 عبء العمل الشهري للمخزن الصيدلية.
وتفيد التقارير PH.7.5 عبء العمل الشهري المعمل في الخلطات.
وتفيد التقارير PH.7.6 عبء العمل الشهري لصيدلية العيادات الخارجية.
وتفيد التقارير PH.7.7 عبء العمل الشهري لخدمات الصيدلة السريرية.( الاكلينيكية)
وتفيد التقارير PH.7.8 القوى العاملة الشهري (التوظيف، FTE حجم العمل الفعلي)
وتفيد التقارير PH.7.9 عبء العمل الشهري لأنشطة أخرى (على سبيل المثال اجتماعات، في الخدمات، وعمليات التفتيش ، وما إلى ذلك).
وذكرت الإحصاءات المتعلقة بحجم العمل PH.7.10 الشهرية إلى لجنة المناسب والقيادة للتخطيط في المستقبل والتوظيف الصيدلة.
PH.7.11 الصيدلية لديها القوى العاملة اللازمة لتشغيل الخدمة متوفرة كما يتضح من إحصاءات حجم العمل.
.
Recommendation
Monthly workload statistics of the pharmacy is reported to the appropriate committee and leadership.

Standard time for each pharmacy task is well defined

Comprehensive workload statistic report including all available services (inpatient, outpatient, IV admixture, etc..).

Pharmacy has the necessary manpower to operate the available services
المعيار الثامن
The pharmacy has administrative rules regarding availability of medications 24-hours a day.
PH.8.1 The Pharmacy is open 24 hr/day for inpatient areas, EMS, and clinic prescriptions.
PH.8.2 If the pharmacy is not open 24hr/day.
PH.8.2.1 Availability of on-call pharmacist within 20 minutes whenever pharmacy is closed.
PH.8.2.2 On-call service is announced to all hospital service areas (written schedule, communication numbers, etc.) for use after working hours
الصيدلية والأدوار الإدارية المتعلقة بتوافر الأدوية على مدار 24 ساعة في اليوم.
PH.8.1 والصيدلة مفتوح على مدار 24 ساعة / يوم لأقسام المرضى الداخليين، EMS، وصفات العيادات.
PH.8.2 إذا لم يتم فتح صيدلية 24hr/day.
PH.8.2.1 توفر عند الطلب الصيدلي في غضون 20 دقيقة كلما يتم إغلاق الصيدلية.
وأعلنت PH.8.2.2 في خدمة تحت الطلب لخدمة جميع المناطق المستشفى (الجدول مكتوب، أرقام الاتصال، وما إلى ذلك) نظام المناوبة بعد ساعات العمل..
Recommendation
The pharmacy provides 24 hours daily services for inpatient and emergency room customers

The pharmacy provides on-call services within reasonable time frame (20 minutes) after the normal working hours
المعيار التاسع
The Hospital has an updated formulary system.
PH.9.1 The Hospital formulary is established in collaboration with the pharmacy and therapeutics committee.
PH.9.2 The Hospital formulary is updated every TWO years at least.
PH.9.3 The Hospital formulary is available to healthcare team (hardcopy or electronic).
Recommendation
Updated (within 2 years) and approved hospital formulary by the Pharmacy and Therapeutics committee

Pharmacy and therapeutics committee is actively participating in establishing the hospital formualry

Availability of updated hospital formulary in all patient care units
المعيار العاشر
The Hospital formulary is very well structured.
PH.10.1. Hospital formulary has at least generic & brand name information, formulations, strength, therapeutic classification, and prescribing information.
PH.10.2 The Hospital formulary is properly indexed using alphabetical indexing for both generics- and brand-named available drugs.
PH.10.3 An approved abbreviation list for prescribing is included in a separate section and there is evidence of implementation.
Recommendation
Well structured hospital formulary (including brand, generic, formulation, strength, therapeutic class, prescribing information, approved prescribing abbreviations and alphabetical index

Implementation of the approved prescribing abbreviations (Check Outpatient prescriptions and open medical records during hospital tour).

المعيار الحادي عشر
The Hospital formulary provides guidance to antibiotic use.
PH.11.1 Antibiotic utilization guidelines and/or restriction are included in a separate section.
PH.11.2 Evidence of implementation by prescribers of the antibiotic utilization guidelines.
PH.11.3 Antibiotic dispensing as per antibiotic hospital policy (dosing, duration, restriction, etc.).
Recommendation
Antibiotic use guidelines are published through the hospital formulary

Antibiotics use guidelines are approved by the Pharmacy and Therapeutics committee.


Antibiotic prescribing as per antibiotic hospital policy (restriction or prescribing privileges

Antibiotic dispensing as per antibiotic hospital policy (dose, duration and restrictions).
المعيار الثاني عشر
The pharmacy has infection control guidelines that include:
PH.12.1 Written policies and procedures.
PH.12.2 Guidelines verbalized by pharmacy staff.
PH.12.3 Guidelines adhered to by pharmacy staff.
PH.12.4 No food, drink, or smoking allowed in the pharmacy.
PH.12.5 A sink, soap, and antiseptic hand scrub are available in the pharmacy.
PH.12.6 Separate housekeeping materials of the IV admixture room
Recommendation
Written policy on pharmacy infection control

Implementation and verbalization of infection control guidelines by staff

Availability of sink, soap, antiseptic hand scrub and separate housekeeping materials of the IV admixture room (if IV room is available
المعيار الثالث عشر
The pharmacy has a system for accepting verbal orders.
PH.13.1 There is a written multidisciplinary IPP for accepting and transcribing verbal orders by medical staff.
PH.13.2 IPP clearly defines urgency/emergency situation for accepting verbal orders “code” and time frame for order authentication.
PH.13.3 IPP clearly defines restriction on drugs that may be ordered verbally.
PH.13.4 IPP clearly defines non-medical staff who may accept a verbal order.
PH.13.5 IPP defines proper procedure for receiving and documenting verbal orders. PH.13.6 Staff (pharmacy and/or nurse) clearly understands how to handle verbal orders
Recommendation
Comprehensive multidisciplinary verbal orders policy is clearly written and approved (define urgent situation for verbal order, who can accept, time frame for authentication, receiving and documentation

Staff understanding of verbal order (Interview medical, nursing and pharmacy staff during unit tour

المعيار الرابع عشر
The pharmacy has a system for accepting telephone orders:
PH.14.1 Written multidisciplinary IPP for accepting and transcribing telephone orders by medical staff.
PH.14.2 IPP clearly defines urgency situation for accepting telephone orders and time frame for order authentication.
PH.14.3 IPP clearly defines restriction on drugs that may be ordered by telephone.
PH.14.4 IPP clearly defines staff who may accept a telephone order.
PH.14.5 IPP defines proper procedure for receiving and documenting telephone orders.
PH.14.6 Staff (pharmacy and nurse) clearly understand how to handle telephone orders.
Recommendation
Comprehensive multidisciplinary telephone orders policy is clearly written and approved (define urgent situation for telephone order, who can accept, time frame for authentication, receiving and documentation).

Staff understanding of telephone order (Interview medical, nursing and pharmacy staff during unit tour).
بمشيئة الله سوف يتم استكمال المعايير والترجمة في وقت لاحق
عدد معايير الصيدلية 62 معيار
شارك
مشاركة في فيسبوك مشاركة في تويترمشاركة في قوقل بلص
مل الصبر مني و Moon M معجبون بهذا.


من مواضيعي : الكفاح
  رقم المشاركة : [ 2 ]
قديم 10-13-2012, 11:23 PM
صحي نشيط
 

مل الصبر مني will become famous soon enough
افتراضي رد: متطلبات معايير الصيدلية



الله يعطيكي الف عافيه
و بانتظار باقي المعايير مع الترجمه
من مواضيع : مل الصبر مني
مل الصبر مني غير متواجد حالياً  
  رقم المشاركة : [ 3 ]
قديم 10-14-2012, 04:26 PM
افتراضي رد: متطلبات معايير الصيدلية

اقتباس
  المشاركة الأصلية كتبت بواسطة مل الصبر مني


الله يعطيكي الف عافيه
و بانتظار باقي المعايير مع الترجمه

الله يعااافيك ويسلمك ..
أسعدني مرورك العطر ..

كل الشكر ..

اعذرني اخوي مل الصبر مني
سوف اتأخر عن استكمال باقي المعايير لوجود حالة وفاة بالعائلة
بإذن الله لي عودة بعد العزاء

من مواضيع : الكفاح
الكفاح غير متواجد حالياً  
  رقم المشاركة : [ 4 ]
قديم 10-17-2012, 11:31 AM
افتراضي رد: متطلبات معايير الصيدلية

المعيار الخامس عشر
There is a list of Medical staff signatures who are authorized to prescribe medication.
PH.15.1 The list contains medical staff name, signature, ID number, specialty, and stamp or code (if available) and updated every year.
PH.15.2 Clear copy of the signature list is available to pharmacy staff in each drug dispensing area.

PH.15.3 Pharmacy staff is aware of the list
هناك قائمة من تواقيع الطاقم الطبي المصرح لهم بكتابة وصفة الدواء.

PH.15.1وتتضمن القائمة اسم الطبيب ، التوقيع، رقم الهوية، والتخصص، وختم أو رمز (إن وجد) وتحديثها كل عام.
PH.15.2 صورة واضحة من نموذج التوقيع متاح لموظفي الصيدلية في مكان صرف دواء
موظفين الصيدلية على علم بالقائمة
PH.15.3.
Recommendation
Comprehensive and updated records of all prescribers' signatures are readily available in the pharmacy
There is pharmacy staff awareness of prescribers' signature records.
المعيار السادس عشر
There is an updated list of prescribers and their prescribing privileges.
PH.16.1 The list contains medical staff specialties and their prescribing privileges.
PH.16.2 The list clearly defines prescribing privileges especially for narcotics, controlled drugs, psychotropics, chemotherapeutics, and high risk medications, etc.
PH.16.3 The list is updated every year and whenever a new medical staff joins.
PH.16.4 Clear copy of the privilege list is available to pharmacy staff in each drug dispensing area.
PH.16.5 Pharmacy staff is aware of the list.
PH.16.6 There is clear evidence of proper implementation
هناك قائمة محدثة من الأطباء الذين يكتبون الوصفات الطبية وامتيازاتهم التي تفرض بمعنى مالمسموح للطبيب المقيم ان يصف كذلك اخصائي الباطنة ماهي الأدوية التي مسموح بها وصفها
كذلك الاستشاري كل فئة طبية لها نوع من الدوية مسمح بها صرفها مثلا استشاري القلب له ادوية مخصصة يصفها لكن غير مسموح لإستشاري الباطنة وصفها.

PH.16.1وتتضمن القائمة التخصصات الطبية والموظفين امتيازاتهم التي يسمح لهم ضمن تخصصهم ودرجتهم العلمية.
PH.16.2 قائمة تحدد بوضوح امتيازات خاصة لوصف الأدوية المخدرة، والمخدرات التي عليها رقابة، والمؤثرات العقلية، و المعالجة الكيميائية، والأدوية عالية المخاطر، الخ.
PH.16.3 يتم تحديث القائمة كل عام وكلما ينضم طبيب جديد.
صورة واضحة من قائمة الامتيازات تتوفر للموظفين في كل صيدلية تركيب العقاقيرPH.16.4
PH.16.5 الموظفين في الصدلية علم بالقائمة.
PH.16.6 هناك دليل واضح على التطبيق السليم.

Recommendation
Comprehensive, updated and approved list of medical staff prescribing privileges is readily available in the pharmacy
Prescribing privileges are clearly defined and approved by the pharmacy and therapeutics committee
There is proper implementation of prescribing privileges (Check at least 5 medical records for compliance
المعيار السابع عشر
The pharmacy has a system for handling drug recall.

PH.17.1 Clearly written IPP including identification and handling drug recalls, time frame, and procedures for informing patients who received any recalled drug.
PH.17.2 Evidence of proper recall is documented (memos, recall forms, hospital exit documents).
PH.17.3 None of the recalled drugs is available in the pharmacy or patient care areas

الصيدلية لديها نظام للتعامل مع سحب الأدوية المخدرة.

PH.17.1 IPP سياسات مكتوبة بوضوح بما في ذلك تحديد ومعالجة المخدرات تذكر، والإطار الزمني، وإجراءات لإبلاغ عن المرضى الذين تلقوا أي نوع من المخدرات .
تم توثيقه PH.17.2 الدليل على الارجاع ( السحب) الصحيح (المذكرات، وأشكال الاستدعاء والوثائق خروج المستشفى).
PH.17.3 أي من الأدوية المسحوبة(التي تم ارجاعها) توجد في اقسام التنويم أو عند المريض
Recommendation
Written policy and procedures on handling drug recall
There is proper recall system (documentation of actual recalls, absence of recall drugs in the hospital
Drug recalls are monitored on timely basis by the pharmacy and therapeutics committee
المعيار الثامن عشر
The pharmacy has a system for identifying and handling expired medications.

PH.18.1 Written policy clearly defines expiry date, expired medications, nearly expired medications, and proper procedure for handling expired drugs, and inspection form(s).
PH.18.2 All expired and/or nearly-expired medications are properly labeled and stored separate from other medications.
PH.18.3 No expired drugs are found in any patient care area.
PH.18.4 Documents of return of expired drugs to supplier or manufacturer are maintained on file or evidence of proper destruction.
Recommendation
Written policy on identification and proper handling of expired and nearly expired drugs
There is proper labeling, isolation, destruction, and/or return of expired drugs to the supplier/vendor
المعيار التاسع عشر
The pharmacy has a system for handling pharmaceutical sales representatives and free medical samples.

PH.19.1 Written multidisciplinary IPP to outline the relationship of pharmaceutical sales representatives with healthcare professionals.
PH.19.2 Written multidisciplinary IPP for handling and dispensing free medical samples that has been approved by the Pharmacy and Therapeutic committee.
PH.19.3 All free medical samples are kept under tight inventory control in a separate and properly labeled cabinet in the pharmacy.
PH.19.4 No free medical samples are found in the inpatient areas or the outpatient clinics (OPD

الصيدلية لديها نظام للتعامل مع أدوية مندوبي المبيعات والعينات الطبية المجانية.

PH.19.1سياسة داخلية مكتوبة من الفريق متعدد التخصصات لتحديد العلاقة بين ممثلي مبيعات الأدوية ومع المتخصصين في الرعاية الصحية.
• PH.19.2 السياسات المكتوبة من الفريق متعدد التخصصات للتعامل مع العينات الدوائية الطبية والمجانية تمت الموافقة عليها من قبل لجنة الصيدلة والعلاجية.
PH.19.3• جميع العينات الطبية المجانية تحت مراقبة المخزون تجرد و يتم الاحتفاظ بها في خزنة منفصلة
PH.19.4لا توجدالعينات المجانية الطبية في اقسام المرضى الداخليين أو العيادات الخارجية
Recommendation
Written multidisciplinary policy for handling pharmaceutical sales representatives and free medical samples
There is tight control of free medical samples by the pharmacy (no samples in all patient care areas
The use of free medical samples is controlled and monitored by the pharmacy and therapeutics committee
المعيار العشرون
The pharmacy has a system for handling non-formulary drug requests.

PH.20.1 Written multidisciplinary IPP for handling non-formulary drugs including clearly defined time frame for drug procurement.
PH.20.2 Non-formulary drug request form is available.
PH.20.3 Clear evidence of proper handling of non-formulary drug request is available

Recommendation
Written multidisciplinary policy on handling non-formulary drug requests
There is proper handling of non-formulary drug requests (actual samples on file
All non-formulary drug requests are reviewed and evaluated by the pharmacy and therapeutics committee on regular basis
المعيار الحادي والعشرون
The pharmacy has a system for using formulary drugs for un-approved indications.

PH.21.1 Written multidisciplinary IPP for using a formulary drug for an un-approved indication and/or investigation.
PH.21.2 Request form for using formulary drug for an un-approved indication is available.
PH.21.3 Clear evidence of proper adherence to the IPP for using formulary drugs for an un-approved indications
Recommendation
Written multidisciplinary policy for the use of formulary drugs for unapproved indications
There is proper implementation of using drugs for unapproved indications (actual samples on file
All requests for using drugs for un-approved indications are reviewed and evaluated by the pharmacy and therapeutics committee on regular basis.
المعيار الثاني والعشرون
The pharmacy has a system for handling out-of-stock medications and PRN.

PH.22.1 Written IPP for handling out-of-stock formulary medications including clearly defined time frame for drug procurement.
PH.22.2 Written IPP and evidence of implementation for handling PRN drugs e.g. NTG, S.L Isordil, Voltaren, etc
Recommendation
Written policy for handling out-of-stock medications
Active involvement of the pharmacy and therapeutics committee in the proper management of out-of-stock formulary medications
Written policy for handling PRN (as needed) drug orders
There is proper implementation of PRN drug orders
المعيار الثالث والعشرون
The pharmacy has a system for handling patient’s own medications (brought from home).

PH.23.1 Written multidisciplinary IPP for handling patient’s own medications (brought from home).
PH.23.2 Patient’s own medications are properly labeled by the pharmacy before use.
PH.23.3 Evidence of proper implementation of patient’s own medication (documentation in patient’s drug profile and nursing MAR).
Recommendation
Written multidisciplinary policy on handling patients own medications (brought from home
There is proper implementation of patient's own medication system (observation in the patient care units and nursing MAR)
المعيار الرابع والعشرون
The pharmacy has a system for ensuring preparedness of crash cart medications.

PH.24.1 Developing and maintaining a set of guidelines for crash cart medication (all drugs on crash carts throughout the hospital are standardized) - multidisciplinary policy.
PH.24.2 Updating the crash cart drug list in accordance to the Saudi Heart/American Heart Association recommendation.
PH.24.3 Protecting emergency medications from loss or theft using safety plastic seal.
PH.24.4 Keeping plastic seals stocked in a safe place under supervision of pharmacy or nursing.
PH.24.5 Monitoring emergency medications and replacing them in a timely manner after use or when expired or damaged.
PH.24.6 Performing documented monthly inspection of crash cart medications and maintaining records in the pharmacy
Recommendation
Written multidisciplinary policy on standardization of crash cart medication contents (according to Saudi/American Heart recommendations
Emergency medications are protected from loss or theft (Properly locked and easily open, lock number is recorded, tight control on extra locks
Regular monitoring and replacement of expired, damaged or used medication(s).
There are documented monthly inspection of crash cart medications (crash cart records of the pharmacy
المعيار الخامس والعشرون
The pharmacy has a system for ensuring stability of medication available in multi-dose containers.

PH.25.1 Developing and maintaining a set of guidelines for ensuring stability of multi-dose vials, multi-dose oral liquid, and other multi-dose medications (e.g., eye, ear, and nose drops, creams, ointments, nebulization solution, etc.).
PH.25.2 Ensuring that all open multi-dose containers carry open date, expiry date, initials, and time (if necessary).
PH.25.3 Ensuring that no expired open or unlabeled open multi-dose containers are available in patient care areas
Recommendation
Availability of pharmacy stability guidelines of multi-dose vials and containers in all patient care units
There is proper labeling of vials and multi-dose containers after the first use

المعيار السادس والعشرون
The pharmacy has a system for managing floor stock medications

PH.26.1 An approved list of floor stock medication is allowed on each unit or clinic.
PH.26.2 Floor stock supply is available in limited quantities.
PH.26.3 Floor stock supply is not accessible to patients or visitors.
PH.26.4 Floor stock medications are stored under proper condition (temperature, light protection). Storage area is clean and organized.
PH.26.5 No expired medications are available.
PH.26.6 All floor stock medications are well separated and properly labeled
Recommendation
Well structured and approved system for floor stock medication assignment in limited quantities according to each service unit needs.
There is proper storage and maintenance of floor stock drugs (locked, inaccessible to visitor/patients, properly labeled, proper storage condition, not expired, not overstocked
المعيار السابع والعشرون
The pharmacy has a system for handling high-risk medications.

PH.27.1 Written guidelines for handling high-risk medications (including a defined list).
PH.27.2 Concentrated intravenous potassium, magnesium and hypertonic saline are not allowed as floor stock except as part of the crash cart medication as per Saudi Heart recommendation.
PH.27.3 Only, if necessary, critical care areas may stock limited quantities of intravenous potassium, and magnesium in a separate, locked and properly labeled cabinet.
PH.27.4 Standard drug concentrations of all intravenous drips in the hospital.
Recommendation
Written guidelines for high-risk medications
The guidelines for handling high-risk medications are closely monitored and reviewed by the pharmacy and therapeutics committee
Concentrated intravenous electrolytes are not readily available in patient care units
There is standardization of intravenous drip concentrations in patient care units
المعيار الثامن والعشرون
The pharmacy has a system developed for handling outpatient prescriptions which includes:

PH.28.1 A policy for filling, refilling prescriptions, discharge medications, and self-medication of healthcare professionals.
PH.28.2 All prescriptions have the patient’s name, hospital number, age, ***, diagnosis, prescriber's name, pager # or code & signature, clinic name and date.
PH.28.3 Any prescription is double-checked by another pharmacist before dispensing
Recommendation
Written policy on handling outpatient prescriptions
All prescriptions have the patients name, hospital number, age, ***, diagnosis, prescriber's name, pager # or code & signature, clinic name and date (Sample of pharmacy received prescriptions
Double check system is implemented (sample dispensed medicine
المعيار التاسع والعشرون
The outpatient pharmacy has a system developed for proper labeling of drugs which includes:

PH.29.1 All outpatient drugs are labeled in Arabic and/or English according to patient preference.
PH.29.2 Outpatient label reflects Hospital name, patient name, drug name, strength, dosage, and directions.
PH.29.3 Colored auxiliary labels that stick out are used whenever applicable (e.g. refrigerate, do not refrigerate, shake before use, external use, etc).
Recommendation
There is appropriate labeling language (Arabic and/or English according to patient preference
There is complete labeling information (hospital, patient and drug name, strength, dosage, directions, colored auxiliary cautions
المعيار الثلاثون
The outpatient pharmacy has a system developed for patient and family education before going home which includes:

PH.30.1 Patients and families are offered education for dispensed medications.
PH.30.2 Written drug counseling materials are available in easy understandable language (Arabic and English).
PH.30.3 There is a private area for patient counseling
Recommendation
Availability of patient and family education system (for outpatients and going home patients, written education materials in the appropriate language, private area for counseling
There is appropriate education (staff awareness and skills)- observation of at least three educational cases in the outpatient pharmacy
المعيار الحادي والثلاثون
The pharmacy shows evidence of continuing education and staff training by:

PH.31.1 Written policy and well defined pharmacy orientation and continuing education program.
PH.31.2 Evidence of completion of pharmacy orientation by all newly hired pharmacy staff.
PH.31.3 Evidence of continuing education activities (provision or attendance of lectures, in-services, conferences & symposia, or distant learning e.g., internet or CE articles).
PH.31.4 Each pharmacy section has the following reference manuals and/or policies (relevant policy and procedure manual, infection control manual, safety manual, operating manual of equipments, MSDS manual).
PH.31.5 The pharmacy staff operates equipment safely by maintaining skills in the use of equipment including trouble-shooting.
PH.31.6 The pharmacy staff knows how to report and properly label malfunctioning equipment so that staff do not use it.
Recommendation
Written policy on pharmacy orientation and continuing education program
There is completion of pharmacy orientation and continuing education program (randomly screen 10% or at least 5 personnel files

Availability of all necessary manuals (pharmacy, infection control, equipment operation, and MSDS manual
There is safe operation of all available pharmacy equipment (interview pharmacy staff operating equipments
المعيار الثاني والثلاثون
The pharmacy has a system for drug storage (inpatient, outpatient, store, patient care areas) and includes:

PH.32.1 Storage of items requiring refrigeration at a temperature of 2-8 °C and those requiring freezing at -20° to -10 °C.
PH.32.2 All medication refrigerators and freezers are equipped with appropriate thermometers (digital and non-digital) and temperature log sheet and temperature is recorded at least once daily.
PH.32.3 Vaccine refrigerator is connected to emergency power source, (electric outlets are marked) and temperature is recorded 24-h daily.
PH.32.4 Food, drinks, biological samples, culture media are not allowed in medication refrigerators.
PH.32.5 Storing antiseptics, disinfectants and drugs for external use separately from internal and injectable medications.
PH.32.6 All medications are well separated and properly labeled upon display on the shelves
Recommendation
Written policy on drug storage across the hospital.
There is at least daily monitoring and recording of refrigerators (2-8 آ°C) and freezers (-20 to -10آ°C) temperature using digital or non-digital means
The vaccine refrigerator(s) are connected to emergency power supply and its temperature is recorded around the clock
The antiseptics/disinfectants and externally used drugs are well separated from those used internally or by injection
المعيار الثالث والثلاثون
The following rules are written and implemented as to the dispensing mechanism for inpatient:

PH.33.1 There is a quiet, adequately illuminated and low-noise working environment that does not permit interruption of work.
PH.33.2 A log is maintained as to the person pre-packing & the person checking all unit doses made. If Unit-dose pre-packing is not available, doses of each drug are placed in plastic bag and properly labeled.
PH.33.3 No more than 24-h supply is dispensed at a time except for bulk (liquids, ointments, etc.)
Recommendation
Written policy on inpatient pharmacy dispensing mechanism
The Pharmacy dispensing area is quiet, adequately illuminated and low noise
Only 24 hours drug supply is dispensed as unit-dose for inpatient and a log is maintained for pre-packing activities
المعيار الرابع والثلاثون
The following rules are written and implemented as to handling inpatient drug orders.

PH.34.1 A copy or fax of the original physician order or electronic version is sent to the pharmacy.
PH.34.2 Any new physician order, reorder or changing order is made in writing.
PH.34.3 Stat orders are separated from regular and filled within 30 minutes of transmittal
Recommendation
Clearly written rules on handling inpatient drug orders (electronic or hard copy or fax for new, reorder or change of order
Stat drug orders are separated from regular and filled within 30 minutes of transmittal
المعيار الخامس والثلاثون
The pharmacy maintains updated drug profiles for all admitted patients.

PH.35.1 Each patient has a drug profile maintained in the inpatient pharmacy (electronic or hard copy).
PH.35.2 Drug profile reflects patient name, MRN#, age, ***, weight/height, allergies, diagnosis, and location in the hospital.
PH.35.3 Drug profile reflects all active and inactive medication orders during current admission (drug name, strength, formulation, dosage, special instruction).
PH.35.4 Drug profile reflects the start date, stop date, number of dispensed doses and pharmacist signature.
PH.35.5 Drug profile reflects any stat, single dose, PRN, controlled/narcotics, and floor stock medications.
PH.35.6 Drug profile reflects IV fluids, TPN, and chemotherapy.
Recommendation
Availability of complete drug profiles (paper or electronic) for all current inpatients.
All patient drug profiles in the pharmacy are complete and updated (patient demographics, diagnosis, allergies, location, most responsible physician (Sample10% or at least 10 profiles
All drug profiles reflect both active and inactive drug orders of current admission (Sample 10% or at least 10 profiles).
Drug profile reflects all types of drug orders (Stat, regular, PRN, IV, TPN, chemotherapy, IV fluids, etc..) with start/stop date, number of unit-doses dispensed and pharmacist signature. (Sample 10% or at least 10 profiles).
المعيار السادس والثلاثون
There is a system to monitor drug allergies and includes the following:

PH.36.1 There is a written mechanism to ensure allergies are identified by the attending physician and immediately communicated to the pharmacy in writing.
PH.36.2 Allergies are documented in each patient drug profile before dispensing any medication.
PH.36.3 There is a written mechanism in place that allows for pharmacy intervention including stop dispensing when patient is identified as being allergic to prescribed drug(s).
Recommendation
Written mechanism for monitoring drug allergies (identification, documentation and communication, and pharmacy intervention
There is a pharmacy flagging patient's drug profile for drug allergies (sample 10% or at least 10 profiles).
المعيار السابع والثلاثون
There is a process for monitoring, detecting, and reporting adverse drug reactions (ADRs) and includes:

PH.37.1 Written policy and procedure for ADR.
PH.37.2 Definition of a significant or serious ADR and timeframe for reporting.
PH.37.3 ADR reporting forms are available
PH.37.4 Intensive analysis is performed for all significant or serious ADRs.
PH.37.5 Notification of treating physician.
PH.37.6 There is evidence that the patient receives appropriate care for the ADR.
PH.37.7 There is evidence that the medical record has been flagged for known allergies.
PH.37.8. Process for improving ADR reporting.
PH.37.9. Evidence of reporting any serious or unexpected ADR to the MOH.
Recommendation
Comprehensive policy on adverse drug reaction (ADRs) reporting including definition of serious /significant ADR, time frame and reporting format.
There is an active reporting, analyzing, and proper medical record flagging system (sample 10% or at least 10 reports available on file
The pharmacy and therapeutics committee reviews and utilizes the reported data to improve ADR reporting.
المعيار الثامن والثلاثون
There is a process for monitoring, identifying and reporting significant medication errors & includes:

PH.38.1 Written policy and procedure for medication error reporting.
PH.38.2 Definition of a significant medication error, timeframe for reporting, and reporting format.
PH.38.3 Evidence of active reporting exists.
PH.38.4 Intensive root-cause analysis is performed for all significant medication errors.
PH.38.5 Evidence for using reported data to improve medication use process and reduce error rate.
PH.38.6 Mechanisms to prevent serious medication errors (e.g. removal of concentrated intravenous potassium, magnesium, hypertonic saline, other high risk stocks from nursing units
Recommendation
Comprehensive policy on medication errors reporting including definition of significant errors, time frame and reporting format
There is an active reporting and root-cause analysis of significant errors. (sample 10% or at least 10 medication errors reports available on file
The pharmacy and therapeutics committee reviews and utilizes the reported data to improve medication safety
المعيار التاسع والثلاثون
PH.39.1 There is a procedure for pharmacy intervention /clarification of physician orders.
PH.39.2 The pharmacy notifies the prescribing physician if a drug prescribed is not available.
PH.39.3 Evidence of evaluation, monitoring, and documentation of drug-drug and drug-food interactions.
PH.39.4 Drugs are prescribed and dispensed for their approved indications as evidenced by the given diagnosis.
PH.39.5 Standard administration time is announced and adopted by pharmacy & nursing
Recommendation
Written procedures for pharmacy monitoring prescribed medication (including indication, dosing, administration, and interactions).
There is pharmacy intervention and clarification of drug orders (sample 10% or at least 10 drug orders/clarification forms
Implementation of standard drug administration time
المعيار الأربعون
The pharmacy has a system for automatic stop orders (ASO):

PH.40.1 Written policy and procedure for handling automatic stop orders.
PH.40.2 All physician orders are valid for 7 days unless shorter period is specified.
PH.40.3 ASO for all drugs at time of surgery.
PH.40.4 ASO for antibiotics as per hospital policy.
PH.40.5 Daily orders for anticoagulants (e.g. intravenous heparin, warfarin).
PH.40.6 Daily order for any continuous intravenous drips (e.g. dopamine, dobutamine, KCL, NTG, fentanyl, midazolam, etc.)
PH.40.7 ASO for IV, IM, and oral controlled medications
Recommendation
Written policy and procedures on automatic stop orders (ASO).
There is compliance with ASO at the time of surgery (sample medical records, MAR, and Pharmacy drug profile
There is compliance with ASO for anticoagulants, continuous intravenous drips, narcotics and controlled medications (Sample medical records, MAR, and Pharmacy drug profile
المعيار الحادي والأربعون
There is a system for verification of prescriptions:

PH.41.1 A qualified pharmacist initially verifies all physician orders.
PH.41.2 A pharmacist or technician fills medication trolley according to a dispensing list, patient drug profile or physician orders.
PH.41.3 All medications dispensed for inpatients are checked by another licensed pharmacist.
PH.41.4 Generic equivalent may be dispensed for brand name for the same strength or concentration and dosage form.
Recommendation
Clear system for prescription verification, filling, and double checking before dispensing
Qualified pharmacist initially verifies all physician orders
There is a generic substitution system (during staff interview or by observation in the pharmacy records of dispensing).
المعيار الثاني والأربعون
There is evidence for safe packaging of the medications given to patients by:

PH.42.1 Using unit-dose packaging system for solid dosage forms.
PH.42.2 Using unit-dose packaging system for liquid dosage forms.
PH.42.3 Using plastic “Ziploc” bags for tablets or capsules.
PH.42.4 Using plastic “Ziploc” bags for ampoules, vials, or suppositories.
PH.42.5 Using plastic or umber-colored glass for bulk liquids.
PH.42.6 Properly labeling all unit-dose, plastic Ziploc bags or original bulk liquids.
PH.42.7 The expiry date of repackaged unit dose should comply with the current American Society of Health-System Pharmacists (ASHP) guidelines.
Recommendation
Availability of safe unit-dose pre-packaging system

Availability of Ziplocs plastic bags for ampoules, vials, suppositories and non-prepackaged drugs

There is protection for light sensitive medications (umber colored material, aluminum foil, etc.).
There is compliance of the pre-packaged material with the current expiry date guidelines
المعيار الثالث والأربعون
There is a system to ensure safe labeling of all Inpatient medications and includes the following:

PH.43.1 Printed or hand written label for any dispensed medication.
PH.43.2 Unit-dose pre-pack is labeled with drug name, strength, formulation, lot # and expiry date.
PH.43.3 If Unit-dose pre-packing is not available, doses of each drug are placed in plastic bag & labeled with: Patient MRN #, Location (ward #, Bed #), drug name, dosage, lot # and expiry date.
PH.43.4 Label is affixed to the immediate container after removal of outside carton.
PH.43.5 Colored auxiliary label (stick out) is used as appropriate (e.g. refrigerate, do not refrigerate, shake before use, external use only, etc.).
PH.43.6 Inpatient drug cassettes are labeled with patient Name, MRN#, and bed number.
Recommendation
Safe labeling of all Inpatient medications (including generic name, strength, formulation, expiry date, and lot number).
Safe labeling of patients' medication cassettes (Patient full name, MRN, and room/bed number
Main label and all necessary colored auxiliary labels are affixed to the immediate container after removal of outside carton
المعيار الرابع والأربعون
The pharmacy has a safe system for Extemporaneous Preparations and:

PH.44.1 Written IPP for extemporaneous preps.
PH.44.2 Only Oral and Topical preparations are extemporaneously prepared.
PH.44.3 There are adequate equipment and glass wares (e.g., weighing scale, bottles, jars, mortar, filters, electric heater, thermometer, etc).
PH.44.4 There is a sink with water supply and stainless steel surface.
PH.44.5 Working bench is clean with a smooth surface.
PH.44.6 A log is maintained as of preparation name, strength, quantity prepared, batch number, preparation and expiration date, prepared by & checked by, etc.
PH.44.7 Printed or hand written label should reflect preparation name, strength, batch number, and expiration date.
PH.44.8 Preparation manual (formula book) is available and properly referenced (ASHP, BP and or USP Guidelines).
PH.44.9. If compounding is done by an outside vendor, a copy of contract, registration license, and formulation should be available.
Recommendation
Written policy for safe compounding of extemporaneous preparations or evidence of contract with recognized outside vendor
Availability of equipment, chemicals and facilities (space, working surface, sink, etc.) necessary for compounding
Compounding manual, workbook, and log book are updated for all available extemporaneous preparations
Safe labeling of compounded pharmaceuticals (including product name, strength, batch number and expiry date
المعيار الخامس والأربعون
There is a system for handling Narcotics and Psychotropic Drugs (Controlled Drugs) in accordance with MOH regulations and includes but is not limited to:
PH.45.1 There is a written policy and procedure for handling narcotics and psychotropics.
PH.45.2 Receiving, storing and dispensing controlled drugs by the pharmacy.
PH.45.3 Keeping controlled drugs behind steel doors with double locks.
PH.45.4 Keeping limited floor stock supply in a double door, double locked cabinet.
Recommendation
Written policy and procedures on handling narcotics and psychotropics
There is tight security (controlled by pharmacy, stored behind steel doors, limited supplies in patient care units in double-door double-locked cabinets
المعيار السادس والأربعون
There is a system for auditing Narcotics and Psychotropic Drugs in accordance with MOH regulations:

PH.46.1 Auditing every shift in the pharmacy.
PH.46.2 Auditing every shift in each nursing unit.
PH.46.3 Maintaining proper documentation of drug count and accountability in the pharmacy.
PH.46.4 Maintaining proper documentation of drug count & accountability in each nursing unit.
PH.46.5 Maintaining proper documentation of empty containers of narcotics.
PH.46.6 Evidence of proper disposal of unused portion of an ampoule or a tablet
Recommendation
Auditing system for narcotics and psychotropics all over the hospital (every shift, full and empty ampoule, proper written document
There is proper disposal and documentation of unused portion of an ampoule or a tablet (sample nursing unit records

المعيار السابع والأربعون
There is a system for Prescribing Narcotics and Psychotropic Drugs (Controlled Drugs) in accordance with MOH regulations and includes but is not limited to:

PH.47.1 Using the MOH approved prescriptions.
PH.47.2 Not allowing physicians to prescribe controlled drugs for self or family members.
PH.47.3 Allowing only clinical privileged physicians to prescribe.
PH.47.4 Allowing only psychiatrists and specialists to prescribe psychotropics (except during emergency).
PH.47.5 Not allowing injectable narcotics and controlled drugs for outpatients.
Recommendation
There is full compliance with MOH prescribing guidelines (MOH approved prescriptions, prescribing privileges, dispensed quantities) (sample at least 10 different drug prescriptions
المعيار الثامن والأربعون
The pharmacy provides all Intravenous admixture services in the hospital.

Recommendation
Pharmacy provides all intravenous admixture services (no partial score is allowed here. It is either zero or 3).
المعيار التاسع والأربعون
The Pharmacy Intravenous admixture service is safe and:

PH.49.1 There is a written policy and procedure for IV admixture services.
PH.49.2 There is a manual for proper aseptic technique & IV room cleanliness. Aseptic techniques are strictly followed.
PH.49.3 There are written guidelines for drug stability and compatibility. Guidelines are strictly followed.
PH.49.4 The IV pharmacy staff is well trained and certified.
PH.49.5 There are policy and procedures for recycling of returned IV admixtures in accordance with ASHP guidelines.
PH.49.6 There are guidelines for drugs that may be safely given IV push.
Recommendation
Written policy and procedures on safe intravenous admixture services
Availability of manuals (aseptic technique, drug-stability and -compatibility) and guidelines (IV push guidelines, recycling).
Qualification, training and experience of IV pharmacy staff (recognized training center, recognized trainer, official certificate).

المعيار الخمسون
The Pharmacy Intravenous Admixture section is fully equipped and well maintained.

PH.50.1 The IV room space, design, floor cover, wall painting, air flow and pressure are in compliance with ASHP requirements for clean room.
PH.50.2 The LAFH has HEPA filter (99.97% efficiency) and has visible pressure gauge for detecting leaks or defects.
PH.50.3 The LAFH is tested in accordance with the manufacturer requirements and in accordance with ASHP guidelines.
PH.50.4 The IV admixture area is separate form chemotherapy area.
PH.50.5 All IV Products are labeled to show: patient name, MRN#, location, drug name(s) and concentration, diluents name and volume, infusion rate, date and time of preparation, prepared and checked by.
PH.50.6 All I.V. admixtures are checked by another licensed pharmacist
Recommendation
Availability of adequate space, design (floor cover, wall painting, air flow and pressure) and equipments (including functional and certified LAFH
There is proper labeling of final product (patient name, MRN, location, drug name and concentration, diluents name and volume, infusion rate, date and time of preparation, prepared and checked by
المعيار الحادي والخمسون
If no Pharmacy-based IV admixture program is in place, pharmacy provides:

PH.51.1 A manual for proper aseptic technique & area cleanliness.
PH.51.2 Assurance that aseptic techniques are strictly followed.
PH.51.3 Written guidelines for drug stability and compatibility. Guidelines are strictly followed.
PH.51.4 That IV admixture area is completely separate from the chemotherapy area.
PH.51.5 Guidelines for drugs that may be safely given IV push.
PH.51.6 That dispensing area is appropriate (location, space, cleanliness, traffic, etc).
Recommendation
Availability of manuals (aseptic technique, drug-stability and -compatibility) and guidelines (IV push guidelines, recycling) in each nursing unit.
Availability of appropriate dispensing area (location, space, cleanliness, traffic, etc) in the patient care area
Qualification, training and experience of IV nurse(s) (recognized training center, recognized trainer, official certificate).
المعيار الثاني والخمسون
If no Pharmacy-based IV admixture program is in place, the pharmacy is responsible for:

PH.52.1 Training and monitoring performance and qualifications of non-pharmacy personnel forming parenteral products.
PH.52.2 Monitoring IV admixture areas all over the hospital (cleanliness, proper storage, etc).
PH.52.3 All IV Products are labeled to show: (patient name, MRN#, location, drug name(s) and concentration, diluents name and volume, infusion rate, date and time of preparation, prepared and checked by
Recommendation
The pharmacy is training and regularly monitoring the performance of nursing doing IV admixture
There is proper labeling of final product (patient name, MRN, location, drug name and concentration, diluents name and volume, infusion rate, date and time of preparation, prepared and checked by
المعيار الثالث والخمسون
Only Pharmacy Department provides Chemotherapy admixture services.
Recommendation
Only Pharmacy provides chemotherapy admixture services (no partial score is allowed here. It is either zero or 3).
المعيار الرابع والخمسون
Chemotherapy Preparation Service is provided by certified pharmacy staff in a fully equipped and properly designed place according to Occupational Safety and Health Administration (OSHA) Standards.

PH.54.1 Written policy and procedures for handling chemotherapy.
PH.54.2 Preparation is done under a biological safety cabinet (Vertical LAFH) type B.
Exhaust is separated from air circulation to outside the building.
PH.54.3 Work is done by well-trained and certified chemotherapy pharmacist.
PH.54.4 Aseptic techniques are strictly followed.
PH.54.5 Chemotherapy area is isolated from IV admixture area
Recommendation
Written policy and procedures on chemotherapy preparation services
Availability of functional and certified biosafety cabinet (Vertical LAFH with proper exhaust system) isolated from regular IV admixture area.
Qualification, training and experience of chemotherapy pharmacy staff (recognized training center, recognized trainer, official certificate).

المعيار الخامس والخمسون
There is a safe system for handling Chemotherapy Preparation and includes but is not limited to the following processes:

PH.55.1 OSHA guidelines are adopted.
PH.55.2 All preparations are double checked by a certified pharmacy staff and records of dispensed prescription are kept for at least 30 days.
PH.55.3 All preparations are placed inside a Ziploc plastic bag and labeled "Cytotoxic".
PH.55.4 All wastage and spillage are handled separately according to OSHA.
PH.55.5 Special chemotherapy protective gloves, masks and gowns are in use.
PH.55.6 Chemotherapy spill kit is available and staff is trained on how to use it.
Recommendation
Availability of personal protective equipment, chemotherapy spill kits, Ziploc cytotoxic plastic bags, chemotherapy waste disposal bags
Staff are fully trained on using chemotherapy spill kit

المعيار السادس والخمسون
Only the pharmacy provides Total Parenteral Nutrition (TPN) services
Recommendation
Only Pharmacy provides Total Parenteral Nutrition (TPN) services (no partial score is allowed here. It is either zero or 3)..
المعيار السابع والخمسون
There is a safe system for Total Parenteral Nutrition (TPN) Services which includes but is not limited to the following:

PH.57.1 Written IPP for handling TPN
PH.57.2 Work is done under LAFH-type A.
PH.57.3 Aseptic techniques are strictly followed.
PH.57.4 Work is done by well-trained & certified TPN pharmacy staff.
PH.57.5 Availability of macro- & micro-nutrients and TPN filters.
PH.57.6 Stability / compatibility references are available.
PH.57.7 Double check policy at each stage of admixture is implemented.
PH.57.8 Final product passes visual inspection for particles.
PH.57.9 Proper labeling to reflect ingredients and their quantities, volume, infusion rate, expiry date, patient demographics, etc.
PH.57.10 All TPN orders are monitored by qualified pharmacist.
Recommendation
Written policy and procedures on TPN preparation
Availability of equipment (functional and certified LAFH), micro- and macro-nutrients, TPN filter, bags, and volume transfer system), and manuals (stability and compatibility, etc.)
All TPN orders are monitored by qualified, trained and experienced TPN pharmacist (recognized training center, recognized trainer, official certificate).
There is proper labeling of TPN (ingredients, quantities, volume, infusion rate, expiry date, patient demographics, etc.)

المعيار الثامن والخمسون
Drug Information Service is available and includes:

PH.58.1 Written policies and procedures.
PH.58.2 Drug information center is staffed by qualified pharmacist with special training in drug information.
PH.58.3 A good collection of up-to-date information resources: Micromedex, IOWA drug information system, local and international pharmacy and therapeutics journals, pharmacy textbooks and manuals, Saudi national formulary, specialty references as neede
PH.58.4 Being equipped with: Microfiche reader/ printer, photocopier machine, computer with printer, reading table with chairs, storage shelves & cabinets, telephone line with internet connection, quiet and well illuminated reading area.
PH.58.5 All questions being logged in with date and time of arrival. All answers are documented and filed in order.
PH.58.6 Giving priority to poisoning and critical care patients.
PH.58.7 Posting and making available telephone number for the nearest poison control center and poison antidote information
Recommendation
Written policies and procedures on Drug Information Services
Qualification, training and experience of the drug information pharmacist(s) (recognized training center, recognized trainer, official certificate
Availability of appropriate space, design, environment, equipments, and updated information resources
There is appropriate documentation (of all answered questions) and posting of necessary information (poisoning antidotes, poison center telephone numbers
المعيار التاسع والخمسون
If drug information service is not available, pharmacy areas should have adequate drug information resources and includes but is not limited to:

PH.59.1 Saudi National Formulary (SNF).
PH.59.2 British National Formulary (BNF).
PH.59.3 Middle East Medical Index.
PH.59.4 Martindale the extra pharmacopoeia.
PH.59.5 Specialty drug references according to available services.
PH.59.6 Posting and making available telephone number for the nearest poison control center and poison antidote information

Recommendation
Availability of updated drug information references (including Saudi National Formulary, British National Formulary, Martindale the extra pharmacopoeia, Middle East Medical Index, and other Specialty drug references
Posting all necessary information (poisoning antidotes, poison center telephone numbers).
المعيار الستون
The pharmacy shows evidence of Quality Improvement by:

PH.60.1 Appointing a Quality Management Coordinator who reports to the pharmacy head.
PH.60.2 Having standards for all the pharmaceutical care processes.
PH.60.3 Subjecting current standards to evaluation.
PH.60.4 Having a Pharmacist who is actively involved with drug utilization committee process/function.
PH.60.5 Developing and maintaining a plan and documented performance improvement program.
PH.60.6 Continually determining areas for improvement.
PH.60.7 Immediately reporting life threatening issues to the pharmacy head and hospital TQM department (e.g. morbidity, mortality, teratogenicity), drugs required immediate surgical intervention, any new ADR or toxic events of a new drug(s).
PH.60.8 Reporting any questionable drug quality to pharmacy head (e.g. ineffective medication, inconvenient size, shape, volume or color, package or label, etc.).
Recommendation
Availability of quality management coordinator who reports directly to pharmacy director/head
There is continuous performance improvement program
There is reporting of any questionable drug quality issues (both locally and to MOH authorities
There is an active drug utilization evaluation (DUE) program
المعيار الحادي والستون
Security measures are in place and include:

PH.61.1 Limited access to pharmacy.
PH.61.2 Visible name tags for all personnel.
PH.61.3 Proper locking procedures for any pharmacy not open 24h a day.
PH.61.4 The pharmacy doors and windows being locked during operation.
PH.61.5 Identification of which pharmacy personnel have keys to pharmacy.
PH.61.6 Having an IPP for non-pharmacy staff accessing pharmacy after hours in case of emergency (fire, flood, etc
Recommendation
Appropriate pharmacy security (visible name tags, limited access, doors and windows are closed during operation, key holding, etc.)

Written policy and procedures on emergency opening pharmacy after working hours

المعيار الثاني والستون
Safety measures are in place and include but is not limited to:

PH.62.1 Having an IPP for safe handling of dangerous substances and changing the HEPA filter of biological safety cabinets.
PH.62.2 Keeping a list of hazardous materials readily available in areas where they are stored or used.
PH.62.3 Storing all chemicals in a separate place on low shelves, & in the original labeled container.
PH.62.4 Keeping material safety data sheets (MSDS) available in areas where hazardous materials are stored or used.
PH.62.5 Keeping all flammables in a well-ventilated area where no smoke is allowed.
PH.62.6 Keeping spill kits available in areas where hazardous materials are stored or used.
PH.62.7 Keeping personnel protective equipment (gowns, gloves, eye & face protection) readily available.
PH.62.8 Storing Cancer chemotherapy drugs separately.
PH.62.9 Not allowing pregnant and lactating mother to work with chemotherapy. Regular medical checks for chemo worker (Family Medicine).
PH.62.10 Having eye wash stations and shower rooms available in appropriate area.
PH.62.11 Collecting all chemotherapy wastes in orange plastic bags to be incinerated.
PH.62.12 Training all staff on how to handle spills.
Recommendation
Written policy and procedures on identification, safe handling, stocking, and transportation of hazardous materials (chemicals, chemotherapy, flammables, etc.)


There is safe storage of hazardous materials (Hazardous list, safety cabinets, good ventilation, low shelves, original labeled container



Availability of personnel protective equipments, eye wash station, MSDS, and spill kits

There is staff training on handling spills and waste disposal (may ask few staff to demonstrate spill handling using spill kit

سوف يتم عمل الترجمة في مشاركة منفصلة
من مواضيع : الكفاح
الكفاح غير متواجد حالياً  
  رقم المشاركة : [ 5 ]
قديم 10-17-2012, 12:40 PM
افتراضي رد: متطلبات معايير الصيدلية

المعيار العشرون
الصيدلية لديها نظام لمعالجة الطلبات الغير متوفرة في كتيب الوصفات الدوائية .

PH.20.1 سياسة داخلية مكتوبة من الفريق متعدد التخصصات للتعامل مع الأدوية غير متوفرة في كتيب الوصفات الدوائية بما في ذلك يوضح الوقت الزمني لشراء الأدوية.
PH.20.2 الأدوية غير متوفرة في كتيب الوصفات الدوائية لها نموذج خاص عند طلبها.
PH.20.3 دليل واضح على التعامل السليم مع طلب الأدوية غير المتوفرة في كتيب الوصفات الدوائية.

المعيار الحادي والعشرون
الصيدلية لديها نظام لاستخدام الأدوية التي في كتيب الوصفات الدوائية الغير موافق عليها والغير معتمد تأثيرها.

PH.21.1 سياسة داخلية مكتوبة من الفريق متعدد التخصصات لاستخدام الأدوية التي في كتيب الوصفات الدوائية الغير معتمد تأثيرها والغير معتمد اختبارها وفحصها
PH.21.2 نموذج طلب لاستخدام الأدوية التي في كتيب الوصفات الدوائية الغير معتمد تأثيرها والغير معتمد اختبارها وفحصها.
PH.21.3 الدليل الواضح على الالتزام السليم لاستخدام الأدوية التي في كتيب الوصفات الدوائية الغير معتمد تأثيرها والغير معتمد اختبارها وفحصها.

المعيار الثاني والعشرون
الصيدلية لديها نظام للتعامل مع الأدوية التي لايسمح بها التخزين في أقسام التنويم والأدوية عند اللزوم.

PH.22. سياسات داخلية مكتوبة عن الأدوية التي لايسمح تخزينها في أقسام التنويم والأدوية عند اللزوم.

PH.22.2 سياسات داخلية مكتوبة كتب وأدلة لتطبيق التعامل مع الأدوية مثل عند اللزوم NTG، S.L Isordil، فولتارين، الخ


المعيار الثالث والعشرون
الصيدلية لديها نظام للتعامل مع أدوية المريض الشخصية التي جلبها بنفسه. (التي يحضرها معه من المنزل اثناء التنويم)
PH.23.1 سياسات داخلية مكتوبة من الفريق متعدد التخصصات للتعامل مع الأدوية التي يستخدمها المريض ويحضرها معه من المنزل أثناء فترة بقاءه بالمستشفى
• PH.23.2 يتم عمل ملصق من الصيدلية على الأدوية التي احضرها المريض بنفسه .
PH.23.3 الدليل على التطبيق السليم مع الدواء التي يحضرها المريض بنفسه (يتم التوثيق في سجل المريض الطبي للأدوية ونموذج إعطاء الدواء الخاص بالتمريض).

باقي الترجمة سوف يتم عملها متى ماسنحت الفرصة
مل الصبر مني معجبون بهذا.
من مواضيع : الكفاح
الكفاح غير متواجد حالياً  
موضوع مغلق

مواقع النشر (المفضلة)

الكلمات الدليلية (Tags)
متطلبات, معايير, الصيدلية


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