Inspector checklist - Monitoring and inspec.pdf - General ...

Pharmacy proceduresAre there adequate and up-to-date SOPs in place forthe following:• Arrangements to ensure that medicinal productsare:-- ordered- stored- prepared- sold by retail- supplied in circumstances corresponding to retail sale- delivered outside the pharmacy and- disposed of in a safe and effective manner.• The circumstances in which a member of pharmacystaff who is not a pharmacist may give advice aboutmedicinal products;• The identification of members of pharmacy staffwho are, in the view of the responsible pharmacist,competent to perform specified tasks relating to thepharmacy business;• The keeping of records about the matters mentionedabove;• Arrangements which are to apply during the absenceof the responsible pharmacist from the premises;• Steps to be taken when there is a change ofresponsible pharmacist at the premises;• The procedure which is followed if a complaint ismade about the pharmacy business;• The procedure which is to be followed if an incidentoccurs which may indicate that the pharmacy businessis not running in a safe and effective manner and;• The manner in which changes to the pharmacyprocedures are to be notified to the staff.Is there evidence that the pharmacy procedures arereviewed?3 Version 1.0 September 2010

Pharmacy recordIs there evidence that the pharmacy record is accurateand entries are made contemporaneously?Is the pharmacy record maintained for at least 5years?AbsenceIs the responsible pharmacist ever absent from theregistered pharmacy?When absent does the responsible pharmacist remaincontactable or arrange for another pharmacist to becontactable and be available to provide advice?Staff trainingAre staff appropriately trained for the tasksundertaken or undergoing appropriate training?Service provisionAre SOPs available where required?Do service provisions comply with best practice?(Please indicate which service provisions werechecked).DispensingExamine a random sample of medicines awaitingcollection to ensure, for example, the use ofappropriate advisory and cautionary warning labels,appropriate container. Do they comply with theMedicines Act 1968?Is there an adequate audit trail to identify thepharmacist responsible for the supply?Is there an adequate audit trail to identify other staffinvolved in the dispensing process?In addition for MDS only:Is medication identifiable?4 Version 1.0 September 2010

e.g. descriptions/IDs of drugs included on labellinge.g. white, bevelled tablet marked BZ5Are there adequate procedures in place for handlingmedication or dosage changes occurring mid-cycle?Are medicines supplied in MDS for domiciliarypatients? If so, approximately how many?Are medicines supplied in MDS for patients in carehomes? If so, approximately how many?Medicine stock, containers and storageAre medicines stored appropriately?(i.e. in original boxes, fully labelled, no loose blisters,mixed batches and in an organised fashion).Are unlicensed medicines in stock?Are medicines stored in appropriate conditions?(e.g. temperature, humidity etc.).Are there adequate date checking procedures inoperation?Are dispensing containers appropriately stored?Record keepingAre private prescription records legally compliant?Are emergency supply records legally compliant?Are poison records legally compliant (includingpermits and other documentation where necessary)?Are records of sales of veterinary medicines legallycompliant (Veterinary Medicines Regulations)?Are specials records legally compliant?Are there appropriate records of extemporaneouslyprepared products (incl. Methadone)Does the pharmacy maintain an error log andsystems for documenting and auditing dispensingerrors that have reached the patient?5 Version 1.0 September 2010

Does the pharmacy maintain incident or near misslogs and systems for documenting and auditing errorspicked up during the dispensing process?Does the pharmacy maintain records of clinicalinterventions / significant events?Waste disposalAre procedures in place for the safe disposal ofreturned medicines from individuals or households(includes care homes), including hazardous waste?Are patient returned medicines clearly segregated?Are there procedures for the management of dateexpired pharmacy stock?Are staff trained to deal with waste and is appropriateprotective equipment available (including gloves,overalls and materials to deal with spillages)?ChemicalsAre chemicals stored, labelled and supplied incompliance with the Chemicals (Hazard Informationand Packaging for Supply) Regulations 2002?Are COSHH assessments available for hazardouschemicals stocked or supplied?Information sourcesAre main information services and/or referencesources available and up to date?Is there a system for dealing with Drug Alerts?Is an information pack available for locums?ComputerIs computer software regularly updated?Is the use of data registered in accordance with Data6 Version 1.0 September 2010

Protection Act 1998?Are patient confidential computer records accessibleonly to staff who need access?Are computer records regularly backed up?General premises checkFascia and front access to premisesShop AreaDispensary area(s)Consultation RoomSecurityStock roomsOther e.g. toilets, external stores7 Version 1.0 September 2010