Week 25 - workplace regulation the responsible pharmacist Flashcards
Legislation
->Medicines Act 1968 (as amended by the Health Act 2006)
->Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008
The responsible pharmacist
In order to lawfully conduct a retail pharmacy business, a registered pharmacist must be in charge of the registered pharmacy as the
responsible pharmacist
Responsible for;
->Secure the safe and effective running of the pharmacy
->Display a notice with your name, registration number and the fact that you are in charge of the pharmacy at that time
->Complete the pharmacy record
->Establish, maintain and keeping under review pharmacy procedures for safe working
Securing the safe and effective running of the pharmacy
-You can only be the Responsible Pharmacist in charge of one pharmacy at any given time
-If you believe a pharmacy is not safe or patients are at risk then
you’ll need to take steps to secure the safe and effective running of the pharmacy
Ask your self…
-Are all members of staff present?
-Are the computer systems working properly?
-Are you aware of any messages left by the previous responsible pharmacist or the employer?
-Have you displayed the notice with your details?
-Have you completed the pharmacy record?
-Do you know where the pharmacy procedures are?
-Do the procedures cover all the required aspects?
-Do pharmacy procedures need to be amended or reviewed (due to changes in staff, other conditions or incidents) or because the procedures have not been reviewed for two years?
-Is an audit trail in place to show what changes have been made to procedures, by whom and when?
-If you conduct a review of a procedure, have you notified the person in position of authority of any changes you made?
-Are you intending to be absent from the pharmacy for up to two hours?
-Have you let staff members know if you are planning to be absent?
-Are staff aware of what procedures they should follow when you are absent from the pharmacy?
-Do the staff know who to contact if you are not contactable?
-Have you checked the fridge temperature and the log?
-Do you know where the CD cabinet keys are?
Displaying a notice
Displaying a notice is a requirement!!!
Information must include:
-Your name
-Your GPhC registration number
-The fact you are in charge of the pharmacy at the time
Your notice
The layout and design of the notice is at your discretion
If you are designing your own notice:
-Try make sure it is clear and professional in appearance
- Avoid handwritten, printed is preferable
The pharmacy record
Audit trail of who was accountable for the safe and effective running of the pharmacy
-Allows you to find out the Responsible Pharmacist on any given date and at any time
-The record must be accurate and made at the time by the
Responsible Pharmacist
-The record should also accurately record any absence
The following details must be recorded in the pharmacy record:
-The Responsible Pharmacist’s name
-The Responsible Pharmacist’s registration number
-The date and time at which the pharmacist became the Responsible Pharmacist
-The date and time at which the Responsible Pharmacist stopped being the Responsible Pharmacist
If you are absent from the premises:
-The date of absence
-The time at which you leave the pharmacy
-The time at which you come back
The pharmacy record must…
The pharmacy owner or superintendent pharmacist must keep the pharmacy record for a period of FIVE years
-The record must be available at the pharmacy to which it relates
The Pharmacy Record may be kept in the following formats:
-In writing
-Electronically
->Or in both forms
If the record is kept electronically it needs to be backed up, kept on the
pharmacy premises, and available for GPhC inspection if required
The pharmacy record
Any alterations or amendments need to identify when and by whom the alteration / amendment was made
->This applies to both paper based or electronic pharmacy records
-The Responsible Pharmacist is required to personally make entries in the pharmacy record
Examples of absences
-To see patients in a consultation room in the non-registered area of the pharmacy
-To participate in a meeting with your local GP
-To visit patients at home or in a residential care home to advise on their medicines
Absences
->The Responsible Pharmacist may be absent for up to a maximum period of two hours during the pharmacy’s business hours between midnight and midnight
->If there is more than one Responsible Pharmacist in charge of the pharmacy during the pharmacy’s business hours, the total period of absence for all the Responsible Pharmacists must not exceed two hours
->Do not remove the notice if you intend to remain the Responsible Pharmacist during your absence
The following arrangements must be in place:
-Only be absent if the pharmacy can continue to run safely and
effectively
-Remain contactable with the pharmacy staff
-Be able to return to the pharmacy with reasonable promptness
->In circumstances when a Responsible Pharmacist cannot remain contactable, they must arrange for another pharmacist to be contactable and available to provide advice -> this does not need to be another Responsible Pharmacist
Pharmacy record and absence
In the pharmacy record note the following if you are absent from the premises:
-The date of absence
-The time at which you leave the pharmacy
-The time at which you come back
Activities (Responsible Pharmacist present)
-Professional check (clinical and legal check) of a prescription
-Sale/Supply of pharmacy medicines
-Sale/Supply of prescription-only medicines (e.g. handing dispensed medicines to patient, patient representative or a delivery person)
-Supply of medicines under a patient group direction (PGD)
-Wholesale of medicines
-Emergency Supply of a medicine(s) at the request of a patient or healthcare professional
Activities (Responsible Pharmacist absent but supervising)
‘Supervision’ in this context may not require the physical presence of a pharmacist
->The assembly process:
-Generating a dispensing label
-Taking medicines off the dispensary shelves
-Assembly of the item (e.g. counting tablets)
-Labelling of containers with the dispensing label
-Accuracy checking
Activities (Responsible Pharmacist absent)
-Sale of general sale list (GSL) medicines
-Processing waste stock medicines or patient returned medicines (excluding Controlled Drugs)
Activities (No Responsible Pharmacist)
-Ordering stock from pharmaceutical wholesalers
-Receiving stock from pharmaceutical wholesalers into the building (excluding Controlled Drugs)
-Putting medicinal stock received from the wholesaler away onto the pharmacy shelves (GSL, P, and POMs, excluding CDs)
-Date Checking (excluding CDs)
-Stocking pharmacy with consumables
-Cleaning of the pharmacy
-Responding to enquiries (about medicine issues)
-Accessing the PMR
-Receiving prescription directly from patients or collecting from a surgery
-Processing of prescription forms that have been dispensed (eg. Counting number of items dispensed, sorting prior submission for reimbursement)
-Delivery person conveying medicines to patient
-Receiving patient returned medicines (excluding controlled drugs)
