Pharmacy Law

• Initial education and training standards for pharmacists

  The GPhC have powers to register fit, proper and suitably experienced people to act as pharmacists and pharmacy technicians on a temporary basis if an emergency is declared by the Secretary of State as was the case during Covid. This allowed trainee pharmacists to work as an RP before having passed their registration assessment.
• These powers ceased when the emergency ended
• Revalidation of pharmacists


  The process all pharmacists and registered technicians will go through to renew their registration with GPhC
• Why revalidation?


  • Skills and knowledge are up to date.
  • Provide safe effective care
  • Trust in pharmacy is well placed
• When?


  Annual process started Sept 2018
• Revalidation requirements


  • 4 pieces of CPD
  • Peer Discussion
  • Reflective Account
• Planned CPD


  A piece of planned CPD is where you have developed your practice based on a learning event that you knew was going to occur
• Unplanned CPD


  This is where you did not know that you were going to learn something and the learning happened as a result of an activity, task or interaction you may have experienced throughout the working day
• Peer Discussion


  A learning and development activity that encourages you to engage with others in your reflection on learning and practice. To be most effective , these discussions should be designed to aid your development, open and honest and with someone who you can trust.
• Reflective Account


  This encourages you to think about how you meet the GPhC standards for pharmacy professionals in your field of work. It should include a short summary of your practice over the last 12 months, how you have met the standards with practical examples to support your reflection
• During Covid 19, the revalidation requirements were reduced to include one reflective account to reflect the intense pressure pharmacists were under due to the pandemic.
• This has now returned to: 4 pieces of CPD, Peer Discussion, Reflective Account as the pandemic is no longer a major threat
• Prescriptions from EEA or Switzerland

  • Patient's details: full name and date of birth
  • Prescribers details: full name , professional qualifications direct contact details, work address including the country worked in
  • Prescribed medicine: name, form, quantity, strength & dosage details
  • Prescriber's signature
  • Valid for 6 months except S4 CDs 28 days
  • S1,2 & 3 and unlicensed medicines cannot be dispensed in UK if prescribed on an EEA Rx. Can prescribe 'off-label' medicines (i.e. using a licensed medicine outside of its approved use)
  • Emergency supplies allowed but excludes S1,2,& 3 CDs including phenobarbital
• Dispensing such Rxs


  • Use professional judgement when handlings Rxs or emergency supplies from approved Health professionals from approved countries.
  • If you are not satisfied that a Rx is clinically appropriate or legally valid and an emergency supply is not appropriate, then it may be more appropriate to refer the patient to a prescriber based in the UK as an alternative.
• CD Regulations - Formulation


  Replaced by Form (tabs or caps acceptable)
• CD Regulations - Total quantity


  To provide clarification on expressing it as the total number of dosage units or total quantity of drug.
• Expressing the quantity of different strength tablets on the same Rx

  • MST 30mg and MST 10mg (thirty of each)
  • 30 thirty 10mg tablets
  • 30 thirty 30mg tablets
• CD Regulations - Can now be prescribed by EPS
• Not legally acceptable CD doses


  • As directed
  • When required
  • PRN
  • As per chart
  • Titration dose
  • Weekly (this is a frequency not a dose)
  • Decrease dose by 3.5ml every four days
  • Twice a day
• Legally acceptable CD doses

  • One as directed
  • Two when required
  • One PRN
  • Three ampoules to be given as directed (better three ampoules to be given over 24 hours as directed)
  • One or two when required
• Discrepancies in the CD register

  • Wrong quantity entered from wholesaler
  • Wrong quantity entered that was issued to the patient
  • Miscounting number of tab/caps in CD cabinet
  • Mixing up patient returns with stock (although should always be kept separate)
  • Error in calculation when totalling up balance
  • Missing entries
  • Entering in the wrong section
• How to make corrections in the CD register

  • Standard Operating procedures (SOPs) should clearly define the action to be taken if a discrepancy arises in relation to CD balances.
  • Once resolved, a note should be made in the Controlled Drug Register correcting the discrepancy in the balance. It is also advisable to keep appropriate records of the action taken when discrepancies arise.
  • No crossing out
• Dealing with over-the-counter stimulant laxatives in community pharmacy - GSL stimulant laxatives

  • New posology: licensed only for people aged 18 years and over
  • Revised indication: "For the short-term relief of occasional constipation"
  • Reduced pack sizes: standard strength tablets in a pack size of 20, maximum strength tablets in a pack size of 10 and syrups in a pack size of 100ml
  • More prominent warnings included that stimulant laxatives do not aid weight loss.
• Dealing with over-the-counter stimulant laxatives in community pharmacy - P stimulant laxatives

  • New posology: licensed only for people aged 12 years and over
  • Revised indication: removal of indications not appropriate for the self-care setting
  • More prominent warnings included that stimulant laxatives do not aid weight loss.
• Children collecting and purchasing medicines

  • Knowledge of the child
  • Maturity of the child
  • Nature of the medicine(s) supplied
  • Is their a prior arrangement
  • Reasons why the child is collecting
  • Advising on the use of the medicines
  • Proof of identity if collecting S2 CDs
• Recent Pom to P change - Estradiol


  • Estradiol is licensed as a pharmacy (P) medicine and is available over the counter (OTC) as Gina 10 microgram vaginal tablets.
  • Pharmacists should be satisfied that the supply will be clinically suitable, and the product will be used appropriately.
• The development of pharmacy professionals should not stop once their initial education is complete. In fact, further development continues through foundation and then advanced level practice. Some pharmacists are also practicing at a consultant level.
• NEED TO UPDATE REGISTER AND NEW INVOICE
• Demands from GPhC


  • Pharmaceutical Journal
  • Chemist & Druggist
  • Other journals
  • Local educational meetings
  • CPPE
  • RPS
• Keeping up to date
• Success of a business

  Depends largely on the people who work in it
• Information, policies and procedures

  In place to set out the main terms and conditions of employment
• Avoids misunderstandings after accepting employment
• Written statements


  If you are an employee you must get a written statement of employment particulars setting out some of your main terms. Your employer must give you this within two months of starting work
• If the terms of the contract change

  Your employer must give you the new information in writing within one month
• Terms of Contract


  • Pay
  • Hours of work
  • Holiday entitlement
  • Sick pay
  • Arrangements for notice period
  • Information about disciplinary and grievance procedures
• You must adhere to the terms and conditions on your contract of employment whether written or verbal
• Statement of particulars relating to employment

  • Commencement date
  • Period of employment
  • Job title
  • Place of work
  • Remuneration
  • Probationary period
• Working Hours


  Your normal working hours should be set out in your contract of employment. Unless you choose to (or work in a sector with its own special rules) you should not have to work more than 48 hours a week on average
• The 48 hour week rule


  Most workers should not have to work more than an average of 48 hours a week according to the Working Time Regulations. Your average working hours are calculated over a 17 week period. You can work more than 48 hours in one week as long as the overall average is less than 48 hours. There are special rules for some workers, such as young workers, trainee doctors and mobile workers in the transport industry