Patient Group Directions Flashcards
Patient Group Directions (PGDs)
- In use since August 2000
- A legal framework which allows certain health care professionals to supply and administer medicines to groups of patients that fit prespecified criteria without the need for a prescription or an instruction from a prescriber
- They are not a form of prescribing
Definition of a PGD
“A written instruction for the sale, supply and / or administration of named medicines in an identified clinical situation. It applies to groups of patients who may not be individually identified before presenting for treatment.”
PGDs
Examples of use:
- Travel clinics – vaccinations
- Emergency hormonal contraception
- Treatment of sexually transmitted diseases
- Emergency treatments by paramedics
- Seasonal influenza vaccinations administered by community pharmacists
For PGDs to be valid certain criteria should be met
- Used by specified groups of healthcare professionals
- Does not need to relate to a specific location – E.g. patient’s home, surgery, health centre, pharmacy, walk-in centre
- Can be used by non-NHS organisations
- Patients must meet inclusion criteria but often not identified prior to presentation
- All professionals must be fully qualified, competent and trained to use PGDs however no additional qualifications are required
- Individual practitioners using a PGD must be named
- Organisations have a responsibility to ensure that only fully competent and trained registered healthcare professionals use PGDs
Classes of persons allowed to supply /
administer under PGDs
- Paramedics
- Pharmacists
- Dietitians
- Nurses and Midwives
- Dental hygienist and dental therapists
- Occupational therapists
- Orthotists (make foot drops and walking, feet wedges) and prosthetists
- Speech and language therapists
- Optometrists
- Chiropodists and podiatrists
- Orthoptists
- Physiotherapists
- Radiographers
What should a PGD contain?
- The name of the body to which it applies e.g. Kettleton CCG
- Date it comes into force and date it expires
- Description of medicine(s) covered
- Clinical conditions covered
- When to seek further advice and arrangements for referral
- Patients excluded
- Appropriate dosage & max total dosage, quantity, pharmaceutical form & strength, route and frequency of administration, minor max period over which medicine should be administered
- Relevant warnings, including potential adverse reactions
- Details of any follow-up action and the circumstances
- Statement of records to be kept
Records must be kept, but may be a copy of the records needed by PGD authorising body
Producing a PGD
• PGDs should be produced by a multi-disciplinary group
• Must be signed by:
– Senior doctor or dentist (can be two)
– Senior pharmacist
– Authorising authority for organisation (e.g. from within CCGs, LA, or NHS Trusts)
multi-disciplinary group – doctor or dentist, pharmacist, representative of professional group expected to supply and/or administer under the PGD. Good practice to involve local DT/med man committees, APCs or similar.
(eg clinical commissioning groups, local authorities, NHS trusts or NHS foundation trusts, special health authorities, the NHS Commissioning Board)
Senior doctor and pharmacist should be involved in developing the PGD – if across CCGs, must be signed by CG lead from each CCG
- The PGD must relate to medicines with a product license, but it can be for an “off-license” use
- Can include black triangle drugs
- PGDs cannot be used for appliances, dressings, medical devices, radiopharmaceuticals, abortifacients (Mifepristone) or unlicensed medicines
PGD must state that the product is being used outside SPC and why
Special considerations
Controlled drugs
• The Misuse of Drugs (Amendment No.2) Regulations 2012 states:
– Nurses and pharmacists can supply Morphine and Diamorphine in any setting “where administration of such drugs is required for the immediate, necessary treatment of sick or injured persons (excluding the treatment of addiction)
• Any of named professions can supply or administer:
– A schedule 5 drug
– Midazolam, Schedule 3
– Any Schedule 4 Part (1) as long as it is not in parenteral form for treatment of addiction
Special Considerations
Antimicrobials
- Resistance is a major public health concern
- Only to be used if absolutely necessary
- Must involve a local microbiologist or public health specialist in creating PGD
- Local DTCs/APCs to ensure PGD consistent with local policies
- PGD needs to be audited regularly
E.g. not for minor viral diseases without good evidence of bacterial infection e.g. sore throats
Other considerations
• All medicines should be appropriately pre- packed
• Security and storage needs to be considered
• Need to provide PIL with each supply
• Audit of the PGD system should be undertaken regularly
• When using a PGD, pharmacists must:
– Be satisfied the PGD is valid and approved
– Ensure supply follows protocol and maintain records – Have up to date knowledge on clinical area
– Have undertaken relevant training
• When writing a PGD, a pharmacist is accountable for their content and must:
– Be familiar with their role, responsibilities and relevant guidance
– Ensure approved PGDs comply with guidance
– Ensure staff are appropriately trained
– Ensure appropriate people approve and sign the PGD
– Ensure they have up-to-date knowledge in the subject area
Should be ‘appropriately’ pre-packed i.e can be split if labelled as a dispensed medicine.
Exemptions from section 52 and 53 of Medicines Act 1968 allow supply of P and GSL medicines on PGD
Indemnity insurance
- As a pharmacist you will be required to have appropriate professional indemnity insurance cover to allow you to practice
- This was explicitly stated in the previous GPhC Standards of Conduct, Ethics and Performance; although it is not in the new standards, it is part of the annual registration declaration
Non-medical prescribing
- Prescribing by individuals other than doctors or dentists
* Maybe ‘supplementary’ or ‘independent’ prescribers
Aims of NMP
- Improve patient care without compromising patient safety
- Make it easier for patients to get the medicines they need
- Increase patient choice in accessing medicines
- Make better use of the skills of health professionals
- Contribute to the introduction of more flexible team working across the NHS
Benefit to GPs/medics – reduce their workload so they can focus on the more complex cases.
Studies have shown it to be safe, acceptable to patients and acceptable to other clinicians
Amending law
- Originally, the Medicines Act 1968 allowed only doctors and dentists to write prescriptions for POMs
- The Crown Report: ‘Review of prescribing, supply & administration of medicines’ (1999)
- Changes in legislation followed
NMP and the law
• Nurse prescribing introduced in The Medicinal Products: Prescription by Nurses etc. Act 1992
• Section 63 of the Health and Social CareAct 2001
– Extended prescribing responsibilities to other health professions, including pharmacists
– Introduced new types of prescribers, including the concept of a supplementary prescriber
• 2006: Further regulatory change enabled introduction of independent prescribing
The nurse prescribing scheme for district nurses and health visitors was based on the recommendations contained in the Report of the Advisory Group on Nurse Prescribing 1989, which advised Ministers how patient care in the community might be improved by introducing nurse prescribing.
The Medicinal Products: Prescription by Nurses, etc. Act 1992 which amended the National Health Service Act 1977 (section 41) and the Medicines Act 1968 (section 58)];
The necessary legislation to enable community nurses in Scotland with either a district nursing or health visiting recordable qualification to prescribe from a limited formulary was passed in 1996.
2001 – supplementary prescribing
Changes to regulations in May 2006 enable nurses who train and qualify as ‘nurse independent prescribers’, to be able to prescribe any licensed medicine (i.e. products with a UK marketing authorisation) for any medical condition they are competent to treat.
