Consent Taking

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Please also review “consent taking” in last page and include it here
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Referencing style Vancouver- with intext citation like (1), (2, 4) etc

Legal-Framework for Injection-Therapy (IT) (1):
The legal framework governing injection therapy is elucidated in the guidelines provided by the Chartered Society of Physiotherapy (CSP) (1). Providers of therapeutic injections generally utilize prescription-only medicines (POMs) and are instructed to adhere to the established lawful drug framework, which is regulated by the Human Medicines Regulations of 2012 in the United Kingdom. It is imperative for practitioners engaging in injection-therapy to possess a comprehensive understanding of the medicinal framework.
a) The Patient-Specific-Direction (PSD):
Physiotherapists (PTs) have the authority to deliver injections using the PSD in complying with terms of the prescription. This authorization must be obtained from a suitable prescriber. PTs are obligated to precisely follow the written instructions provided by a responsible prescriber and are prohibited from executing oral instructions. Maintaining a note of the prescription authorized under a PSD is essential.
b) The Patient-Group-Direction (PGD):
Regarded as a framework for supplying & delivering drugs, it is not considered as a prescribing measure for PTs. While some PTs might be allowed to deliver drugs by Injection-Therapy in alignment with PGD, though legal limitations exist regarding the inclusion of specific drugs in PGD and the methods by which they can be administered for instance, the mixing of drugs is prohibited. PTs must administer drugs according to the instructions outlined within the framework.
c) Exclusions:
There are no lawful exemptions applicable to PTs which allow certain listed drugs to be delivered or supplied by specific healthcare professionals without adhering to specific frameworks.
d) Supplementary Prescribing:
Supplementary-prescribing allows PTs to deliver injections if a written “clinical management plan” for specific patient is present. The terms of use and definition, as stipulated by the law, must be authorized by a prescriber before the injection is delivered.
e) Independent Prescribing:
Under this framework, PTs have the authority to order, supply or administer drugs to patients. This practice is based on the professional judgment of PTs, allowing them to use medications that are deemed suitable for the individual requirements.

Therapeutic Injection Therapy (TIT) Practice (2):
The Chartered Society of Physiotherapy’s (CSP) information paper (2) sheds light on Therapeutic Injection Therapy (TIT) within the scope of physiotherapy practice. It is imperative to note that TIT does not encompass procedures such as providing general or local anesthesia for chronic pain treatment, cosmetic purposes, subcutaneous or IM/IV drug administration, syringe/catheter or vaccine administration.
Physiotherapists are authorized to utilize CS with or without LA and inert substances for managing soft tissue and joint related degenerative conditions and inflammatory disorders. While PTs can develop advanced skills for peripheral nerve blocks and spinal injections, however, this requires further learning/training & falls beyond the scope of this module. It’s crucial to note that PTs engaging in TIT need not be independent prescribers. PTs licensed with the HCPC as IPs have the authority to prescribe, supply, or administer drugs being utilized in injections.
The HCPC advises HCPs to adhere to legal requirements pertinent to their practice and to align with drug entitlements for their profession. Presently, the CSP excludes the use of instruments/drugs for cosmetic changes, lipid cell products, stem cells, or LA/GA from the TIT scope. Lubricants and similar products are legally excluded from medicines. Sugar, saline or LA and similar products used in prolotherapy, are considered medicines and must be handled within the legal scope/drug framework. HCPs should follow guidelines and observe evidence-based literature, such as those from the National Institute for Health and Care Excellence (NICE). However, it remains the responsibility of individual members to demonstrate compliance with CSP expectations on TIT when requested.
HCPs providing IA injections in various clinical environments must ensure the presence of appropriate governance to ensure the safe and effective administration of injections. The recommended governance structure includes information delivery, patient care pathways, clinical reasoning, continuous and supervised professional developments, infection prevention and control, utilization frameworks, procedures and policies for Injection-Therapy, efficient record-keeping, effective communication, quality improvement strategies, audit and frameworks for reporting adverse reaction & serious incidents.
All injection therapist must hold appropriate professional indemnity insurance. For PTs, injection therapy is covered by the CSP Professional Liability Insurance scheme, subject to specific terms and conditions.
a) Private Practice & Injection Therapy:
PTs registered with HCPC do not need to be registered with Care Quality Commission (CQC) to practice Injection-Therapy in private settings. However, if they involve other HCPs to administer injections, CQC enrollment might be necessary. Independent practices registered with CQC may develop their specific PGDs if certain requirements are fulfilled. Those consulting NHS patients following a formal specific contract with NHS can use PGDs developed by NHS for that particular contract.
Individual private physio can administer and practice Injection-Therapy if prescribed by a GP or legit prescriber. Physios registered with HCPC as independent-prescribers can prescribe drugs privately, but the responsibility of all costs is on patients.
Private practice physios cannot get drugs prescribed for their private patients by NHS doctors, as this may be regarded as unauthorized use of NHS resources, leading to potential legal consequences if get reported.
Finally, the article highly recommends that injection-therapy practitioners hold valid anaphylaxis management, basic life support certifications, and must give proof of vaccination for Hepatitis B.

Consent taking, Good-Practice & Record-Keeping
a) Consent:
It is imperative legally to give comprehensive education to the patients; therefore, merely providing mere information leaflet and consent form may not suffice until concerns are communicated in detail, and the patient has had the chance to ask additional queries if required (3).
The Medical Protection Society’s web-page emphasizes that while documentation need not be too detailed, they should articulate the specifications of the particular intervention/procedure. This should include an itemized account of the benefits, risks and alternative options communicated. Additionally, specific concerns or threats highlighted by the patient should be duly documented (4).
Considering the injection-therapy, it is essential to furnish the patient with information about the potential effects and side effects associated with the therapy (5). While it’s not an obligation for the patient to sign a consent form in England, practitioners should document in their notes that a comprehensive discussion took place, and the patient provided consent for the treatment (5).
b Good-Practice:
In accordance with General Medical Practice (GMC), good medical practice involves several key principles (6):
• Up-to-date Knowledge and Compliance with Laws:
o Staying abreast of current knowledge.
o Adherence to relevant laws and regulations in the professional domain.
• Competence and Patient-Centered Care:
o Assessing and practicing within one’s own scope of competence.
o Developing a thorough understanding of the patient’s health.
o Addressing patient needs through appropriate interventions.
• Evidence-Based Treatment:
o Providing interventions based on the best current research.
o Ensuring treatments align with other interventions the patient may be receiving.
• Resource Utilization:
o Making efficient use of available resources.
• Documentation:
o Maintaining clear, precise, and comprehensible notes and clinical records.
o Entering or updating clinical records promptly.
• Safety and Guidelines Compliance:
o Referring to the Medicines and Healthcare products Regulatory Agency’s (MHRA) web-page for information on safely using drugs and alerts on medicine safety (7).
o Adhering to guidelines from the National Institute for Health and Care Excellence (NICE) that combine the best evidence to recommend cost-effective, efficient and safe interventions for managing different pathologies (6)

Additional Professional Guidelines:
In alignment with the General Medical Council (GMC) advice, clinicians are urged to:
• Reference to BNF Guidelines:
o Familiarize yourself with the British National Formulary (BNF) guidelines.
o Seek guidance from prescribing advisors, experienced team members, colleagues or clinical pharmacists incase unsure about drugs (6).
• Avoid Personal Expressions and Unlawful Advertisement:
o Avoid from expressing personal faiths including moral, religious and political view-points, to the treating patient (6).
o Avoid engaging in unlawful drug advertising to the public (8).
• Shared Care and Patient Safety:
o Ensure shared care agreements involve all parties, including the patient.
o Base decisions on the continuity of care on the best interests of the patient, rather than the suitability or price, F/Us or relevant monitoring (6).
o Inform patients on how to directly notify the Medicines and Healthcare products Regulatory Agency (MHRA) in case of possible adverse reactions from medicines (6).
• NHS Emphasis on Patient Safety:
o Prioritize patient safety at the core of practice.
o Raise concerns if the working setting lacks adequate safeguards.
o Conduct relevant identity and verification checks (9).
• Anti-Doping Regulations:
o Abide by the World Anti-Doping Agency’s regulations, which ban glucocorticoids when utilized by IM, IV or oral/rectal routes in sports or competitions (10).
• Reporting Adverse Effects:
o Inform the MHRA about any severe negative side-effects of medicines through the Yellow Card Scheme in the UK (11).
• Health Precautions and Immunization:
o Show evidence of established vaccination for hepatitis B (12).
o Comply with local regulations regarding needle and sharp injuries and follow guidance for preventing exposure to HIV in clinical settings.
o Reduce risks by being prepared and avoiding rushing around (5).
• Injection Therapy Beyond License:
o Acknowledge that injection therapy may involve the use of drugs beyond their license, such as off-label use of approved drugs like Kenalog or sclerosants.
o Recognize the importance of addressing the risks to practitioners through clinical governance (5).
o Exercise a balanced approach between the benefits and harms when using unlicensed drugs and monitor current clinical practice through evidence-from current literature and audits (13).
o Obtain informed and clear consent ahead of procedure, ensuring documentation of all possible risks (13).

c) Record-Keeping:
Healthcare professionals bear professional and legal responsibilities to uphold accurate records about the patient interactions (14). The Health and Care Professions Council (HCPC) standards (15) specify the following:
• Comprehensive Records:
o Keep an accurate, clear, and complete documentation for every patient consulted by a HCP.
• Timely Record Updates:
o Enter or update clinical records promptly, suggested by the General Medical Council (GMC).
• Security Measures:
o Ensure records are secure, safeguarding them from inappropriate access, damage and loss.
GMC guidelines (6) outline that clinical records should encompass:
• Essential Components:
o Related clinical findings and observations.
o Discussions, decisions, and agreed plan of care.
o Education given to the patient.
o Details of medicine, other treatments, and investigations conducted.
o Name of the individual developing the documentation.
Chartered Society of Physiotherapy (CSP) guidelines (14) on clinical records advocate for:
• Record Characteristics:
o Comprehensive, written in permanent ink if handwritten.
o Duly signed with the name, appropriately numbered page, and dated and timed with each consultation.
o Amendments to written records must be dated, timed, and signed, ensuring the initial documentation is clear.
o Electronic records should display the individual responsible, amendments, and data locking.
o Adherence to General Data Protection Regulations (GDPR) guidance.
During discussions with a supervisor, the advice was to always check the date of expiry of drugs and mention this information in patients’ consultation, along with the dose, type and batch number of the drug utilized. This practice is emphasized during practical and theory sessions in the course. This thorough approach is followed consistently while delivering all injections. A template of steroid injection therapy is employed, capturing information such as diagnosis, shared decision-making discussions, comprehensive overview of risks and benefits, consent and drug details.

Discussion on Drug Mixing & Communication with Patients:
In-depth discussions with the supervisor delved into nuanced aspects of drug mixing and effective patient communication. Manufacturing guidelines from pharmaceutical companies, particularly for widely used drugs like Depo-medrone, Kenalog, and Adcortyl, strictly prohibit their mixture with other solutions, as this action is legally construed as the creation of a novel drug without the requisite license (5).
The common practice of combining steroids with local anesthetic (LA) in day-to-day clinical routines, albeit considered off-label, was justified based on its perceived benefits. This practice, aimed at minimizing procedural pain and enhancing safety by avoiding needle switching, has been ingrained in clinical tradition for decades, with limited evidence suggesting any adverse effects. Stephanie Saunders’ book also supports this approach (5).
Guidelines from the Chartered Society of Physiotherapy (CSP) indicated the potential for drug mixing under the Patient Specific Direction (PSD) but strictly discouraged it under the PGD. Clinicians aspiring to mix glucocorticoids with other solutions were mandated to hold independent prescribing authority or administer within the PSD framework (16).
Given the absence of independent prescribing capabilities, practical options were explored. These included administering under PSD, utilizing Lederspan 20 mg/ml (authorized for mixing with LA in the UK), opting for pre-mixed Depo-medrone with lidocaine, administering LA first, replacing the syringe, and delivering the steroid via the same needle. Alternatives included using two syringes and needles, acknowledging potential pain and infection risks, or administering only the steroid, particularly suitable for treating small stiff joints.
On the topic of effective patient communication, it was mutually agreed to endorse a patient-centric approach. Recognizing personal beliefs and values, specifically those related to obesity and pain, is crucial, as these factors can subtly influence interactions with patients. Encouraging a two-way communication process, employing simple language to encourage engagement, & incorporating both non-verbal and verbal cues to cater to patients’ information needs were identified as essential strategies. Addressing concerns, responding to questions with accuracy, and guiding patients to reliable information sources were emphasized. Efficient collaboration with colleagues to provide integrated care, respecting the team dynamic, and fostering a culture of mutual learning were deemed vital components of effective communication, aligning with established standards from NICE and the Osteoarthritis Research Society International OARSI core capability framework (17, 18)

References

1. Chartered Society of Physiotherapy (CSP). (2021). Medicines use in physiotherapy practice (5th Edn., PD019). [Information paper].
2. Chartered Society of Physiotherapy (CSP). (2021). Therapeutic injection-therapy in physiotherapy practice (6th Edn., PD003). [Information paper]. Available from: file:///C:/Steroid%20Injection%20Course/Learning%20outcome%205/Learning%20outcome%206/CSP%20Therapeutic%20injection-therapy%20in%20physiotherapy%20practice.pdf
3. Mazur DJ. (2003). Influence of the law on risk and informed consent. BMJ 2003;327(731-734).
4. Douglas L, Primary care rheumatology society. (2017). Joint and soft tissue injection guidelines. [Internet]. Available from: https://www.pcrsociety.org/resources/other/joint-injections-guidelines.
5. Saunders S, Longworth S. (2019). Injection techniques in musculoskeletal medicine (5th ed.). Elsevier.
6. General Medical Council. (2021). Good practice in prescribing and managing medicines and devices. [Internet]. Available from: http://www.gmc-uk.org/guidance
7. The Medicines and Healthcare products Regulatory Agency’s (MHRA). Drug Safety Update and Central Alerting System. [Internet]. 2022 [accessed 2023 Sep 23]; Available from: https://www.cas.mhra.gov.uk/Home.aspx
8. The Medicines and Healthcare products Regulatory Agency’s (MHRA). Human Medicines Regulations 2012 Number 1916 – SI 2012/1916.
9. National Health Service (NHS). DCB3051 Identity Verification and Authentication Standard for Digital Health and Care Services, [Internet]. Updated 2022 [accessed 2023 Sep 23]; Available from: https://digital.nhs.uk/data-and-information/information-standards/information-standards-and-data-collections-including-extractions/publications-and-notifications/standards-and-collections/dcb3051-identity-verification-and-authentication-standard-for-digital-health-and-care-services.
10. World Anti-Doping Agency (WADA). Prohibited list. [Internet]. Jan 2019 [accessed 2023 Sep 10]; Available from: https://www.wada-ama.org/sites/default/files/wada_2019_english_prohibited_list.pdf.
11. Medicines and Healthcare products Regulatory Agency (MHRA): Yellow card. [Internet]. [accessed 2023 Sep 10]; Available from: https://yellowcard.mhra.gov.uk/information
12. Snashall D. Occupational infections. ABC of work-related disorders. BMJ. 1996;313:551-554.
13. General Medical Council. Prescribing unlicensed medicines. [Internet]. 2021 [accessed 2023 Sep 23]; Available from: https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-practice-in-prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines.
14. Chartered Society of Physiotherapy (CSP). Information paper. Record Keeping Guidance [Internet]. 2021 [accessed 2023 July 10]; Available from: https://www.csp.org.uk/system/files/publication_files/RecordKeepingFINAL_Sara%20Conroy.pdf.
15. Health and Care Professional Council (HCPC). Standards of conduct, performance and ethics. [Internet]. 2016 [accessed 2023 July 10]; Available from: https://www.hcpc-uk.org/resources/standards/standards-of-conduct-performance-and-ethics/
16. Chartered Society of Physiotherapy (CSP). Information paper. The use of medicines with injection-therapy in physiotherapy services,.
17. Chartered Society of Physiotherapy (CSP). Good Communication Standards.
18. Hinman RS, Allen KD, Benell KL, Berenbaum F, Betteridge L, Briggs AM, et al. Development of core capability framework for qualified health professionals to optimize care for people with osteoarthritis: an OARSI initiative. Osteoarthritis and Cartilage. 2020;28:154-166.
19. Consent form: please include this information is the main body of the work
    Organisations require procedures in place relating to the dissemination of patient information and consent. The law on informed consent changed following a Supreme Court judgment in the case Montgomery v Lanarkshire Health Board 2015. The change however simply enshrines in law consent practices which had previously been recommended by the GMC and defence unions.

Doctors must now ensure that patients are aware of any “material risks” (write about in appendix) involved when undergoing a proposed treatment, and of reasonable alternatives. This replaces the “Bolam test”, which asks whether a doctor’s conduct would be supported by a responsible body of medical opinion. “The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”6. In the context of joint and soft tissue injections, the patient must be informed about the relevant risks and benefits of the injection. The clinician should document that such a discussion has taken place and that the patient has consented to the treatment. In England the patient is not required to sign a consent form and this may in fact be less medico legally robust than clear and reasonable documentation of the discussion in the notes.

According to the MPS website ‘The notes do not need to be exhaustive, but should state the nature of the proposed procedure or treatment and itemise the risks, benefits and alternatives brought to the attention of the patient. Any particular fears or concerns raised by the patient should also be noted’7.

It is helpful for patient and clinician if the patient receives an information sheet to read prior to the procedure and to take away, detailing potential relevant adverse effects.
Please see the relevant guidance provided by medical defence organisations and the GMC for further details8, 9, 10.

References

1. Stephens M.B, Beutler A. I, O’Connor, F.G. Musculoskeletal Injections: A Review of the
   Evidence. Am Fam Physician. 2008 Oct 15; 78(8):971-976.
2. EULAR Textbook on Rheumatic Diseases. Bilsma J W J: BMJ Group First Edition 2012
3. Weitoft T, Larsson A, Saxne T, Rönnblom L: Changes of cartilage and bone markers after
   intra-articular glucocorticoid treatment with and without post injection rest in patients with
   rheumatoid arthritis . Ann Rheum Dis 2005; 64:1750-1753
4. Brinks A, Koes B W, Volkers A C W, Verhaar J A N, Bierma-Zeinstra S M A: Adverse effects
   of extra-articular corticosteroid injections: a systematic review. Musculoskeletal Disorders
   2010,11:206
5. Philipose J, Baker K, O’rourke K S, Deodhar A; Joint Aspiration and Injection: A Look at the
   Basics. Tapping into a valuable diagnostic and treatment resource. The Journal of
   Musculoskeletal Medicine. Vol. 28 No. 6 07 June 2011
6. http://www.medicalprotection.org/uk/for-members/news/news/2015/03/20/new
   judgment-on-patient-consent Accessed Mar 2017
7. http://www.medicalprotection.org/uk/resources/factsheets/england/england
   factsheets/uk-eng-consent-the-basics Accessed May 2017
8. https://www.themdu.com/guidance-and-advice/topics/consent Accessed May 2017
9. https://www.mddus.com/resources/publications-library/fyi/issue-08/informed-consent
   Accessed May 2017
10. http://www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_index.asp
    Accessed May 2017
11. Andreasen R A, Just S A, Hansen I M J : The risk of intraarticular steroid injections are
    overestimated. Annals of the Rheumatic Diseases; Jun 2014; vol. 73