What Are Racetams?

Racetams are structurally related compounds that include:

• Piracetam – the original racetam developed in the 1960s
• Aniracetam – known for mood-enhancing properties
• Oxiracetam, Pramiracetam, Phenylpiracetam – more potent variants, often with different neurological effects

These compounds are believed to act on neurotransmitters like acetylcholine and glutamate, enhancing synaptic plasticity and memory. The evidence for their efficacy in cognitive enhancement is mixed and varies across different compounds and conditions.

Evidence for Cognitive Enhancement

• Oxiracetam: A study on patients with vascular cognitive impairment suggests that oxiracetam may have a modest effect on preventing cognitive decline, particularly when combined with exercise1. Additionally, oxiracetam and aniracetam have shown potential in reversing cognitive deficits in Alzheimer’s disease, potentially offering more benefits than some current medications like donepezil and tacrine.
• Piracetam: Despite its popularity, the evidence for piracetam’s impact on memory enhancement is inconclusive. A systematic review and meta-analysis found no significant clinical difference in memory enhancement between piracetam and placebo in adults with memory impairment. However, piracetam and related compounds have been noted for their ability to reverse amnesia and provide some benefits in mild to moderate dementia.
• Mechanisms of Action: The exact mechanisms by which racetams enhance cognition are not fully understood. They are believed to potentiate neurotransmission, possibly through modulating ion flux and neurotransmitter levels, but no universally accepted mechanism has been established.

Potential Risks of Racetams

Despite anecdotal praise, racetams carry several potential risks:

1. Unknown Long-Term Effects

Most racetams have not undergone long-term human studies, especially in healthy populations. Their safety profiles are largely unknown beyond short-term use.

2. Lack of Regulation

Because they’re not approved by regulatory agencies in most countries, racetams can vary in purity and dosage, especially when bought online.

3. Side Effects

Reported side effects include:

• Headaches (often linked to choline depletion)
• Insomnia or over-stimulation
• Anxiety or irritability
• Gastrointestinal discomfort

Side effects can worsen when racetams are combined with other substances without medical supervision.

How Racetams Are Obtained Online

Racetams are not directly sold in pharmacies or mainstream supplement stores, as in many countries they are classified a prescription-only medicines for specific conditions such as myoclonus. Instead, they are usually:

• Purchased from niche nootropic websites
• Sold as “research chemicals” or “not for human consumption”
• Shipped internationally, often without customs guarantees

Some websites may claim third-party lab testing, but consumers have no reliable way to verify the authenticity or safety of the product.

Note: Importing racetams may violate national regulations and can result in seizure or legal trouble at customs.

Legal Status of Racetams

The legality of racetams varies by country:

Always consult local drug regulations before purchasing racetams from any source online.

Conclusion: Proceed With Caution

While racetams are praised in online forums for their cognitive effects, there are serious questions about their safety, legality, and effectiveness. Self-medicating with unregulated substances carries risks—especially when the long-term effects are still largely unknown.

If you’re considering racetams or any nootropic regimen, consult a licensed healthcare provider. There’s a big difference between anecdotal hype and scientific validation. This article delves deeper as to what is actually effective, the most evidence for medicines which cause cognitive enhancement are modafinil and methylphenidate.

References

Lim, J., Lee, J., Kang, Y., Park, H., Kim, D., Cha, J., Park, T., Heo, J., Lee, K., Park, J., Oh, M., Kim, E., Chang, D., Heo, S., Park, M., Park, H., Yi, S., Lee, Y., Park, K., Lee, S., Kim, J., Lee, J., Cho, K., Rha, J., Kim, Y., Lee, J., Choi, J., Oh, K., Kwon, J., Kim, C., Park, J., Jung, K., Sung, S., Chung, J., Lee, Y., Kim, H., Cho, H., Park, J., Moon, W., & Bae, H. (2023). Efficacy and safety of oxiracetam in patients with vascular cognitive impairment: A multicenter, randomized, double-blinded, placebo-controlled, phase IV clinical trial.. Contemporary clinical trials, 107108 . https://doi.org/10.1016/j.cct.2023.107108.

Gouliaev, A., & Senning, A. (1994). Piracetam and other structurally related nootropics. Brain Research Reviews, 19, 180-222. https://doi.org/10.1016/0165-0173(94)90011-6.

Gouhie, F., Barbosa, K., Cruz, A., Wellichan, M., & Zampolli, T. (2024). Cognitive effects of piracetam in adults with memory impairment: A systematic review and meta-analysis. Clinical Neurology and Neurosurgery, 243. https://doi.org/10.1016/j.clineuro.2024.108358.

Tripati, A., Mathew, M., Nayak, V., & Bairy, L. (2016). Cognitive Enhancers- Truth vs. Hype. Research journal of pharmaceutical, biological and chemical sciences, 7, 729-741.

The General Pharmaceutical Council (GPhC) has recently published updated guidance for registered pharmacies providing services remotely. This guidance, issued in February 2025, underscores the importance of maintaining high standards of patient care while addressing the unique challenges associated with distance pharmacy services. In this blog post, we’ll break down the key elements of the guidance and explore what it means for pharmacies, pharmacists, and patients.

Why Is This Guidance Important?

With the rise of online pharmacies and remote healthcare services, the need for clear regulations has become paramount. Distance pharmacy services offer convenience and accessibility, but they also bring risks such as the potential for improper medication use, data breaches, and reduced patient engagement. The GPhC’s updated guidance aims to mitigate these risks by ensuring that registered pharmacies uphold their responsibilities, even when services are delivered remotely.

Key Highlights of the Guidance

Here are the primary aspects covered in the GPhC’s guidance:

1. Patient Safety and Care

Pharmacies must prioritize patient safety in all aspects of their operations. This includes ensuring that:

• For higher-risk medicines, the prescriber now cannot base prescribing decisions on the information provided in a questionnaire alone. Instead, the prescriber has to independently verify the information the person provides.
• Patients receive adequate information to use their medicines safely.
• Pharmacists are available to provide advice and address concerns.

2. Verification of Patient Identity

Pharmacies providing distance services must have robust systems to verify the identity of patients. This helps prevent fraudulent activities and ensures that medications are supplied to the correct individuals.

3. Safeguarding and Vulnerable Patients

Pharmacies must take extra care when serving vulnerable patients. This includes:

• Identifying and supporting patients who may be at risk.
• Taking appropriate steps to ensure their safety and access to care.

4. Prescription Legaility

Pharmacies are required to verify the validity and authenticity of prescriptions before dispensing medications. This step is crucial in combating the misuse of online platforms for obtaining prescription medicines.

The guidance goes on to highlight that online pharmacies need to follow the law and guidance on the advertising and promotion of medicines.

5. Data Protection and Privacy

With sensitive patient information being handled electronically, pharmacies must adhere to data protection laws and ensure robust cybersecurity measures are in place.

6. Transparency in Operations

Pharmacies must provide clear and accessible information about their services, including:

• Contact details.
• The process for raising concerns or complaints.
• The identity of the superintendent pharmacist or pharmacy owner.

What Does This Mean for Pharmacies?

Registered pharmacies providing distance services must review their policies and processes to ensure compliance with the GPhC’s updated guidance. Key steps include:

• Training staff on the new requirements.
• Implementing secure systems for patient identity verification and data protection.
• Regularly reviewing practices to identify and mitigate risks.

Final Thoughts

The GPhC’s updated guidance on distance pharmacy services is a significant step toward ensuring the safe and effective delivery of pharmacy services in an increasingly digital world. By prioritizing patient safety, data protection, and operational transparency, the guidance sets a robust framework for the future of remote pharmacy care. However, implementing these changes is often costly and difficult to achieve.

If you would like more information about how to achieve these new standards, get in contact with our distance-selling pharmacy consultant here.

1. Objective Setting:
   • Define the scope and objectives of the penetration test. Focus on systems that store, process, or transmit patient data, including pharmacy management systems, electronic health records, and online prescription services.
2. Compliance Considerations:
   • Ensure the test aligns with NHS and General Pharmaceutical Council (GPhC) guidelines.
   • Understand the requirements of the DSPT and the UK’s General Data Protection Regulation (GDPR).
3. Choosing a Testing Provider:
   • Select a reputable and certified penetration testing provider.
   • Ensure they have experience in healthcare and are aware of the specific needs and regulations of the sector.
4. Pre-Test Preparations:
   • Notify all relevant parties, including staff and possibly the Information Commissioner’s Office (ICO), if required.
   • Back up all systems and ensure that there are contingency plans in place in case of system disruptions.
5. Conducting the Test:
   • Perform the test during off-peak hours to minimize disruption.
   • Include both external (networks, applications, and perimeter defenses) and internal (behind the firewall) aspects.
   • Test for a wide range of threats, including SQL injection, cross-site scripting, and ransomware.
6. Data Handling:
   • Ensure that all data collected during the test is handled securely and in compliance with GDPR.
   • Sensitive data should not leave the premises or be exposed to unauthorized personnel.
7. Post-Test Analysis:
   • Review the test results with the testing provider.
   • Prioritize vulnerabilities based on their potential impact and the likelihood of exploitation.
8. Remediation Plan:
   • Develop a prioritized action plan to address identified vulnerabilities.
   • Consider both technical fixes and changes in processes or staff training.
9. Documentation and Reporting:
   • Document the entire process and results for compliance purposes.
   • Report significant vulnerabilities and incidents to the relevant authorities as required by law.
10. Review and Continuous Improvement:
    • Schedule regular penetration tests (at least annually).
    • Review and update security policies and procedures in light of test findings.

Additional Considerations:

• Staff Awareness and Training: Ensure staff are aware of the test and understand the importance of cybersecurity.
• Legal and Ethical Considerations: The test should be legal, ethical, and not harm patients or their data.
• Budget and Resources: Allocate sufficient budget and resources for both the test and the subsequent remediation actions.

Remember, the specifics of the plan will vary based on the size of the pharmacy, the complexity of its IT systems, and the types of data handled. It’s also important to stay updated with NHS and GPhC guidelines, as they may change over time.

This is the first question the GPhC ask in their GPhC voluntary logo application form. It is of primary importance to them as one of the greatest risks associated with dispensing medicines online is ensuring the Prescription Only Medicine that is dispatched to the patient is received by the patient that needs it.

There have been a few documents considered Best Practices in the UK on this subject, most notably:

• UK Government Good Practice Guide (GPG) 45 – details the different confidence levels (listed below).
• The Royal College of General Practitioners – mainly talks about ID verification online for GP services.
• Patient Online Services in Primary Care – by NHS England details out what is considered Good Practice Guidance on Identity Verification in primary care.

In summary, there are 4 different levels of confidence:

• low confidence
• medium confidence
• high confidence
• very high confidence

If you are a healthcare provider you should be looking to get as close to high confidence as possible, however, this is often weighed against the practicality of the validation process which can take up a lot of the patient’s time and can be frustrating.

Low confidence in someone’s identity

Compared to not doing any identity checks, having low confidence in someone’s identity will lower the risk of you accepting either:

• synthetic identities
• impostors who do not have a relationship with the claimed identity

Medium confidence in someone’s identity

Having medium confidence in someone’s identity will protect you against the same things as low confidence. It will also lower the risk of you accepting impostors who have information about the claimed identity that’s not in the public domain.

For example, it would protect you against someone who works for the claimed identity’s employer’s HR department from using any information they have to impersonate the claimed identity.

High confidence in someone’s identity

Having high confidence in someone’s identity will protect you against the same things as medium confidence. It will also lower the risk of you accepting impostors who:

• know the claimed identity (this includes their close friends or family)
• do not match the claimed identity’s photo or biometric information
• Very high confidence in someone’s identity
• Having very high confidence in someone’s identity will protect you against the same things as high confidence. It will also lower the risk of you accepting impostors who are trying to look like the claimed identity, for example by wearing a mask or make-up.

How to check a patient’s capacity online.

The ethical concept of respecting autonomy and giving informed consent to medical treatment both depend on one’s ability to make their own decisions. Therefore, assessing a person’s capacity to make decisions is a fundamental component of all interactions between a prescriber, dispenser and patient. In the UK, as many interactions online are the first instance that the patient has come across that particular access point to the healthcare system, the only way is to ask the patient directly whether they have capacity. This may be in the form of a statement, such as:

Greetings! Your online consultation is built around the answers to this questionnaire. Please be truthful, and if you have any questions about any of your responses, check with your doctor before utilising the service:

• I am 18 years old or above.
• I am using this service on my own behalf and of my own free will. Any treatment or advice is for my sole use only.

After this initial statement which excludes age capacity and free will a more precise statement should read as follows:

I confirm the above statements are true
We try our best to help our patients, but sometimes our online service is not able to meet all of your needs. If you need help filling out forms, reading, writing or understanding complicated information, or your acne is severely affecting your mood and self-confidence, then please see your GP.

As part of our service, we will need at least two photos which clearly show the acne, so we can give you advice. We may suggest treatments that you can choose to purchase online, or we may refer you back to your GP if we feel treatment online is not the best option for you.

Conclusion

Patient identification mistakes can affect patient care and safety, reimbursement, data sharing, and interoperability, among other things. Worldwide, a variety of patient identification methods, including hybrid models, algorithms, and unique patient identities, have been put into use. However, no patient identification method currently in use has achieved a 100% match rate.

The best way to meet the requirements set out by the different regulators is to use a third party service provider known as a Know your patient (KYP) service provider. This will ensure you meet one of these confidence levels but work towards improving to a higher level. There are a wide range of service providers here is a short list we have found:

• www.veriff.com
• www.onfido.com

Key Points

• Many prescribers are now undertaking duties and procedures that were previously done by doctors.
• If a non-medical prescriber takes on a task that was previously undertaken by a medical practitioner, then their competence to perform that role needs to be at the level of a medical practitioner.
• Prescribers are accountable to the public through criminal law, their patients through civil law, and their employer and their profession through their contract of employment.
• To ensure that they abide by the law, a prescriber needs to keep their knowledge and skill up to date and to work within their competencies.

This article will give a general overview of the English legal system and describe how it operates in England, Wales, and Northern Ireland with respect to medical liability. Additionally, it will look at how the law would see prescribers in relation to their duties as practitioners and assess the legal ramifications for those working in England, Wales, or Northern Ireland.

Online Prescribing in England

There are several tiers to the English legal system, including criminal law and civil law.

• In criminal law, a person is detained by the police and charged with breaching the law. The Crown Prosecution Service brings the case to court, where the person has to be found ‘guilty beyond reasonable doubt’.
  
• In civil law, a person files a lawsuit against another person or business.. The case is heard in a civil court, and the person may be found guilty on a ‘balance of probability‘, rather than absolutely, as is the case in criminal cases. Because no one may be imprisoned in a civil court, it is easier to establish guilt.
  

Accountability

As a non-medical prescriber, you are accountable to:

• The patient, through civil law
• The public, through criminal law
• The profession, through the professional code of conduct.
• Your employer, through your contract of employment.

Accountability to the patient through civil law

A patient may file a civil lawsuit to recover damages if they were harmed or lost something as a result of your activities, especially if they were rendered unable to work.

The plaintiff (patient) would only have to prove on a ‘balance of probability’ that you were to blame. The practitioner’s professional standards would be used to establish liability, in general, there is often clause pertaining to:

You must be confident in your own evaluation of the patient or client before you can write a prescription for them. This assessment must include obtaining a complete history from them and, if at all feasible, viewing their whole clinical file.

Criminal law

• Criminal law is the system for the state punishment of offences.
• Under criminal law, a person can be imprisoned, have sanctions, such as movement restrictions (electronic tags), imposed against them or can incur financial penalties (fines).
• In a criminal case, the Crown usually brings the prosecution, known as the action, against the defendant.
• An individual may bring a private prosecution, but in practice, these are very rare.
• A criminal case is usually referred to as R v Smith, which is the Regina versus Smith.
• Regina is the official title of a reigning Monarch.
• Because the present monarch approved the laws, the person is breaking the laws endorsed by the Queen, hence R v Smith.
• 95% of all criminal cases are tried by a Magistrates’ Court.
• These courts are composed of justices of the peace (JP), who are laymen or women and not lawyers.
• They have limited powers, in as much as they can only give sentences up to 6 months’ imprisonment and/or a £5,000 fine.
• Magistrates try minor criminal offences, such as petty theft and road traffic offences, in a local courtroom.
• In addition, they hear evidence in relation to more serious criminal offences before committing these cases for trial at the Crown Court.
• In the Crown Court, cases are heard by a judge, usually sitting with a jury of 12 laypersons selected at random from the electoral register in the local community.
• Criminal charges in relation to the care of a patient are rare, but when they do arise they attract considerable publicity, such as the prosecution of Dr Harold Shipman in 2000.

Civil law

• In civil law, the action is brought by a person who has suffered harm or loss — known as the plaintiff — against another person or organisation — known as the defendant.
• The plaintiff seeks a remedy, usually in the form of financial compensation (damages). In addition, the plaintiff may claim an ‘injunction’ to stop a particular type of conduct.
• A civil law case is normally referred to as Bloggs v. Smith, and the legal term for a civil wrong is a tort.
• Examples of torts include negligence, trespass (to property, land or person), nuisance, breach of statutory duty and defamation.
• Civil cases, where the claim is for less than £50,000, are tried in a County Court (which is a local court); thus, county courts deal with 75% of all civil litigation.
• A judge will sit alone to settle these cases; however, cases where the claim is over £50,000 are tried in the High Court, and a jury can be called for these.

Public law

• In some situations, a person may want to challenge a decision of a government body, health authority or other public body.
• They may claim that the public body went beyond the powers given to it by statute or that it has wrongly exercised a discretion granted under statute.
• Such claims against public bodies are called ‘judicial reviews’ and the court determines if the public body has acted legally.
• The Royal Brompton Hospital in London is presently seeking a judicial review in an attempt to block the closure of its children’s heart surgery unit as part of plans for major reorganisations of the NHS.

Accountability to the public through criminal law

If you intended to do harm to your patient and knowingly gave them a drug that would cause harm, the police would investigate and could prosecute you for administering a noxious substance so as to endanger life or inflict grievous bodily harm (GBH). The Offences Against the Persons Act 1861 contains two offences of wounding or causing GBH, under Sections 18 and 20. Section 18 is by far the most serious because it carries a maximum sentence of life imprisonment, whereas the maximum sentence under Section 20 is 5 years. The difference is that the prosecution must prove that you intended to cause serious bodily harm under Section 18, whereas they need to only show that you acted recklessly under Section 20.

Under both sections, an assault that causes grievous bodily harm or wounding is defined as follows: ‘To constitute a wound the whole skin must be broken. It must be more than a scratch, but one drop of blood would be sufficient.’ Grievous bodily harm must be ‘really serious harm’, an obvious example of which would be a broken bone. There is no legal definition of grievous bodily harm, however, and it is ‘a question of fact’, for a jury to decide.

Both offences under Section 18 and Section 20 are arrestable under Section 24 of the Police and Criminal Evidence Act 1984. They would be tried at Crown Court because either offence carries the potential for a lengthy jail term.

If it is shown that your carelessness led to the death of your patient, you may be prosecuted for manslaughter. Criminal charges are uncommon but may generate a lot of media attention.

Coroner’s Court

• The coroner must be a barrister, solicitor or registered medical practitioner with at least 5-years standing.
• The main jurisdictions of the coroner are inquests into the death of a person who appears to have died a violent or unnatural death or where death occurred in a prison or psychiatric hospital.
• The purpose of an inquest is to establish the cause of death.
• A coroner may summon a jury of 7–11 people.

You are responsible for your choice to prescribe, and you may only do so in situations when you are adequately informed about the patient’s health and medical background. You would be held accountable if it could be demonstrated that you fell short of the required standard, for example, by failing to determine whether a patient was allergic to penicillin or by prescribing a prescription that interacts negatively with their current treatment.

Accountability to your employer through disciplinary action

Your employer may discipline you if your acts were work-related, especially if you violated your employment contract by failing to follow the right processes and rules.

Accountability to the profession through the professional governing body

Your professional body can remove your name from their register to stop you from practising as a professional if you do not follow their code of conduct. The Council for Healthcare Regulatory Excellence (CHRE) is an independent, non-departmental public body funded by the Department of Health and answerable to Parliament. It scrutinises and oversees the work of nine regulatory bodies, including the NMC, the General Medical Council (GMC), and the Health Professional Council. If the CHRE considers that the decision by a regulatory body has been unduly lenient, it could refer the case to the High Court for a decision.

Professional indemnity insurance

Most professional organisations now insist that practitioners have their own professional indemnity insurance. Whilst employers have vicarious liability for the negligent acts and/ or omissions of their employees, such cover does not normally extend to activities undertaken outside the registrant’s employment. Independent practice would not be covered by vicarious liability. It is the individual registrant’s responsibility to establish their insurance status and take appropriate action.

In situations where an employer does not have vicarious liability, it is recommended that registrants obtain adequate professional indemnity insurance. If unable to secure professional indemnity insurance, a registrant will need to demonstrate that all their clients and patients
are fully informed of this fact and the implications this might have in the event of a claim for professional negligence.

Role expansion

Role expansion is particularly important to prescribers because many are undertaking duties and procedures that were previously done by doctors. In this new role, the prescribers are signing prescriptions, which was a role formerly done by doctors.

Consider the tasks and duties that you undertake. Which of these were previously done by a doctor?

The GMC defines delegation in their Good Medical Practice (GMC, 2006) guide as

‘…asking a colleague to provide treatment or care on your behalf. Although you will not be accountable for the decisions and actions of those to whom you delegate, you will still be responsible for the overall management of the patient, and accountable for your decision to delegate. When you delegate care or treatment, you must be satisfied that the person to whom you delegate has the qualifications, experience, knowledge and skills to provide the care or treatment involved. You must always pass on enough information about the patient and the treatment they need.’

It can, therefore, be argued that the delegating doctor may be negligent if they fail to follow the guidelines listed above. The boundaries between tasks that are undertaken as part of an expanded role and those that follow from delegation are unclear. The law has no mechanism to find a team negligent; rather, it would find particular individuals negligent and usually this is the person in charge.

To bring a successful claim of negligence it is necessary to prove the following:

• The patient (plaintiff) was owed a duty of care by the defendant (prescriber).
• The defendant (prescriber) breached that duty of care by failing to reach the standard required of them by law.
• That the breach caused harm.
• That the harm is of a type that was foreseeable.

Duty of care

The plaintiff (patient) must first establish that the defendant (prescriber) owed him a legal duty of care. In medical negligence, the existence of a duty owed to the patient is usually regarded as automatic, even if the patient has left the hospital. A duty of care appears to be owed as soon as the patient presents for treatment.

This was established by the case Donoghue v Stephenson (1932), in which the House of Lords held, for the first time in this country, that there could be a liability for negligently causing personal injury (Donoghue v Stephenson [1932] AC 562). A decomposing snail was discovered
in a bottle of ginger beer made by the manufacturer, Stephenson, after Mrs Donoghue had drunk some of it.

The basic concept of the law of negligence is: ‘You must take reasonable care to avoid acts or omissions which you can reasonably foresee which would be likely to injure your neighbour. Who then-in-law is my neighbour? The answer seems to be persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts or omissions which are called in question.’
This clearly would show that a duty of care could be established for anyone to whom you issued a prescription.

Breach of standard

The court will have to decide whether a non-medical prescriber or other healthcare professionals or carers have met the standard that the law expects them to meet.
When a non-medical prescriber performs their usual duties, the standard of practice required is that of the ordinary skilled person in his or her speciality. The Bolam test is currently the standard by which the courts in England and Wales assess doctors’ clinical practice (Bolam v Friern Hospital Management Committee [1957] 2 AllER 118; WLR 528). However, the principles of the Bolam test can be applied to examine the actions of any professional person. Similar standards operate in Scotland and Northern Ireland. ‘The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill at the risk of being found negligent…it is sufficient if he exercises the skill of an ordinary competent man exercising that particular art.’

The key words here are professing and exercising.

• Professing is what you say you are — nurse, pharmacist or physiotherapist — and what level you are in your profession.
• Exercising is what you do, i.e. what task were you actually doing?

Doing your job properly is a defence against accusations of negligence. How- ever, if you are performing an expanded role, then the standard is different. The leading case in this area is Wilsher v Essex Area Health Authority (1986) (Wilsher v Essex Area Health Authority [1986] 3 All ER 801). In this case, the plaintiff, Martin Wilsher, was born about 3 months prematurely. He was in a special care baby unit and he was very ill. An inexperienced junior doctor inserted an arterial line into a vein, rather than into an artery. He asked a senior doctor to check the line, but the registrar failed to notice the mistake; furthermore, when the registrar replaced the line himself, hours later, he made the same mistake. The error resulted in a low blood oxygen measurement being recorded, and the infant was given excess oxygen. This caused retrolental fibroplasia, which left Martin Wilsher blind.

A key issue discussed by the Court of Appeal was the standard of legal care to be exercised by the junior doctor in the case. Lord Mustill stated: ‘In a case such as the present, the standard is not just that of the averagely competent and well-informed junior houseman (or whatever the position of the doctor) but of such a person who fills a post in a unit offering a highly specialised service.’
Lord Glidewell stated: ‘In my view, the law requires the trainee or learner to be judged by the same standard as his more experienced colleagues. If it did not, inexperience would frequently be urged as a defence to an action for professional negligence.’ The case was settled for £116,724.40, and the registrar, but not the house officer, was found to be negligent because the junior had done the reasonable thing and asked his superior for supervision. The key point to be taken from the Wilsher case is that a practitioner is liable to be judged by the professional standard of the post that they are holding at the time. This means that, if the practitioner
is performing an expanded role that was previously carried out by a doctor,
the practitioner would be judged by the standard of a reasonably competent doctor performing that role or in that post. If a practitioner undertakes a task for which they have insufficient training, this in itself may constitute negligence.

Of the tasks you undertake that were previously performed by a doctor, do you think you reach the same standard as a doctor? Many new posts have been created, such as transplant clinician’s assistants and cardiac surgeons’ assistants, and many different healthcare professionals can occupy these posts. How would you judge their standard of care?

The courts would have difficulty in assessing the appropriate standard of care for a professional if only one or two posts exist in the country. The court could look at the nature of the tasks performed and determine who normally performs those tasks. If doctors normally undertake these tasks, then a medical standard of care and skill will be expected. Some useful criteria that a court might take into account when determining the standard of care in an expanded role case, could include:

• The nature of the task.
• The way the practitioner ‘holds themself’ to patients.

If the prescriber takes on a task that was previously undertaken by a medical practitioner, then their competence to perform that role needs to be at the level of the medical practitioner. The courts may be looking for the non-medical prescriber to exercise and maintain medical knowledge, and if the non-medical prescriber does not reach the correct standard of competence to do that task, they could be found negligent and in breach of their professional code of conduct.

Inexperience is not a defence to a negligence action. It is very important that prescribers closely adhere to the principles of their professional code of conduct and, in particular, take steps to remedy any deficits in their knowledge. If you are, for example, a physiotherapist performing a task done solely by physiotherapists, and the patient sees you as a physiotherapist and not as another practitioner, you would be judged under the Bolam test. Hence it is important that the patient knows your profession. Alternatively, if the patient had good reason to believe you were a doctor (you were not wearing a uniform or the patient saw you in a GP’s surgery), you might be judged under the standard of care seen in the Wilsher case (i.e. as a doctor).

Causation

The claimant must now demonstrate that the negligent act or omission caused the injury complained of once the duty of care and failure to reach the requisite level of care has been established. The criteria used to determine causality have changed throughout time. If the defendant hadn’t acted or failed to act negligently, would the plaintiff have been injured? That is the first issue the court would require an answer for. This test is known as the “but for” test.

According to civil law, the court must be convinced that the negligent act or omission caused the injury on a balance of probability. It must be demonstrated that there is at least a 50% chance that it was the cause. In complicated medical situations, this is especially challenging.

Foreseeability

Only those harms that are foreseeable can be recovered. In Roe v. Ministry of Health and Others, Woolley v Same (1954), two patients had operations. Before both operations, a spinal anaesthetic consisting of Nupercaine® was administered to the patients by lumbar puncture. The plaintiffs were permanently paralysed from the waist down. The injuries were caused by the Nupercaine® being contaminated by phenol; the ampoules had been immersed in phenol, which had percolated through the glass. Because it was an unforeseeable occurrence, the defendant was not legally expected to anticipate the danger (Roe v Ministry of Health and Others, Woolley v Same [1954] 2 All ER 131).

Lord Denning stated ‘Every surgical operation is attended by risks. We cannot take the benefits without taking the risks. Every advance in technology is also attended by risks. Doctors, like the rest of us, have to learn by experience, and experience often teaches the hard way. Something goes wrong and shows up as a weakness, and then it is put right.

Summary

To bring a successful negligence claim it is necessary to prove the following:

• The plaintiff (patient) was owed a duty of care by the defendant (prescriber).
• The defendant (prescriber) breached that duty of care by failing to reach the standard required of them by law.
• That the breach caused harm.
• That the harm is of a type that was foreseeable.

The defence for a prescriber against negligence is that the prescriber is aware of the standard of care expected for the position they hold and that they have the necessary competencies to maintain that standard of care. To ensure defence, a registered prescriber needs to keep up to date in the knowledge and skills required for the position and work within their competencies. They must also ensure that any deficiencies in their knowledge or skills are corrected before they start prescribing in a particular area.

Many studies have found that people who use psychedelics are more likely to have pro-environmental behavior and ecology beliefs when compared to other people. A recent study by the University of Oregon found that people who took psychedelics were more likely to recycle, donate money to environmental organisations, buy products with less plastic packaging, or use public transportation. The results were not just because of the drugs themselves but also because of the spiritual experiences they create.

Over the last two decades, there has been a gradual political shift, towards a resurgence of psychedelic research, culminating in the first experimental study involving LSD administration in 40 years. First and foremost, many of these new research programs focus on clinical applications of psychedelic substances in the treatment of anxiety and mood disorders. Although oftentimes limited to small sample sizes, preliminary results of these studies indicate that administration of psychedelics can considerably benefit psychotherapeutic interventions, revealing a marked reduction of anxiety in patients who suffer from various life-threatening conditions.

One common experience encountered by many during the neuroplastic state induced by psychedelics is a profound feeling of connectedness or unity—a presumed consequence of a loss of self-awareness or ego-dissolution. This manifests in a sense of connectedness with all living beings, certain plants and animals, or nature as a whole.

References

1.  Manifesting Minds: A Review of Psychedelics in Science, Medicine, Sex, and Spirituality. Doblin, Rick; Brad Burge (2014) North Atlantic Books. ISBN 1583947272.
2. ↑ Lifetime experience with (classic) psychedelics predicts pro-environmental behavior through an increase in nature relatedness. Matthias Forstmann and Christina Sagioglou Journal of Psychopharmacology 2017. DOI: 10.1177/0269881117714049
3. ↑ From Egoism to Ecoism: Psychedelics Increase Nature Relatedness in a State-Mediated and Context-Dependent Manner. Hannes Kettner, Sam Gandy, Eline C. H. M. Haijen and Robin L. Carhart-Harris Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London. International Journal of Environmental Research and Public Health. Published: December 2019 DOI: 10.3390/ijerph16245147

Recently cybersecurity has become a hot topic within the pharmacy sector. As such, as we intend to be responsive to any new emerging threat to pharmacy technological or otherwise we have created a Standard Operating Procedure to manage Pharmacy Cybersecurity.

Standard Operating Procedure for Pharmacy Cybersecurity

Purpose 

To allow for safe and secure transactions over the internet, applying the utmost care to patient safety and data security.

Scope

Our organisation is committed to and is responsible for ensuring the confidentiality, integrity, and availability of the data and information stored on its systems.The main scope of this SOP covers data security of pharmacy systems. 

General Cybersecurity Measures

1. Vulnerability testing.

Before training can be given to staff about data security, management must first understand the key risks to their organisation in respects to cybersecurity. A vulnerability assessment should be produced to evaluate information system vulnerabilities and the management of associated risk. A vulnerability assessment should include the following:

• servers used for internal hosting and supporting Infrastructure
• servers which will be accessed through a reverse proxy
• desktops and workstations
• perimeter network devices exposed to the internet
• all external-facing servers and services
• network appliances, streaming devices and essential IP assets that are internet facing.
• public-facing applications and devices (wifi connected blood pressure machines, weight scales, BMI calculators etc)
• cloud-based services 

2. Ensure that all staff understand the main cybersecurity threats, more specific detail can be seen below.

Either create your own course for your staff or use a reputable provider like Voyager Medical (courses can be found within the hubnet.io). Within a high-quality cybersecurity, course staff will learn about the importance of using two-factor authentication, enabling automatic updates and the use of anti-virus software / ad-blocking browser plugins.

Specific cybersecurity measures

3. Protection from Malware.

• Detection, prevention and recovery controls – supported by user awareness procedures – must be implemented to protect against malware. Key methods to avoid malware include:
  • installing, updating and using software designed to scan, detect, isolate and delete malicious code.
  • preventing unauthorised Users from disabling installed security controls.
  • prohibiting the use of unauthorised software.
  • checking files, email attachments and file downloads for malicious code before use.
  • maintaining business continuity plans to recover from malicious code incidents.
  • maintain a critical incident management plan to identify and respond to malicious code incidents.
  • maintaining a register of specific malicious code countermeasures (e.g. blocked websites, blocked file extensions, blocked network ports) including a description, rationale, approval authority and the date applied.
  • developing user awareness programs for malicious code countermeasures.

4. Limiting Operation Software.

The installation of software on production information systems must be controlled. To protect the general cybersecurity health of the organisation when installing new software responsible persons should ensure:

• updates of production systems are planned, approved, assessed for impacts, tested and logged.
• operations personnel and end-users must be notified of the changes, potential impacts and, if required, given additional training;
• production systems must not contain development code or compilers.
• old software versions must be archived with configuration details and system documentation; and updates to program libraries must be logged.

5. Limiting patient wifi access.

Some pharmacies offer patients free access to their wifi network. The pharmacy should ensure that this wifi network sits separate from the mechanism by which they communicate patient medical records to the central health authority. If the pharmacy offers a separate wifi access point, the password for guest access should be rotated at a minimum of once a month and staff should be trained to spot potential “man in the middle attacks“.

6. Backup.

Backup copies of information, software and system images must be made, secured, and be available for recovery. More specifically:

• Information Owners and System Owners must define and document backup and recovery processes that consider the confidentiality, integrity and availability requirements of information and information systems. Key aspects all processes must address include:
  • use approved encryption;
  • physical security;
  • access controls;
  • methods of transit to and from off-site locations;
  • appropriate environmental conditions while in storage; and
  • off-site locations must be at a sufficient distance to escape damage from an event at the main site.

7. Event logging.

All staff should be appropriately trained to constantly monitor for cybersecurity threats. In the event that an event occurs this should be reported directly to the staff members line manager. This should be done using the hubnet.io error reporting system, an event should be logged and details recorded. This log for every location within an organisation should be monitored by an authorised management team. Once an event has been identified appropriate corrective action should be taken which includes a report which details:

• identification of the event;
• isolation of the event and affected assets;
• identification and isolation of the source;
• corrective action;
• forensic analysis;
• action to prevent recurrence; and
• securing of event logs as evidence

Review Procedure

This SOP will be reviewed in the event that there are any changes to best practice concerning pharmacy cybersecurity or in the event of staff changes. It will also be reviewed in the event of incidents or errors that have been logged. In the absence of any of these events, it will be reviewed yearly from the date of publication.  

Known Risks

• Security gaps.
• Malware.
• Man in the middle attacks.

A Pharmacy Technician could be placed in a hospital, community pharmacy, general practice or care home. Whilst the role of a Pharmacy Technician in each of these settings is similar: reviewing and recording the medication patients should be taking, ensuring sufficient supplies, administering medicines, and educating patients to support their understanding on how to use their medicines safely, some roles may differ depending on where one is are located. In a hospital, for example, they would be involved in the aseptic preparation of medicines, whilst in a community pharmacy, they may offer advice to patients on public health initiatives such as stopping smoking.

Job growth in the sector is expected to increase by 10.7%, leading to 3,737 new jobs by 2027¹.

According to the National Careers Service², the average annual salary of a Pharmacy Technician in the UK starts at £21,892 and can reach £30,615 for experienced Pharmacy Technicians. Taking an average, a mid-career Pharmacy Technician may expect to earn around £26,254. They would work 37 to 40 hours weekly on this salary.

According to another source³, the average salary was reported to be £25,000 annually (around £1710 monthly), which is about £4600 lower (16%) than the national average salary in the UK. A starting average salary is around £19,000 and the highest salaries, for experienced Pharmacy Technicians can exceed £40,000. A mid-career Pharmacy Technician with 4-9 years of experience could earn £23,800, while a Senior Pharmacy Technician with 10-20 years of experience makes, on average, £32,250. Highly experienced Pharmacy Technicians with more than 20 years of expertise earn £35,800 on average. According to this same source, it’s reported that 86% of Pharmacy Technicians are female, and just 18% are male.

Other sources quoted average salaries as £21,259⁴, £26,778⁵, £26,683⁶, £32,573⁷ and £22,855⁸ annually.

Putting this into perspective, here are some related jobs and annual salaries³:

References:

Pharmacy Technician, accessed on 26/07/21 via https://www.healthcareers.nhs.uk/explore-roles/pharmacy/roles-pharmacy/pharmacy-technician

¹ Job group: Pharmaceutical technicians, accessed on 26/07/21 via https://nationalcareers.service.gov.uk/job-groups/3217/pharmacy-technician

The reality of climate change is becoming harder to ignore and pharmacies are often overlooked in being able to make a difference. Below is a list of our Top 10 ways pharmacies can adopt better environmental practice:

1. Conserve energy

Something all businesses can do is use energy-efficient lighting and heating such as automatic light sensors that turn on or off upon entering or leaving a room and manual thermostats to regulate the temperature, especially when your pharmacy closed.

In addition, powering off inactive electronics conserves energy which, ultimately, saves money. Simply unplugging unused devices and using appliances in power-saving mode helps. A great way to do this is to use a WiFi plug which turns on and off on a scheduled basis, setting this up at the beginning of an extension cord and programming it via Google Home (other services are available!) to switch on 10 minutes before opening and off 10 minutes after closing could save you and the planet a packet!

2. Go paperless

An example of paperless success is the NHS Electronic Prescription Service which is predicted to save the NHS £300m by 2021¹ by reducing paper processing and prescribing errors.

Whilst paper receipts are typically made from the lowest quality paper, minimising the production of vast amounts of mostly unnecessary material can be beneficial. Receipts, once printed, are either discarded immediately or clutter one’s wallet. The average paper receipt costs between $0.015 – $0.05² (£0.011 – £0.036) which may not seem monumental, but if a pharmacy prints 100 receipts a day, annually this would cost, on average, $1186.25 (£856.83). E-receipts, which are emails sent to the customer, could be used, this has the added bonus of creating a marketing mailing list if the customer opts in.

Discontinuing payments using paper cheques to both manufacturers and employees by switching to Direct Debits limits paper usage. Making use of this digital incentive, digital timesheets can be used for employees, as opposed to paper.

3. Encourage green logistics

Another thing all businesses can do is encourage ecologically friendlier transportation of goods and staff to and from work. Using battery-powered delivery vehicles can save massively on fuel costs. Encouraging employees to cycle to work by installing a bike rack is also a great idea.

4. Sell eco-friendly products

Selling environmentally friendly products may attract customers and improve your company’s image. Some examples, specific to a pharmacy are:

• Recycled toilet paper,
• Bamboo toothbrushes,
• Toothbrushes with recycled plastic handles,
• Soap bars,
• Eco-friendly cleaning supplies and cosmetics.

Many pharmacies sell other items for instance, reusable bottles and straws, made from metal or silicone, and stationery made from recycled materials.

5. Use recyclable paper bags

Recent data published by the NHS Business Service Authority showed that across the UK, 92,840,309 prescriptions were dispensed in March 2020³. With large numbers of prescriptions being dispensed, using non-recyclable materials would have catastrophic impacts on the environment, therefore pharmacies should endeavour to use recyclable paper bags. For other items, encourage customers to use reusable shopping bags.

6. Order larger bottles

Specific to the pharmaceutical industry, large amounts of packaging waste is generated. Larger bottles of medications can be ordered from manufacturers rather than several smaller bottles to reduce waste. This may only work, however, if the patient is prescribed this amount, else large amounts of waste can still be produced. See 8.

7. Reuse pill containers

Once a pill container is emptied, they are often thrown away or recycled. Alternatively, if a patient requires a repeat prescription, they could bring in their empty pill container and refill this as opposed to using a new container – all that is needed is a new label. For sanitary reasons, the container should only be used for the same patient and same medication. If this is not possible, you can either repurpose the containers or ensure the containers are correctly disposed.

8. Only give patients what they need

One of the biggest issues in the industry is pharmaceutical waste.  If a patient is given an excess of medication, this can lead to disposal problems. Too often, pharmaceuticals are flushed down the toilet where they enter sewage treatment works. As purification isn’t 100% accurate, some quantities of pharmaceuticals can still remain present and enter aquatic ecosystems and drinking water. This can have health and environmental impacts. Some studies have shown concerning effects for small organisms, such as fish which displayed evidence of feminisation⁵ and behavioural changes⁶.  

A factor that exacerbates the problem is poor drug absorptivity in the body. Although the amount varies, between 30 and 90%⁴ of ingredients in pharmaceuticals are excreted unchanged after consumption. Drug redesign, using the ‘benign by design’ approach is a solution being used to combat this, by altering drugs to be better absorbed by the body or more rapidly bio-degrade, thereby making them more environmentally friendly.

Provide patients with the exact amount they require to avoid wastage and clearly label disposal methods on the medication to encourage proper disposal.

9. Educate

Your pharmacy can act as an educating platform, encouraging both employees and patients to become more eco-friendly by teaching them about the impact pharmaceutical waste has on the environment. This will invoke conscious decision making on correct disposal of excess medication and containers. Your pharmacy could display such posters and signs as well as having easily accessible recycling and waste bins.

10. Recycle

Perhaps the simplest of all, but often overlooked, is recycling. Recycling has huge benefits, such as conserving natural resources thereby cutting emissions as there is a lower demand for raw materials, protects ecosystems and saves energy and money.

References

¹ Universal electronic prescriptions could save NHS £300m in next three years, accessed on 06/07/2021 via https://www.nhsbsa.nhs.uk/universal-electronic-prescriptions-could-save-nhs-ps300m-next-three-years

² Everyone wants Digital Receipts, So Why is the Retail Industry Not Adopting It?, accessed on 05/07/2021 via https://hackernoon.com/digital-receipts-in-retail-b415fbdfde3f

³ Press Release: New NHS Data Shows Record 93 Million Prescription Items Dispensed in March, accessed on 05/07/2021 via https://thecca.org.uk/press-release-new-nhs-data-shows-record-93-million-prescription-items-dispensed-in-march/

⁴ Green pharma: the growing demand for environmentally friendly drugs, accessed on 05/07/2021 via https://www.pharmaceutical-technology.com/comment/commentgreen-pharma-the-growing-demand-for-environmentally-friendly-drugs-5937344/

⁵ Assessment of Feminization of Male Fish in English Rivers by the Environment Agency of England and Wales, accessed on 05/07/2021 via https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1874176/

⁶ Dilute Concentrations of a Psychiatric Drug Alter Behavior of Fish from Natural Populations, accessed on 05/07/2021 via https://science.sciencemag.org/content/339/6121/814

How to Make Your Pharmacy Go Green and Wow Patients, accessed on 05/07/2021 via https://www.pbahealth.com/make-pharmacy-go-green-wow-patients/

Sustainable Pharmacies: How to Go Green, accessed on 05/07/2021 via https://alphascrip.com/archives/sustainable-pharmacies-how-to-go-green/