Informed Consent ~ The Maths Don't Add Up

 

Earlier this week I posed the following question on Twitter:

Do time constraints persuade psychiatrists and GPs to prescribe brain pellets?

The question wasn't really posed for those that follow my Twitter account, it was, in the main, directed at the large number of brain pellet prescribers, one of which answered my question with:

"No, just necessity, when necessary."

This got me thinking.

70.3 million prescriptions for brain pellets were dispensed in 2019 (UK). If most of these were repeat prescriptions that's still a substantial amount, especially when the average appointment time with a GP is 9.2 mins.

How do we know the 9.2 minute statistic?

Well, in 2019, the Royal College of GPs announced that "the average length of GP consultations in the UK is 9.2 minutes, one of the lowest amongst economically advanced nations."

Further, they called for GP appointments to last "at least 15 minutes", at the same time condoning the current system as “unfit for purpose”.

Depression Assessment Instruments

*The following is from the American Psychological Association

Many of the instruments described below were used in the studies that served as the evidence base of the systematic reviews that under-gird the guideline recommendations. These instruments include both interview and self-report measures and may be used to screen, diagnose and/or track treatment outcomes. Each instrument has been demonstrated to be valid and reliable, and most are available at no cost.

In viewing the American Psychological Association I wanted to determine how long each assessment takes.

The Beck Depression Inventory (BDI) 

The Beck Depression Inventory (BDI) is widely used to screen for depression and to measure behavioral manifestations and severity of depression. The BDI can be used for ages 13 to 80. The inventory contains 21 self-report items which individuals complete using multiple choice response formats. The BDI takes approximately 10 minutes to complete.

The Center for Epidemiologic Studies Depression Scale (CES-D)

The Center for Epidemiologic Studies Depression Scale (CES-D) was designed for use in the general population and is now used as a screener for depression in primary care settings. The CES-D can be used for children as young as 6 and through older adulthood. It has been tested across gender and cultural populations and maintains consistent validity and reliability. The scale takes about 20 minutes to administer, including scoring.

EQ-5D

EQ-5D is a standardized, non-disease specific instrument for describing and evaluating health-related quality of life. The instrument measures quality of life in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Respondents can complete the questionnaire in under 5 minutes.

Hamilton Depression Rating Scale (HAM-D)

The Hamilton Depression Rating Scale (HAM-D) measures depression in individuals before, during and after treatment. It takes 15 to 20 minutes to complete and score.

One test not mentioned on the American Psychological Association webpage is the PHQ-9 test.

Patient Health Questionnaire (PHQ-9)

The PHQ-9 test is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. It is the 9-question depression scale from the Patient Health Questionnaire (PHQ). The results of the PHQ-9 may be used to make a depression diagnosis according to DSM-IV criteria and takes less than 3 minutes to complete. It's important to note that the Patient Health Questionnaire (PHQ) was underwritten by an educational grant from brain pellet manufacturers, Pfizer US.

Given the average GP appointment is just 9.2 minutes, only two of these assessments (EQ-5D and PHQ-9) could be being used by GPs across the UK. If others were being used then the average appointment time with a UK GP would be much higher than 9.2 minutes.

Informed Consent

Informed Consent is defined as: permission granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits.

I'm going to be using Prozac as an example here. Let's just say a patient takes either the EQ-5D or PHQ-9 assessment.

For the EQ-5D a GP will have approximately 4.2 minutes to relay his/her full knowledge of the possible risks to the patient. With the PHQ-9 the GP will have approximately 6.2 minutes to relay his/her full knowledge of the possible risks to the patient.

Both these figures decrease when we take into account the scenario.

Patient walks into GPs office and is asked, 'How can I help you?' - The patient then explains to the GP how they are feeling and possible reasons, work-related problems, marital problems etc. These then prompt the GP to mentally use either the EQ-5D or PHQ-9 assessment. 

Let's just see the possible risks associated with Prozac use. Remember, a GP, when giving informed consent, must give full knowledge of the possible risks to the patient.

Here is a list of risks associated with Prozac use. One has to bear in mind here that not everyone of these risks are self-explanatory and a GP would need to, if asked, explain what some of them mean. This would further eat into the average of 9.2 minutes.

**Reported Prozac Risks taken from the MHRA website:

Risks

Blood disorders
Cardiac disorders
Congenital disorders
Ear disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
Asthenic conditions
Death and sudden death
Febrile disorders
Feeling abnormal
Feeling jittery
Fibrosis
Gait disturbance
Peripheral swelling
Face oedema
Chest pain
Drug withdrawal syndrome
Hepatic disorders
Immune system disorders
Infections
Exposure during breast feeding
Foetal exposure during pregnancy
Fractures and dislocations
Electrocardiogram QT prolonged
Heart rate increased
Abnormal liver function
Blood sodium decreased
Weight decrease
Weight increase
Blood prolactin increase
Platelet count decrease
Haemoglobin decrease
Blood creatine phosphokinase increase
Blood pressure increase
Blood pressure decrease
Metabolic disorders
Muscle & tissue disorders
Neoplasms
Nervous system disorders
Seizures and seizure disorders
Tremors
Foetal growth complications
Ectopic pregnancy
Foetal death
Abnormal behaviour
Agitation
Anxiety
Nervousness
Aggression
Disinhibition
Homicidal ideation
Hostility
Paranoia
Personality change
Violence-related symptoms
Confusion and disorientation
Delusion
Depression
Depersonalisation/derealisation disorders
Insomnia
Eating disorders
Emotional and mood disturbances
Fluctuating mood symptoms
Impulsive behaviour
Restlessness
Mental disorders
Tearfulness
Apathy
Orgasmic disorders and disturbances
Panic attacks
Nightmares and abnormal dreams
Hallucinations
Personality disorders
Acute psychosis
Psychotic behaviour
Psychotic disorders
Schizophrenia
Libido decrease
Libido increase
Loss of libido
Sleep disorders
Dysphemia
Bruxism
Alcohol abuse
Akathisia
Completed suicide
Intentional self-injury
Suicidal ideation
Thinking abnormal
Tics
Renal & urinary disorders
Reproductive & breast disorders
Respiratory disorders
Skin disorders
Homicide completion
Vascular disorders

As you see there are some rather vaguely named risks that would need further explanation from a GP to their patient.

Two questions:

1. Of the 70.3 million brain pellet prescriptions (2019), how many were handed over with the patient being given full knowledge of the possible risks?

2. Can a mental health 'disorder' be diagnosed and full knowledge of the possible risks of treatment be given in 9.2 minutes and under?

One needs to take into account that the above reported risks were from patients and GPs who took advantage of the MHRA Yellow Card Reporting System. As yet, no drug company has ever released individual patient data from clinical trials.

Food for thought.

Bob Fiddaman

*Hat-Tip: @QuestioningJenn

**Prozac - Benefits Vs Risks - MHRA Correspondence