How safe is self-care?

Self-care through self-medication and self-diagnosis was commonplace in many countries even before the COVID pandemic. In the digital and information explosion era, the consumer is the king. And, the COVID pandemic has further led to a heightened number of patients opting to self-medicate with over-the-counter medications (OTC) rather than visit a doctor.

As healthcare literacy increases, patients are taking more control over their treatment. Self-care plays a vital role in healthcare; It is defined as “the independent act of preventing, diagnosing, and treating one’s own illnesses without seeking professional advice.” Self-care includes dietary interventions, dietary supplements, non-prescription or OTC products, home diagnostics, and monitoring and lifestyle modifications.

Change in global market trends – Emergence of mass commodity market for medicines 

Apart from the customer taking the rein of self-care in their hand the other reasons for pushing more and more Prescription Only Medicines (POM) to OTC by the industry, are- shrinkage of the ethical market, innovations of medicines are very difficult and expensive, there are too many medicines and too much competition in the ethical market. 

This is mainly done through acquisitions of other units in the following two ways: (2)

1) By OTC merging with ethical drugs, for example, NOVARTIS has merged the OTC business with GSK Consumer to create the world’s biggest Consumer Health Business. 

2) By medicine merging with consumer products, -for example, Hindustan Unilever Ltd (HUL) has merged with GlaxoSmithKline Consumer Healthcare Limited. Under the deal, HUL will distribute GSK’s commodity drugs like Eno, Crocin, Sensodyne etc. with consumer brands such as Horlicks, Boost, and Maltova.

As a result, more and more POMs are being pushed into the consumer market. In general, the consumer has also benefited from this process, by availing the wider and easier access to formerly POM such as diphenhydramine, ibuprofen, sodium naproxen, cetirizine, loratadine, fexofenadine, nicotine, omeprazole, and lansoprazole etc. (3/6) However, there is a growing concern about the potential harms associated with these medications. Many are driven to be more informed and involved with their healthcare, blurring the divide between patients and professionals.  A few studies and examples reveal how serious the problem is. 

For instance, an extensive study published in 2007, has concluded, “More than 80 ingredients or 700 medications have been changed from POM to OTC status. Although the POM-to-OTC switch has resulted in significant cost savings for consumers ($13 billion dollars) and in Managed Care Organisations (MCOs $20 million dollars), the misuse of medications can cause side effects, hospitalisations, and even death

The blurred line between use, misuse and abuse 

Overuse and improper use – The most commonly used medicines are pain killers, cough and cold anti-allergy and antacids medicines. The poison surveillance database showed that paracetamol-associated overdoses account for about 56,000 emergency room visits and 26,000 hospitalisations yearly. Analysis of national mortality files shows 458 deaths occur each year from paracetamol-associated overdoses; 100 of these are unintentional. near-doubling in the number of fatalities associated with its use from 98 in 1997 to 173 in 2001.

Misuse and drug abuse: Some abuse OTC drugs to self-medicate for mental illnesses like anxiety and depression. Abusing these medications can also give users a euphoric “high” or hallucinations. 

Some commonly abused OTC medications and their misuse include:

Cough medicines (Dextromethorphan, or DXM and Chlorpheniramine Maleate, cough medicines can cause hallucinations. These are popular among young people, as they’re often readily accessible in medicine cabinets at home or on and offline. However they are highly potent hence maximum recommended daily dose of DXM is 120 mg; beyond that, intoxication and dangerous side effects begin to appear. High doses of DXM can cause irregular or slow breathing, blackening out, Muscle twitching, Extreme drowsiness, Heart palpitations, hanging in blood pressure, either too high or too low, elevated body temperature, Vomiting, Rapid heart rate, blurred vision and even brain damage.

Cold medicines containing Pseudoephedrine and antiallergic medicines like Loratidine- These are used to relieve nasal and sinus congestion from colds or allergies and may also relieve congestion. In rare cases, one may abuse pseudoephedrine for hallucinations or an intense “body high.”. Abusing pseudoephedrine can cause irregular heartbeat, shortness of breath, high blood pressure, dizziness and seizures.

Motion sickness pills containing Dimenhydrinate- It is used to treat motion sickness and vertigo. In high doses, the drug can cause hallucinations, ringing in the ears, nausea, irregular heartbeat, seizures, coma and even death. The drug is often abused for its psychedelic properties. The drug is considered a deliriant when taken in high doses (between 200-1200 mg depending on body weight).

OTC drug addiction and tolerance –Recreational OTC user builds a tolerance to the drugs, needing more of the substance to get the previous effects. Those addicted to OTC drugs may also develop withdrawal symptoms when they stop using.

Use during pregnancy- Most medications have not been adequately studied for their safety during pregnancy. One report notes that more than 90 per cent of the medications approved by the FDA from 1980 to 2000 had insufficient data to determine safety in pregnancy. Therefore, it is very important to pay special attention to medications used during pregnancy, especially during the first trimester, which is a crucial time of development for your baby. However, according to the CDC, about two-thirds of women in the U.S. take one or more prescription medications during pregnancy (6/13) 

Extent of use – In India self-medication is not a new thing, its existence can be traced back to centuries. The extent of use in India is almost close to 76 per cent, out of this 71 per cent of the population is from rural India. 

Shortcomings and gaps in the Indian regulation for the OTC Market 

India didn’t have any regulatory policies implemented till 2019 for OTC drugs. The term OTC or non-prescription drugs has no legal recognition in India and all the drugs which are not included in the list of Schedule H, H1, and X are considered to be non – prescription drugs or OTC drugs. Only recently, in August 2019, the decision to have a separate provision for OTC under the Drugs & Cosmetic Act was taken during the meeting of the Drugs Consultative Committee. The CDSCO has now decided to classify OTCs into two categories⁠, OTC-1 and OTC-2⁠—based on the extent of evidence, safety, therapeutic index, and need for accessibility to patients, etc. The aim of shifting POM to OTC as stated by CDSCO is –promoting self-care and reducing the cost of treatment without compromising the safety of the patient. However, there are no strict mechanisms to ensure safe use in place. 

Disconnect between central and state drug authorities

Drug Licensing is the primary responsibility of state drug administration and there is a total absence of a central database of medicines. This leads to the disconnect between the central and states and in two states. For example, the State Government of Delhi announced in 2015, that aspirin which was earlier included in the list of household remedies (Schedule K) should be sold only with a prescription in Delhi. This was because there was an increased number of deaths in dengue patients who bought aspirin OTC (8/16). However, this is not followed in other Indian states

Role of National Pharmacovigilance Authority 

All medicines are invented in a few developed countries, and introduced in the market after studying safety in a limited number of patients. 

However, there are mandatory provisions on drug regulatory and also medical fraternity and also for the public to monitor the use of all new medicines and report all ADRs to the national and international pharmacovigilance agencies WHO pharmacovigilance centre at Uppsala, Sweden is maintaining a global database based on this information from all countries since last three decades.

However, in India, we never bothered to have such mechanisms in place till 2005, when for the first time our pharmacovigilance department was set up under CDSCO. Naturally, there is no data on ADRs specific to the Indian population neither in the case of POM nor for OTC medicines. Under such circumstances, it is not only paradoxical but most unfortunate to say that the use of OTC medicines is safe in India because it is safe in developed countries. It’s high time now that we come out of this illusion of safety and have a separate database on ADRs on OTC medicines under the National Self-Care Strategy. 

Most recent positive efforts by DCGI

With this intention in mind, a first of its kind “event was organised to educate on the importance of reporting ADRs for both POM and OTC medicines by the National Pharmacovigilance Centre at the insistence and under the chairmanship of Dr Raghuwanshi, DCGI, at the Trauma Centre of BHU, Varanasi on 2nd March. Dr Raghuwanshi in his address to the patients gathered at the OPD of Trauma Centre explained in detail the role of patients in reporting ADR. He also informed various attempts being made by his department in this respect and giving examples emphasised how the reporting of ADR by patients and by the public at large is important in developing the database on ADRs in the Indian population. 

During the session where I was also called to talk on this important topic, I tried to emphasise a few burning issues which have remained unattended and which need immediate attention in the use of OTC medicines. After my lecture, I have also written to DCGI and have requested to initiate immediate action in case of the following two classes of medicines (letter emailed on 24, April 2024)

Class 1- OTC medicines – Cough and cold syrups and antihistaminic preparations: Because of their easy availability and addictive effects these medicines are being used uncontrolled and indiscriminately across India. As per a news report by Business Standard: For the past two-and-a-half years, India has had around Rs 5,400-crore cough syrup market and is evaluated to grow with a CAGR of 3.52 per cent over the forecasting years.

Class 2- POM medicines: These medicines are sedatives which induce sleep and are from the antipsychotics class which cause an inability to hold still (akathisia and dyskinesia) 

Because of the effects of these medicines on attention, consumption of these medicines during driving, swimming, operating on machines and similar activities (where attention and alertness are of topmost importance) need to be avoided as slight loss of attention caused by them can result in fatal accidents. However, unaware of these effects and addiction potential the cough and cold preparations are very routinely consumed by lorry drivers across India. This act is not only putting their lives at fatal risk but others’ lives too. 

How to control this improper and misuse? 

The following steps have been suggested to control the risk potential of these medicines: 

1) Issue of driving licences – All the concerned state and national level regional authorities engaged in the issue of driving licences should ask all the persons who have applied for driving licences about their history of consumption of these medicines and also get a certification from the doctor that:

1. A) They have not been prescribed any antipsychotic medicines which cause drowsiness or sedation
2. B) They have been informed that they should not consume the medicines under the above two classes, which cause drowsiness and sedation at least eight hours before driving the vehicle.

2) Issue of licences for swimming pools- The concerned civil and municipal authorities issuing licences to hotels and swimming clubs should make it mandatory to display the boards at all places near swimming pools in hotels and also at other locations like open beaches and riversides, stating boldly that ‘’ Don’t take any medicines at least eight hours prior for going for swimming as some medicines do cause side effects like drowsiness and sedation and because of these side affects you may end up in fatal accidents”

3) Industrial locations- A similar notice as mentioned above should be displayed at all places in industrial locations where operators are deployed to work on machines, doing welding and similar high-risk jobs which require high attention 

4) At all retail medical stores – The licensing authorities should see that all retail pharmacy stores display a board mentioning that-“All  Patients should note that they should not consume medicines causing drowsiness and sedation ( e.g. cough preparations and antipsychotic medicines ) at least 8 hours before driving a vehicle, before going for swimming,  or for working on machines where attention is very important as it may cause fatal accidents “.The Licensing authority should specifically see that the pharmacists educate the patients before dispensing these medicines. 

5) A package insert should be made mandatory mentioning these instructions in regional languages or at least in Hindi, 

6)All such accidental deaths especially of lorry drivers, swimmers and machine operators should be subjected to blood tests during autopsy for the absence of these medicines in blood samples. This will also help in generating real data for such types of accidents 

7) Education and counselling- Regional transport and drug licencing authorities should organise education and awareness campaigns for lorry drivers and the public at large. 

8) In the case of antipsychotic medicines patients’ as well as family’s consciousness and education is the most important thing that will make such patients refrain from driving.

Uncontrolled self-use of medical devices for self-diagnosis

This is another area which also needs immediate attention.Thousands of medical devices are now available for patients to monitor their important health parameters like blood glucose, blood oxygen, blood pressure, heart rate, pulse, etc. Some are also imported from China and also manufactured in India without any proper and strict regulation on their quality standards like mandatory requirements of regular calibration for the assurance of the results. Self-use of such uncalibrated and not having international standards devices patients are putting their life at risk.

Conclusion

The healthcare systems as well as individuals benefit from self-medication; however, there is an urgent need for clear policies by national governments. Because the long-term benefits of many of these medications are still uncertain and need further exploration.

In the absence of proper regulation in place, we can’t expect people to know instinctively when they need to see a doctor and when it would be better to self-care, It is therefore important to know how policymakers ensure self-medication is undertaken safely, and everyone has the necessary tools to know and to treat their minor ailments effectively and safely. Citizens can play an active role in their health, only if there is safety assurance in place by the regulators.

 

References 

1. 1. Chapter 7. Non-prescription and Self-Care- (https://accesspharmacy.mhmedical.com/content.aspx?sectionid=45145842&bookid=684#57472235)
   2. Switching from prescription to over-the-counter medications: a consumer and managed care perspective. Managed Care Interface, 01 Jan 2007, 20(1):42-47-PMID: 17310652) 
   3. As cited in Non-prescription drug safe use regulatory expansion DE Baker – 2013 – journals.sagepub.com Henderson, ML.

• In: Krinsky, DL (ed), Handbook of Non-prescription Drugs: An Interactive Approach to Self-Care. 17th ed. Washington, DC: American Pharmacists Association; 2012:3–16.) 

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