FDA approved vs FDA cleared

Dr KK Aggarwal

(CNET Excerpts): The FDA (DCGI and FSSAI) is responsible for telling us which foods, drugs and medical devices are safe for us to use.

There is a big distinction between a drug or medical device that has been FDA approved and those that are FDA cleared. It's important to understand the difference.

What does the FDA regulate?

·         Prescription drugs for humans and animals

·         Over-the-counter drugs

·         Biologics (e.g. vaccines, blood products, biotechnology products and gene therapy)

·         Dietary supplements (not all are subject to FDA regulation)

·         Medical devices (everything from tongue depressors to pacemakers)

·         Surgical implants

·         Food additives

·         Cosmetics

·         Products that give off radiation (e.g. X-rays, microwave ovens)

·         Nicotine replacement therapy  (NRT) products

·         Infant formula

What does 'FDA approved' mean?

"FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use."

Manufacturers must submit results of clinical testing in order to get approval.

When deciding to approve a product or drug, the FDA has to decide if the benefits outweigh the risks. The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant -- like an artificial heart valve that can save someone's life.

What products need to be FDA approved?

FDA approval is usually mandatory to market or sell products that might have a significant risk of injury or illness, but can also benefit your health -- such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.

The FDA categorizes medical devices into Class III, Class II and Class I. Complex medical devices that are implanted in your body, are life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants.

Lower-risk devices and products used outside of the body, like condoms, motorized wheelchairs and bandages, fall into Class II and Class I. For reference, Apple's ECG app for the Apple Watch is in Class II.

What does 'FDA cleared' mean?

Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.

Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.

The system isn't perfect

The problem with the FDA's approval system is that often companies get their product cleared by using older predicates that were recalled for safety reasons.

FDA does not develop any of the products it evaluates for approval. Nor does it conduct its own testing -- instead, it reviews the results of independent lab and clinical testing to determine if the product, drug or food additive is safe and as effective as it claims to be.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Clinical Practice Guidelines 2019

Approach to uncomplicated recurrent UTIs in women: 10 Key Takeaways

Clinical practice guidelines on the diagnosis and treatment of uncomplicated recurrent urinary tract infections (UTIs) in women were released this year by the American Urological Association (AUA), Canadian Urological Association (CUA), and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) and published online May 1, 2019 in the Journal of Urology. 

Here are 10 key takeaways from the guidelines.

1.     A complete patient history must be elicited along with pelvic examination in women presenting with recurrent UTIs.

2.     Documentation of positive urine cultures associated with prior symptomatic episodes in order to make a diagnosis of recurrent UTI. Repeat urine test if initial urine specimen is suspect for contamination.

3.     Routine cystoscopy and upper tract imaging should be avoided in the index patient (otherwise healthy adult female with an uncomplicated recurrent UTI).

4.     Urine examination, urine culture and sensitivity should be obtained with each episode of symptomatic acute cystitis before starting treatment.

5.     Do not treat asymptomatic bacteriuria in patients.

6.     Use first-line therapy - nitrofurantoin, trimethoprim-sulfamethoxazole (TMP-SMX), fosfomycin - depending on the local antibiogram for the treatment of symptomatic UTIs.

7.     Antibiotics should be prescribed for a short duration as is reasonable; usually no longer than 7 days.

8.     In patients with recurrent UTIs experiencing acute cystitis episodes associated with urine cultures resistant to oral antibiotics, treat with short-term (no longer than 7 days) culture-directed parenteral antibiotics.

9.     On follow up, post-treatment test of cure urinalysis or urine culture in asymptomatic patients is not to be done. But, if symptoms persist, then repeat urine cultures should be obtained to guide further management.

10.  In peri– and post–menopausal women with recurrent UTIs, vaginal estrogen therapy may be used to reduce the risk of future UTIs if there is no contraindication to estrogen therapy

(Source: Anger J, et al. Recurrent uncomplicated urinary tract infections in women: AUA/CUA/SUFU Guideline. J Urol. 2019 May 1:101097JU0000000000000296)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Doctor’s Dilemma

Reproduced from: http://www.indialegallive.com/did-you-know-facts-about-news/perspective-news/attack-on-doctors-doctors-dilemma-67480, Published June 22, 2019

The strike by medical professionals is yet another reminder of the need for a one-time solution in the form of a central act against violence with stringent punishment

By Dr KK Aggarwal

It started as a small protest by doctors at a Kolkata hospital, two of whom were assaulted by a dead patient’s relative. But it did not take long for it to spread into a nationwide movement with government doctors in various states expressing solidarity and resorting to agitations. On June 17, the Indian Medical Association (IMA) staged a 24-hour-long protest across the country, demanding a comprehensive central law to deal with attacks on doctors and healthcare professionals in hospitals. The strike impacted medical services and all non-essential healthcare facilities, including OPDs, were closed from early morning on that day. The IMA also staged a dharna at its headquarters in Delhi.

Mercifully, normalcy was restored later the same day after West Bengal Chief Minister Mamata Banerjee accepted the demands of the protesting doctors. As the strike was called off, the Supreme Court on June 18 did not pass any order on a PIL seeking measures for the safety and security of doctors in hospitals across India and posted it for July.

The IMA has been urging the centre to frame a central law to check violence against medical professionals in hospitals for a long time. This writer was president of the IMA when it submitted to the centre a draft law in this regard. On June 15, the Union health minister, Dr Harsh Vardhan, attached a copy of the draft in his letter to all chief ministers asking them to frame laws for the protection of medical professionals.

This is not the first time that doctors have been assaulted. A 2015 IMA survey found that over 70 percent of them had faced mental torture and/or physical violence in their careers. It polled 1,781 doctors of whom only 37.7 percent said that they were happy with their profession; 82 percent were stressed out; 34.5 percent had high blood pressure; 18.6 percent had diabetes; 61.6 percent had fear of violence during patient visits; 56.5 percent had thought of hiring security at the place of their practice; 31.6 percent never wanted their children to become doctors; for 45.4 percent, the main source of stress was the fear of violence and 75.6 percent faced anxiety attacks.

There are several legal provisions that deal with the violence against doctors and healthcare professionals:

·         Criminal Law: Any assault or attack on doctors, nurses and other staff, as well as clinical establishments, etc, are punishable under the provisions of the Indian Penal Code (IPC), 1860. The provisions can be further placed under:

1.     Criminal conspiracy—Sections 120A and 120B of IPC

2.     Offences disturbing public tranquility—unlawful assembly (Sections 141, 143 and 144 of IPC), rioting (Sections 146, 147 and 148 of IPC), affray (Sections 159 and 160 IPC).

3.     Offences affecting public health, safety, convenience, decency and morals—public nuisance (Sections 268, 269 and 294 of IPC).

4.     Offences affecting human body—hurt (Sections 319, 323 and 324 of IPC); grievous hurt (Sections 320, 325, 326 and 326A of IPC); act endangering life or personal safety of others (Sections 336 337 and 338 of IPC); wrongful restraint (Sections 339 and 341 of IPC); criminal force and assault (Sections 350, 351, 352 and 355 of IPC).

5.     Offences against property—theft (Sections 378 and 379 of IPC); mischief (Sections 425 and 426 of IPC); criminal trespass (Sections 441 and 447 of IPC).

6.     Offence of defamation (Sections 499 and 500 of IPC).

7.     Offences of criminal intimidation, insult and annoyance (Sections 503, 504 and 506 of IPC).

8.     Offences outraging and insulting the modesty of women (Sections 354, 354A, 354B, 354C and 509 of IPC).

In case of the above mentioned offences, the doctors and their staff can lodge a police complaint under Section 154 of the Code of Criminal Procedure and get an FIR registered against the said offender.

·         Civil Law: A civil suit can also be filed by victims on the ground of offences committed as mentioned above. It could be a suit for permanent injunction, for damages or for defamation.

·         Apart from these legal remedies, around 15 states and Union Territories have their respective legislation related to violence against doctors. For example, there is legislation like the Delhi Medicare Service Personnel and Medicare Service Institutions Act, 2008; the Bihar Medical Service Institution and Person Protection Act, 2011, and so on. In all these laws, the accused, once convicted, can be punished with imprisonment which may extend up to three years or fine up to Rs 10,000, or both. The convicted person/s will also have to pay compensation which is twice the price of the damaged property. However, legislation is not effective and doctors and police authorities are hardly aware about the legal provisions.

·         Government doctors have additional protection against violence under IPC Section 186—obstructing a public servant in discharge of public functions which says: “Whoever voluntarily obstructs a public servant in the discharge of his public functions, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to five hundred rupees, or with both.”

An Indian businessman was recently sentenced to life imprisonment for a hijack hoax on a Jet Airways’ domestic flight from Mumbai to Delhi in 2017 that resulted in an emergency landing in Ahmedabad. Birju Kishor Salla, a resident of Mumbai, was arrested and charged for posing a threat to the safety of passengers and crew on board the aircraft. He was also fined Rs 50 million ($720,000), which a special National Investigation Agency (NIA) court ruled would be given as compensation to the crew and passengers. Each pilot will get a compensation of Rs 100,000 out of the fine amount, while each member of the cabin crew will receive Rs 50,000, and each passenger will be paid Rs 25,000 for the “misery” the incident caused, according to a statement released by NIA.

The situation described in the fake hijack incident is the same as when a doctor is beaten by relatives/friends of a patient in a hospital. The safety of all patients in a hospital is at stake. And there may be more number of patients in a hospital than in an aircraft. The doctor’s role and importance is the same as that of a pilot.

The IMA has zero tolerance for patients or their relatives if they indulge in violence. The medical profession demands accountability but not at the cost of violence. A patient doesn’t have any right to attack doctors or indulge in violence at medical establishments. At the same time, doctors should not resort to violence as an answer for assault. They need to follow the principle of humanity. It is paramount for every doctor to be­come a role model in society as far as healthcare is concerned.

So, is strike the answer? In People for Better Treatment (PBT) vs West Bengal Medical Council (WBMC) & Ors on June 14, 2019, the Chief Justice of the Calcutta High Court, Thottathil B Nair Radhakrishnan, and Justice Suvra Ghosh said: “At the outset, let us record that we do not propose to proceed with the matter as an adversarial litigation. However, we need to provide appropriate push with requisite grease to ensure that the ongoing strike by a section of doctors comes to an end through governmental intervention by way of persuasion or otherwise, in accordance with law. We do so because, within the parameters of Article 21 of the Constitution of India, ‘human rights’ as understood in the civilised societies and recognised in the international domain through terms of international conventions, which bind different nations, it is the fundamental requirement that the right to health is given top priority and any need for medical help is immediately extended to any human being even if he is not a citizen.

“Therefore, we take this opportunity to state that resolution of disputes which would have arisen as a consequence of certain unfortunate events even in the hospital is not to be countered by action of eminent and well informed people like doctors by keeping away from their primary and fundamental duty to serve the people.

“Be that as it may, the State Government has also to ensure that the grievance of the doctors, particularly in relation to certain incidents which are alleged to have occurred, are addressed in accordance with law without any delay. We record the submission made by the Learned Advocate General that First Information Report has been lodged and arrests have been made insofar as the alleged incidents in which the doctors are stated to be victims. This means that the State Government has taken efforts to push the machinery in that regard. As a necessary consequence, it is definitely for the doctors to now turn themselves to the reconciliatory mode in the larger interest of the suffering people and answer their oath which they have taken when they became doctors. The great advice given through the Hippocratic Oath ought to lead them to better ways of dealing with the problems which they are faced with. The State Government shall also ensure that adequate protection is provided to the hospitals and place of work of all doctors and also such places where doctors may feel insecure in any circumstances.”

Every time there is a doctors’ strike, courts have to intervene. The solution is a central act with harsh punishment.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

HR/June 19/10: Safer nicotine products - Types of e-cigarettes

Dr KK Aggarwal

Over the last decade, there are other options for ingesting nicotine which are not only less reinforcing than nicotine delivered in a combustible cigarette, but do not involve the high-level release of toxic chemicals.

These have been called safer nicotine products (SNP) in the report No Fire, No Smoke Global State of Tobacco Harm Reduction, 2018 and they break down into three main types: e-cigarettes, heat-not-burn (HNB) devices and an option that is very far from new but enjoying a renaissance: smokeless tobacco, in the form of snus from Sweden.

Types of e-cigarettes

There are now many types of e-cigarette. They range from entry level disposable types, which cannot be customised and are known as ‘closed systems’, through to mechanical modified types, or ‘mods’, which the vaper is able to fully customise and are at the top end of what are known as ‘open systems’. The higher up the device scale you go, the more control the vaper has over the whole vaping experience.

All e-cigarettes have three basic elements; a battery, which heats up a coil or atomiser, turning the flavoured e-liquid or juice into a vapour, which is then inhaled.

E-liquid comprises four ingredients: vegetable glycerine, propylene glycol, nicotine, and flavouring.

Some liquids can contain no nicotine.

Vegetable glycerine (VG) is a thick, naturally sweet liquid that provides the vapour from the liquid.

Propylene glycol (PG) is a thin liquid, which acts as the flavour carrier. Some people are allergic to PG and e-liquid without that ingredient is available.

The VG/PG ratio is the ratio of VG and PG in a liquid.

The higher the VG percentage, the more cloud and the smoother the vape, but there is less flavour.

Higher PG gives less cloud, more ‘throat hit’ and possibly more flavour. Throat hit refers to the feeling a smoker gets when inhaling nicotine. The problem that most smokers switching to vaping report is the fact that they do not feel the same kind of throat hit that they would with a regular cigarette.

The flavourings are the same as used in food and confectionery production and the range of flavours available for vaping runs into the thousands.

(Source: No Fire, No Smoke Global State of Tobacco Harm Reduction, 2018 (2018). London: Knowledge-Action-Change)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Doctors to dispense generic drugs only

As per the minutes of the 56th Meeting of Drugs Consultative Committee held on 1^st JUNE, 2019 at New Delhi, agenda 4, one the proposed amendments has been done in the Drugs and Cosmetic Rules 1945 and medical practitioners will not be able to dispense branded drugs to their patient. The amendment is to prevent misuse of the exemption, which allows them to be out of the schedule H, exemption from procuring a license to dispense the medicine.

“CONSIDERATION OF THE PROPOSAL FOR AMENDMENT OF THE EXEMPTIONS PROVIDED UNDER SCHEDULE K REGARDING SUPPLYING OF MEDICINES BY REGISTERED MEDICAL PRACTITIONERS TO THEIR PATIENTS

DCC was apprised that Registered Medical Practitioners (RMP) can supply different categories of medicines including vaccines to their patients as per the exemption provided with certain conditions under Schedule K of the Drugs and Cosmetics Rules, 1945.

Currently, there is no specific category which can be supplied by RMP to their patients. It is proposed that the following additional conditions may be incorporated under the conditions of exemption to prevent the misuse of the exemption:

1. The Registered Medical Practitioner shall supply generic medicines only.

2. The Registered Medical Practitioners shall supply the ‘Physicians Samples’ at free of cost.

DCC deliberated the proposal and agreed to amend Schedule K of the Drugs and Cosmetics Rules, 1945 to specify the medicines to be supplied by RMP to their patients.”

Appropriate MCI provisions

3.7.1 A physician shall clearly display his fees and other charges on the board of his chamber and/or the hospitals he is visiting. Prescription should also make clear if the Physician himself dispensed any medicine.

6.5 Secret Remedies: The prescribing or dispensing by a physician of secret remedial agents of which he does not know the composition, or the manufacture or promotion of their use is unethical and as such prohibited. All the drugs prescribed by a physician should always carry a proprietary formula and clear name.

6.3 Running an open shop (Dispensing of Drugs and Appliances by Physicians): - A physician should not run an open shop for sale of medicine for dispensing prescriptions prescribed by doctors other than himself or for sale of medical or surgical appliances. It is not unethical for a physician to prescribe or supply drugs, remedies or appliances as long as there is no exploitation of the patient. Drugs prescribed by a physician or brought from the market for a patient should explicitly state the proprietary formulae as well as generic name of the drug.

Drugs and Cosmetic Rules Schedule K(5): Drugs supplied by a registered medical practitioner to his own patient or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale of drugs in India to a degree which render him liable to the provisions of Chapter IV of the Act and the rules thereunder.

All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the following conditions:

5[(1)The drugs shall be purchased only from a dealer or a manufacturer licensed under these rules and records of such purchases showing the names and quantities of such drugs together with their batch numbers and the names and addresses of the manufacturers shall be maintained. Such records shall be open to inspection by an Inspector appointed under the Act, who may, if necessary, make enquiries about purchases of the drugs and may also take samples for test.

(2) In the case of medicine containing a substance specified in 1 [Schedule G, H or X] the following additional conditions shall be complied with]:

(a) the medicine shall be labelled with the name and address of the registered medical practitioner by whom it is supplied;

(b) if the medicine is for external application, it shall be labelled with the words  “For external use only” or if it is for internal use with the dose;

(c) the name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient and the date of supply and the name of the person who gave the prescription shall be entered at the time of supply in register to be maintained for the purpose;

(d) the entry in the register shall be given a number and that number shall be entered on the label of the container;

(e) the register and the prescription, if any, on which the medicines are issued shall be preserved for not less than two years from the date of the last entry in the register or the date of the prescription, as the case may be.

3[(3)The drug will be stored under proper storage conditions as directed on the label.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA